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Study Detects Bacteria in Tattoo, Permanent Makeup Inks
When US researchers tested 75 unopened and sealed tattoo and permanent makeup inks from 14 different manufacturers, they discovered that about 35% of the products were contaminated with bacteria.
They detected both aerobic bacteria and anaerobic bacteria, which thrive in low-oxygen environments like the dermal layer of the skin.
“This suggests that contaminated tattoo inks could be a source of infection from both types of bacteria,” Seong-Jae Peter Kim, PhD, a microbiologist with the Division of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, who worked on the study, said in a news release.
The findings “are concerning,” said Waleed Javaid, MD, professor of medicine and director of infection prevention and control for the Mount Sinai Health System in New York City. “This contamination poses a significant health risk, as these inks are injected into the dermal layer of the skin, creating an environment conducive to bacterial infections,” said Dr. Javaid, who wasn’t involved in the study, which was published online in Applied and Environmental Microbiology.
New Body Art Culture
Tattoos are more popular than ever, and it is estimated that at least 32% of people in the United States have at least one tattoo. And the rise in popularity has coincided with an increase in ink-related infections.
This new research joins previous studies that have demonstrated that commercial tattoo and permanent makeup inks are often contaminated with pathogenic microorganisms.
Of the 75 ink samples that Dr. Kim and colleagues tested, 26 were contaminated with 34 bacterial isolates classified into 14 genera and 22 species. Among the 34 bacterial isolates, 19 were identified as possibly pathogenic bacterial strains.
Two species — Cutibacterium acnes (four strains) and Staphylococcus epidermidis (two strains) — were isolated under anaerobic conditions.
Two possibly pathogenic bacterial strains — Staphylococcus saprophyticus and C acnes — were isolated from the same two ink samples, indicating that tattoo and permanent makeup inks can harbor both aerobic (S saprophyticus) and anaerobic (C acnes) bacteria.
There was no significant association between sterility claims on the ink label and the absence of bacterial contamination.
“The presence of bacteria like Cutibacterium acnes and Staphylococcus epidermidis, which can cause skin infections and other complications, underscores the potential danger to individuals receiving tattoos or permanent makeup,” Dr. Javaid explained.
The results “emphasize the importance of monitoring these products for both aerobic and anaerobic bacteria, including possibly pathogenic microorganisms,” Dr. Kim said in the news release.
The next steps, according to the researchers, include developing more efficient and accurate microbial detection methods for tattoo inks to streamline the monitoring process and examining the occurrence, co-occurrence, and diversity of microbial contaminants in tattoo inks to prevent future contamination.
Counseling Patients
Healthcare professionals play a “crucial role in counseling patients about the risks associated with tattoos. They should inform patients about the potential for infections, allergic reactions, and other complications related to tattooing and permanent ink,” said Dr. Javaid.
Specific advice can include ensuring that the tattoo parlor adheres to strict hygiene practices and verifying that tattoo inks are from reputable sources and, if possible, have undergone sterilization.
Clinicians should discuss the importance of proper aftercare to minimize the risk for infection, recommend patients with compromised immune systems or skin conditions to reconsider getting a tattoo, and encourage patients to be aware of the signs of infection and to seek medical attention promptly if any symptoms arise.
“Enhanced regulatory measures would help reduce the risk of infections and ensure safer tattooing practices for consumers,” Dr. Javaid said. The findings of Dr. Kim and colleagues “indicate that current manufacturing and sterilization processes are inadequate.”
Regulations could include stricter manufacturing standards to ensure sterility, the mandatory testing of inks for microbial contamination before they reach the market, clear labeling requirements that accurately reflect the sterility and safety of products, and regular inspections and audits of tattoo ink manufacturers, he said, which could encourage the development of more effective sterilization techniques to eliminate bacterial contamination.
The FDA has created a document — Think Before You Ink: Tattoo Safety — for consumers who are considering getting a tattoo.
A version of this article first appeared on Medscape.com.
When US researchers tested 75 unopened and sealed tattoo and permanent makeup inks from 14 different manufacturers, they discovered that about 35% of the products were contaminated with bacteria.
They detected both aerobic bacteria and anaerobic bacteria, which thrive in low-oxygen environments like the dermal layer of the skin.
“This suggests that contaminated tattoo inks could be a source of infection from both types of bacteria,” Seong-Jae Peter Kim, PhD, a microbiologist with the Division of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, who worked on the study, said in a news release.
The findings “are concerning,” said Waleed Javaid, MD, professor of medicine and director of infection prevention and control for the Mount Sinai Health System in New York City. “This contamination poses a significant health risk, as these inks are injected into the dermal layer of the skin, creating an environment conducive to bacterial infections,” said Dr. Javaid, who wasn’t involved in the study, which was published online in Applied and Environmental Microbiology.
New Body Art Culture
Tattoos are more popular than ever, and it is estimated that at least 32% of people in the United States have at least one tattoo. And the rise in popularity has coincided with an increase in ink-related infections.
This new research joins previous studies that have demonstrated that commercial tattoo and permanent makeup inks are often contaminated with pathogenic microorganisms.
Of the 75 ink samples that Dr. Kim and colleagues tested, 26 were contaminated with 34 bacterial isolates classified into 14 genera and 22 species. Among the 34 bacterial isolates, 19 were identified as possibly pathogenic bacterial strains.
Two species — Cutibacterium acnes (four strains) and Staphylococcus epidermidis (two strains) — were isolated under anaerobic conditions.
Two possibly pathogenic bacterial strains — Staphylococcus saprophyticus and C acnes — were isolated from the same two ink samples, indicating that tattoo and permanent makeup inks can harbor both aerobic (S saprophyticus) and anaerobic (C acnes) bacteria.
There was no significant association between sterility claims on the ink label and the absence of bacterial contamination.
“The presence of bacteria like Cutibacterium acnes and Staphylococcus epidermidis, which can cause skin infections and other complications, underscores the potential danger to individuals receiving tattoos or permanent makeup,” Dr. Javaid explained.
The results “emphasize the importance of monitoring these products for both aerobic and anaerobic bacteria, including possibly pathogenic microorganisms,” Dr. Kim said in the news release.
The next steps, according to the researchers, include developing more efficient and accurate microbial detection methods for tattoo inks to streamline the monitoring process and examining the occurrence, co-occurrence, and diversity of microbial contaminants in tattoo inks to prevent future contamination.
Counseling Patients
Healthcare professionals play a “crucial role in counseling patients about the risks associated with tattoos. They should inform patients about the potential for infections, allergic reactions, and other complications related to tattooing and permanent ink,” said Dr. Javaid.
Specific advice can include ensuring that the tattoo parlor adheres to strict hygiene practices and verifying that tattoo inks are from reputable sources and, if possible, have undergone sterilization.
Clinicians should discuss the importance of proper aftercare to minimize the risk for infection, recommend patients with compromised immune systems or skin conditions to reconsider getting a tattoo, and encourage patients to be aware of the signs of infection and to seek medical attention promptly if any symptoms arise.
“Enhanced regulatory measures would help reduce the risk of infections and ensure safer tattooing practices for consumers,” Dr. Javaid said. The findings of Dr. Kim and colleagues “indicate that current manufacturing and sterilization processes are inadequate.”
Regulations could include stricter manufacturing standards to ensure sterility, the mandatory testing of inks for microbial contamination before they reach the market, clear labeling requirements that accurately reflect the sterility and safety of products, and regular inspections and audits of tattoo ink manufacturers, he said, which could encourage the development of more effective sterilization techniques to eliminate bacterial contamination.
The FDA has created a document — Think Before You Ink: Tattoo Safety — for consumers who are considering getting a tattoo.
A version of this article first appeared on Medscape.com.
When US researchers tested 75 unopened and sealed tattoo and permanent makeup inks from 14 different manufacturers, they discovered that about 35% of the products were contaminated with bacteria.
They detected both aerobic bacteria and anaerobic bacteria, which thrive in low-oxygen environments like the dermal layer of the skin.
“This suggests that contaminated tattoo inks could be a source of infection from both types of bacteria,” Seong-Jae Peter Kim, PhD, a microbiologist with the Division of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, who worked on the study, said in a news release.
The findings “are concerning,” said Waleed Javaid, MD, professor of medicine and director of infection prevention and control for the Mount Sinai Health System in New York City. “This contamination poses a significant health risk, as these inks are injected into the dermal layer of the skin, creating an environment conducive to bacterial infections,” said Dr. Javaid, who wasn’t involved in the study, which was published online in Applied and Environmental Microbiology.
New Body Art Culture
Tattoos are more popular than ever, and it is estimated that at least 32% of people in the United States have at least one tattoo. And the rise in popularity has coincided with an increase in ink-related infections.
This new research joins previous studies that have demonstrated that commercial tattoo and permanent makeup inks are often contaminated with pathogenic microorganisms.
Of the 75 ink samples that Dr. Kim and colleagues tested, 26 were contaminated with 34 bacterial isolates classified into 14 genera and 22 species. Among the 34 bacterial isolates, 19 were identified as possibly pathogenic bacterial strains.
Two species — Cutibacterium acnes (four strains) and Staphylococcus epidermidis (two strains) — were isolated under anaerobic conditions.
Two possibly pathogenic bacterial strains — Staphylococcus saprophyticus and C acnes — were isolated from the same two ink samples, indicating that tattoo and permanent makeup inks can harbor both aerobic (S saprophyticus) and anaerobic (C acnes) bacteria.
There was no significant association between sterility claims on the ink label and the absence of bacterial contamination.
“The presence of bacteria like Cutibacterium acnes and Staphylococcus epidermidis, which can cause skin infections and other complications, underscores the potential danger to individuals receiving tattoos or permanent makeup,” Dr. Javaid explained.
The results “emphasize the importance of monitoring these products for both aerobic and anaerobic bacteria, including possibly pathogenic microorganisms,” Dr. Kim said in the news release.
The next steps, according to the researchers, include developing more efficient and accurate microbial detection methods for tattoo inks to streamline the monitoring process and examining the occurrence, co-occurrence, and diversity of microbial contaminants in tattoo inks to prevent future contamination.
Counseling Patients
Healthcare professionals play a “crucial role in counseling patients about the risks associated with tattoos. They should inform patients about the potential for infections, allergic reactions, and other complications related to tattooing and permanent ink,” said Dr. Javaid.
Specific advice can include ensuring that the tattoo parlor adheres to strict hygiene practices and verifying that tattoo inks are from reputable sources and, if possible, have undergone sterilization.
Clinicians should discuss the importance of proper aftercare to minimize the risk for infection, recommend patients with compromised immune systems or skin conditions to reconsider getting a tattoo, and encourage patients to be aware of the signs of infection and to seek medical attention promptly if any symptoms arise.
“Enhanced regulatory measures would help reduce the risk of infections and ensure safer tattooing practices for consumers,” Dr. Javaid said. The findings of Dr. Kim and colleagues “indicate that current manufacturing and sterilization processes are inadequate.”
Regulations could include stricter manufacturing standards to ensure sterility, the mandatory testing of inks for microbial contamination before they reach the market, clear labeling requirements that accurately reflect the sterility and safety of products, and regular inspections and audits of tattoo ink manufacturers, he said, which could encourage the development of more effective sterilization techniques to eliminate bacterial contamination.
The FDA has created a document — Think Before You Ink: Tattoo Safety — for consumers who are considering getting a tattoo.
A version of this article first appeared on Medscape.com.
FROM APPLIED AND ENVIRONMENTAL MICROBIOLOGY
‘Chemoresistance Can Be Reversed’: Toughest Cancers Targeted
In the war against cancer, doctors and patients have long reached for three main weapons to target diseased cells: chemotherapy, radiation, and surgery.
But new research published this month in the journal Nature Materials suggests that manipulating the tissue around those cells — a strategy known as
“Our study shows the importance of the tumor microenvironment and its properties in dictating how cancer progresses and responds to drug treatment,” said first author Bauer LeSavage, PhD, who conducted the study as a postdoctoral researcher in the Bioengineering Department at Stanford University, Stanford, California. “It also demonstrates that chemoresistance can be reversed.”
Each year, about 66,000 people are diagnosed with pancreatic cancer, and 52,000 die from it. It is a particularly lethal type of cancer, with 5-year survival rates hovering around 7% — a rate that has not improved much since 1996 when the first-line chemotherapy drug gemcitabine was approved.
It looks different from many cancers, said Lynn Matrisian, PhD, chief science officer for the nonprofit Pancreatic Cancer Action Network. Instead of a tumorous mass, it is made of islands of cancer cells surrounded by unusually dense fibrous tissue known as the extracellular matrix, which can collapse blood vessels and prevent drugs from reaching the tumor.
For the study, Dr. LeSavage and his team engineered synthetic but lifelike three-dimensional pancreas tissue with varying degrees of stiffness and different biochemical properties. Then they inserted bits of real tumors from patients with pancreatic cancer, watched them grow, and tried to kill them with drugs.
They found that cells growing in a stiff matrix were more resistant to chemotherapy than those growing in a softer matrix. But the story didn’t end there.
They also found that high amounts of the tissue-strengthening protein hyaluronic acid in stiff tissue seemed to signal the cancer cells to develop tiny pumps on their surface which shuttled out the drugs before they could take effect.
When the researchers moved the cancer cells into either a softer matrix or a stiff matrix in which the hyaluronic acid receptor, called CD44, was blocked, the chemotherapy drugs started working again.
“This suggests that if we can disrupt the stiffness signaling that’s happening through the CD44 receptor, we could make patients’ pancreatic cancer treatable again by normal chemotherapy,” said senior study author Sarah Heilshorn, PhD, a professor of materials science and engineering at Stanford. “These results suggest an exciting new direction for new drug development.”
Targeting Nearby Tissue: A Novel Approach to Fighting Chemoresistance
The study is not the first to suggest that chemically targeting the microenvironment surrounding a tumor can influence how patients respond to treatment.
In one recent clinical trial, patients with metastatic pancreatic cancer were given an experimental drug to inhibit a protein called connective tissue growth factor, reduce fibrous tissue, and make pancreatic tumors easier to surgically remove. Results have not been published yet.
Other research suggests that the generic blood pressure drug losartan, when given in combination with chemotherapy and radiation, can boost survival in patients with advanced pancreatic cancer by, in part, improving the health of blood vessels that carry drugs to the tumor.
But other studies of such mechanotherapeutics have yielded inconclusive results, said Dr. Matrisian.
“This paper points to another reason why we should not give up on this approach,” she said.
Ning Wang, PhD, director of the new Institute for Mechanobiology at Northeastern University College of Engineering, Boston, said there is no question that the composition of a tumor’s environment can influence how cancer progresses or responds to drugs. The new paper, he said, adds an important new chapter to the evolving story.
“But it’s very complicated. It’s not as simple as saying make it softer or stiffer and you can change the outcome for the patient,” Dr. Wang said.
In fact, some research has shown that tissue becomes stiffer when cancer arises so it can contain it from spreading.
In one animal study of pancreatic cancer that had spread to the liver, administering drugs to soften the surrounding tissue, or stroma, actually had the opposite effect — accelerating tumor growth and reducing survival rates.
Dr. Wang also noted that any drug designed to influence the extracellular matrix would need to be extremely localized, to prevent damage to other tissues, like bone or heart muscle.
Dr. LeSavage said he sees the paper as a case study in how important the extracellular matrix is and an example of how artificially grown organs or tissues can play a key role in testing how drugs work or don’t work.
He imagines a day when doctors could personalize treatments by taking a bit of a patient’s tumor, growing it in artificial tissue, and seeing how different tissue-altering drugs affect different therapies.
“This isn’t something that is just unique to pancreatic cancer,” he said, noting that the extracellular matrix throughout the body interacts with different cancers. “If we could take someone who has a chemoresistant tumor and convert it into something that is sensitive to existing therapies again, we could give them a second chance.”
A version of this article appeared on Medscape.com.
In the war against cancer, doctors and patients have long reached for three main weapons to target diseased cells: chemotherapy, radiation, and surgery.
But new research published this month in the journal Nature Materials suggests that manipulating the tissue around those cells — a strategy known as
“Our study shows the importance of the tumor microenvironment and its properties in dictating how cancer progresses and responds to drug treatment,” said first author Bauer LeSavage, PhD, who conducted the study as a postdoctoral researcher in the Bioengineering Department at Stanford University, Stanford, California. “It also demonstrates that chemoresistance can be reversed.”
Each year, about 66,000 people are diagnosed with pancreatic cancer, and 52,000 die from it. It is a particularly lethal type of cancer, with 5-year survival rates hovering around 7% — a rate that has not improved much since 1996 when the first-line chemotherapy drug gemcitabine was approved.
It looks different from many cancers, said Lynn Matrisian, PhD, chief science officer for the nonprofit Pancreatic Cancer Action Network. Instead of a tumorous mass, it is made of islands of cancer cells surrounded by unusually dense fibrous tissue known as the extracellular matrix, which can collapse blood vessels and prevent drugs from reaching the tumor.
For the study, Dr. LeSavage and his team engineered synthetic but lifelike three-dimensional pancreas tissue with varying degrees of stiffness and different biochemical properties. Then they inserted bits of real tumors from patients with pancreatic cancer, watched them grow, and tried to kill them with drugs.
They found that cells growing in a stiff matrix were more resistant to chemotherapy than those growing in a softer matrix. But the story didn’t end there.
They also found that high amounts of the tissue-strengthening protein hyaluronic acid in stiff tissue seemed to signal the cancer cells to develop tiny pumps on their surface which shuttled out the drugs before they could take effect.
