Type 2 diabetes was associated with a 20% increased risk of tooth loss after adjusting for multiple other risk factors in a meta-analysis of 22 recent observational studies from around the world.

The risk of tooth loss with type 2 diabetes (versus no diabetes) ranged from 15% higher in cross-sectional studies to 29% higher in cohort studies to five times higher in case-control studies.

“For diabetes, there are various known complications that are considered in [patient] treatment and management, including neuropathy, nephropathy, cardiovascular [disease] and hypertension, and kidney disease,” senior author Abdolhalim Rajabi, PhD, told this news organization in an email.

“However, a chronic complication of this disease, which may be less noticeable and less tangible, is missing teeth, which can also exacerbate other complications in patients with diabetes,” Dr. Rajabi, a biostatistician at Golestan University of Medical Sciences, Gorgan, Iran, continued.

The meta-analysis showed that “physicians should pay attention to [dental health] in the management and control of diabetic patients,” he summarized.

The analysis by Amir Reza Ahmadian, DDS, dean of the Faculty of Dentistry, Golestan University of Medical Sciences, and colleagues was recently published in BMC Endocrine Disorders.

“Our study is the first comprehensive meta-analysis about the association between [type 2 diabetes] and tooth loss,” Dr. Ahmadian and colleagues write. It summarizes articles in dentistry and medicine about “an important question:” the relationship between type 2 diabetes and tooth loss.  

Nevertheless, “large-scale prospective studies are needed to validate the current results in the future,” they conclude.
 

Oral complications of diabetes

Diabetes increases the risk of oral disease directly by a gingival inflammatory response and indirectly by decreased saliva production due to antidiabetic medications.

Oral complications arising from this include dry mouth, tooth decay, and periodontal disease (gum disease). The latter ranges from gingivitis (gum inflammation) to severe periodontal disease (periodontitis) that can lead to tooth loss, the authors explain.

About a third of people with diabetes have severe periodontal disease, and the American Diabetes Association estimates that one in five cases of tooth loss in adults is related to diabetes.

Tooth loss has decreased over the past decades but is still a major health problem and is associated with poorer quality of life as well as risk of cardiovascular disease, hypertension, stroke, and cancer.

Previous studies and meta-analyses of the relationship between type 2 diabetes and tooth loss have reported inconsistent findings, and they did not include several more recent studies.

Therefore, Dr. Ahmadian and colleagues performed a meta-analysis of 13 cross-sectional, six cohort, and three case-control studies that investigated the link between type 2 diabetes and tooth loss published from 2007 to 2021.

Eleven studies were from North and South America: Brazil (2), Columbia (1), Mexico (2), and the United States (6). Seven studies were from Europe: Belgium (1), Finland (2), France (1), Germany (2), and Portugal (1). Four studies were from the Middle East and Asia: Saudi Arabia (1), South Korea (1), Thailand (1), and Yemen (1).

Diabetes was diagnosed based on glucose or A1c levels in half the studies and based on self-report in the other studies. Most studies investigated any tooth loss (16 studies) and the rest only considered loss of five or more teeth.

The meta-analysis included 677,532 patients, ranging from 60 to 379,021 patients per study. Most studies (77%) were judged to be of moderate or high quality.

The studies adjusted for confounders, including age, sex, place of residence, education, lifestyle factors (smoking, alcohol consumption, physical activity), use of medications and vitamin supplements, and health insurance.

Overall, after adjusting for confounders, participants with type 2 diabetes had a significantly (20%) greater risk of tooth loss than participants without diabetes (adjusted odds ratio, 1.20; P < 0.001).

The association persisted in the different study types. The risk of tooth loss was highest in the case-control studies (OR, 5.10), but was also significantly higher in the cohort (OR, 1.29) and cross-sectional studies (OR, 1.15).

The association “was also present in other subgroups, including ... method of diagnosing type 2 diabetes, continent, study quality, and number of tooth loss,” the researchers write.

“This event seems to be in line with what has been reported in other epidemiologic studies, as several cases have supported the link between diabetes, periodontal disease, and tooth decay,” which “are two common reasons for the endpoint of the tooth loss parameter,” they note.

The researchers did not find any publication bias. However, most of the studies were cross-sectional, so they cannot determine a causal relationship between diabetes and tooth loss.

The authors have reported no relevant financial disclosures.

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

Type 2 diabetes was associated with a 20% increased risk of tooth loss after adjusting for multiple other risk factors in a meta-analysis of 22 recent observational studies from around the world.

The risk of tooth loss with type 2 diabetes (versus no diabetes) ranged from 15% higher in cross-sectional studies to 29% higher in cohort studies to five times higher in case-control studies.

“For diabetes, there are various known complications that are considered in [patient] treatment and management, including neuropathy, nephropathy, cardiovascular [disease] and hypertension, and kidney disease,” senior author Abdolhalim Rajabi, PhD, told this news organization in an email.

“However, a chronic complication of this disease, which may be less noticeable and less tangible, is missing teeth, which can also exacerbate other complications in patients with diabetes,” Dr. Rajabi, a biostatistician at Golestan University of Medical Sciences, Gorgan, Iran, continued.

The meta-analysis showed that “physicians should pay attention to [dental health] in the management and control of diabetic patients,” he summarized.

The analysis by Amir Reza Ahmadian, DDS, dean of the Faculty of Dentistry, Golestan University of Medical Sciences, and colleagues was recently published in BMC Endocrine Disorders.

“Our study is the first comprehensive meta-analysis about the association between [type 2 diabetes] and tooth loss,” Dr. Ahmadian and colleagues write. It summarizes articles in dentistry and medicine about “an important question:” the relationship between type 2 diabetes and tooth loss.  

Nevertheless, “large-scale prospective studies are needed to validate the current results in the future,” they conclude.
 

Oral complications of diabetes

Diabetes increases the risk of oral disease directly by a gingival inflammatory response and indirectly by decreased saliva production due to antidiabetic medications.

Oral complications arising from this include dry mouth, tooth decay, and periodontal disease (gum disease). The latter ranges from gingivitis (gum inflammation) to severe periodontal disease (periodontitis) that can lead to tooth loss, the authors explain.

About a third of people with diabetes have severe periodontal disease, and the American Diabetes Association estimates that one in five cases of tooth loss in adults is related to diabetes.

Tooth loss has decreased over the past decades but is still a major health problem and is associated with poorer quality of life as well as risk of cardiovascular disease, hypertension, stroke, and cancer.

Previous studies and meta-analyses of the relationship between type 2 diabetes and tooth loss have reported inconsistent findings, and they did not include several more recent studies.

Therefore, Dr. Ahmadian and colleagues performed a meta-analysis of 13 cross-sectional, six cohort, and three case-control studies that investigated the link between type 2 diabetes and tooth loss published from 2007 to 2021.

Eleven studies were from North and South America: Brazil (2), Columbia (1), Mexico (2), and the United States (6). Seven studies were from Europe: Belgium (1), Finland (2), France (1), Germany (2), and Portugal (1). Four studies were from the Middle East and Asia: Saudi Arabia (1), South Korea (1), Thailand (1), and Yemen (1).

Diabetes was diagnosed based on glucose or A1c levels in half the studies and based on self-report in the other studies. Most studies investigated any tooth loss (16 studies) and the rest only considered loss of five or more teeth.

The meta-analysis included 677,532 patients, ranging from 60 to 379,021 patients per study. Most studies (77%) were judged to be of moderate or high quality.

The studies adjusted for confounders, including age, sex, place of residence, education, lifestyle factors (smoking, alcohol consumption, physical activity), use of medications and vitamin supplements, and health insurance.

Overall, after adjusting for confounders, participants with type 2 diabetes had a significantly (20%) greater risk of tooth loss than participants without diabetes (adjusted odds ratio, 1.20; P < 0.001).

The association persisted in the different study types. The risk of tooth loss was highest in the case-control studies (OR, 5.10), but was also significantly higher in the cohort (OR, 1.29) and cross-sectional studies (OR, 1.15).

The association “was also present in other subgroups, including ... method of diagnosing type 2 diabetes, continent, study quality, and number of tooth loss,” the researchers write.

“This event seems to be in line with what has been reported in other epidemiologic studies, as several cases have supported the link between diabetes, periodontal disease, and tooth decay,” which “are two common reasons for the endpoint of the tooth loss parameter,” they note.

The researchers did not find any publication bias. However, most of the studies were cross-sectional, so they cannot determine a causal relationship between diabetes and tooth loss.

The authors have reported no relevant financial disclosures.

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

Type 2 diabetes was associated with a 20% increased risk of tooth loss after adjusting for multiple other risk factors in a meta-analysis of 22 recent observational studies from around the world.

The risk of tooth loss with type 2 diabetes (versus no diabetes) ranged from 15% higher in cross-sectional studies to 29% higher in cohort studies to five times higher in case-control studies.

“For diabetes, there are various known complications that are considered in [patient] treatment and management, including neuropathy, nephropathy, cardiovascular [disease] and hypertension, and kidney disease,” senior author Abdolhalim Rajabi, PhD, told this news organization in an email.

“However, a chronic complication of this disease, which may be less noticeable and less tangible, is missing teeth, which can also exacerbate other complications in patients with diabetes,” Dr. Rajabi, a biostatistician at Golestan University of Medical Sciences, Gorgan, Iran, continued.

The meta-analysis showed that “physicians should pay attention to [dental health] in the management and control of diabetic patients,” he summarized.

The analysis by Amir Reza Ahmadian, DDS, dean of the Faculty of Dentistry, Golestan University of Medical Sciences, and colleagues was recently published in BMC Endocrine Disorders.

“Our study is the first comprehensive meta-analysis about the association between [type 2 diabetes] and tooth loss,” Dr. Ahmadian and colleagues write. It summarizes articles in dentistry and medicine about “an important question:” the relationship between type 2 diabetes and tooth loss.  

Nevertheless, “large-scale prospective studies are needed to validate the current results in the future,” they conclude.
 

Oral complications of diabetes

Diabetes increases the risk of oral disease directly by a gingival inflammatory response and indirectly by decreased saliva production due to antidiabetic medications.

Oral complications arising from this include dry mouth, tooth decay, and periodontal disease (gum disease). The latter ranges from gingivitis (gum inflammation) to severe periodontal disease (periodontitis) that can lead to tooth loss, the authors explain.

About a third of people with diabetes have severe periodontal disease, and the American Diabetes Association estimates that one in five cases of tooth loss in adults is related to diabetes.

Tooth loss has decreased over the past decades but is still a major health problem and is associated with poorer quality of life as well as risk of cardiovascular disease, hypertension, stroke, and cancer.

Previous studies and meta-analyses of the relationship between type 2 diabetes and tooth loss have reported inconsistent findings, and they did not include several more recent studies.

Therefore, Dr. Ahmadian and colleagues performed a meta-analysis of 13 cross-sectional, six cohort, and three case-control studies that investigated the link between type 2 diabetes and tooth loss published from 2007 to 2021.

Eleven studies were from North and South America: Brazil (2), Columbia (1), Mexico (2), and the United States (6). Seven studies were from Europe: Belgium (1), Finland (2), France (1), Germany (2), and Portugal (1). Four studies were from the Middle East and Asia: Saudi Arabia (1), South Korea (1), Thailand (1), and Yemen (1).

Diabetes was diagnosed based on glucose or A1c levels in half the studies and based on self-report in the other studies. Most studies investigated any tooth loss (16 studies) and the rest only considered loss of five or more teeth.

The meta-analysis included 677,532 patients, ranging from 60 to 379,021 patients per study. Most studies (77%) were judged to be of moderate or high quality.

The studies adjusted for confounders, including age, sex, place of residence, education, lifestyle factors (smoking, alcohol consumption, physical activity), use of medications and vitamin supplements, and health insurance.

Overall, after adjusting for confounders, participants with type 2 diabetes had a significantly (20%) greater risk of tooth loss than participants without diabetes (adjusted odds ratio, 1.20; P < 0.001).

The association persisted in the different study types. The risk of tooth loss was highest in the case-control studies (OR, 5.10), but was also significantly higher in the cohort (OR, 1.29) and cross-sectional studies (OR, 1.15).

The association “was also present in other subgroups, including ... method of diagnosing type 2 diabetes, continent, study quality, and number of tooth loss,” the researchers write.

“This event seems to be in line with what has been reported in other epidemiologic studies, as several cases have supported the link between diabetes, periodontal disease, and tooth decay,” which “are two common reasons for the endpoint of the tooth loss parameter,” they note.

