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The Ohio House of Representatives recently passed a bill that would enable patients to use drug manufacturer coupons and other co-pay assistance as payment toward their annual deductible.

According to the Kaiser Family Foundation, approximately 1 in 4 Americans have difficulty paying for their prescription drugs, while almost half of U.S. adults report difficulty paying out-of-pocket costs not covered by their health insurance.

Supporting the bill that restricts co-pay accumulators are groups such as the Ohio State Medical Association, the Crohn’s and Colitis Foundation, Susan C. Komen, the National Multiple Sclerosis Society, and the American Diabetes Association. The bill faced opposition from health insurers and pharmacy benefit managers, reported The Columbus Dispatch.

“The debate on the management of rising drug costs between manufacturers and insurers unfortunately leaves patients caught in the middle, and practices like co-pay accumulators can have a devastating impact,” Monica Hueckel, senior director of government relations for the Ohio State Medical Association, told this news organization.

“Patients often do not even know about these policies until the coupons are no longer usable. As you can imagine, for patients with expensive medications and/or high deductible health plans, the impact is disastrous,” she said.

Ohio State Representative Susan Manchester, who co-sponsored the bill, told The Columbus Dispatch that the legislation “is needed to assist our constituents who find themselves increasingly subjected to more out-of-pocket costs as part of their insurance coverage.”

Other states blocking health insurers’ co-pay policies

With the passage of the bill, Ohio joins 12 states and Puerto Rico in preventing the use of health insurers’ co-pays to increase patients’ out-of-pocket costs, reported The Columbus Dispatch; 15 states are also considering this type of legislation.

Eighty-three percent of patients are in plans that include a co-pay accumulator, according to consulting firm Avalere, which wrote that, beginning in 2023, the Center for Medicare & Medicaid Services requires patients with Medicaid to receive “the full value of co-pay assistance” on drugs.

According to the National Conference of State Legislatures, co-pay adjustment programs present challenges for patients, with plans that include high cost sharing or co-insurance whereby a patient pays a percentage of the cost instead of a flat amount.

For example, with a co-pay adjustment policy, a patient with a $2,000 deductible plan couldn’t use a $500 coupon toward meeting the deductible, writes the National Conference of State Legislatures. Conversely, a patient in a plan without a co-pay adjustment policy could use the coupon to satisfy their annual deductible.

Patients with complex conditions, such as cancer, rheumatoid arthritis, and diabetes, which often require expensive medications, may have little choice but to fork over the unexpected co-pays, according to the organization that represents state legislatures in the United States.

The bill now moves to the Ohio Senate, reported The Columbus Dispatch.

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

The Ohio House of Representatives recently passed a bill that would enable patients to use drug manufacturer coupons and other co-pay assistance as payment toward their annual deductible.

According to the Kaiser Family Foundation, approximately 1 in 4 Americans have difficulty paying for their prescription drugs, while almost half of U.S. adults report difficulty paying out-of-pocket costs not covered by their health insurance.

Supporting the bill that restricts co-pay accumulators are groups such as the Ohio State Medical Association, the Crohn’s and Colitis Foundation, Susan C. Komen, the National Multiple Sclerosis Society, and the American Diabetes Association. The bill faced opposition from health insurers and pharmacy benefit managers, reported The Columbus Dispatch.

“The debate on the management of rising drug costs between manufacturers and insurers unfortunately leaves patients caught in the middle, and practices like co-pay accumulators can have a devastating impact,” Monica Hueckel, senior director of government relations for the Ohio State Medical Association, told this news organization.

“Patients often do not even know about these policies until the coupons are no longer usable. As you can imagine, for patients with expensive medications and/or high deductible health plans, the impact is disastrous,” she said.

Ohio State Representative Susan Manchester, who co-sponsored the bill, told The Columbus Dispatch that the legislation “is needed to assist our constituents who find themselves increasingly subjected to more out-of-pocket costs as part of their insurance coverage.”

Other states blocking health insurers’ co-pay policies

With the passage of the bill, Ohio joins 12 states and Puerto Rico in preventing the use of health insurers’ co-pays to increase patients’ out-of-pocket costs, reported The Columbus Dispatch; 15 states are also considering this type of legislation.

Eighty-three percent of patients are in plans that include a co-pay accumulator, according to consulting firm Avalere, which wrote that, beginning in 2023, the Center for Medicare & Medicaid Services requires patients with Medicaid to receive “the full value of co-pay assistance” on drugs.

According to the National Conference of State Legislatures, co-pay adjustment programs present challenges for patients, with plans that include high cost sharing or co-insurance whereby a patient pays a percentage of the cost instead of a flat amount.

For example, with a co-pay adjustment policy, a patient with a $2,000 deductible plan couldn’t use a $500 coupon toward meeting the deductible, writes the National Conference of State Legislatures. Conversely, a patient in a plan without a co-pay adjustment policy could use the coupon to satisfy their annual deductible.

Patients with complex conditions, such as cancer, rheumatoid arthritis, and diabetes, which often require expensive medications, may have little choice but to fork over the unexpected co-pays, according to the organization that represents state legislatures in the United States.

The bill now moves to the Ohio Senate, reported The Columbus Dispatch.

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

The Ohio House of Representatives recently passed a bill that would enable patients to use drug manufacturer coupons and other co-pay assistance as payment toward their annual deductible.

According to the Kaiser Family Foundation, approximately 1 in 4 Americans have difficulty paying for their prescription drugs, while almost half of U.S. adults report difficulty paying out-of-pocket costs not covered by their health insurance.

Supporting the bill that restricts co-pay accumulators are groups such as the Ohio State Medical Association, the Crohn’s and Colitis Foundation, Susan C. Komen, the National Multiple Sclerosis Society, and the American Diabetes Association. The bill faced opposition from health insurers and pharmacy benefit managers, reported The Columbus Dispatch.

“The debate on the management of rising drug costs between manufacturers and insurers unfortunately leaves patients caught in the middle, and practices like co-pay accumulators can have a devastating impact,” Monica Hueckel, senior director of government relations for the Ohio State Medical Association, told this news organization.

“Patients often do not even know about these policies until the coupons are no longer usable. As you can imagine, for patients with expensive medications and/or high deductible health plans, the impact is disastrous,” she said.

Ohio State Representative Susan Manchester, who co-sponsored the bill, told The Columbus Dispatch that the legislation “is needed to assist our constituents who find themselves increasingly subjected to more out-of-pocket costs as part of their insurance coverage.”

Other states blocking health insurers’ co-pay policies

With the passage of the bill, Ohio joins 12 states and Puerto Rico in preventing the use of health insurers’ co-pays to increase patients’ out-of-pocket costs, reported The Columbus Dispatch; 15 states are also considering this type of legislation.

Eighty-three percent of patients are in plans that include a co-pay accumulator, according to consulting firm Avalere, which wrote that, beginning in 2023, the Center for Medicare & Medicaid Services requires patients with Medicaid to receive “the full value of co-pay assistance” on drugs.

According to the National Conference of State Legislatures, co-pay adjustment programs present challenges for patients, with plans that include high cost sharing or co-insurance whereby a patient pays a percentage of the cost instead of a flat amount.

For example, with a co-pay adjustment policy, a patient with a $2,000 deductible plan couldn’t use a $500 coupon toward meeting the deductible, writes the National Conference of State Legislatures. Conversely, a patient in a plan without a co-pay adjustment policy could use the coupon to satisfy their annual deductible.

Patients with complex conditions, such as cancer, rheumatoid arthritis, and diabetes, which often require expensive medications, may have little choice but to fork over the unexpected co-pays, according to the organization that represents state legislatures in the United States.

The bill now moves to the Ohio Senate, reported The Columbus Dispatch.

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

Emma Moore felt cornered. At a community health clinic in Portland, Ore., the 29-year-old nurse practitioner said she felt overwhelmed and undertrained. Coronavirus patients flooded the clinic for 2 years, and Ms. Moore struggled to keep up.

Then the stakes became clear. On March 25, about 2,400 miles away in a Tennessee courtroom, former nurse RaDonda Vaught was convicted of two felonies and facing 8 years in prison for a fatal medication mistake.

Like many nurses, Ms. Moore wondered if that could be her. She’d made medication errors before, although none so grievous. But what about the next one? In the pressure cooker of pandemic-era health care, another mistake felt inevitable.

Four days after Ms. Vaught’s verdict, Ms. Moore quit. She said Ms. Vaught’s verdict contributed to her decision.

“It’s not worth the possibility or the likelihood that this will happen,” Ms. Moore said, “if I’m in a situation where I’m set up to fail.”

In the wake of Ms. Vaught’s trial – an extremely rare case of a health care worker being criminally prosecuted for a medical error – nurses and nursing organizations have condemned the verdict through tens of thousands of social media posts, shares, comments, and videos. They warn that the fallout will ripple through their profession, demoralizing and depleting the ranks of nurses already stretched thin by the pandemic. Ultimately, they say, it will worsen health care for all.

Statements from the American Nurses Association, the American Association of Critical-Care Nurses, and the National Medical Association said Ms. Vaught’s conviction set a “dangerous precedent.” Linda H. Aiken, PhD, RN, a nursing and sociology professor at the University of Pennsylvania, Philadelphia, said that although Ms. Vaught’s case is an “outlier,” it will make nurses less forthcoming about mistakes.

“One thing that everybody agrees on is it’s going to have a dampening effect on the reporting of errors or near misses, which then has a detrimental effect on safety,” Dr. Aiken said. “The only way you can really learn about errors in these complicated systems is to have people say, ‘Oh, I almost gave the wrong drug because …’

“Well, nobody is going to say that now.”

Fear and outrage about Ms. Vaught’s case have swirled among nurses on Facebook, Twitter, and Reddit. On TikTok, a video platform increasingly popular among medical professionals, videos with the “#RaDondaVaught” hashtag totaled more than 47 million views.

Ms. Vaught’s supporters catapulted a plea for her clemency to the top of Change.org, a petition website. And thousands also joined a Facebook group planning to gather in protest outside Ms. Vaught’s sentencing hearing in May.

Ashley Bartholomew, BSN, RN, a 36-year-old Tampa nurse who followed the trial through YouTube and Twitter, echoed the fear of many others. Nurses have long felt forced into “impossible situations” by mounting responsibilities and staffing shortages, she said, particularly in hospitals that operate with lean staffing models.

“The big response we are seeing is because all of us are acutely aware of how bad the pandemic has exacerbated the existing problems,” Ms. Bartholomew said. And “setting a precedent for criminally charging [for] an error is only going to make this exponentially worse.”

Ms. Vaught, who worked at Vanderbilt University Medical Center in Nashville, Tenn., was convicted in the death of Charlene Murphey, a 75-year-old patient who died from a drug mix-up in 2017. Ms. Murphey was prescribed a dose of a sedative, Versed, but Ms. Vaught accidentally withdrew a powerful paralyzer, vecuronium, from an automated medication-dispensing cabinet and administered it to the patient.

Prosecutors argued that Ms. Vaught overlooked many obvious signs she’d withdrawn the wrong drug and did not monitor Ms. Murphey after she was given a deadly dose. Ms. Vaught owned up to the error but said it was an honest mistake, not a crime.

Some of Ms. Vaught’s peers support the conviction.

Scott G. Shelp, BSN, RN, a California nurse with a small YouTube channel, posted a 26-minute self-described “unpopular opinion” that Ms. Vaught deserves to serve prison time. “We need to stick up for each other,” he said, “but we cannot defend the indefensible.”

Mr. Shelp said he would never make the same error as Ms. Vaught and “neither would any competent nurse.” Regarding concerns that the conviction would discourage nurses from disclosing errors, Mr. Shelp said “dishonest” nurses “should be weeded out” of the profession anyway.

“In any other circumstance, I can’t believe anyone – including nurses – would accept ‘I didn’t mean to’ as a serious defense,” Mr. Shelp said. “Punishment for a harmful act someone actually did is justice.”

Ms. Vaught was acquitted of reckless homicide but convicted of a lesser charge, criminally negligent homicide, and gross neglect of an impaired adult. As outrage spread across social media, the Nashville district attorney’s office defended the conviction, saying in a statement it was “not an indictment against the nursing profession or the medical community.”

“This case is, and always has been, about the one single individual who made 17 egregious actions, and inactions, that killed an elderly woman,” said the office’s spokesperson, Steve Hayslip. “The jury found that Vaught’s actions were so far below the protocols and standard level of care, that the jury (which included a longtime nurse and another health care professional) returned a guilty verdict in less than four hours.”

The office of Tennessee Gov. Bill Lee confirmed he is not considering clemency for Ms. Vaught despite the Change.org petition, which had amassed about 187,000 signatures as of April 4.

Casey Black, press secretary for Gov. Lee, said that outside of death penalty cases the governor relies on the Board of Parole to recommend defendants for clemency, which happens only after sentencing and a board investigation.

But the controversy around Ms. Vaught’s case is far from over. As of April 4, more than 8,200 people had joined a Facebook group planning a march in protest outside the courthouse during her sentencing May 13.

Among the event’s planners is Tina Visant, the host of “Good Nurse Bad Nurse,” a podcast that followed Ms. Vaught’s case and opposed her prosecution.

“I don’t know how Nashville is going to handle it,” Ms. Visant said of the protest during a recent episode about Ms. Vaught’s trial. “There are a lot of people coming from all over.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Emma Moore felt cornered. At a community health clinic in Portland, Ore., the 29-year-old nurse practitioner said she felt overwhelmed and undertrained. Coronavirus patients flooded the clinic for 2 years, and Ms. Moore struggled to keep up.

Then the stakes became clear. On March 25, about 2,400 miles away in a Tennessee courtroom, former nurse RaDonda Vaught was convicted of two felonies and facing 8 years in prison for a fatal medication mistake.

Like many nurses, Ms. Moore wondered if that could be her. She’d made medication errors before, although none so grievous. But what about the next one? In the pressure cooker of pandemic-era health care, another mistake felt inevitable.

Four days after Ms. Vaught’s verdict, Ms. Moore quit. She said Ms. Vaught’s verdict contributed to her decision.

“It’s not worth the possibility or the likelihood that this will happen,” Ms. Moore said, “if I’m in a situation where I’m set up to fail.”

In the wake of Ms. Vaught’s trial – an extremely rare case of a health care worker being criminally prosecuted for a medical error – nurses and nursing organizations have condemned the verdict through tens of thousands of social media posts, shares, comments, and videos. They warn that the fallout will ripple through their profession, demoralizing and depleting the ranks of nurses already stretched thin by the pandemic. Ultimately, they say, it will worsen health care for all.

Statements from the American Nurses Association, the American Association of Critical-Care Nurses, and the National Medical Association said Ms. Vaught’s conviction set a “dangerous precedent.” Linda H. Aiken, PhD, RN, a nursing and sociology professor at the University of Pennsylvania, Philadelphia, said that although Ms. Vaught’s case is an “outlier,” it will make nurses less forthcoming about mistakes.

“One thing that everybody agrees on is it’s going to have a dampening effect on the reporting of errors or near misses, which then has a detrimental effect on safety,” Dr. Aiken said. “The only way you can really learn about errors in these complicated systems is to have people say, ‘Oh, I almost gave the wrong drug because …’

“Well, nobody is going to say that now.”

Fear and outrage about Ms. Vaught’s case have swirled among nurses on Facebook, Twitter, and Reddit. On TikTok, a video platform increasingly popular among medical professionals, videos with the “#RaDondaVaught” hashtag totaled more than 47 million views.

Ms. Vaught’s supporters catapulted a plea for her clemency to the top of Change.org, a petition website. And thousands also joined a Facebook group planning to gather in protest outside Ms. Vaught’s sentencing hearing in May.

Ashley Bartholomew, BSN, RN, a 36-year-old Tampa nurse who followed the trial through YouTube and Twitter, echoed the fear of many others. Nurses have long felt forced into “impossible situations” by mounting responsibilities and staffing shortages, she said, particularly in hospitals that operate with lean staffing models.

“The big response we are seeing is because all of us are acutely aware of how bad the pandemic has exacerbated the existing problems,” Ms. Bartholomew said. And “setting a precedent for criminally charging [for] an error is only going to make this exponentially worse.”

Ms. Vaught, who worked at Vanderbilt University Medical Center in Nashville, Tenn., was convicted in the death of Charlene Murphey, a 75-year-old patient who died from a drug mix-up in 2017. Ms. Murphey was prescribed a dose of a sedative, Versed, but Ms. Vaught accidentally withdrew a powerful paralyzer, vecuronium, from an automated medication-dispensing cabinet and administered it to the patient.

Prosecutors argued that Ms. Vaught overlooked many obvious signs she’d withdrawn the wrong drug and did not monitor Ms. Murphey after she was given a deadly dose. Ms. Vaught owned up to the error but said it was an honest mistake, not a crime.

Some of Ms. Vaught’s peers support the conviction.

Scott G. Shelp, BSN, RN, a California nurse with a small YouTube channel, posted a 26-minute self-described “unpopular opinion” that Ms. Vaught deserves to serve prison time. “We need to stick up for each other,” he said, “but we cannot defend the indefensible.”

Mr. Shelp said he would never make the same error as Ms. Vaught and “neither would any competent nurse.” Regarding concerns that the conviction would discourage nurses from disclosing errors, Mr. Shelp said “dishonest” nurses “should be weeded out” of the profession anyway.

“In any other circumstance, I can’t believe anyone – including nurses – would accept ‘I didn’t mean to’ as a serious defense,” Mr. Shelp said. “Punishment for a harmful act someone actually did is justice.”

Ms. Vaught was acquitted of reckless homicide but convicted of a lesser charge, criminally negligent homicide, and gross neglect of an impaired adult. As outrage spread across social media, the Nashville district attorney’s office defended the conviction, saying in a statement it was “not an indictment against the nursing profession or the medical community.”

“This case is, and always has been, about the one single individual who made 17 egregious actions, and inactions, that killed an elderly woman,” said the office’s spokesperson, Steve Hayslip. “The jury found that Vaught’s actions were so far below the protocols and standard level of care, that the jury (which included a longtime nurse and another health care professional) returned a guilty verdict in less than four hours.”

The office of Tennessee Gov. Bill Lee confirmed he is not considering clemency for Ms. Vaught despite the Change.org petition, which had amassed about 187,000 signatures as of April 4.

Casey Black, press secretary for Gov. Lee, said that outside of death penalty cases the governor relies on the Board of Parole to recommend defendants for clemency, which happens only after sentencing and a board investigation.

But the controversy around Ms. Vaught’s case is far from over. As of April 4, more than 8,200 people had joined a Facebook group planning a march in protest outside the courthouse during her sentencing May 13.

Among the event’s planners is Tina Visant, the host of “Good Nurse Bad Nurse,” a podcast that followed Ms. Vaught’s case and opposed her prosecution.

“I don’t know how Nashville is going to handle it,” Ms. Visant said of the protest during a recent episode about Ms. Vaught’s trial. “There are a lot of people coming from all over.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Emma Moore felt cornered. At a community health clinic in Portland, Ore., the 29-year-old nurse practitioner said she felt overwhelmed and undertrained. Coronavirus patients flooded the clinic for 2 years, and Ms. Moore struggled to keep up.

Then the stakes became clear. On March 25, about 2,400 miles away in a Tennessee courtroom, former nurse RaDonda Vaught was convicted of two felonies and facing 8 years in prison for a fatal medication mistake.

Like many nurses, Ms. Moore wondered if that could be her. She’d made medication errors before, although none so grievous. But what about the next one? In the pressure cooker of pandemic-era health care, another mistake felt inevitable.

Four days after Ms. Vaught’s verdict, Ms. Moore quit. She said Ms. Vaught’s verdict contributed to her decision.

“It’s not worth the possibility or the likelihood that this will happen,” Ms. Moore said, “if I’m in a situation where I’m set up to fail.”

In the wake of Ms. Vaught’s trial – an extremely rare case of a health care worker being criminally prosecuted for a medical error – nurses and nursing organizations have condemned the verdict through tens of thousands of social media posts, shares, comments, and videos. They warn that the fallout will ripple through their profession, demoralizing and depleting the ranks of nurses already stretched thin by the pandemic. Ultimately, they say, it will worsen health care for all.

Statements from the American Nurses Association, the American Association of Critical-Care Nurses, and the National Medical Association said Ms. Vaught’s conviction set a “dangerous precedent.” Linda H. Aiken, PhD, RN, a nursing and sociology professor at the University of Pennsylvania, Philadelphia, said that although Ms. Vaught’s case is an “outlier,” it will make nurses less forthcoming about mistakes.

