Free testosterone linked to frailty in older men

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A new study provides more evidence of a link between lower free testosterone levels and higher levels of frailty in older men, but a researcher says proof of a causal connection remains elusive.

“Our study demonstrates clear associations between testosterone and frailty progression, and, although causality and directionality of the hormone/frailty relationships require clarification, the results presented here make a strong case for large interventional trials of testosterone therapy in frail men to determine whether such treatment would be beneficial,” lead author Agnieszka Swiecicka, MD, of the andrology research unit in the division of diabetes, endocrinology, and gastroenterology at the University of Manchester (England), said in an interview.

As Dr. Swiecicka noted, “in men, testosterone levels decline with age, and it has been suggested that this phenomenon might play a role in the development of frailty.”

However, evidence is limited, and studies have offered conflicting results Dr. Swiecicka said.

For the new study, the researchers prospectively tracked 3,369 community-dwelling men aged 40-79 years from eight European centers. Hundreds were excluded for various reasons or lost to follow-up, and 2,278 men were ultimately included.

The average age was 58 years, and the average body mass index was 28 kg/m2.

Hormone measurements were performed, and frailty was tracked via frailty status (FS, n = 2,278) and frailty phenotype (FP, n = 1,980).

After adjusting their statistics to account for various factors, the researchers were able to link only free testosterone – and not testosterone or dihydrotestosterone – to changes in frailty index (FI). They linked each standard deviation improvement in free testosterone level at baseline to a –2.8% change in FI over 4 years (95% confidence interval, –4.9 to –0.3, P = .030).

“Higher free testosterone levels were associated with a lower risk of worsening frailty status. The direction of this association was consistent regardless of the frailty construct used (FI and FP),” Dr. Swiecicka said. “Higher androgen remained significantly associated with improving frailty status, as assessed by FI, despite age adjustment, suggesting that these relationships cannot be explained by age-related differences in androgen levels.”

Overall, “sex hormones are associated with the development/worsening of frailty in middle-aged and older men, but these relationships vary between different constructs of frailty assessment,” Dr. Swiecicka said. “In light of the findings, a therapeutic role for testosterone in the context of physical frailty prevention or alleviation remains an attractive possibility that should be further explored.”

The study was published in the Journal of Clinical Endocrinology and Metabolism.

 

 


In an interview, Steve Borst, PhD, of the University of Florida, questioned the study’s approach because it looks only at baseline hormone levels. “What would be much more interesting to study would be changes in hormone levels vs. changes in frailty,” he said.

Dr. Borst added that researchers already know that “the relationship between testosterone and frailty is both large in magnitude and causal in nature.”

He pointed to his group’s research that linked testosterone injections to an increase in muscle strength, and he said others have linked testosterone administration to an increase in bone density. “While these measures are not exactly the same as frailty index,” he said, “it is well established that lower body muscle strength keeps older people in an independent living state and that the changes in bone mineral density are enough to account for protection against fracture.”

John Morley, MBBCh, of Saint Louis University, said in an interview that testosterone has a role in combating frailty. “But it’s not like it’s going to turn people into super people,” he said.

He added that “we shouldn’t say ‘Let’s do testosterone before we do exercise.’ It’s better to do resistance exercise than it is to take testosterone. But most older males are loath to do any physical work to make themselves better. That’s just human nature.”

The study was funded by various European research-based organizations. The study authors reported multiple disclosures. Dr. Morley reports no disclosures.

SOURCE: Swiecicka A et al. J Clin Endocrinol Metab. 2018 Feb;103(2):701-9.

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A new study provides more evidence of a link between lower free testosterone levels and higher levels of frailty in older men, but a researcher says proof of a causal connection remains elusive.

“Our study demonstrates clear associations between testosterone and frailty progression, and, although causality and directionality of the hormone/frailty relationships require clarification, the results presented here make a strong case for large interventional trials of testosterone therapy in frail men to determine whether such treatment would be beneficial,” lead author Agnieszka Swiecicka, MD, of the andrology research unit in the division of diabetes, endocrinology, and gastroenterology at the University of Manchester (England), said in an interview.

As Dr. Swiecicka noted, “in men, testosterone levels decline with age, and it has been suggested that this phenomenon might play a role in the development of frailty.”

However, evidence is limited, and studies have offered conflicting results Dr. Swiecicka said.

For the new study, the researchers prospectively tracked 3,369 community-dwelling men aged 40-79 years from eight European centers. Hundreds were excluded for various reasons or lost to follow-up, and 2,278 men were ultimately included.

The average age was 58 years, and the average body mass index was 28 kg/m2.

Hormone measurements were performed, and frailty was tracked via frailty status (FS, n = 2,278) and frailty phenotype (FP, n = 1,980).

After adjusting their statistics to account for various factors, the researchers were able to link only free testosterone – and not testosterone or dihydrotestosterone – to changes in frailty index (FI). They linked each standard deviation improvement in free testosterone level at baseline to a –2.8% change in FI over 4 years (95% confidence interval, –4.9 to –0.3, P = .030).

“Higher free testosterone levels were associated with a lower risk of worsening frailty status. The direction of this association was consistent regardless of the frailty construct used (FI and FP),” Dr. Swiecicka said. “Higher androgen remained significantly associated with improving frailty status, as assessed by FI, despite age adjustment, suggesting that these relationships cannot be explained by age-related differences in androgen levels.”

Overall, “sex hormones are associated with the development/worsening of frailty in middle-aged and older men, but these relationships vary between different constructs of frailty assessment,” Dr. Swiecicka said. “In light of the findings, a therapeutic role for testosterone in the context of physical frailty prevention or alleviation remains an attractive possibility that should be further explored.”

The study was published in the Journal of Clinical Endocrinology and Metabolism.

 

 


In an interview, Steve Borst, PhD, of the University of Florida, questioned the study’s approach because it looks only at baseline hormone levels. “What would be much more interesting to study would be changes in hormone levels vs. changes in frailty,” he said.

Dr. Borst added that researchers already know that “the relationship between testosterone and frailty is both large in magnitude and causal in nature.”

He pointed to his group’s research that linked testosterone injections to an increase in muscle strength, and he said others have linked testosterone administration to an increase in bone density. “While these measures are not exactly the same as frailty index,” he said, “it is well established that lower body muscle strength keeps older people in an independent living state and that the changes in bone mineral density are enough to account for protection against fracture.”

John Morley, MBBCh, of Saint Louis University, said in an interview that testosterone has a role in combating frailty. “But it’s not like it’s going to turn people into super people,” he said.

He added that “we shouldn’t say ‘Let’s do testosterone before we do exercise.’ It’s better to do resistance exercise than it is to take testosterone. But most older males are loath to do any physical work to make themselves better. That’s just human nature.”

The study was funded by various European research-based organizations. The study authors reported multiple disclosures. Dr. Morley reports no disclosures.

SOURCE: Swiecicka A et al. J Clin Endocrinol Metab. 2018 Feb;103(2):701-9.

 

A new study provides more evidence of a link between lower free testosterone levels and higher levels of frailty in older men, but a researcher says proof of a causal connection remains elusive.

“Our study demonstrates clear associations between testosterone and frailty progression, and, although causality and directionality of the hormone/frailty relationships require clarification, the results presented here make a strong case for large interventional trials of testosterone therapy in frail men to determine whether such treatment would be beneficial,” lead author Agnieszka Swiecicka, MD, of the andrology research unit in the division of diabetes, endocrinology, and gastroenterology at the University of Manchester (England), said in an interview.

As Dr. Swiecicka noted, “in men, testosterone levels decline with age, and it has been suggested that this phenomenon might play a role in the development of frailty.”

However, evidence is limited, and studies have offered conflicting results Dr. Swiecicka said.

For the new study, the researchers prospectively tracked 3,369 community-dwelling men aged 40-79 years from eight European centers. Hundreds were excluded for various reasons or lost to follow-up, and 2,278 men were ultimately included.

The average age was 58 years, and the average body mass index was 28 kg/m2.

Hormone measurements were performed, and frailty was tracked via frailty status (FS, n = 2,278) and frailty phenotype (FP, n = 1,980).

After adjusting their statistics to account for various factors, the researchers were able to link only free testosterone – and not testosterone or dihydrotestosterone – to changes in frailty index (FI). They linked each standard deviation improvement in free testosterone level at baseline to a –2.8% change in FI over 4 years (95% confidence interval, –4.9 to –0.3, P = .030).

“Higher free testosterone levels were associated with a lower risk of worsening frailty status. The direction of this association was consistent regardless of the frailty construct used (FI and FP),” Dr. Swiecicka said. “Higher androgen remained significantly associated with improving frailty status, as assessed by FI, despite age adjustment, suggesting that these relationships cannot be explained by age-related differences in androgen levels.”