The researchers did not find any publication bias. However, most of the studies were cross-sectional, so they cannot determine a causal relationship between diabetes and tooth loss.

The authors have reported no relevant financial disclosures.

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

The Food and Drug Administration announced on May 10 that it is taking several steps to improve the supply of baby formula in the United States.

The nationwide formula shortage has grown worse in recent weeks due to supply chain issues and a recall of certain Abbott Nutrition products, including major labels such as Similac, Alimentum, and EleCare.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert Califf, MD, said in a statement.

“We are doing everything in our power to ensure there is adequate product available where and when they need it,” he said.

About three-quarters of babies are fed formula for the first 6 months of their lives as a substitute for human milk, Axios reported.

In mid-February, the FDA warned consumers not to use certain powdered infant formula products from Abbott’s facility in Sturgis, Mich. Since then, the FDA has been working with Abbott and other manufacturers to increase the supply in the U.S. market.

“In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand,” the FDA said in the statement. “Notably, more infant formula was purchased in the month of April than in the month prior to the recall.”

The FDA released a list of steps the agency is taking to increase supply, such as meeting with major infant formula makers to increase output and prioritize product lines in high demand, particularly specialty formulas for infants with allergies or specific diet needs.

But other manufacturers have struggled to quickly increase production because their operations tend to focus on a steady level of supply, according to The New York Times.

“Some industries are very good at ramping up and ramping down,” Rudi Leuschner, PhD, an associate professor of supply chain management at Rutgers Business School, Newark, N.J., told the newspaper.

“You flip a switch and they can produce 10 times as much,” he said. “Baby formula is not that type of a product.”

The FDA is also keeping an eye on the infant formula shortage by using the agency’s 21 Forward food supply chain continuity system. The system was developed during the pandemic to provide a full understanding of how COVID-19 is impacting food supply chains, the FDA said.

The FDA is compiling data on trends for in-stock rates at national and regional levels to understand where infant formula is available and where it should go.

Products are also being brought in from other countries, the FDA said. The agency is trying to speed up the process to get more formula into the U.S. and move it more quickly around the country.

For babies on a special diet, the FDA has decided to release some Abbott products that have been on hold at the Sturgis facility to those who need an urgent supply of metabolic formulas, on a case-by-case basis.

“In these circumstances, the benefit of allowing caregivers, in consultation with their health care providers, to access these products may outweigh the potential risk of bacterial infection,” the FDA said in the statement.

The FDA continues to advise against making homemade infant formulas and recommends talking to the child’s health care provider for recommendations on changing feeding practices or switching to other formulas, if necessary.

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

The Food and Drug Administration announced on May 10 that it is taking several steps to improve the supply of baby formula in the United States.

The nationwide formula shortage has grown worse in recent weeks due to supply chain issues and a recall of certain Abbott Nutrition products, including major labels such as Similac, Alimentum, and EleCare.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert Califf, MD, said in a statement.

“We are doing everything in our power to ensure there is adequate product available where and when they need it,” he said.

About three-quarters of babies are fed formula for the first 6 months of their lives as a substitute for human milk, Axios reported.

In mid-February, the FDA warned consumers not to use certain powdered infant formula products from Abbott’s facility in Sturgis, Mich. Since then, the FDA has been working with Abbott and other manufacturers to increase the supply in the U.S. market.

“In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand,” the FDA said in the statement. “Notably, more infant formula was purchased in the month of April than in the month prior to the recall.”

The FDA released a list of steps the agency is taking to increase supply, such as meeting with major infant formula makers to increase output and prioritize product lines in high demand, particularly specialty formulas for infants with allergies or specific diet needs.

But other manufacturers have struggled to quickly increase production because their operations tend to focus on a steady level of supply, according to The New York Times.

“Some industries are very good at ramping up and ramping down,” Rudi Leuschner, PhD, an associate professor of supply chain management at Rutgers Business School, Newark, N.J., told the newspaper.

“You flip a switch and they can produce 10 times as much,” he said. “Baby formula is not that type of a product.”

The FDA is also keeping an eye on the infant formula shortage by using the agency’s 21 Forward food supply chain continuity system. The system was developed during the pandemic to provide a full understanding of how COVID-19 is impacting food supply chains, the FDA said.

The FDA is compiling data on trends for in-stock rates at national and regional levels to understand where infant formula is available and where it should go.

Products are also being brought in from other countries, the FDA said. The agency is trying to speed up the process to get more formula into the U.S. and move it more quickly around the country.

For babies on a special diet, the FDA has decided to release some Abbott products that have been on hold at the Sturgis facility to those who need an urgent supply of metabolic formulas, on a case-by-case basis.

“In these circumstances, the benefit of allowing caregivers, in consultation with their health care providers, to access these products may outweigh the potential risk of bacterial infection,” the FDA said in the statement.

The FDA continues to advise against making homemade infant formulas and recommends talking to the child’s health care provider for recommendations on changing feeding practices or switching to other formulas, if necessary.

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

The Food and Drug Administration announced on May 10 that it is taking several steps to improve the supply of baby formula in the United States.

The nationwide formula shortage has grown worse in recent weeks due to supply chain issues and a recall of certain Abbott Nutrition products, including major labels such as Similac, Alimentum, and EleCare.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert Califf, MD, said in a statement.

“We are doing everything in our power to ensure there is adequate product available where and when they need it,” he said.

About three-quarters of babies are fed formula for the first 6 months of their lives as a substitute for human milk, Axios reported.

In mid-February, the FDA warned consumers not to use certain powdered infant formula products from Abbott’s facility in Sturgis, Mich. Since then, the FDA has been working with Abbott and other manufacturers to increase the supply in the U.S. market.

“In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand,” the FDA said in the statement. “Notably, more infant formula was purchased in the month of April than in the month prior to the recall.”

The FDA released a list of steps the agency is taking to increase supply, such as meeting with major infant formula makers to increase output and prioritize product lines in high demand, particularly specialty formulas for infants with allergies or specific diet needs.

But other manufacturers have struggled to quickly increase production because their operations tend to focus on a steady level of supply, according to The New York Times.

“Some industries are very good at ramping up and ramping down,” Rudi Leuschner, PhD, an associate professor of supply chain management at Rutgers Business School, Newark, N.J., told the newspaper.

“You flip a switch and they can produce 10 times as much,” he said. “Baby formula is not that type of a product.”

The FDA is also keeping an eye on the infant formula shortage by using the agency’s 21 Forward food supply chain continuity system. The system was developed during the pandemic to provide a full understanding of how COVID-19 is impacting food supply chains, the FDA said.

The FDA is compiling data on trends for in-stock rates at national and regional levels to understand where infant formula is available and where it should go.

Products are also being brought in from other countries, the FDA said. The agency is trying to speed up the process to get more formula into the U.S. and move it more quickly around the country.

For babies on a special diet, the FDA has decided to release some Abbott products that have been on hold at the Sturgis facility to those who need an urgent supply of metabolic formulas, on a case-by-case basis.

“In these circumstances, the benefit of allowing caregivers, in consultation with their health care providers, to access these products may outweigh the potential risk of bacterial infection,” the FDA said in the statement.

The FDA continues to advise against making homemade infant formulas and recommends talking to the child’s health care provider for recommendations on changing feeding practices or switching to other formulas, if necessary.

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

Reduced exercise capacity and peak ventilation were significant predictors of early mortality in adults with chronic obstructive pulmonary disease, based on data from 126 individuals.

Cardiopulmonary exercise testing (CPET) is a common assessment for cardiorespiratory disease patients, but its role as a predictor of clinically relevant outcomes in chronic obstructive pulmonary disease (COPD) has not been investigated, and data on changes in exercise capacity over time in COPD patients are limited, wrote Cassia da Luz Goulart, MD, of the Federal University of São Carlos, Brazil, and colleagues.

The researchers hypothesized that CPET threshold values could be used as predictors of mortality in COPD.

In a prospective study published in Respiratory Medicine, the researchers identified 126 adults with COPD who were followed for 42 months. At study entry, each patient completed a clinical evaluation, followed by a pulmonary function test and CPET. The average age of the patients was 65 years, and 73% were men. All patients were on optimal medical management for COPD.

The researchers recorded data on peak oxygen consumption (VO₂, mL/min), VCO₂ (mL/min), minute ventilation (VE, L/min), the oxygen uptake efficiency slope (OUES), and ventilatory efficiency (the VE/VCO₂ slope).

The participants performed CPET on a cycle ergometer, with breath-by-breath analysis measured throughout the test using a computer-based system.

A total of 48 patients (38%) died during the 42-month follow-up period. Overall, the significant predictors of mortality were VE/VCO₂ slope of 30 or higher, peak VE of 25.7 L/min, and peak VO₂ ≤ 13.8 mLO₂ kg^–1 min^–1 were strong predictors of mortality in COPD patients in a Cox regression analysis.

When comparing the 78 survivors to the 48 nonsurvivors, the researchers found that the nonsurvivors were significantly more likely to be women, with worse lung function, inspiratory muscle weakness, and poorer CPET responses (P < .050 for all).

“The VE peak response is directly related to the FEV₁ in COPD patients, factors such as dyspnea and increased leg discomfort negatively impact the VE response during exercise,” the researchers wrote in their discussion of the findings. In this context, our results may hold clinical utility in refining the prognostic accuracy when a patient with COPD has a VE peak ≤ 25.7 L/min,” they explained.

The study findings were limited by the inability to assess complete pulmonary function in the COPD patients, and the assessment only of three CPET measures, the researchers noted.

However, the results support the use of CPET as a clinical assessment tool for COPD patients, they said. “Moreover, therapeutic approaches, such as cardiopulmonary rehabilitation, may consider focusing on improving these metabolic and ventilatory markers as an indicator of clinical improvement and prognosis in patients with COPD,” they added.

The study was supported by the Fundação de Amparo a Pesquisa do Estado de São Paulo, Brazil, and by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil. The researchers had no financial conflicts to disclose.

Reduced exercise capacity and peak ventilation were significant predictors of early mortality in adults with chronic obstructive pulmonary disease, based on data from 126 individuals.

Cardiopulmonary exercise testing (CPET) is a common assessment for cardiorespiratory disease patients, but its role as a predictor of clinically relevant outcomes in chronic obstructive pulmonary disease (COPD) has not been investigated, and data on changes in exercise capacity over time in COPD patients are limited, wrote Cassia da Luz Goulart, MD, of the Federal University of São Carlos, Brazil, and colleagues.

The researchers hypothesized that CPET threshold values could be used as predictors of mortality in COPD.

In a prospective study published in Respiratory Medicine, the researchers identified 126 adults with COPD who were followed for 42 months. At study entry, each patient completed a clinical evaluation, followed by a pulmonary function test and CPET. The average age of the patients was 65 years, and 73% were men. All patients were on optimal medical management for COPD.

The researchers recorded data on peak oxygen consumption (VO₂, mL/min), VCO₂ (mL/min), minute ventilation (VE, L/min), the oxygen uptake efficiency slope (OUES), and ventilatory efficiency (the VE/VCO₂ slope).

The participants performed CPET on a cycle ergometer, with breath-by-breath analysis measured throughout the test using a computer-based system.

A total of 48 patients (38%) died during the 42-month follow-up period. Overall, the significant predictors of mortality were VE/VCO₂ slope of 30 or higher, peak VE of 25.7 L/min, and peak VO₂ ≤ 13.8 mLO₂ kg^–1 min^–1 were strong predictors of mortality in COPD patients in a Cox regression analysis.

When comparing the 78 survivors to the 48 nonsurvivors, the researchers found that the nonsurvivors were significantly more likely to be women, with worse lung function, inspiratory muscle weakness, and poorer CPET responses (P < .050 for all).

“The VE peak response is directly related to the FEV₁ in COPD patients, factors such as dyspnea and increased leg discomfort negatively impact the VE response during exercise,” the researchers wrote in their discussion of the findings. In this context, our results may hold clinical utility in refining the prognostic accuracy when a patient with COPD has a VE peak ≤ 25.7 L/min,” they explained.

The study findings were limited by the inability to assess complete pulmonary function in the COPD patients, and the assessment only of three CPET measures, the researchers noted.

However, the results support the use of CPET as a clinical assessment tool for COPD patients, they said. “Moreover, therapeutic approaches, such as cardiopulmonary rehabilitation, may consider focusing on improving these metabolic and ventilatory markers as an indicator of clinical improvement and prognosis in patients with COPD,” they added.

The study was supported by the Fundação de Amparo a Pesquisa do Estado de São Paulo, Brazil, and by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil. The researchers had no financial conflicts to disclose.