“One thing that everybody agrees on is it’s going to have a dampening effect on the reporting of errors or near misses, which then has a detrimental effect on safety,” Dr. Aiken said. “The only way you can really learn about errors in these complicated systems is to have people say, ‘Oh, I almost gave the wrong drug because …’

“Well, nobody is going to say that now.”

Fear and outrage about Ms. Vaught’s case have swirled among nurses on Facebook, Twitter, and Reddit. On TikTok, a video platform increasingly popular among medical professionals, videos with the “#RaDondaVaught” hashtag totaled more than 47 million views.

Ms. Vaught’s supporters catapulted a plea for her clemency to the top of Change.org, a petition website. And thousands also joined a Facebook group planning to gather in protest outside Ms. Vaught’s sentencing hearing in May.

Ashley Bartholomew, BSN, RN, a 36-year-old Tampa nurse who followed the trial through YouTube and Twitter, echoed the fear of many others. Nurses have long felt forced into “impossible situations” by mounting responsibilities and staffing shortages, she said, particularly in hospitals that operate with lean staffing models.

“The big response we are seeing is because all of us are acutely aware of how bad the pandemic has exacerbated the existing problems,” Ms. Bartholomew said. And “setting a precedent for criminally charging [for] an error is only going to make this exponentially worse.”

Ms. Vaught, who worked at Vanderbilt University Medical Center in Nashville, Tenn., was convicted in the death of Charlene Murphey, a 75-year-old patient who died from a drug mix-up in 2017. Ms. Murphey was prescribed a dose of a sedative, Versed, but Ms. Vaught accidentally withdrew a powerful paralyzer, vecuronium, from an automated medication-dispensing cabinet and administered it to the patient.

Prosecutors argued that Ms. Vaught overlooked many obvious signs she’d withdrawn the wrong drug and did not monitor Ms. Murphey after she was given a deadly dose. Ms. Vaught owned up to the error but said it was an honest mistake, not a crime.

Some of Ms. Vaught’s peers support the conviction.

Scott G. Shelp, BSN, RN, a California nurse with a small YouTube channel, posted a 26-minute self-described “unpopular opinion” that Ms. Vaught deserves to serve prison time. “We need to stick up for each other,” he said, “but we cannot defend the indefensible.”

Mr. Shelp said he would never make the same error as Ms. Vaught and “neither would any competent nurse.” Regarding concerns that the conviction would discourage nurses from disclosing errors, Mr. Shelp said “dishonest” nurses “should be weeded out” of the profession anyway.

“In any other circumstance, I can’t believe anyone – including nurses – would accept ‘I didn’t mean to’ as a serious defense,” Mr. Shelp said. “Punishment for a harmful act someone actually did is justice.”

Ms. Vaught was acquitted of reckless homicide but convicted of a lesser charge, criminally negligent homicide, and gross neglect of an impaired adult. As outrage spread across social media, the Nashville district attorney’s office defended the conviction, saying in a statement it was “not an indictment against the nursing profession or the medical community.”

“This case is, and always has been, about the one single individual who made 17 egregious actions, and inactions, that killed an elderly woman,” said the office’s spokesperson, Steve Hayslip. “The jury found that Vaught’s actions were so far below the protocols and standard level of care, that the jury (which included a longtime nurse and another health care professional) returned a guilty verdict in less than four hours.”

The office of Tennessee Gov. Bill Lee confirmed he is not considering clemency for Ms. Vaught despite the Change.org petition, which had amassed about 187,000 signatures as of April 4.

Casey Black, press secretary for Gov. Lee, said that outside of death penalty cases the governor relies on the Board of Parole to recommend defendants for clemency, which happens only after sentencing and a board investigation.

But the controversy around Ms. Vaught’s case is far from over. As of April 4, more than 8,200 people had joined a Facebook group planning a march in protest outside the courthouse during her sentencing May 13.

Among the event’s planners is Tina Visant, the host of “Good Nurse Bad Nurse,” a podcast that followed Ms. Vaught’s case and opposed her prosecution.

“I don’t know how Nashville is going to handle it,” Ms. Visant said of the protest during a recent episode about Ms. Vaught’s trial. “There are a lot of people coming from all over.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Most surgeons report being affected by performance anxiety in relation to their work, with the anxiety frequently having a negative effect on well-being, a new study of surgeons in the United Kingdom shows.

“Performance anxiety or stage fright is a widely recognized problem in music and sports, and there are many similarities between these arenas and the operating theater,” first author Robert Miller, MRCS, of the Surgical Psychology and Performance Group and the department of plastic and reconstructive surgery at St. George’s Hospital NHS Trust, London, said in an interview. “We were aware of it anecdotally in a surgical context, but for one reason or another, perhaps professional pride and fear of negative perception, this is rarely openly discussed amongst surgeons.”

In the cross-sectional study, published in Annals of Surgery, Dr. Miller and colleagues surveyed surgeons in all specialties working in the United Kingdom who had at least 1 year of postgraduate surgical training.

Of a total of 631 responses received, 523 (83%) were included in the analysis. The median age of those who responded was 41.2 years, and the mean duration of surgical experience was 15.3 years (range, 1-52 years). Among them, 62% were men, and 52% were of consultant/attending grade.

All of the respondents – 100% – said they believed that performance anxiety affected surgeons, 87% reported having experienced it themselves, and 65% said they felt that performance anxiety had an effect on their surgical performance.

Both male and female surgeons who reported experiencing performance anxiety had significantly worse mental well-being, as assessed using the Short Warwick Edinburgh Mental Wellbeing Scale, compared with those who did not have performance anxiety (P < .0001 for men and P < .001 for women).

Overall, however, male surgeons had significantly better mental well-being, compared with female surgeons (P = .003), yet both genders had significantly lower mental well-being scores compared with U.K. population norms (P = .0019 for men and P = .0001 for women).

The gender differences are “clearly an important topic, which is likely multifactorial,” Dr. Miller told this news organization. “The gender well-being gap requires more in-depth research, and qualitative work involving female surgeons is critical.”

Surgical perfectionism was significantly more common among respondents who did have performance anxiety in comparison with those who did not (P < .0001).

“Although perfectionism may be a beneficial trait in surgery, our findings from hierarchical multiple regression analysis also indicate that perfectionism, [as well as] sex and experience, may drive surgical performance anxiety and help predict those experiencing [the anxiety],” the authors noted.
 

Performing in presence of colleagues a key trigger

By far, the leading trigger that was identified as prompting surgeon performance anxiety was the presence – and scrutiny – of colleagues within the parent specialty. This was reported by 151 respondents. Other triggers were having to perform on highly complex or high-risk cases (66 responses) and a lack of experience (30 responses).

Next to planning and preparation, opening up and talking about the anxiety and shedding light on the issue was seen as a leading strategy to help with the problem, but very few respondents reported openly sharing their struggles. Only 9% reported that they had shared it openly; 27% said they had confided in someone, and 47% did not respond to the question.

“I wish we talked about it more and shared our insecurities,” one respondent lamented. “Most of my colleagues pretend they are living gods.”

Only about 45% of respondents reported a specific technique for overcoming their anxiety. In addition to being open about the problem, other techniques included self-care, such as exercise; and distraction outside of work to get perspective; relaxation techniques such as deep or controlled breathing; music; mindfulness; and positive self-statements.

About 9% said they had received psychological counseling for performance anxiety, and only 3% reported using medication for the problem.
 

Anxiety a positive factor?

Surprisingly, 70% of respondents reported feeling that surgical performance anxiety could have a positive impact on surgical performance, which the authors noted is consistent with some theories.

“This may be explained by the traditional bell-curve relationship between arousal and performance, which describes a dose-dependent relationship between performance and arousal until a ‘tipping point,’ after which performance declines,” the authors explained. “A heightened awareness secondary to anxiety may be beneficial, but at high doses, anxiety can negatively affect attentional control and cause somatic symptoms.”

They noted that “the challenge would be to reap the benefits of low-level stimulation without incurring possible adverse effects.”

Dr. Miller said that, in determining whether selection bias had a role in the results, a detailed analysis showed that “our respondents were not skewed to those with only high levels of trait anxiety.

“We also had a good spread of consultants versus trainees [about half and half], and different specialties, so we feel this is likely to be a representative sample,” he told this news organization.

That being said, the results underscore the need for increased awareness – and open discussion – of the issue of surgical performance anxiety.

“Within other professions, particularly the performing arts and sports, performance psychology is becoming an integral part of training and development,” Dr. Miller said. “We feel surgeons should be supported in a similar manner.

“Surgical performance anxiety is normal for surgeons at all levels and not something to be ashamed about,” Dr. Miller added. “Talk about it, acknowledge it, and be supportive to your colleagues.”
 

Many keep it to themselves in ‘prevailing culture of stoicism’

Commenting on the study, Carter C. Lebares, MD, an associate professor of surgery and director of the Center for Mindfulness in Surgery, department of surgery, University of California, San Francisco, said she was not surprised to see the high rates of performance anxiety among surgeons.

“As surgeons, no matter how hard we train or how thoroughly we prepare our intellectual understanding or the patient, the disease process, and the operation, there may be surprises, unforeseen challenges, or off days,” Dr. Lebares said.

“And whatever we encounter, we are managing these things directly under the scrutiny of others – people who can affect our reputation, operating privileges, and mental health. So, I am not surprised this is a prevalent and widely recognized issue.”

Dr. Lebares noted that the reluctance to share the anxiety is part of a “challenging and recognized conundrum in both medicine and surgery and is a matter of the prevailing culture of stoicism.

“We often are called to shoulder tremendous weight intraoperatively (having perseverance, self-confidence, or sustained focus), and in owning the weight of complications (which eventually we all will have),” she said.

“So, we do need to be strong and not complain, [but] we also need to be able to set that aside [when appropriate] and ask for help or allow others to shoulder the weight for a while, and this is not [yet] a common part of surgical culture.”

Dr. Lebares added that randomized, controlled trials have shown benefits of mindfulness interventions on burnout and anxiety.

“We have observed positive effects on mental noise, self-perception, conflict resolution, and resilience in surgical residents trained in mindfulness-based cognitive skills,” she said. “[Residents] report applying these skills in the OR, in their home lives, and in how they approach their training/education.”

The authors disclosed no relevant financial relationships. Dr. Lebares has developed mindfulness-based cognitive skills training for surgeons but receives no financial compensation for the activities.

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

Most surgeons report being affected by performance anxiety in relation to their work, with the anxiety frequently having a negative effect on well-being, a new study of surgeons in the United Kingdom shows.

“Performance anxiety or stage fright is a widely recognized problem in music and sports, and there are many similarities between these arenas and the operating theater,” first author Robert Miller, MRCS, of the Surgical Psychology and Performance Group and the department of plastic and reconstructive surgery at St. George’s Hospital NHS Trust, London, said in an interview. “We were aware of it anecdotally in a surgical context, but for one reason or another, perhaps professional pride and fear of negative perception, this is rarely openly discussed amongst surgeons.”

In the cross-sectional study, published in Annals of Surgery, Dr. Miller and colleagues surveyed surgeons in all specialties working in the United Kingdom who had at least 1 year of postgraduate surgical training.

Of a total of 631 responses received, 523 (83%) were included in the analysis. The median age of those who responded was 41.2 years, and the mean duration of surgical experience was 15.3 years (range, 1-52 years). Among them, 62% were men, and 52% were of consultant/attending grade.

All of the respondents – 100% – said they believed that performance anxiety affected surgeons, 87% reported having experienced it themselves, and 65% said they felt that performance anxiety had an effect on their surgical performance.

Both male and female surgeons who reported experiencing performance anxiety had significantly worse mental well-being, as assessed using the Short Warwick Edinburgh Mental Wellbeing Scale, compared with those who did not have performance anxiety (P < .0001 for men and P < .001 for women).

Overall, however, male surgeons had significantly better mental well-being, compared with female surgeons (P = .003), yet both genders had significantly lower mental well-being scores compared with U.K. population norms (P = .0019 for men and P = .0001 for women).

The gender differences are “clearly an important topic, which is likely multifactorial,” Dr. Miller told this news organization. “The gender well-being gap requires more in-depth research, and qualitative work involving female surgeons is critical.”

Surgical perfectionism was significantly more common among respondents who did have performance anxiety in comparison with those who did not (P < .0001).

“Although perfectionism may be a beneficial trait in surgery, our findings from hierarchical multiple regression analysis also indicate that perfectionism, [as well as] sex and experience, may drive surgical performance anxiety and help predict those experiencing [the anxiety],” the authors noted.
 

Performing in presence of colleagues a key trigger

By far, the leading trigger that was identified as prompting surgeon performance anxiety was the presence – and scrutiny – of colleagues within the parent specialty. This was reported by 151 respondents. Other triggers were having to perform on highly complex or high-risk cases (66 responses) and a lack of experience (30 responses).

Next to planning and preparation, opening up and talking about the anxiety and shedding light on the issue was seen as a leading strategy to help with the problem, but very few respondents reported openly sharing their struggles. Only 9% reported that they had shared it openly; 27% said they had confided in someone, and 47% did not respond to the question.

“I wish we talked about it more and shared our insecurities,” one respondent lamented. “Most of my colleagues pretend they are living gods.”

Only about 45% of respondents reported a specific technique for overcoming their anxiety. In addition to being open about the problem, other techniques included self-care, such as exercise; and distraction outside of work to get perspective; relaxation techniques such as deep or controlled breathing; music; mindfulness; and positive self-statements.

About 9% said they had received psychological counseling for performance anxiety, and only 3% reported using medication for the problem.
 

Anxiety a positive factor?

Surprisingly, 70% of respondents reported feeling that surgical performance anxiety could have a positive impact on surgical performance, which the authors noted is consistent with some theories.

“This may be explained by the traditional bell-curve relationship between arousal and performance, which describes a dose-dependent relationship between performance and arousal until a ‘tipping point,’ after which performance declines,” the authors explained. “A heightened awareness secondary to anxiety may be beneficial, but at high doses, anxiety can negatively affect attentional control and cause somatic symptoms.”

They noted that “the challenge would be to reap the benefits of low-level stimulation without incurring possible adverse effects.”

Dr. Miller said that, in determining whether selection bias had a role in the results, a detailed analysis showed that “our respondents were not skewed to those with only high levels of trait anxiety.

“We also had a good spread of consultants versus trainees [about half and half], and different specialties, so we feel this is likely to be a representative sample,” he told this news organization.

That being said, the results underscore the need for increased awareness – and open discussion – of the issue of surgical performance anxiety.

“Within other professions, particularly the performing arts and sports, performance psychology is becoming an integral part of training and development,” Dr. Miller said. “We feel surgeons should be supported in a similar manner.

“Surgical performance anxiety is normal for surgeons at all levels and not something to be ashamed about,” Dr. Miller added. “Talk about it, acknowledge it, and be supportive to your colleagues.”
 

Many keep it to themselves in ‘prevailing culture of stoicism’

Commenting on the study, Carter C. Lebares, MD, an associate professor of surgery and director of the Center for Mindfulness in Surgery, department of surgery, University of California, San Francisco, said she was not surprised to see the high rates of performance anxiety among surgeons.

“As surgeons, no matter how hard we train or how thoroughly we prepare our intellectual understanding or the patient, the disease process, and the operation, there may be surprises, unforeseen challenges, or off days,” Dr. Lebares said.

“And whatever we encounter, we are managing these things directly under the scrutiny of others – people who can affect our reputation, operating privileges, and mental health. So, I am not surprised this is a prevalent and widely recognized issue.”

Dr. Lebares noted that the reluctance to share the anxiety is part of a “challenging and recognized conundrum in both medicine and surgery and is a matter of the prevailing culture of stoicism.

“We often are called to shoulder tremendous weight intraoperatively (having perseverance, self-confidence, or sustained focus), and in owning the weight of complications (which eventually we all will have),” she said.

“So, we do need to be strong and not complain, [but] we also need to be able to set that aside [when appropriate] and ask for help or allow others to shoulder the weight for a while, and this is not [yet] a common part of surgical culture.”

Dr. Lebares added that randomized, controlled trials have shown benefits of mindfulness interventions on burnout and anxiety.

“We have observed positive effects on mental noise, self-perception, conflict resolution, and resilience in surgical residents trained in mindfulness-based cognitive skills,” she said. “[Residents] report applying these skills in the OR, in their home lives, and in how they approach their training/education.”

The authors disclosed no relevant financial relationships. Dr. Lebares has developed mindfulness-based cognitive skills training for surgeons but receives no financial compensation for the activities.

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

Most surgeons report being affected by performance anxiety in relation to their work, with the anxiety frequently having a negative effect on well-being, a new study of surgeons in the United Kingdom shows.

“Performance anxiety or stage fright is a widely recognized problem in music and sports, and there are many similarities between these arenas and the operating theater,” first author Robert Miller, MRCS, of the Surgical Psychology and Performance Group and the department of plastic and reconstructive surgery at St. George’s Hospital NHS Trust, London, said in an interview. “We were aware of it anecdotally in a surgical context, but for one reason or another, perhaps professional pride and fear of negative perception, this is rarely openly discussed amongst surgeons.”

In the cross-sectional study, published in Annals of Surgery, Dr. Miller and colleagues surveyed surgeons in all specialties working in the United Kingdom who had at least 1 year of postgraduate surgical training.

Of a total of 631 responses received, 523 (83%) were included in the analysis. The median age of those who responded was 41.2 years, and the mean duration of surgical experience was 15.3 years (range, 1-52 years). Among them, 62% were men, and 52% were of consultant/attending grade.

All of the respondents – 100% – said they believed that performance anxiety affected surgeons, 87% reported having experienced it themselves, and 65% said they felt that performance anxiety had an effect on their surgical performance.

Both male and female surgeons who reported experiencing performance anxiety had significantly worse mental well-being, as assessed using the Short Warwick Edinburgh Mental Wellbeing Scale, compared with those who did not have performance anxiety (P < .0001 for men and P < .001 for women).

Overall, however, male surgeons had significantly better mental well-being, compared with female surgeons (P = .003), yet both genders had significantly lower mental well-being scores compared with U.K. population norms (P = .0019 for men and P = .0001 for women).

The gender differences are “clearly an important topic, which is likely multifactorial,” Dr. Miller told this news organization. “The gender well-being gap requires more in-depth research, and qualitative work involving female surgeons is critical.”

Surgical perfectionism was significantly more common among respondents who did have performance anxiety in comparison with those who did not (P < .0001).

“Although perfectionism may be a beneficial trait in surgery, our findings from hierarchical multiple regression analysis also indicate that perfectionism, [as well as] sex and experience, may drive surgical performance anxiety and help predict those experiencing [the anxiety],” the authors noted.
 

Performing in presence of colleagues a key trigger

By far, the leading trigger that was identified as prompting surgeon performance anxiety was the presence – and scrutiny – of colleagues within the parent specialty. This was reported by 151 respondents. Other triggers were having to perform on highly complex or high-risk cases (66 responses) and a lack of experience (30 responses).

Next to planning and preparation, opening up and talking about the anxiety and shedding light on the issue was seen as a leading strategy to help with the problem, but very few respondents reported openly sharing their struggles. Only 9% reported that they had shared it openly; 27% said they had confided in someone, and 47% did not respond to the question.

“I wish we talked about it more and shared our insecurities,” one respondent lamented. “Most of my colleagues pretend they are living gods.”

Only about 45% of respondents reported a specific technique for overcoming their anxiety. In addition to being open about the problem, other techniques included self-care, such as exercise; and distraction outside of work to get perspective; relaxation techniques such as deep or controlled breathing; music; mindfulness; and positive self-statements.

About 9% said they had received psychological counseling for performance anxiety, and only 3% reported using medication for the problem.
 

Anxiety a positive factor?

Surprisingly, 70% of respondents reported feeling that surgical performance anxiety could have a positive impact on surgical performance, which the authors noted is consistent with some theories.

“This may be explained by the traditional bell-curve relationship between arousal and performance, which describes a dose-dependent relationship between performance and arousal until a ‘tipping point,’ after which performance declines,” the authors explained. “A heightened awareness secondary to anxiety may be beneficial, but at high doses, anxiety can negatively affect attentional control and cause somatic symptoms.”

They noted that “the challenge would be to reap the benefits of low-level stimulation without incurring possible adverse effects.”

