Cardiology News

These should be the best of times for geriatric medicine.

The baby boom has become a senior surge, bringing in a rapidly growing pool of aging patients for geriatricians to treat. According to the U.S. Census Bureau, more than 56 million adults aged 65 and older live in the United States. They account for about 17% of the nation’s population. That number is expected to hit 73 million by 2030 and 86 million by 2050.

The American Geriatrics Society estimates that 30% of older people require the attention of geriatricians. These clinicians excel in managing complex cases – patients with multiple comorbidities, such as coronary artery disease, dementia, and osteoporosis, who are taking a half dozen, and often more, medications.

But instead of thriving, geriatrics as a medical specialty appears to be hobbling. In the 2010s, geriatricians called for “25,000 [such specialists] by 2025.” As of 2021, 7123 certified geriatricians were practicing in the United States, according to the American Board of Medical Specialties.

The Health Resources and Services Administration, a federal agency that addresses medical workforce shortages, estimates that there will be 6,230 geriatricians by 2025, or approximately 1 for every 3,000 older adults requiring geriatric care. HRSA projects a shortage of 27,000 geriatricians by 2025.

The specialty has faced an uphill battle to attract fellows. This year, only 43% of the nation’s 177 geriatrics fellowship slots were filled, according to November’s National Resident Match Program report. Family medicine–based geriatrics achieved only a 32% fill rate, while internal medicine–based programs saw a rate of 45%.

“Our numbers are shrinking so we need another approach to make sure older adults get the care they need and deserve,” said G. Michael Harper, MD, president of the 6,000-member AGS.

But Dr. Harper, who practices at the University of California, San Francisco, and the San Francisco VA Medical Center, added a positive note: “We may be struggling to increase the number of board-certified geriatricians, but the field itself has made a lot of progress in terms of improving clinical care through advancements in science and in the ways we deliver care.”

Dr. Harper cited the Hospital Elder Life Program, a hospital model developed at the Harvard-affiliated Marcus Institute for Aging Research, which uses an interprofessional team and trained volunteers to prevent delirium and functional decline. HELP has been adopted by more than 200 hospitals worldwide and has been successful at returning older adults to their homes or previous living situations with maintained or improved ability to function, he said.

Mark Supiano, MD, professor and chief of geriatrics at the University of Utah, Salt Lake City, said the specialty has been in shortage mode since ABMS recognized it in 1988. He was in the initial cohort of fellowship-trained geriatricians, sitting for the first certifying exam in geriatrics offered that year.

“Back then, the demographic imperative of the aging of our society was on the horizon. We’re living it now. I knew enough to recognize it was coming and saw an opportunity,” Dr. Supiano said in an interview. “There was so much then that we didn’t know about how to understand aging or how to care for older adults that there really was such a knowledge gap.”

Dr. Supiano is an associate editor of Hazzard’s Geriatric Medicine and Gerontology (McGraw-Hill Education), which has more than doubled in pages and word count during his career.
 

Unfavorable finances

Katherine Thompson, MD, director of the geriatrics fellowship program at the University of Chicago and codirector of UChicago’s Successful Aging and Frailty Evaluation Clinic, said money is a major reason for the struggle. “I think probably the biggest driver is financial,” she said. “A lot of people are graduating medical school with really astronomical amounts of medical school loans.”

Geriatricians, like other doctors, carry a large debt – $200,000, on average, not counting undergraduate debt, according to the Association of American Medical Colleges.

But the typical geriatrician earns less than an internist or family medicine doctor who doesn’t undergo the additional year of training, Dr. Thompson said. “There’s not a lot of financial motivation to do this fellowship,” she said.

The jobs website Zippia reports that geriatricians earned roughly $165,000 per year on average in 2022. The average annual incomes in 2022 were $191,000 for pediatricians, $215,000 for family physicians, and $223,000 for internists, according to the site.

In other words, Dr. Harper said, “geriatrics is one of the few professions where you can actually do additional training and make less money.”

The reason for the pay issue is simple: Geriatricians treat patients covered by Medicare, whose reimbursement schedules lag behind those of commercial insurers. The Kaiser Family Foundation reported in 2020 that private insurance paid 143% of Medicare rates on average for physician services.

Dr. Harper said overall compensation for geriatricians has “not gained a lot of traction,” but they can earn comfortable livings.

Still, representation of the specialty on the American Medical Association’s Relative Value Scale Update Committee has led to approval by the Centers for Medicare & Medicaid Services of billing codes that pay geriatricians “for what they do. Examples include chronic care management, advance care planning, and dementia evaluation,” he said.

But the geriatrician gap goes beyond money.

Ageism, too, may play a role in residents not choosing geriatrics.

“Our culture is ageist. It definitely focuses on youth and looks at aging as being loss rather than just a change in what works well and what doesn’t work well,” said Mary Tinetti, MD, a geriatrician and researcher at Yale University, New Haven, Conn. “Ageism happens among physicians, just because they’re part of the broader society.”
 

Time for a new goal?

Dr. Tinetti said she’s optimistic that new ideas about geriatricians teaching other primary care clinicians about the tenets of geriatric medicine, which offer a wholistic approach to comorbidities, such as diabetes, atrial fibrillation, dementia, hypertension, hyperlipidemia, and polypharmacy problems faced by this population, especially those 85 and older.

She has called on her profession to abandon the goal of increasing the numbers of board-certified geriatricians – whom she refers to as big “G” geriatricians. She instead wants to develop a “small, elite workforce” that discovers and tests geriatrics principles through research, teaches these principles to all healthcare professions and to the public, and disseminates and implements the policies.

“We need a cadre of geriatricians who train all other clinicians in the care of older adults,” Dr. Tinetti said. “The goal is not more geriatricians but rather the preparation of all clinicians in the care of older adults.”

Dr. Thompson said geriatricians are teaching primary care specialists, nurses, social workers, and other health care providers the principles of age-friendly care. AGS has for the past 20 years led a program called the Geriatrics for Specialists Initiative to increase geriatrics knowledge and expertise of surgical and medical specialists.

Some specialties have taken the cue and have added geriatrics-related hyphens through additional training: geriatric-emergency, geriatric-general surgery, geriatric-hospitalists, and more.

HRSA runs programs to encourage physicians to train as geriatricians and geriatrics faculty, and it encourages the geriatrics interdisciplinary team approach.

Richard Olague, director of public affairs for HRSA, said his agency has invested over $160 million over the past 4 years in the education and training of geriatricians and other health care professionals who care for the elderly through its Geriatrics Workforce Enhancement Program and Geriatrics Academic Career Awards Program. In the academic year 2020-2021, the two programs trained 109 geriatricians; 456 other geriatric/gerontology providers and students; 44,450 other healthcare workforce professionals and students; and served 17,666 patients and 5,409 caregivers.

Dr. Harper, like his fellow geriatricians, tells young doctors that geriatrics is a fulfilling specialty.

“I get to care for the whole person and sometimes their families, too, and in the process form rich and meaningful relationships. And while I’m rarely in the position to cure, I always have the ability to care,” he said. “Sometimes that can mean being an advocate trying to make sure my patients receive the care they need, and other times it might mean protecting them from burdensome care that is unlikely to lead to any meaningful benefit. There is great reward in all of that.”

Dr. Supiano said geriatric patients are being helped by the Age-Friendly Health System initiative of the John A. Hartford Foundation and the Institute for Healthcare Improvement in partnership with the American Hospital Association and the Catholic Health Association of the United States. This is sort of a seal of approval for facilities committed to age-friendly care.

“When you go to your hospital, if they don’t have this age-friendly health system banner on the front door ... you either ask why that is not there, or you vote with your feet and go to another health system that is age friendly,” he said. “Geriatricians are eternal optimists.”

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

These should be the best of times for geriatric medicine.

The baby boom has become a senior surge, bringing in a rapidly growing pool of aging patients for geriatricians to treat. According to the U.S. Census Bureau, more than 56 million adults aged 65 and older live in the United States. They account for about 17% of the nation’s population. That number is expected to hit 73 million by 2030 and 86 million by 2050.

The American Geriatrics Society estimates that 30% of older people require the attention of geriatricians. These clinicians excel in managing complex cases – patients with multiple comorbidities, such as coronary artery disease, dementia, and osteoporosis, who are taking a half dozen, and often more, medications.

But instead of thriving, geriatrics as a medical specialty appears to be hobbling. In the 2010s, geriatricians called for “25,000 [such specialists] by 2025.” As of 2021, 7123 certified geriatricians were practicing in the United States, according to the American Board of Medical Specialties.

The Health Resources and Services Administration, a federal agency that addresses medical workforce shortages, estimates that there will be 6,230 geriatricians by 2025, or approximately 1 for every 3,000 older adults requiring geriatric care. HRSA projects a shortage of 27,000 geriatricians by 2025.

The specialty has faced an uphill battle to attract fellows. This year, only 43% of the nation’s 177 geriatrics fellowship slots were filled, according to November’s National Resident Match Program report. Family medicine–based geriatrics achieved only a 32% fill rate, while internal medicine–based programs saw a rate of 45%.

“Our numbers are shrinking so we need another approach to make sure older adults get the care they need and deserve,” said G. Michael Harper, MD, president of the 6,000-member AGS.

But Dr. Harper, who practices at the University of California, San Francisco, and the San Francisco VA Medical Center, added a positive note: “We may be struggling to increase the number of board-certified geriatricians, but the field itself has made a lot of progress in terms of improving clinical care through advancements in science and in the ways we deliver care.”

Dr. Harper cited the Hospital Elder Life Program, a hospital model developed at the Harvard-affiliated Marcus Institute for Aging Research, which uses an interprofessional team and trained volunteers to prevent delirium and functional decline. HELP has been adopted by more than 200 hospitals worldwide and has been successful at returning older adults to their homes or previous living situations with maintained or improved ability to function, he said.

Mark Supiano, MD, professor and chief of geriatrics at the University of Utah, Salt Lake City, said the specialty has been in shortage mode since ABMS recognized it in 1988. He was in the initial cohort of fellowship-trained geriatricians, sitting for the first certifying exam in geriatrics offered that year.

“Back then, the demographic imperative of the aging of our society was on the horizon. We’re living it now. I knew enough to recognize it was coming and saw an opportunity,” Dr. Supiano said in an interview. “There was so much then that we didn’t know about how to understand aging or how to care for older adults that there really was such a knowledge gap.”

Dr. Supiano is an associate editor of Hazzard’s Geriatric Medicine and Gerontology (McGraw-Hill Education), which has more than doubled in pages and word count during his career.
 

Unfavorable finances

Katherine Thompson, MD, director of the geriatrics fellowship program at the University of Chicago and codirector of UChicago’s Successful Aging and Frailty Evaluation Clinic, said money is a major reason for the struggle. “I think probably the biggest driver is financial,” she said. “A lot of people are graduating medical school with really astronomical amounts of medical school loans.”

Geriatricians, like other doctors, carry a large debt – $200,000, on average, not counting undergraduate debt, according to the Association of American Medical Colleges.

But the typical geriatrician earns less than an internist or family medicine doctor who doesn’t undergo the additional year of training, Dr. Thompson said. “There’s not a lot of financial motivation to do this fellowship,” she said.

The jobs website Zippia reports that geriatricians earned roughly $165,000 per year on average in 2022. The average annual incomes in 2022 were $191,000 for pediatricians, $215,000 for family physicians, and $223,000 for internists, according to the site.

In other words, Dr. Harper said, “geriatrics is one of the few professions where you can actually do additional training and make less money.”

The reason for the pay issue is simple: Geriatricians treat patients covered by Medicare, whose reimbursement schedules lag behind those of commercial insurers. The Kaiser Family Foundation reported in 2020 that private insurance paid 143% of Medicare rates on average for physician services.

Dr. Harper said overall compensation for geriatricians has “not gained a lot of traction,” but they can earn comfortable livings.

Still, representation of the specialty on the American Medical Association’s Relative Value Scale Update Committee has led to approval by the Centers for Medicare & Medicaid Services of billing codes that pay geriatricians “for what they do. Examples include chronic care management, advance care planning, and dementia evaluation,” he said.

But the geriatrician gap goes beyond money.

Ageism, too, may play a role in residents not choosing geriatrics.

“Our culture is ageist. It definitely focuses on youth and looks at aging as being loss rather than just a change in what works well and what doesn’t work well,” said Mary Tinetti, MD, a geriatrician and researcher at Yale University, New Haven, Conn. “Ageism happens among physicians, just because they’re part of the broader society.”
 

Time for a new goal?

Dr. Tinetti said she’s optimistic that new ideas about geriatricians teaching other primary care clinicians about the tenets of geriatric medicine, which offer a wholistic approach to comorbidities, such as diabetes, atrial fibrillation, dementia, hypertension, hyperlipidemia, and polypharmacy problems faced by this population, especially those 85 and older.

She has called on her profession to abandon the goal of increasing the numbers of board-certified geriatricians – whom she refers to as big “G” geriatricians. She instead wants to develop a “small, elite workforce” that discovers and tests geriatrics principles through research, teaches these principles to all healthcare professions and to the public, and disseminates and implements the policies.

“We need a cadre of geriatricians who train all other clinicians in the care of older adults,” Dr. Tinetti said. “The goal is not more geriatricians but rather the preparation of all clinicians in the care of older adults.”

Dr. Thompson said geriatricians are teaching primary care specialists, nurses, social workers, and other health care providers the principles of age-friendly care. AGS has for the past 20 years led a program called the Geriatrics for Specialists Initiative to increase geriatrics knowledge and expertise of surgical and medical specialists.

Some specialties have taken the cue and have added geriatrics-related hyphens through additional training: geriatric-emergency, geriatric-general surgery, geriatric-hospitalists, and more.

HRSA runs programs to encourage physicians to train as geriatricians and geriatrics faculty, and it encourages the geriatrics interdisciplinary team approach.

Richard Olague, director of public affairs for HRSA, said his agency has invested over $160 million over the past 4 years in the education and training of geriatricians and other health care professionals who care for the elderly through its Geriatrics Workforce Enhancement Program and Geriatrics Academic Career Awards Program. In the academic year 2020-2021, the two programs trained 109 geriatricians; 456 other geriatric/gerontology providers and students; 44,450 other healthcare workforce professionals and students; and served 17,666 patients and 5,409 caregivers.

Dr. Harper, like his fellow geriatricians, tells young doctors that geriatrics is a fulfilling specialty.

“I get to care for the whole person and sometimes their families, too, and in the process form rich and meaningful relationships. And while I’m rarely in the position to cure, I always have the ability to care,” he said. “Sometimes that can mean being an advocate trying to make sure my patients receive the care they need, and other times it might mean protecting them from burdensome care that is unlikely to lead to any meaningful benefit. There is great reward in all of that.”

Dr. Supiano said geriatric patients are being helped by the Age-Friendly Health System initiative of the John A. Hartford Foundation and the Institute for Healthcare Improvement in partnership with the American Hospital Association and the Catholic Health Association of the United States. This is sort of a seal of approval for facilities committed to age-friendly care.

“When you go to your hospital, if they don’t have this age-friendly health system banner on the front door ... you either ask why that is not there, or you vote with your feet and go to another health system that is age friendly,” he said. “Geriatricians are eternal optimists.”

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

These should be the best of times for geriatric medicine.

The baby boom has become a senior surge, bringing in a rapidly growing pool of aging patients for geriatricians to treat. According to the U.S. Census Bureau, more than 56 million adults aged 65 and older live in the United States. They account for about 17% of the nation’s population. That number is expected to hit 73 million by 2030 and 86 million by 2050.

The American Geriatrics Society estimates that 30% of older people require the attention of geriatricians. These clinicians excel in managing complex cases – patients with multiple comorbidities, such as coronary artery disease, dementia, and osteoporosis, who are taking a half dozen, and often more, medications.

But instead of thriving, geriatrics as a medical specialty appears to be hobbling. In the 2010s, geriatricians called for “25,000 [such specialists] by 2025.” As of 2021, 7123 certified geriatricians were practicing in the United States, according to the American Board of Medical Specialties.

