The Hospitalist

Eli Lilly announced it will halt its ACTIV-3 trial evaluating the antibody bamlanivimab in combination with remdesivir for people hospitalized with COVID-19, after new evidence regarding efficacy emerged.

The new data from the National Institutes of Health suggest that the experimental neutralizing antibody therapy does not offer significant clinical benefit for people with more advanced COVID-19 illness, according to a company statement.

Eli Lilly also announced it plans to continue its other trials evaluating the antibody, including those assessing a potential role in treating people in the earlier stages of COVID-19.

“While there was insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments in hospitalized patients with COVID-19, we remain confident based on data from Lilly’s BLAZE-1 study that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19,” the statement reads.

The ACTIV-3 trial was paused on October 13 after a data and safety monitoring board cited safety concerns.

The most recent data update that triggered an end to the trial did not reveal any significant differences in safety, though.  
 

This article first appeared on Medscape.com.

Eli Lilly announced it will halt its ACTIV-3 trial evaluating the antibody bamlanivimab in combination with remdesivir for people hospitalized with COVID-19, after new evidence regarding efficacy emerged.

The new data from the National Institutes of Health suggest that the experimental neutralizing antibody therapy does not offer significant clinical benefit for people with more advanced COVID-19 illness, according to a company statement.

Eli Lilly also announced it plans to continue its other trials evaluating the antibody, including those assessing a potential role in treating people in the earlier stages of COVID-19.

“While there was insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments in hospitalized patients with COVID-19, we remain confident based on data from Lilly’s BLAZE-1 study that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19,” the statement reads.

The ACTIV-3 trial was paused on October 13 after a data and safety monitoring board cited safety concerns.

The most recent data update that triggered an end to the trial did not reveal any significant differences in safety, though.  
 

This article first appeared on Medscape.com.

Eli Lilly announced it will halt its ACTIV-3 trial evaluating the antibody bamlanivimab in combination with remdesivir for people hospitalized with COVID-19, after new evidence regarding efficacy emerged.

The new data from the National Institutes of Health suggest that the experimental neutralizing antibody therapy does not offer significant clinical benefit for people with more advanced COVID-19 illness, according to a company statement.

Eli Lilly also announced it plans to continue its other trials evaluating the antibody, including those assessing a potential role in treating people in the earlier stages of COVID-19.

“While there was insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments in hospitalized patients with COVID-19, we remain confident based on data from Lilly’s BLAZE-1 study that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19,” the statement reads.

The ACTIV-3 trial was paused on October 13 after a data and safety monitoring board cited safety concerns.

The most recent data update that triggered an end to the trial did not reveal any significant differences in safety, though.  
 

This article first appeared on Medscape.com.

I have had the pleasure of working on the Society of Hospital Medicine’s signature Leadership Academies since 2010, and I enjoy working with hospital medicine leaders from around the country every year. I started as a hospital medicine leader in 2000 and served during the unprecedented growth of the field when it was “the most rapidly growing specialty in the history of medicine.”

Most businesses dream of having a year of double-digit growth; my department grew an average of 15% annually for more than 10 years. These unique experiences have taught me many lessons and afforded me the opportunity to watch many stars of hospital medicine rise, as well as to learn from several less-scrupulous leaders about the darker side of hospital politics.

One of the lessons I learned the hard way about hospital politics is striking the “Authority/Accountability balance” in your career. I shared this perspective at the SHM annual conference in 2018, at speaking engagements on the West Coast, and with my leadership group at the academies. I am sharing it with you because the feedback I have received has been very positive.

The Authority/Accountability balance is a tool for evaluating your current career trajectory and measuring if it is set up for success or failure. The essence is that your Authority and Accountability need to be balanced for you to be successful in your career, regardless of your station. Everybody from the hospitalist fresh out of residency to the CEO needs to have Authority and Accountability in balance to be successful. And as you use the tool to measure your own potential for success or failure, learn to apply it to those who report to you.

I believe the rising tide lifts all boats and the success of your subordinates, through mentoring and support, will add to your success. There is another, more cynical view of subordinates that can be identified using the Authority/Accountability balance, which I will address.
 

Authority

In this construct, “Authority” has a much broader meaning than just the ability to tell people what to do. The ability to tell people what to do is important but not sufficient for success in hospital politics.

Financial resources are essential for a successful Authority/Accountability balance – not only the hardware such as computers, telephones, pagers, and so on, but also clerical support, technical support, and analytic support so that you are getting high-quality data on the performance of the members of your hospital medicine group (HMG). These “soft” resources (clerical, technical, and analytical) are often overlooked as needs that HMG leaders must advocate for; I speak with many HMG leaders who remain under-resourced with “soft” assets. However, being appropriately resourced in these areas can be transformational for a group. Hospitalists don’t like doing clerical work, and if you don’t like a menial job assigned to you, you probably won’t do it very well. Having an unlicensed person dedicated to these clerical activities not only will cost less, but will ensure the job is done better.

Reporting structure is critically important, often overlooked, and historically misaligned in HMGs. When hospital medicine was starting in the late 1990s and early 2000s, rapidly growing hospitalist groups were typically led by young, early-career physicians who had chosen hospital medicine as a career. The problem was that they often lacked the seniority and connections at the executive level to advocate for their HMG. All too often the hospitalist group was tucked in under another department or division which, in turn, reported HMG updates and issues to the board of directors and the CEO.

A common reporting structure in the early days was that a senior member of the medical staff, or group, had once worked in the hospital and therefore “understood” the issues and challenges that the hospitalists were facing. It was up to this physician with seniority and connections to advocate for the hospitalists as they saw fit. The problem was that the hospital landscape was, and is, constantly evolving in innumerable ways. These “once removed” reporting structures for HMGs failed to get the required information on the rapidly changing, and evolving, hospitalist landscape to the desks of executives who had the financial and structural control to address the challenges that the hospitalists in the trenches were facing.

Numerous HMGs failed in the early days of hospital medicine because of this type of misaligned reporting structure. This is a lesson that should not be forgotten: Make sure your HMG leader has a seat at the table where executive decisions are made, including but not limited to the board of directors. To be in balance, you have to be “in the room where it happens.”
 

Accountability

The outcomes that you are responsible for need to be explicit, appropriately resourced with Authority, and clearly spelled out in your job description. Your job description is a document you should know, own, and revisit regularly with whomever you report to, in order to ensure success.

Once you have the Authority side of the equation appropriately resourced, setting outcomes that are a stretch, but still realistic and achievable within the scope of your position, is critical to your success. It is good to think about short-, medium-, and long-term goals, especially if you are in a leadership role. For example, one expectation you will have, regardless of your station, is that you keep up on your email and answer your phone. These are short-term goals that will often be included in your job description. However, taking on a new hospital contract and making sure that it has 24/7 hospitalist coverage, that all the hospitalists are meeting the geometric mean length of stay, and that all the physicians are having 15 encounters per day doesn’t happen immediately. Long-term goals, such as taking on a new hospital contract, are the big-picture stuff that can make or break the career of an HMG leader. Long-term goals also need to be delineated in the job description, along with specific time stamps and the resources you need to accomplish big ticket items – which are spelled out in the Authority side (that is, physician recruiter, secretary, background checks, and so on).

One of the classic misuses of Accountability is the “Fall Guy” scenario. The Fall Guy scenario is often used by cynical hospital and medical group executives to expand their influence while limiting their liability. In the Fall Guy scenario, the executive is surrounded with junior partners who are underpowered with Authority, and then the executive makes decisions for which the junior partners are Accountable. This allows the senior executive to make risky decisions on behalf of the hospital or medical group without the liability of being held accountable when the decision-making process fails. When the risky, and often ill-informed, decision fails, the junior partner who lacked the Authority to make the decision – but held the Accountability for it – becomes the Fall Guy for the failed endeavor. This is a critical outcome that the Authority/Accountability balance can help you avoid, if you use it wisely and properly.

If you find yourself in the Fall Guy position, it is time for a change. The Authority, the Accountability, or both need to change so that they are in better balance. Or your employer needs to change. Changing employers is an outcome worth avoiding, if at all possible. I have scrutinized thousands of resumes in my career, and frequent job changes always wave a red flag to prospective employers. However, changing jobs remains a crucial option if you are being set up for failure when Authority and Accountability are out of balance.

If you are unable to negotiate for the balance that will allow you to be successful with your current group, remember that HMG leaders are a prized commodity and in short supply. Leaving a group that has been your career is hard, but it is better to leave than stay in a position where you are set up for failure as the Fall Guy. Further, the most effective time to expand your Authority is when you are negotiating the terms of a new position. Changing positions is the nuclear option. However, it is better than becoming the Fall Guy, and a change can create opportunities that will accelerate your career and influence, if done right.

When I talk about Authority/Accountability balance, I always counter the Fall Guy with an ignominious historical figure: General George B. McClellan. General McClellan was the commander of the Army of the Potomac during the early years of the American Civil War. General McClellan had the industrial might of the Union north at his beck and call, as well as extraordinary resources for recruiting and retaining soldiers for his army. At every encounter with General Robert E. Lee’s Army of Northern Virginia, General McClellan outnumbered them, sometimes by more than two to one. Yet General McClellan was outfoxed repeatedly for the same reason: He failed to take decisive action.

Every time that McClellan failed, he blamed insufficient resources and told President Lincoln that he needed more troops and more equipment to be successful. In summary, while the Fall Guy scenario needs to be avoided, once you are adequately resourced, success requires taking decisive and strategic action, or you will suffer as did General McClellan. Failing to act when you are appropriately resourced can be just as damaging to your career and credibility as allowing yourself to become the Fall Guy.
 

Job description

Everybody has somebody that they report to, no matter how high up on the executive ladder they have climbed. Even the CEO must report to the board of directors. And that reporting structure usually involves periodic formal reviews. Your formal review is a good time to go over your job description, note what is relevant, remove what is irrelevant, and add new elements that have evolved in importance since your last review.

Job descriptions take many forms, but they always include a list of qualifications. If you have the job, you have the qualifications, so that is not likely to change. You may become more qualified for a higher-level position, but that is an entirely different discussion. I like to think of a well-written job description as including short-term and long-term goals. Short-term goals are usually the daily stuff that keeps operations running smoothly but garners little attention. Examples would include staying current on your emails, answering your phone, organizing meetings, and regularly attending various committees. Even some of these short-term goals can and will change over time. I always enjoyed quality oversight in my department, but as the department and my responsibilities grew, I realized I couldn’t do everything that I wanted to do. I needed to focus on the things only I could do and delegate those things that could be done by someone else, even though I wanted to continue doing them myself. I created a position for a clinical quality officer, and quality oversight moved off of my job description.

Long-term goals are the aspirational items, such as increasing market share, decreasing readmissions, improving patient satisfaction, and the like. Effective leaders are often focused on these aspirational, long-term goals, but they still must effectively execute their short-term goals. Stephen Covey outlines the dilemma with the “time management matrix” in his seminal work “The 7 Habits of Highly Effective People.” An in-depth discussion is beyond the scope of this article, but the time management matrix places tasks into one of four categories based on urgency and importance, and provides strategies for staying up on short-term goals while continually moving long-term goals forward.If you show up at your review with a list of accomplishments as well as an understanding of how the “time management matrix” affects your responsibilities, your boss will be impressed. It is also worth mentioning that Covey’s first habit is “Proactivity.” He uses the term Proactivity in a much more nuanced form than we typically think of, however. Simply put, Proactivity is the opposite of Reactivity, and it is another invaluable tool for success with those long-term goals that will help you make a name for yourself.

When you show up for your review, be it annual, biannual, or other, be prepared. Not only should you bring your job description and recommendations for how it should be adapted in the changing environment, but also bring examples of your accomplishments since the last review.

I talk with leaders frequently who are hardworking and diligent and hate bragging about their achievements; I get that. At the same time, if you don’t inform your superiors about your successes, there is no guarantee that they will hear about them or understand them in the appropriate context. Bragging about how great you are in the physician’s lounge is annoying; telling your boss about your accomplishments since the last review is critical to maintaining the momentum of past accomplishments. If you are not willing to toot your own horn, there is a very good chance that your horn will remain silent. I don’t think self-promotion comes easily to anyone, and it has to be done with a degree of humility and sensitivity; but it has to be done, so prepare for it.
 

Look out for yourself and others

We talk about teamwork and collaboration as hospitalists, and SHM is always underscoring the importance of teamwork and highlighting examples of successful teamwork in its many conferences and publications. Most hospital executives are focused on their own careers, however, and many have no reservations about damaging your career (your brand) if they think it will promote theirs. You have to look out for yourself and size up every leadership position you get into.

Physicians can expect their careers to last decades. The average hospital CEO has a tenure of less than 3.5 years, however, and when a new CEO is hired, almost half of chief financial, chief operating, and chief information officers are fired within 9 months. You may be focused on the long-term success of your organization as you plan your career, but many hospital administrators are interested only in short-term gains. It is similar to some members of Congress who are interested only in what they need to do now to win the next election and not in the long-term needs of the country. You should understand this disconnect when dealing with hospital executives, and how you and your credibility can become cannon fodder in their quest for short-term self-preservation.

You have to look out for and take care of yourself as you promote your group. With a better understanding of the Authority/Accountability balance, you have new tools to assess your chances of success and to advocate for yourself so that you and your group can be successful.

Despite my cynicism toward executives in the medical field, I personally advocate for supporting the career development of those around you and advise against furthering your career at the expense of others. Many unscrupulous executives will use this approach, surrounding themselves with Fall Guys, but my experience shows that this is not a sustainable strategy for success. It can lead to short-term gains, but eventually the piper must be paid. Moreover, the most successful medical executives and leaders that I have encountered have been those who genuinely cared about their subordinates, looked out for them, and selflessly promoted their careers.

In the age of social media, tearing others down seems to be the fastest way to get more “likes.” However, I strongly believe that you can’t build up your group, and our profession, just by tearing people down. Lending a helping hand may bring you less attention in the short term, but such action raises your stature, creates loyalty, and leads to sustainable success for the long run.
 

Dr. McIlraith is the founding chairman of the Hospital Medicine Department at Mercy Medical Group in Sacramento, Calif. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016 and is currently a member of the SHM Practice Management and Awards Committees, as well as the SHM Critical Care Task Force.