Dr. Miller said that, in determining whether selection bias had a role in the results, a detailed analysis showed that “our respondents were not skewed to those with only high levels of trait anxiety.

“We also had a good spread of consultants versus trainees [about half and half], and different specialties, so we feel this is likely to be a representative sample,” he told this news organization.

That being said, the results underscore the need for increased awareness – and open discussion – of the issue of surgical performance anxiety.

“Within other professions, particularly the performing arts and sports, performance psychology is becoming an integral part of training and development,” Dr. Miller said. “We feel surgeons should be supported in a similar manner.

“Surgical performance anxiety is normal for surgeons at all levels and not something to be ashamed about,” Dr. Miller added. “Talk about it, acknowledge it, and be supportive to your colleagues.”
 

Many keep it to themselves in ‘prevailing culture of stoicism’

Commenting on the study, Carter C. Lebares, MD, an associate professor of surgery and director of the Center for Mindfulness in Surgery, department of surgery, University of California, San Francisco, said she was not surprised to see the high rates of performance anxiety among surgeons.

“As surgeons, no matter how hard we train or how thoroughly we prepare our intellectual understanding or the patient, the disease process, and the operation, there may be surprises, unforeseen challenges, or off days,” Dr. Lebares said.

“And whatever we encounter, we are managing these things directly under the scrutiny of others – people who can affect our reputation, operating privileges, and mental health. So, I am not surprised this is a prevalent and widely recognized issue.”

Dr. Lebares noted that the reluctance to share the anxiety is part of a “challenging and recognized conundrum in both medicine and surgery and is a matter of the prevailing culture of stoicism.

“We often are called to shoulder tremendous weight intraoperatively (having perseverance, self-confidence, or sustained focus), and in owning the weight of complications (which eventually we all will have),” she said.

“So, we do need to be strong and not complain, [but] we also need to be able to set that aside [when appropriate] and ask for help or allow others to shoulder the weight for a while, and this is not [yet] a common part of surgical culture.”

Dr. Lebares added that randomized, controlled trials have shown benefits of mindfulness interventions on burnout and anxiety.

“We have observed positive effects on mental noise, self-perception, conflict resolution, and resilience in surgical residents trained in mindfulness-based cognitive skills,” she said. “[Residents] report applying these skills in the OR, in their home lives, and in how they approach their training/education.”

The authors disclosed no relevant financial relationships. Dr. Lebares has developed mindfulness-based cognitive skills training for surgeons but receives no financial compensation for the activities.

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

It’s tough being on the receiving end of care. I’ve tried to avoid it as much as possible, being ever mindful of the law from Samuel Shem’s The House of God: “They can always hurt you more.”

I recently had several medical encounters at three different facilities, highlighting systemic problems in medical care. Fortunately, each procedure went more smoothly than the prior one.

The first was not so elective. I had some uncomfortable symptoms while exercising and, not wanting to totally be in denial, contacted my doctor to ensure that it was not cardiac in origin since symptoms are often atypical in women.

My physician promptly saw me, then scheduled a nuclear stress test. There was a series of needless glitches. Registration at the diagnostic center had me on their schedule but did not have an order. They would have canceled the procedure had I not been able to get hold of the doctor’s office. Why isn’t an order automatically entered when the physician schedules the test?

While I was given the euphemistic “Patient Rights” brochure, asking to have reports sent to a physician outside of the University of Pittsburgh Medical Center empire is apparently not included.

The staff canceled the stress test because I was not fasting. I had received no instructions from diagnostic cardiology. They suggested it was my internist’s responsibility.

I deliberately ate (2 hours earlier) because my trainer always wants me to eat a light meal so I don’t get hypoglycemic during our workouts, and an exercise stress test, is, of course, a workout. The nurse practitioner said that they were concerned I would vomit. I offered to sign a waiver. She parried, saying they would not be able to get adequate images, so I was out of luck.

When I expressed concern about getting hypoglycemic and having difficulty with the test if fasting, the tech said I should bring a soda and snack. Who tells a “borderline” diabetic to bring a soda?

The tech also said she had called our home to give instructions but encountered a busy signal and had not had time to call back. I had not left the house during the prior week (or most of the past 2 years), so this was a pretty lame excuse.

I suggested to the administration that the hospital offer to email the patient instructions well ahead of time (and perhaps ask for confirmation of receipt). If calling, they should try more than once. They should also have patient instruction sheets at the physician’s office and perhaps have them on their website.

It turns out that the hospital mailed me instructions, not on the date it was ordered, but with the postmark being the day of the procedure itself. With Trump donor Louis DeJoy in charge of the U.S. Postal Service, mail across town now has to travel to Baltimore, 3 hours away, be sorted, and returned.

I did finally have the stress test, which was reassuringly normal. I was not surprised, given that the fury I felt on the first attempt had not precipitated symptoms. The hospital sent a patient ombudsman to meet me there to discuss my previous complaints. I have no idea if they implemented any of the changes I had suggested. In 2021, when I urgently had to take my husband to the ED, I couldn’t see the sign pointing toward the ED and had to ask for directions at the main entrance. They said they would fix that promptly but still have not improved the signage. How I miss the friendly community hospital we had before!

Next was trigger-finger surgery. I had developed that in 1978 from using crutches after a fall. I figured that the relative lull in COVID and my activities made it as good a time as any to finally have it fixed. The surgicenter was great; the surgeon was someone I had worked with and respected for decades. The only glitch was not really knowing how long I was going to be out of commission.

The third encounter (at yet another institution) went really well, despite some early administrative glitches. My major complaint was with the lack of communication between preoperative anesthesia and the operating room and the lack of personalization of preoperative instructions. Despite EPIC, medicines were not correctly reconciled between the different encounters, even on the same day!

After about 15 years of diplopia, which has been gradually worsening, my eye doc had suggested that I consider strabismus surgery as a sort of last-ditch effort to improve my quality of life.

Anesthesiology has stock instructions, which they made no effort to individualize. For example, there is no reason to stop NSAIDs a week before such minor surgery. That’s a problem if you depend on NSAIDs for pain control. Similarly, nothing by mouth after midnight is passé and could be tailored for the patient. I felt particularly inconvenienced that I had to go out of town for the preoperative visit and then have a redundant preoperative clearance by my physician.

The nurses in the preoperative area made me feel quite comfortable and as relaxed as I could be under the circumstances. They had a good sense of humor, which helped too. And from the time I met him a few weeks earlier, I instantly liked my surgeon and felt very comfortable with him and had complete trust.

I was pleased that the chief anesthesiologist responded promptly and undefensively to my letter expressing concerns. I do believe that he will try to improve the systemic problems.

The best part: The surgery appears to have been successful and I should have a significantly improved quality of life.

Hospitals could do so much better by improving communications with patients and by viewing them as customers whose loyalty they must earn and will value. With monopolies growing, memories of such care are quickly fading, soon to be as extinct as the family doc who made house calls.

Dr. Stone is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph over Evil and Conducting Clinical Research: A Practical Guide. She disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

It’s tough being on the receiving end of care. I’ve tried to avoid it as much as possible, being ever mindful of the law from Samuel Shem’s The House of God: “They can always hurt you more.”

I recently had several medical encounters at three different facilities, highlighting systemic problems in medical care. Fortunately, each procedure went more smoothly than the prior one.

The first was not so elective. I had some uncomfortable symptoms while exercising and, not wanting to totally be in denial, contacted my doctor to ensure that it was not cardiac in origin since symptoms are often atypical in women.

My physician promptly saw me, then scheduled a nuclear stress test. There was a series of needless glitches. Registration at the diagnostic center had me on their schedule but did not have an order. They would have canceled the procedure had I not been able to get hold of the doctor’s office. Why isn’t an order automatically entered when the physician schedules the test?

While I was given the euphemistic “Patient Rights” brochure, asking to have reports sent to a physician outside of the University of Pittsburgh Medical Center empire is apparently not included.

The staff canceled the stress test because I was not fasting. I had received no instructions from diagnostic cardiology. They suggested it was my internist’s responsibility.

I deliberately ate (2 hours earlier) because my trainer always wants me to eat a light meal so I don’t get hypoglycemic during our workouts, and an exercise stress test, is, of course, a workout. The nurse practitioner said that they were concerned I would vomit. I offered to sign a waiver. She parried, saying they would not be able to get adequate images, so I was out of luck.

When I expressed concern about getting hypoglycemic and having difficulty with the test if fasting, the tech said I should bring a soda and snack. Who tells a “borderline” diabetic to bring a soda?

The tech also said she had called our home to give instructions but encountered a busy signal and had not had time to call back. I had not left the house during the prior week (or most of the past 2 years), so this was a pretty lame excuse.

I suggested to the administration that the hospital offer to email the patient instructions well ahead of time (and perhaps ask for confirmation of receipt). If calling, they should try more than once. They should also have patient instruction sheets at the physician’s office and perhaps have them on their website.

It turns out that the hospital mailed me instructions, not on the date it was ordered, but with the postmark being the day of the procedure itself. With Trump donor Louis DeJoy in charge of the U.S. Postal Service, mail across town now has to travel to Baltimore, 3 hours away, be sorted, and returned.

I did finally have the stress test, which was reassuringly normal. I was not surprised, given that the fury I felt on the first attempt had not precipitated symptoms. The hospital sent a patient ombudsman to meet me there to discuss my previous complaints. I have no idea if they implemented any of the changes I had suggested. In 2021, when I urgently had to take my husband to the ED, I couldn’t see the sign pointing toward the ED and had to ask for directions at the main entrance. They said they would fix that promptly but still have not improved the signage. How I miss the friendly community hospital we had before!

Next was trigger-finger surgery. I had developed that in 1978 from using crutches after a fall. I figured that the relative lull in COVID and my activities made it as good a time as any to finally have it fixed. The surgicenter was great; the surgeon was someone I had worked with and respected for decades. The only glitch was not really knowing how long I was going to be out of commission.

The third encounter (at yet another institution) went really well, despite some early administrative glitches. My major complaint was with the lack of communication between preoperative anesthesia and the operating room and the lack of personalization of preoperative instructions. Despite EPIC, medicines were not correctly reconciled between the different encounters, even on the same day!

After about 15 years of diplopia, which has been gradually worsening, my eye doc had suggested that I consider strabismus surgery as a sort of last-ditch effort to improve my quality of life.

Anesthesiology has stock instructions, which they made no effort to individualize. For example, there is no reason to stop NSAIDs a week before such minor surgery. That’s a problem if you depend on NSAIDs for pain control. Similarly, nothing by mouth after midnight is passé and could be tailored for the patient. I felt particularly inconvenienced that I had to go out of town for the preoperative visit and then have a redundant preoperative clearance by my physician.

The nurses in the preoperative area made me feel quite comfortable and as relaxed as I could be under the circumstances. They had a good sense of humor, which helped too. And from the time I met him a few weeks earlier, I instantly liked my surgeon and felt very comfortable with him and had complete trust.

I was pleased that the chief anesthesiologist responded promptly and undefensively to my letter expressing concerns. I do believe that he will try to improve the systemic problems.

The best part: The surgery appears to have been successful and I should have a significantly improved quality of life.

Hospitals could do so much better by improving communications with patients and by viewing them as customers whose loyalty they must earn and will value. With monopolies growing, memories of such care are quickly fading, soon to be as extinct as the family doc who made house calls.

Dr. Stone is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph over Evil and Conducting Clinical Research: A Practical Guide. She disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

It’s tough being on the receiving end of care. I’ve tried to avoid it as much as possible, being ever mindful of the law from Samuel Shem’s The House of God: “They can always hurt you more.”

I recently had several medical encounters at three different facilities, highlighting systemic problems in medical care. Fortunately, each procedure went more smoothly than the prior one.

The first was not so elective. I had some uncomfortable symptoms while exercising and, not wanting to totally be in denial, contacted my doctor to ensure that it was not cardiac in origin since symptoms are often atypical in women.

My physician promptly saw me, then scheduled a nuclear stress test. There was a series of needless glitches. Registration at the diagnostic center had me on their schedule but did not have an order. They would have canceled the procedure had I not been able to get hold of the doctor’s office. Why isn’t an order automatically entered when the physician schedules the test?

While I was given the euphemistic “Patient Rights” brochure, asking to have reports sent to a physician outside of the University of Pittsburgh Medical Center empire is apparently not included.

The staff canceled the stress test because I was not fasting. I had received no instructions from diagnostic cardiology. They suggested it was my internist’s responsibility.

I deliberately ate (2 hours earlier) because my trainer always wants me to eat a light meal so I don’t get hypoglycemic during our workouts, and an exercise stress test, is, of course, a workout. The nurse practitioner said that they were concerned I would vomit. I offered to sign a waiver. She parried, saying they would not be able to get adequate images, so I was out of luck.

When I expressed concern about getting hypoglycemic and having difficulty with the test if fasting, the tech said I should bring a soda and snack. Who tells a “borderline” diabetic to bring a soda?

The tech also said she had called our home to give instructions but encountered a busy signal and had not had time to call back. I had not left the house during the prior week (or most of the past 2 years), so this was a pretty lame excuse.

I suggested to the administration that the hospital offer to email the patient instructions well ahead of time (and perhaps ask for confirmation of receipt). If calling, they should try more than once. They should also have patient instruction sheets at the physician’s office and perhaps have them on their website.

It turns out that the hospital mailed me instructions, not on the date it was ordered, but with the postmark being the day of the procedure itself. With Trump donor Louis DeJoy in charge of the U.S. Postal Service, mail across town now has to travel to Baltimore, 3 hours away, be sorted, and returned.

I did finally have the stress test, which was reassuringly normal. I was not surprised, given that the fury I felt on the first attempt had not precipitated symptoms. The hospital sent a patient ombudsman to meet me there to discuss my previous complaints. I have no idea if they implemented any of the changes I had suggested. In 2021, when I urgently had to take my husband to the ED, I couldn’t see the sign pointing toward the ED and had to ask for directions at the main entrance. They said they would fix that promptly but still have not improved the signage. How I miss the friendly community hospital we had before!

Next was trigger-finger surgery. I had developed that in 1978 from using crutches after a fall. I figured that the relative lull in COVID and my activities made it as good a time as any to finally have it fixed. The surgicenter was great; the surgeon was someone I had worked with and respected for decades. The only glitch was not really knowing how long I was going to be out of commission.

The third encounter (at yet another institution) went really well, despite some early administrative glitches. My major complaint was with the lack of communication between preoperative anesthesia and the operating room and the lack of personalization of preoperative instructions. Despite EPIC, medicines were not correctly reconciled between the different encounters, even on the same day!

After about 15 years of diplopia, which has been gradually worsening, my eye doc had suggested that I consider strabismus surgery as a sort of last-ditch effort to improve my quality of life.

Anesthesiology has stock instructions, which they made no effort to individualize. For example, there is no reason to stop NSAIDs a week before such minor surgery. That’s a problem if you depend on NSAIDs for pain control. Similarly, nothing by mouth after midnight is passé and could be tailored for the patient. I felt particularly inconvenienced that I had to go out of town for the preoperative visit and then have a redundant preoperative clearance by my physician.

The nurses in the preoperative area made me feel quite comfortable and as relaxed as I could be under the circumstances. They had a good sense of humor, which helped too. And from the time I met him a few weeks earlier, I instantly liked my surgeon and felt very comfortable with him and had complete trust.

I was pleased that the chief anesthesiologist responded promptly and undefensively to my letter expressing concerns. I do believe that he will try to improve the systemic problems.

The best part: The surgery appears to have been successful and I should have a significantly improved quality of life.

Hospitals could do so much better by improving communications with patients and by viewing them as customers whose loyalty they must earn and will value. With monopolies growing, memories of such care are quickly fading, soon to be as extinct as the family doc who made house calls.

Dr. Stone is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph over Evil and Conducting Clinical Research: A Practical Guide. She disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

The 5 days that she spent at her mother’s bedside were eye-opening for an oncologist used to being on the other side of the clinician–patient relationship.

“As a physician, I thought I had a unique perspective of things that were done well – and things that were not,” commented Pamela Kunz, MD.

Dr. Kunz, who was named the 2021 Woman Oncologist of the Year, is director of the Center for Gastrointestinal Cancers at Smilow Cancer Hospital and of the Yale Cancer Center, New Haven, Conn.

But she was propelled into quite a different role when her mother was admitted to the hospital.

Her mom, who has trouble hearing, was easily confused by jargon and by “all of the people coming in and out with no introductions,” she explained.

“She needed someone to translate what was going on because she didn’t feel well,” she added.

Seeing inpatient care through her mother’s eyes was enlightening, and at times it was “shocking to be on the other side.”

Physicians get used to “checking boxes, getting through the day,” she said. “It’s easy to forget the human side.”

“Seeing a loved one sick, [struggling] through this – I just wished I had seen things done differently,” added Dr. Kunz.

The experience prompted Dr. Kunz to share several “communication pearls” via Twitter. Her thread has since garnered thousands of “likes” and scores of comments and retweets.

She began the Twitter thread explaining what prompted her comments:

“I spent many hours last week observing the practice of medicine while sitting at my mom’s hospital bedside and was reminded of some important communication pearls. Some musings ...”

“1. Introduce yourself by full name, role, and team and have ID badges visible. It can get very confusing for [patients] and family members with the number of people in and out of rooms. E.g. ‘My name is Dr. X. I’m the intern on the primary internal medicine team.’

2.  End your patient visit with a summary of the plan for the day.

3. Avoid medical jargon & speak slowly, clearly, and logically. Remember you are a teacher for your [patients] and their family.

4. Masks make it harder to hear, especially for [patients] with hearing loss (and they no longer have the aid of lip reading).

5. Many older [patients] get confused in the hospital. Repetition is a good thing.

6. Speak to a family member at least once per day to relay the plan.

7. Try to avoid last minute or surprise discharges – they make [patients] and family members anxious. Talk about discharge planning from day 1 and what milestones must occur prior to a safe discharge. ‘In order for you to leave the hospital, X, Y, X must happen.’

8. Talk with your [patients] about something other than what brought them to the hospital (a tip I once learned from a wise mentor).

9.  When possible, sit at eye level with your patient (I love these stools from @YNHH).

10. Take time to listen.”

Dr. Kunz closed with her golden rule: “Lastly, treat your patients how you would want your own family member treated.”

Twitter user @BrunaPellini replied: “I love this, especially ‘Treat your patients how you would want your own family member treated.’ My mom and grandma always said that to me since I was a med student, and this is definitely one of my core values.”

Other clinicians shared similar experiences, and some added to Dr. Kunz’s list.

“Agree entirely, love the list – and while none of us can always practice perfectly, my experiences with my own mother’s illness taught me an enormous amount about communication,” @hoperugo responded.

Twitter user @mariejacork added: “Everyone in health care please read ... if you are lucky enough to not have had a loved one unwell in hospital, these may get forgotten. Having sat with my dad for a few days before he died a few years ago, I felt a lot of these, and it changed my practice forever.”

@bjcohenmd provided additional advice: “And use the dry erase board that should be in every room. Never start a medication without explaining it. Many docs will see the patient and then go to the computer, decide to order a med, but never go back to explain it.”

Patients also shared experiences and offered suggestions.

“As a chronic pain patient I’d add – we know it’s frustrating you can’t cure us but PLEASE do not SIGH if we say something didn’t work or [tell] us to be more positive. Just say ‘I know this is very hard, I’m here to listen.’ We don’t expect a cure, we do expect to be believed,” said @ppenguinsmt. “It makes me feel like I’m causing distress to you if I say the pain has been unrelenting. I leave feeling worse. ...You may have heard 10 [people] in pain before me but this is MY only [appointment].”

Twitter user @KatieCahoots added: “These are perfect. I wish doctors would do this not only in the hospital but in the doctor’s office, as well. I would add one caveat: When you try not to use medical jargon, don’t dumb it down as though I don’t know anything about science or haven’t done any of my own research.”

Dr. Kunz said she was taken aback but pleased by the response to her Tweet.

“It’s an example of the human side of medicine, so it resonates with physicians and with patients,” she commented. Seeing through her mom’s eyes how care was provided made her realize that medical training should include more emphasis on communication, including “real-time feedback to interns, residents, fellows, and students.”

Yes, it takes time, and “we don’t all have a lot of extra time,” she acknowledged.

“But some of these elements don’t take that much more time to do. They can help build trust and can, in the long run, actually save time if patients understand and family members feel engaged and like they are participants,” she said. “I think a little time investment will go a long way.”