The Health Resources and Services Administration, a federal agency that addresses medical workforce shortages, estimates that there will be 6,230 geriatricians by 2025, or approximately 1 for every 3,000 older adults requiring geriatric care. HRSA projects a shortage of 27,000 geriatricians by 2025.

The specialty has faced an uphill battle to attract fellows. This year, only 43% of the nation’s 177 geriatrics fellowship slots were filled, according to November’s National Resident Match Program report. Family medicine–based geriatrics achieved only a 32% fill rate, while internal medicine–based programs saw a rate of 45%.

“Our numbers are shrinking so we need another approach to make sure older adults get the care they need and deserve,” said G. Michael Harper, MD, president of the 6,000-member AGS.

But Dr. Harper, who practices at the University of California, San Francisco, and the San Francisco VA Medical Center, added a positive note: “We may be struggling to increase the number of board-certified geriatricians, but the field itself has made a lot of progress in terms of improving clinical care through advancements in science and in the ways we deliver care.”

Dr. Harper cited the Hospital Elder Life Program, a hospital model developed at the Harvard-affiliated Marcus Institute for Aging Research, which uses an interprofessional team and trained volunteers to prevent delirium and functional decline. HELP has been adopted by more than 200 hospitals worldwide and has been successful at returning older adults to their homes or previous living situations with maintained or improved ability to function, he said.

Mark Supiano, MD, professor and chief of geriatrics at the University of Utah, Salt Lake City, said the specialty has been in shortage mode since ABMS recognized it in 1988. He was in the initial cohort of fellowship-trained geriatricians, sitting for the first certifying exam in geriatrics offered that year.

“Back then, the demographic imperative of the aging of our society was on the horizon. We’re living it now. I knew enough to recognize it was coming and saw an opportunity,” Dr. Supiano said in an interview. “There was so much then that we didn’t know about how to understand aging or how to care for older adults that there really was such a knowledge gap.”

Dr. Supiano is an associate editor of Hazzard’s Geriatric Medicine and Gerontology (McGraw-Hill Education), which has more than doubled in pages and word count during his career.
 

Unfavorable finances

Katherine Thompson, MD, director of the geriatrics fellowship program at the University of Chicago and codirector of UChicago’s Successful Aging and Frailty Evaluation Clinic, said money is a major reason for the struggle. “I think probably the biggest driver is financial,” she said. “A lot of people are graduating medical school with really astronomical amounts of medical school loans.”

Geriatricians, like other doctors, carry a large debt – $200,000, on average, not counting undergraduate debt, according to the Association of American Medical Colleges.

But the typical geriatrician earns less than an internist or family medicine doctor who doesn’t undergo the additional year of training, Dr. Thompson said. “There’s not a lot of financial motivation to do this fellowship,” she said.

The jobs website Zippia reports that geriatricians earned roughly $165,000 per year on average in 2022. The average annual incomes in 2022 were $191,000 for pediatricians, $215,000 for family physicians, and $223,000 for internists, according to the site.

In other words, Dr. Harper said, “geriatrics is one of the few professions where you can actually do additional training and make less money.”

The reason for the pay issue is simple: Geriatricians treat patients covered by Medicare, whose reimbursement schedules lag behind those of commercial insurers. The Kaiser Family Foundation reported in 2020 that private insurance paid 143% of Medicare rates on average for physician services.

Dr. Harper said overall compensation for geriatricians has “not gained a lot of traction,” but they can earn comfortable livings.

Still, representation of the specialty on the American Medical Association’s Relative Value Scale Update Committee has led to approval by the Centers for Medicare & Medicaid Services of billing codes that pay geriatricians “for what they do. Examples include chronic care management, advance care planning, and dementia evaluation,” he said.

But the geriatrician gap goes beyond money.

Ageism, too, may play a role in residents not choosing geriatrics.

“Our culture is ageist. It definitely focuses on youth and looks at aging as being loss rather than just a change in what works well and what doesn’t work well,” said Mary Tinetti, MD, a geriatrician and researcher at Yale University, New Haven, Conn. “Ageism happens among physicians, just because they’re part of the broader society.”
 

Time for a new goal?

Dr. Tinetti said she’s optimistic that new ideas about geriatricians teaching other primary care clinicians about the tenets of geriatric medicine, which offer a wholistic approach to comorbidities, such as diabetes, atrial fibrillation, dementia, hypertension, hyperlipidemia, and polypharmacy problems faced by this population, especially those 85 and older.

She has called on her profession to abandon the goal of increasing the numbers of board-certified geriatricians – whom she refers to as big “G” geriatricians. She instead wants to develop a “small, elite workforce” that discovers and tests geriatrics principles through research, teaches these principles to all healthcare professions and to the public, and disseminates and implements the policies.

“We need a cadre of geriatricians who train all other clinicians in the care of older adults,” Dr. Tinetti said. “The goal is not more geriatricians but rather the preparation of all clinicians in the care of older adults.”

Dr. Thompson said geriatricians are teaching primary care specialists, nurses, social workers, and other health care providers the principles of age-friendly care. AGS has for the past 20 years led a program called the Geriatrics for Specialists Initiative to increase geriatrics knowledge and expertise of surgical and medical specialists.

Some specialties have taken the cue and have added geriatrics-related hyphens through additional training: geriatric-emergency, geriatric-general surgery, geriatric-hospitalists, and more.

HRSA runs programs to encourage physicians to train as geriatricians and geriatrics faculty, and it encourages the geriatrics interdisciplinary team approach.

Richard Olague, director of public affairs for HRSA, said his agency has invested over $160 million over the past 4 years in the education and training of geriatricians and other health care professionals who care for the elderly through its Geriatrics Workforce Enhancement Program and Geriatrics Academic Career Awards Program. In the academic year 2020-2021, the two programs trained 109 geriatricians; 456 other geriatric/gerontology providers and students; 44,450 other healthcare workforce professionals and students; and served 17,666 patients and 5,409 caregivers.

Dr. Harper, like his fellow geriatricians, tells young doctors that geriatrics is a fulfilling specialty.

“I get to care for the whole person and sometimes their families, too, and in the process form rich and meaningful relationships. And while I’m rarely in the position to cure, I always have the ability to care,” he said. “Sometimes that can mean being an advocate trying to make sure my patients receive the care they need, and other times it might mean protecting them from burdensome care that is unlikely to lead to any meaningful benefit. There is great reward in all of that.”

Dr. Supiano said geriatric patients are being helped by the Age-Friendly Health System initiative of the John A. Hartford Foundation and the Institute for Healthcare Improvement in partnership with the American Hospital Association and the Catholic Health Association of the United States. This is sort of a seal of approval for facilities committed to age-friendly care.

“When you go to your hospital, if they don’t have this age-friendly health system banner on the front door ... you either ask why that is not there, or you vote with your feet and go to another health system that is age friendly,” he said. “Geriatricians are eternal optimists.”

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

It’s time for my once-a-decade (more or less) list of resolutions. As long as you are pledging to turn over a new leaf at home, why not do it at the office as well?

I can’t presume to know what issues need addressing in your practice, but I do know the ones I get asked about most often, so I can offer some suggestions that might provide inspiration:

1. Keep your website up to date. Check it now, then make a note to check it regularly. Most people find their physicians online these days, and you don’t want them finding a year-old presentation with outdated photos, personnel, services, and rates. Keep your site current, or hire someone to do it for you.

2. Be an authoritative presence on social media. Like it or not, you should be on Facebook, Twitter (at least for now), Instagram, TikTok – wherever your patients congregate. Medical topics are popular search categories, and they are searching for expert advice. You are the expert. There is a ton of medical misinformation online, and it needs to be countered with accurate, factual data from bona fide experts.

8. Back up your data. Now is an excellent time to verify that the information on your office and personal computers is being backed up – locally and online – on a regular schedule. Don’t wait until something crashes.

9. Keep a closer eye on your office finances. Most physicians delegate the bookkeeping, and that’s fine. But ignoring the financial side completely creates an atmosphere that facilitates embezzlement. Set aside a couple of hours each month to review the books personally. And make sure your employees know you’re doing it.

10. Make sure your long-range financial planning is on track. I’ve said this before, but it can’t be repeated too often. Economic conditions change all the time. Once a year, you should sit down with your accountant and lawyer and make sure your investments are well-diversified and all other aspects of your finances – budgets, credit ratings, insurance coverage, tax situations, college savings, estate plans, retirement accounts – are in the best shape possible.

11. Pay down your debt. Another oldie but goodie. Debt can destroy the best laid retirement plans. If you carry significant debt, set up a plan to pay it off as soon as you can.

12. Take more vacations. Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.” If you’ve been working too much, this is the year to start spending more time enjoying your life, your friends and family, and the world. As John Lennon said, “Life is what happens to you while you’re busy making other plans.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

It’s time for my once-a-decade (more or less) list of resolutions. As long as you are pledging to turn over a new leaf at home, why not do it at the office as well?

I can’t presume to know what issues need addressing in your practice, but I do know the ones I get asked about most often, so I can offer some suggestions that might provide inspiration:

1. Keep your website up to date. Check it now, then make a note to check it regularly. Most people find their physicians online these days, and you don’t want them finding a year-old presentation with outdated photos, personnel, services, and rates. Keep your site current, or hire someone to do it for you.

2. Be an authoritative presence on social media. Like it or not, you should be on Facebook, Twitter (at least for now), Instagram, TikTok – wherever your patients congregate. Medical topics are popular search categories, and they are searching for expert advice. You are the expert. There is a ton of medical misinformation online, and it needs to be countered with accurate, factual data from bona fide experts.

8. Back up your data. Now is an excellent time to verify that the information on your office and personal computers is being backed up – locally and online – on a regular schedule. Don’t wait until something crashes.

9. Keep a closer eye on your office finances. Most physicians delegate the bookkeeping, and that’s fine. But ignoring the financial side completely creates an atmosphere that facilitates embezzlement. Set aside a couple of hours each month to review the books personally. And make sure your employees know you’re doing it.

10. Make sure your long-range financial planning is on track. I’ve said this before, but it can’t be repeated too often. Economic conditions change all the time. Once a year, you should sit down with your accountant and lawyer and make sure your investments are well-diversified and all other aspects of your finances – budgets, credit ratings, insurance coverage, tax situations, college savings, estate plans, retirement accounts – are in the best shape possible.

11. Pay down your debt. Another oldie but goodie. Debt can destroy the best laid retirement plans. If you carry significant debt, set up a plan to pay it off as soon as you can.

12. Take more vacations. Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.” If you’ve been working too much, this is the year to start spending more time enjoying your life, your friends and family, and the world. As John Lennon said, “Life is what happens to you while you’re busy making other plans.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

It’s time for my once-a-decade (more or less) list of resolutions. As long as you are pledging to turn over a new leaf at home, why not do it at the office as well?

I can’t presume to know what issues need addressing in your practice, but I do know the ones I get asked about most often, so I can offer some suggestions that might provide inspiration:

1. Keep your website up to date. Check it now, then make a note to check it regularly. Most people find their physicians online these days, and you don’t want them finding a year-old presentation with outdated photos, personnel, services, and rates. Keep your site current, or hire someone to do it for you.

2. Be an authoritative presence on social media. Like it or not, you should be on Facebook, Twitter (at least for now), Instagram, TikTok – wherever your patients congregate. Medical topics are popular search categories, and they are searching for expert advice. You are the expert. There is a ton of medical misinformation online, and it needs to be countered with accurate, factual data from bona fide experts.

8. Back up your data. Now is an excellent time to verify that the information on your office and personal computers is being backed up – locally and online – on a regular schedule. Don’t wait until something crashes.

9. Keep a closer eye on your office finances. Most physicians delegate the bookkeeping, and that’s fine. But ignoring the financial side completely creates an atmosphere that facilitates embezzlement. Set aside a couple of hours each month to review the books personally. And make sure your employees know you’re doing it.

10. Make sure your long-range financial planning is on track. I’ve said this before, but it can’t be repeated too often. Economic conditions change all the time. Once a year, you should sit down with your accountant and lawyer and make sure your investments are well-diversified and all other aspects of your finances – budgets, credit ratings, insurance coverage, tax situations, college savings, estate plans, retirement accounts – are in the best shape possible.

11. Pay down your debt. Another oldie but goodie. Debt can destroy the best laid retirement plans. If you carry significant debt, set up a plan to pay it off as soon as you can.

12. Take more vacations. Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.” If you’ve been working too much, this is the year to start spending more time enjoying your life, your friends and family, and the world. As John Lennon said, “Life is what happens to you while you’re busy making other plans.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Bribery really is the solution to all of life’s problems

Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.

The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.

Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.

The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.

The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
 

More green space, less medicine

Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.

rawpixel

If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.

We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.

In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.

Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.

“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”

The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
 

Said the toilet to the engineer: Do you hear what I hear?

A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.

Maia Gatlin

Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.

She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.

The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.

They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.

Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.

That would be a heroic toilet indeed.

Bribery really is the solution to all of life’s problems

Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.

The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.

Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.

The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.

The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
 

More green space, less medicine

Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.

rawpixel

If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.

We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.

In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.

Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.

“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”

The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
 

Said the toilet to the engineer: Do you hear what I hear?

A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.

Maia Gatlin

Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.

She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.

The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.

They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.

Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.

That would be a heroic toilet indeed.

Bribery really is the solution to all of life’s problems

Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.

The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.

Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.

The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.

The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
 

More green space, less medicine

Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.

rawpixel

If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.

We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.

In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.

Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.

“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”

The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
 

Said the toilet to the engineer: Do you hear what I hear?

A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.

Maia Gatlin

Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.

She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.

The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.

They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.

Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.

That would be a heroic toilet indeed.

CHICAGO – Extended follow-up of patients with heart failure enrolled in the RAFT trial strengthens the case for starting treatment early with a cardiac resynchronization therapy plus defibrillation (CRT-D) device in appropriate patients.

RAFT, which compared CRT-D with treatment with an implantable cardioverter defibrillator (ICD) alone, showed that the early survival benefit produced by CRT-D during an average 40-month follow-up in the original trial persisted during an additional mean follow-up of about 5 years. This result strengthens the case for starting treatment early with a CRT-D device in appropriate patients with heart failure.

Mitchel L. Zoler/MDedge News

During extended follow-up of more than half of the enrolled patients, out to an average of 7.6 years overall and to an average of 12.9 years among survivors, patients who received a CRT-D device had a significant 21% relative reduction in their rate of all-cause mortality compared with randomized patients who received an ICD and no cardiac resynchronization, John L. Sapp, MD, reported at the American Heart Association scientific sessions.

The primary results of RAFT were first reported in 2010.

This magnitude of a survival benefit among the patients originally randomized to CRT is “dramatic,” given that many of the comparator patients who initially received no CRT likely crossed over to receive a CRT-D device once the initial, randomized 4 years of the study finished, commented Lynne W. Stevenson, MD, director of cardiomyopathy and the Lisa M. Jacobson Professor of Cardiology at Vanderbilt University Medical Center in Nashville, Tenn., who was not involved with the study.

‘CRT can remap heart failure trajectory’

The new findings “strengthen our conviction that CRT can remap the trajectory” of selected patients with heart failure, and that “candidates for CRT should be vigorously identified,” Dr. Stevenson said in an interview.

She also noted that the benefit with extended follow-up was “strikingly parallel” to that seen at 12 years after the addition of an ACE inhibitor for mild heart failure during the 4 years of the landmark SOLVD trial. The new RAFT extended follow-up, as well as the 12-year follow-up of the SOLVD trial, “support the concept that longer follow-up reveals vital information not provided by the relatively short randomized trial period,” she said.

“The new data say ‘don’t delay starting CRT in appropriate patients with heart failure,’ and ‘don’t think of CRT as just a treatment that makes patients feel better.’