When the researchers moved the cancer cells into either a softer matrix or a stiff matrix in which the hyaluronic acid receptor, called CD44, was blocked, the chemotherapy drugs started working again.
“This suggests that if we can disrupt the stiffness signaling that’s happening through the CD44 receptor, we could make patients’ pancreatic cancer treatable again by normal chemotherapy,” said senior study author Sarah Heilshorn, PhD, a professor of materials science and engineering at Stanford. “These results suggest an exciting new direction for new drug development.”
Targeting Nearby Tissue: A Novel Approach to Fighting Chemoresistance
The study is not the first to suggest that chemically targeting the microenvironment surrounding a tumor can influence how patients respond to treatment.
In one recent clinical trial, patients with metastatic pancreatic cancer were given an experimental drug to inhibit a protein called connective tissue growth factor, reduce fibrous tissue, and make pancreatic tumors easier to surgically remove. Results have not been published yet.
Other research suggests that the generic blood pressure drug losartan, when given in combination with chemotherapy and radiation, can boost survival in patients with advanced pancreatic cancer by, in part, improving the health of blood vessels that carry drugs to the tumor.
But other studies of such mechanotherapeutics have yielded inconclusive results, said Dr. Matrisian.
“This paper points to another reason why we should not give up on this approach,” she said.
Ning Wang, PhD, director of the new Institute for Mechanobiology at Northeastern University College of Engineering, Boston, said there is no question that the composition of a tumor’s environment can influence how cancer progresses or responds to drugs. The new paper, he said, adds an important new chapter to the evolving story.
“But it’s very complicated. It’s not as simple as saying make it softer or stiffer and you can change the outcome for the patient,” Dr. Wang said.
In fact, some research has shown that tissue becomes stiffer when cancer arises so it can contain it from spreading.
In one animal study of pancreatic cancer that had spread to the liver, administering drugs to soften the surrounding tissue, or stroma, actually had the opposite effect — accelerating tumor growth and reducing survival rates.
Dr. Wang also noted that any drug designed to influence the extracellular matrix would need to be extremely localized, to prevent damage to other tissues, like bone or heart muscle.
Dr. LeSavage said he sees the paper as a case study in how important the extracellular matrix is and an example of how artificially grown organs or tissues can play a key role in testing how drugs work or don’t work.
He imagines a day when doctors could personalize treatments by taking a bit of a patient’s tumor, growing it in artificial tissue, and seeing how different tissue-altering drugs affect different therapies.
“This isn’t something that is just unique to pancreatic cancer,” he said, noting that the extracellular matrix throughout the body interacts with different cancers. “If we could take someone who has a chemoresistant tumor and convert it into something that is sensitive to existing therapies again, we could give them a second chance.”
A version of this article appeared on Medscape.com.
In the war against cancer, doctors and patients have long reached for three main weapons to target diseased cells: chemotherapy, radiation, and surgery.
But new research published this month in the journal Nature Materials suggests that manipulating the tissue around those cells — a strategy known as
“Our study shows the importance of the tumor microenvironment and its properties in dictating how cancer progresses and responds to drug treatment,” said first author Bauer LeSavage, PhD, who conducted the study as a postdoctoral researcher in the Bioengineering Department at Stanford University, Stanford, California. “It also demonstrates that chemoresistance can be reversed.”
Each year, about 66,000 people are diagnosed with pancreatic cancer, and 52,000 die from it. It is a particularly lethal type of cancer, with 5-year survival rates hovering around 7% — a rate that has not improved much since 1996 when the first-line chemotherapy drug gemcitabine was approved.
It looks different from many cancers, said Lynn Matrisian, PhD, chief science officer for the nonprofit Pancreatic Cancer Action Network. Instead of a tumorous mass, it is made of islands of cancer cells surrounded by unusually dense fibrous tissue known as the extracellular matrix, which can collapse blood vessels and prevent drugs from reaching the tumor.
For the study, Dr. LeSavage and his team engineered synthetic but lifelike three-dimensional pancreas tissue with varying degrees of stiffness and different biochemical properties. Then they inserted bits of real tumors from patients with pancreatic cancer, watched them grow, and tried to kill them with drugs.
They found that cells growing in a stiff matrix were more resistant to chemotherapy than those growing in a softer matrix. But the story didn’t end there.
They also found that high amounts of the tissue-strengthening protein hyaluronic acid in stiff tissue seemed to signal the cancer cells to develop tiny pumps on their surface which shuttled out the drugs before they could take effect.
When the researchers moved the cancer cells into either a softer matrix or a stiff matrix in which the hyaluronic acid receptor, called CD44, was blocked, the chemotherapy drugs started working again.
“This suggests that if we can disrupt the stiffness signaling that’s happening through the CD44 receptor, we could make patients’ pancreatic cancer treatable again by normal chemotherapy,” said senior study author Sarah Heilshorn, PhD, a professor of materials science and engineering at Stanford. “These results suggest an exciting new direction for new drug development.”
Targeting Nearby Tissue: A Novel Approach to Fighting Chemoresistance
The study is not the first to suggest that chemically targeting the microenvironment surrounding a tumor can influence how patients respond to treatment.
In one recent clinical trial, patients with metastatic pancreatic cancer were given an experimental drug to inhibit a protein called connective tissue growth factor, reduce fibrous tissue, and make pancreatic tumors easier to surgically remove. Results have not been published yet.
Other research suggests that the generic blood pressure drug losartan, when given in combination with chemotherapy and radiation, can boost survival in patients with advanced pancreatic cancer by, in part, improving the health of blood vessels that carry drugs to the tumor.
But other studies of such mechanotherapeutics have yielded inconclusive results, said Dr. Matrisian.
“This paper points to another reason why we should not give up on this approach,” she said.
Ning Wang, PhD, director of the new Institute for Mechanobiology at Northeastern University College of Engineering, Boston, said there is no question that the composition of a tumor’s environment can influence how cancer progresses or responds to drugs. The new paper, he said, adds an important new chapter to the evolving story.
“But it’s very complicated. It’s not as simple as saying make it softer or stiffer and you can change the outcome for the patient,” Dr. Wang said.
In fact, some research has shown that tissue becomes stiffer when cancer arises so it can contain it from spreading.
In one animal study of pancreatic cancer that had spread to the liver, administering drugs to soften the surrounding tissue, or stroma, actually had the opposite effect — accelerating tumor growth and reducing survival rates.
Dr. Wang also noted that any drug designed to influence the extracellular matrix would need to be extremely localized, to prevent damage to other tissues, like bone or heart muscle.
Dr. LeSavage said he sees the paper as a case study in how important the extracellular matrix is and an example of how artificially grown organs or tissues can play a key role in testing how drugs work or don’t work.
He imagines a day when doctors could personalize treatments by taking a bit of a patient’s tumor, growing it in artificial tissue, and seeing how different tissue-altering drugs affect different therapies.
“This isn’t something that is just unique to pancreatic cancer,” he said, noting that the extracellular matrix throughout the body interacts with different cancers. “If we could take someone who has a chemoresistant tumor and convert it into something that is sensitive to existing therapies again, we could give them a second chance.”
A version of this article appeared on Medscape.com.
Which GI Side Effects Should GLP-1 Prescribers Worry About?
Several recent studies have sought to expound upon what role, if any, GLP-1 RAs may have in increasing the risk for specific gastrointestinal (GI) adverse events.
Herein is a summary of the most current information on this topic, as well as my best guidance for clinicians on integrating it into the clinical care of their patients.
Aspiration Risks
Albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tirzepatide are among the class of medications known as GLP-1 RAs. These medications all work by mimicking the action of hormonal incretins, which are released postprandially. Incretins affect the pancreatic glucose-dependent release of insulin, inhibit release of glucagon, stimulate satiety, and reduce gastric emptying. This last effect has raised concerns that patients taking GLP-1 RAs might be at an elevated risk for endoscopy-related aspiration.
In June 2023, the American Society of Anesthesiologists released recommendations asking providers to consider holding back GLP-1 RAs in patients with scheduled elective procedures.
In August 2023, five national GI societies — the American Gastroenterological Association, American Association for the Study of Liver Diseases, American College of Gastroenterology, American Society for Gastrointestinal Endoscopy, and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition — issued their own joint statement on the issue.
In the absence of sufficient evidence, these groups suggested that healthcare providers “exercise best practices when performing endoscopy on these patients on GLP-1 [RAs].” They called for more data and encouraged key stakeholders to work together to develop the necessary evidence to provide guidance for these patients prior to elective endoscopy. A rapid clinical update issued by the American Gastroenterological Association in 2024 was consistent with these earlier multisociety recommendations.
Two studies presented at 2024’s Digestive Disease Week provided additional reassurance that concerns about aspiration with these medications were perhaps unwarranted.
The first (since published in The American Journal of Gastroenterology ) was a case-control study of 16,295 patients undergoing upper endoscopy, among whom 306 were taking GLP-1 RAs. It showed a higher rate of solid gastric residue among those taking GLP-1 RAs compared with controls (14% vs 4%, respectively). Patients who had prolonged fasting and clear liquids for concurrent colonoscopy had lower residue rates (2% vs 11%, respectively). However, there were no recorded incidents of procedural complications or aspiration.
The second was a retrospective cohort study using TriNetX, a federated cloud-based network pulling millions of data points from multiple US healthcare organizations. It found that the incidence of aspiration pneumonitis and emergent intubation during or immediately after esophagogastroduodenoscopy and colonoscopy among those taking GLP-1 RAs was not increased compared with those not taking these medications.
These were followed in June 2024 by a systematic review and meta-analysis published by Hiramoto and colleagues, which included 15 studies. The researchers showed a 36-minute prolongation for solid-food emptying and no delay in liquid emptying for patients taking GLP-1 RAs vs controls. The authors concluded that the minimal delay in solid-food emptying would be offset by standard preprocedural fasting periods.
There is concern that patients with complicated type 2 diabetes may have a bit more of a risk for aspiration. However, this was not supported by an analysis from Barlowe and colleagues, who used a national claims database to identify 15,119 patients with type 2 diabetes on GLP-1 RAs. They found no increased events of pulmonary complications (ie, aspiration, pneumonia, respiratory failure) within 14 days following esophagogastroduodenoscopy. Additional evidence suggests that the risk for aspiration in these patients seems to be offset by prolonged fasting and intake of clear liquids.
Although physicians clearly need to use clinical judgment when performing endoscopic procedures on these patients, the emerging evidence on safety has been encouraging.
Association With GI Adverse Events
A recent retrospective analysis of real-world data from 10,328 new users of GLP-1 RAs with diabetes/obesity reported that the most common GI adverse events in this cohort were abdominal pain (57.6%), constipation (30.4%), diarrhea (32.7%), nausea and vomiting (23.4%), GI bleeding (15.9%), gastroparesis (5.1%), and pancreatitis (3.4%).
Notably, dulaglutide and liraglutide had higher rates of abdominal pain, constipation, diarrhea, and nausea and vomiting than did semaglutide and exenatide. Compared with semaglutide, dulaglutide and liraglutide had slightly higher odds of abdominal pain, gastroparesis, and nausea and vomiting. There were no significant differences between the GLP-1 RAs in the risk for GI bleeding or pancreatitis.
A 2023 report in JAMA observed that the risk for bowel obstruction is also elevated among patients using these agents for weight loss. Possible reasons for this are currently unknown.
Studies are needed to analyze possible variations in safety profiles between GLP-1 RAs to better guide selection of these drugs, particularly in patients with GI risk factors. Furthermore, the causal relationship between GLP-1 RAs with other concomitant medications requires further investigation.
Although relatively infrequent, the risk for GI adverse events should be given special consideration by providers when prescribing them for weight loss, because the risk/benefit ratios may be different from those in patients with diabetes.
A Lack of Hepatic Concerns
GLP-1 RAs have demonstrated a significant impact on body weight and glycemic control, as well as beneficial effects on clinical, biochemical, and histologic markers in patients with metabolic dysfunction–associated steatotic liver disease (MASLD). These favorable changes are evident by reductions in the hepatic cytolysis markers (ie, aspartate aminotransferase and alanine aminotransferase).
GLP-1 RAs may provide a protective function by reducing the accumulation of hepatic triglycerides and expression of several collagen genes. Some preclinical data suggest a risk reduction for progression to hepatocellular carcinoma, and animal studies indicate that complete suppression of hepatic carcinogenesis is achieved with liraglutide.
The most recent assessment of risk reduction for MASLD progression comes from a Scandinavian cohort analysis of national registries. In looking at 91,479 patients using GLP-1 RAs, investigators demonstrated this treatment was associated with a significant reduction in the composite primary endpoint of hepatocellular carcinoma, as well as both compensated and decompensated cirrhosis.
Given the various favorable hepatic effects of GLP-1 RAs, it is likely that the composite benefit on MASLD is multifactorial. The current literature is clear that it is safe to use these agents across the spectrum of MASLD with or without fibrosis, although it must be noted that GLP-1 RAs are not approved by the Food and Drug Administration for this indication.
Dr. Johnson is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Virginia, and a past president of the American College of Gastroenterology. He disclosed ties with ISOTHRIVE and Johnson & Johnson.
A version of this article appeared on Medscape.com.
Several recent studies have sought to expound upon what role, if any, GLP-1 RAs may have in increasing the risk for specific gastrointestinal (GI) adverse events.
Herein is a summary of the most current information on this topic, as well as my best guidance for clinicians on integrating it into the clinical care of their patients.
Aspiration Risks
Albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tirzepatide are among the class of medications known as GLP-1 RAs. These medications all work by mimicking the action of hormonal incretins, which are released postprandially. Incretins affect the pancreatic glucose-dependent release of insulin, inhibit release of glucagon, stimulate satiety, and reduce gastric emptying. This last effect has raised concerns that patients taking GLP-1 RAs might be at an elevated risk for endoscopy-related aspiration.
In June 2023, the American Society of Anesthesiologists released recommendations asking providers to consider holding back GLP-1 RAs in patients with scheduled elective procedures.
In August 2023, five national GI societies — the American Gastroenterological Association, American Association for the Study of Liver Diseases, American College of Gastroenterology, American Society for Gastrointestinal Endoscopy, and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition — issued their own joint statement on the issue.
In the absence of sufficient evidence, these groups suggested that healthcare providers “exercise best practices when performing endoscopy on these patients on GLP-1 [RAs].” They called for more data and encouraged key stakeholders to work together to develop the necessary evidence to provide guidance for these patients prior to elective endoscopy. A rapid clinical update issued by the American Gastroenterological Association in 2024 was consistent with these earlier multisociety recommendations.
Two studies presented at 2024’s Digestive Disease Week provided additional reassurance that concerns about aspiration with these medications were perhaps unwarranted.
The first (since published in The American Journal of Gastroenterology ) was a case-control study of 16,295 patients undergoing upper endoscopy, among whom 306 were taking GLP-1 RAs. It showed a higher rate of solid gastric residue among those taking GLP-1 RAs compared with controls (14% vs 4%, respectively). Patients who had prolonged fasting and clear liquids for concurrent colonoscopy had lower residue rates (2% vs 11%, respectively). However, there were no recorded incidents of procedural complications or aspiration.
The second was a retrospective cohort study using TriNetX, a federated cloud-based network pulling millions of data points from multiple US healthcare organizations. It found that the incidence of aspiration pneumonitis and emergent intubation during or immediately after esophagogastroduodenoscopy and colonoscopy among those taking GLP-1 RAs was not increased compared with those not taking these medications.
These were followed in June 2024 by a systematic review and meta-analysis published by Hiramoto and colleagues, which included 15 studies. The researchers showed a 36-minute prolongation for solid-food emptying and no delay in liquid emptying for patients taking GLP-1 RAs vs controls. The authors concluded that the minimal delay in solid-food emptying would be offset by standard preprocedural fasting periods.
There is concern that patients with complicated type 2 diabetes may have a bit more of a risk for aspiration. However, this was not supported by an analysis from Barlowe and colleagues, who used a national claims database to identify 15,119 patients with type 2 diabetes on GLP-1 RAs. They found no increased events of pulmonary complications (ie, aspiration, pneumonia, respiratory failure) within 14 days following esophagogastroduodenoscopy. Additional evidence suggests that the risk for aspiration in these patients seems to be offset by prolonged fasting and intake of clear liquids.
Although physicians clearly need to use clinical judgment when performing endoscopic procedures on these patients, the emerging evidence on safety has been encouraging.
Association With GI Adverse Events
A recent retrospective analysis of real-world data from 10,328 new users of GLP-1 RAs with diabetes/obesity reported that the most common GI adverse events in this cohort were abdominal pain (57.6%), constipation (30.4%), diarrhea (32.7%), nausea and vomiting (23.4%), GI bleeding (15.9%), gastroparesis (5.1%), and pancreatitis (3.4%).
Notably, dulaglutide and liraglutide had higher rates of abdominal pain, constipation, diarrhea, and nausea and vomiting than did semaglutide and exenatide. Compared with semaglutide, dulaglutide and liraglutide had slightly higher odds of abdominal pain, gastroparesis, and nausea and vomiting. There were no significant differences between the GLP-1 RAs in the risk for GI bleeding or pancreatitis.
A 2023 report in JAMA observed that the risk for bowel obstruction is also elevated among patients using these agents for weight loss. Possible reasons for this are currently unknown.
Studies are needed to analyze possible variations in safety profiles between GLP-1 RAs to better guide selection of these drugs, particularly in patients with GI risk factors. Furthermore, the causal relationship between GLP-1 RAs with other concomitant medications requires further investigation.
Although relatively infrequent, the risk for GI adverse events should be given special consideration by providers when prescribing them for weight loss, because the risk/benefit ratios may be different from those in patients with diabetes.