In her case, she very much appreciated the one trainee who tried to call her and update her about her mother’s care each afternoon. “I really valued that,” she said.

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

The 5 days that she spent at her mother’s bedside were eye-opening for an oncologist used to being on the other side of the clinician–patient relationship.

“As a physician, I thought I had a unique perspective of things that were done well – and things that were not,” commented Pamela Kunz, MD.

Dr. Kunz, who was named the 2021 Woman Oncologist of the Year, is director of the Center for Gastrointestinal Cancers at Smilow Cancer Hospital and of the Yale Cancer Center, New Haven, Conn.

But she was propelled into quite a different role when her mother was admitted to the hospital.

Her mom, who has trouble hearing, was easily confused by jargon and by “all of the people coming in and out with no introductions,” she explained.

“She needed someone to translate what was going on because she didn’t feel well,” she added.

Seeing inpatient care through her mother’s eyes was enlightening, and at times it was “shocking to be on the other side.”

Physicians get used to “checking boxes, getting through the day,” she said. “It’s easy to forget the human side.”

“Seeing a loved one sick, [struggling] through this – I just wished I had seen things done differently,” added Dr. Kunz.

The experience prompted Dr. Kunz to share several “communication pearls” via Twitter. Her thread has since garnered thousands of “likes” and scores of comments and retweets.

She began the Twitter thread explaining what prompted her comments:

“I spent many hours last week observing the practice of medicine while sitting at my mom’s hospital bedside and was reminded of some important communication pearls. Some musings ...”

“1. Introduce yourself by full name, role, and team and have ID badges visible. It can get very confusing for [patients] and family members with the number of people in and out of rooms. E.g. ‘My name is Dr. X. I’m the intern on the primary internal medicine team.’

2.  End your patient visit with a summary of the plan for the day.

3. Avoid medical jargon & speak slowly, clearly, and logically. Remember you are a teacher for your [patients] and their family.

4. Masks make it harder to hear, especially for [patients] with hearing loss (and they no longer have the aid of lip reading).

5. Many older [patients] get confused in the hospital. Repetition is a good thing.

6. Speak to a family member at least once per day to relay the plan.

7. Try to avoid last minute or surprise discharges – they make [patients] and family members anxious. Talk about discharge planning from day 1 and what milestones must occur prior to a safe discharge. ‘In order for you to leave the hospital, X, Y, X must happen.’

8. Talk with your [patients] about something other than what brought them to the hospital (a tip I once learned from a wise mentor).

9.  When possible, sit at eye level with your patient (I love these stools from @YNHH).

10. Take time to listen.”

Dr. Kunz closed with her golden rule: “Lastly, treat your patients how you would want your own family member treated.”

Twitter user @BrunaPellini replied: “I love this, especially ‘Treat your patients how you would want your own family member treated.’ My mom and grandma always said that to me since I was a med student, and this is definitely one of my core values.”

Other clinicians shared similar experiences, and some added to Dr. Kunz’s list.

“Agree entirely, love the list – and while none of us can always practice perfectly, my experiences with my own mother’s illness taught me an enormous amount about communication,” @hoperugo responded.

Twitter user @mariejacork added: “Everyone in health care please read ... if you are lucky enough to not have had a loved one unwell in hospital, these may get forgotten. Having sat with my dad for a few days before he died a few years ago, I felt a lot of these, and it changed my practice forever.”

@bjcohenmd provided additional advice: “And use the dry erase board that should be in every room. Never start a medication without explaining it. Many docs will see the patient and then go to the computer, decide to order a med, but never go back to explain it.”

Patients also shared experiences and offered suggestions.

“As a chronic pain patient I’d add – we know it’s frustrating you can’t cure us but PLEASE do not SIGH if we say something didn’t work or [tell] us to be more positive. Just say ‘I know this is very hard, I’m here to listen.’ We don’t expect a cure, we do expect to be believed,” said @ppenguinsmt. “It makes me feel like I’m causing distress to you if I say the pain has been unrelenting. I leave feeling worse. ...You may have heard 10 [people] in pain before me but this is MY only [appointment].”

Twitter user @KatieCahoots added: “These are perfect. I wish doctors would do this not only in the hospital but in the doctor’s office, as well. I would add one caveat: When you try not to use medical jargon, don’t dumb it down as though I don’t know anything about science or haven’t done any of my own research.”

Dr. Kunz said she was taken aback but pleased by the response to her Tweet.

“It’s an example of the human side of medicine, so it resonates with physicians and with patients,” she commented. Seeing through her mom’s eyes how care was provided made her realize that medical training should include more emphasis on communication, including “real-time feedback to interns, residents, fellows, and students.”

Yes, it takes time, and “we don’t all have a lot of extra time,” she acknowledged.

“But some of these elements don’t take that much more time to do. They can help build trust and can, in the long run, actually save time if patients understand and family members feel engaged and like they are participants,” she said. “I think a little time investment will go a long way.”

In her case, she very much appreciated the one trainee who tried to call her and update her about her mother’s care each afternoon. “I really valued that,” she said.

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

The 5 days that she spent at her mother’s bedside were eye-opening for an oncologist used to being on the other side of the clinician–patient relationship.

“As a physician, I thought I had a unique perspective of things that were done well – and things that were not,” commented Pamela Kunz, MD.

Dr. Kunz, who was named the 2021 Woman Oncologist of the Year, is director of the Center for Gastrointestinal Cancers at Smilow Cancer Hospital and of the Yale Cancer Center, New Haven, Conn.

But she was propelled into quite a different role when her mother was admitted to the hospital.

Her mom, who has trouble hearing, was easily confused by jargon and by “all of the people coming in and out with no introductions,” she explained.

“She needed someone to translate what was going on because she didn’t feel well,” she added.

Seeing inpatient care through her mother’s eyes was enlightening, and at times it was “shocking to be on the other side.”

Physicians get used to “checking boxes, getting through the day,” she said. “It’s easy to forget the human side.”

“Seeing a loved one sick, [struggling] through this – I just wished I had seen things done differently,” added Dr. Kunz.

The experience prompted Dr. Kunz to share several “communication pearls” via Twitter. Her thread has since garnered thousands of “likes” and scores of comments and retweets.

She began the Twitter thread explaining what prompted her comments:

“I spent many hours last week observing the practice of medicine while sitting at my mom’s hospital bedside and was reminded of some important communication pearls. Some musings ...”

“1. Introduce yourself by full name, role, and team and have ID badges visible. It can get very confusing for [patients] and family members with the number of people in and out of rooms. E.g. ‘My name is Dr. X. I’m the intern on the primary internal medicine team.’

2.  End your patient visit with a summary of the plan for the day.

3. Avoid medical jargon & speak slowly, clearly, and logically. Remember you are a teacher for your [patients] and their family.

4. Masks make it harder to hear, especially for [patients] with hearing loss (and they no longer have the aid of lip reading).

5. Many older [patients] get confused in the hospital. Repetition is a good thing.

6. Speak to a family member at least once per day to relay the plan.

7. Try to avoid last minute or surprise discharges – they make [patients] and family members anxious. Talk about discharge planning from day 1 and what milestones must occur prior to a safe discharge. ‘In order for you to leave the hospital, X, Y, X must happen.’

8. Talk with your [patients] about something other than what brought them to the hospital (a tip I once learned from a wise mentor).

9.  When possible, sit at eye level with your patient (I love these stools from @YNHH).

10. Take time to listen.”

Dr. Kunz closed with her golden rule: “Lastly, treat your patients how you would want your own family member treated.”

Twitter user @BrunaPellini replied: “I love this, especially ‘Treat your patients how you would want your own family member treated.’ My mom and grandma always said that to me since I was a med student, and this is definitely one of my core values.”

Other clinicians shared similar experiences, and some added to Dr. Kunz’s list.

“Agree entirely, love the list – and while none of us can always practice perfectly, my experiences with my own mother’s illness taught me an enormous amount about communication,” @hoperugo responded.

Twitter user @mariejacork added: “Everyone in health care please read ... if you are lucky enough to not have had a loved one unwell in hospital, these may get forgotten. Having sat with my dad for a few days before he died a few years ago, I felt a lot of these, and it changed my practice forever.”

@bjcohenmd provided additional advice: “And use the dry erase board that should be in every room. Never start a medication without explaining it. Many docs will see the patient and then go to the computer, decide to order a med, but never go back to explain it.”

Patients also shared experiences and offered suggestions.

“As a chronic pain patient I’d add – we know it’s frustrating you can’t cure us but PLEASE do not SIGH if we say something didn’t work or [tell] us to be more positive. Just say ‘I know this is very hard, I’m here to listen.’ We don’t expect a cure, we do expect to be believed,” said @ppenguinsmt. “It makes me feel like I’m causing distress to you if I say the pain has been unrelenting. I leave feeling worse. ...You may have heard 10 [people] in pain before me but this is MY only [appointment].”

Twitter user @KatieCahoots added: “These are perfect. I wish doctors would do this not only in the hospital but in the doctor’s office, as well. I would add one caveat: When you try not to use medical jargon, don’t dumb it down as though I don’t know anything about science or haven’t done any of my own research.”

Dr. Kunz said she was taken aback but pleased by the response to her Tweet.

“It’s an example of the human side of medicine, so it resonates with physicians and with patients,” she commented. Seeing through her mom’s eyes how care was provided made her realize that medical training should include more emphasis on communication, including “real-time feedback to interns, residents, fellows, and students.”

Yes, it takes time, and “we don’t all have a lot of extra time,” she acknowledged.

“But some of these elements don’t take that much more time to do. They can help build trust and can, in the long run, actually save time if patients understand and family members feel engaged and like they are participants,” she said. “I think a little time investment will go a long way.”

In her case, she very much appreciated the one trainee who tried to call her and update her about her mother’s care each afternoon. “I really valued that,” she said.

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

U.S. hospitals are being warned to prepare for a potential cyberattack from either the Russian government, criminal gangs resident in Russia, or both, as a result of the invasion of Ukraine and the U.S. and Western countermeasures against the aggressor nation.

The day after President Biden announced that the war had begun, the American Hospital Association (AHA) issued an alert to hospitals. The cybersecurity division of the Department of Health and Human Services (HHS), known as HC3, joined AHA with another public warning to the healthcare system on March 1. The federal government’s Cybersecurity & Infrastructure Security Agency (CISA) issued a “Shield’s Up” alert to private industry, supporting Biden’s March 21 statement about the need to improve domestic cybersecurity.

CISA warned that the Russian invasion of Ukraine could lead to “malicious cyber activity against the U.S. homeland, including as a response to the unprecedented economic costs imposed on Russia by the U.S. and our allies and partners.” The agency noted that the Russian government is currently exploring options for cyberattacks.

John Riggi, the AHA’s national advisor for cybersecurity and risk, and a former senior executive in the FBI’s cyber division, said in an interview, “We are not aware of any cyberattacks related to the current conflict [in Ukraine]. We don’t know of any specific credible threats targeted against U.S. healthcare from the Russian government.”

He added that there have been reports of Russian hackers searching U.S. health IT security systems for weaknesses.
 

Criminal gangs remain a threat

Besides the Russian government, Mr. Riggi said, Russian criminal gangs are another threat to U.S. hospitals and other healthcare providers. Of particular concern, he noted, is the Conti gang, which “has a history of conducting ransomware attacks against U.S. healthcare and the Irish health system.”

On February 25, said Mr. Riggi, the Conti group announced plans “to retaliate against the West for what they viewed as potential cyber aggression by the West against the Russian federation.”

Sophisticated hacker groups like the Conti gang that operate under the protection of the Russian government have “caused the greatest amount of disruption and have cost the most in terms of recovery and lost business,” Mac McMillan, CEO of CynergisTek, a cybersecurity consulting firm, told this news organization.

However, he said, the current threat is greater for two reasons: first, it will likely come directly from the Russian military intelligence service; and second, there are indications that the malware will be more destructive than ransomware. Two new types of malware identified by HC3 — HermeticWiper and WhisperGate — are designed to wipe out the data in their targets’ systems, rather than just encrypting it and disrupting access to data until a ransom is paid.

The Russian military intelligence service, known as the GRU, is extremely capable and dangerous, Mr. McMillan said. He doubts that many healthcare systems, even if they are fairly well prepared, could withstand an attack from this source. And he fully believes that the attack, when it comes, will aim to wipe out data in victims’ systems in order to create as much chaos and disruption as possible in the United States.
 

Hospitals better prepared, but still have gaps

Like Mr. Riggi, Mr. McMillan said that the healthcare industry is better prepared for cyberattacks now than it was in 2017, when the NotPetya assault on Ukraine’s online infrastructure created considerable collateral damage in the United States. However, he said, hospitals still have a long way to go before they can counter and/or recover from a dedicated Russian government cyberattack.

The NotPetya malware, Mr. Riggi said, was of the destructive variety. “That digital virus spread uncontrollably across the globe like a biological virus. All the organizations and institutions that had contact with Ukraine became infected.”

According to an indictment of six GRU officers that the Department of Justice announced in December 2020, NotPetya disrupted operations at a major pharmaceutical company, subsequently revealed to be Merck, and hospitals and other medical facilities in the Heritage Valley Health System in Pennsylvania. In addition, it temporarily shut down the transcription services of Nuance Communications, which lost $98 million as a result. Merck received $1.4 billion from an insurer to cover its NotPetya loss, Bloomberg reported.

That incident prompted the AHA to urge hospitals to use “geo-fencing” to block online communications with Ukraine and neighboring countries. However, Mr. Riggi said, that solution is not too effective because hackers commonly use proxy servers in other countries to forward their malware to the intended target.

The AHA alert included a list of actions that hospitals and health systems could take to reduce their vulnerability to Russian hacking. Besides geo-fencing, the AHA suggested that hospitals:

• Heighten staff awareness of the increased risk of receiving malware-laden phishing emails;
• Identify all international and third-party mission-critical, clinical, and operational services and technology and put in place business continuity plans and downtime procedures;
• Check the redundancy, resiliency, and security of the organization’s network and data backups;
• Document, update, and practice the organization’s incident response plan.

Hospitals increasingly targeted

In recent years, Mr. Riggi noted, hospitals have invested much more in cybersecurity than before, and hospital executives have told him that this is now one of their top priorities, along with COVID-19 and workforce issues. This has been not only because of NotPetya, but also because healthcare facilities are being increasingly attacked by foreign ransomware gangs, he says.

The hospitals’ biggest vulnerabilities, he said, are phishing emails, remote desktop access, and unpatched vulnerabilities, in that order. It’s not easy to remedy the latter, he observed, because hospital networks can include up to 100,000 connected medical devices and other computers that can access the network, both within and outside the hospital.

“With the new work-at-home environment, you may have thousands of employees who are using the network outside the traditional perimeter of the organization,” he pointed out. “There’s no longer that standard firewall that protects everything.” In addition, he said, hospitals also have to depend on vendors to develop patches and implement them.

In Mr. McMillan’s view, the healthcare industry is a decade behind the financial industry and other sectors in cybersecurity. Among other things, he says, “half of our hospitals still don’t have active monitoring on their networks. They don’t have privileged access on their networks. A bunch don’t have segmentation or endpoint protection. There are so many things that hospitals don’t have that they need to fend off these attacks — they’re better off than they were in 2017, but they still aren’t where they need to be.”
 

Physician practices also at risk

Employed physicians, naturally, are in danger of losing access to their electronic health records if their hospital’s network goes down as the result of a cyberattack, he notes. Many community doctors also use the EHR of a local hospital, and they’d be similarly affected, Mr. Riggi noted.

Physician practices might be saved if the attack were directed at the hospital and they could still connect to the EHR through a cloud provider, Mr. McMillan said. But Mr. Riggi stressed that practices still need a plan for their doctors to keep working if they lose access to a hospital EHR.

“The other possibility is that the practice could be targeted,” he added. “As hospitals become more hardened, often these hackers are looking for the weak link. The practices could become victims of increased targeting. And the practice becomes the conduit for malware to go from its system to the hospital and infect the hospital system.”
 

Hackers can hit service suppliers

Hospitals’ mission-critical service suppliers may also be targeted by Russian hackers and others, or they may be the accidental victims of a cyberattack elsewhere, Mr. Riggi noted. In the case of Nuance, he said, the disruption in transcription services affected thousands of U.S. healthcare providers who were unable to access their transcribed notes. This not only harmed patient care, but also meant that hospitals couldn’t fully bill for their services.

Another type of service supplier, he said, was struck with a ransomware attack last year. This was a cloud-based service that operated linear accelerators used in radiation oncology. “So radiation oncology and cancer treatment for patients across the U.S. was disrupted, and radiation oncology was delayed for some patients up to 3 weeks.”

More recently, another cloud-based service called Kronos was struck by ransomware. Because of this incident, payroll and timekeeping services were disrupted across several industries, including healthcare.

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

U.S. hospitals are being warned to prepare for a potential cyberattack from either the Russian government, criminal gangs resident in Russia, or both, as a result of the invasion of Ukraine and the U.S. and Western countermeasures against the aggressor nation.

The day after President Biden announced that the war had begun, the American Hospital Association (AHA) issued an alert to hospitals. The cybersecurity division of the Department of Health and Human Services (HHS), known as HC3, joined AHA with another public warning to the healthcare system on March 1. The federal government’s Cybersecurity & Infrastructure Security Agency (CISA) issued a “Shield’s Up” alert to private industry, supporting Biden’s March 21 statement about the need to improve domestic cybersecurity.

CISA warned that the Russian invasion of Ukraine could lead to “malicious cyber activity against the U.S. homeland, including as a response to the unprecedented economic costs imposed on Russia by the U.S. and our allies and partners.” The agency noted that the Russian government is currently exploring options for cyberattacks.

John Riggi, the AHA’s national advisor for cybersecurity and risk, and a former senior executive in the FBI’s cyber division, said in an interview, “We are not aware of any cyberattacks related to the current conflict [in Ukraine]. We don’t know of any specific credible threats targeted against U.S. healthcare from the Russian government.”

He added that there have been reports of Russian hackers searching U.S. health IT security systems for weaknesses.
 

Criminal gangs remain a threat

Besides the Russian government, Mr. Riggi said, Russian criminal gangs are another threat to U.S. hospitals and other healthcare providers. Of particular concern, he noted, is the Conti gang, which “has a history of conducting ransomware attacks against U.S. healthcare and the Irish health system.”

On February 25, said Mr. Riggi, the Conti group announced plans “to retaliate against the West for what they viewed as potential cyber aggression by the West against the Russian federation.”

Sophisticated hacker groups like the Conti gang that operate under the protection of the Russian government have “caused the greatest amount of disruption and have cost the most in terms of recovery and lost business,” Mac McMillan, CEO of CynergisTek, a cybersecurity consulting firm, told this news organization.

However, he said, the current threat is greater for two reasons: first, it will likely come directly from the Russian military intelligence service; and second, there are indications that the malware will be more destructive than ransomware. Two new types of malware identified by HC3 — HermeticWiper and WhisperGate — are designed to wipe out the data in their targets’ systems, rather than just encrypting it and disrupting access to data until a ransom is paid.

The Russian military intelligence service, known as the GRU, is extremely capable and dangerous, Mr. McMillan said. He doubts that many healthcare systems, even if they are fairly well prepared, could withstand an attack from this source. And he fully believes that the attack, when it comes, will aim to wipe out data in victims’ systems in order to create as much chaos and disruption as possible in the United States.
 

Hospitals better prepared, but still have gaps

Like Mr. Riggi, Mr. McMillan said that the healthcare industry is better prepared for cyberattacks now than it was in 2017, when the NotPetya assault on Ukraine’s online infrastructure created considerable collateral damage in the United States. However, he said, hospitals still have a long way to go before they can counter and/or recover from a dedicated Russian government cyberattack.

The NotPetya malware, Mr. Riggi said, was of the destructive variety. “That digital virus spread uncontrollably across the globe like a biological virus. All the organizations and institutions that had contact with Ukraine became infected.”

According to an indictment of six GRU officers that the Department of Justice announced in December 2020, NotPetya disrupted operations at a major pharmaceutical company, subsequently revealed to be Merck, and hospitals and other medical facilities in the Heritage Valley Health System in Pennsylvania. In addition, it temporarily shut down the transcription services of Nuance Communications, which lost $98 million as a result. Merck received $1.4 billion from an insurer to cover its NotPetya loss, Bloomberg reported.