 

“The totality of these data shows that CRT also treats the underlying heart muscle weakness, which helps patients live longer. Previous data showed that patients with left bundle branch block eligible for CRT are unlikely to respond well to the usual, recommended heart medications so it is important to start treatment with CRT-D early,” declared Dr. Stevenson, who cochaired the session where Dr. Sapp gave his report.

RAFT randomized 1,798 patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of at least 120 msec to receive either a CRT-D or ICD device. The study’s primary endpoint was death from any cause or hospitalization for heart failure. After an average 40 months of randomized follow-up, the primary endpoint occurred in 40% of the patients with an ICD and in 33% of those with a CRT-D device, a significant 25% relative reduction linked with CRT-D use. Both endpoint components contributed to the combined result significantly and to about the same extent, and the incremental benefit from CRT-D was significant for patients with NYHA class II heart failure as well as for those with class III.

However, prespecified subgroup analyses showed that the incremental benefit from CRT-D was significantly limited to patients with an intrinsic QRS duration of at least 150 msec, while in those with a duration of 120-149 msec CRT-D had a neutral effect compared with ICD. The same pattern also appeared when the analysis split patients into those with a left bundle branch block, who significantly benefited from CRT-D, but the initial benefit was not apparent in patients with right bundle branch block.

A study subgroup with extended follow-up

The new, extended follow-up analysis presented by Dr. Sapp included 1,050 of the original 1,798 patients (58%) enrolled at any of eight participating Canadian centers that each enrolled at least 100 patients and followed them through the end of 2021 (the full study cohort came from 34 centers, including 10 centers outside Canada). This subgroup included 520 patients randomized to receive CRT-D and 530 who received an ICD. Although this was a post hoc subgroup analysis, the CRT-D and ICD arms matched closely in all measured baseline characteristics.

The prespecified primary outcome of this follow-up analysis was the rate of all-cause mortality. Because of their longer disease trajectory, this pared-down study cohort included many more patients with NYHA class II function, 803, and in this subgroup CRT-D exerted a significant 23% incremental reduction in mortality compared with ICD treatment. CRT-D also produced a 17% relative reduction in long-term mortality among patients with NYHA class III function at baseline, but this point estimate of relative benefit was not significant in this subgroup of just 247 patients, said Dr. Sapp, a cardiologist and professor at Dalhousie University & Nova Scotia Health in Halifax.

Based on the original RAFT results from 2010, as well as on evidence from several other trials, the current heart failure management guideline from the AHA, the American College of Cardiology, and the Heart Failure Society of America give the highest level of recommendation, level 1, for CRT in patients with a left ventricular ejection fraction of 35% or less, sinus rhythm with left bundle branch block, a QRS duration of at least 150 msec, and NYHA class II, III, or ambulatory IV symptoms while on guideline-directed medical therapy.

The guideline also gives class 2a (“can be useful”) or 2b (“may be considered”) recommendation for certain other heart failure patients, including those with a QRS duration of 120-149 msec, a left ventricular ejection fraction as high as 50%, no left bundle branch block, or NYHA class I symptoms.

Don’t wait to start CRT

Although this 2022 guideline, as well as earlier versions that had roughly similar recommendations for CRT for about a decade, have led to “common” use of CRT in appropriate patients in U.S. practice, “it has not been used as much as it should be, in part because there’s been a feeling that CRT mostly treats symptoms and so perhaps you can wait” to start it, said Dr. Stevenson.

The findings from the new, extended follow-up RAFT analysis give increased urgency to starting CRT “as soon as possible” in appropriate patients with heart failure, even before they stabilize on guideline-directed medical therapy, said Dr. Stevenson. She also downplayed any ambiguity in the RAFT findings about optimal medical therapy, which during the RAFT study included traditional triple therapy at a time before treatment with sacubitril/valsartan (Entresto) and sodium-glucose cotransporter 2 (SGLT2) inhibitors became recommended.

“There is no reason to think that these treatments will negate the benefit of CRT for patients with heart failure with reduced ejection fraction and a wide left bundle branch block,” Dr. Stevenson said.

She also believes that the extended follow-up results, which showed clear efficacy for CRT-D in patients with NYHA class II function, support the case for upgrading the current 2b recommendation for using CRT treatment in patients with NYHA class I function and ischemic heart failure to a 2a recommendation regardless of whether or not patients have coronary artery disease. “The difference between class I and class II depends more on a patient’s lifestyle rather than on the severity of their heart failure,” Dr. Stevenson noted. “The RAFT study results encourage us to reexamine the clinical class and timing for CRT” in the current heart failure guideline.

RAFT received partial sponsorship from Medtronic. Dr. Sapp has been a consultant to Abbott, Biosense Webster, Medtronic, and Varian and has received research funding from Abbott and Biosense Webster. Dr. Stevenson had no disclosures.

CHICAGO – Extended follow-up of patients with heart failure enrolled in the RAFT trial strengthens the case for starting treatment early with a cardiac resynchronization therapy plus defibrillation (CRT-D) device in appropriate patients.

RAFT, which compared CRT-D with treatment with an implantable cardioverter defibrillator (ICD) alone, showed that the early survival benefit produced by CRT-D during an average 40-month follow-up in the original trial persisted during an additional mean follow-up of about 5 years. This result strengthens the case for starting treatment early with a CRT-D device in appropriate patients with heart failure.

Mitchel L. Zoler/MDedge News

During extended follow-up of more than half of the enrolled patients, out to an average of 7.6 years overall and to an average of 12.9 years among survivors, patients who received a CRT-D device had a significant 21% relative reduction in their rate of all-cause mortality compared with randomized patients who received an ICD and no cardiac resynchronization, John L. Sapp, MD, reported at the American Heart Association scientific sessions.

The primary results of RAFT were first reported in 2010.

This magnitude of a survival benefit among the patients originally randomized to CRT is “dramatic,” given that many of the comparator patients who initially received no CRT likely crossed over to receive a CRT-D device once the initial, randomized 4 years of the study finished, commented Lynne W. Stevenson, MD, director of cardiomyopathy and the Lisa M. Jacobson Professor of Cardiology at Vanderbilt University Medical Center in Nashville, Tenn., who was not involved with the study.

‘CRT can remap heart failure trajectory’

The new findings “strengthen our conviction that CRT can remap the trajectory” of selected patients with heart failure, and that “candidates for CRT should be vigorously identified,” Dr. Stevenson said in an interview.

She also noted that the benefit with extended follow-up was “strikingly parallel” to that seen at 12 years after the addition of an ACE inhibitor for mild heart failure during the 4 years of the landmark SOLVD trial. The new RAFT extended follow-up, as well as the 12-year follow-up of the SOLVD trial, “support the concept that longer follow-up reveals vital information not provided by the relatively short randomized trial period,” she said.

“The new data say ‘don’t delay starting CRT in appropriate patients with heart failure,’ and ‘don’t think of CRT as just a treatment that makes patients feel better.’

 

“The totality of these data shows that CRT also treats the underlying heart muscle weakness, which helps patients live longer. Previous data showed that patients with left bundle branch block eligible for CRT are unlikely to respond well to the usual, recommended heart medications so it is important to start treatment with CRT-D early,” declared Dr. Stevenson, who cochaired the session where Dr. Sapp gave his report.

RAFT randomized 1,798 patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of at least 120 msec to receive either a CRT-D or ICD device. The study’s primary endpoint was death from any cause or hospitalization for heart failure. After an average 40 months of randomized follow-up, the primary endpoint occurred in 40% of the patients with an ICD and in 33% of those with a CRT-D device, a significant 25% relative reduction linked with CRT-D use. Both endpoint components contributed to the combined result significantly and to about the same extent, and the incremental benefit from CRT-D was significant for patients with NYHA class II heart failure as well as for those with class III.

However, prespecified subgroup analyses showed that the incremental benefit from CRT-D was significantly limited to patients with an intrinsic QRS duration of at least 150 msec, while in those with a duration of 120-149 msec CRT-D had a neutral effect compared with ICD. The same pattern also appeared when the analysis split patients into those with a left bundle branch block, who significantly benefited from CRT-D, but the initial benefit was not apparent in patients with right bundle branch block.

A study subgroup with extended follow-up

The new, extended follow-up analysis presented by Dr. Sapp included 1,050 of the original 1,798 patients (58%) enrolled at any of eight participating Canadian centers that each enrolled at least 100 patients and followed them through the end of 2021 (the full study cohort came from 34 centers, including 10 centers outside Canada). This subgroup included 520 patients randomized to receive CRT-D and 530 who received an ICD. Although this was a post hoc subgroup analysis, the CRT-D and ICD arms matched closely in all measured baseline characteristics.

The prespecified primary outcome of this follow-up analysis was the rate of all-cause mortality. Because of their longer disease trajectory, this pared-down study cohort included many more patients with NYHA class II function, 803, and in this subgroup CRT-D exerted a significant 23% incremental reduction in mortality compared with ICD treatment. CRT-D also produced a 17% relative reduction in long-term mortality among patients with NYHA class III function at baseline, but this point estimate of relative benefit was not significant in this subgroup of just 247 patients, said Dr. Sapp, a cardiologist and professor at Dalhousie University & Nova Scotia Health in Halifax.

Based on the original RAFT results from 2010, as well as on evidence from several other trials, the current heart failure management guideline from the AHA, the American College of Cardiology, and the Heart Failure Society of America give the highest level of recommendation, level 1, for CRT in patients with a left ventricular ejection fraction of 35% or less, sinus rhythm with left bundle branch block, a QRS duration of at least 150 msec, and NYHA class II, III, or ambulatory IV symptoms while on guideline-directed medical therapy.

The guideline also gives class 2a (“can be useful”) or 2b (“may be considered”) recommendation for certain other heart failure patients, including those with a QRS duration of 120-149 msec, a left ventricular ejection fraction as high as 50%, no left bundle branch block, or NYHA class I symptoms.

Don’t wait to start CRT

Although this 2022 guideline, as well as earlier versions that had roughly similar recommendations for CRT for about a decade, have led to “common” use of CRT in appropriate patients in U.S. practice, “it has not been used as much as it should be, in part because there’s been a feeling that CRT mostly treats symptoms and so perhaps you can wait” to start it, said Dr. Stevenson.

The findings from the new, extended follow-up RAFT analysis give increased urgency to starting CRT “as soon as possible” in appropriate patients with heart failure, even before they stabilize on guideline-directed medical therapy, said Dr. Stevenson. She also downplayed any ambiguity in the RAFT findings about optimal medical therapy, which during the RAFT study included traditional triple therapy at a time before treatment with sacubitril/valsartan (Entresto) and sodium-glucose cotransporter 2 (SGLT2) inhibitors became recommended.

“There is no reason to think that these treatments will negate the benefit of CRT for patients with heart failure with reduced ejection fraction and a wide left bundle branch block,” Dr. Stevenson said.

She also believes that the extended follow-up results, which showed clear efficacy for CRT-D in patients with NYHA class II function, support the case for upgrading the current 2b recommendation for using CRT treatment in patients with NYHA class I function and ischemic heart failure to a 2a recommendation regardless of whether or not patients have coronary artery disease. “The difference between class I and class II depends more on a patient’s lifestyle rather than on the severity of their heart failure,” Dr. Stevenson noted. “The RAFT study results encourage us to reexamine the clinical class and timing for CRT” in the current heart failure guideline.

RAFT received partial sponsorship from Medtronic. Dr. Sapp has been a consultant to Abbott, Biosense Webster, Medtronic, and Varian and has received research funding from Abbott and Biosense Webster. Dr. Stevenson had no disclosures.

CHICAGO – Extended follow-up of patients with heart failure enrolled in the RAFT trial strengthens the case for starting treatment early with a cardiac resynchronization therapy plus defibrillation (CRT-D) device in appropriate patients.

RAFT, which compared CRT-D with treatment with an implantable cardioverter defibrillator (ICD) alone, showed that the early survival benefit produced by CRT-D during an average 40-month follow-up in the original trial persisted during an additional mean follow-up of about 5 years. This result strengthens the case for starting treatment early with a CRT-D device in appropriate patients with heart failure.

Mitchel L. Zoler/MDedge News

During extended follow-up of more than half of the enrolled patients, out to an average of 7.6 years overall and to an average of 12.9 years among survivors, patients who received a CRT-D device had a significant 21% relative reduction in their rate of all-cause mortality compared with randomized patients who received an ICD and no cardiac resynchronization, John L. Sapp, MD, reported at the American Heart Association scientific sessions.

The primary results of RAFT were first reported in 2010.

This magnitude of a survival benefit among the patients originally randomized to CRT is “dramatic,” given that many of the comparator patients who initially received no CRT likely crossed over to receive a CRT-D device once the initial, randomized 4 years of the study finished, commented Lynne W. Stevenson, MD, director of cardiomyopathy and the Lisa M. Jacobson Professor of Cardiology at Vanderbilt University Medical Center in Nashville, Tenn., who was not involved with the study.

‘CRT can remap heart failure trajectory’

The new findings “strengthen our conviction that CRT can remap the trajectory” of selected patients with heart failure, and that “candidates for CRT should be vigorously identified,” Dr. Stevenson said in an interview.

She also noted that the benefit with extended follow-up was “strikingly parallel” to that seen at 12 years after the addition of an ACE inhibitor for mild heart failure during the 4 years of the landmark SOLVD trial. The new RAFT extended follow-up, as well as the 12-year follow-up of the SOLVD trial, “support the concept that longer follow-up reveals vital information not provided by the relatively short randomized trial period,” she said.

“The new data say ‘don’t delay starting CRT in appropriate patients with heart failure,’ and ‘don’t think of CRT as just a treatment that makes patients feel better.’

 

“The totality of these data shows that CRT also treats the underlying heart muscle weakness, which helps patients live longer. Previous data showed that patients with left bundle branch block eligible for CRT are unlikely to respond well to the usual, recommended heart medications so it is important to start treatment with CRT-D early,” declared Dr. Stevenson, who cochaired the session where Dr. Sapp gave his report.

RAFT randomized 1,798 patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of at least 120 msec to receive either a CRT-D or ICD device. The study’s primary endpoint was death from any cause or hospitalization for heart failure. After an average 40 months of randomized follow-up, the primary endpoint occurred in 40% of the patients with an ICD and in 33% of those with a CRT-D device, a significant 25% relative reduction linked with CRT-D use. Both endpoint components contributed to the combined result significantly and to about the same extent, and the incremental benefit from CRT-D was significant for patients with NYHA class II heart failure as well as for those with class III.

However, prespecified subgroup analyses showed that the incremental benefit from CRT-D was significantly limited to patients with an intrinsic QRS duration of at least 150 msec, while in those with a duration of 120-149 msec CRT-D had a neutral effect compared with ICD. The same pattern also appeared when the analysis split patients into those with a left bundle branch block, who significantly benefited from CRT-D, but the initial benefit was not apparent in patients with right bundle branch block.

A study subgroup with extended follow-up

The new, extended follow-up analysis presented by Dr. Sapp included 1,050 of the original 1,798 patients (58%) enrolled at any of eight participating Canadian centers that each enrolled at least 100 patients and followed them through the end of 2021 (the full study cohort came from 34 centers, including 10 centers outside Canada). This subgroup included 520 patients randomized to receive CRT-D and 530 who received an ICD. Although this was a post hoc subgroup analysis, the CRT-D and ICD arms matched closely in all measured baseline characteristics.

The prespecified primary outcome of this follow-up analysis was the rate of all-cause mortality. Because of their longer disease trajectory, this pared-down study cohort included many more patients with NYHA class II function, 803, and in this subgroup CRT-D exerted a significant 23% incremental reduction in mortality compared with ICD treatment. CRT-D also produced a 17% relative reduction in long-term mortality among patients with NYHA class III function at baseline, but this point estimate of relative benefit was not significant in this subgroup of just 247 patients, said Dr. Sapp, a cardiologist and professor at Dalhousie University & Nova Scotia Health in Halifax.