Overall, “sex hormones are associated with the development/worsening of frailty in middle-aged and older men, but these relationships vary between different constructs of frailty assessment,” Dr. Swiecicka said. “In light of the findings, a therapeutic role for testosterone in the context of physical frailty prevention or alleviation remains an attractive possibility that should be further explored.”

The study was published in the Journal of Clinical Endocrinology and Metabolism.

 

 


In an interview, Steve Borst, PhD, of the University of Florida, questioned the study’s approach because it looks only at baseline hormone levels. “What would be much more interesting to study would be changes in hormone levels vs. changes in frailty,” he said.

Dr. Borst added that researchers already know that “the relationship between testosterone and frailty is both large in magnitude and causal in nature.”

He pointed to his group’s research that linked testosterone injections to an increase in muscle strength, and he said others have linked testosterone administration to an increase in bone density. “While these measures are not exactly the same as frailty index,” he said, “it is well established that lower body muscle strength keeps older people in an independent living state and that the changes in bone mineral density are enough to account for protection against fracture.”

John Morley, MBBCh, of Saint Louis University, said in an interview that testosterone has a role in combating frailty. “But it’s not like it’s going to turn people into super people,” he said.

He added that “we shouldn’t say ‘Let’s do testosterone before we do exercise.’ It’s better to do resistance exercise than it is to take testosterone. But most older males are loath to do any physical work to make themselves better. That’s just human nature.”

The study was funded by various European research-based organizations. The study authors reported multiple disclosures. Dr. Morley reports no disclosures.

SOURCE: Swiecicka A et al. J Clin Endocrinol Metab. 2018 Feb;103(2):701-9.

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Key clinical point: Free testosterone levels are linked to frailty in older men.

Major finding: For each standard deviation improvement in free testosterone level at baseline, frailty index was 2.8% lower at 4 years. (95% CI, –4.9% to –0.3%, P = .030)

Study details: Prospective cohort study of 3,369 men aged 40-79 years at eight European centers.

Disclosures: The study was funded by various European research-based organizations. The investigators reported multiple disclosures.

Source: Swiecicka A et al. J Clin Endocrinol Metab. 2018 Feb;103(2):701-9.

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Breast cancer deaths projected for 2018

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Female breast cancer mortality is expected to be about 25.3 per 100,000 women in 2018, with the highest rate in the District of Columbia and the lowest in Utah.

Approximately 40,920 deaths from invasive female breast cancer are predicted in the United States by the American Cancer Society (ACS) in its Cancer Facts & Figures 2018, which is based on analysis of 2001-2015 data from the National Center for Health Statistics. The death rate has declined 39% since its peak in 1989, and over the last 10 years, the annual decline has been 1.8% for white women and 1.5% for black women per year, the ACS said.

The expected number of deaths for 2018, coupled with a current estimate of nearly 162 million women, works out to an expected death rate of 25.3 per 100,000. The Census Bureau estimates for the state populations and the deaths projected by the ACS produce expected death rates of 31.4 per 100,000 for the District of Columbia and 19.0 for Utah. The state with the highest rate is West Virginia at 30.1, and Alaska (20.0) has the next-lowest rate after Utah.

Breast cancer is the most common cancer in women, as it is expected to account for 30% of the almost 880,000 new cancer cases in 2018, compared with 13% for lung cancer, which is second. Lung cancer, however, is projected to cause more deaths among women – 70,500 – than any other cancer, the ACS reported.

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Female breast cancer mortality is expected to be about 25.3 per 100,000 women in 2018, with the highest rate in the District of Columbia and the lowest in Utah.

Approximately 40,920 deaths from invasive female breast cancer are predicted in the United States by the American Cancer Society (ACS) in its Cancer Facts & Figures 2018, which is based on analysis of 2001-2015 data from the National Center for Health Statistics. The death rate has declined 39% since its peak in 1989, and over the last 10 years, the annual decline has been 1.8% for white women and 1.5% for black women per year, the ACS said.

The expected number of deaths for 2018, coupled with a current estimate of nearly 162 million women, works out to an expected death rate of 25.3 per 100,000. The Census Bureau estimates for the state populations and the deaths projected by the ACS produce expected death rates of 31.4 per 100,000 for the District of Columbia and 19.0 for Utah. The state with the highest rate is West Virginia at 30.1, and Alaska (20.0) has the next-lowest rate after Utah.

Breast cancer is the most common cancer in women, as it is expected to account for 30% of the almost 880,000 new cancer cases in 2018, compared with 13% for lung cancer, which is second. Lung cancer, however, is projected to cause more deaths among women – 70,500 – than any other cancer, the ACS reported.

 

Female breast cancer mortality is expected to be about 25.3 per 100,000 women in 2018, with the highest rate in the District of Columbia and the lowest in Utah.

Approximately 40,920 deaths from invasive female breast cancer are predicted in the United States by the American Cancer Society (ACS) in its Cancer Facts & Figures 2018, which is based on analysis of 2001-2015 data from the National Center for Health Statistics. The death rate has declined 39% since its peak in 1989, and over the last 10 years, the annual decline has been 1.8% for white women and 1.5% for black women per year, the ACS said.

The expected number of deaths for 2018, coupled with a current estimate of nearly 162 million women, works out to an expected death rate of 25.3 per 100,000. The Census Bureau estimates for the state populations and the deaths projected by the ACS produce expected death rates of 31.4 per 100,000 for the District of Columbia and 19.0 for Utah. The state with the highest rate is West Virginia at 30.1, and Alaska (20.0) has the next-lowest rate after Utah.

Breast cancer is the most common cancer in women, as it is expected to account for 30% of the almost 880,000 new cancer cases in 2018, compared with 13% for lung cancer, which is second. Lung cancer, however, is projected to cause more deaths among women – 70,500 – than any other cancer, the ACS reported.

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Fluarix Quadrivalent effective in very young, simplifies flu shots for all ages

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Fluarix Quadrivalent is highly effective against moderate and severe flu strains in children aged 6-35 months, and has the potential to simplify influenza vaccinations for all ages, according the results of a phase 3 clinical trial presented at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

“Fluarix Quadrivalent, at the 0.5-mL dose in young children 6 to 35 months of age, demonstrated efficacy of 63.2% against moderate to severe influenza and 49.8% against any severity influenza disease” stated Leonard Friedland, MD, director of scientific affairs and public health, Vaccines North America, GlaxoSmithKline. Dr. Friedland, a pediatrician in Pennsylvania, said that a standard 0.5-mL dose of Fluarix Quadrivalent has practice-changing implications for physicians. “The use of a 0.5-mL dose (15 mcg per strain) for all persons aged 6 months and older potentially simplifies influenza vaccination by allowing the same vaccine dose to be used for all eligible individuals.”

Cynthia Goldsmith/CDC photo #10073
This negative-stained transmission electron micrograph depicts the ultrastructural details of an influenza virus particle, or a virion.

The high efficacy of Fluarix against almost half of all influenza strains, regardless of severity, and in preventing moderate to severe influenza, correlated with a reduction in health care utilization by pediatric influenza patients, he said. Visits to general practitioners and emergency departments decreased by 47% and 79%, respectively, in children aged 6-35 months. Influenza-associated antibiotic use in these pediatric influenza patients also decreased by 50%.

These findings were the result of D-QIV-004, a phase 3, observer-blinded, randomized trial of 12,018 children aged 6-35 months. These children were split into five cohorts, each in a different influenza season. The study spanned 13 countries and ran from October 2011 to December 2014. To determine the safety of Fluarix, the study utilized noninfluenza vaccine comparator vaccines that were age appropriate, including Prevnar 13, Havrix, and Varivax.

A majority of the children in the study (98%) were vaccine unprimed (had never received two doses of seasonal influenza vaccine) and received two doses of Fluarix. The remaining children received one dose.

On Jan. 11, 2018, the Food and Drug Administration expanded the indication of Fluarix Quadrivalent to include use in persons 6 months and older. Previously, it was approved only for persons 3 years and older.

 

 


“These study results support universal vaccination of all individuals from 6 months of age [with Fluarix] to prevent influenza.” Dr. Friedland concluded.

For live updates and information concerning influenza, visit the CDC website.

ilacy@frontlinemedcom.com

SOURCE: D-QIV-004.

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Fluarix Quadrivalent is highly effective against moderate and severe flu strains in children aged 6-35 months, and has the potential to simplify influenza vaccinations for all ages, according the results of a phase 3 clinical trial presented at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

“Fluarix Quadrivalent, at the 0.5-mL dose in young children 6 to 35 months of age, demonstrated efficacy of 63.2% against moderate to severe influenza and 49.8% against any severity influenza disease” stated Leonard Friedland, MD, director of scientific affairs and public health, Vaccines North America, GlaxoSmithKline. Dr. Friedland, a pediatrician in Pennsylvania, said that a standard 0.5-mL dose of Fluarix Quadrivalent has practice-changing implications for physicians. “The use of a 0.5-mL dose (15 mcg per strain) for all persons aged 6 months and older potentially simplifies influenza vaccination by allowing the same vaccine dose to be used for all eligible individuals.”