A Lack of Hepatic Concerns
GLP-1 RAs have demonstrated a significant impact on body weight and glycemic control, as well as beneficial effects on clinical, biochemical, and histologic markers in patients with metabolic dysfunction–associated steatotic liver disease (MASLD). These favorable changes are evident by reductions in the hepatic cytolysis markers (ie, aspartate aminotransferase and alanine aminotransferase).
GLP-1 RAs may provide a protective function by reducing the accumulation of hepatic triglycerides and expression of several collagen genes. Some preclinical data suggest a risk reduction for progression to hepatocellular carcinoma, and animal studies indicate that complete suppression of hepatic carcinogenesis is achieved with liraglutide.
The most recent assessment of risk reduction for MASLD progression comes from a Scandinavian cohort analysis of national registries. In looking at 91,479 patients using GLP-1 RAs, investigators demonstrated this treatment was associated with a significant reduction in the composite primary endpoint of hepatocellular carcinoma, as well as both compensated and decompensated cirrhosis.
Given the various favorable hepatic effects of GLP-1 RAs, it is likely that the composite benefit on MASLD is multifactorial. The current literature is clear that it is safe to use these agents across the spectrum of MASLD with or without fibrosis, although it must be noted that GLP-1 RAs are not approved by the Food and Drug Administration for this indication.
Dr. Johnson is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Virginia, and a past president of the American College of Gastroenterology. He disclosed ties with ISOTHRIVE and Johnson & Johnson.
A version of this article appeared on Medscape.com.
Several recent studies have sought to expound upon what role, if any, GLP-1 RAs may have in increasing the risk for specific gastrointestinal (GI) adverse events.
Herein is a summary of the most current information on this topic, as well as my best guidance for clinicians on integrating it into the clinical care of their patients.
Aspiration Risks
Albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, and tirzepatide are among the class of medications known as GLP-1 RAs. These medications all work by mimicking the action of hormonal incretins, which are released postprandially. Incretins affect the pancreatic glucose-dependent release of insulin, inhibit release of glucagon, stimulate satiety, and reduce gastric emptying. This last effect has raised concerns that patients taking GLP-1 RAs might be at an elevated risk for endoscopy-related aspiration.
In June 2023, the American Society of Anesthesiologists released recommendations asking providers to consider holding back GLP-1 RAs in patients with scheduled elective procedures.
In August 2023, five national GI societies — the American Gastroenterological Association, American Association for the Study of Liver Diseases, American College of Gastroenterology, American Society for Gastrointestinal Endoscopy, and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition — issued their own joint statement on the issue.
In the absence of sufficient evidence, these groups suggested that healthcare providers “exercise best practices when performing endoscopy on these patients on GLP-1 [RAs].” They called for more data and encouraged key stakeholders to work together to develop the necessary evidence to provide guidance for these patients prior to elective endoscopy. A rapid clinical update issued by the American Gastroenterological Association in 2024 was consistent with these earlier multisociety recommendations.
Two studies presented at 2024’s Digestive Disease Week provided additional reassurance that concerns about aspiration with these medications were perhaps unwarranted.
The first (since published in The American Journal of Gastroenterology ) was a case-control study of 16,295 patients undergoing upper endoscopy, among whom 306 were taking GLP-1 RAs. It showed a higher rate of solid gastric residue among those taking GLP-1 RAs compared with controls (14% vs 4%, respectively). Patients who had prolonged fasting and clear liquids for concurrent colonoscopy had lower residue rates (2% vs 11%, respectively). However, there were no recorded incidents of procedural complications or aspiration.
The second was a retrospective cohort study using TriNetX, a federated cloud-based network pulling millions of data points from multiple US healthcare organizations. It found that the incidence of aspiration pneumonitis and emergent intubation during or immediately after esophagogastroduodenoscopy and colonoscopy among those taking GLP-1 RAs was not increased compared with those not taking these medications.
These were followed in June 2024 by a systematic review and meta-analysis published by Hiramoto and colleagues, which included 15 studies. The researchers showed a 36-minute prolongation for solid-food emptying and no delay in liquid emptying for patients taking GLP-1 RAs vs controls. The authors concluded that the minimal delay in solid-food emptying would be offset by standard preprocedural fasting periods.
There is concern that patients with complicated type 2 diabetes may have a bit more of a risk for aspiration. However, this was not supported by an analysis from Barlowe and colleagues, who used a national claims database to identify 15,119 patients with type 2 diabetes on GLP-1 RAs. They found no increased events of pulmonary complications (ie, aspiration, pneumonia, respiratory failure) within 14 days following esophagogastroduodenoscopy. Additional evidence suggests that the risk for aspiration in these patients seems to be offset by prolonged fasting and intake of clear liquids.
Although physicians clearly need to use clinical judgment when performing endoscopic procedures on these patients, the emerging evidence on safety has been encouraging.
Association With GI Adverse Events
A recent retrospective analysis of real-world data from 10,328 new users of GLP-1 RAs with diabetes/obesity reported that the most common GI adverse events in this cohort were abdominal pain (57.6%), constipation (30.4%), diarrhea (32.7%), nausea and vomiting (23.4%), GI bleeding (15.9%), gastroparesis (5.1%), and pancreatitis (3.4%).
Notably, dulaglutide and liraglutide had higher rates of abdominal pain, constipation, diarrhea, and nausea and vomiting than did semaglutide and exenatide. Compared with semaglutide, dulaglutide and liraglutide had slightly higher odds of abdominal pain, gastroparesis, and nausea and vomiting. There were no significant differences between the GLP-1 RAs in the risk for GI bleeding or pancreatitis.
A 2023 report in JAMA observed that the risk for bowel obstruction is also elevated among patients using these agents for weight loss. Possible reasons for this are currently unknown.
Studies are needed to analyze possible variations in safety profiles between GLP-1 RAs to better guide selection of these drugs, particularly in patients with GI risk factors. Furthermore, the causal relationship between GLP-1 RAs with other concomitant medications requires further investigation.
Although relatively infrequent, the risk for GI adverse events should be given special consideration by providers when prescribing them for weight loss, because the risk/benefit ratios may be different from those in patients with diabetes.
A Lack of Hepatic Concerns
GLP-1 RAs have demonstrated a significant impact on body weight and glycemic control, as well as beneficial effects on clinical, biochemical, and histologic markers in patients with metabolic dysfunction–associated steatotic liver disease (MASLD). These favorable changes are evident by reductions in the hepatic cytolysis markers (ie, aspartate aminotransferase and alanine aminotransferase).
GLP-1 RAs may provide a protective function by reducing the accumulation of hepatic triglycerides and expression of several collagen genes. Some preclinical data suggest a risk reduction for progression to hepatocellular carcinoma, and animal studies indicate that complete suppression of hepatic carcinogenesis is achieved with liraglutide.
The most recent assessment of risk reduction for MASLD progression comes from a Scandinavian cohort analysis of national registries. In looking at 91,479 patients using GLP-1 RAs, investigators demonstrated this treatment was associated with a significant reduction in the composite primary endpoint of hepatocellular carcinoma, as well as both compensated and decompensated cirrhosis.
Given the various favorable hepatic effects of GLP-1 RAs, it is likely that the composite benefit on MASLD is multifactorial. The current literature is clear that it is safe to use these agents across the spectrum of MASLD with or without fibrosis, although it must be noted that GLP-1 RAs are not approved by the Food and Drug Administration for this indication.
Dr. Johnson is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Virginia, and a past president of the American College of Gastroenterology. He disclosed ties with ISOTHRIVE and Johnson & Johnson.
A version of this article appeared on Medscape.com.
For Richer, for Poorer: Low-Carb Diets Work for All Incomes
For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.
Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.
She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.
“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.”
Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.
Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.
“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.
Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened.
“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”
I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.
Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.
Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.
Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis.
A 2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides.
Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.
Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds.
Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado.
“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.
Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com.
Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.
Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked.
A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.
Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.
Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.”
Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice.
A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.
It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.
Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.
When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said.
Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients.
This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged.
OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.)
Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine.
Tools and Tips for Clinicians:
- Free two-page keto starter’s guide by OwnaHealth; Dr. Glandt uses this guide with her patients.
- Illustrated low-carb guides by dietdoctor.com
- Free low-carbohydrate starter guide by the Michigan Collaborative for Type 2 Diabetes
- Low-Carb for Any Budget, a free digital booklet by Mark Cucuzzella, MD, and Kristie Sullivan, PhD
- Recipe and meal ideas from Ruled.me, Keto-Mojo.com, and
Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.
A version of this article appeared on Medscape.com.
For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.
Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.
She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.
“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.”
Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.
Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.
“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.
Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened.
“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”
I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.
Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.
Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.
Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis.
A 2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides.
Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.
Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds.
Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado.
“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.
Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com.
Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.
Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked.
A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.
Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.
Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.”
Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice.
A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.
It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.
Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.
When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said.
Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients.
This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged.
OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.)
Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine.
Tools and Tips for Clinicians:
- Free two-page keto starter’s guide by OwnaHealth; Dr. Glandt uses this guide with her patients.
- Illustrated low-carb guides by dietdoctor.com
- Free low-carbohydrate starter guide by the Michigan Collaborative for Type 2 Diabetes
- Low-Carb for Any Budget, a free digital booklet by Mark Cucuzzella, MD, and Kristie Sullivan, PhD
- Recipe and meal ideas from Ruled.me, Keto-Mojo.com, and
Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.
A version of this article appeared on Medscape.com.
For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.
Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.
She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.
“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.”
Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.
Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.
“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.
Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened.
“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”
I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.
Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.
Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.
Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis.
A 2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides.
Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.
Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds.
Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado.
“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.
Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com.
Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.
Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked.
A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.
Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.
Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.”
Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice.
A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.
It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.
Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.
When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said.
Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients.
This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged.
OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.)
Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine.
Tools and Tips for Clinicians:
- Free two-page keto starter’s guide by OwnaHealth; Dr. Glandt uses this guide with her patients.
- Illustrated low-carb guides by dietdoctor.com
- Free low-carbohydrate starter guide by the Michigan Collaborative for Type 2 Diabetes
- Low-Carb for Any Budget, a free digital booklet by Mark Cucuzzella, MD, and Kristie Sullivan, PhD
- Recipe and meal ideas from Ruled.me, Keto-Mojo.com, and
Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.
A version of this article appeared on Medscape.com.
Pulsed Field Ablation for AF: Are US Electrophysiologists Too Easily Impressed?
It dominated 2024’s heart rhythm meetings, and it dominates my private electrophysiologist chat groups. My Google alert for “AF ablation” most often includes notices on PFA and the expansion of the atrial fibrillation ablation market.
Yet, the excitement does not match the empirical data.
Despite having strong brains, electrophysiologists adopt new things as if we were emotional shoppers. Our neighbor buys a sports car and we think we need the same car. Left atrial appendage occlusion and subcutaneous defibrillators were past examples.
The most recent example of soft thinking (especially in the United States) is the enthusiasm and early adoption of first-generation PFA systems for the treatment of AF.
Readers of cardiac news (including some of my patients) might think PFA has solved the AF puzzle. It has not.
A true breakthrough in AF would be to find its cause. PFA is simply another way to destroy (ablate) cardiac myocytes. PFA uses electrical energy (think shocks) to create pores in the cell membranes of myocytes. It’s delivered through various types of catheters.
The main theoretical advantage of PFA is cardioselectivity, which is possible because myocytes have lower thresholds for irreversible electroporation than surrounding tissues. The dose of electrical energy that ablates cardiac tissue does not affect surrounding tissues. Cardioselectivity decreases the chance of the most feared complication of standard AF ablation, thermal damage to the esophagus, which is often fatal. The esophagus lies immediately behind the posterior wall of the left atrium and can be inadvertently injured during thermal ablation.
The challenge in assessing this potential advantage is that thermal esophageal damage is, thankfully, exceedingly rare. Its incidence is in the range of 1 in 10,000 AF ablations. But it might be even lower than that in contemporary practice, because knowledge of esophageal injury has led to innovations that probably have reduced its incidence even further.
Proponents of PFA would rightly point to the fact that not having to worry about esophageal injury allows operators to add posterior wall ablation to the normal pulmonary vein isolation lesion set. This ability, they would argue, is likely to improve AF ablation outcomes. The problem is that the strongest and most recent trial of posterior wall isolation (with radiofrequency ablation) did not show better outcomes. A more recent observational analysis also showed no benefit to posterior wall isolation (using PFA) over pulmonary vein isolation alone.
What About PFA Efficacy?
I’ve long spoken and written about the lack of progress in AF ablation. In 1998, the first report on ablation of AF showed a 62% arrhythmia-free rate. Two decades later, in the carefully chosen labs treating patients in the CABANA trial, arrhythmia-free rates after AF ablation remain unchanged. We have improved our speed and ability to isolate pulmonary veins, but this has not increased our success in eliminating AF. The reason, I believe, is that we have made little to no progress in understanding the pathophysiology of AF.
The Food and Drug Administration regulatory trial called ADVENT randomly assigned more than 600 patients to thermal ablation or PFA, and the primary endpoint of ablation success was nearly identical. Single-center studies, observational registries, and single-arm studies have all shown similar efficacy of PFA and thermal ablation.
Proponents of PFA might argue that these early studies used first-generation PFA systems, and iteration will lead to better efficacy. Perhaps, but we’ve had 20 years of iteration of thermal ablation, and its efficacy has not budged.
What About PFA Safety?
In the ADVENT randomized trial, safety results were similar, though the one death, caused by cardiac perforation and tamponade, occurred in the PFA arm. In the MANIFEST-17K multinational survey of PFA ablation, safety events were in the range reported with thermal ablation. PFA still involves placing catheters in the heart, and complications such as tamponade, stroke, and vascular damage occur.
The large MANIFEST-17K survey also exposed two PFA-specific complications: coronary artery spasm, which can occur when PFA is delivered close to coronary arteries; and hemolysis-related kidney failure — severe enough to require dialysis in five patients. Supporters of PFA speculate that hemolysis occurs because electrical energy within the atrium can shred red blood cells. Their solution is to strive for good contact and use hydration. The irony of this latter fix is that one of the best advances in thermal ablation has been catheters that deliver less fluid and less need for diuresis after the procedure.
No PFA study has shown a decreased incidence of thermal damage to the esophagus with PFA ablation. Of course, this is because it is such a low-incidence event.
One of my concerns with PFA is brain safety. PFA creates substantial microbubbles in the left atrium, which can then travel north to the brain. In a small series from ADVENT, three patients had brain lesions after PFA vs none with thermal ablation. PFA proponents wrote that brain safety was important to study, but few patients have been systematically studied with brain MRI scans. Asymptomatic brain lesions have been noted after many arterial procedures. The clinical significance of these is not known. As a new technology, and one that creates substantial microbubbles in the left atrium, I agree with the PFA proponents that brain safety should be thoroughly studied — before widespread adoption.
What About Speed and Cost?
Observational studies from European labs report fast procedure times. I have seen PFA procedures in Europe; they’re fast — typically under an hour. A standard thermal ablation takes me about 60-70 minutes.
I am not sure that US operators can duplicate European procedural times. In the ADVENT regulatory trial, the mean procedure time was 105 minutes and that was in experienced US centers. While this still represents early experience with PFA, the culture of US AF ablation entails far more mapping and extra catheters than I have seen used in European labs.
Cost is a major issue. It’s hard to sort out exact costs in the United States, but a PFA catheter costs approximately threefold more than a standard ablation catheter. A recent study from Liverpool, England, found that PFA ablation was faster but more expensive than standard thermal ablation because of higher PFA equipment prices. For better or worse, US patients are not directly affected by the higher procedural costs. But the fact remains that PFA adds more costs to the healthcare system.
What Drives the Enthusiasm for First-Generation PFA?
So why all the enthusiasm? It’s surely not the empirical data. Evidence thus far shows no obvious advantage in safety or efficacy. European use of PFA does seem to reduce procedure time. But in many electrophysiology labs in the United States, the rate-limiting step for AF ablation is not time in the lab but having enough staff to turn rooms around.
The main factor driving early acceptance of PFA relates to basic human nature. It is the fear of missing out. Marketing works on consumers, and it surely works on doctors. Companies that make PFA systems sponsor key opinion leaders to discuss PFA. These companies have beautiful booths in the expo of our meetings; they host dinners and talks. When a hospital in a city does PFA, the other hospitals feel the urge to keep up. It’s hard to be a Top Person in electrophysiology and not be a PFA user.
One of my favorite comments came from a key opinion leader. He told me that he advised his administration to buy a PFA system, promote that they have it, and keep it in the closet until better systems are released.
Iteration in the medical device field is tricky. There are negatives to being too harsh on first-generation systems. Early cardiac resynchronization tools, for instance, were horrible. Now CRT is transformative in selected patients with heart failure.
It’s possible (but not certain) that electrical ablative therapy will iterate and surpass thermal ablation in the future. Maybe.
But for now, the enthusiasm for PFA far outstrips its evidence. Until better evidence emerges, I will be a slow adopter. And I hope that our field gathers evidence before widespread adoption makes it impossible to do proper studies.
Dr. Mandrola, clinical electrophysiologist, Baptist Medical Associates, Louisville, Kentucky, has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
It dominated 2024’s heart rhythm meetings, and it dominates my private electrophysiologist chat groups. My Google alert for “AF ablation” most often includes notices on PFA and the expansion of the atrial fibrillation ablation market.
Yet, the excitement does not match the empirical data.
Despite having strong brains, electrophysiologists adopt new things as if we were emotional shoppers. Our neighbor buys a sports car and we think we need the same car. Left atrial appendage occlusion and subcutaneous defibrillators were past examples.