Based on the original RAFT results from 2010, as well as on evidence from several other trials, the current heart failure management guideline from the AHA, the American College of Cardiology, and the Heart Failure Society of America give the highest level of recommendation, level 1, for CRT in patients with a left ventricular ejection fraction of 35% or less, sinus rhythm with left bundle branch block, a QRS duration of at least 150 msec, and NYHA class II, III, or ambulatory IV symptoms while on guideline-directed medical therapy.

The guideline also gives class 2a (“can be useful”) or 2b (“may be considered”) recommendation for certain other heart failure patients, including those with a QRS duration of 120-149 msec, a left ventricular ejection fraction as high as 50%, no left bundle branch block, or NYHA class I symptoms.

Don’t wait to start CRT

Although this 2022 guideline, as well as earlier versions that had roughly similar recommendations for CRT for about a decade, have led to “common” use of CRT in appropriate patients in U.S. practice, “it has not been used as much as it should be, in part because there’s been a feeling that CRT mostly treats symptoms and so perhaps you can wait” to start it, said Dr. Stevenson.

The findings from the new, extended follow-up RAFT analysis give increased urgency to starting CRT “as soon as possible” in appropriate patients with heart failure, even before they stabilize on guideline-directed medical therapy, said Dr. Stevenson. She also downplayed any ambiguity in the RAFT findings about optimal medical therapy, which during the RAFT study included traditional triple therapy at a time before treatment with sacubitril/valsartan (Entresto) and sodium-glucose cotransporter 2 (SGLT2) inhibitors became recommended.

“There is no reason to think that these treatments will negate the benefit of CRT for patients with heart failure with reduced ejection fraction and a wide left bundle branch block,” Dr. Stevenson said.

She also believes that the extended follow-up results, which showed clear efficacy for CRT-D in patients with NYHA class II function, support the case for upgrading the current 2b recommendation for using CRT treatment in patients with NYHA class I function and ischemic heart failure to a 2a recommendation regardless of whether or not patients have coronary artery disease. “The difference between class I and class II depends more on a patient’s lifestyle rather than on the severity of their heart failure,” Dr. Stevenson noted. “The RAFT study results encourage us to reexamine the clinical class and timing for CRT” in the current heart failure guideline.

RAFT received partial sponsorship from Medtronic. Dr. Sapp has been a consultant to Abbott, Biosense Webster, Medtronic, and Varian and has received research funding from Abbott and Biosense Webster. Dr. Stevenson had no disclosures.

Automated alerts to aid clinical decision-making are designed with the best of intentions but can be easy to ignore or overlook. But a randomized trial testing such electronic alerts or “nudges” for promoting statin prescribing may have identified a few design features that help their success, researchers say.

In the trial’s primary finding, for example, reminders displayed to primary care physicians in the electronic health record worked best when the system also reached out to the patient.

Ariel Skelley/DigitalVision/Getty Images

Reminders sent only to the clinician also boosted statin prescribing, but not as well, and nudging only the patient didn’t work at all, compared to a nudge-free usual care approach. The patient-only nudges consisted of text messages explaining why a statin prescription may figure in their upcoming appointment.
 

Nudge trustworthiness

Importantly, the clinician nudges were more than simply reminders to consider a statin prescription, Mitesh S. Patel, MD, MBA, Ascension Health, St. Louis, told this news organization. They also displayed the patient’s atherosclerotic cardiovascular disease (ASCVD) 10-year risk score and explained why a statin may be appropriate. He thinks that information, often left out of such clinical decision support alerts, increases physician trust in them.

In another key feature, Dr. Patel said, the EHR nudges themselves were actionable – that is, they were functional in ways that streamlined the prescribing process. In particular, they include checkbox shortcuts to prescribing statins at appropriate patient-specific dosages, making the entire process “faster and easier,” said Dr. Patel, who is senior author on the study published in JAMA Cardiology with lead author Srinath Adusumalli, MD, University of Pennsylvania, Philadelphia.

The timing may matter as well, he observed. In previous iterations of the study’s EHR nudge system, the nudge would appear “when you open the chart,” he said. “Now, it’s when you go to the orders section, which is when you’re going to be in the mindset of ordering prescriptions and tests.”

Prescription rates were higher with the doctor-patient nudges than with the doctor-only approach, Dr. Patel speculates, largely because the decision process for initiating statins is shared. “The most effective intervention is going to recognize that and try to bring the two groups together.”
 

Two text messages

The trial, with 158 participating physicians in 28 primary care practices, randomly assigned 4,131 patients to three intervention groups and one control group. Nudges were sent only to the physician, only to the patient, or to both physician and patient; and there was a no-nudge usual-care group.

Patient nudges consisted of two text messages, one 4 days and another 15 minutes before the appointment, announcing that prescription of a statin “to reduce the chance of a heart attack” would be discussed with the physician, the report states.

Statins are grossly underprescribed nationally, it notes, and that was reflected in prescription rates seen during the study’s initial 12-month, no-intervention period of observation. Rates ranged from only 4.7% up to 6% of patients across the four assignment groups.

During the subsequent 6-month intervention period, however, the rates climbed in the doctor-only and doctor-plus-patient nudge groups compared with usual care, by 5.5 (P = .01) and 7.2 (P = .001) absolute percentage points, respectively.

The overall cohort’s mean age was 65.5. About half were male, 29% were Black, 66% were White, and 22.6% already had a cardiovascular disease diagnosis. The analysis was adjusted for calendar month and preintervention statin prescribing rates. Further adjustment for demographics, insurance type, household income, and comorbidities yielded results similar to the primary analysis, the report states.
 

The results in context

“Although the differences in the combined clinician and patient and clinician-only arms were small, this outcome needs to be interpreted in the context of the population in which the study was performed,” an editorial accompanying the published report states.

For example, “the majority of untreated patients were candidates for primary, not secondary, prevention, making this group of patients particularly challenging for seeing large effect sizes of interventions.”

Moreover, “There was a high baseline prescription rate of statins in the statin-eligible population (approximately 70%) and a high rate of already established patients,” write Faraz S. Ahmad, MD, and Stephen D. Persell, MD, of Northwestern University, Chicago.

Among the approximately 30% of patients who had not previously been prescribed statins, the true target of the nudge interventions, the published trial report states, about 98% were not seeing the physician for the first time.

So “this may not have been the first opportunity to discuss statins,” they write. “It is possible that many of these patients were resistant to statins in the past, which could have created a ceiling effect for prescribing rates.”

Dr. Patel reports owning and receiving personal fees from Catalyst Health and serving on an advisory board for and receiving personal fees from Humana. Dr. Adusumalli reports having been employed by CVS Health. Dr. Ahmad reports receiving consulting fees from Teladoc Livongo and Pfizer. Dr. Persell discloses receiving grants from Omron Healthcare.

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

Automated alerts to aid clinical decision-making are designed with the best of intentions but can be easy to ignore or overlook. But a randomized trial testing such electronic alerts or “nudges” for promoting statin prescribing may have identified a few design features that help their success, researchers say.

In the trial’s primary finding, for example, reminders displayed to primary care physicians in the electronic health record worked best when the system also reached out to the patient.

Ariel Skelley/DigitalVision/Getty Images

Reminders sent only to the clinician also boosted statin prescribing, but not as well, and nudging only the patient didn’t work at all, compared to a nudge-free usual care approach. The patient-only nudges consisted of text messages explaining why a statin prescription may figure in their upcoming appointment.
 

Nudge trustworthiness

Importantly, the clinician nudges were more than simply reminders to consider a statin prescription, Mitesh S. Patel, MD, MBA, Ascension Health, St. Louis, told this news organization. They also displayed the patient’s atherosclerotic cardiovascular disease (ASCVD) 10-year risk score and explained why a statin may be appropriate. He thinks that information, often left out of such clinical decision support alerts, increases physician trust in them.

In another key feature, Dr. Patel said, the EHR nudges themselves were actionable – that is, they were functional in ways that streamlined the prescribing process. In particular, they include checkbox shortcuts to prescribing statins at appropriate patient-specific dosages, making the entire process “faster and easier,” said Dr. Patel, who is senior author on the study published in JAMA Cardiology with lead author Srinath Adusumalli, MD, University of Pennsylvania, Philadelphia.

The timing may matter as well, he observed. In previous iterations of the study’s EHR nudge system, the nudge would appear “when you open the chart,” he said. “Now, it’s when you go to the orders section, which is when you’re going to be in the mindset of ordering prescriptions and tests.”

Prescription rates were higher with the doctor-patient nudges than with the doctor-only approach, Dr. Patel speculates, largely because the decision process for initiating statins is shared. “The most effective intervention is going to recognize that and try to bring the two groups together.”
 

Two text messages

The trial, with 158 participating physicians in 28 primary care practices, randomly assigned 4,131 patients to three intervention groups and one control group. Nudges were sent only to the physician, only to the patient, or to both physician and patient; and there was a no-nudge usual-care group.

Patient nudges consisted of two text messages, one 4 days and another 15 minutes before the appointment, announcing that prescription of a statin “to reduce the chance of a heart attack” would be discussed with the physician, the report states.

Statins are grossly underprescribed nationally, it notes, and that was reflected in prescription rates seen during the study’s initial 12-month, no-intervention period of observation. Rates ranged from only 4.7% up to 6% of patients across the four assignment groups.

During the subsequent 6-month intervention period, however, the rates climbed in the doctor-only and doctor-plus-patient nudge groups compared with usual care, by 5.5 (P = .01) and 7.2 (P = .001) absolute percentage points, respectively.

The overall cohort’s mean age was 65.5. About half were male, 29% were Black, 66% were White, and 22.6% already had a cardiovascular disease diagnosis. The analysis was adjusted for calendar month and preintervention statin prescribing rates. Further adjustment for demographics, insurance type, household income, and comorbidities yielded results similar to the primary analysis, the report states.
 

The results in context

“Although the differences in the combined clinician and patient and clinician-only arms were small, this outcome needs to be interpreted in the context of the population in which the study was performed,” an editorial accompanying the published report states.

For example, “the majority of untreated patients were candidates for primary, not secondary, prevention, making this group of patients particularly challenging for seeing large effect sizes of interventions.”

Moreover, “There was a high baseline prescription rate of statins in the statin-eligible population (approximately 70%) and a high rate of already established patients,” write Faraz S. Ahmad, MD, and Stephen D. Persell, MD, of Northwestern University, Chicago.

Among the approximately 30% of patients who had not previously been prescribed statins, the true target of the nudge interventions, the published trial report states, about 98% were not seeing the physician for the first time.

So “this may not have been the first opportunity to discuss statins,” they write. “It is possible that many of these patients were resistant to statins in the past, which could have created a ceiling effect for prescribing rates.”

Dr. Patel reports owning and receiving personal fees from Catalyst Health and serving on an advisory board for and receiving personal fees from Humana. Dr. Adusumalli reports having been employed by CVS Health. Dr. Ahmad reports receiving consulting fees from Teladoc Livongo and Pfizer. Dr. Persell discloses receiving grants from Omron Healthcare.

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

Automated alerts to aid clinical decision-making are designed with the best of intentions but can be easy to ignore or overlook. But a randomized trial testing such electronic alerts or “nudges” for promoting statin prescribing may have identified a few design features that help their success, researchers say.

In the trial’s primary finding, for example, reminders displayed to primary care physicians in the electronic health record worked best when the system also reached out to the patient.

Ariel Skelley/DigitalVision/Getty Images

Reminders sent only to the clinician also boosted statin prescribing, but not as well, and nudging only the patient didn’t work at all, compared to a nudge-free usual care approach. The patient-only nudges consisted of text messages explaining why a statin prescription may figure in their upcoming appointment.
 

Nudge trustworthiness

Importantly, the clinician nudges were more than simply reminders to consider a statin prescription, Mitesh S. Patel, MD, MBA, Ascension Health, St. Louis, told this news organization. They also displayed the patient’s atherosclerotic cardiovascular disease (ASCVD) 10-year risk score and explained why a statin may be appropriate. He thinks that information, often left out of such clinical decision support alerts, increases physician trust in them.

In another key feature, Dr. Patel said, the EHR nudges themselves were actionable – that is, they were functional in ways that streamlined the prescribing process. In particular, they include checkbox shortcuts to prescribing statins at appropriate patient-specific dosages, making the entire process “faster and easier,” said Dr. Patel, who is senior author on the study published in JAMA Cardiology with lead author Srinath Adusumalli, MD, University of Pennsylvania, Philadelphia.

The timing may matter as well, he observed. In previous iterations of the study’s EHR nudge system, the nudge would appear “when you open the chart,” he said. “Now, it’s when you go to the orders section, which is when you’re going to be in the mindset of ordering prescriptions and tests.”

Prescription rates were higher with the doctor-patient nudges than with the doctor-only approach, Dr. Patel speculates, largely because the decision process for initiating statins is shared. “The most effective intervention is going to recognize that and try to bring the two groups together.”
 

Two text messages

The trial, with 158 participating physicians in 28 primary care practices, randomly assigned 4,131 patients to three intervention groups and one control group. Nudges were sent only to the physician, only to the patient, or to both physician and patient; and there was a no-nudge usual-care group.

Patient nudges consisted of two text messages, one 4 days and another 15 minutes before the appointment, announcing that prescription of a statin “to reduce the chance of a heart attack” would be discussed with the physician, the report states.

Statins are grossly underprescribed nationally, it notes, and that was reflected in prescription rates seen during the study’s initial 12-month, no-intervention period of observation. Rates ranged from only 4.7% up to 6% of patients across the four assignment groups.

During the subsequent 6-month intervention period, however, the rates climbed in the doctor-only and doctor-plus-patient nudge groups compared with usual care, by 5.5 (P = .01) and 7.2 (P = .001) absolute percentage points, respectively.

The overall cohort’s mean age was 65.5. About half were male, 29% were Black, 66% were White, and 22.6% already had a cardiovascular disease diagnosis. The analysis was adjusted for calendar month and preintervention statin prescribing rates. Further adjustment for demographics, insurance type, household income, and comorbidities yielded results similar to the primary analysis, the report states.
 

The results in context

“Although the differences in the combined clinician and patient and clinician-only arms were small, this outcome needs to be interpreted in the context of the population in which the study was performed,” an editorial accompanying the published report states.

For example, “the majority of untreated patients were candidates for primary, not secondary, prevention, making this group of patients particularly challenging for seeing large effect sizes of interventions.”

Moreover, “There was a high baseline prescription rate of statins in the statin-eligible population (approximately 70%) and a high rate of already established patients,” write Faraz S. Ahmad, MD, and Stephen D. Persell, MD, of Northwestern University, Chicago.

Among the approximately 30% of patients who had not previously been prescribed statins, the true target of the nudge interventions, the published trial report states, about 98% were not seeing the physician for the first time.

So “this may not have been the first opportunity to discuss statins,” they write. “It is possible that many of these patients were resistant to statins in the past, which could have created a ceiling effect for prescribing rates.”

Dr. Patel reports owning and receiving personal fees from Catalyst Health and serving on an advisory board for and receiving personal fees from Humana. Dr. Adusumalli reports having been employed by CVS Health. Dr. Ahmad reports receiving consulting fees from Teladoc Livongo and Pfizer. Dr. Persell discloses receiving grants from Omron Healthcare.

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

A novel approach for stratifying patients into one of two phenotypes for coronary artery disease (CAD) helped differentiate those who would benefit from percutaneous coronary intervention (PCI) from those who wouldn’t, researchers in Belgium reported in a subanalysis of a single-center, randomized clinical trial.

“What this study adds is that we are actually creating a refined definition of the appropriateness criteria for PCI,” lead study author Carlos Collet, MD, PhD, of the Cardiovascular Center at OLV Hospital in Aalst, Belgium, said in an interview. “We have been too long implanting stents in diffuse disease that actually have no benefit for the patient.”

The study found that patients with diffuse CAD were almost twice as likely to have residual angina 3 months after PCI than patients with focal CAD, with respective rates of 51.9% vs. 27.5% after PCI (P = .02).