Cynthia Goldsmith/CDC photo #10073
This negative-stained transmission electron micrograph depicts the ultrastructural details of an influenza virus particle, or a virion.

The high efficacy of Fluarix against almost half of all influenza strains, regardless of severity, and in preventing moderate to severe influenza, correlated with a reduction in health care utilization by pediatric influenza patients, he said. Visits to general practitioners and emergency departments decreased by 47% and 79%, respectively, in children aged 6-35 months. Influenza-associated antibiotic use in these pediatric influenza patients also decreased by 50%.

These findings were the result of D-QIV-004, a phase 3, observer-blinded, randomized trial of 12,018 children aged 6-35 months. These children were split into five cohorts, each in a different influenza season. The study spanned 13 countries and ran from October 2011 to December 2014. To determine the safety of Fluarix, the study utilized noninfluenza vaccine comparator vaccines that were age appropriate, including Prevnar 13, Havrix, and Varivax.

A majority of the children in the study (98%) were vaccine unprimed (had never received two doses of seasonal influenza vaccine) and received two doses of Fluarix. The remaining children received one dose.

On Jan. 11, 2018, the Food and Drug Administration expanded the indication of Fluarix Quadrivalent to include use in persons 6 months and older. Previously, it was approved only for persons 3 years and older.

 

 


“These study results support universal vaccination of all individuals from 6 months of age [with Fluarix] to prevent influenza.” Dr. Friedland concluded.

For live updates and information concerning influenza, visit the CDC website.

ilacy@frontlinemedcom.com

SOURCE: D-QIV-004.

 

Fluarix Quadrivalent is highly effective against moderate and severe flu strains in children aged 6-35 months, and has the potential to simplify influenza vaccinations for all ages, according the results of a phase 3 clinical trial presented at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

“Fluarix Quadrivalent, at the 0.5-mL dose in young children 6 to 35 months of age, demonstrated efficacy of 63.2% against moderate to severe influenza and 49.8% against any severity influenza disease” stated Leonard Friedland, MD, director of scientific affairs and public health, Vaccines North America, GlaxoSmithKline. Dr. Friedland, a pediatrician in Pennsylvania, said that a standard 0.5-mL dose of Fluarix Quadrivalent has practice-changing implications for physicians. “The use of a 0.5-mL dose (15 mcg per strain) for all persons aged 6 months and older potentially simplifies influenza vaccination by allowing the same vaccine dose to be used for all eligible individuals.”

Cynthia Goldsmith/CDC photo #10073
This negative-stained transmission electron micrograph depicts the ultrastructural details of an influenza virus particle, or a virion.

The high efficacy of Fluarix against almost half of all influenza strains, regardless of severity, and in preventing moderate to severe influenza, correlated with a reduction in health care utilization by pediatric influenza patients, he said. Visits to general practitioners and emergency departments decreased by 47% and 79%, respectively, in children aged 6-35 months. Influenza-associated antibiotic use in these pediatric influenza patients also decreased by 50%.

These findings were the result of D-QIV-004, a phase 3, observer-blinded, randomized trial of 12,018 children aged 6-35 months. These children were split into five cohorts, each in a different influenza season. The study spanned 13 countries and ran from October 2011 to December 2014. To determine the safety of Fluarix, the study utilized noninfluenza vaccine comparator vaccines that were age appropriate, including Prevnar 13, Havrix, and Varivax.

A majority of the children in the study (98%) were vaccine unprimed (had never received two doses of seasonal influenza vaccine) and received two doses of Fluarix. The remaining children received one dose.

On Jan. 11, 2018, the Food and Drug Administration expanded the indication of Fluarix Quadrivalent to include use in persons 6 months and older. Previously, it was approved only for persons 3 years and older.

 

 


“These study results support universal vaccination of all individuals from 6 months of age [with Fluarix] to prevent influenza.” Dr. Friedland concluded.

For live updates and information concerning influenza, visit the CDC website.

ilacy@frontlinemedcom.com

SOURCE: D-QIV-004.

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Key clinical point: The high efficacy of Fluarix against almost half of all influenza strains, regardless of severity, as well as preventing moderate to severe influenza, reduced health care utilization by pediatric influenza patients.

Major finding: Fluarix Quadrivalent was effective against moderate to severe influenza in 63.2% and against any severity of influenza in 49.8% of children aged 6-35 months.

Study details: A phase 3, observer-blinded, randomized trial of 12,018 children aged 6-35 months, in which the children were split into five cohorts, each in a different influenza season from October 2011 to December 2014.

Disclosures: No disclosures were reported.

Source: The D-QIV-004 study.

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Guidelines update best practices for hemorrhoid treatment

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Each year, more than 2.2 million patients in the United States undergo evaluations for symptoms of hemorrhoids, according to updated guidelines on the management of hemorrhoids issued by the American Society of Colon and Rectal Surgeons.

“As a result, it is important to identify symptomatic hemorrhoids as the underlying source of the anorectal symptom and to have a clear understanding of the evaluation and management of this disease process,” wrote Bradley R. Davis, MD, FACS, chief of colon and rectal surgery at the Carolinas Medical Center, Charlotte, N.C., and the fellow members of the Clinical Practice Guidelines Committee of the ASCRS.

Dmitrii Kotin/Thinkstock.com

The guidelines are based on the ASCRS Practice Parameters for the Management of Hemorrhoids published in 2011. The 2018 update was published in the Diseases of the Colon & Rectum.

The guidelines recommend evaluation of hemorrhoids based on a disease-specific history, and a physical that emphasizes the degree and duration of symptoms and identifies risk factors. But the guideline writers note that the recommendation is a grade 1C because the supporting data mainly come from observational or case studies.

 

 


“The cardinal signs of internal hemorrhoids are painless bleeding with bowel movements with intermittent protrusion,” the committee said, also emphasizing that patients should be evaluated for fecal incontinence, which could inform surgical decision making.

In addition, the guidelines call for a complete endoscopic evaluation of the colon for patients who present with symptomatic hemorrhoids and rectal bleeding; this recommendation is based on moderately strong evidence, and presented with a grade of 1B.

Medical management of hemorrhoids may include office-based procedures or surgery, according to the guidelines.

“Most patients with grade I and II and select patients with grade III internal hemorrhoidal disease who fail medical treatment can be effectively treated with office-based procedures, such as banding, sclerotherapy, and infrared coagulation,” the committee wrote, and medical office treatment received a strong grade 1A recommendation based on high-quality evidence. Although office procedures are generally well tolerated, the condition can recur. Bleeding is the most common complication, and it is more likely after rubber-band ligation than other office-based options, the guidelines state.
 

 



The guidelines offer a weak recommendation of 2C, based on the lack of quality evidence, for the use of early surgical excision to treat patients with thrombosed external hemorrhoids. “Although most patients treated nonoperatively will experience eventual resolution of their symptoms, excision of thrombosed external hemorrhoids may result in more rapid symptom resolution, lower incidence of recurrence, and longer remission intervals,” the committee noted.

Surgical hemorrhoidectomy received the strongest possible recommendation (1A, based on high-quality evidence) for the treatment of patients with external hemorrhoids or a combination of internal and external hemorrhoids with prolapse.

Surgical options described in the recommendations include surgical excision (hemorrhoidectomy), hemorrhoidopexy, and Doppler-guided hemorrhoidectomy, with citations of studies on each procedure. Data from a meta-analysis of 18 randomized prospective studies comparing hemorrhoidectomy with office-based procedures showed that hemorrhoidectomy was “the most effective treatment for patients with grade III hemorrhoids,” but it was associated with greater pain and complication rates, according to the guidelines.

However, complications in general are low after surgical hemorrhoidectomy, with reported complication rates of 1%-2% for the most common complication of postprocedure hemorrhage, the guidelines state. After surgery, the guidelines recommend with a 1B grade (moderate quality evidence) that patients use “a multimodality pain regimen to reduce narcotic usage and promote a faster recovery.”
 

 


The committee members had no financial conflicts to disclose.

SOURCE: Davis BR et al. Dis Colon Rectum. 2018; 61:284-92.

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Each year, more than 2.2 million patients in the United States undergo evaluations for symptoms of hemorrhoids, according to updated guidelines on the management of hemorrhoids issued by the American Society of Colon and Rectal Surgeons.