That incident prompted the AHA to urge hospitals to use “geo-fencing” to block online communications with Ukraine and neighboring countries. However, Mr. Riggi said, that solution is not too effective because hackers commonly use proxy servers in other countries to forward their malware to the intended target.

The AHA alert included a list of actions that hospitals and health systems could take to reduce their vulnerability to Russian hacking. Besides geo-fencing, the AHA suggested that hospitals:

• Heighten staff awareness of the increased risk of receiving malware-laden phishing emails;
• Identify all international and third-party mission-critical, clinical, and operational services and technology and put in place business continuity plans and downtime procedures;
• Check the redundancy, resiliency, and security of the organization’s network and data backups;
• Document, update, and practice the organization’s incident response plan.

Hospitals increasingly targeted

In recent years, Mr. Riggi noted, hospitals have invested much more in cybersecurity than before, and hospital executives have told him that this is now one of their top priorities, along with COVID-19 and workforce issues. This has been not only because of NotPetya, but also because healthcare facilities are being increasingly attacked by foreign ransomware gangs, he says.

The hospitals’ biggest vulnerabilities, he said, are phishing emails, remote desktop access, and unpatched vulnerabilities, in that order. It’s not easy to remedy the latter, he observed, because hospital networks can include up to 100,000 connected medical devices and other computers that can access the network, both within and outside the hospital.

“With the new work-at-home environment, you may have thousands of employees who are using the network outside the traditional perimeter of the organization,” he pointed out. “There’s no longer that standard firewall that protects everything.” In addition, he said, hospitals also have to depend on vendors to develop patches and implement them.

In Mr. McMillan’s view, the healthcare industry is a decade behind the financial industry and other sectors in cybersecurity. Among other things, he says, “half of our hospitals still don’t have active monitoring on their networks. They don’t have privileged access on their networks. A bunch don’t have segmentation or endpoint protection. There are so many things that hospitals don’t have that they need to fend off these attacks — they’re better off than they were in 2017, but they still aren’t where they need to be.”
 

Physician practices also at risk

Employed physicians, naturally, are in danger of losing access to their electronic health records if their hospital’s network goes down as the result of a cyberattack, he notes. Many community doctors also use the EHR of a local hospital, and they’d be similarly affected, Mr. Riggi noted.

Physician practices might be saved if the attack were directed at the hospital and they could still connect to the EHR through a cloud provider, Mr. McMillan said. But Mr. Riggi stressed that practices still need a plan for their doctors to keep working if they lose access to a hospital EHR.

“The other possibility is that the practice could be targeted,” he added. “As hospitals become more hardened, often these hackers are looking for the weak link. The practices could become victims of increased targeting. And the practice becomes the conduit for malware to go from its system to the hospital and infect the hospital system.”
 

Hackers can hit service suppliers

Hospitals’ mission-critical service suppliers may also be targeted by Russian hackers and others, or they may be the accidental victims of a cyberattack elsewhere, Mr. Riggi noted. In the case of Nuance, he said, the disruption in transcription services affected thousands of U.S. healthcare providers who were unable to access their transcribed notes. This not only harmed patient care, but also meant that hospitals couldn’t fully bill for their services.

Another type of service supplier, he said, was struck with a ransomware attack last year. This was a cloud-based service that operated linear accelerators used in radiation oncology. “So radiation oncology and cancer treatment for patients across the U.S. was disrupted, and radiation oncology was delayed for some patients up to 3 weeks.”

More recently, another cloud-based service called Kronos was struck by ransomware. Because of this incident, payroll and timekeeping services were disrupted across several industries, including healthcare.

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

U.S. hospitals are being warned to prepare for a potential cyberattack from either the Russian government, criminal gangs resident in Russia, or both, as a result of the invasion of Ukraine and the U.S. and Western countermeasures against the aggressor nation.

The day after President Biden announced that the war had begun, the American Hospital Association (AHA) issued an alert to hospitals. The cybersecurity division of the Department of Health and Human Services (HHS), known as HC3, joined AHA with another public warning to the healthcare system on March 1. The federal government’s Cybersecurity & Infrastructure Security Agency (CISA) issued a “Shield’s Up” alert to private industry, supporting Biden’s March 21 statement about the need to improve domestic cybersecurity.

CISA warned that the Russian invasion of Ukraine could lead to “malicious cyber activity against the U.S. homeland, including as a response to the unprecedented economic costs imposed on Russia by the U.S. and our allies and partners.” The agency noted that the Russian government is currently exploring options for cyberattacks.

John Riggi, the AHA’s national advisor for cybersecurity and risk, and a former senior executive in the FBI’s cyber division, said in an interview, “We are not aware of any cyberattacks related to the current conflict [in Ukraine]. We don’t know of any specific credible threats targeted against U.S. healthcare from the Russian government.”

He added that there have been reports of Russian hackers searching U.S. health IT security systems for weaknesses.
 

Criminal gangs remain a threat

Besides the Russian government, Mr. Riggi said, Russian criminal gangs are another threat to U.S. hospitals and other healthcare providers. Of particular concern, he noted, is the Conti gang, which “has a history of conducting ransomware attacks against U.S. healthcare and the Irish health system.”

On February 25, said Mr. Riggi, the Conti group announced plans “to retaliate against the West for what they viewed as potential cyber aggression by the West against the Russian federation.”

Sophisticated hacker groups like the Conti gang that operate under the protection of the Russian government have “caused the greatest amount of disruption and have cost the most in terms of recovery and lost business,” Mac McMillan, CEO of CynergisTek, a cybersecurity consulting firm, told this news organization.

However, he said, the current threat is greater for two reasons: first, it will likely come directly from the Russian military intelligence service; and second, there are indications that the malware will be more destructive than ransomware. Two new types of malware identified by HC3 — HermeticWiper and WhisperGate — are designed to wipe out the data in their targets’ systems, rather than just encrypting it and disrupting access to data until a ransom is paid.

The Russian military intelligence service, known as the GRU, is extremely capable and dangerous, Mr. McMillan said. He doubts that many healthcare systems, even if they are fairly well prepared, could withstand an attack from this source. And he fully believes that the attack, when it comes, will aim to wipe out data in victims’ systems in order to create as much chaos and disruption as possible in the United States.
 

Hospitals better prepared, but still have gaps

Like Mr. Riggi, Mr. McMillan said that the healthcare industry is better prepared for cyberattacks now than it was in 2017, when the NotPetya assault on Ukraine’s online infrastructure created considerable collateral damage in the United States. However, he said, hospitals still have a long way to go before they can counter and/or recover from a dedicated Russian government cyberattack.

The NotPetya malware, Mr. Riggi said, was of the destructive variety. “That digital virus spread uncontrollably across the globe like a biological virus. All the organizations and institutions that had contact with Ukraine became infected.”

According to an indictment of six GRU officers that the Department of Justice announced in December 2020, NotPetya disrupted operations at a major pharmaceutical company, subsequently revealed to be Merck, and hospitals and other medical facilities in the Heritage Valley Health System in Pennsylvania. In addition, it temporarily shut down the transcription services of Nuance Communications, which lost $98 million as a result. Merck received $1.4 billion from an insurer to cover its NotPetya loss, Bloomberg reported.

That incident prompted the AHA to urge hospitals to use “geo-fencing” to block online communications with Ukraine and neighboring countries. However, Mr. Riggi said, that solution is not too effective because hackers commonly use proxy servers in other countries to forward their malware to the intended target.

The AHA alert included a list of actions that hospitals and health systems could take to reduce their vulnerability to Russian hacking. Besides geo-fencing, the AHA suggested that hospitals:

• Heighten staff awareness of the increased risk of receiving malware-laden phishing emails;
• Identify all international and third-party mission-critical, clinical, and operational services and technology and put in place business continuity plans and downtime procedures;
• Check the redundancy, resiliency, and security of the organization’s network and data backups;
• Document, update, and practice the organization’s incident response plan.

Hospitals increasingly targeted

In recent years, Mr. Riggi noted, hospitals have invested much more in cybersecurity than before, and hospital executives have told him that this is now one of their top priorities, along with COVID-19 and workforce issues. This has been not only because of NotPetya, but also because healthcare facilities are being increasingly attacked by foreign ransomware gangs, he says.

The hospitals’ biggest vulnerabilities, he said, are phishing emails, remote desktop access, and unpatched vulnerabilities, in that order. It’s not easy to remedy the latter, he observed, because hospital networks can include up to 100,000 connected medical devices and other computers that can access the network, both within and outside the hospital.

“With the new work-at-home environment, you may have thousands of employees who are using the network outside the traditional perimeter of the organization,” he pointed out. “There’s no longer that standard firewall that protects everything.” In addition, he said, hospitals also have to depend on vendors to develop patches and implement them.

In Mr. McMillan’s view, the healthcare industry is a decade behind the financial industry and other sectors in cybersecurity. Among other things, he says, “half of our hospitals still don’t have active monitoring on their networks. They don’t have privileged access on their networks. A bunch don’t have segmentation or endpoint protection. There are so many things that hospitals don’t have that they need to fend off these attacks — they’re better off than they were in 2017, but they still aren’t where they need to be.”
 

Physician practices also at risk

Employed physicians, naturally, are in danger of losing access to their electronic health records if their hospital’s network goes down as the result of a cyberattack, he notes. Many community doctors also use the EHR of a local hospital, and they’d be similarly affected, Mr. Riggi noted.

Physician practices might be saved if the attack were directed at the hospital and they could still connect to the EHR through a cloud provider, Mr. McMillan said. But Mr. Riggi stressed that practices still need a plan for their doctors to keep working if they lose access to a hospital EHR.

“The other possibility is that the practice could be targeted,” he added. “As hospitals become more hardened, often these hackers are looking for the weak link. The practices could become victims of increased targeting. And the practice becomes the conduit for malware to go from its system to the hospital and infect the hospital system.”
 

Hackers can hit service suppliers

Hospitals’ mission-critical service suppliers may also be targeted by Russian hackers and others, or they may be the accidental victims of a cyberattack elsewhere, Mr. Riggi noted. In the case of Nuance, he said, the disruption in transcription services affected thousands of U.S. healthcare providers who were unable to access their transcribed notes. This not only harmed patient care, but also meant that hospitals couldn’t fully bill for their services.

Another type of service supplier, he said, was struck with a ransomware attack last year. This was a cloud-based service that operated linear accelerators used in radiation oncology. “So radiation oncology and cancer treatment for patients across the U.S. was disrupted, and radiation oncology was delayed for some patients up to 3 weeks.”

More recently, another cloud-based service called Kronos was struck by ransomware. Because of this incident, payroll and timekeeping services were disrupted across several industries, including healthcare.

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

Treatment with a novel myosin-inhibiting agent may improve symptoms and hemodynamics enough in patients with obstructive hypertrophic cardiomyopathy (OHCM) so that they can avoid or at least delay septal reduction therapy (SRT), suggests a randomized trial of modest size and duration.

Of 112 patients with OHCM who were sick enough while receiving standard medications to qualify for SRT, those assigned to take mavacamten (MyoKardia) instead of placebo were far less likely to still be eligible for SRT 16 weeks later.

In other words, their OHCM had improved enough during therapy with mavacamten such that SRT, either surgical septal myectomy or transcatheter alcohol septal ablation, could no longer be recommended per guidelines.

Mavacamten, which lessens myocardial contractility by selective inhibition of cardiac myosin, is the first agent tested in prospective trials to appear as a viable medical option in patients with severe, symptomatic OHCM, observed principal investigator Milind Y. Desai, MD, MBA, of the Cleveland Clinic.

“There’s clearly an unmet need for noninvasive therapies, medical therapies, that work in OHCM,” he said in an interview. Mavacamten “adds to the armamentarium” of OHCM management options and may give patients with symptoms despite conventional medications an alternative to SRT, which is considered definitive but has drawbacks.

The goal of SRT is to alleviate obstruction of the left ventricular outflow tract (LVOT), but surgical SRT requires a sternotomy, with all the risks and recovery time that entails. Catheter-based alcohol septal ablation is a less common alternative for some patients with suitable anatomy, Dr. Desai noted.

But those procedures “are not uniformly available, and even when  available, the outcomes are fairly heterogeneous,” he said. “The guidelines recommend that you should go to a center with a mortality rate of less than 1% with these procedures. Centers like that are very few across the world,” and procedural mortality can be much higher at centers with less SRT experience.

Dr. Desai presented the results of VALOR-HCM at the annual scientific sessions of the American College of Cardiology. Of the 56 patients assigned to mavacamten, 10 (17.9%) decided to undergo SRT by the end of the trial, or otherwise still met guideline-recommended criteria for receiving SRT, the primary endpoint. In comparison, 43 of the 56 patients (76.8%) in the control group (P < .0001) met that endpoint.

More patients receiving mavacamten improved by at least one New York Heart Association (NYHA) functional class during the trial’s 16 weeks: 63% versus 21% for those assigned to placebo. And 27% and 2%, respectively, improved by at least two NYHA classes, Dr. Desai said.

Guidelines recommend that SRT be reserved for patients in NYHA class III or IV heart failure with a resting or provoked LVOT gradient of at least 50 mm Hg.

Of note, Desai said, only two patients in each group elected to undergo SRT during the study. “The primary endpoint was driven by reduction in guideline eligibility for SRT, but 95% of patients in the study chose to continue with medical therapy.”

Speaking as a panelist after Dr. Desai’s presentation, Lynne W. Stevenson, MD, lauded the phase 3 trial’s “brave design,” which featured a highly unusual subjective primary endpoint and framed it as an advantage.

That the trial showed a significant mavacamten effect for that endpoint “answered, in one step, the question of what does this actually mean to the patient – which often takes much longer,” observed Dr. Stevenson, from Vanderbilt University, Nashville, Tenn.

Even so, she added, whether patients still qualified for SRT in the trial at least had to be supported by objective measures of LVOT gradient and NT-proBNP levels.

“My perspective is that of a cardiac surgeon who performs septal myectomies,” said John Cleveland, MD, University of Colorado at Denver, Aurora, who said he was impressed at how few patients receiving mavacamten went on to undergo SRT, while the rest were able to at least defer that decision.

Current recommendations are that patients who go to SRT “should be maximally medically treated and still symptomatic,” Dr. Cleveland observed at a press conference on VALOR-HCM. Should mavacamten be added to the list of agents to use before resorting to invasive therapy? “My answer would be yes,” he said, and patients who remain symptomatic even while receiving the myosin inhibitor and other medications should proceed to SRT.

The trial’s patients had documented OHCM, severe symptoms, and a resting or provoked LVOT gradient of at least 50 mm Hg despite maximally tolerated medications – which could include disopyramide, beta-blockers, and calcium channel blockers. About half the study population was female, and 89% were White. All had been referred for SRT.

Active therapy consisted of mavacamten initiated at 5 mg/day, with up-titrations at 8 and 12 weeks as tolerated, guided by echocardiographic left ventricular ejection fraction and LVOT gradient.  

Most secondary endpoints improved significantly in patients receiving the drug, compared with placebo. They included measures of quality of life, symptom status, ventricular function, natriuretic peptides, and troponin I.

The secondary outcomes are consistent with what was observed in the EXPLORER-HCM trial, which in 2020 suggested that mavacamten could improve measures of quality of life, NYHA functional class, LVOT gradient, peak VO2, and other metrics in patients with OHCM.

Dr. Desai said mavacamten was well tolerated. “There were two patients who had a transient drop in ejection fraction to less than 50%, so the drug was temporarily discontinued, but resumed at a lower dose and they were able to complete the study.”

Dr. Stevenson commented on the “pretty quick” up-titration of mavacamten dosages in a study lasting only 4 months, which could have been a concern given the drug’s limited track record and its mechanism of action targeting contractility. “Fortunately, no serious safety signals” were observed.

Dr. Desai emphasized that mavacamten up-titrations were strictly guided by regular echocardiographic monitoring and assessment of LVOT gradients, in addition to clinical responses. And that, he said, is likely how up-titrations should be carried out if mavacamten is approved for OHCM.

VALOR-HCM was supported by MyoKardia. Dr. Desai disclosed receiving honoraria or consulting fees from Caristo Diagnostics, Medtronic, and MyoKardia. Dr. Stevenson disclosed receiving honoraria or consulting fees from Novartis; serving on a data safety monitoring board for Livanova; and other relationships with Abbott Medical, Biotronik, Boston Scientific, Bristol-Myers Squibb, Endotronic, Gore Medical, and Johnson & Johnson. Dr. Cleveland had no disclosures.

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

Treatment with a novel myosin-inhibiting agent may improve symptoms and hemodynamics enough in patients with obstructive hypertrophic cardiomyopathy (OHCM) so that they can avoid or at least delay septal reduction therapy (SRT), suggests a randomized trial of modest size and duration.

Of 112 patients with OHCM who were sick enough while receiving standard medications to qualify for SRT, those assigned to take mavacamten (MyoKardia) instead of placebo were far less likely to still be eligible for SRT 16 weeks later.

In other words, their OHCM had improved enough during therapy with mavacamten such that SRT, either surgical septal myectomy or transcatheter alcohol septal ablation, could no longer be recommended per guidelines.

Mavacamten, which lessens myocardial contractility by selective inhibition of cardiac myosin, is the first agent tested in prospective trials to appear as a viable medical option in patients with severe, symptomatic OHCM, observed principal investigator Milind Y. Desai, MD, MBA, of the Cleveland Clinic.

“There’s clearly an unmet need for noninvasive therapies, medical therapies, that work in OHCM,” he said in an interview. Mavacamten “adds to the armamentarium” of OHCM management options and may give patients with symptoms despite conventional medications an alternative to SRT, which is considered definitive but has drawbacks.

The goal of SRT is to alleviate obstruction of the left ventricular outflow tract (LVOT), but surgical SRT requires a sternotomy, with all the risks and recovery time that entails. Catheter-based alcohol septal ablation is a less common alternative for some patients with suitable anatomy, Dr. Desai noted.

But those procedures “are not uniformly available, and even when  available, the outcomes are fairly heterogeneous,” he said. “The guidelines recommend that you should go to a center with a mortality rate of less than 1% with these procedures. Centers like that are very few across the world,” and procedural mortality can be much higher at centers with less SRT experience.

Dr. Desai presented the results of VALOR-HCM at the annual scientific sessions of the American College of Cardiology. Of the 56 patients assigned to mavacamten, 10 (17.9%) decided to undergo SRT by the end of the trial, or otherwise still met guideline-recommended criteria for receiving SRT, the primary endpoint. In comparison, 43 of the 56 patients (76.8%) in the control group (P < .0001) met that endpoint.

More patients receiving mavacamten improved by at least one New York Heart Association (NYHA) functional class during the trial’s 16 weeks: 63% versus 21% for those assigned to placebo. And 27% and 2%, respectively, improved by at least two NYHA classes, Dr. Desai said.

Guidelines recommend that SRT be reserved for patients in NYHA class III or IV heart failure with a resting or provoked LVOT gradient of at least 50 mm Hg.

Of note, Desai said, only two patients in each group elected to undergo SRT during the study. “The primary endpoint was driven by reduction in guideline eligibility for SRT, but 95% of patients in the study chose to continue with medical therapy.”

Speaking as a panelist after Dr. Desai’s presentation, Lynne W. Stevenson, MD, lauded the phase 3 trial’s “brave design,” which featured a highly unusual subjective primary endpoint and framed it as an advantage.

That the trial showed a significant mavacamten effect for that endpoint “answered, in one step, the question of what does this actually mean to the patient – which often takes much longer,” observed Dr. Stevenson, from Vanderbilt University, Nashville, Tenn.

Even so, she added, whether patients still qualified for SRT in the trial at least had to be supported by objective measures of LVOT gradient and NT-proBNP levels.

“My perspective is that of a cardiac surgeon who performs septal myectomies,” said John Cleveland, MD, University of Colorado at Denver, Aurora, who said he was impressed at how few patients receiving mavacamten went on to undergo SRT, while the rest were able to at least defer that decision.

Current recommendations are that patients who go to SRT “should be maximally medically treated and still symptomatic,” Dr. Cleveland observed at a press conference on VALOR-HCM. Should mavacamten be added to the list of agents to use before resorting to invasive therapy? “My answer would be yes,” he said, and patients who remain symptomatic even while receiving the myosin inhibitor and other medications should proceed to SRT.

The trial’s patients had documented OHCM, severe symptoms, and a resting or provoked LVOT gradient of at least 50 mm Hg despite maximally tolerated medications – which could include disopyramide, beta-blockers, and calcium channel blockers. About half the study population was female, and 89% were White. All had been referred for SRT.