The most recent example of soft thinking (especially in the United States) is the enthusiasm and early adoption of first-generation PFA systems for the treatment of AF.
Readers of cardiac news (including some of my patients) might think PFA has solved the AF puzzle. It has not.
A true breakthrough in AF would be to find its cause. PFA is simply another way to destroy (ablate) cardiac myocytes. PFA uses electrical energy (think shocks) to create pores in the cell membranes of myocytes. It’s delivered through various types of catheters.
The main theoretical advantage of PFA is cardioselectivity, which is possible because myocytes have lower thresholds for irreversible electroporation than surrounding tissues. The dose of electrical energy that ablates cardiac tissue does not affect surrounding tissues. Cardioselectivity decreases the chance of the most feared complication of standard AF ablation, thermal damage to the esophagus, which is often fatal. The esophagus lies immediately behind the posterior wall of the left atrium and can be inadvertently injured during thermal ablation.
The challenge in assessing this potential advantage is that thermal esophageal damage is, thankfully, exceedingly rare. Its incidence is in the range of 1 in 10,000 AF ablations. But it might be even lower than that in contemporary practice, because knowledge of esophageal injury has led to innovations that probably have reduced its incidence even further.
Proponents of PFA would rightly point to the fact that not having to worry about esophageal injury allows operators to add posterior wall ablation to the normal pulmonary vein isolation lesion set. This ability, they would argue, is likely to improve AF ablation outcomes. The problem is that the strongest and most recent trial of posterior wall isolation (with radiofrequency ablation) did not show better outcomes. A more recent observational analysis also showed no benefit to posterior wall isolation (using PFA) over pulmonary vein isolation alone.
What About PFA Efficacy?
I’ve long spoken and written about the lack of progress in AF ablation. In 1998, the first report on ablation of AF showed a 62% arrhythmia-free rate. Two decades later, in the carefully chosen labs treating patients in the CABANA trial, arrhythmia-free rates after AF ablation remain unchanged. We have improved our speed and ability to isolate pulmonary veins, but this has not increased our success in eliminating AF. The reason, I believe, is that we have made little to no progress in understanding the pathophysiology of AF.
The Food and Drug Administration regulatory trial called ADVENT randomly assigned more than 600 patients to thermal ablation or PFA, and the primary endpoint of ablation success was nearly identical. Single-center studies, observational registries, and single-arm studies have all shown similar efficacy of PFA and thermal ablation.
Proponents of PFA might argue that these early studies used first-generation PFA systems, and iteration will lead to better efficacy. Perhaps, but we’ve had 20 years of iteration of thermal ablation, and its efficacy has not budged.
What About PFA Safety?
In the ADVENT randomized trial, safety results were similar, though the one death, caused by cardiac perforation and tamponade, occurred in the PFA arm. In the MANIFEST-17K multinational survey of PFA ablation, safety events were in the range reported with thermal ablation. PFA still involves placing catheters in the heart, and complications such as tamponade, stroke, and vascular damage occur.
The large MANIFEST-17K survey also exposed two PFA-specific complications: coronary artery spasm, which can occur when PFA is delivered close to coronary arteries; and hemolysis-related kidney failure — severe enough to require dialysis in five patients. Supporters of PFA speculate that hemolysis occurs because electrical energy within the atrium can shred red blood cells. Their solution is to strive for good contact and use hydration. The irony of this latter fix is that one of the best advances in thermal ablation has been catheters that deliver less fluid and less need for diuresis after the procedure.
No PFA study has shown a decreased incidence of thermal damage to the esophagus with PFA ablation. Of course, this is because it is such a low-incidence event.
One of my concerns with PFA is brain safety. PFA creates substantial microbubbles in the left atrium, which can then travel north to the brain. In a small series from ADVENT, three patients had brain lesions after PFA vs none with thermal ablation. PFA proponents wrote that brain safety was important to study, but few patients have been systematically studied with brain MRI scans. Asymptomatic brain lesions have been noted after many arterial procedures. The clinical significance of these is not known. As a new technology, and one that creates substantial microbubbles in the left atrium, I agree with the PFA proponents that brain safety should be thoroughly studied — before widespread adoption.
What About Speed and Cost?
Observational studies from European labs report fast procedure times. I have seen PFA procedures in Europe; they’re fast — typically under an hour. A standard thermal ablation takes me about 60-70 minutes.
I am not sure that US operators can duplicate European procedural times. In the ADVENT regulatory trial, the mean procedure time was 105 minutes and that was in experienced US centers. While this still represents early experience with PFA, the culture of US AF ablation entails far more mapping and extra catheters than I have seen used in European labs.
Cost is a major issue. It’s hard to sort out exact costs in the United States, but a PFA catheter costs approximately threefold more than a standard ablation catheter. A recent study from Liverpool, England, found that PFA ablation was faster but more expensive than standard thermal ablation because of higher PFA equipment prices. For better or worse, US patients are not directly affected by the higher procedural costs. But the fact remains that PFA adds more costs to the healthcare system.
What Drives the Enthusiasm for First-Generation PFA?
So why all the enthusiasm? It’s surely not the empirical data. Evidence thus far shows no obvious advantage in safety or efficacy. European use of PFA does seem to reduce procedure time. But in many electrophysiology labs in the United States, the rate-limiting step for AF ablation is not time in the lab but having enough staff to turn rooms around.
The main factor driving early acceptance of PFA relates to basic human nature. It is the fear of missing out. Marketing works on consumers, and it surely works on doctors. Companies that make PFA systems sponsor key opinion leaders to discuss PFA. These companies have beautiful booths in the expo of our meetings; they host dinners and talks. When a hospital in a city does PFA, the other hospitals feel the urge to keep up. It’s hard to be a Top Person in electrophysiology and not be a PFA user.
One of my favorite comments came from a key opinion leader. He told me that he advised his administration to buy a PFA system, promote that they have it, and keep it in the closet until better systems are released.
Iteration in the medical device field is tricky. There are negatives to being too harsh on first-generation systems. Early cardiac resynchronization tools, for instance, were horrible. Now CRT is transformative in selected patients with heart failure.
It’s possible (but not certain) that electrical ablative therapy will iterate and surpass thermal ablation in the future. Maybe.
But for now, the enthusiasm for PFA far outstrips its evidence. Until better evidence emerges, I will be a slow adopter. And I hope that our field gathers evidence before widespread adoption makes it impossible to do proper studies.
Dr. Mandrola, clinical electrophysiologist, Baptist Medical Associates, Louisville, Kentucky, has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
It dominated 2024’s heart rhythm meetings, and it dominates my private electrophysiologist chat groups. My Google alert for “AF ablation” most often includes notices on PFA and the expansion of the atrial fibrillation ablation market.
Yet, the excitement does not match the empirical data.
Despite having strong brains, electrophysiologists adopt new things as if we were emotional shoppers. Our neighbor buys a sports car and we think we need the same car. Left atrial appendage occlusion and subcutaneous defibrillators were past examples.
The most recent example of soft thinking (especially in the United States) is the enthusiasm and early adoption of first-generation PFA systems for the treatment of AF.
Readers of cardiac news (including some of my patients) might think PFA has solved the AF puzzle. It has not.
A true breakthrough in AF would be to find its cause. PFA is simply another way to destroy (ablate) cardiac myocytes. PFA uses electrical energy (think shocks) to create pores in the cell membranes of myocytes. It’s delivered through various types of catheters.
The main theoretical advantage of PFA is cardioselectivity, which is possible because myocytes have lower thresholds for irreversible electroporation than surrounding tissues. The dose of electrical energy that ablates cardiac tissue does not affect surrounding tissues. Cardioselectivity decreases the chance of the most feared complication of standard AF ablation, thermal damage to the esophagus, which is often fatal. The esophagus lies immediately behind the posterior wall of the left atrium and can be inadvertently injured during thermal ablation.
The challenge in assessing this potential advantage is that thermal esophageal damage is, thankfully, exceedingly rare. Its incidence is in the range of 1 in 10,000 AF ablations. But it might be even lower than that in contemporary practice, because knowledge of esophageal injury has led to innovations that probably have reduced its incidence even further.
Proponents of PFA would rightly point to the fact that not having to worry about esophageal injury allows operators to add posterior wall ablation to the normal pulmonary vein isolation lesion set. This ability, they would argue, is likely to improve AF ablation outcomes. The problem is that the strongest and most recent trial of posterior wall isolation (with radiofrequency ablation) did not show better outcomes. A more recent observational analysis also showed no benefit to posterior wall isolation (using PFA) over pulmonary vein isolation alone.
What About PFA Efficacy?
I’ve long spoken and written about the lack of progress in AF ablation. In 1998, the first report on ablation of AF showed a 62% arrhythmia-free rate. Two decades later, in the carefully chosen labs treating patients in the CABANA trial, arrhythmia-free rates after AF ablation remain unchanged. We have improved our speed and ability to isolate pulmonary veins, but this has not increased our success in eliminating AF. The reason, I believe, is that we have made little to no progress in understanding the pathophysiology of AF.
The Food and Drug Administration regulatory trial called ADVENT randomly assigned more than 600 patients to thermal ablation or PFA, and the primary endpoint of ablation success was nearly identical. Single-center studies, observational registries, and single-arm studies have all shown similar efficacy of PFA and thermal ablation.
Proponents of PFA might argue that these early studies used first-generation PFA systems, and iteration will lead to better efficacy. Perhaps, but we’ve had 20 years of iteration of thermal ablation, and its efficacy has not budged.
What About PFA Safety?
In the ADVENT randomized trial, safety results were similar, though the one death, caused by cardiac perforation and tamponade, occurred in the PFA arm. In the MANIFEST-17K multinational survey of PFA ablation, safety events were in the range reported with thermal ablation. PFA still involves placing catheters in the heart, and complications such as tamponade, stroke, and vascular damage occur.
The large MANIFEST-17K survey also exposed two PFA-specific complications: coronary artery spasm, which can occur when PFA is delivered close to coronary arteries; and hemolysis-related kidney failure — severe enough to require dialysis in five patients. Supporters of PFA speculate that hemolysis occurs because electrical energy within the atrium can shred red blood cells. Their solution is to strive for good contact and use hydration. The irony of this latter fix is that one of the best advances in thermal ablation has been catheters that deliver less fluid and less need for diuresis after the procedure.
No PFA study has shown a decreased incidence of thermal damage to the esophagus with PFA ablation. Of course, this is because it is such a low-incidence event.
One of my concerns with PFA is brain safety. PFA creates substantial microbubbles in the left atrium, which can then travel north to the brain. In a small series from ADVENT, three patients had brain lesions after PFA vs none with thermal ablation. PFA proponents wrote that brain safety was important to study, but few patients have been systematically studied with brain MRI scans. Asymptomatic brain lesions have been noted after many arterial procedures. The clinical significance of these is not known. As a new technology, and one that creates substantial microbubbles in the left atrium, I agree with the PFA proponents that brain safety should be thoroughly studied — before widespread adoption.
What About Speed and Cost?
Observational studies from European labs report fast procedure times. I have seen PFA procedures in Europe; they’re fast — typically under an hour. A standard thermal ablation takes me about 60-70 minutes.
I am not sure that US operators can duplicate European procedural times. In the ADVENT regulatory trial, the mean procedure time was 105 minutes and that was in experienced US centers. While this still represents early experience with PFA, the culture of US AF ablation entails far more mapping and extra catheters than I have seen used in European labs.
Cost is a major issue. It’s hard to sort out exact costs in the United States, but a PFA catheter costs approximately threefold more than a standard ablation catheter. A recent study from Liverpool, England, found that PFA ablation was faster but more expensive than standard thermal ablation because of higher PFA equipment prices. For better or worse, US patients are not directly affected by the higher procedural costs. But the fact remains that PFA adds more costs to the healthcare system.
What Drives the Enthusiasm for First-Generation PFA?
So why all the enthusiasm? It’s surely not the empirical data. Evidence thus far shows no obvious advantage in safety or efficacy. European use of PFA does seem to reduce procedure time. But in many electrophysiology labs in the United States, the rate-limiting step for AF ablation is not time in the lab but having enough staff to turn rooms around.
The main factor driving early acceptance of PFA relates to basic human nature. It is the fear of missing out. Marketing works on consumers, and it surely works on doctors. Companies that make PFA systems sponsor key opinion leaders to discuss PFA. These companies have beautiful booths in the expo of our meetings; they host dinners and talks. When a hospital in a city does PFA, the other hospitals feel the urge to keep up. It’s hard to be a Top Person in electrophysiology and not be a PFA user.
One of my favorite comments came from a key opinion leader. He told me that he advised his administration to buy a PFA system, promote that they have it, and keep it in the closet until better systems are released.
Iteration in the medical device field is tricky. There are negatives to being too harsh on first-generation systems. Early cardiac resynchronization tools, for instance, were horrible. Now CRT is transformative in selected patients with heart failure.
It’s possible (but not certain) that electrical ablative therapy will iterate and surpass thermal ablation in the future. Maybe.
But for now, the enthusiasm for PFA far outstrips its evidence. Until better evidence emerges, I will be a slow adopter. And I hope that our field gathers evidence before widespread adoption makes it impossible to do proper studies.
Dr. Mandrola, clinical electrophysiologist, Baptist Medical Associates, Louisville, Kentucky, has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Targeted Pancreatic Cancer Screening May Save Lives
TOPLINE:
METHODOLOGY:
- Pancreatic ductal adenocarcinoma has poor 5-year survival rates and is often detected at later stages. General population screening is not recommended, but high-risk individuals, such as those with familial or genetic predispositions, may benefit from regular surveillance.
- The Cancer of the Pancreas Screening (CAPS) program, initiated in 1998, has been evaluating the effectiveness of such targeted surveillance for over two decades, but whether targeted surveillance confers a survival benefit remains unclear.
- The current study evaluated 26 high-risk individuals in the CAPS program who were ultimately diagnosed with pancreatic ductal adenocarcinoma. These high-risk individuals had undergone surveillance with annual endoscopic ultrasonography or MRI prior to diagnosis.
- The researchers compared these 26 individuals with 1504 matched control patients with pancreatic ductal adenocarcinoma from the Surveillance, Epidemiology, and End Results (SEER) database. The high-risk individuals and SEER control patients were matched on age, sex, and year of diagnosis.
- The primary outcomes were tumor stage at diagnosis, overall survival, and pancreatic cancer-specific mortality.
TAKEAWAY:
- High-risk individuals were significantly more likely to be diagnosed with early-stage pancreatic cancer: 38.5% were diagnosed at stage I vs 10.3% in the general US population, and 30.8% were diagnosed at stage II vs 25.1% in the general US population (P < .001).
- The median tumor size at diagnosis was smaller in high-risk individuals than in control patients (2.5 vs 3.6 cm; P < .001), and significantly fewer high-risk individuals had distant metastases at diagnosis (M1 stage) vs control patients (26.9% vs 53.8%; P = .01).
- Overall, high-risk individuals lived about 4.5 years longer — median of 61.7 months vs 8 months for control patients (hazard ratio [HR], 4.19; P < .001). In the 20 high-risk patients with screen-detected cancer, median overall survival was even higher at 144 months.
- The probability of surviving 5 years was significantly better in the high-risk group (50%) than in the control group (9%). And at 5 years, high-risk individuals had a significantly lower probability of dying from pancreatic cancer (HR, 3.58; P < .001).
IN PRACTICE:
Surveillance of high-risk individuals led to detection of “smaller pancreatic cancers, a greater number of patients with stage I disease,” as well as “a much higher likelihood of long-term survival than unscreened patients in the general population,” the authors concluded. “These findings suggest that selective surveillance of individuals at high risk for pancreatic cancer may improve clinical outcomes.”
SOURCE:
This study, with first author Amanda L. Blackford, from Johns Hopkins Medical Institutions, Baltimore, was published online July 3 in JAMA Oncology.
LIMITATIONS:
The findings might have limited generalizability due to enrollment at academic referral centers, limited racial and ethnic diversity, and a small number of high-risk individuals progressing to pancreatic cancer. The study also lacked a control group of unscreened high-risk individuals.
DISCLOSURES:
This study was supported by the National Institutes of Health, Susan Wojcicki and Dennis Troper, and others. Several authors reported financial ties outside this work.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Pancreatic ductal adenocarcinoma has poor 5-year survival rates and is often detected at later stages. General population screening is not recommended, but high-risk individuals, such as those with familial or genetic predispositions, may benefit from regular surveillance.
- The Cancer of the Pancreas Screening (CAPS) program, initiated in 1998, has been evaluating the effectiveness of such targeted surveillance for over two decades, but whether targeted surveillance confers a survival benefit remains unclear.
- The current study evaluated 26 high-risk individuals in the CAPS program who were ultimately diagnosed with pancreatic ductal adenocarcinoma. These high-risk individuals had undergone surveillance with annual endoscopic ultrasonography or MRI prior to diagnosis.
- The researchers compared these 26 individuals with 1504 matched control patients with pancreatic ductal adenocarcinoma from the Surveillance, Epidemiology, and End Results (SEER) database. The high-risk individuals and SEER control patients were matched on age, sex, and year of diagnosis.
- The primary outcomes were tumor stage at diagnosis, overall survival, and pancreatic cancer-specific mortality.
TAKEAWAY:
- High-risk individuals were significantly more likely to be diagnosed with early-stage pancreatic cancer: 38.5% were diagnosed at stage I vs 10.3% in the general US population, and 30.8% were diagnosed at stage II vs 25.1% in the general US population (P < .001).