“As a result, it is important to identify symptomatic hemorrhoids as the underlying source of the anorectal symptom and to have a clear understanding of the evaluation and management of this disease process,” wrote Bradley R. Davis, MD, FACS, chief of colon and rectal surgery at the Carolinas Medical Center, Charlotte, N.C., and the fellow members of the Clinical Practice Guidelines Committee of the ASCRS.

Dmitrii Kotin/Thinkstock.com

The guidelines are based on the ASCRS Practice Parameters for the Management of Hemorrhoids published in 2011. The 2018 update was published in the Diseases of the Colon & Rectum.

The guidelines recommend evaluation of hemorrhoids based on a disease-specific history, and a physical that emphasizes the degree and duration of symptoms and identifies risk factors. But the guideline writers note that the recommendation is a grade 1C because the supporting data mainly come from observational or case studies.

 

 


“The cardinal signs of internal hemorrhoids are painless bleeding with bowel movements with intermittent protrusion,” the committee said, also emphasizing that patients should be evaluated for fecal incontinence, which could inform surgical decision making.

In addition, the guidelines call for a complete endoscopic evaluation of the colon for patients who present with symptomatic hemorrhoids and rectal bleeding; this recommendation is based on moderately strong evidence, and presented with a grade of 1B.

Medical management of hemorrhoids may include office-based procedures or surgery, according to the guidelines.

“Most patients with grade I and II and select patients with grade III internal hemorrhoidal disease who fail medical treatment can be effectively treated with office-based procedures, such as banding, sclerotherapy, and infrared coagulation,” the committee wrote, and medical office treatment received a strong grade 1A recommendation based on high-quality evidence. Although office procedures are generally well tolerated, the condition can recur. Bleeding is the most common complication, and it is more likely after rubber-band ligation than other office-based options, the guidelines state.
 

 



The guidelines offer a weak recommendation of 2C, based on the lack of quality evidence, for the use of early surgical excision to treat patients with thrombosed external hemorrhoids. “Although most patients treated nonoperatively will experience eventual resolution of their symptoms, excision of thrombosed external hemorrhoids may result in more rapid symptom resolution, lower incidence of recurrence, and longer remission intervals,” the committee noted.

Surgical hemorrhoidectomy received the strongest possible recommendation (1A, based on high-quality evidence) for the treatment of patients with external hemorrhoids or a combination of internal and external hemorrhoids with prolapse.

Surgical options described in the recommendations include surgical excision (hemorrhoidectomy), hemorrhoidopexy, and Doppler-guided hemorrhoidectomy, with citations of studies on each procedure. Data from a meta-analysis of 18 randomized prospective studies comparing hemorrhoidectomy with office-based procedures showed that hemorrhoidectomy was “the most effective treatment for patients with grade III hemorrhoids,” but it was associated with greater pain and complication rates, according to the guidelines.

However, complications in general are low after surgical hemorrhoidectomy, with reported complication rates of 1%-2% for the most common complication of postprocedure hemorrhage, the guidelines state. After surgery, the guidelines recommend with a 1B grade (moderate quality evidence) that patients use “a multimodality pain regimen to reduce narcotic usage and promote a faster recovery.”
 

 


The committee members had no financial conflicts to disclose.

SOURCE: Davis BR et al. Dis Colon Rectum. 2018; 61:284-92.

 

Each year, more than 2.2 million patients in the United States undergo evaluations for symptoms of hemorrhoids, according to updated guidelines on the management of hemorrhoids issued by the American Society of Colon and Rectal Surgeons.

“As a result, it is important to identify symptomatic hemorrhoids as the underlying source of the anorectal symptom and to have a clear understanding of the evaluation and management of this disease process,” wrote Bradley R. Davis, MD, FACS, chief of colon and rectal surgery at the Carolinas Medical Center, Charlotte, N.C., and the fellow members of the Clinical Practice Guidelines Committee of the ASCRS.

Dmitrii Kotin/Thinkstock.com

The guidelines are based on the ASCRS Practice Parameters for the Management of Hemorrhoids published in 2011. The 2018 update was published in the Diseases of the Colon & Rectum.

The guidelines recommend evaluation of hemorrhoids based on a disease-specific history, and a physical that emphasizes the degree and duration of symptoms and identifies risk factors. But the guideline writers note that the recommendation is a grade 1C because the supporting data mainly come from observational or case studies.

 

 


“The cardinal signs of internal hemorrhoids are painless bleeding with bowel movements with intermittent protrusion,” the committee said, also emphasizing that patients should be evaluated for fecal incontinence, which could inform surgical decision making.

In addition, the guidelines call for a complete endoscopic evaluation of the colon for patients who present with symptomatic hemorrhoids and rectal bleeding; this recommendation is based on moderately strong evidence, and presented with a grade of 1B.

Medical management of hemorrhoids may include office-based procedures or surgery, according to the guidelines.

“Most patients with grade I and II and select patients with grade III internal hemorrhoidal disease who fail medical treatment can be effectively treated with office-based procedures, such as banding, sclerotherapy, and infrared coagulation,” the committee wrote, and medical office treatment received a strong grade 1A recommendation based on high-quality evidence. Although office procedures are generally well tolerated, the condition can recur. Bleeding is the most common complication, and it is more likely after rubber-band ligation than other office-based options, the guidelines state.
 

 



The guidelines offer a weak recommendation of 2C, based on the lack of quality evidence, for the use of early surgical excision to treat patients with thrombosed external hemorrhoids. “Although most patients treated nonoperatively will experience eventual resolution of their symptoms, excision of thrombosed external hemorrhoids may result in more rapid symptom resolution, lower incidence of recurrence, and longer remission intervals,” the committee noted.

Surgical hemorrhoidectomy received the strongest possible recommendation (1A, based on high-quality evidence) for the treatment of patients with external hemorrhoids or a combination of internal and external hemorrhoids with prolapse.

Surgical options described in the recommendations include surgical excision (hemorrhoidectomy), hemorrhoidopexy, and Doppler-guided hemorrhoidectomy, with citations of studies on each procedure. Data from a meta-analysis of 18 randomized prospective studies comparing hemorrhoidectomy with office-based procedures showed that hemorrhoidectomy was “the most effective treatment for patients with grade III hemorrhoids,” but it was associated with greater pain and complication rates, according to the guidelines.

However, complications in general are low after surgical hemorrhoidectomy, with reported complication rates of 1%-2% for the most common complication of postprocedure hemorrhage, the guidelines state. After surgery, the guidelines recommend with a 1B grade (moderate quality evidence) that patients use “a multimodality pain regimen to reduce narcotic usage and promote a faster recovery.”
 

 


The committee members had no financial conflicts to disclose.

SOURCE: Davis BR et al. Dis Colon Rectum. 2018; 61:284-92.

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How to lower occupational radiation exposure in the cath lab

Protecting staff members from scatter beams
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Adding some lead shielding in cardiac catheterization labs can cut the amount of radiation that nurse circulators and scrub technologists are exposed to, according to a single-center study of more than 750 patients.

“The simple and relatively inexpensive approach of providing staff members with a dedicated accessory lead shield during cardiac catheterization was associated with a nearly two-thirds reduction in radiation exposure among both nurses and technologists” according to Ryan Madder, MD, and his associates. “The present study is the first, to our knowledge, to observe a similar benefit among nonphysician staff members, an observation that may have important implications for occupational safety in the cardiac catheterization laboratory.”

Dr. Ryan Madder


The report was published in JACC: Cardiovascular Interventions.

SHIELD (Combining Robotic-Stenting and Proactive Shielding Techniques in the Catheterization Laboratory to Achieve Lowest Possible Radiation Exposure to Physicians and Staff) was a single-center, prospective, observational designed study to research radiation exposure levels among physicians and other staff members in cardiac catheterization labs. Dr. Madder, a cardiologist at Spectrum Health in Grand Rapids, Mich., and his colleagues collected radiation exposure information for staff members such as nurse circulators and scrub technologists during August 2015–February 2016 and measured radiation exposure in 764 consecutive cases. Radiation exposure was monitored for these staff members by dosimeters worn on either the left anterior side of the glasses or thyroid collar, and a body dosimeter underneath the lead apparel on the V-neck of their scrub shirt.

The radiation protection used in the study followed standard institutional operating procedures, which includes two shields between the patient and physician, a ceiling mounted upper body shield with a patient contour cutout, and a lower body shield attached to the side of the operating table, extending from the table to the floor. Staff members wore traditional lead garments, consisting of a lead skirt, apron, and thyroid collar. Additional radiation absorbing disposable pads were used as desired by the staff members.



The study was split into two phases to evaluate the effectiveness of accessory shields with phase 1 (401 cases) utilizing traditional protective measures. Phase 2 (363 cases) used the same material as phase I, but a dedicated accessory lead shield was used. For nurse circulators, this shield was placed between the patient and the intravenous medication pole. For scrub technologists, the shield was placed at the foot of the patient’s bed.