Active therapy consisted of mavacamten initiated at 5 mg/day, with up-titrations at 8 and 12 weeks as tolerated, guided by echocardiographic left ventricular ejection fraction and LVOT gradient.  

Most secondary endpoints improved significantly in patients receiving the drug, compared with placebo. They included measures of quality of life, symptom status, ventricular function, natriuretic peptides, and troponin I.

The secondary outcomes are consistent with what was observed in the EXPLORER-HCM trial, which in 2020 suggested that mavacamten could improve measures of quality of life, NYHA functional class, LVOT gradient, peak VO2, and other metrics in patients with OHCM.

Dr. Desai said mavacamten was well tolerated. “There were two patients who had a transient drop in ejection fraction to less than 50%, so the drug was temporarily discontinued, but resumed at a lower dose and they were able to complete the study.”

Dr. Stevenson commented on the “pretty quick” up-titration of mavacamten dosages in a study lasting only 4 months, which could have been a concern given the drug’s limited track record and its mechanism of action targeting contractility. “Fortunately, no serious safety signals” were observed.

Dr. Desai emphasized that mavacamten up-titrations were strictly guided by regular echocardiographic monitoring and assessment of LVOT gradients, in addition to clinical responses. And that, he said, is likely how up-titrations should be carried out if mavacamten is approved for OHCM.

VALOR-HCM was supported by MyoKardia. Dr. Desai disclosed receiving honoraria or consulting fees from Caristo Diagnostics, Medtronic, and MyoKardia. Dr. Stevenson disclosed receiving honoraria or consulting fees from Novartis; serving on a data safety monitoring board for Livanova; and other relationships with Abbott Medical, Biotronik, Boston Scientific, Bristol-Myers Squibb, Endotronic, Gore Medical, and Johnson & Johnson. Dr. Cleveland had no disclosures.

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

Treatment with a novel myosin-inhibiting agent may improve symptoms and hemodynamics enough in patients with obstructive hypertrophic cardiomyopathy (OHCM) so that they can avoid or at least delay septal reduction therapy (SRT), suggests a randomized trial of modest size and duration.

Of 112 patients with OHCM who were sick enough while receiving standard medications to qualify for SRT, those assigned to take mavacamten (MyoKardia) instead of placebo were far less likely to still be eligible for SRT 16 weeks later.

In other words, their OHCM had improved enough during therapy with mavacamten such that SRT, either surgical septal myectomy or transcatheter alcohol septal ablation, could no longer be recommended per guidelines.

Mavacamten, which lessens myocardial contractility by selective inhibition of cardiac myosin, is the first agent tested in prospective trials to appear as a viable medical option in patients with severe, symptomatic OHCM, observed principal investigator Milind Y. Desai, MD, MBA, of the Cleveland Clinic.

“There’s clearly an unmet need for noninvasive therapies, medical therapies, that work in OHCM,” he said in an interview. Mavacamten “adds to the armamentarium” of OHCM management options and may give patients with symptoms despite conventional medications an alternative to SRT, which is considered definitive but has drawbacks.

The goal of SRT is to alleviate obstruction of the left ventricular outflow tract (LVOT), but surgical SRT requires a sternotomy, with all the risks and recovery time that entails. Catheter-based alcohol septal ablation is a less common alternative for some patients with suitable anatomy, Dr. Desai noted.

But those procedures “are not uniformly available, and even when  available, the outcomes are fairly heterogeneous,” he said. “The guidelines recommend that you should go to a center with a mortality rate of less than 1% with these procedures. Centers like that are very few across the world,” and procedural mortality can be much higher at centers with less SRT experience.

Dr. Desai presented the results of VALOR-HCM at the annual scientific sessions of the American College of Cardiology. Of the 56 patients assigned to mavacamten, 10 (17.9%) decided to undergo SRT by the end of the trial, or otherwise still met guideline-recommended criteria for receiving SRT, the primary endpoint. In comparison, 43 of the 56 patients (76.8%) in the control group (P < .0001) met that endpoint.

More patients receiving mavacamten improved by at least one New York Heart Association (NYHA) functional class during the trial’s 16 weeks: 63% versus 21% for those assigned to placebo. And 27% and 2%, respectively, improved by at least two NYHA classes, Dr. Desai said.

Guidelines recommend that SRT be reserved for patients in NYHA class III or IV heart failure with a resting or provoked LVOT gradient of at least 50 mm Hg.

Of note, Desai said, only two patients in each group elected to undergo SRT during the study. “The primary endpoint was driven by reduction in guideline eligibility for SRT, but 95% of patients in the study chose to continue with medical therapy.”

Speaking as a panelist after Dr. Desai’s presentation, Lynne W. Stevenson, MD, lauded the phase 3 trial’s “brave design,” which featured a highly unusual subjective primary endpoint and framed it as an advantage.

That the trial showed a significant mavacamten effect for that endpoint “answered, in one step, the question of what does this actually mean to the patient – which often takes much longer,” observed Dr. Stevenson, from Vanderbilt University, Nashville, Tenn.

Even so, she added, whether patients still qualified for SRT in the trial at least had to be supported by objective measures of LVOT gradient and NT-proBNP levels.

“My perspective is that of a cardiac surgeon who performs septal myectomies,” said John Cleveland, MD, University of Colorado at Denver, Aurora, who said he was impressed at how few patients receiving mavacamten went on to undergo SRT, while the rest were able to at least defer that decision.

Current recommendations are that patients who go to SRT “should be maximally medically treated and still symptomatic,” Dr. Cleveland observed at a press conference on VALOR-HCM. Should mavacamten be added to the list of agents to use before resorting to invasive therapy? “My answer would be yes,” he said, and patients who remain symptomatic even while receiving the myosin inhibitor and other medications should proceed to SRT.

The trial’s patients had documented OHCM, severe symptoms, and a resting or provoked LVOT gradient of at least 50 mm Hg despite maximally tolerated medications – which could include disopyramide, beta-blockers, and calcium channel blockers. About half the study population was female, and 89% were White. All had been referred for SRT.

Active therapy consisted of mavacamten initiated at 5 mg/day, with up-titrations at 8 and 12 weeks as tolerated, guided by echocardiographic left ventricular ejection fraction and LVOT gradient.  

Most secondary endpoints improved significantly in patients receiving the drug, compared with placebo. They included measures of quality of life, symptom status, ventricular function, natriuretic peptides, and troponin I.

The secondary outcomes are consistent with what was observed in the EXPLORER-HCM trial, which in 2020 suggested that mavacamten could improve measures of quality of life, NYHA functional class, LVOT gradient, peak VO2, and other metrics in patients with OHCM.

Dr. Desai said mavacamten was well tolerated. “There were two patients who had a transient drop in ejection fraction to less than 50%, so the drug was temporarily discontinued, but resumed at a lower dose and they were able to complete the study.”

Dr. Stevenson commented on the “pretty quick” up-titration of mavacamten dosages in a study lasting only 4 months, which could have been a concern given the drug’s limited track record and its mechanism of action targeting contractility. “Fortunately, no serious safety signals” were observed.

Dr. Desai emphasized that mavacamten up-titrations were strictly guided by regular echocardiographic monitoring and assessment of LVOT gradients, in addition to clinical responses. And that, he said, is likely how up-titrations should be carried out if mavacamten is approved for OHCM.

VALOR-HCM was supported by MyoKardia. Dr. Desai disclosed receiving honoraria or consulting fees from Caristo Diagnostics, Medtronic, and MyoKardia. Dr. Stevenson disclosed receiving honoraria or consulting fees from Novartis; serving on a data safety monitoring board for Livanova; and other relationships with Abbott Medical, Biotronik, Boston Scientific, Bristol-Myers Squibb, Endotronic, Gore Medical, and Johnson & Johnson. Dr. Cleveland had no disclosures.

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

A new subanalysis of the FAME 3 trial, which failed to show that percutaneous intervention (PCI) guided by fractional flow reserve (FFR) is noninferior to coronary artery bypass grafting (CABG) for treating three-vessel coronary artery disease, has associated PCI with early quality of life (QOL) advantages, according to findings presented at the annual scientific sessions of the American College of Cardiology.

Despite a modestly greater risk of major adverse cardiac events (MACE) at the end of 12 months’ follow-up among those treated with FFR-guided PCI, the greater QOL early after the procedure might be relevant to patients weighing these options, according to Frederik M. Zimmerman, MD, of Catharina Hospital in Eindhoven, the Netherlands.

“FFR-guided PCI results in a faster improvement in quality of life than CABG during the first year after revascularization, and it improved working status in patients younger than 65 years of age,” Dr. Zimmermann said.

The primary results of FAME 3 were presented at the 2021 Transcatheter Cardiovascular Therapeutics annual meeting by lead author William F. Fearon, MD, of Stanford (Calif.) University and published simultaneously in the New England Journal of Medicine.

Rather than confirming the hypothesis that FFR-guided PCI is comparable with CABG for the primary composite MACE outcome death from any cause, myocardial infarction, stroke, or revascularization, the incidence of MACE at 12 months was 10.6% in those randomized to PCI and 6.9% in the group assigned to CABG.

This translated into a hazard ratio for MACE of 1.5, signifying a 50% increase in risk for FFR-guided PCI relative to CABG for the primary outcome, a difference that negated the study definition of noninferiority (P = .35).

In this new health-related subanalysis, which was published simultaneously with his ACC presentation, the groups were compared over 12 months for QOL as measured with European Quality of Life–5 dimensions (EQ-5D) scale, angina as measured with the Canadian Cardiovascular Classification (CCC) system, and employment.

Outcomes data available in >85% of patients

Of the 1,500 patients enrolled and randomized in FAME 3 (757 to FFR-guided PCI and 743 to CABG), this health outcomes subanalysis was performed with complete data at 12 months from 89% of those in the PCI group and 88% of those in the CABG group.

Ultimately, the study did not show differences in any of these measures at the end of 12 months, but there were significant differences in QOL and employment at earlier time points. In particular, the significantly different (P < .001) trajectory for QOL improvement at 1 and 6 months favored FFR-guided PCI whether evaluated with the EQ-5D instrument or an EQ visual analog scale.

Rates of angina defined by as CCC class of at least 2 were low after revascularization in both arms of the study, negating any opportunity for differences, but patients aged younger than 65 years were almost twice as likely to have returned to full- or part-time work 1 month after revascularization (60.2% vs. 33.1%), and they remained at higher odds for working at 12 months (68.1% vs. 57.4%).

In patients aged older than 65 years, return-to-work rates did not differ significantly at any time point.

These results suggest potentially clinically meaningful early advantages for FFR-guided PCI, but some experts questioned the rationale for reporting positive secondary findings from a negative trial.

“This subanalysis is curious,” said Allen Jeremias, MD, director of interventional cardiology research, Saint Francis Hospital, Roslyn, N.Y. He pointed out that reporting these data is an anomaly.
 

Subanalyses uncommon in negative trials

“CABG was found to be better, so why look at QOL,” said Dr. Jeremias, who was an ACC-invited expert to discuss the results. However, he went on to say, “this could be an exception to the rule.”

The reason, according to Dr. Jeremias, is that the absolute difference at 12 months between FFR-guided PCI and CABG for the MACE events of greatest concern – death, MI, or stroke – was only about 2% greater in the FFR-guided PCI group (7.3% vs. 5.2%). The biggest contributor to the difference in MACE in FAME 3 at 12 months was the higher rate of repeat revascularization (5.9% vs. 3.9%).

Moreover, patients randomized to FFR-guided PCI had lower rates of many adverse events. This included risk of bleeding (1.6% vs. 3.8%; P = .009 as defined by type ≥3 Bleeding Academic Research Consortium , acute kidney injury (0.1% vs. 0.9%; P = .04), atrial fibrillation (2.4% vs. 14.1%; P < .001) and rehospitalization within 30 days (5.5% vs. 10.2%; P < .001).

In the context of a modest increase in risk of MACE and the lower rate of several important treatment-related adverse events, the QOL advantages identified in this subanalysis “might be a reasonable topic for patient-shared decision-making,” Dr. Jeremias suggested.
 

New data might inform patient decision-making

He granted the possibility that well-informed patients might accept the modestly increased risk of MACE for one or more of the outcomes, such as a higher likelihood of an early return to work, that favored FFR-guided PCI.

This is the point of this subanalysis, agreed Dr. Zimmermann.

“It is all about shared decision-making,” he said. Also emphasizing that the negative trial endpoint of FAME 3 “was driven largely by an increased risk of revascularization,” he believes that these new data might be a basis for discussions with patients weighing relative risks and benefits.

There are more data to come, according to Dr. Zimmermann, who said that follow-up of up to 5 years is planned. The 3-year data will be made available in 2023.

Dr. Zimmermann reported no potential conflicts of interest. Dr. Jeremias reported financial relationships with Abbott, ACIST, Boston Scientific, and Volcano. The investigator-initiated trial received research grants from Abbott Vascular and Medtronic.

A new subanalysis of the FAME 3 trial, which failed to show that percutaneous intervention (PCI) guided by fractional flow reserve (FFR) is noninferior to coronary artery bypass grafting (CABG) for treating three-vessel coronary artery disease, has associated PCI with early quality of life (QOL) advantages, according to findings presented at the annual scientific sessions of the American College of Cardiology.

Despite a modestly greater risk of major adverse cardiac events (MACE) at the end of 12 months’ follow-up among those treated with FFR-guided PCI, the greater QOL early after the procedure might be relevant to patients weighing these options, according to Frederik M. Zimmerman, MD, of Catharina Hospital in Eindhoven, the Netherlands.

“FFR-guided PCI results in a faster improvement in quality of life than CABG during the first year after revascularization, and it improved working status in patients younger than 65 years of age,” Dr. Zimmermann said.

The primary results of FAME 3 were presented at the 2021 Transcatheter Cardiovascular Therapeutics annual meeting by lead author William F. Fearon, MD, of Stanford (Calif.) University and published simultaneously in the New England Journal of Medicine.

Rather than confirming the hypothesis that FFR-guided PCI is comparable with CABG for the primary composite MACE outcome death from any cause, myocardial infarction, stroke, or revascularization, the incidence of MACE at 12 months was 10.6% in those randomized to PCI and 6.9% in the group assigned to CABG.

This translated into a hazard ratio for MACE of 1.5, signifying a 50% increase in risk for FFR-guided PCI relative to CABG for the primary outcome, a difference that negated the study definition of noninferiority (P = .35).

In this new health-related subanalysis, which was published simultaneously with his ACC presentation, the groups were compared over 12 months for QOL as measured with European Quality of Life–5 dimensions (EQ-5D) scale, angina as measured with the Canadian Cardiovascular Classification (CCC) system, and employment.

Outcomes data available in >85% of patients

Of the 1,500 patients enrolled and randomized in FAME 3 (757 to FFR-guided PCI and 743 to CABG), this health outcomes subanalysis was performed with complete data at 12 months from 89% of those in the PCI group and 88% of those in the CABG group.

Ultimately, the study did not show differences in any of these measures at the end of 12 months, but there were significant differences in QOL and employment at earlier time points. In particular, the significantly different (P < .001) trajectory for QOL improvement at 1 and 6 months favored FFR-guided PCI whether evaluated with the EQ-5D instrument or an EQ visual analog scale.

Rates of angina defined by as CCC class of at least 2 were low after revascularization in both arms of the study, negating any opportunity for differences, but patients aged younger than 65 years were almost twice as likely to have returned to full- or part-time work 1 month after revascularization (60.2% vs. 33.1%), and they remained at higher odds for working at 12 months (68.1% vs. 57.4%).

In patients aged older than 65 years, return-to-work rates did not differ significantly at any time point.

These results suggest potentially clinically meaningful early advantages for FFR-guided PCI, but some experts questioned the rationale for reporting positive secondary findings from a negative trial.

“This subanalysis is curious,” said Allen Jeremias, MD, director of interventional cardiology research, Saint Francis Hospital, Roslyn, N.Y. He pointed out that reporting these data is an anomaly.
 

Subanalyses uncommon in negative trials

“CABG was found to be better, so why look at QOL,” said Dr. Jeremias, who was an ACC-invited expert to discuss the results. However, he went on to say, “this could be an exception to the rule.”

The reason, according to Dr. Jeremias, is that the absolute difference at 12 months between FFR-guided PCI and CABG for the MACE events of greatest concern – death, MI, or stroke – was only about 2% greater in the FFR-guided PCI group (7.3% vs. 5.2%). The biggest contributor to the difference in MACE in FAME 3 at 12 months was the higher rate of repeat revascularization (5.9% vs. 3.9%).

Moreover, patients randomized to FFR-guided PCI had lower rates of many adverse events. This included risk of bleeding (1.6% vs. 3.8%; P = .009 as defined by type ≥3 Bleeding Academic Research Consortium , acute kidney injury (0.1% vs. 0.9%; P = .04), atrial fibrillation (2.4% vs. 14.1%; P < .001) and rehospitalization within 30 days (5.5% vs. 10.2%; P < .001).

In the context of a modest increase in risk of MACE and the lower rate of several important treatment-related adverse events, the QOL advantages identified in this subanalysis “might be a reasonable topic for patient-shared decision-making,” Dr. Jeremias suggested.
 

New data might inform patient decision-making

He granted the possibility that well-informed patients might accept the modestly increased risk of MACE for one or more of the outcomes, such as a higher likelihood of an early return to work, that favored FFR-guided PCI.

This is the point of this subanalysis, agreed Dr. Zimmermann.

“It is all about shared decision-making,” he said. Also emphasizing that the negative trial endpoint of FAME 3 “was driven largely by an increased risk of revascularization,” he believes that these new data might be a basis for discussions with patients weighing relative risks and benefits.

There are more data to come, according to Dr. Zimmermann, who said that follow-up of up to 5 years is planned. The 3-year data will be made available in 2023.

Dr. Zimmermann reported no potential conflicts of interest. Dr. Jeremias reported financial relationships with Abbott, ACIST, Boston Scientific, and Volcano. The investigator-initiated trial received research grants from Abbott Vascular and Medtronic.

A new subanalysis of the FAME 3 trial, which failed to show that percutaneous intervention (PCI) guided by fractional flow reserve (FFR) is noninferior to coronary artery bypass grafting (CABG) for treating three-vessel coronary artery disease, has associated PCI with early quality of life (QOL) advantages, according to findings presented at the annual scientific sessions of the American College of Cardiology.

Despite a modestly greater risk of major adverse cardiac events (MACE) at the end of 12 months’ follow-up among those treated with FFR-guided PCI, the greater QOL early after the procedure might be relevant to patients weighing these options, according to Frederik M. Zimmerman, MD, of Catharina Hospital in Eindhoven, the Netherlands.

“FFR-guided PCI results in a faster improvement in quality of life than CABG during the first year after revascularization, and it improved working status in patients younger than 65 years of age,” Dr. Zimmermann said.

The primary results of FAME 3 were presented at the 2021 Transcatheter Cardiovascular Therapeutics annual meeting by lead author William F. Fearon, MD, of Stanford (Calif.) University and published simultaneously in the New England Journal of Medicine.

Rather than confirming the hypothesis that FFR-guided PCI is comparable with CABG for the primary composite MACE outcome death from any cause, myocardial infarction, stroke, or revascularization, the incidence of MACE at 12 months was 10.6% in those randomized to PCI and 6.9% in the group assigned to CABG.

This translated into a hazard ratio for MACE of 1.5, signifying a 50% increase in risk for FFR-guided PCI relative to CABG for the primary outcome, a difference that negated the study definition of noninferiority (P = .35).

In this new health-related subanalysis, which was published simultaneously with his ACC presentation, the groups were compared over 12 months for QOL as measured with European Quality of Life–5 dimensions (EQ-5D) scale, angina as measured with the Canadian Cardiovascular Classification (CCC) system, and employment.

Outcomes data available in >85% of patients

Of the 1,500 patients enrolled and randomized in FAME 3 (757 to FFR-guided PCI and 743 to CABG), this health outcomes subanalysis was performed with complete data at 12 months from 89% of those in the PCI group and 88% of those in the CABG group.

Ultimately, the study did not show differences in any of these measures at the end of 12 months, but there were significant differences in QOL and employment at earlier time points. In particular, the significantly different (P < .001) trajectory for QOL improvement at 1 and 6 months favored FFR-guided PCI whether evaluated with the EQ-5D instrument or an EQ visual analog scale.