Reduced exercise capacity and peak ventilation were significant predictors of early mortality in adults with chronic obstructive pulmonary disease, based on data from 126 individuals.

Cardiopulmonary exercise testing (CPET) is a common assessment for cardiorespiratory disease patients, but its role as a predictor of clinically relevant outcomes in chronic obstructive pulmonary disease (COPD) has not been investigated, and data on changes in exercise capacity over time in COPD patients are limited, wrote Cassia da Luz Goulart, MD, of the Federal University of São Carlos, Brazil, and colleagues.

The researchers hypothesized that CPET threshold values could be used as predictors of mortality in COPD.

In a prospective study published in Respiratory Medicine, the researchers identified 126 adults with COPD who were followed for 42 months. At study entry, each patient completed a clinical evaluation, followed by a pulmonary function test and CPET. The average age of the patients was 65 years, and 73% were men. All patients were on optimal medical management for COPD.

The researchers recorded data on peak oxygen consumption (VO₂, mL/min), VCO₂ (mL/min), minute ventilation (VE, L/min), the oxygen uptake efficiency slope (OUES), and ventilatory efficiency (the VE/VCO₂ slope).

The participants performed CPET on a cycle ergometer, with breath-by-breath analysis measured throughout the test using a computer-based system.

A total of 48 patients (38%) died during the 42-month follow-up period. Overall, the significant predictors of mortality were VE/VCO₂ slope of 30 or higher, peak VE of 25.7 L/min, and peak VO₂ ≤ 13.8 mLO₂ kg^–1 min^–1 were strong predictors of mortality in COPD patients in a Cox regression analysis.

When comparing the 78 survivors to the 48 nonsurvivors, the researchers found that the nonsurvivors were significantly more likely to be women, with worse lung function, inspiratory muscle weakness, and poorer CPET responses (P < .050 for all).

“The VE peak response is directly related to the FEV₁ in COPD patients, factors such as dyspnea and increased leg discomfort negatively impact the VE response during exercise,” the researchers wrote in their discussion of the findings. In this context, our results may hold clinical utility in refining the prognostic accuracy when a patient with COPD has a VE peak ≤ 25.7 L/min,” they explained.

The study findings were limited by the inability to assess complete pulmonary function in the COPD patients, and the assessment only of three CPET measures, the researchers noted.

However, the results support the use of CPET as a clinical assessment tool for COPD patients, they said. “Moreover, therapeutic approaches, such as cardiopulmonary rehabilitation, may consider focusing on improving these metabolic and ventilatory markers as an indicator of clinical improvement and prognosis in patients with COPD,” they added.

The study was supported by the Fundação de Amparo a Pesquisa do Estado de São Paulo, Brazil, and by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil. The researchers had no financial conflicts to disclose.

Transplanting fecal microbiota from young mice into older mice can reverse signs of aging in the gut, brain, and eyes, a team of scientists from the United Kingdom has found. Conversely, transplanting microbiota from old mice to young mice has the opposite effect.

This research provides “tantalizing evidence for the direct involvement of gut microbes in aging and the functional decline of brain function and vision and offers a potential solution in the form of gut microbe replacement therapy,” Simon Carding, PhD, who heads the gut microbes and health research program at the Quadram Institute in Norwich, England, said in a news release.

The study was published online in the journal Microbiome.

The fountain of youth?

Age-related changes in diversity, composition, and function of the gut microbiota are associated with low-grade systemic inflammation, declining tissue function, and increased susceptibility to age-related chronic diseases.

Dr. Carding and colleagues at the Quadram Institute and the University of East Anglia used fecal microbiota transplant (FMT) to exchange the intestinal microbiota of young mice and aged mice.

Young mice who received aged microbiota showed increased intestinal barrier permeability (leaky gut) coupled with upregulated inflammation in the brain and retina, as well as loss of a key functional protein in the eye, they report.

Conversely, these detrimental effects were reversed when microbiota from young mice was transferred to aged mice. FMT with young microbiota also led to enrichment of beneficial taxa in aged mice.

“Our data support the suggestion that altered gut microbiota in old age contributes to intestinal and systemic inflammation, and so may contribute to driving inflammatory pathologies of aged organs,” the study team wrote.

“Targeting the gut-brain axis in aging, by modification of microbial composition to modulate immune and metabolic pathways, may therefore be a potential avenue for therapeutic approaches to age-associated inflammatory and functional decline,” they suggested.

In ongoing studies, the study team are working to understand how long the beneficial effects of young donor microbiota last, which will establish whether FMT can promote long-term health benefits in aged individuals and ameliorate age-associated neurodegeneration and retinal functional deterioration.

“Our results provide more evidence of the important links between microbes in the gut and healthy aging of tissues and organs around the body,” lead author Aimée Parker, PhD, from the Quadram Institute, said in the release.

“We hope that our findings will contribute ultimately to understanding how we can manipulate our diet and our gut bacteria to maximize good health in later life,” she added.

Support for this research was provided by the Biotechnology and Biological Sciences Research Council. The authors report no relevant financial relationships .

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

Transplanting fecal microbiota from young mice into older mice can reverse signs of aging in the gut, brain, and eyes, a team of scientists from the United Kingdom has found. Conversely, transplanting microbiota from old mice to young mice has the opposite effect.

This research provides “tantalizing evidence for the direct involvement of gut microbes in aging and the functional decline of brain function and vision and offers a potential solution in the form of gut microbe replacement therapy,” Simon Carding, PhD, who heads the gut microbes and health research program at the Quadram Institute in Norwich, England, said in a news release.

The study was published online in the journal Microbiome.

The fountain of youth?

Age-related changes in diversity, composition, and function of the gut microbiota are associated with low-grade systemic inflammation, declining tissue function, and increased susceptibility to age-related chronic diseases.

Dr. Carding and colleagues at the Quadram Institute and the University of East Anglia used fecal microbiota transplant (FMT) to exchange the intestinal microbiota of young mice and aged mice.

Young mice who received aged microbiota showed increased intestinal barrier permeability (leaky gut) coupled with upregulated inflammation in the brain and retina, as well as loss of a key functional protein in the eye, they report.

Conversely, these detrimental effects were reversed when microbiota from young mice was transferred to aged mice. FMT with young microbiota also led to enrichment of beneficial taxa in aged mice.

“Our data support the suggestion that altered gut microbiota in old age contributes to intestinal and systemic inflammation, and so may contribute to driving inflammatory pathologies of aged organs,” the study team wrote.

“Targeting the gut-brain axis in aging, by modification of microbial composition to modulate immune and metabolic pathways, may therefore be a potential avenue for therapeutic approaches to age-associated inflammatory and functional decline,” they suggested.

In ongoing studies, the study team are working to understand how long the beneficial effects of young donor microbiota last, which will establish whether FMT can promote long-term health benefits in aged individuals and ameliorate age-associated neurodegeneration and retinal functional deterioration.

“Our results provide more evidence of the important links between microbes in the gut and healthy aging of tissues and organs around the body,” lead author Aimée Parker, PhD, from the Quadram Institute, said in the release.

“We hope that our findings will contribute ultimately to understanding how we can manipulate our diet and our gut bacteria to maximize good health in later life,” she added.

Support for this research was provided by the Biotechnology and Biological Sciences Research Council. The authors report no relevant financial relationships .

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

Transplanting fecal microbiota from young mice into older mice can reverse signs of aging in the gut, brain, and eyes, a team of scientists from the United Kingdom has found. Conversely, transplanting microbiota from old mice to young mice has the opposite effect.

This research provides “tantalizing evidence for the direct involvement of gut microbes in aging and the functional decline of brain function and vision and offers a potential solution in the form of gut microbe replacement therapy,” Simon Carding, PhD, who heads the gut microbes and health research program at the Quadram Institute in Norwich, England, said in a news release.

The study was published online in the journal Microbiome.

The fountain of youth?

Age-related changes in diversity, composition, and function of the gut microbiota are associated with low-grade systemic inflammation, declining tissue function, and increased susceptibility to age-related chronic diseases.

Dr. Carding and colleagues at the Quadram Institute and the University of East Anglia used fecal microbiota transplant (FMT) to exchange the intestinal microbiota of young mice and aged mice.

Young mice who received aged microbiota showed increased intestinal barrier permeability (leaky gut) coupled with upregulated inflammation in the brain and retina, as well as loss of a key functional protein in the eye, they report.

Conversely, these detrimental effects were reversed when microbiota from young mice was transferred to aged mice. FMT with young microbiota also led to enrichment of beneficial taxa in aged mice.

“Our data support the suggestion that altered gut microbiota in old age contributes to intestinal and systemic inflammation, and so may contribute to driving inflammatory pathologies of aged organs,” the study team wrote.

“Targeting the gut-brain axis in aging, by modification of microbial composition to modulate immune and metabolic pathways, may therefore be a potential avenue for therapeutic approaches to age-associated inflammatory and functional decline,” they suggested.

In ongoing studies, the study team are working to understand how long the beneficial effects of young donor microbiota last, which will establish whether FMT can promote long-term health benefits in aged individuals and ameliorate age-associated neurodegeneration and retinal functional deterioration.

“Our results provide more evidence of the important links between microbes in the gut and healthy aging of tissues and organs around the body,” lead author Aimée Parker, PhD, from the Quadram Institute, said in the release.

“We hope that our findings will contribute ultimately to understanding how we can manipulate our diet and our gut bacteria to maximize good health in later life,” she added.

Support for this research was provided by the Biotechnology and Biological Sciences Research Council. The authors report no relevant financial relationships .

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

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

WASHINGTON – Speaker after speaker, veteran emergency department physicians and nurses approached the podium for a May 4 press conference on the U.S. Capitol lawn across from the East Senate steps to describe violent incidents – being bitten, punched, slapped, kicked, choked, spat on, threatened – that they have both observed and have been subject to while working in EDs.

The press conference was cosponsored by the American College of Emergency Physicians and the Emergency Nurses Association, which have partnered since 2019 on the No Silence on ED Violence campaign.

Fuse/thinkstockphotos.com

The numbers confirm their experience. A 2018 poll of 3,500 ED physicians nationwide, which was conducted by Marketing General and was reported at ACEP’s annual meeting, found that nearly half of respondents had been assaulted at work; 27% of them were injured from the assault. Nurses, who spend more time with patients, may face even higher rates.

Incidence was reported to be increasing in 2018, and that was before the social and psychological upheavals imposed by the COVID pandemic caused assaults on staff in the hospital to go up an estimated 200%-300%.

But what really grated was that more than 95% of such cases, mostly perpetrated by patients, were never prosecuted, said Jennifer Casaletto, MD, FACEP, a North Carolina emergency physician and president of the state’s ACEP chapter. “Hospital and law enforcement see violence as just part of the job in our EDs.”

It’s no secret that workplace violence is increasing, Dr. Casaletto said. Four weeks ago, she stitched up the face of a charge nurse who had been assaulted. The nurse didn’t report the incident because she didn’t believe anything would change.

“Listening to my colleagues, I know the terror they have felt in the moment – for themselves, their colleagues, their patients. I know that raw fear of being attacked, and the complex emotions that follow. I’ve been hit, bit, and punched and watched colleagues getting choked.”

Dr. Casaletto was present in the ED when an out-of-control patient clubbed a nurse with an IV pole as she tried to close the doors to other patients’ rooms. “Instinctively, I pulled my stethoscope from around my neck, hoping I wouldn’t be strangled with it.”

Tennessee emergency nurse Todd Haines, MSN, RN, AEMT, CEN, said he has stepped in to help pull patients off coworkers. “I’ve seen some staff so severely injured they could not return to the bedside. I’ve been verbally threatened. My family has been threatened by patients and their families,” he reported. “We’ve all seen it. And COVID has made some people even meaner. They just lose their minds, and ED staff take the brunt of their aggression. But then to report these incidents and hear: ‘It’s just part of your job,’ well, it’s not part of my job.”

Mr. Haines spent 10 years in law enforcement with a sheriff’s department in middle Tennessee and was on its special tactical response team before becoming an ED nurse. He said he saw many more verbal and physical assaults in 11 years in the ED than during his police career.

“I love emergency nursing at the bedside, but it got to the point where I took the first chance to leave the bedside. And I’m not alone. Other nurses are leaving in droves.” Mr. Haines now has a job directing a trauma program, and he volunteers on policy issues for the Tennessee ENA. But he worries about the toll of this violence on the ED workforce, with so many professionals already mulling over leaving the field because of job stress and burnout.

“We have to do something to keep experienced hospital emergency staff at the bedside.”