Sources

Quinn R. HM Turns 20: A look at the evolution of hospital medicine. The Hospitalist. 2016 August. https://www.the-hospitalist.org/hospitalist/article/121525/hm-turns-20-look-evolution-hospital-medicine

Stephen R. Covey. The 7 Habits of Highly Effective People: Powerful Lessons in Personal Change. Simon & Schuster. 1989.

10 Statistics on CEO Turnover, Recruitment. Becker’s Hospital Review. 2020. https://www.beckershospitalreview.com/hospital-management-administration/10-statistics-on-ceo-turnover-recruitment.html

I have had the pleasure of working on the Society of Hospital Medicine’s signature Leadership Academies since 2010, and I enjoy working with hospital medicine leaders from around the country every year. I started as a hospital medicine leader in 2000 and served during the unprecedented growth of the field when it was “the most rapidly growing specialty in the history of medicine.”

Most businesses dream of having a year of double-digit growth; my department grew an average of 15% annually for more than 10 years. These unique experiences have taught me many lessons and afforded me the opportunity to watch many stars of hospital medicine rise, as well as to learn from several less-scrupulous leaders about the darker side of hospital politics.

One of the lessons I learned the hard way about hospital politics is striking the “Authority/Accountability balance” in your career. I shared this perspective at the SHM annual conference in 2018, at speaking engagements on the West Coast, and with my leadership group at the academies. I am sharing it with you because the feedback I have received has been very positive.

The Authority/Accountability balance is a tool for evaluating your current career trajectory and measuring if it is set up for success or failure. The essence is that your Authority and Accountability need to be balanced for you to be successful in your career, regardless of your station. Everybody from the hospitalist fresh out of residency to the CEO needs to have Authority and Accountability in balance to be successful. And as you use the tool to measure your own potential for success or failure, learn to apply it to those who report to you.

I believe the rising tide lifts all boats and the success of your subordinates, through mentoring and support, will add to your success. There is another, more cynical view of subordinates that can be identified using the Authority/Accountability balance, which I will address.
 

Authority

In this construct, “Authority” has a much broader meaning than just the ability to tell people what to do. The ability to tell people what to do is important but not sufficient for success in hospital politics.

Financial resources are essential for a successful Authority/Accountability balance – not only the hardware such as computers, telephones, pagers, and so on, but also clerical support, technical support, and analytic support so that you are getting high-quality data on the performance of the members of your hospital medicine group (HMG). These “soft” resources (clerical, technical, and analytical) are often overlooked as needs that HMG leaders must advocate for; I speak with many HMG leaders who remain under-resourced with “soft” assets. However, being appropriately resourced in these areas can be transformational for a group. Hospitalists don’t like doing clerical work, and if you don’t like a menial job assigned to you, you probably won’t do it very well. Having an unlicensed person dedicated to these clerical activities not only will cost less, but will ensure the job is done better.

Reporting structure is critically important, often overlooked, and historically misaligned in HMGs. When hospital medicine was starting in the late 1990s and early 2000s, rapidly growing hospitalist groups were typically led by young, early-career physicians who had chosen hospital medicine as a career. The problem was that they often lacked the seniority and connections at the executive level to advocate for their HMG. All too often the hospitalist group was tucked in under another department or division which, in turn, reported HMG updates and issues to the board of directors and the CEO.

A common reporting structure in the early days was that a senior member of the medical staff, or group, had once worked in the hospital and therefore “understood” the issues and challenges that the hospitalists were facing. It was up to this physician with seniority and connections to advocate for the hospitalists as they saw fit. The problem was that the hospital landscape was, and is, constantly evolving in innumerable ways. These “once removed” reporting structures for HMGs failed to get the required information on the rapidly changing, and evolving, hospitalist landscape to the desks of executives who had the financial and structural control to address the challenges that the hospitalists in the trenches were facing.

Numerous HMGs failed in the early days of hospital medicine because of this type of misaligned reporting structure. This is a lesson that should not be forgotten: Make sure your HMG leader has a seat at the table where executive decisions are made, including but not limited to the board of directors. To be in balance, you have to be “in the room where it happens.”
 

Accountability

The outcomes that you are responsible for need to be explicit, appropriately resourced with Authority, and clearly spelled out in your job description. Your job description is a document you should know, own, and revisit regularly with whomever you report to, in order to ensure success.

Once you have the Authority side of the equation appropriately resourced, setting outcomes that are a stretch, but still realistic and achievable within the scope of your position, is critical to your success. It is good to think about short-, medium-, and long-term goals, especially if you are in a leadership role. For example, one expectation you will have, regardless of your station, is that you keep up on your email and answer your phone. These are short-term goals that will often be included in your job description. However, taking on a new hospital contract and making sure that it has 24/7 hospitalist coverage, that all the hospitalists are meeting the geometric mean length of stay, and that all the physicians are having 15 encounters per day doesn’t happen immediately. Long-term goals, such as taking on a new hospital contract, are the big-picture stuff that can make or break the career of an HMG leader. Long-term goals also need to be delineated in the job description, along with specific time stamps and the resources you need to accomplish big ticket items – which are spelled out in the Authority side (that is, physician recruiter, secretary, background checks, and so on).

One of the classic misuses of Accountability is the “Fall Guy” scenario. The Fall Guy scenario is often used by cynical hospital and medical group executives to expand their influence while limiting their liability. In the Fall Guy scenario, the executive is surrounded with junior partners who are underpowered with Authority, and then the executive makes decisions for which the junior partners are Accountable. This allows the senior executive to make risky decisions on behalf of the hospital or medical group without the liability of being held accountable when the decision-making process fails. When the risky, and often ill-informed, decision fails, the junior partner who lacked the Authority to make the decision – but held the Accountability for it – becomes the Fall Guy for the failed endeavor. This is a critical outcome that the Authority/Accountability balance can help you avoid, if you use it wisely and properly.

If you find yourself in the Fall Guy position, it is time for a change. The Authority, the Accountability, or both need to change so that they are in better balance. Or your employer needs to change. Changing employers is an outcome worth avoiding, if at all possible. I have scrutinized thousands of resumes in my career, and frequent job changes always wave a red flag to prospective employers. However, changing jobs remains a crucial option if you are being set up for failure when Authority and Accountability are out of balance.

If you are unable to negotiate for the balance that will allow you to be successful with your current group, remember that HMG leaders are a prized commodity and in short supply. Leaving a group that has been your career is hard, but it is better to leave than stay in a position where you are set up for failure as the Fall Guy. Further, the most effective time to expand your Authority is when you are negotiating the terms of a new position. Changing positions is the nuclear option. However, it is better than becoming the Fall Guy, and a change can create opportunities that will accelerate your career and influence, if done right.

When I talk about Authority/Accountability balance, I always counter the Fall Guy with an ignominious historical figure: General George B. McClellan. General McClellan was the commander of the Army of the Potomac during the early years of the American Civil War. General McClellan had the industrial might of the Union north at his beck and call, as well as extraordinary resources for recruiting and retaining soldiers for his army. At every encounter with General Robert E. Lee’s Army of Northern Virginia, General McClellan outnumbered them, sometimes by more than two to one. Yet General McClellan was outfoxed repeatedly for the same reason: He failed to take decisive action.

Every time that McClellan failed, he blamed insufficient resources and told President Lincoln that he needed more troops and more equipment to be successful. In summary, while the Fall Guy scenario needs to be avoided, once you are adequately resourced, success requires taking decisive and strategic action, or you will suffer as did General McClellan. Failing to act when you are appropriately resourced can be just as damaging to your career and credibility as allowing yourself to become the Fall Guy.
 

Job description

Everybody has somebody that they report to, no matter how high up on the executive ladder they have climbed. Even the CEO must report to the board of directors. And that reporting structure usually involves periodic formal reviews. Your formal review is a good time to go over your job description, note what is relevant, remove what is irrelevant, and add new elements that have evolved in importance since your last review.

Job descriptions take many forms, but they always include a list of qualifications. If you have the job, you have the qualifications, so that is not likely to change. You may become more qualified for a higher-level position, but that is an entirely different discussion. I like to think of a well-written job description as including short-term and long-term goals. Short-term goals are usually the daily stuff that keeps operations running smoothly but garners little attention. Examples would include staying current on your emails, answering your phone, organizing meetings, and regularly attending various committees. Even some of these short-term goals can and will change over time. I always enjoyed quality oversight in my department, but as the department and my responsibilities grew, I realized I couldn’t do everything that I wanted to do. I needed to focus on the things only I could do and delegate those things that could be done by someone else, even though I wanted to continue doing them myself. I created a position for a clinical quality officer, and quality oversight moved off of my job description.

Long-term goals are the aspirational items, such as increasing market share, decreasing readmissions, improving patient satisfaction, and the like. Effective leaders are often focused on these aspirational, long-term goals, but they still must effectively execute their short-term goals. Stephen Covey outlines the dilemma with the “time management matrix” in his seminal work “The 7 Habits of Highly Effective People.” An in-depth discussion is beyond the scope of this article, but the time management matrix places tasks into one of four categories based on urgency and importance, and provides strategies for staying up on short-term goals while continually moving long-term goals forward.If you show up at your review with a list of accomplishments as well as an understanding of how the “time management matrix” affects your responsibilities, your boss will be impressed. It is also worth mentioning that Covey’s first habit is “Proactivity.” He uses the term Proactivity in a much more nuanced form than we typically think of, however. Simply put, Proactivity is the opposite of Reactivity, and it is another invaluable tool for success with those long-term goals that will help you make a name for yourself.

When you show up for your review, be it annual, biannual, or other, be prepared. Not only should you bring your job description and recommendations for how it should be adapted in the changing environment, but also bring examples of your accomplishments since the last review.

I talk with leaders frequently who are hardworking and diligent and hate bragging about their achievements; I get that. At the same time, if you don’t inform your superiors about your successes, there is no guarantee that they will hear about them or understand them in the appropriate context. Bragging about how great you are in the physician’s lounge is annoying; telling your boss about your accomplishments since the last review is critical to maintaining the momentum of past accomplishments. If you are not willing to toot your own horn, there is a very good chance that your horn will remain silent. I don’t think self-promotion comes easily to anyone, and it has to be done with a degree of humility and sensitivity; but it has to be done, so prepare for it.
 

Look out for yourself and others

We talk about teamwork and collaboration as hospitalists, and SHM is always underscoring the importance of teamwork and highlighting examples of successful teamwork in its many conferences and publications. Most hospital executives are focused on their own careers, however, and many have no reservations about damaging your career (your brand) if they think it will promote theirs. You have to look out for yourself and size up every leadership position you get into.

Physicians can expect their careers to last decades. The average hospital CEO has a tenure of less than 3.5 years, however, and when a new CEO is hired, almost half of chief financial, chief operating, and chief information officers are fired within 9 months. You may be focused on the long-term success of your organization as you plan your career, but many hospital administrators are interested only in short-term gains. It is similar to some members of Congress who are interested only in what they need to do now to win the next election and not in the long-term needs of the country. You should understand this disconnect when dealing with hospital executives, and how you and your credibility can become cannon fodder in their quest for short-term self-preservation.

You have to look out for and take care of yourself as you promote your group. With a better understanding of the Authority/Accountability balance, you have new tools to assess your chances of success and to advocate for yourself so that you and your group can be successful.

Despite my cynicism toward executives in the medical field, I personally advocate for supporting the career development of those around you and advise against furthering your career at the expense of others. Many unscrupulous executives will use this approach, surrounding themselves with Fall Guys, but my experience shows that this is not a sustainable strategy for success. It can lead to short-term gains, but eventually the piper must be paid. Moreover, the most successful medical executives and leaders that I have encountered have been those who genuinely cared about their subordinates, looked out for them, and selflessly promoted their careers.

In the age of social media, tearing others down seems to be the fastest way to get more “likes.” However, I strongly believe that you can’t build up your group, and our profession, just by tearing people down. Lending a helping hand may bring you less attention in the short term, but such action raises your stature, creates loyalty, and leads to sustainable success for the long run.
 

Dr. McIlraith is the founding chairman of the Hospital Medicine Department at Mercy Medical Group in Sacramento, Calif. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016 and is currently a member of the SHM Practice Management and Awards Committees, as well as the SHM Critical Care Task Force.

Sources

Quinn R. HM Turns 20: A look at the evolution of hospital medicine. The Hospitalist. 2016 August. https://www.the-hospitalist.org/hospitalist/article/121525/hm-turns-20-look-evolution-hospital-medicine

Stephen R. Covey. The 7 Habits of Highly Effective People: Powerful Lessons in Personal Change. Simon & Schuster. 1989.

10 Statistics on CEO Turnover, Recruitment. Becker’s Hospital Review. 2020. https://www.beckershospitalreview.com/hospital-management-administration/10-statistics-on-ceo-turnover-recruitment.html

I have had the pleasure of working on the Society of Hospital Medicine’s signature Leadership Academies since 2010, and I enjoy working with hospital medicine leaders from around the country every year. I started as a hospital medicine leader in 2000 and served during the unprecedented growth of the field when it was “the most rapidly growing specialty in the history of medicine.”

Most businesses dream of having a year of double-digit growth; my department grew an average of 15% annually for more than 10 years. These unique experiences have taught me many lessons and afforded me the opportunity to watch many stars of hospital medicine rise, as well as to learn from several less-scrupulous leaders about the darker side of hospital politics.

One of the lessons I learned the hard way about hospital politics is striking the “Authority/Accountability balance” in your career. I shared this perspective at the SHM annual conference in 2018, at speaking engagements on the West Coast, and with my leadership group at the academies. I am sharing it with you because the feedback I have received has been very positive.

The Authority/Accountability balance is a tool for evaluating your current career trajectory and measuring if it is set up for success or failure. The essence is that your Authority and Accountability need to be balanced for you to be successful in your career, regardless of your station. Everybody from the hospitalist fresh out of residency to the CEO needs to have Authority and Accountability in balance to be successful. And as you use the tool to measure your own potential for success or failure, learn to apply it to those who report to you.

I believe the rising tide lifts all boats and the success of your subordinates, through mentoring and support, will add to your success. There is another, more cynical view of subordinates that can be identified using the Authority/Accountability balance, which I will address.
 

Authority

In this construct, “Authority” has a much broader meaning than just the ability to tell people what to do. The ability to tell people what to do is important but not sufficient for success in hospital politics.