The researchers analyzed 103 patients from the TARGET-FFR (Trial of Angiography vs. pressure-Ratio-Guided Enhancement Techniques–Fractional Flow Reserve) conducted at the Golden Jubilee National Hospital in Glasgow. Study patients completed the 7-item Seattle Angina Questionnaire at baseline and at 3 months after PCI, which provided the researchers information on outcomes.

The study, published in JACC: Cardiovascular Interventions, used median pullback pressure gradient (PPG) to define focal and diffuse CAD. The operators used the PressureWire X Guidewire (Abbott Vascular) to measure fractional flow reserve (FFR).

The procedure involved administering a 200-mcg bolus of intracoronary nitrate and then positioning the pressure wire sensor at the tip of the guide catheter equalized with aortic pressure. The pressure wire was then advanced to the position sensor in the distal third of the vessel. After hyperemia was induced, coronary flow reserve was assessed using bolus thermodilution. Manual FFR pullback maneuvers were done at a constant speed for 20-30 seconds. The PPG index was calculated post hoc from the manual FFR pullback recordings obtained pre-PCI.

In this study, patients with low PPG needed longer (48 mm vs. 37 mm; P = .015) and more (1.5 vs. 1.0; P = .036) stents during PCI, Dr. Collet and colleagues reported. They concluded that patients with low PPG can be treated with medical therapy.

“The beauty of the PPG is that everything happens before you implant the stent,” Dr. Collet said. “We’re starting to understand that we cannot treat diffuse disease with a focal disease therapy.”

The challenge with differentiating diffuse from focal CAD has been that it relies on visual assessment. “It’s subject to operator variability, and that’s the reason why there are no trials with focal or diffuse disease specifically because, until now, we didn’t have any metric that quantified the diffuseness or the focality of the disease,” Dr. Collet said.

The PPG itself isn’t novel, Dr. Collet said. “The novelty is that for first time we can quantify in a reproducible way the information from the pullback,” he added.

Courtesy Cardiovascular Research Foundation

“What this study tells us is that once you have a patient with diffuse coronary artery disease, don’t try PCI because it will not help half of them,” Patrick W. Serruys, MD, PhD, a cardiologist at the National University of Ireland, Galway, and author of the accompanying editorial, said in an interview.

He noted that one limitation of the study was that Dr. Collet and colleagues used mechanical PPG to measure the pressure gradient. “We use now a surrogate, which is angiography,” Dr. Serruys said. “It’s not exactly the same as a measurement of pressure with the pressure wire, but we know from many, many studies that it’s quite a good surrogate.” Future research should focus on use of angiography without the pressure wire to evaluate the pressure gradient.

The ongoing PPG Global registry will aim to further validate findings from the subanalysis, Dr. Collet said, and the PPG Primetime study will evaluate deferring PCI in patients with low PPG.

Dr. Collet disclosed relationships with Biosensor, Coroventis Research, Medis Medical Imaging, Pie Medical Imaging, CathWorks, Boston Scientific, Siemens, HeartFlow, OpSens, Abbott Vascular and Philips Volcano. Dr. Serruys disclosed relationships with Sinomedical Sciences Technology, Sahajanand Medical Technological, Philips Volcano, Xeltis and HeartFlow.

A novel approach for stratifying patients into one of two phenotypes for coronary artery disease (CAD) helped differentiate those who would benefit from percutaneous coronary intervention (PCI) from those who wouldn’t, researchers in Belgium reported in a subanalysis of a single-center, randomized clinical trial.

“What this study adds is that we are actually creating a refined definition of the appropriateness criteria for PCI,” lead study author Carlos Collet, MD, PhD, of the Cardiovascular Center at OLV Hospital in Aalst, Belgium, said in an interview. “We have been too long implanting stents in diffuse disease that actually have no benefit for the patient.”

The study found that patients with diffuse CAD were almost twice as likely to have residual angina 3 months after PCI than patients with focal CAD, with respective rates of 51.9% vs. 27.5% after PCI (P = .02).

The researchers analyzed 103 patients from the TARGET-FFR (Trial of Angiography vs. pressure-Ratio-Guided Enhancement Techniques–Fractional Flow Reserve) conducted at the Golden Jubilee National Hospital in Glasgow. Study patients completed the 7-item Seattle Angina Questionnaire at baseline and at 3 months after PCI, which provided the researchers information on outcomes.

The study, published in JACC: Cardiovascular Interventions, used median pullback pressure gradient (PPG) to define focal and diffuse CAD. The operators used the PressureWire X Guidewire (Abbott Vascular) to measure fractional flow reserve (FFR).

The procedure involved administering a 200-mcg bolus of intracoronary nitrate and then positioning the pressure wire sensor at the tip of the guide catheter equalized with aortic pressure. The pressure wire was then advanced to the position sensor in the distal third of the vessel. After hyperemia was induced, coronary flow reserve was assessed using bolus thermodilution. Manual FFR pullback maneuvers were done at a constant speed for 20-30 seconds. The PPG index was calculated post hoc from the manual FFR pullback recordings obtained pre-PCI.

In this study, patients with low PPG needed longer (48 mm vs. 37 mm; P = .015) and more (1.5 vs. 1.0; P = .036) stents during PCI, Dr. Collet and colleagues reported. They concluded that patients with low PPG can be treated with medical therapy.

“The beauty of the PPG is that everything happens before you implant the stent,” Dr. Collet said. “We’re starting to understand that we cannot treat diffuse disease with a focal disease therapy.”

The challenge with differentiating diffuse from focal CAD has been that it relies on visual assessment. “It’s subject to operator variability, and that’s the reason why there are no trials with focal or diffuse disease specifically because, until now, we didn’t have any metric that quantified the diffuseness or the focality of the disease,” Dr. Collet said.

The PPG itself isn’t novel, Dr. Collet said. “The novelty is that for first time we can quantify in a reproducible way the information from the pullback,” he added.

Courtesy Cardiovascular Research Foundation

“What this study tells us is that once you have a patient with diffuse coronary artery disease, don’t try PCI because it will not help half of them,” Patrick W. Serruys, MD, PhD, a cardiologist at the National University of Ireland, Galway, and author of the accompanying editorial, said in an interview.

He noted that one limitation of the study was that Dr. Collet and colleagues used mechanical PPG to measure the pressure gradient. “We use now a surrogate, which is angiography,” Dr. Serruys said. “It’s not exactly the same as a measurement of pressure with the pressure wire, but we know from many, many studies that it’s quite a good surrogate.” Future research should focus on use of angiography without the pressure wire to evaluate the pressure gradient.

The ongoing PPG Global registry will aim to further validate findings from the subanalysis, Dr. Collet said, and the PPG Primetime study will evaluate deferring PCI in patients with low PPG.

Dr. Collet disclosed relationships with Biosensor, Coroventis Research, Medis Medical Imaging, Pie Medical Imaging, CathWorks, Boston Scientific, Siemens, HeartFlow, OpSens, Abbott Vascular and Philips Volcano. Dr. Serruys disclosed relationships with Sinomedical Sciences Technology, Sahajanand Medical Technological, Philips Volcano, Xeltis and HeartFlow.

A novel approach for stratifying patients into one of two phenotypes for coronary artery disease (CAD) helped differentiate those who would benefit from percutaneous coronary intervention (PCI) from those who wouldn’t, researchers in Belgium reported in a subanalysis of a single-center, randomized clinical trial.

“What this study adds is that we are actually creating a refined definition of the appropriateness criteria for PCI,” lead study author Carlos Collet, MD, PhD, of the Cardiovascular Center at OLV Hospital in Aalst, Belgium, said in an interview. “We have been too long implanting stents in diffuse disease that actually have no benefit for the patient.”

The study found that patients with diffuse CAD were almost twice as likely to have residual angina 3 months after PCI than patients with focal CAD, with respective rates of 51.9% vs. 27.5% after PCI (P = .02).

The researchers analyzed 103 patients from the TARGET-FFR (Trial of Angiography vs. pressure-Ratio-Guided Enhancement Techniques–Fractional Flow Reserve) conducted at the Golden Jubilee National Hospital in Glasgow. Study patients completed the 7-item Seattle Angina Questionnaire at baseline and at 3 months after PCI, which provided the researchers information on outcomes.

The study, published in JACC: Cardiovascular Interventions, used median pullback pressure gradient (PPG) to define focal and diffuse CAD. The operators used the PressureWire X Guidewire (Abbott Vascular) to measure fractional flow reserve (FFR).

The procedure involved administering a 200-mcg bolus of intracoronary nitrate and then positioning the pressure wire sensor at the tip of the guide catheter equalized with aortic pressure. The pressure wire was then advanced to the position sensor in the distal third of the vessel. After hyperemia was induced, coronary flow reserve was assessed using bolus thermodilution. Manual FFR pullback maneuvers were done at a constant speed for 20-30 seconds. The PPG index was calculated post hoc from the manual FFR pullback recordings obtained pre-PCI.

In this study, patients with low PPG needed longer (48 mm vs. 37 mm; P = .015) and more (1.5 vs. 1.0; P = .036) stents during PCI, Dr. Collet and colleagues reported. They concluded that patients with low PPG can be treated with medical therapy.

“The beauty of the PPG is that everything happens before you implant the stent,” Dr. Collet said. “We’re starting to understand that we cannot treat diffuse disease with a focal disease therapy.”

The challenge with differentiating diffuse from focal CAD has been that it relies on visual assessment. “It’s subject to operator variability, and that’s the reason why there are no trials with focal or diffuse disease specifically because, until now, we didn’t have any metric that quantified the diffuseness or the focality of the disease,” Dr. Collet said.

The PPG itself isn’t novel, Dr. Collet said. “The novelty is that for first time we can quantify in a reproducible way the information from the pullback,” he added.

Courtesy Cardiovascular Research Foundation

“What this study tells us is that once you have a patient with diffuse coronary artery disease, don’t try PCI because it will not help half of them,” Patrick W. Serruys, MD, PhD, a cardiologist at the National University of Ireland, Galway, and author of the accompanying editorial, said in an interview.

He noted that one limitation of the study was that Dr. Collet and colleagues used mechanical PPG to measure the pressure gradient. “We use now a surrogate, which is angiography,” Dr. Serruys said. “It’s not exactly the same as a measurement of pressure with the pressure wire, but we know from many, many studies that it’s quite a good surrogate.” Future research should focus on use of angiography without the pressure wire to evaluate the pressure gradient.

The ongoing PPG Global registry will aim to further validate findings from the subanalysis, Dr. Collet said, and the PPG Primetime study will evaluate deferring PCI in patients with low PPG.

Dr. Collet disclosed relationships with Biosensor, Coroventis Research, Medis Medical Imaging, Pie Medical Imaging, CathWorks, Boston Scientific, Siemens, HeartFlow, OpSens, Abbott Vascular and Philips Volcano. Dr. Serruys disclosed relationships with Sinomedical Sciences Technology, Sahajanand Medical Technological, Philips Volcano, Xeltis and HeartFlow.

A new meta-analysis of 884 studies evaluating 27 different types of antioxidant supplements has suggested that some of these micronutrients – including omega-3 fatty acids, folic acid, and coenzyme Q10 – may produce significant cardiovascular benefits.

Other antioxidant supplements that showed some evidence of reducing cardiovascular risk were omega-6 fatty acids, L-arginine, L-citrulline, magnesium, zinc, alpha-lipoic acid, melatonin, catechin, curcumin, flavanol, genistein, and quercetin.

No effect was seen with vitamin C, vitamin D, vitamin E, or selenium, and beta-carotene supplementation was linked to an increase in all-cause mortality in the analysis.

The study is published in the Journal of the American College of Cardiology and was also published online.

“Our systematic assessment and quantification of multiple differential effects of a wide variety of micronutrients and phytochemicals on cardiometabolic health indicate that an optimal nutritional strategy to promote cardiometabolic health will likely involve personalized combinations of these nutrients,” the authors, led by Peng An, PhD, China Agricultural University, Beijing, conclude.

“Identifying the optimal mixture of micronutrients is important, as not all are beneficial, and some may even have harmful effects,” senior author Simin Liu, MD, professor of epidemiology and medicine at Brown University, Providence, R.I., said in an American College of Cardiology press release.

“The micronutrients identified require further validation in large, high-quality interventional trials to establish clinical efficacy to determine their long-term balance of risks and benefits,” the authors add.
 

Experts cautious

Experts in the field of cardiovascular risk and preventative medicine have urged caution in interpreting these results.

JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, told this news organization that she has concerns that some of the results in the meta-analysis may be inflated by publication bias and some are chance findings that haven’t been well replicated.

“Although this meta-analysis of micronutrients and cardiometabolic health was based on randomized clinical trials, the quality of randomized trials on this subject varies widely,” she noted.

“The study is informative, but the conclusions are only as good as the quality of the evidence. Some of the trials are limited by short duration, and included trials have a wide range of quality, dosing, inclusion criteria, imperfect blinding, and few of them focus on hard clinical events,” Dr. Manson said. “Also, with trials of this nature, the potential for publication bias warrants consideration, because many of the smaller trials with unfavorable or neutral results may remain unpublished or not even be submitted for publication.”   

However, she added, “despite these limitations, this is an important contribution to the literature on micronutrients and health – and goes a long way in separating the wheat from the chaff.”

Steve Nissen, MD, chief academic officer of the Heart Vascular and Thoracic Institute at the Cleveland Clinic, was more critical of the meta-analysis.

“This study does not make sense. Some of the ‘micronutrients’ in this meta-analysis have undergone thorough testing in large randomized clinical trials that showed different results. I am skeptical whether any of the purported benefits of these supplements would be confirmed in a high-quality randomized controlled trial,” he said.

Dr. Nissen added that many of the included studies are low in quality. “I must quote [renowned cardiologist, Dr.] Franz Messerli: ‘A meta-analysis is like making bouillabaisse. ... One rotten fish can spoil the broth.’ This type of analysis does not override high-quality large, randomized trials.”

In the JACC paper, the study investigators note that the American Heart Association now recommends dietary patterns, including the Mediterranean diet and DASH (the Dietary Approach to Stop Hypertension), as preventive or treatment approaches for cardiovascular disease. A common feature of these dietary patterns is that they are low in saturated fat and sodium and rich in micronutrients such as phytochemicals, unsaturated fatty acids, antioxidant vitamins, and minerals.

“To personalize cardiometabolic preventive and therapeutic dietary practices, it is of critical importance to have a comprehensive and in-depth understanding of the balance of benefits and risks associated with constituent micronutrients in diverse dietary patterns,” they note.

They therefore conducted the current systematic review and meta-analyses of all available randomized controlled trials investigating the effect of micronutrients with antioxidant properties on cardiovascular risk factors and events in diverse populations.

The meta-analysis included a total of 884 randomized trials evaluating 27 types of micronutrients among 883,627 participants.

Results showed that supplementation with n-3 fatty acids, n-6 fatty acids, L-arginine, L-citrulline, folic acid, magnesium, zinc, alpha-lipoic acid, coenzyme Q10, melatonin, catechin, curcumin, flavanol, genistein, and quercetin had “moderate-to high-quality evidence” for reducing cardiovascular risk factors.

Specifically, n-3 fatty acid supplementation was linked to reduced rates of cardiovascular mortality (relative risk, 0.93), myocardial infarction (RR, 0.85), and coronary heart disease events (RR, 0.86). Folic acid supplementation was linked to a decreased stroke risk (RR, 0.84) and coenzyme Q10 was associated with a lower rate of all-cause mortality (RR, 0.68).

“The current study represents the first attempt in providing a comprehensive and most up-to-date evidence map that systematically assessed the quality and quantity of all randomized trials linking the effects of a wide variety of micronutrients on cardiovascular risk factors,” the authors say.

“The comprehensive evidence map presented here highlights the importance of micronutrient diversity and the balance of benefits and risks in the design of whole food–based dietary patterns to promote cardiometabolic health, which may require cultural adaptations to apply globally,” they conclude.

Commenting on some of the specific beneficial findings, Dr. Manson said: “I do believe that the marine omega-3s confer heart benefits, but results are not consistent and vary by dose and formulation.”