What’s the answer?

Also speaking at the press conference was Senator Tammy Baldwin (D-Wis.), who pledged to introduce the Workplace Violence Prevention for Health Care and Social Services Workers Act, which passed the House in April. This bill would direct the Occupational Health and Safety Administration to issue a standard requiring employers in health care and social services to develop and implement workplace violence prevention plans. It would cover a variety of health facilities but not doctor’s offices or home-based services.

An interim final standard would be due within a year of enactment, with a final version to follow. Covered employers would have 6 months to develop and implement their own comprehensive workplace violence prevention plans, with the meaningful participation of direct care employees, tailored for and specific to the conditions and hazards of their facility, informed by past violent incidents, and subject to the size and complexity of the setting.

The plan would also name an individual responsible for its implementation, would include staff training and education, and would require facilities to track incidents and prohibit retaliation against employees who reported incidents of workplace violence.

On Wednesday, Sen. Baldwin called for unanimous consent on the Senate floor to fast-track this bill, but that was opposed by Senator Mike Braun (R-Ind.). She will soon introduce legislation similar to HR 1195, which the House passed.

“This bill will provide long overdue protections and safety standards,” she said. It will ensure that workplaces adopt proven protection techniques, such as those in OSHA’s 2015 guideline for preventing health care workplace violence. The American Hospital Association opposed the House bill on the grounds that hospitals have already implemented policies and programs specifically tailored to address workplace violence, so the OSHA standards required by the bill are not warranted.

Another speaker at the press conference, Aisha Terry, MD, MPH, FACEP, an emergency physician for George Washington University and Veterans Affairs in Washington, D.C., and current vice president of ACEP, described an incident that occurred when she was at work. A patient punched the nurse caring for him in the face, knocking her unconscious to the floor. “I’ll never forget that sound,” Dr. Terry said. “To this day, it has impacted her career. She hasn’t known what to do.”

Many people don’t realize how bad workplace violence really is, Dr. Terry added. “You assume you can serve as the safety net of this country, taking care of patients in the context of the pandemic, and feel safe – and not have to worry about your own safety. It’s past due that we put an end to this.”
 

Biggest win

Mr. Haines called the workplace violence bill a game changer for ED professionals, now and into the future. “We’re not going to totally eliminate violence in the emergency department. That is part of our business. But this legislation will support us and give a safer environment for us to do the work we love,” he said.

“The biggest win for this legislation is that it will create a supportive, nonretaliatory environment. It will give us as nurses a structured way to report things.” And, when these incidents do get reported, staff will get the help they need, Mr. Haines said. “The legislation will help show the importance of implementing systems and processes in emergency settings to address the risks and hazards that makes us all vulnerable to violence.”

No relevant financial relationships have been disclosed.

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

WASHINGTON – Speaker after speaker, veteran emergency department physicians and nurses approached the podium for a May 4 press conference on the U.S. Capitol lawn across from the East Senate steps to describe violent incidents – being bitten, punched, slapped, kicked, choked, spat on, threatened – that they have both observed and have been subject to while working in EDs.

The press conference was cosponsored by the American College of Emergency Physicians and the Emergency Nurses Association, which have partnered since 2019 on the No Silence on ED Violence campaign.

Fuse/thinkstockphotos.com

The numbers confirm their experience. A 2018 poll of 3,500 ED physicians nationwide, which was conducted by Marketing General and was reported at ACEP’s annual meeting, found that nearly half of respondents had been assaulted at work; 27% of them were injured from the assault. Nurses, who spend more time with patients, may face even higher rates.

Incidence was reported to be increasing in 2018, and that was before the social and psychological upheavals imposed by the COVID pandemic caused assaults on staff in the hospital to go up an estimated 200%-300%.

But what really grated was that more than 95% of such cases, mostly perpetrated by patients, were never prosecuted, said Jennifer Casaletto, MD, FACEP, a North Carolina emergency physician and president of the state’s ACEP chapter. “Hospital and law enforcement see violence as just part of the job in our EDs.”

It’s no secret that workplace violence is increasing, Dr. Casaletto said. Four weeks ago, she stitched up the face of a charge nurse who had been assaulted. The nurse didn’t report the incident because she didn’t believe anything would change.

“Listening to my colleagues, I know the terror they have felt in the moment – for themselves, their colleagues, their patients. I know that raw fear of being attacked, and the complex emotions that follow. I’ve been hit, bit, and punched and watched colleagues getting choked.”

Dr. Casaletto was present in the ED when an out-of-control patient clubbed a nurse with an IV pole as she tried to close the doors to other patients’ rooms. “Instinctively, I pulled my stethoscope from around my neck, hoping I wouldn’t be strangled with it.”

Tennessee emergency nurse Todd Haines, MSN, RN, AEMT, CEN, said he has stepped in to help pull patients off coworkers. “I’ve seen some staff so severely injured they could not return to the bedside. I’ve been verbally threatened. My family has been threatened by patients and their families,” he reported. “We’ve all seen it. And COVID has made some people even meaner. They just lose their minds, and ED staff take the brunt of their aggression. But then to report these incidents and hear: ‘It’s just part of your job,’ well, it’s not part of my job.”

Mr. Haines spent 10 years in law enforcement with a sheriff’s department in middle Tennessee and was on its special tactical response team before becoming an ED nurse. He said he saw many more verbal and physical assaults in 11 years in the ED than during his police career.

“I love emergency nursing at the bedside, but it got to the point where I took the first chance to leave the bedside. And I’m not alone. Other nurses are leaving in droves.” Mr. Haines now has a job directing a trauma program, and he volunteers on policy issues for the Tennessee ENA. But he worries about the toll of this violence on the ED workforce, with so many professionals already mulling over leaving the field because of job stress and burnout.

“We have to do something to keep experienced hospital emergency staff at the bedside.”

What’s the answer?

Also speaking at the press conference was Senator Tammy Baldwin (D-Wis.), who pledged to introduce the Workplace Violence Prevention for Health Care and Social Services Workers Act, which passed the House in April. This bill would direct the Occupational Health and Safety Administration to issue a standard requiring employers in health care and social services to develop and implement workplace violence prevention plans. It would cover a variety of health facilities but not doctor’s offices or home-based services.

An interim final standard would be due within a year of enactment, with a final version to follow. Covered employers would have 6 months to develop and implement their own comprehensive workplace violence prevention plans, with the meaningful participation of direct care employees, tailored for and specific to the conditions and hazards of their facility, informed by past violent incidents, and subject to the size and complexity of the setting.

The plan would also name an individual responsible for its implementation, would include staff training and education, and would require facilities to track incidents and prohibit retaliation against employees who reported incidents of workplace violence.

On Wednesday, Sen. Baldwin called for unanimous consent on the Senate floor to fast-track this bill, but that was opposed by Senator Mike Braun (R-Ind.). She will soon introduce legislation similar to HR 1195, which the House passed.

“This bill will provide long overdue protections and safety standards,” she said. It will ensure that workplaces adopt proven protection techniques, such as those in OSHA’s 2015 guideline for preventing health care workplace violence. The American Hospital Association opposed the House bill on the grounds that hospitals have already implemented policies and programs specifically tailored to address workplace violence, so the OSHA standards required by the bill are not warranted.

Another speaker at the press conference, Aisha Terry, MD, MPH, FACEP, an emergency physician for George Washington University and Veterans Affairs in Washington, D.C., and current vice president of ACEP, described an incident that occurred when she was at work. A patient punched the nurse caring for him in the face, knocking her unconscious to the floor. “I’ll never forget that sound,” Dr. Terry said. “To this day, it has impacted her career. She hasn’t known what to do.”

Many people don’t realize how bad workplace violence really is, Dr. Terry added. “You assume you can serve as the safety net of this country, taking care of patients in the context of the pandemic, and feel safe – and not have to worry about your own safety. It’s past due that we put an end to this.”
 

Biggest win

Mr. Haines called the workplace violence bill a game changer for ED professionals, now and into the future. “We’re not going to totally eliminate violence in the emergency department. That is part of our business. But this legislation will support us and give a safer environment for us to do the work we love,” he said.

“The biggest win for this legislation is that it will create a supportive, nonretaliatory environment. It will give us as nurses a structured way to report things.” And, when these incidents do get reported, staff will get the help they need, Mr. Haines said. “The legislation will help show the importance of implementing systems and processes in emergency settings to address the risks and hazards that makes us all vulnerable to violence.”

No relevant financial relationships have been disclosed.

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

WASHINGTON – Speaker after speaker, veteran emergency department physicians and nurses approached the podium for a May 4 press conference on the U.S. Capitol lawn across from the East Senate steps to describe violent incidents – being bitten, punched, slapped, kicked, choked, spat on, threatened – that they have both observed and have been subject to while working in EDs.

The press conference was cosponsored by the American College of Emergency Physicians and the Emergency Nurses Association, which have partnered since 2019 on the No Silence on ED Violence campaign.

Fuse/thinkstockphotos.com

The numbers confirm their experience. A 2018 poll of 3,500 ED physicians nationwide, which was conducted by Marketing General and was reported at ACEP’s annual meeting, found that nearly half of respondents had been assaulted at work; 27% of them were injured from the assault. Nurses, who spend more time with patients, may face even higher rates.

Incidence was reported to be increasing in 2018, and that was before the social and psychological upheavals imposed by the COVID pandemic caused assaults on staff in the hospital to go up an estimated 200%-300%.

But what really grated was that more than 95% of such cases, mostly perpetrated by patients, were never prosecuted, said Jennifer Casaletto, MD, FACEP, a North Carolina emergency physician and president of the state’s ACEP chapter. “Hospital and law enforcement see violence as just part of the job in our EDs.”

It’s no secret that workplace violence is increasing, Dr. Casaletto said. Four weeks ago, she stitched up the face of a charge nurse who had been assaulted. The nurse didn’t report the incident because she didn’t believe anything would change.

“Listening to my colleagues, I know the terror they have felt in the moment – for themselves, their colleagues, their patients. I know that raw fear of being attacked, and the complex emotions that follow. I’ve been hit, bit, and punched and watched colleagues getting choked.”

Dr. Casaletto was present in the ED when an out-of-control patient clubbed a nurse with an IV pole as she tried to close the doors to other patients’ rooms. “Instinctively, I pulled my stethoscope from around my neck, hoping I wouldn’t be strangled with it.”

Tennessee emergency nurse Todd Haines, MSN, RN, AEMT, CEN, said he has stepped in to help pull patients off coworkers. “I’ve seen some staff so severely injured they could not return to the bedside. I’ve been verbally threatened. My family has been threatened by patients and their families,” he reported. “We’ve all seen it. And COVID has made some people even meaner. They just lose their minds, and ED staff take the brunt of their aggression. But then to report these incidents and hear: ‘It’s just part of your job,’ well, it’s not part of my job.”

Mr. Haines spent 10 years in law enforcement with a sheriff’s department in middle Tennessee and was on its special tactical response team before becoming an ED nurse. He said he saw many more verbal and physical assaults in 11 years in the ED than during his police career.

“I love emergency nursing at the bedside, but it got to the point where I took the first chance to leave the bedside. And I’m not alone. Other nurses are leaving in droves.” Mr. Haines now has a job directing a trauma program, and he volunteers on policy issues for the Tennessee ENA. But he worries about the toll of this violence on the ED workforce, with so many professionals already mulling over leaving the field because of job stress and burnout.

“We have to do something to keep experienced hospital emergency staff at the bedside.”

What’s the answer?

Also speaking at the press conference was Senator Tammy Baldwin (D-Wis.), who pledged to introduce the Workplace Violence Prevention for Health Care and Social Services Workers Act, which passed the House in April. This bill would direct the Occupational Health and Safety Administration to issue a standard requiring employers in health care and social services to develop and implement workplace violence prevention plans. It would cover a variety of health facilities but not doctor’s offices or home-based services.

An interim final standard would be due within a year of enactment, with a final version to follow. Covered employers would have 6 months to develop and implement their own comprehensive workplace violence prevention plans, with the meaningful participation of direct care employees, tailored for and specific to the conditions and hazards of their facility, informed by past violent incidents, and subject to the size and complexity of the setting.

The plan would also name an individual responsible for its implementation, would include staff training and education, and would require facilities to track incidents and prohibit retaliation against employees who reported incidents of workplace violence.

On Wednesday, Sen. Baldwin called for unanimous consent on the Senate floor to fast-track this bill, but that was opposed by Senator Mike Braun (R-Ind.). She will soon introduce legislation similar to HR 1195, which the House passed.