Financial resources are essential for a successful Authority/Accountability balance – not only the hardware such as computers, telephones, pagers, and so on, but also clerical support, technical support, and analytic support so that you are getting high-quality data on the performance of the members of your hospital medicine group (HMG). These “soft” resources (clerical, technical, and analytical) are often overlooked as needs that HMG leaders must advocate for; I speak with many HMG leaders who remain under-resourced with “soft” assets. However, being appropriately resourced in these areas can be transformational for a group. Hospitalists don’t like doing clerical work, and if you don’t like a menial job assigned to you, you probably won’t do it very well. Having an unlicensed person dedicated to these clerical activities not only will cost less, but will ensure the job is done better.

Reporting structure is critically important, often overlooked, and historically misaligned in HMGs. When hospital medicine was starting in the late 1990s and early 2000s, rapidly growing hospitalist groups were typically led by young, early-career physicians who had chosen hospital medicine as a career. The problem was that they often lacked the seniority and connections at the executive level to advocate for their HMG. All too often the hospitalist group was tucked in under another department or division which, in turn, reported HMG updates and issues to the board of directors and the CEO.

A common reporting structure in the early days was that a senior member of the medical staff, or group, had once worked in the hospital and therefore “understood” the issues and challenges that the hospitalists were facing. It was up to this physician with seniority and connections to advocate for the hospitalists as they saw fit. The problem was that the hospital landscape was, and is, constantly evolving in innumerable ways. These “once removed” reporting structures for HMGs failed to get the required information on the rapidly changing, and evolving, hospitalist landscape to the desks of executives who had the financial and structural control to address the challenges that the hospitalists in the trenches were facing.

Numerous HMGs failed in the early days of hospital medicine because of this type of misaligned reporting structure. This is a lesson that should not be forgotten: Make sure your HMG leader has a seat at the table where executive decisions are made, including but not limited to the board of directors. To be in balance, you have to be “in the room where it happens.”
 

Accountability

The outcomes that you are responsible for need to be explicit, appropriately resourced with Authority, and clearly spelled out in your job description. Your job description is a document you should know, own, and revisit regularly with whomever you report to, in order to ensure success.

Once you have the Authority side of the equation appropriately resourced, setting outcomes that are a stretch, but still realistic and achievable within the scope of your position, is critical to your success. It is good to think about short-, medium-, and long-term goals, especially if you are in a leadership role. For example, one expectation you will have, regardless of your station, is that you keep up on your email and answer your phone. These are short-term goals that will often be included in your job description. However, taking on a new hospital contract and making sure that it has 24/7 hospitalist coverage, that all the hospitalists are meeting the geometric mean length of stay, and that all the physicians are having 15 encounters per day doesn’t happen immediately. Long-term goals, such as taking on a new hospital contract, are the big-picture stuff that can make or break the career of an HMG leader. Long-term goals also need to be delineated in the job description, along with specific time stamps and the resources you need to accomplish big ticket items – which are spelled out in the Authority side (that is, physician recruiter, secretary, background checks, and so on).

One of the classic misuses of Accountability is the “Fall Guy” scenario. The Fall Guy scenario is often used by cynical hospital and medical group executives to expand their influence while limiting their liability. In the Fall Guy scenario, the executive is surrounded with junior partners who are underpowered with Authority, and then the executive makes decisions for which the junior partners are Accountable. This allows the senior executive to make risky decisions on behalf of the hospital or medical group without the liability of being held accountable when the decision-making process fails. When the risky, and often ill-informed, decision fails, the junior partner who lacked the Authority to make the decision – but held the Accountability for it – becomes the Fall Guy for the failed endeavor. This is a critical outcome that the Authority/Accountability balance can help you avoid, if you use it wisely and properly.

If you find yourself in the Fall Guy position, it is time for a change. The Authority, the Accountability, or both need to change so that they are in better balance. Or your employer needs to change. Changing employers is an outcome worth avoiding, if at all possible. I have scrutinized thousands of resumes in my career, and frequent job changes always wave a red flag to prospective employers. However, changing jobs remains a crucial option if you are being set up for failure when Authority and Accountability are out of balance.

If you are unable to negotiate for the balance that will allow you to be successful with your current group, remember that HMG leaders are a prized commodity and in short supply. Leaving a group that has been your career is hard, but it is better to leave than stay in a position where you are set up for failure as the Fall Guy. Further, the most effective time to expand your Authority is when you are negotiating the terms of a new position. Changing positions is the nuclear option. However, it is better than becoming the Fall Guy, and a change can create opportunities that will accelerate your career and influence, if done right.

When I talk about Authority/Accountability balance, I always counter the Fall Guy with an ignominious historical figure: General George B. McClellan. General McClellan was the commander of the Army of the Potomac during the early years of the American Civil War. General McClellan had the industrial might of the Union north at his beck and call, as well as extraordinary resources for recruiting and retaining soldiers for his army. At every encounter with General Robert E. Lee’s Army of Northern Virginia, General McClellan outnumbered them, sometimes by more than two to one. Yet General McClellan was outfoxed repeatedly for the same reason: He failed to take decisive action.

Every time that McClellan failed, he blamed insufficient resources and told President Lincoln that he needed more troops and more equipment to be successful. In summary, while the Fall Guy scenario needs to be avoided, once you are adequately resourced, success requires taking decisive and strategic action, or you will suffer as did General McClellan. Failing to act when you are appropriately resourced can be just as damaging to your career and credibility as allowing yourself to become the Fall Guy.
 

Job description

Everybody has somebody that they report to, no matter how high up on the executive ladder they have climbed. Even the CEO must report to the board of directors. And that reporting structure usually involves periodic formal reviews. Your formal review is a good time to go over your job description, note what is relevant, remove what is irrelevant, and add new elements that have evolved in importance since your last review.

Job descriptions take many forms, but they always include a list of qualifications. If you have the job, you have the qualifications, so that is not likely to change. You may become more qualified for a higher-level position, but that is an entirely different discussion. I like to think of a well-written job description as including short-term and long-term goals. Short-term goals are usually the daily stuff that keeps operations running smoothly but garners little attention. Examples would include staying current on your emails, answering your phone, organizing meetings, and regularly attending various committees. Even some of these short-term goals can and will change over time. I always enjoyed quality oversight in my department, but as the department and my responsibilities grew, I realized I couldn’t do everything that I wanted to do. I needed to focus on the things only I could do and delegate those things that could be done by someone else, even though I wanted to continue doing them myself. I created a position for a clinical quality officer, and quality oversight moved off of my job description.

Long-term goals are the aspirational items, such as increasing market share, decreasing readmissions, improving patient satisfaction, and the like. Effective leaders are often focused on these aspirational, long-term goals, but they still must effectively execute their short-term goals. Stephen Covey outlines the dilemma with the “time management matrix” in his seminal work “The 7 Habits of Highly Effective People.” An in-depth discussion is beyond the scope of this article, but the time management matrix places tasks into one of four categories based on urgency and importance, and provides strategies for staying up on short-term goals while continually moving long-term goals forward.If you show up at your review with a list of accomplishments as well as an understanding of how the “time management matrix” affects your responsibilities, your boss will be impressed. It is also worth mentioning that Covey’s first habit is “Proactivity.” He uses the term Proactivity in a much more nuanced form than we typically think of, however. Simply put, Proactivity is the opposite of Reactivity, and it is another invaluable tool for success with those long-term goals that will help you make a name for yourself.

When you show up for your review, be it annual, biannual, or other, be prepared. Not only should you bring your job description and recommendations for how it should be adapted in the changing environment, but also bring examples of your accomplishments since the last review.

I talk with leaders frequently who are hardworking and diligent and hate bragging about their achievements; I get that. At the same time, if you don’t inform your superiors about your successes, there is no guarantee that they will hear about them or understand them in the appropriate context. Bragging about how great you are in the physician’s lounge is annoying; telling your boss about your accomplishments since the last review is critical to maintaining the momentum of past accomplishments. If you are not willing to toot your own horn, there is a very good chance that your horn will remain silent. I don’t think self-promotion comes easily to anyone, and it has to be done with a degree of humility and sensitivity; but it has to be done, so prepare for it.
 

Look out for yourself and others

We talk about teamwork and collaboration as hospitalists, and SHM is always underscoring the importance of teamwork and highlighting examples of successful teamwork in its many conferences and publications. Most hospital executives are focused on their own careers, however, and many have no reservations about damaging your career (your brand) if they think it will promote theirs. You have to look out for yourself and size up every leadership position you get into.

Physicians can expect their careers to last decades. The average hospital CEO has a tenure of less than 3.5 years, however, and when a new CEO is hired, almost half of chief financial, chief operating, and chief information officers are fired within 9 months. You may be focused on the long-term success of your organization as you plan your career, but many hospital administrators are interested only in short-term gains. It is similar to some members of Congress who are interested only in what they need to do now to win the next election and not in the long-term needs of the country. You should understand this disconnect when dealing with hospital executives, and how you and your credibility can become cannon fodder in their quest for short-term self-preservation.

You have to look out for and take care of yourself as you promote your group. With a better understanding of the Authority/Accountability balance, you have new tools to assess your chances of success and to advocate for yourself so that you and your group can be successful.

Despite my cynicism toward executives in the medical field, I personally advocate for supporting the career development of those around you and advise against furthering your career at the expense of others. Many unscrupulous executives will use this approach, surrounding themselves with Fall Guys, but my experience shows that this is not a sustainable strategy for success. It can lead to short-term gains, but eventually the piper must be paid. Moreover, the most successful medical executives and leaders that I have encountered have been those who genuinely cared about their subordinates, looked out for them, and selflessly promoted their careers.

In the age of social media, tearing others down seems to be the fastest way to get more “likes.” However, I strongly believe that you can’t build up your group, and our profession, just by tearing people down. Lending a helping hand may bring you less attention in the short term, but such action raises your stature, creates loyalty, and leads to sustainable success for the long run.
 

Dr. McIlraith is the founding chairman of the Hospital Medicine Department at Mercy Medical Group in Sacramento, Calif. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016 and is currently a member of the SHM Practice Management and Awards Committees, as well as the SHM Critical Care Task Force.

Sources

Quinn R. HM Turns 20: A look at the evolution of hospital medicine. The Hospitalist. 2016 August. https://www.the-hospitalist.org/hospitalist/article/121525/hm-turns-20-look-evolution-hospital-medicine

Stephen R. Covey. The 7 Habits of Highly Effective People: Powerful Lessons in Personal Change. Simon & Schuster. 1989.

10 Statistics on CEO Turnover, Recruitment. Becker’s Hospital Review. 2020. https://www.beckershospitalreview.com/hospital-management-administration/10-statistics-on-ceo-turnover-recruitment.html

Background: Efforts to reduce and monitor high-risk opioid prescribing have largely focused on outpatient prescribing with less empiric evaluation of inpatient administration. Little is known about the association of inpatient opioid administration and postdischarge opioid use.

This observational study is prone to potential unmeasured confounders negating any clear causation. Rather, hospitalists should be aware of the increasing focus on inpatient opioid administration as it relates to outpatient opioid use, especially in the setting of the current opioid crisis.

Bottom line: Inpatient opioid administration and administration patterns are associated with 90-day postdischarge opioid use in opioid-­naive patients.

Citation: Donohue JM et al. Patterns of opioid administration among opioid-naive inpatients and associations with postdischarge opioid use. Ann Intern Med. 2019 Jun 18:171(2):81-90.

Dr. Ledford is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

Background: Efforts to reduce and monitor high-risk opioid prescribing have largely focused on outpatient prescribing with less empiric evaluation of inpatient administration. Little is known about the association of inpatient opioid administration and postdischarge opioid use.

This observational study is prone to potential unmeasured confounders negating any clear causation. Rather, hospitalists should be aware of the increasing focus on inpatient opioid administration as it relates to outpatient opioid use, especially in the setting of the current opioid crisis.

Bottom line: Inpatient opioid administration and administration patterns are associated with 90-day postdischarge opioid use in opioid-­naive patients.

Citation: Donohue JM et al. Patterns of opioid administration among opioid-naive inpatients and associations with postdischarge opioid use. Ann Intern Med. 2019 Jun 18:171(2):81-90.

Dr. Ledford is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

Background: Efforts to reduce and monitor high-risk opioid prescribing have largely focused on outpatient prescribing with less empiric evaluation of inpatient administration. Little is known about the association of inpatient opioid administration and postdischarge opioid use.

This observational study is prone to potential unmeasured confounders negating any clear causation. Rather, hospitalists should be aware of the increasing focus on inpatient opioid administration as it relates to outpatient opioid use, especially in the setting of the current opioid crisis.

Bottom line: Inpatient opioid administration and administration patterns are associated with 90-day postdischarge opioid use in opioid-­naive patients.

Citation: Donohue JM et al. Patterns of opioid administration among opioid-naive inpatients and associations with postdischarge opioid use. Ann Intern Med. 2019 Jun 18:171(2):81-90.

Dr. Ledford is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

Vertebral fractures appear to be common in people with severe COVID-19, and also raise the mortality risk, findings from a retrospective cohort suggest.

Among 114 patients with COVID-19 who underwent lateral chest x-rays at the San Raffaele Hospital ED in Milan, more than a third were found to have thoracic vertebral fractures. And, those individuals were more than twice as likely to die as were those without vertebral fractures.

“Morphometric vertebral fractures are one of the most common comorbidities among adults hospitalized with COVID-19, and the presence of such fractures may predict the severity of disease outcomes,” lead investigator Andrea Giustina, MD, said in an interview.

This is the first study to examine vertebral fracture prevalence in any coronavirus disease, but such fractures have been linked to an increased risk of pneumonia and impaired respiratory function, including restrictive pulmonary dysfunction. One possible mechanism may be that they cause anatomical changes, such as kyphosis, which negatively impact respiratory function by decreasing vital capacity, forced expiratory volume in 1 second, and inspiratory time, explained Dr. Giustina, professor of endocrinology, San Raffaele Vita Salute University, Milan, and president of the European Society of Endocrinology. The results were published in the Journal of Clinical Endocrinology and Metabolism.

Clinically, the findings suggest that all patients with COVID-19 who are undergoing chest x-rays should have morphometric vertebral x-ray evaluation, said Dr. Giustina.

“One interesting aspect of the study is that without morphometry, approximatively two thirds of vertebral fractures [would have been] missed. Therefore, they are largely underestimated in clinical practice,” he noted.
 