- The median tumor size at diagnosis was smaller in high-risk individuals than in control patients (2.5 vs 3.6 cm; P < .001), and significantly fewer high-risk individuals had distant metastases at diagnosis (M1 stage) vs control patients (26.9% vs 53.8%; P = .01).
- Overall, high-risk individuals lived about 4.5 years longer — median of 61.7 months vs 8 months for control patients (hazard ratio [HR], 4.19; P < .001). In the 20 high-risk patients with screen-detected cancer, median overall survival was even higher at 144 months.
- The probability of surviving 5 years was significantly better in the high-risk group (50%) than in the control group (9%). And at 5 years, high-risk individuals had a significantly lower probability of dying from pancreatic cancer (HR, 3.58; P < .001).
IN PRACTICE:
Surveillance of high-risk individuals led to detection of “smaller pancreatic cancers, a greater number of patients with stage I disease,” as well as “a much higher likelihood of long-term survival than unscreened patients in the general population,” the authors concluded. “These findings suggest that selective surveillance of individuals at high risk for pancreatic cancer may improve clinical outcomes.”
SOURCE:
This study, with first author Amanda L. Blackford, from Johns Hopkins Medical Institutions, Baltimore, was published online July 3 in JAMA Oncology.
LIMITATIONS:
The findings might have limited generalizability due to enrollment at academic referral centers, limited racial and ethnic diversity, and a small number of high-risk individuals progressing to pancreatic cancer. The study also lacked a control group of unscreened high-risk individuals.
DISCLOSURES:
This study was supported by the National Institutes of Health, Susan Wojcicki and Dennis Troper, and others. Several authors reported financial ties outside this work.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Pancreatic ductal adenocarcinoma has poor 5-year survival rates and is often detected at later stages. General population screening is not recommended, but high-risk individuals, such as those with familial or genetic predispositions, may benefit from regular surveillance.
- The Cancer of the Pancreas Screening (CAPS) program, initiated in 1998, has been evaluating the effectiveness of such targeted surveillance for over two decades, but whether targeted surveillance confers a survival benefit remains unclear.
- The current study evaluated 26 high-risk individuals in the CAPS program who were ultimately diagnosed with pancreatic ductal adenocarcinoma. These high-risk individuals had undergone surveillance with annual endoscopic ultrasonography or MRI prior to diagnosis.
- The researchers compared these 26 individuals with 1504 matched control patients with pancreatic ductal adenocarcinoma from the Surveillance, Epidemiology, and End Results (SEER) database. The high-risk individuals and SEER control patients were matched on age, sex, and year of diagnosis.
- The primary outcomes were tumor stage at diagnosis, overall survival, and pancreatic cancer-specific mortality.
TAKEAWAY:
- High-risk individuals were significantly more likely to be diagnosed with early-stage pancreatic cancer: 38.5% were diagnosed at stage I vs 10.3% in the general US population, and 30.8% were diagnosed at stage II vs 25.1% in the general US population (P < .001).
- The median tumor size at diagnosis was smaller in high-risk individuals than in control patients (2.5 vs 3.6 cm; P < .001), and significantly fewer high-risk individuals had distant metastases at diagnosis (M1 stage) vs control patients (26.9% vs 53.8%; P = .01).
- Overall, high-risk individuals lived about 4.5 years longer — median of 61.7 months vs 8 months for control patients (hazard ratio [HR], 4.19; P < .001). In the 20 high-risk patients with screen-detected cancer, median overall survival was even higher at 144 months.
- The probability of surviving 5 years was significantly better in the high-risk group (50%) than in the control group (9%). And at 5 years, high-risk individuals had a significantly lower probability of dying from pancreatic cancer (HR, 3.58; P < .001).
IN PRACTICE:
Surveillance of high-risk individuals led to detection of “smaller pancreatic cancers, a greater number of patients with stage I disease,” as well as “a much higher likelihood of long-term survival than unscreened patients in the general population,” the authors concluded. “These findings suggest that selective surveillance of individuals at high risk for pancreatic cancer may improve clinical outcomes.”
SOURCE:
This study, with first author Amanda L. Blackford, from Johns Hopkins Medical Institutions, Baltimore, was published online July 3 in JAMA Oncology.
LIMITATIONS:
The findings might have limited generalizability due to enrollment at academic referral centers, limited racial and ethnic diversity, and a small number of high-risk individuals progressing to pancreatic cancer. The study also lacked a control group of unscreened high-risk individuals.
DISCLOSURES:
This study was supported by the National Institutes of Health, Susan Wojcicki and Dennis Troper, and others. Several authors reported financial ties outside this work.
A version of this article appeared on Medscape.com.
US 911 System Is Nearing Its Own Emergency
Just after lunchtime on June 18, Massachusetts’ leaders discovered that the statewide 911 system was down.
A scramble to handle the crisis was on.
Police texted out administrative numbers that callers could use, Boston Mayor Michelle Wu gave outage updates at a press conference outlining plans for the Celtics’ championship parade, and local officials urged people to summon help by pulling red fire alarm boxes.
About 7 million people went roughly 2 hours with no 911 service. Such crashes have become more of a feature than a bug in the nation’s fragmented emergency response system.
While some states, cities, and counties have already modernized their systems or have made plans to upgrade, many others are lagging.
911 is typically supported by fees tacked on to phone bills, but state and local governments also tap general funds or other resources.
“Now there are haves and have-nots,” said Jonathan Gilad, vice president of government affairs at the National Emergency Number Association (NENA), which represents 911 first responders. “Next-generation 911 shouldn’t be for people who happen to have an emergency in a good location.”
Meanwhile, federal legislation that could steer billions of dollars into modernizing the patchwork 911 system remains waylaid in Congress.
“This is a national security imperative,” said George Kelemen, executive director of the Industry Council for Emergency Response Technologies, a trade association that represents companies that provide hardware and software to the emergency response industry.
“In a crisis — a school shooting or a house fire or, God forbid, a terrorist attack — people call 911 first,” he said. “The system can’t go down.”
The United States debuted a single, universal 911 emergency number in February 1968 to simplify crisis response. But instead of a seamless national program, the 911 response network has evolved into a massive puzzle of many interlocking pieces. There are more than 6,000 911 call centers to handle an estimated 240 million emergency calls each year, according to federal data. More than three-quarters of call centers experienced outages in the prior 12 months, according to a survey in February by NENA, which sets standards and advocates for 911, and Carbyne, a provider of public safety technology solutions.
In April, widespread 911 outages affected millions in Nebraska, Nevada, South Dakota, and Texas. The shutdown was blamed on workers’ severing a fiber line while installing a light pole.
In February, tens of thousands of people in areas of California, Georgia, Illinois, Texas, and other states lost cellphone service, including some 911 services, from an outage.
And in June, Verizon agreed to pay a $1.05 million fine to settle a Federal Communications Commission (FCC) probe into a December 2022 outage that affected 911 calls in Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.
The fires that raced across the Hawaiian island of Maui in August 2023 highlighted the critical importance of 911 systems. Dispatchers there fielded more than 4,500 contacts, meaning calls and texts, on Aug. 8, the day the fires broke out, compared with about 400 on a typical day, said Davlynn Racadio, emergency services dispatch coordinator in Maui County.
“We’re dying out here,” one caller told 911 operators.
But some cell towers faltered because of widespread service outages, according to county officials. Maui County in May filed a lawsuit against four telecommunications companies, saying they failed to inform dispatchers about the outages.
“If 911 calls came in with no voice, we would send text messages,” Ms. Racadio said. “The state is looking at upgrading our system. Next-generation 911 would take us even further into the future.”
Florida, Illinois, Montana, and Oklahoma passed legislation in 2023 to advance or fund modernized 911 systems, according to the National Conference of State Legislatures. The upgrades include replacing analog 911 infrastructure with digital, Internet-based systems.
Instead of just fielding calls, next-generation systems can pinpoint a caller’s location, accept texts, and enable residents in a crisis to send videos and images to dispatchers. While outages can still occur, modernized systems often include more redundancy to minimize the odds of a shutdown, Mr. Gilad said.
Lawmakers have looked at modernizing 911 systems by tapping revenue the FCC gets from auctioning off the rights to transmit signals over specific bands of the electromagnetic spectrum.
But the U.S. Senate, in March 2023, for the first time allowed a lapse of the FCC’s authority to auction spectrum bands.
Legislation that would allocate almost $15 billion in grants from auction proceeds to speed deployment of next-generation 911 in every state unanimously passed the House Energy and Commerce Committee in May 2023. The bill, HR 3565, sponsored by Rep. Cathy McMorris Rodgers (R-Wash.), would also extend the FCC’s auction authority.
Other bills have been introduced by various lawmakers, including one in March from Sen. Ted Cruz (R-Texas) and legislation from Sen. Maria Cantwell (D-Wash.) to extend the auction authority. For now, neither effort has advanced. Nine former FCC chairs wrote lawmakers in February, urging them to make 911 upgrades a national priority. They suggested Congress tap unspent federal COVID-19 money.
“Whatever the funding source, the need is urgent and the time to act is now,” they wrote.
Ajit Pai, who served as chair of the FCC from 2017 to 2021, said outages often occur in older, legacy systems.
“The fact that the FCC doesn’t have authority to auction spectrum is a real hindrance now,” Mr. Pai said in an interview. “You may never need to call 911, but it can make the difference between life and death. We need more of an organized effort at the federal level because 911 is so decentralized.”
Meanwhile, some safety leaders are making backup plans for 911 outages or conducting investigations into their causes. In Massachusetts, a firewall designed to prevent hacking led to the recent 2-hour outage, according to the state 911 department.
“Outages bring to everyone’s attention that we rely on 911 and we don’t think about how we really rely on it until something happens,” said April Heinze, chief of 911 operations at NENA.
Mass General Brigham, a health system in the Boston area, sent out emergency alerts when the outage happened letting clinics and smaller practices know how to find their 10-digit emergency numbers. In the wake of the outage, it plans to keep the backup numbers next to phones at those facilities.
“Two hours can be a long time,” said Paul Biddinger, chief preparedness and continuity officer at the health system.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Just after lunchtime on June 18, Massachusetts’ leaders discovered that the statewide 911 system was down.
A scramble to handle the crisis was on.
Police texted out administrative numbers that callers could use, Boston Mayor Michelle Wu gave outage updates at a press conference outlining plans for the Celtics’ championship parade, and local officials urged people to summon help by pulling red fire alarm boxes.
About 7 million people went roughly 2 hours with no 911 service. Such crashes have become more of a feature than a bug in the nation’s fragmented emergency response system.
While some states, cities, and counties have already modernized their systems or have made plans to upgrade, many others are lagging.
911 is typically supported by fees tacked on to phone bills, but state and local governments also tap general funds or other resources.
“Now there are haves and have-nots,” said Jonathan Gilad, vice president of government affairs at the National Emergency Number Association (NENA), which represents 911 first responders. “Next-generation 911 shouldn’t be for people who happen to have an emergency in a good location.”
Meanwhile, federal legislation that could steer billions of dollars into modernizing the patchwork 911 system remains waylaid in Congress.
“This is a national security imperative,” said George Kelemen, executive director of the Industry Council for Emergency Response Technologies, a trade association that represents companies that provide hardware and software to the emergency response industry.
“In a crisis — a school shooting or a house fire or, God forbid, a terrorist attack — people call 911 first,” he said. “The system can’t go down.”
The United States debuted a single, universal 911 emergency number in February 1968 to simplify crisis response. But instead of a seamless national program, the 911 response network has evolved into a massive puzzle of many interlocking pieces. There are more than 6,000 911 call centers to handle an estimated 240 million emergency calls each year, according to federal data. More than three-quarters of call centers experienced outages in the prior 12 months, according to a survey in February by NENA, which sets standards and advocates for 911, and Carbyne, a provider of public safety technology solutions.
In April, widespread 911 outages affected millions in Nebraska, Nevada, South Dakota, and Texas. The shutdown was blamed on workers’ severing a fiber line while installing a light pole.
In February, tens of thousands of people in areas of California, Georgia, Illinois, Texas, and other states lost cellphone service, including some 911 services, from an outage.
And in June, Verizon agreed to pay a $1.05 million fine to settle a Federal Communications Commission (FCC) probe into a December 2022 outage that affected 911 calls in Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.
The fires that raced across the Hawaiian island of Maui in August 2023 highlighted the critical importance of 911 systems. Dispatchers there fielded more than 4,500 contacts, meaning calls and texts, on Aug. 8, the day the fires broke out, compared with about 400 on a typical day, said Davlynn Racadio, emergency services dispatch coordinator in Maui County.
“We’re dying out here,” one caller told 911 operators.
But some cell towers faltered because of widespread service outages, according to county officials. Maui County in May filed a lawsuit against four telecommunications companies, saying they failed to inform dispatchers about the outages.
“If 911 calls came in with no voice, we would send text messages,” Ms. Racadio said. “The state is looking at upgrading our system. Next-generation 911 would take us even further into the future.”
Florida, Illinois, Montana, and Oklahoma passed legislation in 2023 to advance or fund modernized 911 systems, according to the National Conference of State Legislatures. The upgrades include replacing analog 911 infrastructure with digital, Internet-based systems.
Instead of just fielding calls, next-generation systems can pinpoint a caller’s location, accept texts, and enable residents in a crisis to send videos and images to dispatchers. While outages can still occur, modernized systems often include more redundancy to minimize the odds of a shutdown, Mr. Gilad said.
Lawmakers have looked at modernizing 911 systems by tapping revenue the FCC gets from auctioning off the rights to transmit signals over specific bands of the electromagnetic spectrum.
But the U.S. Senate, in March 2023, for the first time allowed a lapse of the FCC’s authority to auction spectrum bands.
Legislation that would allocate almost $15 billion in grants from auction proceeds to speed deployment of next-generation 911 in every state unanimously passed the House Energy and Commerce Committee in May 2023. The bill, HR 3565, sponsored by Rep. Cathy McMorris Rodgers (R-Wash.), would also extend the FCC’s auction authority.
Other bills have been introduced by various lawmakers, including one in March from Sen. Ted Cruz (R-Texas) and legislation from Sen. Maria Cantwell (D-Wash.) to extend the auction authority. For now, neither effort has advanced. Nine former FCC chairs wrote lawmakers in February, urging them to make 911 upgrades a national priority. They suggested Congress tap unspent federal COVID-19 money.
“Whatever the funding source, the need is urgent and the time to act is now,” they wrote.
Ajit Pai, who served as chair of the FCC from 2017 to 2021, said outages often occur in older, legacy systems.
“The fact that the FCC doesn’t have authority to auction spectrum is a real hindrance now,” Mr. Pai said in an interview. “You may never need to call 911, but it can make the difference between life and death. We need more of an organized effort at the federal level because 911 is so decentralized.”
Meanwhile, some safety leaders are making backup plans for 911 outages or conducting investigations into their causes. In Massachusetts, a firewall designed to prevent hacking led to the recent 2-hour outage, according to the state 911 department.
“Outages bring to everyone’s attention that we rely on 911 and we don’t think about how we really rely on it until something happens,” said April Heinze, chief of 911 operations at NENA.
Mass General Brigham, a health system in the Boston area, sent out emergency alerts when the outage happened letting clinics and smaller practices know how to find their 10-digit emergency numbers. In the wake of the outage, it plans to keep the backup numbers next to phones at those facilities.
“Two hours can be a long time,” said Paul Biddinger, chief preparedness and continuity officer at the health system.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Just after lunchtime on June 18, Massachusetts’ leaders discovered that the statewide 911 system was down.
A scramble to handle the crisis was on.
Police texted out administrative numbers that callers could use, Boston Mayor Michelle Wu gave outage updates at a press conference outlining plans for the Celtics’ championship parade, and local officials urged people to summon help by pulling red fire alarm boxes.
About 7 million people went roughly 2 hours with no 911 service. Such crashes have become more of a feature than a bug in the nation’s fragmented emergency response system.
While some states, cities, and counties have already modernized their systems or have made plans to upgrade, many others are lagging.
911 is typically supported by fees tacked on to phone bills, but state and local governments also tap general funds or other resources.
“Now there are haves and have-nots,” said Jonathan Gilad, vice president of government affairs at the National Emergency Number Association (NENA), which represents 911 first responders. “Next-generation 911 shouldn’t be for people who happen to have an emergency in a good location.”
Meanwhile, federal legislation that could steer billions of dollars into modernizing the patchwork 911 system remains waylaid in Congress.
“This is a national security imperative,” said George Kelemen, executive director of the Industry Council for Emergency Response Technologies, a trade association that represents companies that provide hardware and software to the emergency response industry.
“In a crisis — a school shooting or a house fire or, God forbid, a terrorist attack — people call 911 first,” he said. “The system can’t go down.”
The United States debuted a single, universal 911 emergency number in February 1968 to simplify crisis response. But instead of a seamless national program, the 911 response network has evolved into a massive puzzle of many interlocking pieces. There are more than 6,000 911 call centers to handle an estimated 240 million emergency calls each year, according to federal data. More than three-quarters of call centers experienced outages in the prior 12 months, according to a survey in February by NENA, which sets standards and advocates for 911, and Carbyne, a provider of public safety technology solutions.
In April, widespread 911 outages affected millions in Nebraska, Nevada, South Dakota, and Texas. The shutdown was blamed on workers’ severing a fiber line while installing a light pole.
In February, tens of thousands of people in areas of California, Georgia, Illinois, Texas, and other states lost cellphone service, including some 911 services, from an outage.
And in June, Verizon agreed to pay a $1.05 million fine to settle a Federal Communications Commission (FCC) probe into a December 2022 outage that affected 911 calls in Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.