However, she pointed out that, regarding folic acid, a previous meta-analysis including eight large randomized trials in more than 37,000 participants found no reduction in coronary events, stroke, or major cardiovascular events with folic acid supplementation, compared with placebo, “so the reported stroke benefit would need further confirmation.”

In an accompanying editorial, Juan Gormaz, PhD, University of Chile, and Rodrigo Carrasco, MD, Chilean Society of Cardiology and Cardiovascular Surgery, both in Santiago, state: “Given that the compounds with more pleiotropic properties produced the better outcomes, the antioxidant paradigm on cardiovascular prevention can be challenged. For example, inasmuch as n-3 fatty acids have antiplatelet and anti-inflammatory properties, they are too complex to enable attribution of the observed benefits solely to their antioxidant capacity.”

The editorialists note that from a research point of view, “although the current information opens interesting perspectives for future consolidation of some antioxidants in preventive cardiology, there is still a long way to go in terms of generating evidence.”

They add that the challenge now for some compounds is to begin establishing consensus in definitions of dose and combinations, as well as continue strengthening the evidence of effectiveness.

“Regarding routine clinical practice, these results begin to open spaces for the integration of new tools into the therapeutic arsenal aimed at cardiovascular prevention in selected populations, which could be easily accessible and, with specific exceptions, would present a low frequency of adverse effects,” they conclude.

This work was partly supported by the United States’ Fulbright Program and by the Beijing Advanced Innovation Center for Food Nutrition and Human Health, the National Natural Science Foundation of China, the Chinese Universities Scientific Fund, and the Beijing Municipal Natural Science Foundation.

Dr. Liu has received honoraria for scientific presentations or reviews at Johns Hopkins University, Fred Hutchinson Cancer Center, Harvard University, University of Buffalo, Guangdong General Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences, and the National Institutes of Health; he is a member of the Data Safety and Monitoring Board for several trials, including the SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) trial sponsored by Novo Nordisk and a trial of pulmonary hypertension in diabetes patients sponsored by Massachusetts General Hospital; he has received royalties from UpToDate and has received an honorarium from the American Society for Nutrition for his duties as Associate Editor. Co-author Jeffrey Mechanick, MD, has received honoraria from Abbott Nutrition for lectures and serves on the advisory boards of Aveta.Life, L-Nutra, and Twin Health. The other authors report no relevant financial relationships.

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

A new meta-analysis of 884 studies evaluating 27 different types of antioxidant supplements has suggested that some of these micronutrients – including omega-3 fatty acids, folic acid, and coenzyme Q10 – may produce significant cardiovascular benefits.

Other antioxidant supplements that showed some evidence of reducing cardiovascular risk were omega-6 fatty acids, L-arginine, L-citrulline, magnesium, zinc, alpha-lipoic acid, melatonin, catechin, curcumin, flavanol, genistein, and quercetin.

No effect was seen with vitamin C, vitamin D, vitamin E, or selenium, and beta-carotene supplementation was linked to an increase in all-cause mortality in the analysis.

The study is published in the Journal of the American College of Cardiology and was also published online.

“Our systematic assessment and quantification of multiple differential effects of a wide variety of micronutrients and phytochemicals on cardiometabolic health indicate that an optimal nutritional strategy to promote cardiometabolic health will likely involve personalized combinations of these nutrients,” the authors, led by Peng An, PhD, China Agricultural University, Beijing, conclude.

“Identifying the optimal mixture of micronutrients is important, as not all are beneficial, and some may even have harmful effects,” senior author Simin Liu, MD, professor of epidemiology and medicine at Brown University, Providence, R.I., said in an American College of Cardiology press release.

“The micronutrients identified require further validation in large, high-quality interventional trials to establish clinical efficacy to determine their long-term balance of risks and benefits,” the authors add.
 

Experts cautious

Experts in the field of cardiovascular risk and preventative medicine have urged caution in interpreting these results.

JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, told this news organization that she has concerns that some of the results in the meta-analysis may be inflated by publication bias and some are chance findings that haven’t been well replicated.

“Although this meta-analysis of micronutrients and cardiometabolic health was based on randomized clinical trials, the quality of randomized trials on this subject varies widely,” she noted.

“The study is informative, but the conclusions are only as good as the quality of the evidence. Some of the trials are limited by short duration, and included trials have a wide range of quality, dosing, inclusion criteria, imperfect blinding, and few of them focus on hard clinical events,” Dr. Manson said. “Also, with trials of this nature, the potential for publication bias warrants consideration, because many of the smaller trials with unfavorable or neutral results may remain unpublished or not even be submitted for publication.”   

However, she added, “despite these limitations, this is an important contribution to the literature on micronutrients and health – and goes a long way in separating the wheat from the chaff.”

Steve Nissen, MD, chief academic officer of the Heart Vascular and Thoracic Institute at the Cleveland Clinic, was more critical of the meta-analysis.

“This study does not make sense. Some of the ‘micronutrients’ in this meta-analysis have undergone thorough testing in large randomized clinical trials that showed different results. I am skeptical whether any of the purported benefits of these supplements would be confirmed in a high-quality randomized controlled trial,” he said.

Dr. Nissen added that many of the included studies are low in quality. “I must quote [renowned cardiologist, Dr.] Franz Messerli: ‘A meta-analysis is like making bouillabaisse. ... One rotten fish can spoil the broth.’ This type of analysis does not override high-quality large, randomized trials.”

In the JACC paper, the study investigators note that the American Heart Association now recommends dietary patterns, including the Mediterranean diet and DASH (the Dietary Approach to Stop Hypertension), as preventive or treatment approaches for cardiovascular disease. A common feature of these dietary patterns is that they are low in saturated fat and sodium and rich in micronutrients such as phytochemicals, unsaturated fatty acids, antioxidant vitamins, and minerals.

“To personalize cardiometabolic preventive and therapeutic dietary practices, it is of critical importance to have a comprehensive and in-depth understanding of the balance of benefits and risks associated with constituent micronutrients in diverse dietary patterns,” they note.

They therefore conducted the current systematic review and meta-analyses of all available randomized controlled trials investigating the effect of micronutrients with antioxidant properties on cardiovascular risk factors and events in diverse populations.

The meta-analysis included a total of 884 randomized trials evaluating 27 types of micronutrients among 883,627 participants.

Results showed that supplementation with n-3 fatty acids, n-6 fatty acids, L-arginine, L-citrulline, folic acid, magnesium, zinc, alpha-lipoic acid, coenzyme Q10, melatonin, catechin, curcumin, flavanol, genistein, and quercetin had “moderate-to high-quality evidence” for reducing cardiovascular risk factors.

Specifically, n-3 fatty acid supplementation was linked to reduced rates of cardiovascular mortality (relative risk, 0.93), myocardial infarction (RR, 0.85), and coronary heart disease events (RR, 0.86). Folic acid supplementation was linked to a decreased stroke risk (RR, 0.84) and coenzyme Q10 was associated with a lower rate of all-cause mortality (RR, 0.68).

“The current study represents the first attempt in providing a comprehensive and most up-to-date evidence map that systematically assessed the quality and quantity of all randomized trials linking the effects of a wide variety of micronutrients on cardiovascular risk factors,” the authors say.

“The comprehensive evidence map presented here highlights the importance of micronutrient diversity and the balance of benefits and risks in the design of whole food–based dietary patterns to promote cardiometabolic health, which may require cultural adaptations to apply globally,” they conclude.

Commenting on some of the specific beneficial findings, Dr. Manson said: “I do believe that the marine omega-3s confer heart benefits, but results are not consistent and vary by dose and formulation.”

However, she pointed out that, regarding folic acid, a previous meta-analysis including eight large randomized trials in more than 37,000 participants found no reduction in coronary events, stroke, or major cardiovascular events with folic acid supplementation, compared with placebo, “so the reported stroke benefit would need further confirmation.”

In an accompanying editorial, Juan Gormaz, PhD, University of Chile, and Rodrigo Carrasco, MD, Chilean Society of Cardiology and Cardiovascular Surgery, both in Santiago, state: “Given that the compounds with more pleiotropic properties produced the better outcomes, the antioxidant paradigm on cardiovascular prevention can be challenged. For example, inasmuch as n-3 fatty acids have antiplatelet and anti-inflammatory properties, they are too complex to enable attribution of the observed benefits solely to their antioxidant capacity.”

The editorialists note that from a research point of view, “although the current information opens interesting perspectives for future consolidation of some antioxidants in preventive cardiology, there is still a long way to go in terms of generating evidence.”

They add that the challenge now for some compounds is to begin establishing consensus in definitions of dose and combinations, as well as continue strengthening the evidence of effectiveness.

“Regarding routine clinical practice, these results begin to open spaces for the integration of new tools into the therapeutic arsenal aimed at cardiovascular prevention in selected populations, which could be easily accessible and, with specific exceptions, would present a low frequency of adverse effects,” they conclude.

This work was partly supported by the United States’ Fulbright Program and by the Beijing Advanced Innovation Center for Food Nutrition and Human Health, the National Natural Science Foundation of China, the Chinese Universities Scientific Fund, and the Beijing Municipal Natural Science Foundation.

Dr. Liu has received honoraria for scientific presentations or reviews at Johns Hopkins University, Fred Hutchinson Cancer Center, Harvard University, University of Buffalo, Guangdong General Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences, and the National Institutes of Health; he is a member of the Data Safety and Monitoring Board for several trials, including the SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) trial sponsored by Novo Nordisk and a trial of pulmonary hypertension in diabetes patients sponsored by Massachusetts General Hospital; he has received royalties from UpToDate and has received an honorarium from the American Society for Nutrition for his duties as Associate Editor. Co-author Jeffrey Mechanick, MD, has received honoraria from Abbott Nutrition for lectures and serves on the advisory boards of Aveta.Life, L-Nutra, and Twin Health. The other authors report no relevant financial relationships.

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

A new meta-analysis of 884 studies evaluating 27 different types of antioxidant supplements has suggested that some of these micronutrients – including omega-3 fatty acids, folic acid, and coenzyme Q10 – may produce significant cardiovascular benefits.

Other antioxidant supplements that showed some evidence of reducing cardiovascular risk were omega-6 fatty acids, L-arginine, L-citrulline, magnesium, zinc, alpha-lipoic acid, melatonin, catechin, curcumin, flavanol, genistein, and quercetin.

No effect was seen with vitamin C, vitamin D, vitamin E, or selenium, and beta-carotene supplementation was linked to an increase in all-cause mortality in the analysis.

The study is published in the Journal of the American College of Cardiology and was also published online.

“Our systematic assessment and quantification of multiple differential effects of a wide variety of micronutrients and phytochemicals on cardiometabolic health indicate that an optimal nutritional strategy to promote cardiometabolic health will likely involve personalized combinations of these nutrients,” the authors, led by Peng An, PhD, China Agricultural University, Beijing, conclude.

“Identifying the optimal mixture of micronutrients is important, as not all are beneficial, and some may even have harmful effects,” senior author Simin Liu, MD, professor of epidemiology and medicine at Brown University, Providence, R.I., said in an American College of Cardiology press release.

“The micronutrients identified require further validation in large, high-quality interventional trials to establish clinical efficacy to determine their long-term balance of risks and benefits,” the authors add.
 

Experts cautious

Experts in the field of cardiovascular risk and preventative medicine have urged caution in interpreting these results.

JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, told this news organization that she has concerns that some of the results in the meta-analysis may be inflated by publication bias and some are chance findings that haven’t been well replicated.

“Although this meta-analysis of micronutrients and cardiometabolic health was based on randomized clinical trials, the quality of randomized trials on this subject varies widely,” she noted.

“The study is informative, but the conclusions are only as good as the quality of the evidence. Some of the trials are limited by short duration, and included trials have a wide range of quality, dosing, inclusion criteria, imperfect blinding, and few of them focus on hard clinical events,” Dr. Manson said. “Also, with trials of this nature, the potential for publication bias warrants consideration, because many of the smaller trials with unfavorable or neutral results may remain unpublished or not even be submitted for publication.”   

However, she added, “despite these limitations, this is an important contribution to the literature on micronutrients and health – and goes a long way in separating the wheat from the chaff.”

Steve Nissen, MD, chief academic officer of the Heart Vascular and Thoracic Institute at the Cleveland Clinic, was more critical of the meta-analysis.

“This study does not make sense. Some of the ‘micronutrients’ in this meta-analysis have undergone thorough testing in large randomized clinical trials that showed different results. I am skeptical whether any of the purported benefits of these supplements would be confirmed in a high-quality randomized controlled trial,” he said.

Dr. Nissen added that many of the included studies are low in quality. “I must quote [renowned cardiologist, Dr.] Franz Messerli: ‘A meta-analysis is like making bouillabaisse. ... One rotten fish can spoil the broth.’ This type of analysis does not override high-quality large, randomized trials.”

In the JACC paper, the study investigators note that the American Heart Association now recommends dietary patterns, including the Mediterranean diet and DASH (the Dietary Approach to Stop Hypertension), as preventive or treatment approaches for cardiovascular disease. A common feature of these dietary patterns is that they are low in saturated fat and sodium and rich in micronutrients such as phytochemicals, unsaturated fatty acids, antioxidant vitamins, and minerals.

“To personalize cardiometabolic preventive and therapeutic dietary practices, it is of critical importance to have a comprehensive and in-depth understanding of the balance of benefits and risks associated with constituent micronutrients in diverse dietary patterns,” they note.

They therefore conducted the current systematic review and meta-analyses of all available randomized controlled trials investigating the effect of micronutrients with antioxidant properties on cardiovascular risk factors and events in diverse populations.

The meta-analysis included a total of 884 randomized trials evaluating 27 types of micronutrients among 883,627 participants.

Results showed that supplementation with n-3 fatty acids, n-6 fatty acids, L-arginine, L-citrulline, folic acid, magnesium, zinc, alpha-lipoic acid, coenzyme Q10, melatonin, catechin, curcumin, flavanol, genistein, and quercetin had “moderate-to high-quality evidence” for reducing cardiovascular risk factors.

Specifically, n-3 fatty acid supplementation was linked to reduced rates of cardiovascular mortality (relative risk, 0.93), myocardial infarction (RR, 0.85), and coronary heart disease events (RR, 0.86). Folic acid supplementation was linked to a decreased stroke risk (RR, 0.84) and coenzyme Q10 was associated with a lower rate of all-cause mortality (RR, 0.68).

“The current study represents the first attempt in providing a comprehensive and most up-to-date evidence map that systematically assessed the quality and quantity of all randomized trials linking the effects of a wide variety of micronutrients on cardiovascular risk factors,” the authors say.

“The comprehensive evidence map presented here highlights the importance of micronutrient diversity and the balance of benefits and risks in the design of whole food–based dietary patterns to promote cardiometabolic health, which may require cultural adaptations to apply globally,” they conclude.

Commenting on some of the specific beneficial findings, Dr. Manson said: “I do believe that the marine omega-3s confer heart benefits, but results are not consistent and vary by dose and formulation.”

However, she pointed out that, regarding folic acid, a previous meta-analysis including eight large randomized trials in more than 37,000 participants found no reduction in coronary events, stroke, or major cardiovascular events with folic acid supplementation, compared with placebo, “so the reported stroke benefit would need further confirmation.”

In an accompanying editorial, Juan Gormaz, PhD, University of Chile, and Rodrigo Carrasco, MD, Chilean Society of Cardiology and Cardiovascular Surgery, both in Santiago, state: “Given that the compounds with more pleiotropic properties produced the better outcomes, the antioxidant paradigm on cardiovascular prevention can be challenged. For example, inasmuch as n-3 fatty acids have antiplatelet and anti-inflammatory properties, they are too complex to enable attribution of the observed benefits solely to their antioxidant capacity.”

The editorialists note that from a research point of view, “although the current information opens interesting perspectives for future consolidation of some antioxidants in preventive cardiology, there is still a long way to go in terms of generating evidence.”