Thoracic vertebral fractures assessed via lateral chest x-rays

The 114 study subjects included were those whose lateral chest x-rays allowed for a high-quality assessment and in which all the thoracic tract of T4-T12 were viewable and assessable. None had been using glucocorticoids and only 3% had a prior diagnosis of osteoporosis.

The majority (75%) were male, and median age was 57 years. Most (79%) were hospitalized after evaluation in the ED. Of those, 12% (13) were admitted to the ICU and 15% (16) died.

Thoracic vertebral fractures were detected on the lateral chest x-rays in 36% (41) of the patients. In contrast, in studies of women aged 50 years and older from the general European population, morphometric vertebral fracture prevalence ranged from 18% to 26%, the investigators noted.

Of the total 65 vertebral fractures detected, 60% were classified as mild (height ratio decrease <25%), 33.3% as moderate (25%-40% decrease) and 7.7% as severe (>40%). Patients with more than one vertebral fracture were classified by their most severe one.

Those with versus without vertebral fractures didn’t differ by sex, body mass index, or clinical or biological parameters evaluated in the ED. But, compared with those without vertebral fractures, those with them were significantly older (68 vs. 54 years) and were more likely to have arterial hypertension (56% vs. 30%) and coronary artery disease (22% vs. 7%).

In multivariate analysis, age was the only statistically significant predictor of vertebral fractures (odds ratio, 1.04; P < .001).

Mortality doubled, though not significantly

Those with vertebral fractures were more likely to be hospitalized, although not significantly (88% vs. 74%). There was no significant difference in ICU admission (11% vs. 12.5%).

However, those with vertebral fractures required noninvasive mechanical ventilation significantly more often (48.8% vs. 27.4%; P = .02), and were more than twice as likely to die (22% vs. 10%; P = .07). While the difference in overall mortality wasn’t quite statistically significant, those with severe vertebral fractures were significantly more likely to die, compared with those with mild or moderate fractures (60%, 7%, 24%, respectively, for severe, moderate, and mild; P = .04), despite no significant differences in clinical or laboratory parameters.

“Our data from the field reinforce the need of implementing previously published recommendations concerning the importance of bone fragility care during the COVID pandemic with at least those patients already treated with antiosteoporotic drugs maintaining their adherence to treatments including vitamin D, which have also been suggested very recently to have no relevant predisposing effect on COVID-19,” Dr. Giustina and colleagues wrote.

Moreover, they added, “continuity of care should also include bone density monitoring despite very restricted access to clinical facilities, during the COVID-19 pandemic. Finally, all patients with fractures should start antiresorptive treatment right away, even during hospital stay.”

The authors reported having no disclosures.

SOURCE: Giustina A et al. J Clin Endocrinol Metab. 2020 Oct 21. doi: 10.1210/clinem/dgaa738.

Vertebral fractures appear to be common in people with severe COVID-19, and also raise the mortality risk, findings from a retrospective cohort suggest.

Among 114 patients with COVID-19 who underwent lateral chest x-rays at the San Raffaele Hospital ED in Milan, more than a third were found to have thoracic vertebral fractures. And, those individuals were more than twice as likely to die as were those without vertebral fractures.

“Morphometric vertebral fractures are one of the most common comorbidities among adults hospitalized with COVID-19, and the presence of such fractures may predict the severity of disease outcomes,” lead investigator Andrea Giustina, MD, said in an interview.

This is the first study to examine vertebral fracture prevalence in any coronavirus disease, but such fractures have been linked to an increased risk of pneumonia and impaired respiratory function, including restrictive pulmonary dysfunction. One possible mechanism may be that they cause anatomical changes, such as kyphosis, which negatively impact respiratory function by decreasing vital capacity, forced expiratory volume in 1 second, and inspiratory time, explained Dr. Giustina, professor of endocrinology, San Raffaele Vita Salute University, Milan, and president of the European Society of Endocrinology. The results were published in the Journal of Clinical Endocrinology and Metabolism.

Clinically, the findings suggest that all patients with COVID-19 who are undergoing chest x-rays should have morphometric vertebral x-ray evaluation, said Dr. Giustina.

“One interesting aspect of the study is that without morphometry, approximatively two thirds of vertebral fractures [would have been] missed. Therefore, they are largely underestimated in clinical practice,” he noted.
 

Thoracic vertebral fractures assessed via lateral chest x-rays

The 114 study subjects included were those whose lateral chest x-rays allowed for a high-quality assessment and in which all the thoracic tract of T4-T12 were viewable and assessable. None had been using glucocorticoids and only 3% had a prior diagnosis of osteoporosis.

The majority (75%) were male, and median age was 57 years. Most (79%) were hospitalized after evaluation in the ED. Of those, 12% (13) were admitted to the ICU and 15% (16) died.

Thoracic vertebral fractures were detected on the lateral chest x-rays in 36% (41) of the patients. In contrast, in studies of women aged 50 years and older from the general European population, morphometric vertebral fracture prevalence ranged from 18% to 26%, the investigators noted.

Of the total 65 vertebral fractures detected, 60% were classified as mild (height ratio decrease <25%), 33.3% as moderate (25%-40% decrease) and 7.7% as severe (>40%). Patients with more than one vertebral fracture were classified by their most severe one.

Those with versus without vertebral fractures didn’t differ by sex, body mass index, or clinical or biological parameters evaluated in the ED. But, compared with those without vertebral fractures, those with them were significantly older (68 vs. 54 years) and were more likely to have arterial hypertension (56% vs. 30%) and coronary artery disease (22% vs. 7%).

In multivariate analysis, age was the only statistically significant predictor of vertebral fractures (odds ratio, 1.04; P < .001).

Mortality doubled, though not significantly

Those with vertebral fractures were more likely to be hospitalized, although not significantly (88% vs. 74%). There was no significant difference in ICU admission (11% vs. 12.5%).

However, those with vertebral fractures required noninvasive mechanical ventilation significantly more often (48.8% vs. 27.4%; P = .02), and were more than twice as likely to die (22% vs. 10%; P = .07). While the difference in overall mortality wasn’t quite statistically significant, those with severe vertebral fractures were significantly more likely to die, compared with those with mild or moderate fractures (60%, 7%, 24%, respectively, for severe, moderate, and mild; P = .04), despite no significant differences in clinical or laboratory parameters.

“Our data from the field reinforce the need of implementing previously published recommendations concerning the importance of bone fragility care during the COVID pandemic with at least those patients already treated with antiosteoporotic drugs maintaining their adherence to treatments including vitamin D, which have also been suggested very recently to have no relevant predisposing effect on COVID-19,” Dr. Giustina and colleagues wrote.

Moreover, they added, “continuity of care should also include bone density monitoring despite very restricted access to clinical facilities, during the COVID-19 pandemic. Finally, all patients with fractures should start antiresorptive treatment right away, even during hospital stay.”

The authors reported having no disclosures.

SOURCE: Giustina A et al. J Clin Endocrinol Metab. 2020 Oct 21. doi: 10.1210/clinem/dgaa738.

Vertebral fractures appear to be common in people with severe COVID-19, and also raise the mortality risk, findings from a retrospective cohort suggest.

Among 114 patients with COVID-19 who underwent lateral chest x-rays at the San Raffaele Hospital ED in Milan, more than a third were found to have thoracic vertebral fractures. And, those individuals were more than twice as likely to die as were those without vertebral fractures.

“Morphometric vertebral fractures are one of the most common comorbidities among adults hospitalized with COVID-19, and the presence of such fractures may predict the severity of disease outcomes,” lead investigator Andrea Giustina, MD, said in an interview.

This is the first study to examine vertebral fracture prevalence in any coronavirus disease, but such fractures have been linked to an increased risk of pneumonia and impaired respiratory function, including restrictive pulmonary dysfunction. One possible mechanism may be that they cause anatomical changes, such as kyphosis, which negatively impact respiratory function by decreasing vital capacity, forced expiratory volume in 1 second, and inspiratory time, explained Dr. Giustina, professor of endocrinology, San Raffaele Vita Salute University, Milan, and president of the European Society of Endocrinology. The results were published in the Journal of Clinical Endocrinology and Metabolism.

Clinically, the findings suggest that all patients with COVID-19 who are undergoing chest x-rays should have morphometric vertebral x-ray evaluation, said Dr. Giustina.

“One interesting aspect of the study is that without morphometry, approximatively two thirds of vertebral fractures [would have been] missed. Therefore, they are largely underestimated in clinical practice,” he noted.
 

Thoracic vertebral fractures assessed via lateral chest x-rays

The 114 study subjects included were those whose lateral chest x-rays allowed for a high-quality assessment and in which all the thoracic tract of T4-T12 were viewable and assessable. None had been using glucocorticoids and only 3% had a prior diagnosis of osteoporosis.

The majority (75%) were male, and median age was 57 years. Most (79%) were hospitalized after evaluation in the ED. Of those, 12% (13) were admitted to the ICU and 15% (16) died.

Thoracic vertebral fractures were detected on the lateral chest x-rays in 36% (41) of the patients. In contrast, in studies of women aged 50 years and older from the general European population, morphometric vertebral fracture prevalence ranged from 18% to 26%, the investigators noted.

Of the total 65 vertebral fractures detected, 60% were classified as mild (height ratio decrease <25%), 33.3% as moderate (25%-40% decrease) and 7.7% as severe (>40%). Patients with more than one vertebral fracture were classified by their most severe one.

Those with versus without vertebral fractures didn’t differ by sex, body mass index, or clinical or biological parameters evaluated in the ED. But, compared with those without vertebral fractures, those with them were significantly older (68 vs. 54 years) and were more likely to have arterial hypertension (56% vs. 30%) and coronary artery disease (22% vs. 7%).

In multivariate analysis, age was the only statistically significant predictor of vertebral fractures (odds ratio, 1.04; P < .001).

Mortality doubled, though not significantly

Those with vertebral fractures were more likely to be hospitalized, although not significantly (88% vs. 74%). There was no significant difference in ICU admission (11% vs. 12.5%).

However, those with vertebral fractures required noninvasive mechanical ventilation significantly more often (48.8% vs. 27.4%; P = .02), and were more than twice as likely to die (22% vs. 10%; P = .07). While the difference in overall mortality wasn’t quite statistically significant, those with severe vertebral fractures were significantly more likely to die, compared with those with mild or moderate fractures (60%, 7%, 24%, respectively, for severe, moderate, and mild; P = .04), despite no significant differences in clinical or laboratory parameters.

“Our data from the field reinforce the need of implementing previously published recommendations concerning the importance of bone fragility care during the COVID pandemic with at least those patients already treated with antiosteoporotic drugs maintaining their adherence to treatments including vitamin D, which have also been suggested very recently to have no relevant predisposing effect on COVID-19,” Dr. Giustina and colleagues wrote.

Moreover, they added, “continuity of care should also include bone density monitoring despite very restricted access to clinical facilities, during the COVID-19 pandemic. Finally, all patients with fractures should start antiresorptive treatment right away, even during hospital stay.”

The authors reported having no disclosures.

SOURCE: Giustina A et al. J Clin Endocrinol Metab. 2020 Oct 21. doi: 10.1210/clinem/dgaa738.

Antibody response to the SARS-CoV-2 virus wanes over time, latest research has suggested.

An ongoing study led by Imperial College London (ICL) found that the proportion of people testing positive for COVID-19 antibodies dropped by 26.5% over a 3-month period between June and September.

The findings from a non–peer reviewed preprint suggested that infection with SARS-CoV-2 confers only limited protection against reinfection.

Professor Paul Elliott, director of the REACT-2 programme at ICL, said: “Testing positive for antibodies does not mean you are immune to COVID-19.

“It remains unclear what level of immunity antibodies provide, or for how long this immunity lasts.”

Experts said that, while the findings suggested that immunity might fade over time, the severity of illness from further infections could be reduced.
 

Antibody prevalence declined in all adults

Results from cross-sectional studies over the 3-month period involved 365,104 adults who self-administered a lateral flow immunoassay test.

There were 17,576 positive tests over the three rounds.

Antibody prevalence, adjusted for test characteristics and weighted to the adult population of England, declined from 6.0% to 4.4%, a reduction of 26.5% over the 3 months.

The decline was seen in all age groups. However, the lowest prevalence of a positive test, and the largest fall, was seen in those aged 75 years and older.

No change was seen in positive antibody tests in health care workers over the 3 months.

The results suggested that people who did not show symptoms of COVID-19 were more likely to lose detectable antibodies sooner than those who did show symptoms.

Prof Helen Ward, one of the lead authors of the report said that, while it was clear that the proportion of people with antibodies was falling over time, “We don’t yet know whether this will leave these people at risk of reinfection with the virus that causes COVID-19, but it is essential that everyone continues to follow guidance to reduce the risk to themselves and others.”
 

Results ‘weaken argument for herd immunity’

Commenting on the results to the Science Media Centre, Rowland Kao, professor of veterinary epidemiology and data science at the University of Edinburgh, warned that, if the results were correct, “any strategy that relies on ‘herd immunity’ lacks credibility.”

However, he added that, “while the decline is substantial, nevertheless substantial proportions of the population do retain some immune response, over 4 months after the peak of the epidemic”.

Eleanor Riley, professor of immunology and infectious disease, also from the University of Edinburgh, said it was too early to assume that immunity to SARS-CoV-2 did not last because “the study does not look at antibody concentrations, antibody function, or other aspects of immunity such as T-cell immunity and does not look at the trajectory of antibody levels in the same individuals over time”.

However, she said the findings did not mean that a vaccine would be ineffective because vaccines contained adjuvants that could induce durable immune responses, particularly with multiple immunizations.

“What is not clear is how quickly antibody levels would rise again if a person encounters the SARS-CoV-2 virus a second time. It is possible they will still rapidly respond, and either have a milder illness, or remain protected through immune memory,” commented Dr. Alexander Edwards, associate professor in biomedical technology at the University of Reading.

Health Minister Lord Bethell said: “Regardless of the result of an antibody test, everyone must continue to comply with government guidelines including social distancing, self-isolating, and getting a test if you have symptoms, and always remember: hands, face, space.”
 

This article first appeared on Medscape.com.

Antibody response to the SARS-CoV-2 virus wanes over time, latest research has suggested.

An ongoing study led by Imperial College London (ICL) found that the proportion of people testing positive for COVID-19 antibodies dropped by 26.5% over a 3-month period between June and September.

The findings from a non–peer reviewed preprint suggested that infection with SARS-CoV-2 confers only limited protection against reinfection.