Radiation exposure was higher in phase 1 than phase 2 for all workers. In phase I, technologists faced an effective dose normalized to the dose-area product (EDAP) of 2.4 mcSv/(mGy x cm2) x 10-5 per case. This dropped significantly in phase 2 to an EDAP of 0.9per case, a 62.5% lower dose per case (P less than .0001).

Nurses experienced a similar decrease in exposure per case from phase 1 (EDAP 1.1) and phase 2 (EDAP 0.4). This accounted for a 63.6% lower dose per case (P less than .0001).

The contrast delivery system used at the lab did not allow technologists to maximize their distance from radiation sources, so it is unclear whether the results of this study can be extrapolated to centers where technologists do not perform contrast injections.

Dr. Madder and his colleagues pointed out that this research only begins to scratch the surface of the occupational hazards that catheterization laboratory personnel face.“The use of accessory lead shields, which might be effective to reduce staff radiation exposure, will not likely reduce other occupational hazards of working in the catheterization laboratory related to wearing heavy lead garments, including the risks for orthopedic injuries and experiencing chronic work-related pain.”

Corindus Vascular Robotics partially funded this study and has provided research support to Dr. Madder. All other researchers have no financial conflicts to report.

SOURCE: Madder R. JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:206-12.

Body

 

While concerns about occupational radiation exposure to cardiologists has prompted equipment, shielding, and behavioral modifications to reduce radiation exposure in cardiologists, exposure to staff members such as nurses and technologists has not received this same attention.

Dr. Kenneth A. Fetterly
These staff members are further away from radiation sources than the physician, yet they are exposed on an almost daily basis. The work of Madder et al. describes how the use of accessory shields can help reduce the occupational radiation doses to cardiovascular technologists and nurses during cardiac catheterization procedures. The scatter of the primary x-ray beam is the main source of occupational radiation, and this is where accessory radiation shielding devices can be of use in protecting nurses and technologists.

Considering that the shield should also absorb approximately 98% of the scatter radiation, the only real issue about its effectiveness is whether technologists and nurses can remain behind the wall while still being able to assist during a procedure.

All cardiology labs should be equipped with these shields to provide adequate radiation protection to those who work there. The work of Madder et al. should provide confidence to nurses and technologists that their occupational radiation exposure can be expected to be low, as well as their cancer risk.

Kenneth A. Fetterly, PhD , a radiologist, and Malcolm R. Bell, MD , a cardiologist and director of the ischemic heart disease program at the Mayo Clinic in Rochester, Minn., made these comments in an editorial ( JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:213-4 ).

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While concerns about occupational radiation exposure to cardiologists has prompted equipment, shielding, and behavioral modifications to reduce radiation exposure in cardiologists, exposure to staff members such as nurses and technologists has not received this same attention.

Dr. Kenneth A. Fetterly
These staff members are further away from radiation sources than the physician, yet they are exposed on an almost daily basis. The work of Madder et al. describes how the use of accessory shields can help reduce the occupational radiation doses to cardiovascular technologists and nurses during cardiac catheterization procedures. The scatter of the primary x-ray beam is the main source of occupational radiation, and this is where accessory radiation shielding devices can be of use in protecting nurses and technologists.

Considering that the shield should also absorb approximately 98% of the scatter radiation, the only real issue about its effectiveness is whether technologists and nurses can remain behind the wall while still being able to assist during a procedure.

All cardiology labs should be equipped with these shields to provide adequate radiation protection to those who work there. The work of Madder et al. should provide confidence to nurses and technologists that their occupational radiation exposure can be expected to be low, as well as their cancer risk.

Kenneth A. Fetterly, PhD , a radiologist, and Malcolm R. Bell, MD , a cardiologist and director of the ischemic heart disease program at the Mayo Clinic in Rochester, Minn., made these comments in an editorial ( JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:213-4 ).

Body

 

While concerns about occupational radiation exposure to cardiologists has prompted equipment, shielding, and behavioral modifications to reduce radiation exposure in cardiologists, exposure to staff members such as nurses and technologists has not received this same attention.

Dr. Kenneth A. Fetterly
These staff members are further away from radiation sources than the physician, yet they are exposed on an almost daily basis. The work of Madder et al. describes how the use of accessory shields can help reduce the occupational radiation doses to cardiovascular technologists and nurses during cardiac catheterization procedures. The scatter of the primary x-ray beam is the main source of occupational radiation, and this is where accessory radiation shielding devices can be of use in protecting nurses and technologists.

Considering that the shield should also absorb approximately 98% of the scatter radiation, the only real issue about its effectiveness is whether technologists and nurses can remain behind the wall while still being able to assist during a procedure.

All cardiology labs should be equipped with these shields to provide adequate radiation protection to those who work there. The work of Madder et al. should provide confidence to nurses and technologists that their occupational radiation exposure can be expected to be low, as well as their cancer risk.

Kenneth A. Fetterly, PhD , a radiologist, and Malcolm R. Bell, MD , a cardiologist and director of the ischemic heart disease program at the Mayo Clinic in Rochester, Minn., made these comments in an editorial ( JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:213-4 ).

Title
Protecting staff members from scatter beams
Protecting staff members from scatter beams

 

Adding some lead shielding in cardiac catheterization labs can cut the amount of radiation that nurse circulators and scrub technologists are exposed to, according to a single-center study of more than 750 patients.

“The simple and relatively inexpensive approach of providing staff members with a dedicated accessory lead shield during cardiac catheterization was associated with a nearly two-thirds reduction in radiation exposure among both nurses and technologists” according to Ryan Madder, MD, and his associates. “The present study is the first, to our knowledge, to observe a similar benefit among nonphysician staff members, an observation that may have important implications for occupational safety in the cardiac catheterization laboratory.”

Dr. Ryan Madder


The report was published in JACC: Cardiovascular Interventions.

SHIELD (Combining Robotic-Stenting and Proactive Shielding Techniques in the Catheterization Laboratory to Achieve Lowest Possible Radiation Exposure to Physicians and Staff) was a single-center, prospective, observational designed study to research radiation exposure levels among physicians and other staff members in cardiac catheterization labs. Dr. Madder, a cardiologist at Spectrum Health in Grand Rapids, Mich., and his colleagues collected radiation exposure information for staff members such as nurse circulators and scrub technologists during August 2015–February 2016 and measured radiation exposure in 764 consecutive cases. Radiation exposure was monitored for these staff members by dosimeters worn on either the left anterior side of the glasses or thyroid collar, and a body dosimeter underneath the lead apparel on the V-neck of their scrub shirt.

The radiation protection used in the study followed standard institutional operating procedures, which includes two shields between the patient and physician, a ceiling mounted upper body shield with a patient contour cutout, and a lower body shield attached to the side of the operating table, extending from the table to the floor. Staff members wore traditional lead garments, consisting of a lead skirt, apron, and thyroid collar. Additional radiation absorbing disposable pads were used as desired by the staff members.



The study was split into two phases to evaluate the effectiveness of accessory shields with phase 1 (401 cases) utilizing traditional protective measures. Phase 2 (363 cases) used the same material as phase I, but a dedicated accessory lead shield was used. For nurse circulators, this shield was placed between the patient and the intravenous medication pole. For scrub technologists, the shield was placed at the foot of the patient’s bed.

Radiation exposure was higher in phase 1 than phase 2 for all workers. In phase I, technologists faced an effective dose normalized to the dose-area product (EDAP) of 2.4 mcSv/(mGy x cm2) x 10-5 per case. This dropped significantly in phase 2 to an EDAP of 0.9per case, a 62.5% lower dose per case (P less than .0001).

Nurses experienced a similar decrease in exposure per case from phase 1 (EDAP 1.1) and phase 2 (EDAP 0.4). This accounted for a 63.6% lower dose per case (P less than .0001).

The contrast delivery system used at the lab did not allow technologists to maximize their distance from radiation sources, so it is unclear whether the results of this study can be extrapolated to centers where technologists do not perform contrast injections.

Dr. Madder and his colleagues pointed out that this research only begins to scratch the surface of the occupational hazards that catheterization laboratory personnel face.“The use of accessory lead shields, which might be effective to reduce staff radiation exposure, will not likely reduce other occupational hazards of working in the catheterization laboratory related to wearing heavy lead garments, including the risks for orthopedic injuries and experiencing chronic work-related pain.”

Corindus Vascular Robotics partially funded this study and has provided research support to Dr. Madder. All other researchers have no financial conflicts to report.

SOURCE: Madder R. JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:206-12.

 

Adding some lead shielding in cardiac catheterization labs can cut the amount of radiation that nurse circulators and scrub technologists are exposed to, according to a single-center study of more than 750 patients.