“This bill will provide long overdue protections and safety standards,” she said. It will ensure that workplaces adopt proven protection techniques, such as those in OSHA’s 2015 guideline for preventing health care workplace violence. The American Hospital Association opposed the House bill on the grounds that hospitals have already implemented policies and programs specifically tailored to address workplace violence, so the OSHA standards required by the bill are not warranted.

Another speaker at the press conference, Aisha Terry, MD, MPH, FACEP, an emergency physician for George Washington University and Veterans Affairs in Washington, D.C., and current vice president of ACEP, described an incident that occurred when she was at work. A patient punched the nurse caring for him in the face, knocking her unconscious to the floor. “I’ll never forget that sound,” Dr. Terry said. “To this day, it has impacted her career. She hasn’t known what to do.”

Many people don’t realize how bad workplace violence really is, Dr. Terry added. “You assume you can serve as the safety net of this country, taking care of patients in the context of the pandemic, and feel safe – and not have to worry about your own safety. It’s past due that we put an end to this.”
 

Biggest win

Mr. Haines called the workplace violence bill a game changer for ED professionals, now and into the future. “We’re not going to totally eliminate violence in the emergency department. That is part of our business. But this legislation will support us and give a safer environment for us to do the work we love,” he said.

“The biggest win for this legislation is that it will create a supportive, nonretaliatory environment. It will give us as nurses a structured way to report things.” And, when these incidents do get reported, staff will get the help they need, Mr. Haines said. “The legislation will help show the importance of implementing systems and processes in emergency settings to address the risks and hazards that makes us all vulnerable to violence.”

No relevant financial relationships have been disclosed.

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

Espresso consumption is associated with higher total cholesterol levels, a population-based, cross-sectional study suggests.

Elevations in serum total cholesterol level were significantly linked to espresso consumption, particularly in men, Åsne Lirhus Svatun, of the Arctic University of Norway, Tromsø, and colleagues reported.

Drinking boiled/plunger coffee was associated with significantly higher serum total cholesterol levels in women and men. There was a significant relationship between filtered coffee consumption and total cholesterol, but only among women, the researchers reported.

SorJongAng/Thinkstock.com

“Doctors could become mindful of asking about coffee consumption when taking up the history of patients with elevated serum cholesterol,” study author Maja-Lisa Løchen, MD, PhD, of the Arctic University of Norway, said in an interview.

“Guiding patients to change from plunger coffee or other unfiltered coffee types to filtered or instant coffee could be a part of a lifestyle intervention to lower serum cholesterol levels.”

The results were published online in the journal Open Heart.

Previous studies of the relationship between serum cholesterol and espresso have had varying outcomes, the researchers noted.

Given that coffee consumption is high worldwide, even slight health effects can have substantial health consequences, the researchers noted. “Coffee was included for the first time in the 2021 ESC [European Society of Cardiology] guidelines on cardiovascular disease prevention in clinical practice. Increased knowledge on espresso coffee’s association with serum cholesterol will improve the recommendations regarding coffee consumption.”

“I don’t think that the findings in this paper are necessarily enough to change any advice about coffee,” said David Kao, MD, an associate professor medicine at the University of Colorado at Denver, Aurora, in commenting on the findings. “This is partly because the most important thing at the end of the day is whether subsequent events like heart attack or stroke increased or decreased. This analysis was not designed to answer that question.”

“If one has to choose between this study, which would suggest to drink less coffee to maintain low cholesterol, and the others, which would suggest increasing coffee consumption might reduce risk of multiple kinds of CVD, one should choose the latter,” Dr. Kao concluded.

In the current study, the investigators assessed 21,083 participants in the Tromsø Study in Northern Norway. The mean age of the participants was 56.4 years. Using multivariable linear regression, the researchers compared the relationship between each level of coffee consumption with no coffee consumption as the reference point and serum total cholesterol as the dependent variable. They tested for sex differences and adjusted for relevant covariates.

The findings indicate that drinking three to five cups of espresso each day was significantly linked with greater serum total cholesterol by 0.16 mmol/L (95% confidence interval, 0.07-0.24) for men and by 0.09 mmol/L (95% CI, 0.01-0.17) for women in comparison with participants who did not drink espresso daily.

Compared with individuals who did not drink plunger/boiled coffee, consumption of six or more cups of plunger/boiled coffee each day was linked with elevated serum total cholesterol levels by 0.23 mmol/L (95% CI, 0.08-0.38) for men and 0.30 mmol/L (95% CI, 0.13-0.48) for women.

Notably, for women but not men, there was an increase in serum total cholesterol of 0.11 mmol/L (95% CI, 0.03-0.19) in association with drinking six or more cups of filtered coffee per day.

When excluding participants who did not drink instant coffee, drinking instant coffee yielded a significant linear pattern for both men and women, but there was not a dose-dependent association.

These data show that sex differences were significant for every coffee type except plunger/boiled coffee, the authors noted.

Limitations of the study include its cross-sectional design; lack of generalizability of the data, given that the cohort primarily consisted of elderly adults and middle-aged White persons; and the fact that the study did not adjust for all confounding variables, the researchers noted.

Also among the study’s limitations were that some data were self-reported, and the missing indicator approach was implemented to assess data, the authors added.

Future research efforts should focus on following this cohort over many years to determine how consumption of various types of coffee is linked with events such as heart failure, stroke, and myocardial infarction. This insight would be important in offering guidance on whether the style of coffee preparation matters, concluded Dr. Kao.

The study was supported by a number of sources, including the Arctic University of Norway and the Northern Norway Regional Health Authority. The study investigators reported no conflicts of interest.

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

Espresso consumption is associated with higher total cholesterol levels, a population-based, cross-sectional study suggests.

Elevations in serum total cholesterol level were significantly linked to espresso consumption, particularly in men, Åsne Lirhus Svatun, of the Arctic University of Norway, Tromsø, and colleagues reported.

Drinking boiled/plunger coffee was associated with significantly higher serum total cholesterol levels in women and men. There was a significant relationship between filtered coffee consumption and total cholesterol, but only among women, the researchers reported.

SorJongAng/Thinkstock.com

“Doctors could become mindful of asking about coffee consumption when taking up the history of patients with elevated serum cholesterol,” study author Maja-Lisa Løchen, MD, PhD, of the Arctic University of Norway, said in an interview.

“Guiding patients to change from plunger coffee or other unfiltered coffee types to filtered or instant coffee could be a part of a lifestyle intervention to lower serum cholesterol levels.”

The results were published online in the journal Open Heart.

Previous studies of the relationship between serum cholesterol and espresso have had varying outcomes, the researchers noted.

Given that coffee consumption is high worldwide, even slight health effects can have substantial health consequences, the researchers noted. “Coffee was included for the first time in the 2021 ESC [European Society of Cardiology] guidelines on cardiovascular disease prevention in clinical practice. Increased knowledge on espresso coffee’s association with serum cholesterol will improve the recommendations regarding coffee consumption.”

“I don’t think that the findings in this paper are necessarily enough to change any advice about coffee,” said David Kao, MD, an associate professor medicine at the University of Colorado at Denver, Aurora, in commenting on the findings. “This is partly because the most important thing at the end of the day is whether subsequent events like heart attack or stroke increased or decreased. This analysis was not designed to answer that question.”

“If one has to choose between this study, which would suggest to drink less coffee to maintain low cholesterol, and the others, which would suggest increasing coffee consumption might reduce risk of multiple kinds of CVD, one should choose the latter,” Dr. Kao concluded.

In the current study, the investigators assessed 21,083 participants in the Tromsø Study in Northern Norway. The mean age of the participants was 56.4 years. Using multivariable linear regression, the researchers compared the relationship between each level of coffee consumption with no coffee consumption as the reference point and serum total cholesterol as the dependent variable. They tested for sex differences and adjusted for relevant covariates.

The findings indicate that drinking three to five cups of espresso each day was significantly linked with greater serum total cholesterol by 0.16 mmol/L (95% confidence interval, 0.07-0.24) for men and by 0.09 mmol/L (95% CI, 0.01-0.17) for women in comparison with participants who did not drink espresso daily.

Compared with individuals who did not drink plunger/boiled coffee, consumption of six or more cups of plunger/boiled coffee each day was linked with elevated serum total cholesterol levels by 0.23 mmol/L (95% CI, 0.08-0.38) for men and 0.30 mmol/L (95% CI, 0.13-0.48) for women.

Notably, for women but not men, there was an increase in serum total cholesterol of 0.11 mmol/L (95% CI, 0.03-0.19) in association with drinking six or more cups of filtered coffee per day.

When excluding participants who did not drink instant coffee, drinking instant coffee yielded a significant linear pattern for both men and women, but there was not a dose-dependent association.

These data show that sex differences were significant for every coffee type except plunger/boiled coffee, the authors noted.

Limitations of the study include its cross-sectional design; lack of generalizability of the data, given that the cohort primarily consisted of elderly adults and middle-aged White persons; and the fact that the study did not adjust for all confounding variables, the researchers noted.

Also among the study’s limitations were that some data were self-reported, and the missing indicator approach was implemented to assess data, the authors added.

Future research efforts should focus on following this cohort over many years to determine how consumption of various types of coffee is linked with events such as heart failure, stroke, and myocardial infarction. This insight would be important in offering guidance on whether the style of coffee preparation matters, concluded Dr. Kao.

The study was supported by a number of sources, including the Arctic University of Norway and the Northern Norway Regional Health Authority. The study investigators reported no conflicts of interest.

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

Espresso consumption is associated with higher total cholesterol levels, a population-based, cross-sectional study suggests.

Elevations in serum total cholesterol level were significantly linked to espresso consumption, particularly in men, Åsne Lirhus Svatun, of the Arctic University of Norway, Tromsø, and colleagues reported.

Drinking boiled/plunger coffee was associated with significantly higher serum total cholesterol levels in women and men. There was a significant relationship between filtered coffee consumption and total cholesterol, but only among women, the researchers reported.

SorJongAng/Thinkstock.com

“Doctors could become mindful of asking about coffee consumption when taking up the history of patients with elevated serum cholesterol,” study author Maja-Lisa Løchen, MD, PhD, of the Arctic University of Norway, said in an interview.

“Guiding patients to change from plunger coffee or other unfiltered coffee types to filtered or instant coffee could be a part of a lifestyle intervention to lower serum cholesterol levels.”

The results were published online in the journal Open Heart.

Previous studies of the relationship between serum cholesterol and espresso have had varying outcomes, the researchers noted.

Given that coffee consumption is high worldwide, even slight health effects can have substantial health consequences, the researchers noted. “Coffee was included for the first time in the 2021 ESC [European Society of Cardiology] guidelines on cardiovascular disease prevention in clinical practice. Increased knowledge on espresso coffee’s association with serum cholesterol will improve the recommendations regarding coffee consumption.”

“I don’t think that the findings in this paper are necessarily enough to change any advice about coffee,” said David Kao, MD, an associate professor medicine at the University of Colorado at Denver, Aurora, in commenting on the findings. “This is partly because the most important thing at the end of the day is whether subsequent events like heart attack or stroke increased or decreased. This analysis was not designed to answer that question.”

“If one has to choose between this study, which would suggest to drink less coffee to maintain low cholesterol, and the others, which would suggest increasing coffee consumption might reduce risk of multiple kinds of CVD, one should choose the latter,” Dr. Kao concluded.

In the current study, the investigators assessed 21,083 participants in the Tromsø Study in Northern Norway. The mean age of the participants was 56.4 years. Using multivariable linear regression, the researchers compared the relationship between each level of coffee consumption with no coffee consumption as the reference point and serum total cholesterol as the dependent variable. They tested for sex differences and adjusted for relevant covariates.

The findings indicate that drinking three to five cups of espresso each day was significantly linked with greater serum total cholesterol by 0.16 mmol/L (95% confidence interval, 0.07-0.24) for men and by 0.09 mmol/L (95% CI, 0.01-0.17) for women in comparison with participants who did not drink espresso daily.

Compared with individuals who did not drink plunger/boiled coffee, consumption of six or more cups of plunger/boiled coffee each day was linked with elevated serum total cholesterol levels by 0.23 mmol/L (95% CI, 0.08-0.38) for men and 0.30 mmol/L (95% CI, 0.13-0.48) for women.

Notably, for women but not men, there was an increase in serum total cholesterol of 0.11 mmol/L (95% CI, 0.03-0.19) in association with drinking six or more cups of filtered coffee per day.

When excluding participants who did not drink instant coffee, drinking instant coffee yielded a significant linear pattern for both men and women, but there was not a dose-dependent association.