Rates of angina defined by as CCC class of at least 2 were low after revascularization in both arms of the study, negating any opportunity for differences, but patients aged younger than 65 years were almost twice as likely to have returned to full- or part-time work 1 month after revascularization (60.2% vs. 33.1%), and they remained at higher odds for working at 12 months (68.1% vs. 57.4%).

In patients aged older than 65 years, return-to-work rates did not differ significantly at any time point.

These results suggest potentially clinically meaningful early advantages for FFR-guided PCI, but some experts questioned the rationale for reporting positive secondary findings from a negative trial.

“This subanalysis is curious,” said Allen Jeremias, MD, director of interventional cardiology research, Saint Francis Hospital, Roslyn, N.Y. He pointed out that reporting these data is an anomaly.
 

Subanalyses uncommon in negative trials

“CABG was found to be better, so why look at QOL,” said Dr. Jeremias, who was an ACC-invited expert to discuss the results. However, he went on to say, “this could be an exception to the rule.”

The reason, according to Dr. Jeremias, is that the absolute difference at 12 months between FFR-guided PCI and CABG for the MACE events of greatest concern – death, MI, or stroke – was only about 2% greater in the FFR-guided PCI group (7.3% vs. 5.2%). The biggest contributor to the difference in MACE in FAME 3 at 12 months was the higher rate of repeat revascularization (5.9% vs. 3.9%).

Moreover, patients randomized to FFR-guided PCI had lower rates of many adverse events. This included risk of bleeding (1.6% vs. 3.8%; P = .009 as defined by type ≥3 Bleeding Academic Research Consortium , acute kidney injury (0.1% vs. 0.9%; P = .04), atrial fibrillation (2.4% vs. 14.1%; P < .001) and rehospitalization within 30 days (5.5% vs. 10.2%; P < .001).

In the context of a modest increase in risk of MACE and the lower rate of several important treatment-related adverse events, the QOL advantages identified in this subanalysis “might be a reasonable topic for patient-shared decision-making,” Dr. Jeremias suggested.
 

New data might inform patient decision-making

He granted the possibility that well-informed patients might accept the modestly increased risk of MACE for one or more of the outcomes, such as a higher likelihood of an early return to work, that favored FFR-guided PCI.

This is the point of this subanalysis, agreed Dr. Zimmermann.

“It is all about shared decision-making,” he said. Also emphasizing that the negative trial endpoint of FAME 3 “was driven largely by an increased risk of revascularization,” he believes that these new data might be a basis for discussions with patients weighing relative risks and benefits.

There are more data to come, according to Dr. Zimmermann, who said that follow-up of up to 5 years is planned. The 3-year data will be made available in 2023.

Dr. Zimmermann reported no potential conflicts of interest. Dr. Jeremias reported financial relationships with Abbott, ACIST, Boston Scientific, and Volcano. The investigator-initiated trial received research grants from Abbott Vascular and Medtronic.

The antifibrinolytic tranexamic acid (TXA) reduced serious bleeding without a significant effect on major vascular outcomes in patients undergoing noncardiac surgery at risk for these complications in the POISE-3 trial.

TXA cut the primary efficacy outcome of life-threatening, major, and critical organ bleeding at 30 days by 24% compared with placebo (9.1% vs. 11.7%; hazard ratio [HR], 0.76; P < .0001).

The primary safety outcome of myocardial injury after noncardiac surgery (MINS), nonhemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism (VTE) at 30 days occurred in 14.2% vs.. 13.9% of patients, respectively (HR, 1.023). This failed, however, to meet the study›s threshold to prove TXA noninferior to placebo (one-sided P = .044).

There was no increased risk for death or stroke with TXA, according to results published April 2 in the New England Journal of Medicine.

Principal investigator P.J. Devereaux, MD, PhD, Population Health Research Institute and McMaster University, Hamilton, Ontario, Canada, pointed out that there is only a 4.4% probability that the composite vascular outcome hazard ratio was above the noninferiority margin and that just 10 events separated the two groups (649 vs.. 639).

“Healthcare providers and patients will have to weigh a clear beneficial reduction in the composite bleeding outcome, which is an absolute difference of 2.7%, a result that was highly statistically significant, versus a low probability of a small increase in risk of the composite vascular endpoint, with an absolute difference of 0.3%,” a nonsignificant result, Dr. Devereaux said during the formal presentation of the results at the hybrid annual scientific sessions of the American College of Cardiology.

The findings, he said, should also be put in the context that 300 million adults have a major surgery each year worldwide and most don’t receive TXA. At the same time, there’s an annual global shortage of 30 million blood product units, and surgical bleeding accounts for up to 40% of all transfusions.

“POISE-3 identifies that use of TXA could avoid upwards of 8 million bleeding events resulting in transfusion on an annual basis, indicating potential for large public health and clinical benefit if TXA become standard practice in noncardiac surgery,” Dr. Devereaux said during the late-breaking trial session.

TXA is indicated for heavy menstrual bleeding and hemophilia and has been used in cardiac surgery, but it is increasingly being used in noncardiac surgeries. As previously reported, POISE showed that the beta-blocker metoprolol lowered the risk for myocardial infarction (MI) but increased the risk for severe stroke and overall death, whereas in POISE-2, perioperative low-dose aspirin lowered the risk for MI but was linked to more major bleeding.

The cumulative data have not shown an increased risk for thrombotic events in other settings, Dr. Devereaux told this news organization.

“I’m a cardiologist, and I think that we’ve been guilty at times of always only focusing on the thrombotic side of the equation and ignoring that bleeding is a very important aspect of the circulatory system,” he said. “And I think this shows for the first time clear unequivocal evidence that there’s a cheap, very encouraging, safe way to prevent this.”

“An important point is that if you can give tranexamic acid and prevent bleeding in your cardiac patients having noncardiac surgery, then you can prevent the delay of reinitiating their anticoagulants and their antiplatelets after surgery and getting them back on the medications that are important for them to prevent their cardiovascular event,” Dr. Devereaux added.

Discussant Michael J. Mack, MD, commented that TXA, widely used in cardiac surgery, is an old, inexpensive drug that “should be more widely used in noncardiac surgery.” Dr. Mack, from Baylor Scott & White Health, Dallas, added that he would limit it to major noncardiac surgery.

International trial

PeriOperative ISchemic Evaluation-3 (POISE-3) investigators at 114 hospitals in 22 countries (including countries in North and South America, Europe, and Africa; Russia; India; and Australia) randomly assigned 9,535 patients, aged 45 years or older, with or at risk for cardiovascular and bleeding complications to receive a TXA 1-g intravenous bolus or placebo at the start and end of inpatient noncardiac surgery.

Patients taking at least one long-term antihypertensive medication were also randomly assigned to a perioperative hypotension- or hypertension-avoidance strategy, which differ in the use of antihypertensives on the morning of surgery and the first 2 days after surgery, and in the target mean arterial pressure during surgery. Results from these cohorts will be presented in a separate session on April 4.

The study had planned to enroll 10,000 patients but was stopped early by the steering committee because of financial constraints resulting from slow enrollment during the pandemic. The decision was made without knowledge of the trial results but with knowledge that aggregate composite bleeding and vascular outcomes were higher than originally estimated, Dr. Devereaux noted.

Among all participants, the mean age was 70 years, 56% were male, almost a third had coronary artery disease, 15% had peripheral artery disease, and 8% had a prior stroke. About 80% were undergoing major surgery. Adherence to the study medications was 96.3% in both groups.

Secondary bleeding outcomes were lower in the TXA and placebo groups, including bleeding independently associated with mortality after surgery (8.7% vs. 11.3%), life-threatening bleeding (1.6% vs. 1.7%), major bleeding (7.6% vs. 10.4%), and critical organ bleeding (0.3% vs. 0.4%).

Importantly, the TXA group had significantly lower rates of International Society on Thrombosis and Haemostasis major bleeding (6.6% vs. 8.7%; P = .0001) and the need for transfusion of 1 or more units of packed red blood cells (9.4% vs. 12.0%; P <.0001), Dr. Devereaux noted.

In terms of secondary vascular outcomes, there were no significant differences between the TXA and placebo groups in rates of MINS (12.8% vs. 12.6%), MINS not fulfilling definition of MI (both 11.5%), MI (1.4% vs. 1.1%), and the net risk-benefit outcome (a composite of vascular death and nonfatal life-threatening, major, or critical organ bleeding, MINS, stroke, peripheral arterial thrombosis, and symptomatic proximal VTE; 20.7% vs. 21.9%).

The two groups had similar rates of all-cause (1.1% vs. 1.2%) and vascular (0.5% vs. 0.6%) mortality.

There also were no significant differences in other tertiary outcomes, such as acute kidney injury (14.1% vs. 13.7%), rehospitalization for vascular reasons (1.8% vs. 1.6%), or seizures (0.2% vs. <0.1%). The latter has been a concern, with the risk reported to increase with higher doses.

Subgroup analyses

Preplanned subgroup analyses showed a benefit for TXA over placebo for the primary efficacy outcome in orthopedic and nonorthopedic surgery and in patients with hemoglobin level below 120 g/L or 120 g/L or higher, with an estimated glomerular filtration rate less than 45 mL/min/1.73 m ²  or 45 mL/min/1.73 m ²  or higher, or with an N-terminal pro– B-type natriuretic peptide level below 200 ng/L or 200 ng/L or higher.

For the primary safety outcome, the benefit favored placebo but the interaction was not statistically significant for any of the four subgroups.

A post hoc subgroup analysis also showed similar results across the major categories of surgery, including general, vascular, urologic, and gynecologic, Dr. Devereaux told this news organization.

Although TXA is commonly used in orthopedic procedures, Dr. Devereaux noted, in other types of surgeries, “it’s not used at all.” But because TXA “is so cheap, and we can apply it to a broad population, even at an economic level it looks like it’s a winner to give to almost all patients having noncardiac surgery.”

The team also recently published a risk prediction tool that can help estimate a patient’s baseline risk for bleeding.

“So just using a model, which will bring together the patient’s type of surgery and their risk factors, you can look to see, okay, this is enough risk of bleeding, I’m just going to give tranexamic acid,” he said. “We will also be doing economic analyses because blood is also not cheap.”

The study was funded by the Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and the Research Grant Council (Hong Kong). Dr. Devereaux reports research/research grants from Abbott Diagnostics, Philips Healthcare, Roche Diagnostics, and Siemens. Dr. Mack reports receiving research grants from Abbott Vascular, Edwards Lifesciences, and Medtronic.

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

The antifibrinolytic tranexamic acid (TXA) reduced serious bleeding without a significant effect on major vascular outcomes in patients undergoing noncardiac surgery at risk for these complications in the POISE-3 trial.

TXA cut the primary efficacy outcome of life-threatening, major, and critical organ bleeding at 30 days by 24% compared with placebo (9.1% vs. 11.7%; hazard ratio [HR], 0.76; P < .0001).

The primary safety outcome of myocardial injury after noncardiac surgery (MINS), nonhemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism (VTE) at 30 days occurred in 14.2% vs.. 13.9% of patients, respectively (HR, 1.023). This failed, however, to meet the study›s threshold to prove TXA noninferior to placebo (one-sided P = .044).

There was no increased risk for death or stroke with TXA, according to results published April 2 in the New England Journal of Medicine.

Principal investigator P.J. Devereaux, MD, PhD, Population Health Research Institute and McMaster University, Hamilton, Ontario, Canada, pointed out that there is only a 4.4% probability that the composite vascular outcome hazard ratio was above the noninferiority margin and that just 10 events separated the two groups (649 vs.. 639).

“Healthcare providers and patients will have to weigh a clear beneficial reduction in the composite bleeding outcome, which is an absolute difference of 2.7%, a result that was highly statistically significant, versus a low probability of a small increase in risk of the composite vascular endpoint, with an absolute difference of 0.3%,” a nonsignificant result, Dr. Devereaux said during the formal presentation of the results at the hybrid annual scientific sessions of the American College of Cardiology.

The findings, he said, should also be put in the context that 300 million adults have a major surgery each year worldwide and most don’t receive TXA. At the same time, there’s an annual global shortage of 30 million blood product units, and surgical bleeding accounts for up to 40% of all transfusions.

“POISE-3 identifies that use of TXA could avoid upwards of 8 million bleeding events resulting in transfusion on an annual basis, indicating potential for large public health and clinical benefit if TXA become standard practice in noncardiac surgery,” Dr. Devereaux said during the late-breaking trial session.

TXA is indicated for heavy menstrual bleeding and hemophilia and has been used in cardiac surgery, but it is increasingly being used in noncardiac surgeries. As previously reported, POISE showed that the beta-blocker metoprolol lowered the risk for myocardial infarction (MI) but increased the risk for severe stroke and overall death, whereas in POISE-2, perioperative low-dose aspirin lowered the risk for MI but was linked to more major bleeding.

The cumulative data have not shown an increased risk for thrombotic events in other settings, Dr. Devereaux told this news organization.

“I’m a cardiologist, and I think that we’ve been guilty at times of always only focusing on the thrombotic side of the equation and ignoring that bleeding is a very important aspect of the circulatory system,” he said. “And I think this shows for the first time clear unequivocal evidence that there’s a cheap, very encouraging, safe way to prevent this.”

“An important point is that if you can give tranexamic acid and prevent bleeding in your cardiac patients having noncardiac surgery, then you can prevent the delay of reinitiating their anticoagulants and their antiplatelets after surgery and getting them back on the medications that are important for them to prevent their cardiovascular event,” Dr. Devereaux added.

Discussant Michael J. Mack, MD, commented that TXA, widely used in cardiac surgery, is an old, inexpensive drug that “should be more widely used in noncardiac surgery.” Dr. Mack, from Baylor Scott & White Health, Dallas, added that he would limit it to major noncardiac surgery.

International trial

PeriOperative ISchemic Evaluation-3 (POISE-3) investigators at 114 hospitals in 22 countries (including countries in North and South America, Europe, and Africa; Russia; India; and Australia) randomly assigned 9,535 patients, aged 45 years or older, with or at risk for cardiovascular and bleeding complications to receive a TXA 1-g intravenous bolus or placebo at the start and end of inpatient noncardiac surgery.

Patients taking at least one long-term antihypertensive medication were also randomly assigned to a perioperative hypotension- or hypertension-avoidance strategy, which differ in the use of antihypertensives on the morning of surgery and the first 2 days after surgery, and in the target mean arterial pressure during surgery. Results from these cohorts will be presented in a separate session on April 4.

The study had planned to enroll 10,000 patients but was stopped early by the steering committee because of financial constraints resulting from slow enrollment during the pandemic. The decision was made without knowledge of the trial results but with knowledge that aggregate composite bleeding and vascular outcomes were higher than originally estimated, Dr. Devereaux noted.

Among all participants, the mean age was 70 years, 56% were male, almost a third had coronary artery disease, 15% had peripheral artery disease, and 8% had a prior stroke. About 80% were undergoing major surgery. Adherence to the study medications was 96.3% in both groups.

Secondary bleeding outcomes were lower in the TXA and placebo groups, including bleeding independently associated with mortality after surgery (8.7% vs. 11.3%), life-threatening bleeding (1.6% vs. 1.7%), major bleeding (7.6% vs. 10.4%), and critical organ bleeding (0.3% vs. 0.4%).

Importantly, the TXA group had significantly lower rates of International Society on Thrombosis and Haemostasis major bleeding (6.6% vs. 8.7%; P = .0001) and the need for transfusion of 1 or more units of packed red blood cells (9.4% vs. 12.0%; P <.0001), Dr. Devereaux noted.

In terms of secondary vascular outcomes, there were no significant differences between the TXA and placebo groups in rates of MINS (12.8% vs. 12.6%), MINS not fulfilling definition of MI (both 11.5%), MI (1.4% vs. 1.1%), and the net risk-benefit outcome (a composite of vascular death and nonfatal life-threatening, major, or critical organ bleeding, MINS, stroke, peripheral arterial thrombosis, and symptomatic proximal VTE; 20.7% vs. 21.9%).

The two groups had similar rates of all-cause (1.1% vs. 1.2%) and vascular (0.5% vs. 0.6%) mortality.

There also were no significant differences in other tertiary outcomes, such as acute kidney injury (14.1% vs. 13.7%), rehospitalization for vascular reasons (1.8% vs. 1.6%), or seizures (0.2% vs. <0.1%). The latter has been a concern, with the risk reported to increase with higher doses.

Subgroup analyses

Preplanned subgroup analyses showed a benefit for TXA over placebo for the primary efficacy outcome in orthopedic and nonorthopedic surgery and in patients with hemoglobin level below 120 g/L or 120 g/L or higher, with an estimated glomerular filtration rate less than 45 mL/min/1.73 m ²  or 45 mL/min/1.73 m ²  or higher, or with an N-terminal pro– B-type natriuretic peptide level below 200 ng/L or 200 ng/L or higher.

For the primary safety outcome, the benefit favored placebo but the interaction was not statistically significant for any of the four subgroups.

A post hoc subgroup analysis also showed similar results across the major categories of surgery, including general, vascular, urologic, and gynecologic, Dr. Devereaux told this news organization.

Although TXA is commonly used in orthopedic procedures, Dr. Devereaux noted, in other types of surgeries, “it’s not used at all.” But because TXA “is so cheap, and we can apply it to a broad population, even at an economic level it looks like it’s a winner to give to almost all patients having noncardiac surgery.”

The team also recently published a risk prediction tool that can help estimate a patient’s baseline risk for bleeding.

“So just using a model, which will bring together the patient’s type of surgery and their risk factors, you can look to see, okay, this is enough risk of bleeding, I’m just going to give tranexamic acid,” he said. “We will also be doing economic analyses because blood is also not cheap.”

The study was funded by the Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and the Research Grant Council (Hong Kong). Dr. Devereaux reports research/research grants from Abbott Diagnostics, Philips Healthcare, Roche Diagnostics, and Siemens. Dr. Mack reports receiving research grants from Abbott Vascular, Edwards Lifesciences, and Medtronic.

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

The antifibrinolytic tranexamic acid (TXA) reduced serious bleeding without a significant effect on major vascular outcomes in patients undergoing noncardiac surgery at risk for these complications in the POISE-3 trial.

TXA cut the primary efficacy outcome of life-threatening, major, and critical organ bleeding at 30 days by 24% compared with placebo (9.1% vs. 11.7%; hazard ratio [HR], 0.76; P < .0001).

The primary safety outcome of myocardial injury after noncardiac surgery (MINS), nonhemorrhagic stroke, peripheral arterial thrombosis, and symptomatic proximal venous thromboembolism (VTE) at 30 days occurred in 14.2% vs.. 13.9% of patients, respectively (HR, 1.023). This failed, however, to meet the study›s threshold to prove TXA noninferior to placebo (one-sided P = .044).

There was no increased risk for death or stroke with TXA, according to results published April 2 in the New England Journal of Medicine.

Principal investigator P.J. Devereaux, MD, PhD, Population Health Research Institute and McMaster University, Hamilton, Ontario, Canada, pointed out that there is only a 4.4% probability that the composite vascular outcome hazard ratio was above the noninferiority margin and that just 10 events separated the two groups (649 vs.. 639).

“Healthcare providers and patients will have to weigh a clear beneficial reduction in the composite bleeding outcome, which is an absolute difference of 2.7%, a result that was highly statistically significant, versus a low probability of a small increase in risk of the composite vascular endpoint, with an absolute difference of 0.3%,” a nonsignificant result, Dr. Devereaux said during the formal presentation of the results at the hybrid annual scientific sessions of the American College of Cardiology.

The findings, he said, should also be put in the context that 300 million adults have a major surgery each year worldwide and most don’t receive TXA. At the same time, there’s an annual global shortage of 30 million blood product units, and surgical bleeding accounts for up to 40% of all transfusions.

“POISE-3 identifies that use of TXA could avoid upwards of 8 million bleeding events resulting in transfusion on an annual basis, indicating potential for large public health and clinical benefit if TXA become standard practice in noncardiac surgery,” Dr. Devereaux said during the late-breaking trial session.

TXA is indicated for heavy menstrual bleeding and hemophilia and has been used in cardiac surgery, but it is increasingly being used in noncardiac surgeries. As previously reported, POISE showed that the beta-blocker metoprolol lowered the risk for myocardial infarction (MI) but increased the risk for severe stroke and overall death, whereas in POISE-2, perioperative low-dose aspirin lowered the risk for MI but was linked to more major bleeding.