The fires that raced across the Hawaiian island of Maui in August 2023 highlighted the critical importance of 911 systems. Dispatchers there fielded more than 4,500 contacts, meaning calls and texts, on Aug. 8, the day the fires broke out, compared with about 400 on a typical day, said Davlynn Racadio, emergency services dispatch coordinator in Maui County.
“We’re dying out here,” one caller told 911 operators.
But some cell towers faltered because of widespread service outages, according to county officials. Maui County in May filed a lawsuit against four telecommunications companies, saying they failed to inform dispatchers about the outages.
“If 911 calls came in with no voice, we would send text messages,” Ms. Racadio said. “The state is looking at upgrading our system. Next-generation 911 would take us even further into the future.”
Florida, Illinois, Montana, and Oklahoma passed legislation in 2023 to advance or fund modernized 911 systems, according to the National Conference of State Legislatures. The upgrades include replacing analog 911 infrastructure with digital, Internet-based systems.
Instead of just fielding calls, next-generation systems can pinpoint a caller’s location, accept texts, and enable residents in a crisis to send videos and images to dispatchers. While outages can still occur, modernized systems often include more redundancy to minimize the odds of a shutdown, Mr. Gilad said.
Lawmakers have looked at modernizing 911 systems by tapping revenue the FCC gets from auctioning off the rights to transmit signals over specific bands of the electromagnetic spectrum.
But the U.S. Senate, in March 2023, for the first time allowed a lapse of the FCC’s authority to auction spectrum bands.
Legislation that would allocate almost $15 billion in grants from auction proceeds to speed deployment of next-generation 911 in every state unanimously passed the House Energy and Commerce Committee in May 2023. The bill, HR 3565, sponsored by Rep. Cathy McMorris Rodgers (R-Wash.), would also extend the FCC’s auction authority.
Other bills have been introduced by various lawmakers, including one in March from Sen. Ted Cruz (R-Texas) and legislation from Sen. Maria Cantwell (D-Wash.) to extend the auction authority. For now, neither effort has advanced. Nine former FCC chairs wrote lawmakers in February, urging them to make 911 upgrades a national priority. They suggested Congress tap unspent federal COVID-19 money.
“Whatever the funding source, the need is urgent and the time to act is now,” they wrote.
Ajit Pai, who served as chair of the FCC from 2017 to 2021, said outages often occur in older, legacy systems.
“The fact that the FCC doesn’t have authority to auction spectrum is a real hindrance now,” Mr. Pai said in an interview. “You may never need to call 911, but it can make the difference between life and death. We need more of an organized effort at the federal level because 911 is so decentralized.”
Meanwhile, some safety leaders are making backup plans for 911 outages or conducting investigations into their causes. In Massachusetts, a firewall designed to prevent hacking led to the recent 2-hour outage, according to the state 911 department.
“Outages bring to everyone’s attention that we rely on 911 and we don’t think about how we really rely on it until something happens,” said April Heinze, chief of 911 operations at NENA.
Mass General Brigham, a health system in the Boston area, sent out emergency alerts when the outage happened letting clinics and smaller practices know how to find their 10-digit emergency numbers. In the wake of the outage, it plans to keep the backup numbers next to phones at those facilities.
“Two hours can be a long time,” said Paul Biddinger, chief preparedness and continuity officer at the health system.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Primary Care Internal Medicine Is Dead
Editor’s Note: This piece was originally published in Dr. Glasser’s bimonthly column in The Jolt, a nonprofit online news organization based in Olympia, Washington. She was inspired to write her story after meeting Christine Laine, MD, one of three female physician presenters at the Sommer Lectures in Portland, Oregon, in May 2024. The article has been edited lightly from the original.
Primary care internal medicine — the medical field I chose, loved, and practiced for four decades — is dead.
The grief and shock I feel about this is personal and transpersonal. The loss of internists (internal medicine physicians) practicing primary care is a major loss to us all.
From the 1970s to roughly 2020, there were three groups of primary care physicians: family practice, pediatricians, and internists. In their 3-year residencies (after 4 years of medical school), pediatricians trained to care for children and adolescents; internists for adults; and FPs for children, adults, and women and pregnancy. Family practitioners are the most general of the generalists, whereas the others’ training involves comprehensive care of complex patients in their age groups.
How and when the field of primary care internal medicine flourished is my story.
I was one of those kids who was hyperfocused on science, math, and the human body. By the end of high school, I was considering medicine for my career.
To learn more, I volunteered at the local hospital. In my typical style, I requested not to be one of those candy stripers serving drinks on the wards. Instead, they put me in the emergency department, where I would transport patients and clean the stretchers. There I was free to watch whatever was going on if I did not interfere with the staff. On my first shift, a 20-year-old drowning victim arrived by ambulance. I watched the entire unsuccessful resuscitation and as shocked and saddened as I was, I knew (in the way only a headstrong 18-year-old can) that medicine was for me.
It was a fortuitous time to graduate as a female pre-med student.
In 1975, our country was in the midst of the women’s movement and a national effort to train primary care physicians. I was accepted to my state medical school. The University of Massachusetts Medical School had been established a few years earlier, with its main purpose to train primary care physicians and spread them around the state (especially out of the Boston metropolitan area). The curriculum was designed to expose students to primary care from year one. I was assigned to shadow a general practice physician in inner-city Springfield who saw over 50 patients a day! The patients knew they could see and afford him, so they crammed into his waiting room until their name was called in order of their arrival. No appointments necessary. His chart notes were a few scribbled sentences. I didn’t see myself in that practice exactly, but his work ethic and dedication inspired me.
Over half of our graduating class chose to train in primary care specialties, and most stayed in-state. It turned out to be a good bet on the part of the government of Massachusetts.
When I applied for residency in 1980, several internal medicine programs had a focus on primary care, which was my goal. I matched at Providence St. Vincent Hospital in Portland, Oregon, and moved across the country to the Pacific Northwest, never to look back. There, my attendings were doctors like I wanted to be: primary care internists in the community, not in academia. It was the perfect choice and an excellent training program.
In 1984, I hung out my private practice internal medicine shingle in Hillsboro, Oregon, across the street from the community hospital. My primary care internal medicine colleagues and I shared weekend calls and admitted and cared for our patients in the hospital, and when they were discharged. That is now called “continuity of care.” It was a time when we ate in the doctors’ lounge together, met in hallways, and informally consulted each other about our patients. These were called “curbside consults.” They were invaluable to our ability to provide comprehensive care to our patients in primary care, led to fewer specialty referrals, and were free. That would now be called interprofessional communication and collegiality.
“Burnout” was not a word you heard. We were busy and happy doing what we had spent 12 years of our precious youth to prepare for.
What did internists offer to primary care? That also is part of my story.
When I moved to Olympia, I took a position in the women’s health clinic at the American Lake Veterans Administration Medical Center.
We were a small group: two family practice doctors, three nurse practitioners, and me, the only internist. Many of our patients were sick and complex. Two of the nurse practitioners (NPs) asked me to take their most complicated patients. Being comfortable with complexity as an internist, I said yes.
One of the NPs was inappropriately hired, as she had experience in women’s health. She came to me freaked out: “Oh my God, I have no idea how to manage COPD!” The other wanted simpler patients. I don’t blame them for the patient transfers. NPs typically have 3 years of training before they practice, in contrast to primary care physicians’ 8.
Guess who made friends with the custodian, staying until 8 p.m. most evenings, and who left by 5:30 p.m.
What was I doing in those extra hours? I was trudging through clerical, yet important, tasks my medical assistant and transcriptionist used to do in private practice. In the 30 minutes allotted for the patient, I needed to focus entirely on them and their multiple complex medical problems.
What is lost with the death of primary care internal medicine?
At the recent Sommer Memorial Lectures in Portland, Steven D. Freer, MD, the current director of the residency program where I trained, has not had a single of his eight annual internal medicine graduates choose primary care in several years. Half (two of four) of those in my year did: One went to Tillamook, an underserved area on the Oregon coast, and I to Hillsboro.
Why are they not choosing primary care? As when the University of Massachusetts Medical School was established, a shortage of primary care physicians persists and probably is more severe than it was in the 1970s. Massachusetts was proactive. We are already years behind catching up. The shortage is no longer in rural areas alone.
Christine Laine, MD, who is editor in chief of Annals of Internal Medicine and spoke at the Sommer Memorial Lectures, lives in Philadelphia. Even there, she has lost her own primary care internal medicine physician and cannot find another primary care physician (much less an internist) for herself.
Washington State, where I live, scores a D grade for our primary care staffing statewide.
Is there hope for the future of primary care in general? Or for the restoration of primary care internal medicine?
Maybe. I was relieved to hear from Dr. Freer and Dr. Laine that efforts are beginning to revive the field.
Just like internists’ patients, the potential restoration of the field will be complex and multilayered. It will require new laws, policies, residency programs, and incentives for students, including debt reduction. Administrative burdens will need to be reduced; de-corporatization and restoring healthcare leadership to those with in-depth medical training will need to be a part of the solution as well.
Let’s all hope the new resuscitation efforts will be successful for the field of primary care in general and primary care internal medicine specifically. It will be good for healthcare and for your patients!
Many work for large systems in which they feel powerless to effect change.
Dr. Glasser is a retired internal medicine physician in Olympia, Washington. She can be reached at [email protected].
A version of this article appeared on Medscape.com.
Editor’s Note: This piece was originally published in Dr. Glasser’s bimonthly column in The Jolt, a nonprofit online news organization based in Olympia, Washington. She was inspired to write her story after meeting Christine Laine, MD, one of three female physician presenters at the Sommer Lectures in Portland, Oregon, in May 2024. The article has been edited lightly from the original.
Primary care internal medicine — the medical field I chose, loved, and practiced for four decades — is dead.
The grief and shock I feel about this is personal and transpersonal. The loss of internists (internal medicine physicians) practicing primary care is a major loss to us all.
From the 1970s to roughly 2020, there were three groups of primary care physicians: family practice, pediatricians, and internists. In their 3-year residencies (after 4 years of medical school), pediatricians trained to care for children and adolescents; internists for adults; and FPs for children, adults, and women and pregnancy. Family practitioners are the most general of the generalists, whereas the others’ training involves comprehensive care of complex patients in their age groups.
How and when the field of primary care internal medicine flourished is my story.
I was one of those kids who was hyperfocused on science, math, and the human body. By the end of high school, I was considering medicine for my career.
To learn more, I volunteered at the local hospital. In my typical style, I requested not to be one of those candy stripers serving drinks on the wards. Instead, they put me in the emergency department, where I would transport patients and clean the stretchers. There I was free to watch whatever was going on if I did not interfere with the staff. On my first shift, a 20-year-old drowning victim arrived by ambulance. I watched the entire unsuccessful resuscitation and as shocked and saddened as I was, I knew (in the way only a headstrong 18-year-old can) that medicine was for me.
It was a fortuitous time to graduate as a female pre-med student.
In 1975, our country was in the midst of the women’s movement and a national effort to train primary care physicians. I was accepted to my state medical school. The University of Massachusetts Medical School had been established a few years earlier, with its main purpose to train primary care physicians and spread them around the state (especially out of the Boston metropolitan area). The curriculum was designed to expose students to primary care from year one. I was assigned to shadow a general practice physician in inner-city Springfield who saw over 50 patients a day! The patients knew they could see and afford him, so they crammed into his waiting room until their name was called in order of their arrival. No appointments necessary. His chart notes were a few scribbled sentences. I didn’t see myself in that practice exactly, but his work ethic and dedication inspired me.
Over half of our graduating class chose to train in primary care specialties, and most stayed in-state. It turned out to be a good bet on the part of the government of Massachusetts.
When I applied for residency in 1980, several internal medicine programs had a focus on primary care, which was my goal. I matched at Providence St. Vincent Hospital in Portland, Oregon, and moved across the country to the Pacific Northwest, never to look back. There, my attendings were doctors like I wanted to be: primary care internists in the community, not in academia. It was the perfect choice and an excellent training program.
In 1984, I hung out my private practice internal medicine shingle in Hillsboro, Oregon, across the street from the community hospital. My primary care internal medicine colleagues and I shared weekend calls and admitted and cared for our patients in the hospital, and when they were discharged. That is now called “continuity of care.” It was a time when we ate in the doctors’ lounge together, met in hallways, and informally consulted each other about our patients. These were called “curbside consults.” They were invaluable to our ability to provide comprehensive care to our patients in primary care, led to fewer specialty referrals, and were free. That would now be called interprofessional communication and collegiality.
“Burnout” was not a word you heard. We were busy and happy doing what we had spent 12 years of our precious youth to prepare for.
What did internists offer to primary care? That also is part of my story.
When I moved to Olympia, I took a position in the women’s health clinic at the American Lake Veterans Administration Medical Center.
We were a small group: two family practice doctors, three nurse practitioners, and me, the only internist. Many of our patients were sick and complex. Two of the nurse practitioners (NPs) asked me to take their most complicated patients. Being comfortable with complexity as an internist, I said yes.
One of the NPs was inappropriately hired, as she had experience in women’s health. She came to me freaked out: “Oh my God, I have no idea how to manage COPD!” The other wanted simpler patients. I don’t blame them for the patient transfers. NPs typically have 3 years of training before they practice, in contrast to primary care physicians’ 8.
Guess who made friends with the custodian, staying until 8 p.m. most evenings, and who left by 5:30 p.m.
What was I doing in those extra hours? I was trudging through clerical, yet important, tasks my medical assistant and transcriptionist used to do in private practice. In the 30 minutes allotted for the patient, I needed to focus entirely on them and their multiple complex medical problems.
What is lost with the death of primary care internal medicine?
At the recent Sommer Memorial Lectures in Portland, Steven D. Freer, MD, the current director of the residency program where I trained, has not had a single of his eight annual internal medicine graduates choose primary care in several years. Half (two of four) of those in my year did: One went to Tillamook, an underserved area on the Oregon coast, and I to Hillsboro.
Why are they not choosing primary care? As when the University of Massachusetts Medical School was established, a shortage of primary care physicians persists and probably is more severe than it was in the 1970s. Massachusetts was proactive. We are already years behind catching up. The shortage is no longer in rural areas alone.
Christine Laine, MD, who is editor in chief of Annals of Internal Medicine and spoke at the Sommer Memorial Lectures, lives in Philadelphia. Even there, she has lost her own primary care internal medicine physician and cannot find another primary care physician (much less an internist) for herself.
Washington State, where I live, scores a D grade for our primary care staffing statewide.
Is there hope for the future of primary care in general? Or for the restoration of primary care internal medicine?
Maybe. I was relieved to hear from Dr. Freer and Dr. Laine that efforts are beginning to revive the field.
Just like internists’ patients, the potential restoration of the field will be complex and multilayered. It will require new laws, policies, residency programs, and incentives for students, including debt reduction. Administrative burdens will need to be reduced; de-corporatization and restoring healthcare leadership to those with in-depth medical training will need to be a part of the solution as well.
Let’s all hope the new resuscitation efforts will be successful for the field of primary care in general and primary care internal medicine specifically. It will be good for healthcare and for your patients!
Many work for large systems in which they feel powerless to effect change.
Dr. Glasser is a retired internal medicine physician in Olympia, Washington. She can be reached at [email protected].
A version of this article appeared on Medscape.com.
Editor’s Note: This piece was originally published in Dr. Glasser’s bimonthly column in The Jolt, a nonprofit online news organization based in Olympia, Washington. She was inspired to write her story after meeting Christine Laine, MD, one of three female physician presenters at the Sommer Lectures in Portland, Oregon, in May 2024. The article has been edited lightly from the original.
Primary care internal medicine — the medical field I chose, loved, and practiced for four decades — is dead.
The grief and shock I feel about this is personal and transpersonal. The loss of internists (internal medicine physicians) practicing primary care is a major loss to us all.
From the 1970s to roughly 2020, there were three groups of primary care physicians: family practice, pediatricians, and internists. In their 3-year residencies (after 4 years of medical school), pediatricians trained to care for children and adolescents; internists for adults; and FPs for children, adults, and women and pregnancy. Family practitioners are the most general of the generalists, whereas the others’ training involves comprehensive care of complex patients in their age groups.
How and when the field of primary care internal medicine flourished is my story.
I was one of those kids who was hyperfocused on science, math, and the human body. By the end of high school, I was considering medicine for my career.
To learn more, I volunteered at the local hospital. In my typical style, I requested not to be one of those candy stripers serving drinks on the wards. Instead, they put me in the emergency department, where I would transport patients and clean the stretchers. There I was free to watch whatever was going on if I did not interfere with the staff. On my first shift, a 20-year-old drowning victim arrived by ambulance. I watched the entire unsuccessful resuscitation and as shocked and saddened as I was, I knew (in the way only a headstrong 18-year-old can) that medicine was for me.
It was a fortuitous time to graduate as a female pre-med student.
In 1975, our country was in the midst of the women’s movement and a national effort to train primary care physicians. I was accepted to my state medical school. The University of Massachusetts Medical School had been established a few years earlier, with its main purpose to train primary care physicians and spread them around the state (especially out of the Boston metropolitan area). The curriculum was designed to expose students to primary care from year one. I was assigned to shadow a general practice physician in inner-city Springfield who saw over 50 patients a day! The patients knew they could see and afford him, so they crammed into his waiting room until their name was called in order of their arrival. No appointments necessary. His chart notes were a few scribbled sentences. I didn’t see myself in that practice exactly, but his work ethic and dedication inspired me.
Over half of our graduating class chose to train in primary care specialties, and most stayed in-state. It turned out to be a good bet on the part of the government of Massachusetts.