These data show that sex differences were significant for every coffee type except plunger/boiled coffee, the authors noted.

Limitations of the study include its cross-sectional design; lack of generalizability of the data, given that the cohort primarily consisted of elderly adults and middle-aged White persons; and the fact that the study did not adjust for all confounding variables, the researchers noted.

Also among the study’s limitations were that some data were self-reported, and the missing indicator approach was implemented to assess data, the authors added.

Future research efforts should focus on following this cohort over many years to determine how consumption of various types of coffee is linked with events such as heart failure, stroke, and myocardial infarction. This insight would be important in offering guidance on whether the style of coffee preparation matters, concluded Dr. Kao.

The study was supported by a number of sources, including the Arctic University of Norway and the Northern Norway Regional Health Authority. The study investigators reported no conflicts of interest.

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

The American Gastroenterological Association has published a clinical practice update on dietary interventions for patients with irritable bowel syndrome (IBS). The topics range from identification of suitable candidates for dietary interventions, to levels of evidence for specific diets, which are becoming increasingly recognized for their key role in managing patients with IBS, according to lead author William D. Chey, MD, of the University of Michigan, Ann Arbor, and colleagues.

“Most medical therapies for IBS improve global symptoms in fewer than one-half of patients, with a therapeutic gain of 7%-15% over placebo,” the researchers wrote in Gastroenterology. “Most patients with IBS associate their GI symptoms with eating food.”

According to Dr. Chey and colleagues, clinicians who are considering dietary modifications for treating IBS should first recognize the inherent challenges presented by this process and be aware that new diets won’t work for everyone.

“Specialty diets require planning and preparation, which may be impractical for some patients,” they wrote, noting that individuals with “decreased cognitive abilities and significant psychiatric disease” may be unable to follow diets or interpret their own responses to specific foods. Special diets may also be inappropriate for patients with financial constraints, and “should be avoided in patients with an eating disorder.”

Because of the challenges involved in dietary interventions, Dr. Chey and colleagues advised clinical support from a registered dietitian nutritionist or other resource.

Patients who are suitable candidates for intervention and willing to try a new diet should first provide information about their current eating habits. A food trial can then be personalized and implemented for a predetermined amount of time. If the patient does not respond, then the diet should be stopped and changed to a new diet or another intervention.

Dr. Chey and colleagues discussed three specific dietary interventions and their corresponding levels of evidence: soluble fiber; the low-fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) diet; and a gluten-free diet.

“Soluble fiber is efficacious in treating global symptoms of IBS,” they wrote, citing 15 randomized controlled trials. Soluble fiber is most suitable for patients with constipation-predominant IBS, and different soluble fibers may yield different outcomes based on characteristics such as rate of fermentation and viscosity. In contrast, insoluble fiber is unlikely to help with IBS, and may worsen abdominal pain and bloating.

The low-FODMAP diet is “currently the most evidence-based diet intervention for IBS,” especially for patients with diarrhea-predominant IBS. Dr. Chey and colleagues offered a clear roadmap for employing the diet. First, patients should eat only low-FODMAP foods for 4-6 weeks. If symptoms don’t improve, the diet should be stopped. If symptoms do improve, foods containing a single FODMAP should be reintroduced one at a time, each in increasing quantities over 3 days, alongside documentation of symptom responses. Finally, the diet should be personalized based on these responses. The majority of patients (close to 80%) “can liberalize” a low-FODMAP diet based on their responses.

In contrast with the low-FODMAP diet, which has a relatively solid body of supporting evidence, efficacy data are still limited for treating IBS with a gluten-free diet. “Although observational studies found that most patients with IBS improve with a gluten-free diet, randomized controlled trials have yielded mixed results,” Dr. Chey and colleagues explained.

Their report cited a recent monograph on the topic that concluded that gluten-free eating offered no significant benefit over placebo (relative risk, 0.46; 95% confidence interval, 0.16-1.28). While some studies have documented positive results with a gluten-free diet, Dr. Chey and colleagues suggested that confounding variables such as the nocebo effect and the impact of other dietary factors have yet to be ruled out. “At present, it remains unclear whether a gluten-free diet is of benefit to patients with IBS.”

Dr. Chey and colleagues also explored IBS biomarkers. While some early data have shown that biomarkers may predict dietary responses, “there is insufficient evidence to support their routine use in clinical practice. ... Further efforts to identify and validate biomarkers that predict response to dietary interventions are needed to deliver ‘personalized nutrition.’ ”

The clinical practice update was commissioned and approved by the AGA CPU Committee and the AGA Governing Board. The researchers disclosed relationships with Biomerica, Salix, Mauna Kea Technologies, and others.

This article was updated May 19, 2022.

The American Gastroenterological Association has published a clinical practice update on dietary interventions for patients with irritable bowel syndrome (IBS). The topics range from identification of suitable candidates for dietary interventions, to levels of evidence for specific diets, which are becoming increasingly recognized for their key role in managing patients with IBS, according to lead author William D. Chey, MD, of the University of Michigan, Ann Arbor, and colleagues.

“Most medical therapies for IBS improve global symptoms in fewer than one-half of patients, with a therapeutic gain of 7%-15% over placebo,” the researchers wrote in Gastroenterology. “Most patients with IBS associate their GI symptoms with eating food.”

According to Dr. Chey and colleagues, clinicians who are considering dietary modifications for treating IBS should first recognize the inherent challenges presented by this process and be aware that new diets won’t work for everyone.

“Specialty diets require planning and preparation, which may be impractical for some patients,” they wrote, noting that individuals with “decreased cognitive abilities and significant psychiatric disease” may be unable to follow diets or interpret their own responses to specific foods. Special diets may also be inappropriate for patients with financial constraints, and “should be avoided in patients with an eating disorder.”

Because of the challenges involved in dietary interventions, Dr. Chey and colleagues advised clinical support from a registered dietitian nutritionist or other resource.

Patients who are suitable candidates for intervention and willing to try a new diet should first provide information about their current eating habits. A food trial can then be personalized and implemented for a predetermined amount of time. If the patient does not respond, then the diet should be stopped and changed to a new diet or another intervention.

Dr. Chey and colleagues discussed three specific dietary interventions and their corresponding levels of evidence: soluble fiber; the low-fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) diet; and a gluten-free diet.

“Soluble fiber is efficacious in treating global symptoms of IBS,” they wrote, citing 15 randomized controlled trials. Soluble fiber is most suitable for patients with constipation-predominant IBS, and different soluble fibers may yield different outcomes based on characteristics such as rate of fermentation and viscosity. In contrast, insoluble fiber is unlikely to help with IBS, and may worsen abdominal pain and bloating.

The low-FODMAP diet is “currently the most evidence-based diet intervention for IBS,” especially for patients with diarrhea-predominant IBS. Dr. Chey and colleagues offered a clear roadmap for employing the diet. First, patients should eat only low-FODMAP foods for 4-6 weeks. If symptoms don’t improve, the diet should be stopped. If symptoms do improve, foods containing a single FODMAP should be reintroduced one at a time, each in increasing quantities over 3 days, alongside documentation of symptom responses. Finally, the diet should be personalized based on these responses. The majority of patients (close to 80%) “can liberalize” a low-FODMAP diet based on their responses.

In contrast with the low-FODMAP diet, which has a relatively solid body of supporting evidence, efficacy data are still limited for treating IBS with a gluten-free diet. “Although observational studies found that most patients with IBS improve with a gluten-free diet, randomized controlled trials have yielded mixed results,” Dr. Chey and colleagues explained.

Their report cited a recent monograph on the topic that concluded that gluten-free eating offered no significant benefit over placebo (relative risk, 0.46; 95% confidence interval, 0.16-1.28). While some studies have documented positive results with a gluten-free diet, Dr. Chey and colleagues suggested that confounding variables such as the nocebo effect and the impact of other dietary factors have yet to be ruled out. “At present, it remains unclear whether a gluten-free diet is of benefit to patients with IBS.”

Dr. Chey and colleagues also explored IBS biomarkers. While some early data have shown that biomarkers may predict dietary responses, “there is insufficient evidence to support their routine use in clinical practice. ... Further efforts to identify and validate biomarkers that predict response to dietary interventions are needed to deliver ‘personalized nutrition.’ ”

The clinical practice update was commissioned and approved by the AGA CPU Committee and the AGA Governing Board. The researchers disclosed relationships with Biomerica, Salix, Mauna Kea Technologies, and others.

This article was updated May 19, 2022.

The American Gastroenterological Association has published a clinical practice update on dietary interventions for patients with irritable bowel syndrome (IBS). The topics range from identification of suitable candidates for dietary interventions, to levels of evidence for specific diets, which are becoming increasingly recognized for their key role in managing patients with IBS, according to lead author William D. Chey, MD, of the University of Michigan, Ann Arbor, and colleagues.

“Most medical therapies for IBS improve global symptoms in fewer than one-half of patients, with a therapeutic gain of 7%-15% over placebo,” the researchers wrote in Gastroenterology. “Most patients with IBS associate their GI symptoms with eating food.”

According to Dr. Chey and colleagues, clinicians who are considering dietary modifications for treating IBS should first recognize the inherent challenges presented by this process and be aware that new diets won’t work for everyone.

“Specialty diets require planning and preparation, which may be impractical for some patients,” they wrote, noting that individuals with “decreased cognitive abilities and significant psychiatric disease” may be unable to follow diets or interpret their own responses to specific foods. Special diets may also be inappropriate for patients with financial constraints, and “should be avoided in patients with an eating disorder.”

Because of the challenges involved in dietary interventions, Dr. Chey and colleagues advised clinical support from a registered dietitian nutritionist or other resource.

Patients who are suitable candidates for intervention and willing to try a new diet should first provide information about their current eating habits. A food trial can then be personalized and implemented for a predetermined amount of time. If the patient does not respond, then the diet should be stopped and changed to a new diet or another intervention.

Dr. Chey and colleagues discussed three specific dietary interventions and their corresponding levels of evidence: soluble fiber; the low-fermentable oligo-, di-, and monosaccharides and polyols (FODMAP) diet; and a gluten-free diet.

“Soluble fiber is efficacious in treating global symptoms of IBS,” they wrote, citing 15 randomized controlled trials. Soluble fiber is most suitable for patients with constipation-predominant IBS, and different soluble fibers may yield different outcomes based on characteristics such as rate of fermentation and viscosity. In contrast, insoluble fiber is unlikely to help with IBS, and may worsen abdominal pain and bloating.

The low-FODMAP diet is “currently the most evidence-based diet intervention for IBS,” especially for patients with diarrhea-predominant IBS. Dr. Chey and colleagues offered a clear roadmap for employing the diet. First, patients should eat only low-FODMAP foods for 4-6 weeks. If symptoms don’t improve, the diet should be stopped. If symptoms do improve, foods containing a single FODMAP should be reintroduced one at a time, each in increasing quantities over 3 days, alongside documentation of symptom responses. Finally, the diet should be personalized based on these responses. The majority of patients (close to 80%) “can liberalize” a low-FODMAP diet based on their responses.

In contrast with the low-FODMAP diet, which has a relatively solid body of supporting evidence, efficacy data are still limited for treating IBS with a gluten-free diet. “Although observational studies found that most patients with IBS improve with a gluten-free diet, randomized controlled trials have yielded mixed results,” Dr. Chey and colleagues explained.

Their report cited a recent monograph on the topic that concluded that gluten-free eating offered no significant benefit over placebo (relative risk, 0.46; 95% confidence interval, 0.16-1.28). While some studies have documented positive results with a gluten-free diet, Dr. Chey and colleagues suggested that confounding variables such as the nocebo effect and the impact of other dietary factors have yet to be ruled out. “At present, it remains unclear whether a gluten-free diet is of benefit to patients with IBS.”

Dr. Chey and colleagues also explored IBS biomarkers. While some early data have shown that biomarkers may predict dietary responses, “there is insufficient evidence to support their routine use in clinical practice. ... Further efforts to identify and validate biomarkers that predict response to dietary interventions are needed to deliver ‘personalized nutrition.’ ”

The clinical practice update was commissioned and approved by the AGA CPU Committee and the AGA Governing Board. The researchers disclosed relationships with Biomerica, Salix, Mauna Kea Technologies, and others.

This article was updated May 19, 2022.

For the past 2 decades, catheter ablation stole most of the excitement in electrophysiology. Cardiac pacing was seen as necessary but boring. His-bundle pacing earned only modest attention. 

But at the annual scientific sessions of the Heart Rhythm Society, cardiac pacing consolidated its comeback and entered the super-cool category.