The cumulative data have not shown an increased risk for thrombotic events in other settings, Dr. Devereaux told this news organization.

“I’m a cardiologist, and I think that we’ve been guilty at times of always only focusing on the thrombotic side of the equation and ignoring that bleeding is a very important aspect of the circulatory system,” he said. “And I think this shows for the first time clear unequivocal evidence that there’s a cheap, very encouraging, safe way to prevent this.”

“An important point is that if you can give tranexamic acid and prevent bleeding in your cardiac patients having noncardiac surgery, then you can prevent the delay of reinitiating their anticoagulants and their antiplatelets after surgery and getting them back on the medications that are important for them to prevent their cardiovascular event,” Dr. Devereaux added.

Discussant Michael J. Mack, MD, commented that TXA, widely used in cardiac surgery, is an old, inexpensive drug that “should be more widely used in noncardiac surgery.” Dr. Mack, from Baylor Scott & White Health, Dallas, added that he would limit it to major noncardiac surgery.

International trial

PeriOperative ISchemic Evaluation-3 (POISE-3) investigators at 114 hospitals in 22 countries (including countries in North and South America, Europe, and Africa; Russia; India; and Australia) randomly assigned 9,535 patients, aged 45 years or older, with or at risk for cardiovascular and bleeding complications to receive a TXA 1-g intravenous bolus or placebo at the start and end of inpatient noncardiac surgery.

Patients taking at least one long-term antihypertensive medication were also randomly assigned to a perioperative hypotension- or hypertension-avoidance strategy, which differ in the use of antihypertensives on the morning of surgery and the first 2 days after surgery, and in the target mean arterial pressure during surgery. Results from these cohorts will be presented in a separate session on April 4.

The study had planned to enroll 10,000 patients but was stopped early by the steering committee because of financial constraints resulting from slow enrollment during the pandemic. The decision was made without knowledge of the trial results but with knowledge that aggregate composite bleeding and vascular outcomes were higher than originally estimated, Dr. Devereaux noted.

Among all participants, the mean age was 70 years, 56% were male, almost a third had coronary artery disease, 15% had peripheral artery disease, and 8% had a prior stroke. About 80% were undergoing major surgery. Adherence to the study medications was 96.3% in both groups.

Secondary bleeding outcomes were lower in the TXA and placebo groups, including bleeding independently associated with mortality after surgery (8.7% vs. 11.3%), life-threatening bleeding (1.6% vs. 1.7%), major bleeding (7.6% vs. 10.4%), and critical organ bleeding (0.3% vs. 0.4%).

Importantly, the TXA group had significantly lower rates of International Society on Thrombosis and Haemostasis major bleeding (6.6% vs. 8.7%; P = .0001) and the need for transfusion of 1 or more units of packed red blood cells (9.4% vs. 12.0%; P <.0001), Dr. Devereaux noted.

In terms of secondary vascular outcomes, there were no significant differences between the TXA and placebo groups in rates of MINS (12.8% vs. 12.6%), MINS not fulfilling definition of MI (both 11.5%), MI (1.4% vs. 1.1%), and the net risk-benefit outcome (a composite of vascular death and nonfatal life-threatening, major, or critical organ bleeding, MINS, stroke, peripheral arterial thrombosis, and symptomatic proximal VTE; 20.7% vs. 21.9%).

The two groups had similar rates of all-cause (1.1% vs. 1.2%) and vascular (0.5% vs. 0.6%) mortality.

There also were no significant differences in other tertiary outcomes, such as acute kidney injury (14.1% vs. 13.7%), rehospitalization for vascular reasons (1.8% vs. 1.6%), or seizures (0.2% vs. <0.1%). The latter has been a concern, with the risk reported to increase with higher doses.

Subgroup analyses

Preplanned subgroup analyses showed a benefit for TXA over placebo for the primary efficacy outcome in orthopedic and nonorthopedic surgery and in patients with hemoglobin level below 120 g/L or 120 g/L or higher, with an estimated glomerular filtration rate less than 45 mL/min/1.73 m ²  or 45 mL/min/1.73 m ²  or higher, or with an N-terminal pro– B-type natriuretic peptide level below 200 ng/L or 200 ng/L or higher.

For the primary safety outcome, the benefit favored placebo but the interaction was not statistically significant for any of the four subgroups.

A post hoc subgroup analysis also showed similar results across the major categories of surgery, including general, vascular, urologic, and gynecologic, Dr. Devereaux told this news organization.

Although TXA is commonly used in orthopedic procedures, Dr. Devereaux noted, in other types of surgeries, “it’s not used at all.” But because TXA “is so cheap, and we can apply it to a broad population, even at an economic level it looks like it’s a winner to give to almost all patients having noncardiac surgery.”

The team also recently published a risk prediction tool that can help estimate a patient’s baseline risk for bleeding.

“So just using a model, which will bring together the patient’s type of surgery and their risk factors, you can look to see, okay, this is enough risk of bleeding, I’m just going to give tranexamic acid,” he said. “We will also be doing economic analyses because blood is also not cheap.”

The study was funded by the Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and the Research Grant Council (Hong Kong). Dr. Devereaux reports research/research grants from Abbott Diagnostics, Philips Healthcare, Roche Diagnostics, and Siemens. Dr. Mack reports receiving research grants from Abbott Vascular, Edwards Lifesciences, and Medtronic.

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

Pointing a finger at COVID-19

The battle against COVID-19 is seemingly never ending. It’s been 2 years and still we struggle against the virus. But now, a new hero rises against the eternal menace, a powerful weapon against this scourge of humanity. And that weapon? Finger length.

Before you break out the sad trombone, hear us out. One of the big questions around COVID-19 is the role testosterone plays in its severity: Does low testosterone increase or decrease the odds of contracting severe COVID-19? To help answer that question, English researchers have published a study analyzing finger length ratios in both COVID-19 patients and a healthy control group. That seems random, but high testosterone in the womb leads to longer ring fingers in adulthood, while high estrogen leads to longer index fingers.

PxHere

According to the researchers, those who had significant left hand–right hand differences in the ratio between the second and fourth digits, as well as the third and fifth digits, were significantly more likely to have severe COVID-19 compared with those with more even ratios. Those with “feminized” short little fingers were also at risk. Those large ratio differences indicate low testosterone and high estrogen, which may explain why elderly men are at such high risk for severe COVID-19. Testosterone naturally falls off as men get older.

The results add credence to clinical trials looking to use testosterone-boosting drugs against COVID-19, the researchers said. It also gives credence to LOTME’s brand-new 12-step finger strength fitness routine and our branded finger weights. Now just $19.95! It’s the bargain of the century! Boost your testosterone naturally and protect yourself from COVID-19! We promise it’s not a scam.
 

Some emergencies need a superhero

Last week, we learned about the most boring person in the world. This week just happens to be opposite week, so we’re looking at a candidate for the most interesting person. Someone who can swoop down from the sky to save the injured and helpless. Someone who can go where helicopters fear to tread. Someone with jet engines for arms. Superhero-type stuff.

Richard Browning/Gravity Industries

The Great North Air Ambulance Service (GNAAS), a charitable organization located in the United Kingdom, recently announced that one of its members has completed training on the Gravity Industries Jet Suit. The suit “has two engines on each arm and a larger engine on the back [that] provide up to 317 pounds of thrust,” Interesting Engineering explained.

GNAAS is putting the suit into operation in England’s Lake District National Park, which includes mountainous terrain that is not very hospitable to helicopter landings. A paramedic using the suit can reach hikers stranded on mountainsides much faster than rescuers who have to run or hike from the nearest helicopter landing site.

“Everyone looks at the wow factor and the fact we are the world’s first jet suit paramedics, but for us, it’s about delivering patient care,” GNAAS’ Andy Mawson told Interesting Engineering. Sounds like superhero-speak to us.

So if you’re in the Lake District and have taken a bit of a tumble, you can call a superhero on your cell phone or you can use this to summon one.
 

Why we’re rejecting food as medicine

Humans have been using food to treat ailments much longer than we’ve had the advances of modern medicine. So why have we rejected its worth in our treatment processes? And what can be done to change that? The Center for Food as Medicine and the Hunter College NYC Food Policy Center just released a 335-page report that answers those questions.

phototake/ThinkStock

First, the why: Meals in health care settings are not medically designed to help with the specific needs of the patient. Produce-prescription and nutrition-incentive programs don’t have the government funds to fully support them. And a lot of medical schools don’t even require students to take a basic nutrition course. So there’s a lack of knowledge and a disconnect between health care providers and food as a resource.

Then there’s a lack of trust in the food industry and their validity. Social media uses food as a means of promoting “pseudoscientific alternative medicine” or spreading false info, pushing away legitimate providers. The food industry has had its fingers in food science studies and an almost mafia-esque chokehold on American dietary guidelines. No wonder food for medicine is getting the boot!

To change the situation, the report offers 10 key recommendations on how to advance the idea of incorporating food into medicine for treatment and prevention. They include boosting the funding for research, making hospitals more food-as-medicine focused, expanding federal programs, and improving public awareness on the role nutrition can play in medical treatment or prevention.

So maybe instead of rejecting food outright, we should be looking a little deeper at how we can use it to our advantage. Just a thought: Ice cream as an antidepressant.
 

Being rude is a good thing, apparently

If you’ve ever been called argumentative, stubborn, or unpleasant, then this LOTME is for you. Researchers at the University of Geneva have found that people who are more stubborn and hate to conform have brains that are more protected against Alzheimer’s disease. That type of personality seems to preserve the part of the brain that usually deteriorates as we grow older.

Piqsels

The original hypothesis that personality may have a protective effect against brain degeneration led the investigators to conduct cognitive and personality assessments of 65 elderly participants over a 5-year period. Researchers have been attempting to create vaccines to protect against Alzheimer’s disease, but these new findings offer a nonbiological way to help.

“For a long time, the brain is able to compensate by activating alternative networks; when the first clinical signs appear, however, it is unfortunately often too late. The identification of early biomarkers is therefore essential for … effective disease management,” lead author Panteleimon Giannakopoulos, MD, said in a Study Finds report.

You may be wondering how people with more agreeable and less confrontational personalities can seek help. Well, researchers are working on that, too. It’s a complex situation, but as always, we’re rooting for you, science!

At least now you can take solace in the fact that your elderly next-door neighbor who yells at you for stepping on his lawn is probably more protected against Alzheimer’s disease.

Pointing a finger at COVID-19

The battle against COVID-19 is seemingly never ending. It’s been 2 years and still we struggle against the virus. But now, a new hero rises against the eternal menace, a powerful weapon against this scourge of humanity. And that weapon? Finger length.

Before you break out the sad trombone, hear us out. One of the big questions around COVID-19 is the role testosterone plays in its severity: Does low testosterone increase or decrease the odds of contracting severe COVID-19? To help answer that question, English researchers have published a study analyzing finger length ratios in both COVID-19 patients and a healthy control group. That seems random, but high testosterone in the womb leads to longer ring fingers in adulthood, while high estrogen leads to longer index fingers.

PxHere

According to the researchers, those who had significant left hand–right hand differences in the ratio between the second and fourth digits, as well as the third and fifth digits, were significantly more likely to have severe COVID-19 compared with those with more even ratios. Those with “feminized” short little fingers were also at risk. Those large ratio differences indicate low testosterone and high estrogen, which may explain why elderly men are at such high risk for severe COVID-19. Testosterone naturally falls off as men get older.

The results add credence to clinical trials looking to use testosterone-boosting drugs against COVID-19, the researchers said. It also gives credence to LOTME’s brand-new 12-step finger strength fitness routine and our branded finger weights. Now just $19.95! It’s the bargain of the century! Boost your testosterone naturally and protect yourself from COVID-19! We promise it’s not a scam.
 

Some emergencies need a superhero

Last week, we learned about the most boring person in the world. This week just happens to be opposite week, so we’re looking at a candidate for the most interesting person. Someone who can swoop down from the sky to save the injured and helpless. Someone who can go where helicopters fear to tread. Someone with jet engines for arms. Superhero-type stuff.

Richard Browning/Gravity Industries

The Great North Air Ambulance Service (GNAAS), a charitable organization located in the United Kingdom, recently announced that one of its members has completed training on the Gravity Industries Jet Suit. The suit “has two engines on each arm and a larger engine on the back [that] provide up to 317 pounds of thrust,” Interesting Engineering explained.

GNAAS is putting the suit into operation in England’s Lake District National Park, which includes mountainous terrain that is not very hospitable to helicopter landings. A paramedic using the suit can reach hikers stranded on mountainsides much faster than rescuers who have to run or hike from the nearest helicopter landing site.

“Everyone looks at the wow factor and the fact we are the world’s first jet suit paramedics, but for us, it’s about delivering patient care,” GNAAS’ Andy Mawson told Interesting Engineering. Sounds like superhero-speak to us.

So if you’re in the Lake District and have taken a bit of a tumble, you can call a superhero on your cell phone or you can use this to summon one.
 

Why we’re rejecting food as medicine

Humans have been using food to treat ailments much longer than we’ve had the advances of modern medicine. So why have we rejected its worth in our treatment processes? And what can be done to change that? The Center for Food as Medicine and the Hunter College NYC Food Policy Center just released a 335-page report that answers those questions.

phototake/ThinkStock

First, the why: Meals in health care settings are not medically designed to help with the specific needs of the patient. Produce-prescription and nutrition-incentive programs don’t have the government funds to fully support them. And a lot of medical schools don’t even require students to take a basic nutrition course. So there’s a lack of knowledge and a disconnect between health care providers and food as a resource.

Then there’s a lack of trust in the food industry and their validity. Social media uses food as a means of promoting “pseudoscientific alternative medicine” or spreading false info, pushing away legitimate providers. The food industry has had its fingers in food science studies and an almost mafia-esque chokehold on American dietary guidelines. No wonder food for medicine is getting the boot!

To change the situation, the report offers 10 key recommendations on how to advance the idea of incorporating food into medicine for treatment and prevention. They include boosting the funding for research, making hospitals more food-as-medicine focused, expanding federal programs, and improving public awareness on the role nutrition can play in medical treatment or prevention.

So maybe instead of rejecting food outright, we should be looking a little deeper at how we can use it to our advantage. Just a thought: Ice cream as an antidepressant.
 

Being rude is a good thing, apparently

If you’ve ever been called argumentative, stubborn, or unpleasant, then this LOTME is for you. Researchers at the University of Geneva have found that people who are more stubborn and hate to conform have brains that are more protected against Alzheimer’s disease. That type of personality seems to preserve the part of the brain that usually deteriorates as we grow older.

Piqsels

The original hypothesis that personality may have a protective effect against brain degeneration led the investigators to conduct cognitive and personality assessments of 65 elderly participants over a 5-year period. Researchers have been attempting to create vaccines to protect against Alzheimer’s disease, but these new findings offer a nonbiological way to help.

“For a long time, the brain is able to compensate by activating alternative networks; when the first clinical signs appear, however, it is unfortunately often too late. The identification of early biomarkers is therefore essential for … effective disease management,” lead author Panteleimon Giannakopoulos, MD, said in a Study Finds report.

You may be wondering how people with more agreeable and less confrontational personalities can seek help. Well, researchers are working on that, too. It’s a complex situation, but as always, we’re rooting for you, science!

At least now you can take solace in the fact that your elderly next-door neighbor who yells at you for stepping on his lawn is probably more protected against Alzheimer’s disease.

Pointing a finger at COVID-19

The battle against COVID-19 is seemingly never ending. It’s been 2 years and still we struggle against the virus. But now, a new hero rises against the eternal menace, a powerful weapon against this scourge of humanity. And that weapon? Finger length.

Before you break out the sad trombone, hear us out. One of the big questions around COVID-19 is the role testosterone plays in its severity: Does low testosterone increase or decrease the odds of contracting severe COVID-19? To help answer that question, English researchers have published a study analyzing finger length ratios in both COVID-19 patients and a healthy control group. That seems random, but high testosterone in the womb leads to longer ring fingers in adulthood, while high estrogen leads to longer index fingers.

PxHere

According to the researchers, those who had significant left hand–right hand differences in the ratio between the second and fourth digits, as well as the third and fifth digits, were significantly more likely to have severe COVID-19 compared with those with more even ratios. Those with “feminized” short little fingers were also at risk. Those large ratio differences indicate low testosterone and high estrogen, which may explain why elderly men are at such high risk for severe COVID-19. Testosterone naturally falls off as men get older.

The results add credence to clinical trials looking to use testosterone-boosting drugs against COVID-19, the researchers said. It also gives credence to LOTME’s brand-new 12-step finger strength fitness routine and our branded finger weights. Now just $19.95! It’s the bargain of the century! Boost your testosterone naturally and protect yourself from COVID-19! We promise it’s not a scam.
 

Some emergencies need a superhero

Last week, we learned about the most boring person in the world. This week just happens to be opposite week, so we’re looking at a candidate for the most interesting person. Someone who can swoop down from the sky to save the injured and helpless. Someone who can go where helicopters fear to tread. Someone with jet engines for arms. Superhero-type stuff.

Richard Browning/Gravity Industries

The Great North Air Ambulance Service (GNAAS), a charitable organization located in the United Kingdom, recently announced that one of its members has completed training on the Gravity Industries Jet Suit. The suit “has two engines on each arm and a larger engine on the back [that] provide up to 317 pounds of thrust,” Interesting Engineering explained.

GNAAS is putting the suit into operation in England’s Lake District National Park, which includes mountainous terrain that is not very hospitable to helicopter landings. A paramedic using the suit can reach hikers stranded on mountainsides much faster than rescuers who have to run or hike from the nearest helicopter landing site.

“Everyone looks at the wow factor and the fact we are the world’s first jet suit paramedics, but for us, it’s about delivering patient care,” GNAAS’ Andy Mawson told Interesting Engineering. Sounds like superhero-speak to us.

So if you’re in the Lake District and have taken a bit of a tumble, you can call a superhero on your cell phone or you can use this to summon one.
 

Why we’re rejecting food as medicine

Humans have been using food to treat ailments much longer than we’ve had the advances of modern medicine. So why have we rejected its worth in our treatment processes? And what can be done to change that? The Center for Food as Medicine and the Hunter College NYC Food Policy Center just released a 335-page report that answers those questions.

phototake/ThinkStock

First, the why: Meals in health care settings are not medically designed to help with the specific needs of the patient. Produce-prescription and nutrition-incentive programs don’t have the government funds to fully support them. And a lot of medical schools don’t even require students to take a basic nutrition course. So there’s a lack of knowledge and a disconnect between health care providers and food as a resource.

Then there’s a lack of trust in the food industry and their validity. Social media uses food as a means of promoting “pseudoscientific alternative medicine” or spreading false info, pushing away legitimate providers. The food industry has had its fingers in food science studies and an almost mafia-esque chokehold on American dietary guidelines. No wonder food for medicine is getting the boot!

To change the situation, the report offers 10 key recommendations on how to advance the idea of incorporating food into medicine for treatment and prevention. They include boosting the funding for research, making hospitals more food-as-medicine focused, expanding federal programs, and improving public awareness on the role nutrition can play in medical treatment or prevention.

So maybe instead of rejecting food outright, we should be looking a little deeper at how we can use it to our advantage. Just a thought: Ice cream as an antidepressant.
 

Being rude is a good thing, apparently

If you’ve ever been called argumentative, stubborn, or unpleasant, then this LOTME is for you. Researchers at the University of Geneva have found that people who are more stubborn and hate to conform have brains that are more protected against Alzheimer’s disease. That type of personality seems to preserve the part of the brain that usually deteriorates as we grow older.

Piqsels

The original hypothesis that personality may have a protective effect against brain degeneration led the investigators to conduct cognitive and personality assessments of 65 elderly participants over a 5-year period. Researchers have been attempting to create vaccines to protect against Alzheimer’s disease, but these new findings offer a nonbiological way to help.

“For a long time, the brain is able to compensate by activating alternative networks; when the first clinical signs appear, however, it is unfortunately often too late. The identification of early biomarkers is therefore essential for … effective disease management,” lead author Panteleimon Giannakopoulos, MD, said in a Study Finds report.

You may be wondering how people with more agreeable and less confrontational personalities can seek help. Well, researchers are working on that, too. It’s a complex situation, but as always, we’re rooting for you, science!

At least now you can take solace in the fact that your elderly next-door neighbor who yells at you for stepping on his lawn is probably more protected against Alzheimer’s disease.