When I applied for residency in 1980, several internal medicine programs had a focus on primary care, which was my goal. I matched at Providence St. Vincent Hospital in Portland, Oregon, and moved across the country to the Pacific Northwest, never to look back. There, my attendings were doctors like I wanted to be: primary care internists in the community, not in academia. It was the perfect choice and an excellent training program.
In 1984, I hung out my private practice internal medicine shingle in Hillsboro, Oregon, across the street from the community hospital. My primary care internal medicine colleagues and I shared weekend calls and admitted and cared for our patients in the hospital, and when they were discharged. That is now called “continuity of care.” It was a time when we ate in the doctors’ lounge together, met in hallways, and informally consulted each other about our patients. These were called “curbside consults.” They were invaluable to our ability to provide comprehensive care to our patients in primary care, led to fewer specialty referrals, and were free. That would now be called interprofessional communication and collegiality.
“Burnout” was not a word you heard. We were busy and happy doing what we had spent 12 years of our precious youth to prepare for.
What did internists offer to primary care? That also is part of my story.
When I moved to Olympia, I took a position in the women’s health clinic at the American Lake Veterans Administration Medical Center.
We were a small group: two family practice doctors, three nurse practitioners, and me, the only internist. Many of our patients were sick and complex. Two of the nurse practitioners (NPs) asked me to take their most complicated patients. Being comfortable with complexity as an internist, I said yes.
One of the NPs was inappropriately hired, as she had experience in women’s health. She came to me freaked out: “Oh my God, I have no idea how to manage COPD!” The other wanted simpler patients. I don’t blame them for the patient transfers. NPs typically have 3 years of training before they practice, in contrast to primary care physicians’ 8.
Guess who made friends with the custodian, staying until 8 p.m. most evenings, and who left by 5:30 p.m.
What was I doing in those extra hours? I was trudging through clerical, yet important, tasks my medical assistant and transcriptionist used to do in private practice. In the 30 minutes allotted for the patient, I needed to focus entirely on them and their multiple complex medical problems.
What is lost with the death of primary care internal medicine?
At the recent Sommer Memorial Lectures in Portland, Steven D. Freer, MD, the current director of the residency program where I trained, has not had a single of his eight annual internal medicine graduates choose primary care in several years. Half (two of four) of those in my year did: One went to Tillamook, an underserved area on the Oregon coast, and I to Hillsboro.
Why are they not choosing primary care? As when the University of Massachusetts Medical School was established, a shortage of primary care physicians persists and probably is more severe than it was in the 1970s. Massachusetts was proactive. We are already years behind catching up. The shortage is no longer in rural areas alone.
Christine Laine, MD, who is editor in chief of Annals of Internal Medicine and spoke at the Sommer Memorial Lectures, lives in Philadelphia. Even there, she has lost her own primary care internal medicine physician and cannot find another primary care physician (much less an internist) for herself.
Washington State, where I live, scores a D grade for our primary care staffing statewide.
Is there hope for the future of primary care in general? Or for the restoration of primary care internal medicine?
Maybe. I was relieved to hear from Dr. Freer and Dr. Laine that efforts are beginning to revive the field.
Just like internists’ patients, the potential restoration of the field will be complex and multilayered. It will require new laws, policies, residency programs, and incentives for students, including debt reduction. Administrative burdens will need to be reduced; de-corporatization and restoring healthcare leadership to those with in-depth medical training will need to be a part of the solution as well.
Let’s all hope the new resuscitation efforts will be successful for the field of primary care in general and primary care internal medicine specifically. It will be good for healthcare and for your patients!
Many work for large systems in which they feel powerless to effect change.
Dr. Glasser is a retired internal medicine physician in Olympia, Washington. She can be reached at [email protected].
A version of this article appeared on Medscape.com.
Flu May Increase MI Risk Sixfold, More If No CVD History
“Our study results confirm previous findings of an increased risk of MI during or immediately following acute severe flu infection and raises the idea of giving prophylactic anticoagulation to these patients,” reported Patricia Bruijning-Verhagen, MD, University Medical Center Utrecht, the Netherlands, who is the senior author of the study, which was published online in NEJM Evidence.
“Our results also change things — in that we now know the focus should be on people without a history of cardiovascular disease — and highlight the importance of flu vaccination, particularly for this group,” she pointed out.
The observational, self-controlled, case-series study linked laboratory records on respiratory virus polymerase chain reaction (PCR) testing from 16 laboratories in the Netherlands to national mortality, hospitalization, medication, and administrative registries. Investigators compared the incidence of acute MI during the risk period — days 1-7 after influenza infection — with that in the control period — 1 year before and 51 weeks after the risk period.
The researchers found 26,221 positive PCR tests for influenza, constituting 23,405 unique influenza illness episodes. Of the episodes of acute MI occurring in the year before or the year after confirmed influenza infection and included in the analysis, 25 cases of acute MI occurred on days 1-7 after influenza infection and 394 occurred during the control period.
The adjusted relative incidence of acute MI during the risk period compared with during the control period was 6.16 (95% CI, 4.11-9.24).
The relative incidence of acute MI in individuals with no previous hospitalization for coronary artery disease was 16.60 (95% CI, 10.45-26.37); for those with a previous hospital admission for coronary artery disease, the relative incidence was 1.43 (95% CI, 0.53-3.84).
A temporary increase in the risk for MI has been reported in several previous studies. A 2018 Canadian study by Kwong and colleagues showed a sixfold elevation in the risk for acute MI after influenza infection, which was subsequently confirmed in studies from the United States, Denmark, and Scotland.
In their study, Dr. Bruijning-Verhagen and colleagues aimed to further quantify the association between laboratory-confirmed influenza infection and acute MI and to look at specific subgroups that might have the potential to guide a more individualized approach to prevention.
They replicated the Canadian study using a self-controlled case-series design that corrects for time-invariant confounding and found very similar results: A sixfold increase in the risk for acute MI in the first week after laboratory-confirmed influenza infection.
“The fact that we found similar results to Kwong et al. strengthens the finding that acute flu infection is linked to increased MI risk. This is becoming more and more clear now. It also shows that this effect is generalizable to other countries,” Dr. Bruijning-Verhagen said.
People Without Cardiovascular Disease at Highest Risk
The researchers moved the field ahead by also looking at whether there is a difference in risk between individuals with flu who already had cardiovascular disease and those who did not.
“Most previous studies of flu and MI didn’t stratify between individuals with and without existing cardiovascular disease. And the ones that did look at this weren’t able to show a difference with any confidence,” Dr. Bruijning-Verhagen explained. “There have been suggestions before of a higher risk of MI in individuals with acute flu infection who do not have existing known cardiovascular disease, but this was uncertain.”
The current study showed a large difference between the two groups, with a much higher risk for MI linked to flu in individuals without any known cardiovascular disease.
“You would think patients with existing cardiovascular disease would be more at risk of MI with flu infection, so this was a surprising result,” reported Dr. Bruijning-Verhagen. “But I think the result is real. The difference between the two groups was too big for it not to be.”
Influenza can cause a hypercoagulable state, systemic inflammation, and vascular changes that can trigger MI, even in patients not thought to be at risk before, she pointed out. And this is on top of high cardiac demands because of the acute infection.
Patients who already have cardiovascular disease may be protected to some extent by the cardiovascular medications that they are taking, she added.
These results could justify the use of short-term anticoagulation in patients with severe flu infection to cover the high-risk period, Dr. Bruijning-Verhagen suggested. “We give short-term anticoagulation as prophylaxis to patients when they have surgery. This would not be that different. But obviously, this approach would have to be tested.”
Clinical studies looking at such a strategy are currently underway.
‘Get Your Flu Shot’
The results reinforce the need for anyone who is eligible to get the flu vaccine. “These results should give extra weight to the message to get your flu shot,” she said. “Even if you do not consider yourself someone at risk of cardiovascular disease, our study shows that you can still have an increased risk of MI as a result of severe flu infection.”
In many countries, the flu vaccine is recommended for everyone older than 60 or 65 years and for younger people with a history of cardiovascular disease. Data on flu vaccination was not available in the current study, but the average age of patients infected with flu was 74 years, so most patients would have been eligible to receive vaccination, she said.
In the Netherlands where the research took place, flu vaccination is recommended for everyone older than 60 years, and uptake is about 60%.
“There will be some cases in younger people, but the number needed to vaccinate to show a benefit would be much larger in younger people, and that may not be cost-effective,” reported Dr. Bruijning-Verhagen.
Flu vaccination policies vary across the world, with many factors being taken into account; some countries already advocate for universal vaccination every year.
Extend Flu Vaccination to Prevent ACS
This study “provides further impetus to policy makers to review and update guidelines on prevention of acute coronary syndromes,” Raina MacIntyre, MBBS, Zubair Akhtar, MPH, and Aye Moa, MPH, University of New South Wales, Sydney, Australia, wrote in an accompanying editorial.
“Although vaccination to prevent influenza is recommended and funded in many countries for people 65 years of age and older, the additional benefits of prevention of ACS [acute coronary syndromes] have not been adopted universally into policy and practice nor have recommendations considered prevention of ACS in people 50-64 years of age,” they added.
“Vaccination is low-hanging fruit for people at risk of acute myocardial infarction who have not yet had a first event. It is time that we viewed influenza vaccine as a routine preventive measure for ACS and for people with coronary artery disease risk factors, along with statins, blood pressure control, and smoking cessation,” she explained.
The question of whether the link found between elevated MI risk and severe flu infection might be the result of MI being more likely to be detected in patients hospitalized with severe flu infection, who would undergo a thorough workup, was raised in a second editorial by Lori E. Dodd, PhD, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
“I think this would be very unlikely to account for the large effect we found,” responded Dr. Bruijning-Verhagen. “There may be the occasional silent MI that gets missed in patients who are not hospitalized, but, in general, acute MI is not something that goes undetected.”
A version of this article appeared on Medscape.com.
“Our study results confirm previous findings of an increased risk of MI during or immediately following acute severe flu infection and raises the idea of giving prophylactic anticoagulation to these patients,” reported Patricia Bruijning-Verhagen, MD, University Medical Center Utrecht, the Netherlands, who is the senior author of the study, which was published online in NEJM Evidence.
“Our results also change things — in that we now know the focus should be on people without a history of cardiovascular disease — and highlight the importance of flu vaccination, particularly for this group,” she pointed out.
The observational, self-controlled, case-series study linked laboratory records on respiratory virus polymerase chain reaction (PCR) testing from 16 laboratories in the Netherlands to national mortality, hospitalization, medication, and administrative registries. Investigators compared the incidence of acute MI during the risk period — days 1-7 after influenza infection — with that in the control period — 1 year before and 51 weeks after the risk period.
The researchers found 26,221 positive PCR tests for influenza, constituting 23,405 unique influenza illness episodes. Of the episodes of acute MI occurring in the year before or the year after confirmed influenza infection and included in the analysis, 25 cases of acute MI occurred on days 1-7 after influenza infection and 394 occurred during the control period.
The adjusted relative incidence of acute MI during the risk period compared with during the control period was 6.16 (95% CI, 4.11-9.24).
The relative incidence of acute MI in individuals with no previous hospitalization for coronary artery disease was 16.60 (95% CI, 10.45-26.37); for those with a previous hospital admission for coronary artery disease, the relative incidence was 1.43 (95% CI, 0.53-3.84).
A temporary increase in the risk for MI has been reported in several previous studies. A 2018 Canadian study by Kwong and colleagues showed a sixfold elevation in the risk for acute MI after influenza infection, which was subsequently confirmed in studies from the United States, Denmark, and Scotland.
In their study, Dr. Bruijning-Verhagen and colleagues aimed to further quantify the association between laboratory-confirmed influenza infection and acute MI and to look at specific subgroups that might have the potential to guide a more individualized approach to prevention.
They replicated the Canadian study using a self-controlled case-series design that corrects for time-invariant confounding and found very similar results: A sixfold increase in the risk for acute MI in the first week after laboratory-confirmed influenza infection.
“The fact that we found similar results to Kwong et al. strengthens the finding that acute flu infection is linked to increased MI risk. This is becoming more and more clear now. It also shows that this effect is generalizable to other countries,” Dr. Bruijning-Verhagen said.
People Without Cardiovascular Disease at Highest Risk
The researchers moved the field ahead by also looking at whether there is a difference in risk between individuals with flu who already had cardiovascular disease and those who did not.
“Most previous studies of flu and MI didn’t stratify between individuals with and without existing cardiovascular disease. And the ones that did look at this weren’t able to show a difference with any confidence,” Dr. Bruijning-Verhagen explained. “There have been suggestions before of a higher risk of MI in individuals with acute flu infection who do not have existing known cardiovascular disease, but this was uncertain.”
The current study showed a large difference between the two groups, with a much higher risk for MI linked to flu in individuals without any known cardiovascular disease.
“You would think patients with existing cardiovascular disease would be more at risk of MI with flu infection, so this was a surprising result,” reported Dr. Bruijning-Verhagen. “But I think the result is real. The difference between the two groups was too big for it not to be.”
Influenza can cause a hypercoagulable state, systemic inflammation, and vascular changes that can trigger MI, even in patients not thought to be at risk before, she pointed out. And this is on top of high cardiac demands because of the acute infection.
Patients who already have cardiovascular disease may be protected to some extent by the cardiovascular medications that they are taking, she added.
These results could justify the use of short-term anticoagulation in patients with severe flu infection to cover the high-risk period, Dr. Bruijning-Verhagen suggested. “We give short-term anticoagulation as prophylaxis to patients when they have surgery. This would not be that different. But obviously, this approach would have to be tested.”
Clinical studies looking at such a strategy are currently underway.
‘Get Your Flu Shot’
The results reinforce the need for anyone who is eligible to get the flu vaccine. “These results should give extra weight to the message to get your flu shot,” she said. “Even if you do not consider yourself someone at risk of cardiovascular disease, our study shows that you can still have an increased risk of MI as a result of severe flu infection.”
In many countries, the flu vaccine is recommended for everyone older than 60 or 65 years and for younger people with a history of cardiovascular disease. Data on flu vaccination was not available in the current study, but the average age of patients infected with flu was 74 years, so most patients would have been eligible to receive vaccination, she said.
In the Netherlands where the research took place, flu vaccination is recommended for everyone older than 60 years, and uptake is about 60%.
“There will be some cases in younger people, but the number needed to vaccinate to show a benefit would be much larger in younger people, and that may not be cost-effective,” reported Dr. Bruijning-Verhagen.
Flu vaccination policies vary across the world, with many factors being taken into account; some countries already advocate for universal vaccination every year.
Extend Flu Vaccination to Prevent ACS
This study “provides further impetus to policy makers to review and update guidelines on prevention of acute coronary syndromes,” Raina MacIntyre, MBBS, Zubair Akhtar, MPH, and Aye Moa, MPH, University of New South Wales, Sydney, Australia, wrote in an accompanying editorial.
“Although vaccination to prevent influenza is recommended and funded in many countries for people 65 years of age and older, the additional benefits of prevention of ACS [acute coronary syndromes] have not been adopted universally into policy and practice nor have recommendations considered prevention of ACS in people 50-64 years of age,” they added.
“Vaccination is low-hanging fruit for people at risk of acute myocardial infarction who have not yet had a first event. It is time that we viewed influenza vaccine as a routine preventive measure for ACS and for people with coronary artery disease risk factors, along with statins, blood pressure control, and smoking cessation,” she explained.
The question of whether the link found between elevated MI risk and severe flu infection might be the result of MI being more likely to be detected in patients hospitalized with severe flu infection, who would undergo a thorough workup, was raised in a second editorial by Lori E. Dodd, PhD, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
“I think this would be very unlikely to account for the large effect we found,” responded Dr. Bruijning-Verhagen. “There may be the occasional silent MI that gets missed in patients who are not hospitalized, but, in general, acute MI is not something that goes undetected.”
A version of this article appeared on Medscape.com.
“Our study results confirm previous findings of an increased risk of MI during or immediately following acute severe flu infection and raises the idea of giving prophylactic anticoagulation to these patients,” reported Patricia Bruijning-Verhagen, MD, University Medical Center Utrecht, the Netherlands, who is the senior author of the study, which was published online in NEJM Evidence.
“Our results also change things — in that we now know the focus should be on people without a history of cardiovascular disease — and highlight the importance of flu vaccination, particularly for this group,” she pointed out.
The observational, self-controlled, case-series study linked laboratory records on respiratory virus polymerase chain reaction (PCR) testing from 16 laboratories in the Netherlands to national mortality, hospitalization, medication, and administrative registries. Investigators compared the incidence of acute MI during the risk period — days 1-7 after influenza infection — with that in the control period — 1 year before and 51 weeks after the risk period.
The researchers found 26,221 positive PCR tests for influenza, constituting 23,405 unique influenza illness episodes. Of the episodes of acute MI occurring in the year before or the year after confirmed influenza infection and included in the analysis, 25 cases of acute MI occurred on days 1-7 after influenza infection and 394 occurred during the control period.
The adjusted relative incidence of acute MI during the risk period compared with during the control period was 6.16 (95% CI, 4.11-9.24).
The relative incidence of acute MI in individuals with no previous hospitalization for coronary artery disease was 16.60 (95% CI, 10.45-26.37); for those with a previous hospital admission for coronary artery disease, the relative incidence was 1.43 (95% CI, 0.53-3.84).
A temporary increase in the risk for MI has been reported in several previous studies. A 2018 Canadian study by Kwong and colleagues showed a sixfold elevation in the risk for acute MI after influenza infection, which was subsequently confirmed in studies from the United States, Denmark, and Scotland.
In their study, Dr. Bruijning-Verhagen and colleagues aimed to further quantify the association between laboratory-confirmed influenza infection and acute MI and to look at specific subgroups that might have the potential to guide a more individualized approach to prevention.