Professor Paul Elliott, director of the REACT-2 programme at ICL, said: “Testing positive for antibodies does not mean you are immune to COVID-19.

“It remains unclear what level of immunity antibodies provide, or for how long this immunity lasts.”

Experts said that, while the findings suggested that immunity might fade over time, the severity of illness from further infections could be reduced.
 

Antibody prevalence declined in all adults

Results from cross-sectional studies over the 3-month period involved 365,104 adults who self-administered a lateral flow immunoassay test.

There were 17,576 positive tests over the three rounds.

Antibody prevalence, adjusted for test characteristics and weighted to the adult population of England, declined from 6.0% to 4.4%, a reduction of 26.5% over the 3 months.

The decline was seen in all age groups. However, the lowest prevalence of a positive test, and the largest fall, was seen in those aged 75 years and older.

No change was seen in positive antibody tests in health care workers over the 3 months.

The results suggested that people who did not show symptoms of COVID-19 were more likely to lose detectable antibodies sooner than those who did show symptoms.

Prof Helen Ward, one of the lead authors of the report said that, while it was clear that the proportion of people with antibodies was falling over time, “We don’t yet know whether this will leave these people at risk of reinfection with the virus that causes COVID-19, but it is essential that everyone continues to follow guidance to reduce the risk to themselves and others.”
 

Results ‘weaken argument for herd immunity’

Commenting on the results to the Science Media Centre, Rowland Kao, professor of veterinary epidemiology and data science at the University of Edinburgh, warned that, if the results were correct, “any strategy that relies on ‘herd immunity’ lacks credibility.”

However, he added that, “while the decline is substantial, nevertheless substantial proportions of the population do retain some immune response, over 4 months after the peak of the epidemic”.

Eleanor Riley, professor of immunology and infectious disease, also from the University of Edinburgh, said it was too early to assume that immunity to SARS-CoV-2 did not last because “the study does not look at antibody concentrations, antibody function, or other aspects of immunity such as T-cell immunity and does not look at the trajectory of antibody levels in the same individuals over time”.

However, she said the findings did not mean that a vaccine would be ineffective because vaccines contained adjuvants that could induce durable immune responses, particularly with multiple immunizations.

“What is not clear is how quickly antibody levels would rise again if a person encounters the SARS-CoV-2 virus a second time. It is possible they will still rapidly respond, and either have a milder illness, or remain protected through immune memory,” commented Dr. Alexander Edwards, associate professor in biomedical technology at the University of Reading.

Health Minister Lord Bethell said: “Regardless of the result of an antibody test, everyone must continue to comply with government guidelines including social distancing, self-isolating, and getting a test if you have symptoms, and always remember: hands, face, space.”
 

This article first appeared on Medscape.com.

Antibody response to the SARS-CoV-2 virus wanes over time, latest research has suggested.

An ongoing study led by Imperial College London (ICL) found that the proportion of people testing positive for COVID-19 antibodies dropped by 26.5% over a 3-month period between June and September.

The findings from a non–peer reviewed preprint suggested that infection with SARS-CoV-2 confers only limited protection against reinfection.

Professor Paul Elliott, director of the REACT-2 programme at ICL, said: “Testing positive for antibodies does not mean you are immune to COVID-19.

“It remains unclear what level of immunity antibodies provide, or for how long this immunity lasts.”

Experts said that, while the findings suggested that immunity might fade over time, the severity of illness from further infections could be reduced.
 

Antibody prevalence declined in all adults

Results from cross-sectional studies over the 3-month period involved 365,104 adults who self-administered a lateral flow immunoassay test.

There were 17,576 positive tests over the three rounds.

Antibody prevalence, adjusted for test characteristics and weighted to the adult population of England, declined from 6.0% to 4.4%, a reduction of 26.5% over the 3 months.

The decline was seen in all age groups. However, the lowest prevalence of a positive test, and the largest fall, was seen in those aged 75 years and older.

No change was seen in positive antibody tests in health care workers over the 3 months.

The results suggested that people who did not show symptoms of COVID-19 were more likely to lose detectable antibodies sooner than those who did show symptoms.

Prof Helen Ward, one of the lead authors of the report said that, while it was clear that the proportion of people with antibodies was falling over time, “We don’t yet know whether this will leave these people at risk of reinfection with the virus that causes COVID-19, but it is essential that everyone continues to follow guidance to reduce the risk to themselves and others.”
 

Results ‘weaken argument for herd immunity’

Commenting on the results to the Science Media Centre, Rowland Kao, professor of veterinary epidemiology and data science at the University of Edinburgh, warned that, if the results were correct, “any strategy that relies on ‘herd immunity’ lacks credibility.”

However, he added that, “while the decline is substantial, nevertheless substantial proportions of the population do retain some immune response, over 4 months after the peak of the epidemic”.

Eleanor Riley, professor of immunology and infectious disease, also from the University of Edinburgh, said it was too early to assume that immunity to SARS-CoV-2 did not last because “the study does not look at antibody concentrations, antibody function, or other aspects of immunity such as T-cell immunity and does not look at the trajectory of antibody levels in the same individuals over time”.

However, she said the findings did not mean that a vaccine would be ineffective because vaccines contained adjuvants that could induce durable immune responses, particularly with multiple immunizations.

“What is not clear is how quickly antibody levels would rise again if a person encounters the SARS-CoV-2 virus a second time. It is possible they will still rapidly respond, and either have a milder illness, or remain protected through immune memory,” commented Dr. Alexander Edwards, associate professor in biomedical technology at the University of Reading.

Health Minister Lord Bethell said: “Regardless of the result of an antibody test, everyone must continue to comply with government guidelines including social distancing, self-isolating, and getting a test if you have symptoms, and always remember: hands, face, space.”
 

This article first appeared on Medscape.com.

Danny Dvir, MD, has a message for physicians who have patients with severe valvular heart disease who are deferring valve replacement or repair until after the COVID-19 pandemic: Urge them not to wait.

Data from the Multicenter International Valve Disease Registry vividly demonstrate that clinical outcomes are poor in patients with uncorrected valve disease who become hospitalized with COVID-19. Indeed, the mortality rate within 30 days after hospital admission in 136 such patients enrolled in the registry from centers in Europe, North America, and Israel was 42%, Dr. Dvir reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

“That’s dramatically higher than for an age-matched population infected with COVID-19 without valvular heart disease, which is 10%-15%,” he noted at the meeting sponsored by the Cardiovascular Research Foundation.

The bright spot was that, in the small subgroup of 15 registry participants who underwent transcatheter or, much less frequently, surgical treatment of their failing valve while COVID-19 infected, 30-day mortality was far lower. In fact, it was comparable with the background rate in hospitalized COVID-19 patients without valve disease, according to Dr. Dvir, an interventional cardiologist at Shaare Zedek Medical Center, Hebrew University, Jerusalem.

He personally did several of the transcatheter aortic valve replacements.

“It’s doable. I truly believe that when you get a severe aortic stenosis patient who’s infected with the coronavirus, they get very unstable, but we can treat them. We can treat them even during the infection,” Dr. Dvir said.

The majority of patients in the registry had severe aortic stenosis. In the 42 such patients aged 80 years or more who didn’t undergo transcatheter aortic valve replacement (TAVR) or surgical valve replacement, 30-day mortality was 60%. In contrast, only one of the six patients in this advanced-age category who underwent valve replacement while infected died. Similarly, 30-day mortality was 24% among those younger than age 80 who valve remained untreated, but it dropped to 11% in those who received a prosthetic valve.

“We try our best to protect our patients through social distancing, but we have a treatment that can potentially reduce their mortality risk if they get infected later on. So I say to my patients: ‘Don’t wait at home. Do not wait! If you get infected when you have severe aortic stenosis, the clinical outcome is bad.’ But it seems reasonable that if they get infected when they’ve already been treated for their aortic stenosis or mitral regurgitation, they will do better.”

Dr. Dvir noted that, although the case numbers in the registry series were small and subject to potential bias, the data suggest this treatment approach may be lifesaving.

Session comoderator Timothy D. Henry, MD, commented that this registry study contains a great take-home point: “This is really consistent with what see in a lot of the other areas of COVID, that what we know to be best clinical care, we should do it, with or without the COVID.”

He asked Dr. Dvir about any special measures he takes while doing TAVR in this extreme setting. In the United States, for example, interventionalists are increasingly using transesophageal echocardiography to guide their procedures using conscious sedation, without intubation, noted Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research at the Christ Hospital, Cincinnati.

“We try to minimize the procedure time; that’s one of the important things,” Dr. Dvir replied. “And you need to be protected during the procedure in a very cautious and meticulous way. You need many fans in the room because you sweat a lot.”

Discussant Renu Virmani, MD, president of the CVPath Institute in Gaithersburg, Md., commented: “The main thing I get from this presentation is the need for patients to be educated that if you’ve got valve disease, you’re better off getting it treated before you’ve got COVID. Obviously, try to prevent getting COVID – that’s the best thing you can do – but you can’t always control that.”

Discussant Mamas Mamas, MD, professor of cardiology at Keele University, Staffordshire, England, said deferred treatment of severe valvular heart disease during the pandemic has created a looming public health crisis in the United Kingdom.

“We’ve analyzed the U.K. management of aortic stenosis, and what we’ve found is that during the COVID pandemic there have been 2,500 fewer cases of aortic stenosis that have been treated. We’ve got 2,500 patients on the waiting list, and we’ve got to work out how we’re going to treat them. We estimate with simulations that about 300 of them are going to die before we can get them treated for their aortic stenosis,” according to Dr. Mamas.

Dr. Henry commented that deferral of valve procedures is “really challenging” for a couple of reasons: Not only are patients scared to come into the hospital because they fear getting COVID, but they don’t want to be hospitalized during the pandemic because their family can’t visit them there.

“These patients are mostly over 80 years old. No one wants to come in the hospital when the family won’t be around, especially when you’re 90 years old,” the interventional cardiologist said.

Dr. Dvir reported serving as a consultant to Medtronic, Edwards Lifesciences, Abbott, and Jena.

[email protected]

Danny Dvir, MD, has a message for physicians who have patients with severe valvular heart disease who are deferring valve replacement or repair until after the COVID-19 pandemic: Urge them not to wait.

Data from the Multicenter International Valve Disease Registry vividly demonstrate that clinical outcomes are poor in patients with uncorrected valve disease who become hospitalized with COVID-19. Indeed, the mortality rate within 30 days after hospital admission in 136 such patients enrolled in the registry from centers in Europe, North America, and Israel was 42%, Dr. Dvir reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

“That’s dramatically higher than for an age-matched population infected with COVID-19 without valvular heart disease, which is 10%-15%,” he noted at the meeting sponsored by the Cardiovascular Research Foundation.

The bright spot was that, in the small subgroup of 15 registry participants who underwent transcatheter or, much less frequently, surgical treatment of their failing valve while COVID-19 infected, 30-day mortality was far lower. In fact, it was comparable with the background rate in hospitalized COVID-19 patients without valve disease, according to Dr. Dvir, an interventional cardiologist at Shaare Zedek Medical Center, Hebrew University, Jerusalem.

He personally did several of the transcatheter aortic valve replacements.

“It’s doable. I truly believe that when you get a severe aortic stenosis patient who’s infected with the coronavirus, they get very unstable, but we can treat them. We can treat them even during the infection,” Dr. Dvir said.

The majority of patients in the registry had severe aortic stenosis. In the 42 such patients aged 80 years or more who didn’t undergo transcatheter aortic valve replacement (TAVR) or surgical valve replacement, 30-day mortality was 60%. In contrast, only one of the six patients in this advanced-age category who underwent valve replacement while infected died. Similarly, 30-day mortality was 24% among those younger than age 80 who valve remained untreated, but it dropped to 11% in those who received a prosthetic valve.

“We try our best to protect our patients through social distancing, but we have a treatment that can potentially reduce their mortality risk if they get infected later on. So I say to my patients: ‘Don’t wait at home. Do not wait! If you get infected when you have severe aortic stenosis, the clinical outcome is bad.’ But it seems reasonable that if they get infected when they’ve already been treated for their aortic stenosis or mitral regurgitation, they will do better.”

Dr. Dvir noted that, although the case numbers in the registry series were small and subject to potential bias, the data suggest this treatment approach may be lifesaving.

Session comoderator Timothy D. Henry, MD, commented that this registry study contains a great take-home point: “This is really consistent with what see in a lot of the other areas of COVID, that what we know to be best clinical care, we should do it, with or without the COVID.”

He asked Dr. Dvir about any special measures he takes while doing TAVR in this extreme setting. In the United States, for example, interventionalists are increasingly using transesophageal echocardiography to guide their procedures using conscious sedation, without intubation, noted Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research at the Christ Hospital, Cincinnati.

“We try to minimize the procedure time; that’s one of the important things,” Dr. Dvir replied. “And you need to be protected during the procedure in a very cautious and meticulous way. You need many fans in the room because you sweat a lot.”

Discussant Renu Virmani, MD, president of the CVPath Institute in Gaithersburg, Md., commented: “The main thing I get from this presentation is the need for patients to be educated that if you’ve got valve disease, you’re better off getting it treated before you’ve got COVID. Obviously, try to prevent getting COVID – that’s the best thing you can do – but you can’t always control that.”

Discussant Mamas Mamas, MD, professor of cardiology at Keele University, Staffordshire, England, said deferred treatment of severe valvular heart disease during the pandemic has created a looming public health crisis in the United Kingdom.

“We’ve analyzed the U.K. management of aortic stenosis, and what we’ve found is that during the COVID pandemic there have been 2,500 fewer cases of aortic stenosis that have been treated. We’ve got 2,500 patients on the waiting list, and we’ve got to work out how we’re going to treat them. We estimate with simulations that about 300 of them are going to die before we can get them treated for their aortic stenosis,” according to Dr. Mamas.

Dr. Henry commented that deferral of valve procedures is “really challenging” for a couple of reasons: Not only are patients scared to come into the hospital because they fear getting COVID, but they don’t want to be hospitalized during the pandemic because their family can’t visit them there.

“These patients are mostly over 80 years old. No one wants to come in the hospital when the family won’t be around, especially when you’re 90 years old,” the interventional cardiologist said.

Dr. Dvir reported serving as a consultant to Medtronic, Edwards Lifesciences, Abbott, and Jena.