“The simple and relatively inexpensive approach of providing staff members with a dedicated accessory lead shield during cardiac catheterization was associated with a nearly two-thirds reduction in radiation exposure among both nurses and technologists” according to Ryan Madder, MD, and his associates. “The present study is the first, to our knowledge, to observe a similar benefit among nonphysician staff members, an observation that may have important implications for occupational safety in the cardiac catheterization laboratory.”

Dr. Ryan Madder


The report was published in JACC: Cardiovascular Interventions.

SHIELD (Combining Robotic-Stenting and Proactive Shielding Techniques in the Catheterization Laboratory to Achieve Lowest Possible Radiation Exposure to Physicians and Staff) was a single-center, prospective, observational designed study to research radiation exposure levels among physicians and other staff members in cardiac catheterization labs. Dr. Madder, a cardiologist at Spectrum Health in Grand Rapids, Mich., and his colleagues collected radiation exposure information for staff members such as nurse circulators and scrub technologists during August 2015–February 2016 and measured radiation exposure in 764 consecutive cases. Radiation exposure was monitored for these staff members by dosimeters worn on either the left anterior side of the glasses or thyroid collar, and a body dosimeter underneath the lead apparel on the V-neck of their scrub shirt.

The radiation protection used in the study followed standard institutional operating procedures, which includes two shields between the patient and physician, a ceiling mounted upper body shield with a patient contour cutout, and a lower body shield attached to the side of the operating table, extending from the table to the floor. Staff members wore traditional lead garments, consisting of a lead skirt, apron, and thyroid collar. Additional radiation absorbing disposable pads were used as desired by the staff members.



The study was split into two phases to evaluate the effectiveness of accessory shields with phase 1 (401 cases) utilizing traditional protective measures. Phase 2 (363 cases) used the same material as phase I, but a dedicated accessory lead shield was used. For nurse circulators, this shield was placed between the patient and the intravenous medication pole. For scrub technologists, the shield was placed at the foot of the patient’s bed.

Radiation exposure was higher in phase 1 than phase 2 for all workers. In phase I, technologists faced an effective dose normalized to the dose-area product (EDAP) of 2.4 mcSv/(mGy x cm2) x 10-5 per case. This dropped significantly in phase 2 to an EDAP of 0.9per case, a 62.5% lower dose per case (P less than .0001).

Nurses experienced a similar decrease in exposure per case from phase 1 (EDAP 1.1) and phase 2 (EDAP 0.4). This accounted for a 63.6% lower dose per case (P less than .0001).

The contrast delivery system used at the lab did not allow technologists to maximize their distance from radiation sources, so it is unclear whether the results of this study can be extrapolated to centers where technologists do not perform contrast injections.

Dr. Madder and his colleagues pointed out that this research only begins to scratch the surface of the occupational hazards that catheterization laboratory personnel face.“The use of accessory lead shields, which might be effective to reduce staff radiation exposure, will not likely reduce other occupational hazards of working in the catheterization laboratory related to wearing heavy lead garments, including the risks for orthopedic injuries and experiencing chronic work-related pain.”

Corindus Vascular Robotics partially funded this study and has provided research support to Dr. Madder. All other researchers have no financial conflicts to report.

SOURCE: Madder R. JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:206-12.

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Key clinical point: Accessory lead shielding reduces radiation exposure for nurses and technologists.

Major finding: Accessory lead shielding reduced radiation exposure by over two-thirds.

Study details: A single-center, prospective, observational study of 764 cases.

Disclosures: Corindus Vascular Robotics partially funded this study and has provided research support to Dr. Madder. All other researchers have no financial conflicts to report.

Source: Madder R. JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:206-12.
 

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Dexmedetomidine: ‘Silver bullet’ for ventilator liberation?

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– Among medications to facilitate extubation, dexmedetomidine offers favorable attributes, but whether it’s the best choice for patients who have difficulty being liberated from the ventilator remains to be proven, said Gilles L. Fraser, BS Pharm, PharmD.

The current CHEST/ATS guidelines on liberation from mechanical ventilation in critically ill adults strongly suggest extubation to noninvasive mechanical ventilation in high-risk patients (Chest. 2017 Jan;151[1]:160-5. doi: 10.1016/j.chest.2016.10.037). Guideline authors also suggested protocols attempting to minimize sedation for acutely hospitalized patients ventilated for more than 24 hours, based on some evidence showing a trend toward shorter ventilation time and ICU stay, as well as lower short-term mortality.

“Is dexmedetomidine the silver bullet to facilitate extubation? It’s absolutely not clear,” said Dr. Fraser, one of the coauthors of the guidelines, during his presentation at the Critical Care Congress sponsored by the Society for Critical Care Medicine.

“I’ll leave you up to your own devices,” he told attendees at a session on conundrums in critical care that are not addressed in current guidelines. “We use it all the time, frankly, but I don’t have any firm data to support that contention.”

Despite best practices, extubation attempts are not always successful: “If you follow the rules of the road, success is going to occur about 85% of the time,” said Dr. Fraser, who is a clinical pharmacist at Maine Medical Center, Portland, and professor of medicine at Tufts University, Boston. “That means that about 15% of our patients have difficulties in being liberated from the ventilator.”

In terms of medications to facilitate ventilator liberation, benzodiazepines, dexmedetomidine, and propofol all have roles to play, according to Dr. Fraser. Clinicians have to consider agent-specific side effects, pharmacokinetics and dynamics, and “econotoxicity,” or the cost of care, he added.

Although there are few comparative data available to guide choice of medication, Dr. Fraser and his colleagues have published a systematic review and meta-analysis of randomized trials of benzodiazepine versus nonbenzodiazepine-based sedation for mechanically ventilated, critically ill adult patients (Crit Care Med. 2013 Sep;41[9 Suppl 1]:S30-8. doi: 10.1097/CCM.0b013e3182a16898).

They found that dexmedetomidine- or propofol-based sedation regimens appeared to reduce mechanical ventilation duration and length of ICU stay versus benzodiazepine-based sedation, but they stated that larger controlled studies would be needed to further define outcomes in this setting.

More recently, other investigators reported an evaluation of 9,603 consecutive mechanical ventilation episodes (Chest. 2016 Jun;149[6]:1373-9. doi: 10.1378/chest.15-1389). In this large, real-world experience, propofol and dexmedetomidine were both associated with less time to extubation versus benzodiazepines, and dexmedetomidine was associated with less time to extubation versus propofol.

Relatively few patients (about 12%), however, received dexmedetomidine in that large series, and that was mostly in the setting of cardiac surgery, Dr. Fraser noted. Moreover, the investigators reported finding no differences between any two agents in hospital discharge or mortality hazard ratio.

“We’re not suggesting the benzodiazepines as routine sedative agents in our patient populations,” Dr. Fraser said in his presentation. “The primary reason is that they result in a longer time on the vent, typically between 1 and 2 days.”

But this doesn’t mean that the benzodiazepines are the “devil’s handiwork,” he added, noting that they may be useful in patients with anxiety related to ventilator weaning and those recovering from hemodynamic instability or at risk for GABA-agonist withdrawal.

Dexmedetomidine is opioid sparing and has a minimal effect on respiratory drive, among other advantages; however, some potential drawbacks include its hemodynamic effects and its cost, according to Dr. Fraser.

Dr. Fraser said that his institution’s daily acquisition cost for dexmedetomidine is $500, compared with $120 for propofol and $40 for benzodiazepines, but some pharmacoeconomic evaluations suggest use of dexmedetomidine may actually save between $3,000 and $9,000 per ICU admission. “At least in our place, one day in the ICU costs about $5,000, so that all makes sense … and I can argue fairly effectively that dexmedetomidine really isn’t that expensive compared to midazolam,” he said.

Dr. Fraser said that he had no disclosures related to his presentation.

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– Among medications to facilitate extubation, dexmedetomidine offers favorable attributes, but whether it’s the best choice for patients who have difficulty being liberated from the ventilator remains to be proven, said Gilles L. Fraser, BS Pharm, PharmD.

The current CHEST/ATS guidelines on liberation from mechanical ventilation in critically ill adults strongly suggest extubation to noninvasive mechanical ventilation in high-risk patients (Chest. 2017 Jan;151[1]:160-5. doi: 10.1016/j.chest.2016.10.037). Guideline authors also suggested protocols attempting to minimize sedation for acutely hospitalized patients ventilated for more than 24 hours, based on some evidence showing a trend toward shorter ventilation time and ICU stay, as well as lower short-term mortality.

“Is dexmedetomidine the silver bullet to facilitate extubation? It’s absolutely not clear,” said Dr. Fraser, one of the coauthors of the guidelines, during his presentation at the Critical Care Congress sponsored by the Society for Critical Care Medicine.

“I’ll leave you up to your own devices,” he told attendees at a session on conundrums in critical care that are not addressed in current guidelines. “We use it all the time, frankly, but I don’t have any firm data to support that contention.”