Not one but three late-breaking clinical trials considered the role of pacing the heart’s conduction system for both preventive and therapeutic purposes. Conduction system pacing, or CSP as we call it, includes pacing the His bundle or the left bundle branch. Left bundle–branch pacing has now largely replaced His-bundle pacing.

Before I tell you about the studies, let’s review why CSP disrupts the status quo.

The core idea goes back to basic physiology: After the impulse leaves the atrioventricular node, the heart’s specialized conduction system allows rapid and synchronous conduction to both the right and left ventricles.

Standard cardiac pacing means fixing a pacing lead into the muscle of the right ventricle. From that spot, conduction spreads via slower muscle-to-muscle conduction, which leads to a wide QRS complex and the right ventricle contracts before the left ventricle.

While such dyssynchronous contraction is better than no contraction, this approach leads to a pacing-induced cardiomyopathy in a substantial number of cases. (The incidence reported in many studies varies widely.)

The most disruptive effect of conduction system pacing is that it is a form of cardiac resynchronization therapy (CRT). And that is nifty because, until recently, resynchronizing the ventricles required placing two ventricular leads: one in the right ventricle and the other in the coronary sinus to pace the left ventricle.
 

Left bundle-branch pacing vs. biventricular pacing

The first of the three HRS studies is the LBBP-RESYNC randomized controlled trial led by Jiangang Zou, MD, PhD, and performed in multiple centers in China. It compared the efficacy of left bundle–branch pacing (LBBP) with that of conventional biventricular pacing in 40 patients with heart failure who were eligible for CRT. The primary endpoint was the change in left ventricular ejection fraction (LVEF) from baseline to 6-month follow-up.

The results favored LBBP. Although both pacing techniques improved LVEF from baseline, the between-group difference in LVEF was greater in the LBBP arm than the biventricular pacing arm by a statistically significant 5.6% (95% confidence interval, 0.3%-10.9%). Secondary endpoints, such as reductions in left ventricular end-systolic volume, N-terminal of the prohormone brain natriuretic peptide, and QRS duration, also favored LBBP.
 

Conduction system pacing vs. biventricular pacing

A second late-breaking study, from the Geisinger group, led by Pugazhendhi Vijayaraman, MD, was simultaneously published in Heart Rhythm.

This nonrandomized observational study compared nearly 500 patients eligible for CRT treated at two health systems. One group favors conduction system pacing and the other does traditional biventricular pacing, which set up a two-armed comparison.

CSP was accomplished by LBBP (65%) and His-bundle pacing (35%).

The primary endpoint of death or first hospitalization for heart failure occurred in 28.3% of patients in the CSP arm versus 38.4% of the biventricular arm (hazard ratio, 1.52; 95% CI, 1.08-2.09). QRS duration and LVEF also improved from baseline in both groups.
 

LBB area pacing as a bailout for failed CRT

The Geisinger group also presented and published an international multicenter study that assessed the feasibility of LBBP as a bailout when standard biventricular pacing did not work – because of inadequate coronary sinus anatomy or CRT nonresponse, defined as lack of clinical or echocardiographic improvement.

This series included 212 patients in whom CRT failed and who underwent attempted LBBP pacing. The bailout was successful in 200 patients (91%). The primary endpoint was defined as an increase in LVEF above 5% on echocardiography.

During 12-month follow-up, 61% of patients had an improvement in LVEF above 5% and nearly 30% had a “super-response,” defined as a 20% or greater increase or normalization of LVEF. Similar to the previous studies, LBBP resulted in shorter QRS duration and improved echocardiography parameters.
 

Am I persuaded?

I was an early adopter of His-bundle pacing. When successful, it delivered both aesthetically pleasing QRS complexes and clinical efficacy. But there were many challenges: it is technically difficult, and capture thresholds are often high at implant and get higher over time, which leads to shorter battery life.

Pacing the left bundle branch mitigates these challenges. Here, the operator approaches from the right side and screws the lead a few millimeters into the septum, so the tip of the lead can capture the left bundle or one of its branches. This allows activation of the heart’s specialized conduction system and thus synchronizes right and left ventricle contraction.

Although there is a learning curve, LBBP is technically easier than His-bundle pacing and ultimately results in far better pacing and sensing parameters. What’s more, the preferred lead for LBBP has a stellar efficacy record – over years.

Chormail/Dreamstime.com

The barriers to getting more CSP trials

The challenge going forward will be funding new trials. CSP stands to prevent pacing-induced cardiomyopathy and offer less costly alternatives to standard biventricular pacing for CRT. This is great for patients, but it would mean that fewer higher-cost CRT devices will be sold.

Heart rhythm research is largely industry-funded because in most cases better therapies for patients mean more profits for industry. In the case of CSP, there is no such confluence of interests.

Conduction system pacing has come about because of the efforts of a few tireless champions who not only published extensively but were also skilled at using social media to spread the excitement. Trials have been small and often self-funded.

The data presented at HRS provides enough equipoise to support a large outcomes-based randomized controlled trial. Imagine if our CSP champions were able to find public-funding sources for such future trials.

Now that would be super cool.

Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

For the past 2 decades, catheter ablation stole most of the excitement in electrophysiology. Cardiac pacing was seen as necessary but boring. His-bundle pacing earned only modest attention. 

But at the annual scientific sessions of the Heart Rhythm Society, cardiac pacing consolidated its comeback and entered the super-cool category.

Not one but three late-breaking clinical trials considered the role of pacing the heart’s conduction system for both preventive and therapeutic purposes. Conduction system pacing, or CSP as we call it, includes pacing the His bundle or the left bundle branch. Left bundle–branch pacing has now largely replaced His-bundle pacing.

Before I tell you about the studies, let’s review why CSP disrupts the status quo.

The core idea goes back to basic physiology: After the impulse leaves the atrioventricular node, the heart’s specialized conduction system allows rapid and synchronous conduction to both the right and left ventricles.

Standard cardiac pacing means fixing a pacing lead into the muscle of the right ventricle. From that spot, conduction spreads via slower muscle-to-muscle conduction, which leads to a wide QRS complex and the right ventricle contracts before the left ventricle.

While such dyssynchronous contraction is better than no contraction, this approach leads to a pacing-induced cardiomyopathy in a substantial number of cases. (The incidence reported in many studies varies widely.)

The most disruptive effect of conduction system pacing is that it is a form of cardiac resynchronization therapy (CRT). And that is nifty because, until recently, resynchronizing the ventricles required placing two ventricular leads: one in the right ventricle and the other in the coronary sinus to pace the left ventricle.
 

Left bundle-branch pacing vs. biventricular pacing

The first of the three HRS studies is the LBBP-RESYNC randomized controlled trial led by Jiangang Zou, MD, PhD, and performed in multiple centers in China. It compared the efficacy of left bundle–branch pacing (LBBP) with that of conventional biventricular pacing in 40 patients with heart failure who were eligible for CRT. The primary endpoint was the change in left ventricular ejection fraction (LVEF) from baseline to 6-month follow-up.

The results favored LBBP. Although both pacing techniques improved LVEF from baseline, the between-group difference in LVEF was greater in the LBBP arm than the biventricular pacing arm by a statistically significant 5.6% (95% confidence interval, 0.3%-10.9%). Secondary endpoints, such as reductions in left ventricular end-systolic volume, N-terminal of the prohormone brain natriuretic peptide, and QRS duration, also favored LBBP.
 

Conduction system pacing vs. biventricular pacing

A second late-breaking study, from the Geisinger group, led by Pugazhendhi Vijayaraman, MD, was simultaneously published in Heart Rhythm.

This nonrandomized observational study compared nearly 500 patients eligible for CRT treated at two health systems. One group favors conduction system pacing and the other does traditional biventricular pacing, which set up a two-armed comparison.

CSP was accomplished by LBBP (65%) and His-bundle pacing (35%).

The primary endpoint of death or first hospitalization for heart failure occurred in 28.3% of patients in the CSP arm versus 38.4% of the biventricular arm (hazard ratio, 1.52; 95% CI, 1.08-2.09). QRS duration and LVEF also improved from baseline in both groups.
 

LBB area pacing as a bailout for failed CRT

The Geisinger group also presented and published an international multicenter study that assessed the feasibility of LBBP as a bailout when standard biventricular pacing did not work – because of inadequate coronary sinus anatomy or CRT nonresponse, defined as lack of clinical or echocardiographic improvement.

This series included 212 patients in whom CRT failed and who underwent attempted LBBP pacing. The bailout was successful in 200 patients (91%). The primary endpoint was defined as an increase in LVEF above 5% on echocardiography.

During 12-month follow-up, 61% of patients had an improvement in LVEF above 5% and nearly 30% had a “super-response,” defined as a 20% or greater increase or normalization of LVEF. Similar to the previous studies, LBBP resulted in shorter QRS duration and improved echocardiography parameters.
 

Am I persuaded?

I was an early adopter of His-bundle pacing. When successful, it delivered both aesthetically pleasing QRS complexes and clinical efficacy. But there were many challenges: it is technically difficult, and capture thresholds are often high at implant and get higher over time, which leads to shorter battery life.

Pacing the left bundle branch mitigates these challenges. Here, the operator approaches from the right side and screws the lead a few millimeters into the septum, so the tip of the lead can capture the left bundle or one of its branches. This allows activation of the heart’s specialized conduction system and thus synchronizes right and left ventricle contraction.

Although there is a learning curve, LBBP is technically easier than His-bundle pacing and ultimately results in far better pacing and sensing parameters. What’s more, the preferred lead for LBBP has a stellar efficacy record – over years.

Chormail/Dreamstime.com

The barriers to getting more CSP trials

The challenge going forward will be funding new trials. CSP stands to prevent pacing-induced cardiomyopathy and offer less costly alternatives to standard biventricular pacing for CRT. This is great for patients, but it would mean that fewer higher-cost CRT devices will be sold.

Heart rhythm research is largely industry-funded because in most cases better therapies for patients mean more profits for industry. In the case of CSP, there is no such confluence of interests.

Conduction system pacing has come about because of the efforts of a few tireless champions who not only published extensively but were also skilled at using social media to spread the excitement. Trials have been small and often self-funded.

The data presented at HRS provides enough equipoise to support a large outcomes-based randomized controlled trial. Imagine if our CSP champions were able to find public-funding sources for such future trials.

Now that would be super cool.

Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

For the past 2 decades, catheter ablation stole most of the excitement in electrophysiology. Cardiac pacing was seen as necessary but boring. His-bundle pacing earned only modest attention. 

But at the annual scientific sessions of the Heart Rhythm Society, cardiac pacing consolidated its comeback and entered the super-cool category.

Not one but three late-breaking clinical trials considered the role of pacing the heart’s conduction system for both preventive and therapeutic purposes. Conduction system pacing, or CSP as we call it, includes pacing the His bundle or the left bundle branch. Left bundle–branch pacing has now largely replaced His-bundle pacing.

Before I tell you about the studies, let’s review why CSP disrupts the status quo.

The core idea goes back to basic physiology: After the impulse leaves the atrioventricular node, the heart’s specialized conduction system allows rapid and synchronous conduction to both the right and left ventricles.

Standard cardiac pacing means fixing a pacing lead into the muscle of the right ventricle. From that spot, conduction spreads via slower muscle-to-muscle conduction, which leads to a wide QRS complex and the right ventricle contracts before the left ventricle.

While such dyssynchronous contraction is better than no contraction, this approach leads to a pacing-induced cardiomyopathy in a substantial number of cases. (The incidence reported in many studies varies widely.)

The most disruptive effect of conduction system pacing is that it is a form of cardiac resynchronization therapy (CRT). And that is nifty because, until recently, resynchronizing the ventricles required placing two ventricular leads: one in the right ventricle and the other in the coronary sinus to pace the left ventricle.
 

Left bundle-branch pacing vs. biventricular pacing

The first of the three HRS studies is the LBBP-RESYNC randomized controlled trial led by Jiangang Zou, MD, PhD, and performed in multiple centers in China. It compared the efficacy of left bundle–branch pacing (LBBP) with that of conventional biventricular pacing in 40 patients with heart failure who were eligible for CRT. The primary endpoint was the change in left ventricular ejection fraction (LVEF) from baseline to 6-month follow-up.

The results favored LBBP. Although both pacing techniques improved LVEF from baseline, the between-group difference in LVEF was greater in the LBBP arm than the biventricular pacing arm by a statistically significant 5.6% (95% confidence interval, 0.3%-10.9%). Secondary endpoints, such as reductions in left ventricular end-systolic volume, N-terminal of the prohormone brain natriuretic peptide, and QRS duration, also favored LBBP.
 