[email protected]

Danny Dvir, MD, has a message for physicians who have patients with severe valvular heart disease who are deferring valve replacement or repair until after the COVID-19 pandemic: Urge them not to wait.

Data from the Multicenter International Valve Disease Registry vividly demonstrate that clinical outcomes are poor in patients with uncorrected valve disease who become hospitalized with COVID-19. Indeed, the mortality rate within 30 days after hospital admission in 136 such patients enrolled in the registry from centers in Europe, North America, and Israel was 42%, Dr. Dvir reported at the Transcatheter Cardiovascular Research Therapeutics virtual annual meeting.

“That’s dramatically higher than for an age-matched population infected with COVID-19 without valvular heart disease, which is 10%-15%,” he noted at the meeting sponsored by the Cardiovascular Research Foundation.

The bright spot was that, in the small subgroup of 15 registry participants who underwent transcatheter or, much less frequently, surgical treatment of their failing valve while COVID-19 infected, 30-day mortality was far lower. In fact, it was comparable with the background rate in hospitalized COVID-19 patients without valve disease, according to Dr. Dvir, an interventional cardiologist at Shaare Zedek Medical Center, Hebrew University, Jerusalem.

He personally did several of the transcatheter aortic valve replacements.

“It’s doable. I truly believe that when you get a severe aortic stenosis patient who’s infected with the coronavirus, they get very unstable, but we can treat them. We can treat them even during the infection,” Dr. Dvir said.

The majority of patients in the registry had severe aortic stenosis. In the 42 such patients aged 80 years or more who didn’t undergo transcatheter aortic valve replacement (TAVR) or surgical valve replacement, 30-day mortality was 60%. In contrast, only one of the six patients in this advanced-age category who underwent valve replacement while infected died. Similarly, 30-day mortality was 24% among those younger than age 80 who valve remained untreated, but it dropped to 11% in those who received a prosthetic valve.

“We try our best to protect our patients through social distancing, but we have a treatment that can potentially reduce their mortality risk if they get infected later on. So I say to my patients: ‘Don’t wait at home. Do not wait! If you get infected when you have severe aortic stenosis, the clinical outcome is bad.’ But it seems reasonable that if they get infected when they’ve already been treated for their aortic stenosis or mitral regurgitation, they will do better.”

Dr. Dvir noted that, although the case numbers in the registry series were small and subject to potential bias, the data suggest this treatment approach may be lifesaving.

Session comoderator Timothy D. Henry, MD, commented that this registry study contains a great take-home point: “This is really consistent with what see in a lot of the other areas of COVID, that what we know to be best clinical care, we should do it, with or without the COVID.”

He asked Dr. Dvir about any special measures he takes while doing TAVR in this extreme setting. In the United States, for example, interventionalists are increasingly using transesophageal echocardiography to guide their procedures using conscious sedation, without intubation, noted Dr. Henry, medical director of the Carl and Edyth Lindner Center for Research at the Christ Hospital, Cincinnati.

“We try to minimize the procedure time; that’s one of the important things,” Dr. Dvir replied. “And you need to be protected during the procedure in a very cautious and meticulous way. You need many fans in the room because you sweat a lot.”

Discussant Renu Virmani, MD, president of the CVPath Institute in Gaithersburg, Md., commented: “The main thing I get from this presentation is the need for patients to be educated that if you’ve got valve disease, you’re better off getting it treated before you’ve got COVID. Obviously, try to prevent getting COVID – that’s the best thing you can do – but you can’t always control that.”

Discussant Mamas Mamas, MD, professor of cardiology at Keele University, Staffordshire, England, said deferred treatment of severe valvular heart disease during the pandemic has created a looming public health crisis in the United Kingdom.

“We’ve analyzed the U.K. management of aortic stenosis, and what we’ve found is that during the COVID pandemic there have been 2,500 fewer cases of aortic stenosis that have been treated. We’ve got 2,500 patients on the waiting list, and we’ve got to work out how we’re going to treat them. We estimate with simulations that about 300 of them are going to die before we can get them treated for their aortic stenosis,” according to Dr. Mamas.

Dr. Henry commented that deferral of valve procedures is “really challenging” for a couple of reasons: Not only are patients scared to come into the hospital because they fear getting COVID, but they don’t want to be hospitalized during the pandemic because their family can’t visit them there.

“These patients are mostly over 80 years old. No one wants to come in the hospital when the family won’t be around, especially when you’re 90 years old,” the interventional cardiologist said.

Dr. Dvir reported serving as a consultant to Medtronic, Edwards Lifesciences, Abbott, and Jena.

[email protected]

Background: PPI use has previously been associated with an increased risk of acute kidney injury, Clostridium difficile infection, osteoporosis, dementia, and all-cause mortality. An estimation of the level of mortality risk, as well as cause-specific mortality risk, may better inform decisions about prescribing PPIs.

Limitations include the observational study design and potential for confounding variables not accounted for by the researchers. There is also a question of broader applicability given the VA patient population. Nevertheless, this study adds to growing evidence regarding risks associated with PPI use. Clinicians should consider prescribing PPIs only for indications and durations where it is known to offer benefit in order minimize risk of adverse events.

Bottom line: PPI use is associated with an excess risk of death, particularly death caused by cardiovascular disease, malignancy, genitourinary diseases, and infection.

CITATION: Xie Y et al. Estimates of all-cause mortality and cause specific mortality associated with proton pump inhibitors among US veterans: Cohort study. BMJ. 2019 May 29;365:l1580.

Dr. Kruse is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

Background: PPI use has previously been associated with an increased risk of acute kidney injury, Clostridium difficile infection, osteoporosis, dementia, and all-cause mortality. An estimation of the level of mortality risk, as well as cause-specific mortality risk, may better inform decisions about prescribing PPIs.

Limitations include the observational study design and potential for confounding variables not accounted for by the researchers. There is also a question of broader applicability given the VA patient population. Nevertheless, this study adds to growing evidence regarding risks associated with PPI use. Clinicians should consider prescribing PPIs only for indications and durations where it is known to offer benefit in order minimize risk of adverse events.

Bottom line: PPI use is associated with an excess risk of death, particularly death caused by cardiovascular disease, malignancy, genitourinary diseases, and infection.

CITATION: Xie Y et al. Estimates of all-cause mortality and cause specific mortality associated with proton pump inhibitors among US veterans: Cohort study. BMJ. 2019 May 29;365:l1580.

Dr. Kruse is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

Background: PPI use has previously been associated with an increased risk of acute kidney injury, Clostridium difficile infection, osteoporosis, dementia, and all-cause mortality. An estimation of the level of mortality risk, as well as cause-specific mortality risk, may better inform decisions about prescribing PPIs.

Limitations include the observational study design and potential for confounding variables not accounted for by the researchers. There is also a question of broader applicability given the VA patient population. Nevertheless, this study adds to growing evidence regarding risks associated with PPI use. Clinicians should consider prescribing PPIs only for indications and durations where it is known to offer benefit in order minimize risk of adverse events.

Bottom line: PPI use is associated with an excess risk of death, particularly death caused by cardiovascular disease, malignancy, genitourinary diseases, and infection.

CITATION: Xie Y et al. Estimates of all-cause mortality and cause specific mortality associated with proton pump inhibitors among US veterans: Cohort study. BMJ. 2019 May 29;365:l1580.

Dr. Kruse is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

Fewer than one-third of women hospitalized with influenza receive the recommended flu vaccine, according to a study using data over nine flu seasons.

Researchers analyzed data from 9,652 women ages 15-44 who were hospitalized with laboratory-confirmed influenza from October through April during the 2010-2019 influenza seasons. Data were pulled from the U.S. Influenza Hospitalization Surveillance Network (FluSurv-NET).

Of those women, 2,697 (28%) were pregnant. Median age was 28 and median gestational age was 32 weeks. Those studied included 36% who were non-Hispanic White; 29% non-Hispanic Black; and 20% Hispanic women.

Some 89% of the women, pregnant and nonpregnant, received antivirals while in the hospital but only 31% reported they had received the flu vaccine in the current season, despite guideline recommendations citing clear evidence that vaccination is safe for mother and baby.

Rachel Holstein, MPH, an epidemiology and information science fellow at the Centers for Disease Control and Prevention, who presented her team’s work as part of IDWeek 2020, explained that the mother’s vaccination can help protect the baby from flu infection for several months after birth, before the baby can be vaccinated.

She noted that pregnant women are at high risk for influenza-associated hospitalization.

“Changes in the immune system, heart, and lungs during pregnancy make pregnant women, and women up to 2 weeks post partum, more prone to severe illness from flu, including illness resulting in hospitalization,” she said in an interview

“Vaccination has been shown to reduce the risk of flu-associated acute respiratory infection in pregnant women by up to one-half,” she said. “A 2018 study showed that getting a flu shot reduced a pregnant woman’s risk of being hospitalized with flu by an average of 40%.»

FluSurv-NET data show hospitalizations were more common in the third trimester of pregnancy compared with the first and second, Holstein said. The most common underlying conditions among these women were asthma (23%) and obesity (10%), and 12% were current tobacco smokers. Overall, 5% of pregnant women with flu required ICU admission, 2% needed mechanical ventilation, and 6% developed pneumonia.
 

Vaccine uptake lowest in first two trimesters

Holstein said vaccine coverage was lowest among women in their first or second trimesters for all 9 seasons, and overall vaccination coverage increased significantly over time.

Uptake also differed by age. The data showed coverage was lower among women aged 15-34 years, compared with women 35 years and older (34% vs. 50%).

“It was as low as 15% among pregnant women aged 15-34 years in the 2011-12 season,” she added.

Jeanne Sheffield, MD, director of the division of maternal-fetal medicine at Johns Hopkins Medicine, Baltimore, said in an interview the low uptake of vaccine shown in this study is both familiar and frustrating.

She said education from health care providers has improved, but women are nonetheless frequently fearful. She pointed out the widespread phenomenon of vaccine hesitancy in the general population.

Coverage was 45.3% among adults in the 2018-2019 flu season, 8.2 percentage points higher than coverage during the 2017-18 season (37.1%) according to CDC estimates.

Added to that, she said, is further hesitancy when women believe vaccination could harm the unborn baby, despite “very good data that flu vaccine is safe in pregnancy, acceptable in pregnancy in all trimesters, and is optimal standard of care.”

Holstein added, “We know from past research that a range of factors – including negative attitudes and beliefs about vaccines, less knowledge about and access to vaccines, and a lack of trust in healthcare providers and vaccines – can contribute to lower vaccination rates.”

Healthcare providers play a key role in increasing flu vaccinations among pregnant women, she said.

“A provider recommendation, combined with an offer to administer a flu vaccine at the time of visit, remains one of the best ways to accomplish this,” Holstein said.

Holstein and Sheffield have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Fewer than one-third of women hospitalized with influenza receive the recommended flu vaccine, according to a study using data over nine flu seasons.

Researchers analyzed data from 9,652 women ages 15-44 who were hospitalized with laboratory-confirmed influenza from October through April during the 2010-2019 influenza seasons. Data were pulled from the U.S. Influenza Hospitalization Surveillance Network (FluSurv-NET).

Of those women, 2,697 (28%) were pregnant. Median age was 28 and median gestational age was 32 weeks. Those studied included 36% who were non-Hispanic White; 29% non-Hispanic Black; and 20% Hispanic women.

Some 89% of the women, pregnant and nonpregnant, received antivirals while in the hospital but only 31% reported they had received the flu vaccine in the current season, despite guideline recommendations citing clear evidence that vaccination is safe for mother and baby.

Rachel Holstein, MPH, an epidemiology and information science fellow at the Centers for Disease Control and Prevention, who presented her team’s work as part of IDWeek 2020, explained that the mother’s vaccination can help protect the baby from flu infection for several months after birth, before the baby can be vaccinated.

She noted that pregnant women are at high risk for influenza-associated hospitalization.

“Changes in the immune system, heart, and lungs during pregnancy make pregnant women, and women up to 2 weeks post partum, more prone to severe illness from flu, including illness resulting in hospitalization,” she said in an interview

“Vaccination has been shown to reduce the risk of flu-associated acute respiratory infection in pregnant women by up to one-half,” she said. “A 2018 study showed that getting a flu shot reduced a pregnant woman’s risk of being hospitalized with flu by an average of 40%.»

FluSurv-NET data show hospitalizations were more common in the third trimester of pregnancy compared with the first and second, Holstein said. The most common underlying conditions among these women were asthma (23%) and obesity (10%), and 12% were current tobacco smokers. Overall, 5% of pregnant women with flu required ICU admission, 2% needed mechanical ventilation, and 6% developed pneumonia.
 

Vaccine uptake lowest in first two trimesters

Holstein said vaccine coverage was lowest among women in their first or second trimesters for all 9 seasons, and overall vaccination coverage increased significantly over time.

Uptake also differed by age. The data showed coverage was lower among women aged 15-34 years, compared with women 35 years and older (34% vs. 50%).

“It was as low as 15% among pregnant women aged 15-34 years in the 2011-12 season,” she added.

Jeanne Sheffield, MD, director of the division of maternal-fetal medicine at Johns Hopkins Medicine, Baltimore, said in an interview the low uptake of vaccine shown in this study is both familiar and frustrating.

She said education from health care providers has improved, but women are nonetheless frequently fearful. She pointed out the widespread phenomenon of vaccine hesitancy in the general population.

Coverage was 45.3% among adults in the 2018-2019 flu season, 8.2 percentage points higher than coverage during the 2017-18 season (37.1%) according to CDC estimates.

Added to that, she said, is further hesitancy when women believe vaccination could harm the unborn baby, despite “very good data that flu vaccine is safe in pregnancy, acceptable in pregnancy in all trimesters, and is optimal standard of care.”

Holstein added, “We know from past research that a range of factors – including negative attitudes and beliefs about vaccines, less knowledge about and access to vaccines, and a lack of trust in healthcare providers and vaccines – can contribute to lower vaccination rates.”

Healthcare providers play a key role in increasing flu vaccinations among pregnant women, she said.

“A provider recommendation, combined with an offer to administer a flu vaccine at the time of visit, remains one of the best ways to accomplish this,” Holstein said.

Holstein and Sheffield have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Fewer than one-third of women hospitalized with influenza receive the recommended flu vaccine, according to a study using data over nine flu seasons.