Despite best practices, extubation attempts are not always successful: “If you follow the rules of the road, success is going to occur about 85% of the time,” said Dr. Fraser, who is a clinical pharmacist at Maine Medical Center, Portland, and professor of medicine at Tufts University, Boston. “That means that about 15% of our patients have difficulties in being liberated from the ventilator.”

In terms of medications to facilitate ventilator liberation, benzodiazepines, dexmedetomidine, and propofol all have roles to play, according to Dr. Fraser. Clinicians have to consider agent-specific side effects, pharmacokinetics and dynamics, and “econotoxicity,” or the cost of care, he added.

Although there are few comparative data available to guide choice of medication, Dr. Fraser and his colleagues have published a systematic review and meta-analysis of randomized trials of benzodiazepine versus nonbenzodiazepine-based sedation for mechanically ventilated, critically ill adult patients (Crit Care Med. 2013 Sep;41[9 Suppl 1]:S30-8. doi: 10.1097/CCM.0b013e3182a16898).

They found that dexmedetomidine- or propofol-based sedation regimens appeared to reduce mechanical ventilation duration and length of ICU stay versus benzodiazepine-based sedation, but they stated that larger controlled studies would be needed to further define outcomes in this setting.

More recently, other investigators reported an evaluation of 9,603 consecutive mechanical ventilation episodes (Chest. 2016 Jun;149[6]:1373-9. doi: 10.1378/chest.15-1389). In this large, real-world experience, propofol and dexmedetomidine were both associated with less time to extubation versus benzodiazepines, and dexmedetomidine was associated with less time to extubation versus propofol.

Relatively few patients (about 12%), however, received dexmedetomidine in that large series, and that was mostly in the setting of cardiac surgery, Dr. Fraser noted. Moreover, the investigators reported finding no differences between any two agents in hospital discharge or mortality hazard ratio.

“We’re not suggesting the benzodiazepines as routine sedative agents in our patient populations,” Dr. Fraser said in his presentation. “The primary reason is that they result in a longer time on the vent, typically between 1 and 2 days.”

But this doesn’t mean that the benzodiazepines are the “devil’s handiwork,” he added, noting that they may be useful in patients with anxiety related to ventilator weaning and those recovering from hemodynamic instability or at risk for GABA-agonist withdrawal.

Dexmedetomidine is opioid sparing and has a minimal effect on respiratory drive, among other advantages; however, some potential drawbacks include its hemodynamic effects and its cost, according to Dr. Fraser.

Dr. Fraser said that his institution’s daily acquisition cost for dexmedetomidine is $500, compared with $120 for propofol and $40 for benzodiazepines, but some pharmacoeconomic evaluations suggest use of dexmedetomidine may actually save between $3,000 and $9,000 per ICU admission. “At least in our place, one day in the ICU costs about $5,000, so that all makes sense … and I can argue fairly effectively that dexmedetomidine really isn’t that expensive compared to midazolam,” he said.

Dr. Fraser said that he had no disclosures related to his presentation.

 

– Among medications to facilitate extubation, dexmedetomidine offers favorable attributes, but whether it’s the best choice for patients who have difficulty being liberated from the ventilator remains to be proven, said Gilles L. Fraser, BS Pharm, PharmD.

The current CHEST/ATS guidelines on liberation from mechanical ventilation in critically ill adults strongly suggest extubation to noninvasive mechanical ventilation in high-risk patients (Chest. 2017 Jan;151[1]:160-5. doi: 10.1016/j.chest.2016.10.037). Guideline authors also suggested protocols attempting to minimize sedation for acutely hospitalized patients ventilated for more than 24 hours, based on some evidence showing a trend toward shorter ventilation time and ICU stay, as well as lower short-term mortality.

“Is dexmedetomidine the silver bullet to facilitate extubation? It’s absolutely not clear,” said Dr. Fraser, one of the coauthors of the guidelines, during his presentation at the Critical Care Congress sponsored by the Society for Critical Care Medicine.

“I’ll leave you up to your own devices,” he told attendees at a session on conundrums in critical care that are not addressed in current guidelines. “We use it all the time, frankly, but I don’t have any firm data to support that contention.”

Despite best practices, extubation attempts are not always successful: “If you follow the rules of the road, success is going to occur about 85% of the time,” said Dr. Fraser, who is a clinical pharmacist at Maine Medical Center, Portland, and professor of medicine at Tufts University, Boston. “That means that about 15% of our patients have difficulties in being liberated from the ventilator.”

In terms of medications to facilitate ventilator liberation, benzodiazepines, dexmedetomidine, and propofol all have roles to play, according to Dr. Fraser. Clinicians have to consider agent-specific side effects, pharmacokinetics and dynamics, and “econotoxicity,” or the cost of care, he added.

Although there are few comparative data available to guide choice of medication, Dr. Fraser and his colleagues have published a systematic review and meta-analysis of randomized trials of benzodiazepine versus nonbenzodiazepine-based sedation for mechanically ventilated, critically ill adult patients (Crit Care Med. 2013 Sep;41[9 Suppl 1]:S30-8. doi: 10.1097/CCM.0b013e3182a16898).

They found that dexmedetomidine- or propofol-based sedation regimens appeared to reduce mechanical ventilation duration and length of ICU stay versus benzodiazepine-based sedation, but they stated that larger controlled studies would be needed to further define outcomes in this setting.

More recently, other investigators reported an evaluation of 9,603 consecutive mechanical ventilation episodes (Chest. 2016 Jun;149[6]:1373-9. doi: 10.1378/chest.15-1389). In this large, real-world experience, propofol and dexmedetomidine were both associated with less time to extubation versus benzodiazepines, and dexmedetomidine was associated with less time to extubation versus propofol.

Relatively few patients (about 12%), however, received dexmedetomidine in that large series, and that was mostly in the setting of cardiac surgery, Dr. Fraser noted. Moreover, the investigators reported finding no differences between any two agents in hospital discharge or mortality hazard ratio.

“We’re not suggesting the benzodiazepines as routine sedative agents in our patient populations,” Dr. Fraser said in his presentation. “The primary reason is that they result in a longer time on the vent, typically between 1 and 2 days.”

But this doesn’t mean that the benzodiazepines are the “devil’s handiwork,” he added, noting that they may be useful in patients with anxiety related to ventilator weaning and those recovering from hemodynamic instability or at risk for GABA-agonist withdrawal.

Dexmedetomidine is opioid sparing and has a minimal effect on respiratory drive, among other advantages; however, some potential drawbacks include its hemodynamic effects and its cost, according to Dr. Fraser.

Dr. Fraser said that his institution’s daily acquisition cost for dexmedetomidine is $500, compared with $120 for propofol and $40 for benzodiazepines, but some pharmacoeconomic evaluations suggest use of dexmedetomidine may actually save between $3,000 and $9,000 per ICU admission. “At least in our place, one day in the ICU costs about $5,000, so that all makes sense … and I can argue fairly effectively that dexmedetomidine really isn’t that expensive compared to midazolam,” he said.

Dr. Fraser said that he had no disclosures related to his presentation.

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Combo therapy does not improve outcomes for A. Baumannii

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Combo therapy does not improve outcomes for A. Baumannii

 

Adding meropenem to colistin had no effect on clinical success in cases of severe Acinetobacter baumannii infections, based on data from 406 patients.

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The primary outcome was defined as clinical success 14 days after randomization; 79% (156) of the colistin-only patients and 73% (152) of the combination patients did not meet the criteria, the researchers said. In addition, no significant difference between the groups was noted in all-cause mortality at 14 days or 28 days, or for any other secondary outcomes including fever and time spent in the ICU.

 

 


The results highlight “the necessity of assessing combination therapy in randomized trials before adopting it into clinical use,” the researchers said.

The study was not designed to examine the effect of the two types of therapy on bacteria other than A. baumannii, the researchers noted. However, based on the findings, “we recommend against the routine use of carbapenems for the treatment of carbapenem-resistant A. baumannii infections,” they said.

The study was supported by EU AIDA grant Health-F3-2011-278348. Dr. Paul had no financial conflicts to disclose.

SOURCE: Paul M et al. Lancet Infect Dis. 2018 Feb 15. doi: 10.1016/S1473-3099(18)30099-9.

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Adding meropenem to colistin had no effect on clinical success in cases of severe Acinetobacter baumannii infections, based on data from 406 patients.

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The primary outcome was defined as clinical success 14 days after randomization; 79% (156) of the colistin-only patients and 73% (152) of the combination patients did not meet the criteria, the researchers said. In addition, no significant difference between the groups was noted in all-cause mortality at 14 days or 28 days, or for any other secondary outcomes including fever and time spent in the ICU.