Conduction system pacing vs. biventricular pacing

A second late-breaking study, from the Geisinger group, led by Pugazhendhi Vijayaraman, MD, was simultaneously published in Heart Rhythm.

This nonrandomized observational study compared nearly 500 patients eligible for CRT treated at two health systems. One group favors conduction system pacing and the other does traditional biventricular pacing, which set up a two-armed comparison.

CSP was accomplished by LBBP (65%) and His-bundle pacing (35%).

The primary endpoint of death or first hospitalization for heart failure occurred in 28.3% of patients in the CSP arm versus 38.4% of the biventricular arm (hazard ratio, 1.52; 95% CI, 1.08-2.09). QRS duration and LVEF also improved from baseline in both groups.
 

LBB area pacing as a bailout for failed CRT

The Geisinger group also presented and published an international multicenter study that assessed the feasibility of LBBP as a bailout when standard biventricular pacing did not work – because of inadequate coronary sinus anatomy or CRT nonresponse, defined as lack of clinical or echocardiographic improvement.

This series included 212 patients in whom CRT failed and who underwent attempted LBBP pacing. The bailout was successful in 200 patients (91%). The primary endpoint was defined as an increase in LVEF above 5% on echocardiography.

During 12-month follow-up, 61% of patients had an improvement in LVEF above 5% and nearly 30% had a “super-response,” defined as a 20% or greater increase or normalization of LVEF. Similar to the previous studies, LBBP resulted in shorter QRS duration and improved echocardiography parameters.
 

Am I persuaded?

I was an early adopter of His-bundle pacing. When successful, it delivered both aesthetically pleasing QRS complexes and clinical efficacy. But there were many challenges: it is technically difficult, and capture thresholds are often high at implant and get higher over time, which leads to shorter battery life.

Pacing the left bundle branch mitigates these challenges. Here, the operator approaches from the right side and screws the lead a few millimeters into the septum, so the tip of the lead can capture the left bundle or one of its branches. This allows activation of the heart’s specialized conduction system and thus synchronizes right and left ventricle contraction.

Although there is a learning curve, LBBP is technically easier than His-bundle pacing and ultimately results in far better pacing and sensing parameters. What’s more, the preferred lead for LBBP has a stellar efficacy record – over years.

Chormail/Dreamstime.com

The barriers to getting more CSP trials

The challenge going forward will be funding new trials. CSP stands to prevent pacing-induced cardiomyopathy and offer less costly alternatives to standard biventricular pacing for CRT. This is great for patients, but it would mean that fewer higher-cost CRT devices will be sold.

Heart rhythm research is largely industry-funded because in most cases better therapies for patients mean more profits for industry. In the case of CSP, there is no such confluence of interests.

Conduction system pacing has come about because of the efforts of a few tireless champions who not only published extensively but were also skilled at using social media to spread the excitement. Trials have been small and often self-funded.

The data presented at HRS provides enough equipoise to support a large outcomes-based randomized controlled trial. Imagine if our CSP champions were able to find public-funding sources for such future trials.

Now that would be super cool.

Dr. Mandrola practices cardiac electrophysiology in Louisville, Ky., and is a writer and podcaster for Medscape. He participates in clinical research and writes often about the state of medical evidence. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

Legislation nearing passage in Colorado would lift a veil of secrecy around sperm donation and grant other protections to people conceived with donated gametes.

The bipartisan bill, which was passed by the state’s house of representatives May 10 after previous approval by the senate, would enable offspring to learn the identity of a sperm or egg donor when they turn 18 and receive a donor’s medical information prior to that. Fertility clinics would be required to update donors’ contact information and medical records every 3 years.

In addition, clinics would have to make “good-faith efforts” to track births to ensure that no more than 25 families conceive babies from a single donor’s sperm. Egg donors could donate up to six times, based on medical risk.

The bill would establish a minimum donor age of 21 years and require dissemination of educational materials to donors and prospective parents about the psychological needs of donor-conceived children.

The provisions would take effect with donations collected on or after Jan. 1, 2025. Violators would be subject to fines of up to $20,000 per day.

Advocates point out that in addition to the benefits of knowing one’s genetic identity, the anonymity of sperm donors has been scuttled by the availability of commercial genetic testing. (Egg donation has tended to be more open.)

Some sperm banks already have adopted systems in which adult offspring can learn the identity of donors if both parties agree. However, a survey by the United States Donor Conceived Council, an advocacy group, found “significant problems” with some of those policies, such as requirements that donor-conceived offspring sign nondisclosure agreements or sperm banks refusing to release information if a donor-conceived person’s parents never registered the child’s birth with the bank.

Some measures in the bill reflect the guidelines of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology, although not all companies follow them, according to the council’s survey. For example, no sperm bank adheres to a recommendation that donors be at least 21 years old.

“The industry is shifting very fast, but there are definitely banks that I think need an extra push to protect the rights of the people that they’re producing,” Tiffany Gardner, a spokesperson for the council, told this news organization.

At a senate hearing, fertility care providers voiced concerns that the legislation would impose undue burdens on the industry and discourage men from donating sperm. In response, sponsors made several amendments, including capping a licensing fee for clinics and banks at $500 and increasing the family limit for each donor, which was originally set at 10.

Still, some in the industry said the bill, introduced April 22, was too rushed to receive adequate scrutiny. While everyone agreed that limiting the number of a person’s half siblings is a good thing, for example, the best way to go about it is unclear, they said.

“There wasn’t enough time to really get experts together to provide more formal, thoughtful, evidence-based feedback on what should be on this bill,” said Cassandra Roeca, MD, of Shady Grove Fertility, which has clinics in Denver and Colorado Springs. Dr. Roeca testified on behalf of Colorado Fertility Advocates, a nonprofit that promotes access to fertility care.

Gov. Jared Polis (D) is expected to sign the bill, an aide to one of the co-sponsors, Rep. Kerry Tipper (D-Lakewood), said in an interview.

Colorado is not the only state considering transparency for donor-conceived offspring. A New York bill would require fertility clinics to verify the medical, educational, and criminal histories of donors and allow donor-conceived people access to the information.

The New York measure is championed by the family of Steven Gunner, a 27-year-old man who died in May 2020 of an opioid overdose. The Wall Street Journal reported that Mr. Gunner’s family had been unaware of his biological father’s history of psychiatric problems.

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

Legislation nearing passage in Colorado would lift a veil of secrecy around sperm donation and grant other protections to people conceived with donated gametes.

The bipartisan bill, which was passed by the state’s house of representatives May 10 after previous approval by the senate, would enable offspring to learn the identity of a sperm or egg donor when they turn 18 and receive a donor’s medical information prior to that. Fertility clinics would be required to update donors’ contact information and medical records every 3 years.

In addition, clinics would have to make “good-faith efforts” to track births to ensure that no more than 25 families conceive babies from a single donor’s sperm. Egg donors could donate up to six times, based on medical risk.

The bill would establish a minimum donor age of 21 years and require dissemination of educational materials to donors and prospective parents about the psychological needs of donor-conceived children.

The provisions would take effect with donations collected on or after Jan. 1, 2025. Violators would be subject to fines of up to $20,000 per day.

Advocates point out that in addition to the benefits of knowing one’s genetic identity, the anonymity of sperm donors has been scuttled by the availability of commercial genetic testing. (Egg donation has tended to be more open.)

Some sperm banks already have adopted systems in which adult offspring can learn the identity of donors if both parties agree. However, a survey by the United States Donor Conceived Council, an advocacy group, found “significant problems” with some of those policies, such as requirements that donor-conceived offspring sign nondisclosure agreements or sperm banks refusing to release information if a donor-conceived person’s parents never registered the child’s birth with the bank.

Some measures in the bill reflect the guidelines of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology, although not all companies follow them, according to the council’s survey. For example, no sperm bank adheres to a recommendation that donors be at least 21 years old.

“The industry is shifting very fast, but there are definitely banks that I think need an extra push to protect the rights of the people that they’re producing,” Tiffany Gardner, a spokesperson for the council, told this news organization.

At a senate hearing, fertility care providers voiced concerns that the legislation would impose undue burdens on the industry and discourage men from donating sperm. In response, sponsors made several amendments, including capping a licensing fee for clinics and banks at $500 and increasing the family limit for each donor, which was originally set at 10.

Still, some in the industry said the bill, introduced April 22, was too rushed to receive adequate scrutiny. While everyone agreed that limiting the number of a person’s half siblings is a good thing, for example, the best way to go about it is unclear, they said.

“There wasn’t enough time to really get experts together to provide more formal, thoughtful, evidence-based feedback on what should be on this bill,” said Cassandra Roeca, MD, of Shady Grove Fertility, which has clinics in Denver and Colorado Springs. Dr. Roeca testified on behalf of Colorado Fertility Advocates, a nonprofit that promotes access to fertility care.

Gov. Jared Polis (D) is expected to sign the bill, an aide to one of the co-sponsors, Rep. Kerry Tipper (D-Lakewood), said in an interview.

Colorado is not the only state considering transparency for donor-conceived offspring. A New York bill would require fertility clinics to verify the medical, educational, and criminal histories of donors and allow donor-conceived people access to the information.

The New York measure is championed by the family of Steven Gunner, a 27-year-old man who died in May 2020 of an opioid overdose. The Wall Street Journal reported that Mr. Gunner’s family had been unaware of his biological father’s history of psychiatric problems.

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

Legislation nearing passage in Colorado would lift a veil of secrecy around sperm donation and grant other protections to people conceived with donated gametes.

The bipartisan bill, which was passed by the state’s house of representatives May 10 after previous approval by the senate, would enable offspring to learn the identity of a sperm or egg donor when they turn 18 and receive a donor’s medical information prior to that. Fertility clinics would be required to update donors’ contact information and medical records every 3 years.

In addition, clinics would have to make “good-faith efforts” to track births to ensure that no more than 25 families conceive babies from a single donor’s sperm. Egg donors could donate up to six times, based on medical risk.

The bill would establish a minimum donor age of 21 years and require dissemination of educational materials to donors and prospective parents about the psychological needs of donor-conceived children.

The provisions would take effect with donations collected on or after Jan. 1, 2025. Violators would be subject to fines of up to $20,000 per day.

Advocates point out that in addition to the benefits of knowing one’s genetic identity, the anonymity of sperm donors has been scuttled by the availability of commercial genetic testing. (Egg donation has tended to be more open.)

Some sperm banks already have adopted systems in which adult offspring can learn the identity of donors if both parties agree. However, a survey by the United States Donor Conceived Council, an advocacy group, found “significant problems” with some of those policies, such as requirements that donor-conceived offspring sign nondisclosure agreements or sperm banks refusing to release information if a donor-conceived person’s parents never registered the child’s birth with the bank.

Some measures in the bill reflect the guidelines of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology, although not all companies follow them, according to the council’s survey. For example, no sperm bank adheres to a recommendation that donors be at least 21 years old.

“The industry is shifting very fast, but there are definitely banks that I think need an extra push to protect the rights of the people that they’re producing,” Tiffany Gardner, a spokesperson for the council, told this news organization.

At a senate hearing, fertility care providers voiced concerns that the legislation would impose undue burdens on the industry and discourage men from donating sperm. In response, sponsors made several amendments, including capping a licensing fee for clinics and banks at $500 and increasing the family limit for each donor, which was originally set at 10.

Still, some in the industry said the bill, introduced April 22, was too rushed to receive adequate scrutiny. While everyone agreed that limiting the number of a person’s half siblings is a good thing, for example, the best way to go about it is unclear, they said.

“There wasn’t enough time to really get experts together to provide more formal, thoughtful, evidence-based feedback on what should be on this bill,” said Cassandra Roeca, MD, of Shady Grove Fertility, which has clinics in Denver and Colorado Springs. Dr. Roeca testified on behalf of Colorado Fertility Advocates, a nonprofit that promotes access to fertility care.

Gov. Jared Polis (D) is expected to sign the bill, an aide to one of the co-sponsors, Rep. Kerry Tipper (D-Lakewood), said in an interview.

Colorado is not the only state considering transparency for donor-conceived offspring. A New York bill would require fertility clinics to verify the medical, educational, and criminal histories of donors and allow donor-conceived people access to the information.

The New York measure is championed by the family of Steven Gunner, a 27-year-old man who died in May 2020 of an opioid overdose. The Wall Street Journal reported that Mr. Gunner’s family had been unaware of his biological father’s history of psychiatric problems.

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