Researchers analyzed data from 9,652 women ages 15-44 who were hospitalized with laboratory-confirmed influenza from October through April during the 2010-2019 influenza seasons. Data were pulled from the U.S. Influenza Hospitalization Surveillance Network (FluSurv-NET).

Of those women, 2,697 (28%) were pregnant. Median age was 28 and median gestational age was 32 weeks. Those studied included 36% who were non-Hispanic White; 29% non-Hispanic Black; and 20% Hispanic women.

Some 89% of the women, pregnant and nonpregnant, received antivirals while in the hospital but only 31% reported they had received the flu vaccine in the current season, despite guideline recommendations citing clear evidence that vaccination is safe for mother and baby.

Rachel Holstein, MPH, an epidemiology and information science fellow at the Centers for Disease Control and Prevention, who presented her team’s work as part of IDWeek 2020, explained that the mother’s vaccination can help protect the baby from flu infection for several months after birth, before the baby can be vaccinated.

She noted that pregnant women are at high risk for influenza-associated hospitalization.

“Changes in the immune system, heart, and lungs during pregnancy make pregnant women, and women up to 2 weeks post partum, more prone to severe illness from flu, including illness resulting in hospitalization,” she said in an interview

“Vaccination has been shown to reduce the risk of flu-associated acute respiratory infection in pregnant women by up to one-half,” she said. “A 2018 study showed that getting a flu shot reduced a pregnant woman’s risk of being hospitalized with flu by an average of 40%.»

FluSurv-NET data show hospitalizations were more common in the third trimester of pregnancy compared with the first and second, Holstein said. The most common underlying conditions among these women were asthma (23%) and obesity (10%), and 12% were current tobacco smokers. Overall, 5% of pregnant women with flu required ICU admission, 2% needed mechanical ventilation, and 6% developed pneumonia.
 

Vaccine uptake lowest in first two trimesters

Holstein said vaccine coverage was lowest among women in their first or second trimesters for all 9 seasons, and overall vaccination coverage increased significantly over time.

Uptake also differed by age. The data showed coverage was lower among women aged 15-34 years, compared with women 35 years and older (34% vs. 50%).

“It was as low as 15% among pregnant women aged 15-34 years in the 2011-12 season,” she added.

Jeanne Sheffield, MD, director of the division of maternal-fetal medicine at Johns Hopkins Medicine, Baltimore, said in an interview the low uptake of vaccine shown in this study is both familiar and frustrating.

She said education from health care providers has improved, but women are nonetheless frequently fearful. She pointed out the widespread phenomenon of vaccine hesitancy in the general population.

Coverage was 45.3% among adults in the 2018-2019 flu season, 8.2 percentage points higher than coverage during the 2017-18 season (37.1%) according to CDC estimates.

Added to that, she said, is further hesitancy when women believe vaccination could harm the unborn baby, despite “very good data that flu vaccine is safe in pregnancy, acceptable in pregnancy in all trimesters, and is optimal standard of care.”

Holstein added, “We know from past research that a range of factors – including negative attitudes and beliefs about vaccines, less knowledge about and access to vaccines, and a lack of trust in healthcare providers and vaccines – can contribute to lower vaccination rates.”

Healthcare providers play a key role in increasing flu vaccinations among pregnant women, she said.

“A provider recommendation, combined with an offer to administer a flu vaccine at the time of visit, remains one of the best ways to accomplish this,” Holstein said.

Holstein and Sheffield have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Major thromboembolic complications and adverse cardiovascular events occurred with high frequency in patients with COVID-19, especially in the intensive care setting, despite a high use of thromboprophylaxis, in a new large observational U.S. study.

“Despite very high rate of antithrombotic prophylaxis there were a high rate of thromboembolic events suggesting that we are probably not providing enough thromboprophylaxis,” lead author Gregory Piazza, MD, Brigham and Women’s Hospital, Boston, said in an interview. 

“Standard prophylaxis as recommended in the guidelines is a low dose of low-molecular-weight heparin once daily, but these results suggest [patients] probably need higher doses,” he added.

However, Dr. Piazza cautioned that this is an observational study and randomized trials are needed to make changes in treatment strategies. Several such trials are currently underway.

The current study was published online ahead of print in the Nov. 3 issue of the Journal of the American College of Cardiology.
 

Rates similar to other very sick patients

The study showed that while thromboembolic complications were high, they were not as high as seen in some of the earlier studies from Asia and Europe, Dr. Piazza noted.

“The numbers we were seeing in early reports were so high we couldn’t figure out how that was possible,” he said. “Our study suggests that, in a U.S. population receiving thromboprophylaxis, the rate of thromboembolic complications [are] more in line with what we would expect to see in other very sick patients who end up in ICU.”

He suggested that the very high rates of thromboembolic complications in the early studies from Asia may have been because of the lack of thromboprophylaxis, which is not routine in hospitalized patients there. “Some of the earlier studies also used routine ultrasound and so picked up asymptomatic thrombotic events, which was not the case in our study. So our results are more representative of the U.S. population.”

Dr. Piazza attributed the high rate of thromboembolic complications being reported with COVID-19 to the sheer number of very sick patients being admitted to the hospital.

“We are accustomed to seeing a rare case of thrombosis despite prophylaxis in hospitalized patients, but we are seeing more in COVID patients. This is probably just because we have more critically ill patients,” he said.

“We are seeing an incredible influx of patients to the ICU that we have never experienced before, so the increase in thromboembolic complications is more obvious. In prior years we probably haven’t had enough critically ill patients at any one time to raise the flag about thromboprophylaxis,” he commented.

The study also found a high rate of cardiovascular complications. They are seeing an increase in the risk of MI, which is to be expected in such sick patients, but they also see quite a bit of new atrial fibrillation, myocarditis, and heart failure in patients who don’t always have underlying cardiovascular disease, he said.

“So this virus does appear to have a predilection to causing cardiovascular complications, but this is probably because it is making patients so sick,” Dr. Piazza said. “If flu was this virulent and resulted in such high rates of acute respiratory distress syndrome (ARDS), we would probably see similar cardiovascular complication rates.”

For the current report, the researchers analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through the Mass General Brigham integrated health network. Of these, 170 had been admitted to the ICU, 229 had been hospitalized but not treated in ICU, and 715 were outpatients. In terms of ethnicity, 22% were Hispanic/Latino and 44% were non-White. 

Cardiovascular risk factors were common, with 36% of patients having hypertension, 29% hyperlipidemia, and 18% diabetes. Prophylactic anticoagulation was prescribed in 89% of patients with COVID-19 in the intensive care cohort and 85% of those in the hospitalized non–intensive care setting.

Results showed that major arterial or venous thromboembolism (VTE) occurred in 35% of the intensive care cohort, 2.6% of those hospitalized but not treated in ICU, and 0% of outpatients.

Major adverse cardiovascular events occurred in 46% of the intensive care cohort, 6.1% of those hospitalized but non-ICU, and 0% of outpatients.

Symptomatic VTE occurred in 27% of those admitted to ICU, 2.2% of those hospitalized but non-ICU, and 0% of outpatients.

“We found that outpatients had a very low rate of thromboembolic complications, with the vast majority of the risk being in hospitalized patients, especially those in ICU,” Dr. Piazza said.

“These results suggest that we don’t need routine thromboprophylaxis for all outpatients with COVID-19, but there will probably be some patients who need it – those with risk factors for thromboembolism.”

Catheter- and device-associated deep vein thrombosis accounted for 76.9% of the DVTs observed in the study.

“Our finding of high frequency of catheter-associated DVT supports the judicious use of central venous catheters that have been widely implemented, especially in the ICU, to minimize recurrent health care team exposure and facilitate monitoring,” the researchers wrote.
 

ARDS biggest risk factor

Of all the markers of disease severity, the presence of ARDS had the strongest association with adverse outcomes, including major arterial or VTE, major adverse cardiovascular events, symptomatic VTE, and death.

“The severe inflammatory state associated with ARDS and other complications of COVID-19 and its resultant hypercoagulability may explain, at least in part, the high frequency of thromboembolic events. Improved risk stratification, utilizing biochemical markers of inflammation and activated coagulation as well as clinical indicators, such as ARDS, may play an important role in the early identification of patients with an increased likelihood of developing symptomatic VTE or arterial thrombosis,” the researchers wrote. “They may benefit from full- or intermediate-intensity antithrombotic therapy rather than prophylactic anticoagulation.”

They point out that this study provides a cross-sectional view of the cardiovascular complications of COVID-19 in a large health care network, consisting of two academic medical centers serving the greater Boston area, several community hospitals, and numerous outpatient care sites.

“The study incorporates a wide scope of clinically meaningful cardiovascular endpoints and utilizes a rigorous process of event adjudication. Although data on patients with COVID-19 in the ICU have been the subject of most reports, our study provides insights into the broad spectrum of all hospitalized and outpatient populations,” the authors noted.

“The high frequency of arterial or venous thromboembolism in hospitalized patients despite routine thromboprophylaxis suggests the need for improved risk stratification and enhanced preventive efforts,” they concluded.

The study is continuing, and the researchers expect to have data on 10,000 patients by the end of winter.
 

Wait for randomized trials

In an accompanying editorial, Robert McBane, MD, Mayo Clinic, Rochester, Minn., said that these data provide important real-world arterial and venous thrombotic event rates across a large, integrated health care network and an experienced roster of clinician-scientists devoted to thrombosis research.

Noting that whether to interpret these results as alarming or reassuring requires a comparison of expected thromboembolic event rates separate from the pandemic, he pointed out that, while the overall VTE rate among ICU patients was high, the vast majority of these events were attributable to central venous lines, and apart from these, the event rates do not appear inflated relative to prior published incidence rates from the pre–COVID-19 era.

“It is therefore important to resist the urge to overprevent or overtreat patients and expose them to the serious risks of major bleeding,” Dr. McBane wrote, adding that “the systematized approach to delivery of guideline-driven VTE prophylaxis across this large, integrated health network likely contributed to the relatively low rates of serious thrombotic outcomes reported.”

He further noted that, as the majority of VTE events were related to central venous lines in ICU patients, “this underscores the importance of a bundled care approach to central venous line management with daily assessment of the continued necessity of central access.

“A number of important clinical trials aimed at optimizing thromboprophylaxis during hospitalization, following hospital dismissal, and in ambulatory settings are underway. Until available, the lessons of thoughtful anticoagulant prophylaxis and treatment guidelines harvested from years of clinical research appear to apply,” he concluded.

This study was funded, in part, by a research grant from Janssen Pharmaceuticals. Dr. Piazza has received research grant support from EKOS Corporation, Bayer, Bristol-Myers Squibb/Pfizer, Portola Pharmaceuticals, and Janssen Pharmaceuticals; and has received consulting fees from Amgen, Pfizer, Boston Scientific, Agile, and Thrombolex. Dr. McBane reported no relevant disclosures.

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

Major thromboembolic complications and adverse cardiovascular events occurred with high frequency in patients with COVID-19, especially in the intensive care setting, despite a high use of thromboprophylaxis, in a new large observational U.S. study.

“Despite very high rate of antithrombotic prophylaxis there were a high rate of thromboembolic events suggesting that we are probably not providing enough thromboprophylaxis,” lead author Gregory Piazza, MD, Brigham and Women’s Hospital, Boston, said in an interview. 

“Standard prophylaxis as recommended in the guidelines is a low dose of low-molecular-weight heparin once daily, but these results suggest [patients] probably need higher doses,” he added.

However, Dr. Piazza cautioned that this is an observational study and randomized trials are needed to make changes in treatment strategies. Several such trials are currently underway.

The current study was published online ahead of print in the Nov. 3 issue of the Journal of the American College of Cardiology.
 

Rates similar to other very sick patients

The study showed that while thromboembolic complications were high, they were not as high as seen in some of the earlier studies from Asia and Europe, Dr. Piazza noted.

“The numbers we were seeing in early reports were so high we couldn’t figure out how that was possible,” he said. “Our study suggests that, in a U.S. population receiving thromboprophylaxis, the rate of thromboembolic complications [are] more in line with what we would expect to see in other very sick patients who end up in ICU.”

He suggested that the very high rates of thromboembolic complications in the early studies from Asia may have been because of the lack of thromboprophylaxis, which is not routine in hospitalized patients there. “Some of the earlier studies also used routine ultrasound and so picked up asymptomatic thrombotic events, which was not the case in our study. So our results are more representative of the U.S. population.”

Dr. Piazza attributed the high rate of thromboembolic complications being reported with COVID-19 to the sheer number of very sick patients being admitted to the hospital.

“We are accustomed to seeing a rare case of thrombosis despite prophylaxis in hospitalized patients, but we are seeing more in COVID patients. This is probably just because we have more critically ill patients,” he said.

“We are seeing an incredible influx of patients to the ICU that we have never experienced before, so the increase in thromboembolic complications is more obvious. In prior years we probably haven’t had enough critically ill patients at any one time to raise the flag about thromboprophylaxis,” he commented.

The study also found a high rate of cardiovascular complications. They are seeing an increase in the risk of MI, which is to be expected in such sick patients, but they also see quite a bit of new atrial fibrillation, myocarditis, and heart failure in patients who don’t always have underlying cardiovascular disease, he said.

“So this virus does appear to have a predilection to causing cardiovascular complications, but this is probably because it is making patients so sick,” Dr. Piazza said. “If flu was this virulent and resulted in such high rates of acute respiratory distress syndrome (ARDS), we would probably see similar cardiovascular complication rates.”

For the current report, the researchers analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through the Mass General Brigham integrated health network. Of these, 170 had been admitted to the ICU, 229 had been hospitalized but not treated in ICU, and 715 were outpatients. In terms of ethnicity, 22% were Hispanic/Latino and 44% were non-White. 

Cardiovascular risk factors were common, with 36% of patients having hypertension, 29% hyperlipidemia, and 18% diabetes. Prophylactic anticoagulation was prescribed in 89% of patients with COVID-19 in the intensive care cohort and 85% of those in the hospitalized non–intensive care setting.

Results showed that major arterial or venous thromboembolism (VTE) occurred in 35% of the intensive care cohort, 2.6% of those hospitalized but not treated in ICU, and 0% of outpatients.

Major adverse cardiovascular events occurred in 46% of the intensive care cohort, 6.1% of those hospitalized but non-ICU, and 0% of outpatients.

Symptomatic VTE occurred in 27% of those admitted to ICU, 2.2% of those hospitalized but non-ICU, and 0% of outpatients.