They add that the challenge now for some compounds is to begin establishing consensus in definitions of dose and combinations, as well as continue strengthening the evidence of effectiveness.

“Regarding routine clinical practice, these results begin to open spaces for the integration of new tools into the therapeutic arsenal aimed at cardiovascular prevention in selected populations, which could be easily accessible and, with specific exceptions, would present a low frequency of adverse effects,” they conclude.

This work was partly supported by the United States’ Fulbright Program and by the Beijing Advanced Innovation Center for Food Nutrition and Human Health, the National Natural Science Foundation of China, the Chinese Universities Scientific Fund, and the Beijing Municipal Natural Science Foundation.

Dr. Liu has received honoraria for scientific presentations or reviews at Johns Hopkins University, Fred Hutchinson Cancer Center, Harvard University, University of Buffalo, Guangdong General Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences, and the National Institutes of Health; he is a member of the Data Safety and Monitoring Board for several trials, including the SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) trial sponsored by Novo Nordisk and a trial of pulmonary hypertension in diabetes patients sponsored by Massachusetts General Hospital; he has received royalties from UpToDate and has received an honorarium from the American Society for Nutrition for his duties as Associate Editor. Co-author Jeffrey Mechanick, MD, has received honoraria from Abbott Nutrition for lectures and serves on the advisory boards of Aveta.Life, L-Nutra, and Twin Health. The other authors report no relevant financial relationships.

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

Heart failure associated with illicit use of the psychostimulant methamphetamine (methHF) is increasing in the United States and around the world across racial, ethnic, and socioeconomic groups, a literature review indicates.

MethHF is associated with increased severity for HF, longer inpatient stay, and more readmissions, compared with non-MethHF, the data show.

Clinicians “need to consider methamphetamine as a potential etiology for heart failure and include a substance use history when evaluating patients. Treating methamphetamine use disorder improves heart failure outcomes,” first author Veena Manja, MD, PhD, with Stanford (Calif.) University, said in an interview.

The study was published online in the journal Heart.
 

Poor outcomes, ‘staggering’ costs

This “thoughtful” review is “important and necessary,” Jonathan Davis, MD, director of the heart failure program, Zuckerberg San Francisco General Hospital, wrote in an editorial in the journal.

Dr. Davis noted that patients with Meth HF are at increased risk for poor outcomes and death and the health care costs related to MethHF are “staggering.”

As an example, inpatient data for California show annual charges related to MethHF rose by 840% from 2008 to 2018, from $41.5 million to $390.2 million, compared with 82% for all HF, which rose from $3.5 billion to $6.8 billion.

Illicit use of methamphetamine – also known as “crystal meth,” “ice,” and “speed” – has been linked to hypertension, MI, stroke, aortic dissection, and sudden death. But until now, there was no comprehensive systematic review of published studies on MethHF.

“Our goal was to compile current knowledge on the topic, increase awareness of this condition and identify areas for future research,” Dr. Manja said.

The researchers reviewed 21 observational studies, mostly from the United States (14 from California), between 1997 and 2020. The mean age of adults with MethHF ranged in age from 35 to 60 and more than half were male (57%).

Illicit methamphetamine was inhaled, injected, swallowed, smoked, and snorted. The reported frequency ranged from daily to every other week, and the total monthly dose ranged from 0.35 g to 24.5 g.

The average duration of meth use before HF diagnosis was 5 years. However, 18% of users developed HF within 1 year of starting to use illicit methamphetamine. In some cases, HF was diagnosed after a single use.

The researchers also note that MethHF with preserved left ventricular ejection fraction, seen in up to 44% of cases, is a distinct entity that may progress to reduced LVEF with continued use.

MethHF is also associated with a greater likelihood of other substance abuse, PTSD, depression, and other heart and kidney disease.

Factors associated with improved MethHF outcomes include female sex, meth abstinence, and adherence to guideline-directed HF therapy.

Improvement in MethHF outcomes is possible even if abstinence is not consistent, a finding that lends support to harm reduction principles of “meeting patients where they are instead of insisting on complete abstinence,” the researchers said.
 

Large gaps in knowledge

They were unable to combine the results into a meta-analysis because of heterogeneity in study design, population, comparator, and outcome assessment. Also, the overall risk of bias is moderate because of the presence of confounders, selection bias and poor matching, and the overall certainty in the evidence is very low,.

No study evaluated the incidence or prevalence of HF among methamphetamine users and inconsistent history taking and testing in patients with HF impeded accurate MethHF prevalence assessment.

Several studies, however, document an increasing incidence of MethHF, particularly over the past decade.

One study from California reported a 585% increase in MethHF hospital admissions between 2008 and 2018. An analysis of the National Inpatient Survey found a 12-fold increase in annual MethHF hospitalizations between 2002 and 2014.

“The results of this systematic review highlight large gaps in our knowledge” of MethHF, Dr. Manja said in an interview.

“We need to understand the epidemiology, prevalence, factors that confer susceptibility to cardiovascular outcomes, and need research into treatment targeted toward this disease,” Dr. Manja added. “We should consider options to integrate substance use treatment in HF/cardiology/primary care clinics and design a multidisciplinary patient-centered approach.”

Dr. Davis agreed. This work “highlights that the standard of care academically and clinically must be a broad team across the care spectrum to simultaneously address methamphetamine use, heart failure, and social determinants of health.”

This research had no specific funding. Dr. Manja and Dr. Davis reported no relevant disclosures.

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

Heart failure associated with illicit use of the psychostimulant methamphetamine (methHF) is increasing in the United States and around the world across racial, ethnic, and socioeconomic groups, a literature review indicates.

MethHF is associated with increased severity for HF, longer inpatient stay, and more readmissions, compared with non-MethHF, the data show.

Clinicians “need to consider methamphetamine as a potential etiology for heart failure and include a substance use history when evaluating patients. Treating methamphetamine use disorder improves heart failure outcomes,” first author Veena Manja, MD, PhD, with Stanford (Calif.) University, said in an interview.

The study was published online in the journal Heart.
 

Poor outcomes, ‘staggering’ costs

This “thoughtful” review is “important and necessary,” Jonathan Davis, MD, director of the heart failure program, Zuckerberg San Francisco General Hospital, wrote in an editorial in the journal.

Dr. Davis noted that patients with Meth HF are at increased risk for poor outcomes and death and the health care costs related to MethHF are “staggering.”

As an example, inpatient data for California show annual charges related to MethHF rose by 840% from 2008 to 2018, from $41.5 million to $390.2 million, compared with 82% for all HF, which rose from $3.5 billion to $6.8 billion.

Illicit use of methamphetamine – also known as “crystal meth,” “ice,” and “speed” – has been linked to hypertension, MI, stroke, aortic dissection, and sudden death. But until now, there was no comprehensive systematic review of published studies on MethHF.

“Our goal was to compile current knowledge on the topic, increase awareness of this condition and identify areas for future research,” Dr. Manja said.

The researchers reviewed 21 observational studies, mostly from the United States (14 from California), between 1997 and 2020. The mean age of adults with MethHF ranged in age from 35 to 60 and more than half were male (57%).

Illicit methamphetamine was inhaled, injected, swallowed, smoked, and snorted. The reported frequency ranged from daily to every other week, and the total monthly dose ranged from 0.35 g to 24.5 g.

The average duration of meth use before HF diagnosis was 5 years. However, 18% of users developed HF within 1 year of starting to use illicit methamphetamine. In some cases, HF was diagnosed after a single use.

The researchers also note that MethHF with preserved left ventricular ejection fraction, seen in up to 44% of cases, is a distinct entity that may progress to reduced LVEF with continued use.

MethHF is also associated with a greater likelihood of other substance abuse, PTSD, depression, and other heart and kidney disease.

Factors associated with improved MethHF outcomes include female sex, meth abstinence, and adherence to guideline-directed HF therapy.

Improvement in MethHF outcomes is possible even if abstinence is not consistent, a finding that lends support to harm reduction principles of “meeting patients where they are instead of insisting on complete abstinence,” the researchers said.
 

Large gaps in knowledge

They were unable to combine the results into a meta-analysis because of heterogeneity in study design, population, comparator, and outcome assessment. Also, the overall risk of bias is moderate because of the presence of confounders, selection bias and poor matching, and the overall certainty in the evidence is very low,.

No study evaluated the incidence or prevalence of HF among methamphetamine users and inconsistent history taking and testing in patients with HF impeded accurate MethHF prevalence assessment.

Several studies, however, document an increasing incidence of MethHF, particularly over the past decade.

One study from California reported a 585% increase in MethHF hospital admissions between 2008 and 2018. An analysis of the National Inpatient Survey found a 12-fold increase in annual MethHF hospitalizations between 2002 and 2014.

“The results of this systematic review highlight large gaps in our knowledge” of MethHF, Dr. Manja said in an interview.

“We need to understand the epidemiology, prevalence, factors that confer susceptibility to cardiovascular outcomes, and need research into treatment targeted toward this disease,” Dr. Manja added. “We should consider options to integrate substance use treatment in HF/cardiology/primary care clinics and design a multidisciplinary patient-centered approach.”

Dr. Davis agreed. This work “highlights that the standard of care academically and clinically must be a broad team across the care spectrum to simultaneously address methamphetamine use, heart failure, and social determinants of health.”

This research had no specific funding. Dr. Manja and Dr. Davis reported no relevant disclosures.

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

Heart failure associated with illicit use of the psychostimulant methamphetamine (methHF) is increasing in the United States and around the world across racial, ethnic, and socioeconomic groups, a literature review indicates.

MethHF is associated with increased severity for HF, longer inpatient stay, and more readmissions, compared with non-MethHF, the data show.

Clinicians “need to consider methamphetamine as a potential etiology for heart failure and include a substance use history when evaluating patients. Treating methamphetamine use disorder improves heart failure outcomes,” first author Veena Manja, MD, PhD, with Stanford (Calif.) University, said in an interview.

The study was published online in the journal Heart.
 

Poor outcomes, ‘staggering’ costs

This “thoughtful” review is “important and necessary,” Jonathan Davis, MD, director of the heart failure program, Zuckerberg San Francisco General Hospital, wrote in an editorial in the journal.

Dr. Davis noted that patients with Meth HF are at increased risk for poor outcomes and death and the health care costs related to MethHF are “staggering.”

As an example, inpatient data for California show annual charges related to MethHF rose by 840% from 2008 to 2018, from $41.5 million to $390.2 million, compared with 82% for all HF, which rose from $3.5 billion to $6.8 billion.

Illicit use of methamphetamine – also known as “crystal meth,” “ice,” and “speed” – has been linked to hypertension, MI, stroke, aortic dissection, and sudden death. But until now, there was no comprehensive systematic review of published studies on MethHF.

“Our goal was to compile current knowledge on the topic, increase awareness of this condition and identify areas for future research,” Dr. Manja said.

The researchers reviewed 21 observational studies, mostly from the United States (14 from California), between 1997 and 2020. The mean age of adults with MethHF ranged in age from 35 to 60 and more than half were male (57%).

Illicit methamphetamine was inhaled, injected, swallowed, smoked, and snorted. The reported frequency ranged from daily to every other week, and the total monthly dose ranged from 0.35 g to 24.5 g.

The average duration of meth use before HF diagnosis was 5 years. However, 18% of users developed HF within 1 year of starting to use illicit methamphetamine. In some cases, HF was diagnosed after a single use.

The researchers also note that MethHF with preserved left ventricular ejection fraction, seen in up to 44% of cases, is a distinct entity that may progress to reduced LVEF with continued use.

MethHF is also associated with a greater likelihood of other substance abuse, PTSD, depression, and other heart and kidney disease.

Factors associated with improved MethHF outcomes include female sex, meth abstinence, and adherence to guideline-directed HF therapy.

Improvement in MethHF outcomes is possible even if abstinence is not consistent, a finding that lends support to harm reduction principles of “meeting patients where they are instead of insisting on complete abstinence,” the researchers said.
 

Large gaps in knowledge

They were unable to combine the results into a meta-analysis because of heterogeneity in study design, population, comparator, and outcome assessment. Also, the overall risk of bias is moderate because of the presence of confounders, selection bias and poor matching, and the overall certainty in the evidence is very low,.

No study evaluated the incidence or prevalence of HF among methamphetamine users and inconsistent history taking and testing in patients with HF impeded accurate MethHF prevalence assessment.

Several studies, however, document an increasing incidence of MethHF, particularly over the past decade.

One study from California reported a 585% increase in MethHF hospital admissions between 2008 and 2018. An analysis of the National Inpatient Survey found a 12-fold increase in annual MethHF hospitalizations between 2002 and 2014.

“The results of this systematic review highlight large gaps in our knowledge” of MethHF, Dr. Manja said in an interview.

“We need to understand the epidemiology, prevalence, factors that confer susceptibility to cardiovascular outcomes, and need research into treatment targeted toward this disease,” Dr. Manja added. “We should consider options to integrate substance use treatment in HF/cardiology/primary care clinics and design a multidisciplinary patient-centered approach.”

Dr. Davis agreed. This work “highlights that the standard of care academically and clinically must be a broad team across the care spectrum to simultaneously address methamphetamine use, heart failure, and social determinants of health.”

This research had no specific funding. Dr. Manja and Dr. Davis reported no relevant disclosures.

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

In 1993, managing patients with stroke had long remained an elusive and somewhat intimidating task for the neurological world. Previous efforts to treat the condition had produced more frustration than success, leaving clinicians and patients alike in despair for a solution. However, some successes in treating coronary thrombosis during that era rejuvenated researchers’ efforts to crack the code. An international team of researchers had studied a Streptococcus derivative (streptokinase) and others had begun to study a natural substance termed tissue plasminogen activator (tPA) as thrombolytic agents to lyse coronary clots and to treat pulmonary embolism. The adverse event of excessive bleeding found in Australian studies done on streptokinase intervention in patients with stroke prompted researchers to contemplate use of tPA in stroke management.

The combination of tPA and advanced imaging technology led researchers to take a unique approach that would forever revolutionize stroke management, beginning in the early 1990s.

A group of German, Japanese, and American investigators began to research thrombolysis in acute stroke patients during the mid-1980s.

“What was unique is that patients had a CT scan followed by a catheter angiogram,” said Louis Caplan, MD, a senior member of the division of cerebrovascular disease at Beth Israel Deaconess Medical Center, Boston, professor of neurology at Harvard Medical School, Boston, and founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center.

“If they had a blocked vessel, they got the drug, delivered either intravenously or intra-arterially.”

The process involved keeping the catheter open after drug administration to determine whether the vessel had opened or remained occluded. The researchers learned which blocked vessels opened when the drug was given intravenously and which required direct introduction of the drug into the clots.

A group of investigators in the United States funded by the National Institute of Neurological Disease and Stroke then performed a randomized therapeutic trial of intravenous tPA given within 90 minutes and 180 minutes after stroke symptom onset. The study was reported in the New England Journal of Medicine. Soon thereafter, in 1995, the Food and Drug Administration approved the use of tPA following the inclusion and exclusion rules used in the NINDS trial.

After the FDA approved tPA in 1995, stroke management was never the same.
 

tPA was just one factor in optimizing stroke management

Despite the major therapeutic breakthrough with tPA’s approval, it took the clinics, hospitals, and other acute care systems a while to catch up. “Neurologists and hospitals weren’t ready for acute stroke intervention and proper stroke management in the mid-90s,” Dr. Caplan recalled. “At the time, stroke wasn’t at the forefront of treatment, general neurologists weren’t trained, and there weren’t enough stroke neurologists.”

The preparation and training deficit was further exacerbated by low reimbursement for services. As a result, only about 5% of patients who were eligible for acute stroke management were treated with tPA.

According to Dr. Caplan, during the next 15-20 years, the accumulation of stroke data from MRI and CT vascular imaging clarified further which patients, with what extent of infarction, with which blocked vessels, would be good candidates for treatment.