They replicated the Canadian study using a self-controlled case-series design that corrects for time-invariant confounding and found very similar results: A sixfold increase in the risk for acute MI in the first week after laboratory-confirmed influenza infection.
“The fact that we found similar results to Kwong et al. strengthens the finding that acute flu infection is linked to increased MI risk. This is becoming more and more clear now. It also shows that this effect is generalizable to other countries,” Dr. Bruijning-Verhagen said.
People Without Cardiovascular Disease at Highest Risk
The researchers moved the field ahead by also looking at whether there is a difference in risk between individuals with flu who already had cardiovascular disease and those who did not.
“Most previous studies of flu and MI didn’t stratify between individuals with and without existing cardiovascular disease. And the ones that did look at this weren’t able to show a difference with any confidence,” Dr. Bruijning-Verhagen explained. “There have been suggestions before of a higher risk of MI in individuals with acute flu infection who do not have existing known cardiovascular disease, but this was uncertain.”
The current study showed a large difference between the two groups, with a much higher risk for MI linked to flu in individuals without any known cardiovascular disease.
“You would think patients with existing cardiovascular disease would be more at risk of MI with flu infection, so this was a surprising result,” reported Dr. Bruijning-Verhagen. “But I think the result is real. The difference between the two groups was too big for it not to be.”
Influenza can cause a hypercoagulable state, systemic inflammation, and vascular changes that can trigger MI, even in patients not thought to be at risk before, she pointed out. And this is on top of high cardiac demands because of the acute infection.
Patients who already have cardiovascular disease may be protected to some extent by the cardiovascular medications that they are taking, she added.
These results could justify the use of short-term anticoagulation in patients with severe flu infection to cover the high-risk period, Dr. Bruijning-Verhagen suggested. “We give short-term anticoagulation as prophylaxis to patients when they have surgery. This would not be that different. But obviously, this approach would have to be tested.”
Clinical studies looking at such a strategy are currently underway.
‘Get Your Flu Shot’
The results reinforce the need for anyone who is eligible to get the flu vaccine. “These results should give extra weight to the message to get your flu shot,” she said. “Even if you do not consider yourself someone at risk of cardiovascular disease, our study shows that you can still have an increased risk of MI as a result of severe flu infection.”
In many countries, the flu vaccine is recommended for everyone older than 60 or 65 years and for younger people with a history of cardiovascular disease. Data on flu vaccination was not available in the current study, but the average age of patients infected with flu was 74 years, so most patients would have been eligible to receive vaccination, she said.
In the Netherlands where the research took place, flu vaccination is recommended for everyone older than 60 years, and uptake is about 60%.
“There will be some cases in younger people, but the number needed to vaccinate to show a benefit would be much larger in younger people, and that may not be cost-effective,” reported Dr. Bruijning-Verhagen.
Flu vaccination policies vary across the world, with many factors being taken into account; some countries already advocate for universal vaccination every year.
Extend Flu Vaccination to Prevent ACS
This study “provides further impetus to policy makers to review and update guidelines on prevention of acute coronary syndromes,” Raina MacIntyre, MBBS, Zubair Akhtar, MPH, and Aye Moa, MPH, University of New South Wales, Sydney, Australia, wrote in an accompanying editorial.
“Although vaccination to prevent influenza is recommended and funded in many countries for people 65 years of age and older, the additional benefits of prevention of ACS [acute coronary syndromes] have not been adopted universally into policy and practice nor have recommendations considered prevention of ACS in people 50-64 years of age,” they added.
“Vaccination is low-hanging fruit for people at risk of acute myocardial infarction who have not yet had a first event. It is time that we viewed influenza vaccine as a routine preventive measure for ACS and for people with coronary artery disease risk factors, along with statins, blood pressure control, and smoking cessation,” she explained.
The question of whether the link found between elevated MI risk and severe flu infection might be the result of MI being more likely to be detected in patients hospitalized with severe flu infection, who would undergo a thorough workup, was raised in a second editorial by Lori E. Dodd, PhD, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
“I think this would be very unlikely to account for the large effect we found,” responded Dr. Bruijning-Verhagen. “There may be the occasional silent MI that gets missed in patients who are not hospitalized, but, in general, acute MI is not something that goes undetected.”
A version of this article appeared on Medscape.com.
FROM NEJM EVIDENCE
Intervention Helps Transition From Postpartum Care to PCP Engagement
, according to study results published in JAMA Network Open. The intervention bundle includes default scheduling of postpartum primary care appointments and tailored reminders and messaging.
Researchers, led by Mark A. Clapp, MD, MPH, with Massachusetts General Hospital in Boston, highlighted a care transition gap common after a woman gives birth. More than 30% of pregnant people have at least one chronic condition and nearly 20% develop gestational diabetes or pregnancy-related hypertension, which increases the risk of future chronic disease, the authors write. They are closely monitored for these conditions during pregnancy, but many face barriers in transitioning to engagement with primary care.
Scheduling appointments, difficulty in finding information, and insurance or billing issues can impede access to care. In this study, the primary outcome measure was whether women completed a primary care visit for routine or chronic condition care within 4 months of delivery.
Intervention vs Control Group
The intervention included an introduction message talking about the importance of a primary care visit and notification that a staff member would be scheduling an appointment on the patients’ behalf within a 4-month window of the estimated due date (EDD). Patients could opt out or ask for specific scheduling. If a patient had already seen their primary care physician (PCP) for an annual visit within the year, they were scheduled for an annual visit when they were next eligible, even if outside the 4-month study follow-up.
For those who did not opt out and had appointments scheduled for them, reminders were sent about 1 month after the EDD and 1 week before the scheduled appointment through the EHR patient portal. Salient labeling of the message was used to describe the visit. For those for whom an appointment could not be scheduled, similar reminders were sent on the importance of primary care follow-up, urging patients to contact their primary care office directly to schedule. Reminders included evidence-based, best-practice wording including that “the appointment had been reserved for them.”
Patients in the control group received one message within 2 weeks of the EDD with a generic recommendation for primary care follow-up after delivery.
Researchers found that 40% of the intervention group (95% confidence interval (CI), 33.1%-47.4%) and 22% of the control group (95% CI, 6.4%-28.8%), completed a primary care visit within 4 months. “[T]he intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points),” they write. Those who received the intervention also had fewer postpartum readmissions (1.7% vs 5.8%) and were more likely to have had these services from a PCP: blood pressure screening (42.8% vs 28.3%); weight assessment (42.8% vs 27.7%); and depression screening (32.8% vs 16.8%).
Meghan Bellerose, MPH, with the Department of Health Services, Policy, and Practice at Brown University School of Public Health in Providence, Rhode Island, described in an accompanying editorial the “postpartum cliff.”
“Health system engagement plummets soon after childbirth in the US,” she writes. “Under current care practices, obstetric clinicians deliver a single postpartum visit within 12 weeks of delivery, after which patients are responsible for navigating the transition to primary care on their own.”
The intervention Dr. Clapp and colleagues propose could help increase the benefit of state and federal policies aimed at increasing care continuity after delivery, she writes. She pointed to the American Rescue Plan Act of 2021, in which states were given the option to provide 12 months of continuous Medicaid coverage to low-income postpartum women, up from the previous 2 months of coverage. By early May of 2024, 46 states had chosen the longer coverage.
Without a better bridge between postpartum and primary care, she notes, “we will not see the full value of extended Medicaid coverage.”
“The findings of Clapp et al. suggest that a relatively low-resource, scalable intervention including default scheduling of postpartum-to-primary care appointments and salient messaging could increase the use of primary care in the postpartum year to extend the effects of this policy.”
Still, Only 40% Used Primary Care
She noted, however, that despite the finding that the intervention in this study nearly doubled the percentage of primary care visits in 4 months, primary care use still was only 40%. Study staff were not able to schedule an appointment for 24% of the intervention group within a year, even though participants identified a PCP at enrollment. Reasons for that included the patient already having used their yearly primary care visit; patients needing to restart care with their primary care clinician or choose a new clinician; and study staff being unable to reach primary care offices for scheduling.
Clearly, “there is more work to be done to remove administrative barriers to care after delivery,” she writes.
Dr. Clapp reports holding equity from the Delfina Care Scientific Advisory Board outside the submitted work. Coauthor Dr. Ganguli reports grants from the National Institute on Aging, Commonwealth Fund, and Arnold Ventures, and personal fees from FPrime outside the submitted work. Dr. Cohen reports grants from the National Academy of Medicine and the National Academy on Aging during the conduct of the study. The study was funded by the National Institute on Aging via the Massachusetts Institute of Technology Roybal Center for Translational Research to Improve Health Care for the Aging and the National Bureau of Economic Research Roybal Center for Behavior Change in Health. Editorialist Meghan Bellerose reported no relevant financial disclosures.
, according to study results published in JAMA Network Open. The intervention bundle includes default scheduling of postpartum primary care appointments and tailored reminders and messaging.
Researchers, led by Mark A. Clapp, MD, MPH, with Massachusetts General Hospital in Boston, highlighted a care transition gap common after a woman gives birth. More than 30% of pregnant people have at least one chronic condition and nearly 20% develop gestational diabetes or pregnancy-related hypertension, which increases the risk of future chronic disease, the authors write. They are closely monitored for these conditions during pregnancy, but many face barriers in transitioning to engagement with primary care.
Scheduling appointments, difficulty in finding information, and insurance or billing issues can impede access to care. In this study, the primary outcome measure was whether women completed a primary care visit for routine or chronic condition care within 4 months of delivery.
Intervention vs Control Group
The intervention included an introduction message talking about the importance of a primary care visit and notification that a staff member would be scheduling an appointment on the patients’ behalf within a 4-month window of the estimated due date (EDD). Patients could opt out or ask for specific scheduling. If a patient had already seen their primary care physician (PCP) for an annual visit within the year, they were scheduled for an annual visit when they were next eligible, even if outside the 4-month study follow-up.
For those who did not opt out and had appointments scheduled for them, reminders were sent about 1 month after the EDD and 1 week before the scheduled appointment through the EHR patient portal. Salient labeling of the message was used to describe the visit. For those for whom an appointment could not be scheduled, similar reminders were sent on the importance of primary care follow-up, urging patients to contact their primary care office directly to schedule. Reminders included evidence-based, best-practice wording including that “the appointment had been reserved for them.”
Patients in the control group received one message within 2 weeks of the EDD with a generic recommendation for primary care follow-up after delivery.
Researchers found that 40% of the intervention group (95% confidence interval (CI), 33.1%-47.4%) and 22% of the control group (95% CI, 6.4%-28.8%), completed a primary care visit within 4 months. “[T]he intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points),” they write. Those who received the intervention also had fewer postpartum readmissions (1.7% vs 5.8%) and were more likely to have had these services from a PCP: blood pressure screening (42.8% vs 28.3%); weight assessment (42.8% vs 27.7%); and depression screening (32.8% vs 16.8%).
Meghan Bellerose, MPH, with the Department of Health Services, Policy, and Practice at Brown University School of Public Health in Providence, Rhode Island, described in an accompanying editorial the “postpartum cliff.”
“Health system engagement plummets soon after childbirth in the US,” she writes. “Under current care practices, obstetric clinicians deliver a single postpartum visit within 12 weeks of delivery, after which patients are responsible for navigating the transition to primary care on their own.”
The intervention Dr. Clapp and colleagues propose could help increase the benefit of state and federal policies aimed at increasing care continuity after delivery, she writes. She pointed to the American Rescue Plan Act of 2021, in which states were given the option to provide 12 months of continuous Medicaid coverage to low-income postpartum women, up from the previous 2 months of coverage. By early May of 2024, 46 states had chosen the longer coverage.
Without a better bridge between postpartum and primary care, she notes, “we will not see the full value of extended Medicaid coverage.”
“The findings of Clapp et al. suggest that a relatively low-resource, scalable intervention including default scheduling of postpartum-to-primary care appointments and salient messaging could increase the use of primary care in the postpartum year to extend the effects of this policy.”
Still, Only 40% Used Primary Care
She noted, however, that despite the finding that the intervention in this study nearly doubled the percentage of primary care visits in 4 months, primary care use still was only 40%. Study staff were not able to schedule an appointment for 24% of the intervention group within a year, even though participants identified a PCP at enrollment. Reasons for that included the patient already having used their yearly primary care visit; patients needing to restart care with their primary care clinician or choose a new clinician; and study staff being unable to reach primary care offices for scheduling.
Clearly, “there is more work to be done to remove administrative barriers to care after delivery,” she writes.
Dr. Clapp reports holding equity from the Delfina Care Scientific Advisory Board outside the submitted work. Coauthor Dr. Ganguli reports grants from the National Institute on Aging, Commonwealth Fund, and Arnold Ventures, and personal fees from FPrime outside the submitted work. Dr. Cohen reports grants from the National Academy of Medicine and the National Academy on Aging during the conduct of the study. The study was funded by the National Institute on Aging via the Massachusetts Institute of Technology Roybal Center for Translational Research to Improve Health Care for the Aging and the National Bureau of Economic Research Roybal Center for Behavior Change in Health. Editorialist Meghan Bellerose reported no relevant financial disclosures.
, according to study results published in JAMA Network Open. The intervention bundle includes default scheduling of postpartum primary care appointments and tailored reminders and messaging.
Researchers, led by Mark A. Clapp, MD, MPH, with Massachusetts General Hospital in Boston, highlighted a care transition gap common after a woman gives birth. More than 30% of pregnant people have at least one chronic condition and nearly 20% develop gestational diabetes or pregnancy-related hypertension, which increases the risk of future chronic disease, the authors write. They are closely monitored for these conditions during pregnancy, but many face barriers in transitioning to engagement with primary care.
Scheduling appointments, difficulty in finding information, and insurance or billing issues can impede access to care. In this study, the primary outcome measure was whether women completed a primary care visit for routine or chronic condition care within 4 months of delivery.
Intervention vs Control Group
The intervention included an introduction message talking about the importance of a primary care visit and notification that a staff member would be scheduling an appointment on the patients’ behalf within a 4-month window of the estimated due date (EDD). Patients could opt out or ask for specific scheduling. If a patient had already seen their primary care physician (PCP) for an annual visit within the year, they were scheduled for an annual visit when they were next eligible, even if outside the 4-month study follow-up.
For those who did not opt out and had appointments scheduled for them, reminders were sent about 1 month after the EDD and 1 week before the scheduled appointment through the EHR patient portal. Salient labeling of the message was used to describe the visit. For those for whom an appointment could not be scheduled, similar reminders were sent on the importance of primary care follow-up, urging patients to contact their primary care office directly to schedule. Reminders included evidence-based, best-practice wording including that “the appointment had been reserved for them.”
Patients in the control group received one message within 2 weeks of the EDD with a generic recommendation for primary care follow-up after delivery.
Researchers found that 40% of the intervention group (95% confidence interval (CI), 33.1%-47.4%) and 22% of the control group (95% CI, 6.4%-28.8%), completed a primary care visit within 4 months. “[T]he intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points),” they write. Those who received the intervention also had fewer postpartum readmissions (1.7% vs 5.8%) and were more likely to have had these services from a PCP: blood pressure screening (42.8% vs 28.3%); weight assessment (42.8% vs 27.7%); and depression screening (32.8% vs 16.8%).
Meghan Bellerose, MPH, with the Department of Health Services, Policy, and Practice at Brown University School of Public Health in Providence, Rhode Island, described in an accompanying editorial the “postpartum cliff.”
“Health system engagement plummets soon after childbirth in the US,” she writes. “Under current care practices, obstetric clinicians deliver a single postpartum visit within 12 weeks of delivery, after which patients are responsible for navigating the transition to primary care on their own.”
The intervention Dr. Clapp and colleagues propose could help increase the benefit of state and federal policies aimed at increasing care continuity after delivery, she writes. She pointed to the American Rescue Plan Act of 2021, in which states were given the option to provide 12 months of continuous Medicaid coverage to low-income postpartum women, up from the previous 2 months of coverage. By early May of 2024, 46 states had chosen the longer coverage.
Without a better bridge between postpartum and primary care, she notes, “we will not see the full value of extended Medicaid coverage.”
“The findings of Clapp et al. suggest that a relatively low-resource, scalable intervention including default scheduling of postpartum-to-primary care appointments and salient messaging could increase the use of primary care in the postpartum year to extend the effects of this policy.”
Still, Only 40% Used Primary Care
She noted, however, that despite the finding that the intervention in this study nearly doubled the percentage of primary care visits in 4 months, primary care use still was only 40%. Study staff were not able to schedule an appointment for 24% of the intervention group within a year, even though participants identified a PCP at enrollment. Reasons for that included the patient already having used their yearly primary care visit; patients needing to restart care with their primary care clinician or choose a new clinician; and study staff being unable to reach primary care offices for scheduling.
Clearly, “there is more work to be done to remove administrative barriers to care after delivery,” she writes.
Dr. Clapp reports holding equity from the Delfina Care Scientific Advisory Board outside the submitted work. Coauthor Dr. Ganguli reports grants from the National Institute on Aging, Commonwealth Fund, and Arnold Ventures, and personal fees from FPrime outside the submitted work. Dr. Cohen reports grants from the National Academy of Medicine and the National Academy on Aging during the conduct of the study. The study was funded by the National Institute on Aging via the Massachusetts Institute of Technology Roybal Center for Translational Research to Improve Health Care for the Aging and the National Bureau of Economic Research Roybal Center for Behavior Change in Health. Editorialist Meghan Bellerose reported no relevant financial disclosures.
FROM JAMA NETWORK OPEN