“We found that outpatients had a very low rate of thromboembolic complications, with the vast majority of the risk being in hospitalized patients, especially those in ICU,” Dr. Piazza said.

“These results suggest that we don’t need routine thromboprophylaxis for all outpatients with COVID-19, but there will probably be some patients who need it – those with risk factors for thromboembolism.”

Catheter- and device-associated deep vein thrombosis accounted for 76.9% of the DVTs observed in the study.

“Our finding of high frequency of catheter-associated DVT supports the judicious use of central venous catheters that have been widely implemented, especially in the ICU, to minimize recurrent health care team exposure and facilitate monitoring,” the researchers wrote.
 

ARDS biggest risk factor

Of all the markers of disease severity, the presence of ARDS had the strongest association with adverse outcomes, including major arterial or VTE, major adverse cardiovascular events, symptomatic VTE, and death.

“The severe inflammatory state associated with ARDS and other complications of COVID-19 and its resultant hypercoagulability may explain, at least in part, the high frequency of thromboembolic events. Improved risk stratification, utilizing biochemical markers of inflammation and activated coagulation as well as clinical indicators, such as ARDS, may play an important role in the early identification of patients with an increased likelihood of developing symptomatic VTE or arterial thrombosis,” the researchers wrote. “They may benefit from full- or intermediate-intensity antithrombotic therapy rather than prophylactic anticoagulation.”

They point out that this study provides a cross-sectional view of the cardiovascular complications of COVID-19 in a large health care network, consisting of two academic medical centers serving the greater Boston area, several community hospitals, and numerous outpatient care sites.

“The study incorporates a wide scope of clinically meaningful cardiovascular endpoints and utilizes a rigorous process of event adjudication. Although data on patients with COVID-19 in the ICU have been the subject of most reports, our study provides insights into the broad spectrum of all hospitalized and outpatient populations,” the authors noted.

“The high frequency of arterial or venous thromboembolism in hospitalized patients despite routine thromboprophylaxis suggests the need for improved risk stratification and enhanced preventive efforts,” they concluded.

The study is continuing, and the researchers expect to have data on 10,000 patients by the end of winter.
 

Wait for randomized trials

In an accompanying editorial, Robert McBane, MD, Mayo Clinic, Rochester, Minn., said that these data provide important real-world arterial and venous thrombotic event rates across a large, integrated health care network and an experienced roster of clinician-scientists devoted to thrombosis research.

Noting that whether to interpret these results as alarming or reassuring requires a comparison of expected thromboembolic event rates separate from the pandemic, he pointed out that, while the overall VTE rate among ICU patients was high, the vast majority of these events were attributable to central venous lines, and apart from these, the event rates do not appear inflated relative to prior published incidence rates from the pre–COVID-19 era.

“It is therefore important to resist the urge to overprevent or overtreat patients and expose them to the serious risks of major bleeding,” Dr. McBane wrote, adding that “the systematized approach to delivery of guideline-driven VTE prophylaxis across this large, integrated health network likely contributed to the relatively low rates of serious thrombotic outcomes reported.”

He further noted that, as the majority of VTE events were related to central venous lines in ICU patients, “this underscores the importance of a bundled care approach to central venous line management with daily assessment of the continued necessity of central access.

“A number of important clinical trials aimed at optimizing thromboprophylaxis during hospitalization, following hospital dismissal, and in ambulatory settings are underway. Until available, the lessons of thoughtful anticoagulant prophylaxis and treatment guidelines harvested from years of clinical research appear to apply,” he concluded.

This study was funded, in part, by a research grant from Janssen Pharmaceuticals. Dr. Piazza has received research grant support from EKOS Corporation, Bayer, Bristol-Myers Squibb/Pfizer, Portola Pharmaceuticals, and Janssen Pharmaceuticals; and has received consulting fees from Amgen, Pfizer, Boston Scientific, Agile, and Thrombolex. Dr. McBane reported no relevant disclosures.

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

Major thromboembolic complications and adverse cardiovascular events occurred with high frequency in patients with COVID-19, especially in the intensive care setting, despite a high use of thromboprophylaxis, in a new large observational U.S. study.

“Despite very high rate of antithrombotic prophylaxis there were a high rate of thromboembolic events suggesting that we are probably not providing enough thromboprophylaxis,” lead author Gregory Piazza, MD, Brigham and Women’s Hospital, Boston, said in an interview. 

“Standard prophylaxis as recommended in the guidelines is a low dose of low-molecular-weight heparin once daily, but these results suggest [patients] probably need higher doses,” he added.

However, Dr. Piazza cautioned that this is an observational study and randomized trials are needed to make changes in treatment strategies. Several such trials are currently underway.

The current study was published online ahead of print in the Nov. 3 issue of the Journal of the American College of Cardiology.
 

Rates similar to other very sick patients

The study showed that while thromboembolic complications were high, they were not as high as seen in some of the earlier studies from Asia and Europe, Dr. Piazza noted.

“The numbers we were seeing in early reports were so high we couldn’t figure out how that was possible,” he said. “Our study suggests that, in a U.S. population receiving thromboprophylaxis, the rate of thromboembolic complications [are] more in line with what we would expect to see in other very sick patients who end up in ICU.”

He suggested that the very high rates of thromboembolic complications in the early studies from Asia may have been because of the lack of thromboprophylaxis, which is not routine in hospitalized patients there. “Some of the earlier studies also used routine ultrasound and so picked up asymptomatic thrombotic events, which was not the case in our study. So our results are more representative of the U.S. population.”

Dr. Piazza attributed the high rate of thromboembolic complications being reported with COVID-19 to the sheer number of very sick patients being admitted to the hospital.

“We are accustomed to seeing a rare case of thrombosis despite prophylaxis in hospitalized patients, but we are seeing more in COVID patients. This is probably just because we have more critically ill patients,” he said.

“We are seeing an incredible influx of patients to the ICU that we have never experienced before, so the increase in thromboembolic complications is more obvious. In prior years we probably haven’t had enough critically ill patients at any one time to raise the flag about thromboprophylaxis,” he commented.

The study also found a high rate of cardiovascular complications. They are seeing an increase in the risk of MI, which is to be expected in such sick patients, but they also see quite a bit of new atrial fibrillation, myocarditis, and heart failure in patients who don’t always have underlying cardiovascular disease, he said.

“So this virus does appear to have a predilection to causing cardiovascular complications, but this is probably because it is making patients so sick,” Dr. Piazza said. “If flu was this virulent and resulted in such high rates of acute respiratory distress syndrome (ARDS), we would probably see similar cardiovascular complication rates.”

For the current report, the researchers analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through the Mass General Brigham integrated health network. Of these, 170 had been admitted to the ICU, 229 had been hospitalized but not treated in ICU, and 715 were outpatients. In terms of ethnicity, 22% were Hispanic/Latino and 44% were non-White. 

Cardiovascular risk factors were common, with 36% of patients having hypertension, 29% hyperlipidemia, and 18% diabetes. Prophylactic anticoagulation was prescribed in 89% of patients with COVID-19 in the intensive care cohort and 85% of those in the hospitalized non–intensive care setting.

Results showed that major arterial or venous thromboembolism (VTE) occurred in 35% of the intensive care cohort, 2.6% of those hospitalized but not treated in ICU, and 0% of outpatients.

Major adverse cardiovascular events occurred in 46% of the intensive care cohort, 6.1% of those hospitalized but non-ICU, and 0% of outpatients.

Symptomatic VTE occurred in 27% of those admitted to ICU, 2.2% of those hospitalized but non-ICU, and 0% of outpatients.

“We found that outpatients had a very low rate of thromboembolic complications, with the vast majority of the risk being in hospitalized patients, especially those in ICU,” Dr. Piazza said.

“These results suggest that we don’t need routine thromboprophylaxis for all outpatients with COVID-19, but there will probably be some patients who need it – those with risk factors for thromboembolism.”

Catheter- and device-associated deep vein thrombosis accounted for 76.9% of the DVTs observed in the study.

“Our finding of high frequency of catheter-associated DVT supports the judicious use of central venous catheters that have been widely implemented, especially in the ICU, to minimize recurrent health care team exposure and facilitate monitoring,” the researchers wrote.
 

ARDS biggest risk factor

Of all the markers of disease severity, the presence of ARDS had the strongest association with adverse outcomes, including major arterial or VTE, major adverse cardiovascular events, symptomatic VTE, and death.

“The severe inflammatory state associated with ARDS and other complications of COVID-19 and its resultant hypercoagulability may explain, at least in part, the high frequency of thromboembolic events. Improved risk stratification, utilizing biochemical markers of inflammation and activated coagulation as well as clinical indicators, such as ARDS, may play an important role in the early identification of patients with an increased likelihood of developing symptomatic VTE or arterial thrombosis,” the researchers wrote. “They may benefit from full- or intermediate-intensity antithrombotic therapy rather than prophylactic anticoagulation.”

They point out that this study provides a cross-sectional view of the cardiovascular complications of COVID-19 in a large health care network, consisting of two academic medical centers serving the greater Boston area, several community hospitals, and numerous outpatient care sites.

“The study incorporates a wide scope of clinically meaningful cardiovascular endpoints and utilizes a rigorous process of event adjudication. Although data on patients with COVID-19 in the ICU have been the subject of most reports, our study provides insights into the broad spectrum of all hospitalized and outpatient populations,” the authors noted.

“The high frequency of arterial or venous thromboembolism in hospitalized patients despite routine thromboprophylaxis suggests the need for improved risk stratification and enhanced preventive efforts,” they concluded.

The study is continuing, and the researchers expect to have data on 10,000 patients by the end of winter.
 

Wait for randomized trials

In an accompanying editorial, Robert McBane, MD, Mayo Clinic, Rochester, Minn., said that these data provide important real-world arterial and venous thrombotic event rates across a large, integrated health care network and an experienced roster of clinician-scientists devoted to thrombosis research.

Noting that whether to interpret these results as alarming or reassuring requires a comparison of expected thromboembolic event rates separate from the pandemic, he pointed out that, while the overall VTE rate among ICU patients was high, the vast majority of these events were attributable to central venous lines, and apart from these, the event rates do not appear inflated relative to prior published incidence rates from the pre–COVID-19 era.

“It is therefore important to resist the urge to overprevent or overtreat patients and expose them to the serious risks of major bleeding,” Dr. McBane wrote, adding that “the systematized approach to delivery of guideline-driven VTE prophylaxis across this large, integrated health network likely contributed to the relatively low rates of serious thrombotic outcomes reported.”

He further noted that, as the majority of VTE events were related to central venous lines in ICU patients, “this underscores the importance of a bundled care approach to central venous line management with daily assessment of the continued necessity of central access.

“A number of important clinical trials aimed at optimizing thromboprophylaxis during hospitalization, following hospital dismissal, and in ambulatory settings are underway. Until available, the lessons of thoughtful anticoagulant prophylaxis and treatment guidelines harvested from years of clinical research appear to apply,” he concluded.

This study was funded, in part, by a research grant from Janssen Pharmaceuticals. Dr. Piazza has received research grant support from EKOS Corporation, Bayer, Bristol-Myers Squibb/Pfizer, Portola Pharmaceuticals, and Janssen Pharmaceuticals; and has received consulting fees from Amgen, Pfizer, Boston Scientific, Agile, and Thrombolex. Dr. McBane reported no relevant disclosures.

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

Background: PICC insertion is associated with risk for venous thrombosis and stenosis. National guidelines recommend avoiding PICC lines in patients with CKD stage 3b (glomerular filtration rate less than 45 mL/min per 1.73 m²) in order to preserve venous integrity for future creation of arteriovenous fistula, which is the ideal vascular access for hemodialysis.

The study is limited by lack of data in a subset of patients who had no documented GFR (2.7%) or missing covariate data (2.7%). The inability to ascertain other clinical information, such as nephrology approval of PICC, functional AV fistula or other hemodialysis access, or PICC complications after discharge further limit the findings.

Hospitalists should first decide if a PICC line is truly indicated, and if so, carefully weigh the risks and benefits of PICC placement in patients with advanced CKD.

Bottom line: PICC placement is common and often inappropriate in hospitalized patients with advanced CKD.

Citation: Paje D et al. Use of peripherally inserted central catheters in patients with advanced chronic kidney disease A prospective cohort study. Ann Intern Med. 2019 Jun 4;171:10-8.

Dr. Hageman is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

Background: PICC insertion is associated with risk for venous thrombosis and stenosis. National guidelines recommend avoiding PICC lines in patients with CKD stage 3b (glomerular filtration rate less than 45 mL/min per 1.73 m²) in order to preserve venous integrity for future creation of arteriovenous fistula, which is the ideal vascular access for hemodialysis.

The study is limited by lack of data in a subset of patients who had no documented GFR (2.7%) or missing covariate data (2.7%). The inability to ascertain other clinical information, such as nephrology approval of PICC, functional AV fistula or other hemodialysis access, or PICC complications after discharge further limit the findings.

Hospitalists should first decide if a PICC line is truly indicated, and if so, carefully weigh the risks and benefits of PICC placement in patients with advanced CKD.

Bottom line: PICC placement is common and often inappropriate in hospitalized patients with advanced CKD.

Citation: Paje D et al. Use of peripherally inserted central catheters in patients with advanced chronic kidney disease A prospective cohort study. Ann Intern Med. 2019 Jun 4;171:10-8.

Dr. Hageman is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

Background: PICC insertion is associated with risk for venous thrombosis and stenosis. National guidelines recommend avoiding PICC lines in patients with CKD stage 3b (glomerular filtration rate less than 45 mL/min per 1.73 m²) in order to preserve venous integrity for future creation of arteriovenous fistula, which is the ideal vascular access for hemodialysis.

The study is limited by lack of data in a subset of patients who had no documented GFR (2.7%) or missing covariate data (2.7%). The inability to ascertain other clinical information, such as nephrology approval of PICC, functional AV fistula or other hemodialysis access, or PICC complications after discharge further limit the findings.

Hospitalists should first decide if a PICC line is truly indicated, and if so, carefully weigh the risks and benefits of PICC placement in patients with advanced CKD.

Bottom line: PICC placement is common and often inappropriate in hospitalized patients with advanced CKD.

Citation: Paje D et al. Use of peripherally inserted central catheters in patients with advanced chronic kidney disease A prospective cohort study. Ann Intern Med. 2019 Jun 4;171:10-8.

Dr. Hageman is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.