More patients received interventional treatment using catheters directed into the area of clotting in attempt to remove the blockages. In addition, information regarding intervention at different periods (10-16 hours, up to 24 hours) and conditions (for example, patients with varying degrees of disability, infarct) were tested.

Eventually, hospitals became more attuned to emergency stroke treatment. More neurologists became trained, more stroke centers emerged, and clinicians enjoyed the benefit of technological advancements that allowed them to explore perfusion.
 

While decentralized care enhances outcomes in stroke management, more progress is needed

As of early 2023, stroke is one of the leading emergency diagnoses, and patients have access to primary and secondary stroke centers that are sprinkled throughout the United States. As impressive as the feat may seem, health care systems still have major strides to make to truly optimize therapy and outcomes in this patient population.

For example, location and access remain important issues. Secondary centers are typically located in large, metropolitan areas. While an urban location makes a primary center geographically more accessible to a larger patient population, traffic frequently hinders door-to-door access.

In the case of rural centers, distance can retard access, but they also face the challenges of how to route patients – especially patients who require more specialized care offered by secondary centers. Fortunately, primary centers have some ways to help better support their patients.

“One thing that happened is that primary centers made agreements with secondary centers via telemedicine to determine whether patients should be treated at the primary center or whether they should be routed to the higher-level center. These arrangements were termed ‘spoke and wheel,’ ” Dr. Caplan told this publication.

However, not all patients who are candidates for transport to a secondary center are able to be transported. In such cases, primary centers can use telemedicine to collaborate with secondary centers for support.

Logistics aside, perhaps today’s greatest challenge for clinicians is ensuring their patients and families receive education to increase their awareness of stroke centers as an important option for treatment and outcome optimization. Many patients and their loved ones do not realize that these centers exist or how to utilize them if and when the time comes.

Right now, some cities have stroke ambulances staffed with physicians to treat patients in the field. This decentralized model helps address access burdens such as door-to-needle delays and transportation while improving survival and recovery. Dr. Caplan said these services are available in Munich, and in a few select U.S. cities such as Cleveland and Houston, which helped pioneer the concept.
 

Better access in the future?

Looking ahead, Dr. Caplan seems optimistic about how stroke management will continue to evolve. Many cities will have stroke ambulances to provide on-site care, while stroke institutions will improve their cross-collaborative efforts to support their patient populations.

At the crux of cross-collaboration lies enhanced communication between peripheral and urban hospitals.

“Peripheral and urban hospitals and state organizations will engage in smoother integration to figure out when to take patient to the bigger hospitals,” Dr. Caplan said. “I also believe we will see greater emphasis on rehabilitation and recovery.”

As promising as the future looks, only time will tell.
 

In 1993, managing patients with stroke had long remained an elusive and somewhat intimidating task for the neurological world. Previous efforts to treat the condition had produced more frustration than success, leaving clinicians and patients alike in despair for a solution. However, some successes in treating coronary thrombosis during that era rejuvenated researchers’ efforts to crack the code. An international team of researchers had studied a Streptococcus derivative (streptokinase) and others had begun to study a natural substance termed tissue plasminogen activator (tPA) as thrombolytic agents to lyse coronary clots and to treat pulmonary embolism. The adverse event of excessive bleeding found in Australian studies done on streptokinase intervention in patients with stroke prompted researchers to contemplate use of tPA in stroke management.

The combination of tPA and advanced imaging technology led researchers to take a unique approach that would forever revolutionize stroke management, beginning in the early 1990s.

A group of German, Japanese, and American investigators began to research thrombolysis in acute stroke patients during the mid-1980s.

“What was unique is that patients had a CT scan followed by a catheter angiogram,” said Louis Caplan, MD, a senior member of the division of cerebrovascular disease at Beth Israel Deaconess Medical Center, Boston, professor of neurology at Harvard Medical School, Boston, and founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center.

“If they had a blocked vessel, they got the drug, delivered either intravenously or intra-arterially.”

The process involved keeping the catheter open after drug administration to determine whether the vessel had opened or remained occluded. The researchers learned which blocked vessels opened when the drug was given intravenously and which required direct introduction of the drug into the clots.

A group of investigators in the United States funded by the National Institute of Neurological Disease and Stroke then performed a randomized therapeutic trial of intravenous tPA given within 90 minutes and 180 minutes after stroke symptom onset. The study was reported in the New England Journal of Medicine. Soon thereafter, in 1995, the Food and Drug Administration approved the use of tPA following the inclusion and exclusion rules used in the NINDS trial.

After the FDA approved tPA in 1995, stroke management was never the same.
 

tPA was just one factor in optimizing stroke management

Despite the major therapeutic breakthrough with tPA’s approval, it took the clinics, hospitals, and other acute care systems a while to catch up. “Neurologists and hospitals weren’t ready for acute stroke intervention and proper stroke management in the mid-90s,” Dr. Caplan recalled. “At the time, stroke wasn’t at the forefront of treatment, general neurologists weren’t trained, and there weren’t enough stroke neurologists.”

The preparation and training deficit was further exacerbated by low reimbursement for services. As a result, only about 5% of patients who were eligible for acute stroke management were treated with tPA.

According to Dr. Caplan, during the next 15-20 years, the accumulation of stroke data from MRI and CT vascular imaging clarified further which patients, with what extent of infarction, with which blocked vessels, would be good candidates for treatment.

More patients received interventional treatment using catheters directed into the area of clotting in attempt to remove the blockages. In addition, information regarding intervention at different periods (10-16 hours, up to 24 hours) and conditions (for example, patients with varying degrees of disability, infarct) were tested.

Eventually, hospitals became more attuned to emergency stroke treatment. More neurologists became trained, more stroke centers emerged, and clinicians enjoyed the benefit of technological advancements that allowed them to explore perfusion.
 

While decentralized care enhances outcomes in stroke management, more progress is needed

As of early 2023, stroke is one of the leading emergency diagnoses, and patients have access to primary and secondary stroke centers that are sprinkled throughout the United States. As impressive as the feat may seem, health care systems still have major strides to make to truly optimize therapy and outcomes in this patient population.

For example, location and access remain important issues. Secondary centers are typically located in large, metropolitan areas. While an urban location makes a primary center geographically more accessible to a larger patient population, traffic frequently hinders door-to-door access.

In the case of rural centers, distance can retard access, but they also face the challenges of how to route patients – especially patients who require more specialized care offered by secondary centers. Fortunately, primary centers have some ways to help better support their patients.

“One thing that happened is that primary centers made agreements with secondary centers via telemedicine to determine whether patients should be treated at the primary center or whether they should be routed to the higher-level center. These arrangements were termed ‘spoke and wheel,’ ” Dr. Caplan told this publication.

However, not all patients who are candidates for transport to a secondary center are able to be transported. In such cases, primary centers can use telemedicine to collaborate with secondary centers for support.

Logistics aside, perhaps today’s greatest challenge for clinicians is ensuring their patients and families receive education to increase their awareness of stroke centers as an important option for treatment and outcome optimization. Many patients and their loved ones do not realize that these centers exist or how to utilize them if and when the time comes.

Right now, some cities have stroke ambulances staffed with physicians to treat patients in the field. This decentralized model helps address access burdens such as door-to-needle delays and transportation while improving survival and recovery. Dr. Caplan said these services are available in Munich, and in a few select U.S. cities such as Cleveland and Houston, which helped pioneer the concept.
 

Better access in the future?

Looking ahead, Dr. Caplan seems optimistic about how stroke management will continue to evolve. Many cities will have stroke ambulances to provide on-site care, while stroke institutions will improve their cross-collaborative efforts to support their patient populations.

At the crux of cross-collaboration lies enhanced communication between peripheral and urban hospitals.

“Peripheral and urban hospitals and state organizations will engage in smoother integration to figure out when to take patient to the bigger hospitals,” Dr. Caplan said. “I also believe we will see greater emphasis on rehabilitation and recovery.”

As promising as the future looks, only time will tell.
 

In 1993, managing patients with stroke had long remained an elusive and somewhat intimidating task for the neurological world. Previous efforts to treat the condition had produced more frustration than success, leaving clinicians and patients alike in despair for a solution. However, some successes in treating coronary thrombosis during that era rejuvenated researchers’ efforts to crack the code. An international team of researchers had studied a Streptococcus derivative (streptokinase) and others had begun to study a natural substance termed tissue plasminogen activator (tPA) as thrombolytic agents to lyse coronary clots and to treat pulmonary embolism. The adverse event of excessive bleeding found in Australian studies done on streptokinase intervention in patients with stroke prompted researchers to contemplate use of tPA in stroke management.

The combination of tPA and advanced imaging technology led researchers to take a unique approach that would forever revolutionize stroke management, beginning in the early 1990s.

A group of German, Japanese, and American investigators began to research thrombolysis in acute stroke patients during the mid-1980s.

“What was unique is that patients had a CT scan followed by a catheter angiogram,” said Louis Caplan, MD, a senior member of the division of cerebrovascular disease at Beth Israel Deaconess Medical Center, Boston, professor of neurology at Harvard Medical School, Boston, and founder of the Harvard Stroke Registry at Beth Israel Deaconess Medical Center.

“If they had a blocked vessel, they got the drug, delivered either intravenously or intra-arterially.”

The process involved keeping the catheter open after drug administration to determine whether the vessel had opened or remained occluded. The researchers learned which blocked vessels opened when the drug was given intravenously and which required direct introduction of the drug into the clots.

A group of investigators in the United States funded by the National Institute of Neurological Disease and Stroke then performed a randomized therapeutic trial of intravenous tPA given within 90 minutes and 180 minutes after stroke symptom onset. The study was reported in the New England Journal of Medicine. Soon thereafter, in 1995, the Food and Drug Administration approved the use of tPA following the inclusion and exclusion rules used in the NINDS trial.

After the FDA approved tPA in 1995, stroke management was never the same.
 

tPA was just one factor in optimizing stroke management

Despite the major therapeutic breakthrough with tPA’s approval, it took the clinics, hospitals, and other acute care systems a while to catch up. “Neurologists and hospitals weren’t ready for acute stroke intervention and proper stroke management in the mid-90s,” Dr. Caplan recalled. “At the time, stroke wasn’t at the forefront of treatment, general neurologists weren’t trained, and there weren’t enough stroke neurologists.”

The preparation and training deficit was further exacerbated by low reimbursement for services. As a result, only about 5% of patients who were eligible for acute stroke management were treated with tPA.

According to Dr. Caplan, during the next 15-20 years, the accumulation of stroke data from MRI and CT vascular imaging clarified further which patients, with what extent of infarction, with which blocked vessels, would be good candidates for treatment.

More patients received interventional treatment using catheters directed into the area of clotting in attempt to remove the blockages. In addition, information regarding intervention at different periods (10-16 hours, up to 24 hours) and conditions (for example, patients with varying degrees of disability, infarct) were tested.

Eventually, hospitals became more attuned to emergency stroke treatment. More neurologists became trained, more stroke centers emerged, and clinicians enjoyed the benefit of technological advancements that allowed them to explore perfusion.
 

While decentralized care enhances outcomes in stroke management, more progress is needed

As of early 2023, stroke is one of the leading emergency diagnoses, and patients have access to primary and secondary stroke centers that are sprinkled throughout the United States. As impressive as the feat may seem, health care systems still have major strides to make to truly optimize therapy and outcomes in this patient population.

For example, location and access remain important issues. Secondary centers are typically located in large, metropolitan areas. While an urban location makes a primary center geographically more accessible to a larger patient population, traffic frequently hinders door-to-door access.

In the case of rural centers, distance can retard access, but they also face the challenges of how to route patients – especially patients who require more specialized care offered by secondary centers. Fortunately, primary centers have some ways to help better support their patients.

“One thing that happened is that primary centers made agreements with secondary centers via telemedicine to determine whether patients should be treated at the primary center or whether they should be routed to the higher-level center. These arrangements were termed ‘spoke and wheel,’ ” Dr. Caplan told this publication.

However, not all patients who are candidates for transport to a secondary center are able to be transported. In such cases, primary centers can use telemedicine to collaborate with secondary centers for support.

Logistics aside, perhaps today’s greatest challenge for clinicians is ensuring their patients and families receive education to increase their awareness of stroke centers as an important option for treatment and outcome optimization. Many patients and their loved ones do not realize that these centers exist or how to utilize them if and when the time comes.

Right now, some cities have stroke ambulances staffed with physicians to treat patients in the field. This decentralized model helps address access burdens such as door-to-needle delays and transportation while improving survival and recovery. Dr. Caplan said these services are available in Munich, and in a few select U.S. cities such as Cleveland and Houston, which helped pioneer the concept.
 

Better access in the future?

Looking ahead, Dr. Caplan seems optimistic about how stroke management will continue to evolve. Many cities will have stroke ambulances to provide on-site care, while stroke institutions will improve their cross-collaborative efforts to support their patient populations.

At the crux of cross-collaboration lies enhanced communication between peripheral and urban hospitals.

“Peripheral and urban hospitals and state organizations will engage in smoother integration to figure out when to take patient to the bigger hospitals,” Dr. Caplan said. “I also believe we will see greater emphasis on rehabilitation and recovery.”

As promising as the future looks, only time will tell.
 

The U.S. Food and Drug Administration has updated the Abiomed Impella RP System’s approved indications in a way that “better reflects the characteristics of the patients who may benefit the most from treatment with the device,” the agency has announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The revised language reflects the final results of a postapproval study in which survival rates for patients who met the premarket-study entry criteria were comparable to rates seen in the premarket studies, the FDA observed.

The postapproval study “further confirms that the device is safe and effective when used for the currently approved indication.” The indication’s added words, however, tighten the description of eligible patients in a way that more precisely reflects the premarket-study population.

The update states that the Impella RP System is “indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥ 1.5 m², who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.”

The FDA “believes that when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP System continue to outweigh the risks.”

The reworded indication is the latest among several updates to the agency’s February 2019 letter to clinicians noting a signal of increased mortality associated with the Impella RP device in an interim analysis of the same postapproval study. Ultimately, no such signal has emerged among the subset of postapproval patients who would have been eligible for the premarket study.

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

The U.S. Food and Drug Administration has updated the Abiomed Impella RP System’s approved indications in a way that “better reflects the characteristics of the patients who may benefit the most from treatment with the device,” the agency has announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The revised language reflects the final results of a postapproval study in which survival rates for patients who met the premarket-study entry criteria were comparable to rates seen in the premarket studies, the FDA observed.

The postapproval study “further confirms that the device is safe and effective when used for the currently approved indication.” The indication’s added words, however, tighten the description of eligible patients in a way that more precisely reflects the premarket-study population.

The update states that the Impella RP System is “indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥ 1.5 m², who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.”

The FDA “believes that when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP System continue to outweigh the risks.”

The reworded indication is the latest among several updates to the agency’s February 2019 letter to clinicians noting a signal of increased mortality associated with the Impella RP device in an interim analysis of the same postapproval study. Ultimately, no such signal has emerged among the subset of postapproval patients who would have been eligible for the premarket study.

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

The U.S. Food and Drug Administration has updated the Abiomed Impella RP System’s approved indications in a way that “better reflects the characteristics of the patients who may benefit the most from treatment with the device,” the agency has announced.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The revised language reflects the final results of a postapproval study in which survival rates for patients who met the premarket-study entry criteria were comparable to rates seen in the premarket studies, the FDA observed.

The postapproval study “further confirms that the device is safe and effective when used for the currently approved indication.” The indication’s added words, however, tighten the description of eligible patients in a way that more precisely reflects the premarket-study population.

The update states that the Impella RP System is “indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥ 1.5 m², who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.”

The FDA “believes that when the device is used for the currently approved indication in appropriately selected patients, the benefits of the Impella RP System continue to outweigh the risks.”

The reworded indication is the latest among several updates to the agency’s February 2019 letter to clinicians noting a signal of increased mortality associated with the Impella RP device in an interim analysis of the same postapproval study. Ultimately, no such signal has emerged among the subset of postapproval patients who would have been eligible for the premarket study.

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