 

 


The results highlight “the necessity of assessing combination therapy in randomized trials before adopting it into clinical use,” the researchers said.

The study was not designed to examine the effect of the two types of therapy on bacteria other than A. baumannii, the researchers noted. However, based on the findings, “we recommend against the routine use of carbapenems for the treatment of carbapenem-resistant A. baumannii infections,” they said.

The study was supported by EU AIDA grant Health-F3-2011-278348. Dr. Paul had no financial conflicts to disclose.

SOURCE: Paul M et al. Lancet Infect Dis. 2018 Feb 15. doi: 10.1016/S1473-3099(18)30099-9.

 

Adding meropenem to colistin had no effect on clinical success in cases of severe Acinetobacter baumannii infections, based on data from 406 patients.

monkeybusinessimages/Thinkstock
The primary outcome was defined as clinical success 14 days after randomization; 79% (156) of the colistin-only patients and 73% (152) of the combination patients did not meet the criteria, the researchers said. In addition, no significant difference between the groups was noted in all-cause mortality at 14 days or 28 days, or for any other secondary outcomes including fever and time spent in the ICU.

 

 


The results highlight “the necessity of assessing combination therapy in randomized trials before adopting it into clinical use,” the researchers said.

The study was not designed to examine the effect of the two types of therapy on bacteria other than A. baumannii, the researchers noted. However, based on the findings, “we recommend against the routine use of carbapenems for the treatment of carbapenem-resistant A. baumannii infections,” they said.

The study was supported by EU AIDA grant Health-F3-2011-278348. Dr. Paul had no financial conflicts to disclose.

SOURCE: Paul M et al. Lancet Infect Dis. 2018 Feb 15. doi: 10.1016/S1473-3099(18)30099-9.

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Commentary—Finding Important Nutrients in Unexpected Places

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While you might not typically put chopped or blended, unsalted, boiled canned oysters on your usual list of recommended infant and toddler foods, maybe you should.

The American Academy of Pediatrics just published a new policy statement on advocacy to improve child nutrition in the first 1,000 days (from conception to age 2). The statement emphasizes the importance of nutrition to optimal brain development. Pediatricians are encouraged to be familiar with community services to support optimal nutrition such as the Special Supplemental Nutrition Program for Women, Infants, and Children, the Supplemental Nutrition Assistance Program, the Child and Adult Care Food Program, and food pantries and soup kitchens, but also to get beyond recommending a “good diet” to something more specific that is high in key nutrients important for brain development such as protein; zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and polyunsaturated fatty acids. That’s where the boiled oysters, a decent source of the listed nutrients and especially loaded with zinc, iron, and vitamin B12, come in. While not everyone is going to rush out to buy their babies such an unexpected (and for many, unfamiliar) food, the statement reminds pediatricians to recommend foods that are good sources of the nutrients that babies and toddlers need most. Other foods that fit the bill include oatmeal, meat and poultry, fish like salmon and tuna, eggs, tofu and soybeans, and other legumes and beans like chickpeas and lentils.

Natalie D. Muth, MD
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Children's Primary Care Medical Group
Carlsbad, California

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While you might not typically put chopped or blended, unsalted, boiled canned oysters on your usual list of recommended infant and toddler foods, maybe you should.

The American Academy of Pediatrics just published a new policy statement on advocacy to improve child nutrition in the first 1,000 days (from conception to age 2). The statement emphasizes the importance of nutrition to optimal brain development. Pediatricians are encouraged to be familiar with community services to support optimal nutrition such as the Special Supplemental Nutrition Program for Women, Infants, and Children, the Supplemental Nutrition Assistance Program, the Child and Adult Care Food Program, and food pantries and soup kitchens, but also to get beyond recommending a “good diet” to something more specific that is high in key nutrients important for brain development such as protein; zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and polyunsaturated fatty acids. That’s where the boiled oysters, a decent source of the listed nutrients and especially loaded with zinc, iron, and vitamin B12, come in. While not everyone is going to rush out to buy their babies such an unexpected (and for many, unfamiliar) food, the statement reminds pediatricians to recommend foods that are good sources of the nutrients that babies and toddlers need most. Other foods that fit the bill include oatmeal, meat and poultry, fish like salmon and tuna, eggs, tofu and soybeans, and other legumes and beans like chickpeas and lentils.

Natalie D. Muth, MD
Pediatrician
Children's Primary Care Medical Group
Carlsbad, California

While you might not typically put chopped or blended, unsalted, boiled canned oysters on your usual list of recommended infant and toddler foods, maybe you should.

The American Academy of Pediatrics just published a new policy statement on advocacy to improve child nutrition in the first 1,000 days (from conception to age 2). The statement emphasizes the importance of nutrition to optimal brain development. Pediatricians are encouraged to be familiar with community services to support optimal nutrition such as the Special Supplemental Nutrition Program for Women, Infants, and Children, the Supplemental Nutrition Assistance Program, the Child and Adult Care Food Program, and food pantries and soup kitchens, but also to get beyond recommending a “good diet” to something more specific that is high in key nutrients important for brain development such as protein; zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and polyunsaturated fatty acids. That’s where the boiled oysters, a decent source of the listed nutrients and especially loaded with zinc, iron, and vitamin B12, come in. While not everyone is going to rush out to buy their babies such an unexpected (and for many, unfamiliar) food, the statement reminds pediatricians to recommend foods that are good sources of the nutrients that babies and toddlers need most. Other foods that fit the bill include oatmeal, meat and poultry, fish like salmon and tuna, eggs, tofu and soybeans, and other legumes and beans like chickpeas and lentils.

Natalie D. Muth, MD
Pediatrician
Children's Primary Care Medical Group
Carlsbad, California

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68
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New device cuts postoperative pulmonary complications

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A device that combines lung expansion, mucus clearance, and aerosol delivery appears to reduce postoperative pulmonary complications, according to results of a nonrandomized study including high-risk patients undergoing elective surgical procedures.

“For certain types of surgical procedures, this therapy (MetaNeb, Hill-Rom) may provide a benefit for high-risk patients in terms of reducing their pulmonary complications and their hospital stay,” said Toan Huynh, MD, lead investigator and director of trauma research at Carolinas HealthCare System, Charlotte, N.C., at the Critical Care Congress sponsored by the Society for Critical Care Medicine.

Currently, aggressive management of high-risk patients with strategies such as optimal analgesia, early ambulation, secretion mobilization, and lung expansion are used to try to reduce the incidence of postoperative pulmonary complications, noted Dr. Huynh, in an interview.

ollega/Thinkstock

In this study, Dr. Huynh and his colleagues from the University of Pennsylvania, Philadelphia, and the Lahey Hospital & Medical Center, Burlington, Mass., sought to evaluate the efficacy of the MetaNeb system, which delivers continuous high-frequency oscillation, continuous positive expiratory pressure, and in-line aerosol flow in one combined unit. To estimate usual postoperative pulmonary complication rates, they first queried CPT and ICD-9-CM codes to identify a total of 210 patients who had undergone thoracic, upper-abdominal, or aortic open surgical procedures. Then, in the second stage of the study, the investigators prospectively enrolled 209 subjects who underwent those types of surgery with the MetaNeb system in addition to a standard postoperative respiratory regimen. All patients were high risk as defined by having either an American Society of Anesthesiologists classification of at least 3 or an ASA classification of 2 along with one or more comorbidities, such as COPD or recent smoking history.

Among the patients managed with MetaNeb, 33 (15.8%) experienced one or more pulmonary complications, compared with 48 (22.9%) in the retrospective cohort (P = 0.06). For intubated patients, at least one complication was seen in 22 patients (36.7%) in the MetaNeb group, compared with 37 (69.8%) in the comparison group (P less than .05). Time on mechanical ventilation was 8.5 hours in the MetaNeb group versus 23.7 hours in the comparison group (P less than .05).

Use of the device was also associated with decreased length of hospital stay, but the difference between lengths of stay was not statistically significant. Hospital length of stay was 6.8 days in the MetaNeb versus 8.4 days in the comparison groups.“In the current day and age of value-based health care, I think any kind of reduction in expenditure related to health care costs would be compelling for clinicians,” Dr. Huynh said in the interview.

Further study may be needed to better define the role of the combined modality system in clinical practice, according to Dr. Huynh.

“This is sort of a ‘before and after’ nonrandomized trial,” Dr. Huynh explained. “I think, ideally, if we can do a truly controlled, randomized trial, that will be much more powerful.”

The study was sponsored by Hill-Rom, which manufactures the device under study. Dr. Huynh said he and coinvestigators had no financial conflicts related to the research.

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A device that combines lung expansion, mucus clearance, and aerosol delivery appears to reduce postoperative pulmonary complications, according to results of a nonrandomized study including high-risk patients undergoing elective surgical procedures.

“For certain types of surgical procedures, this therapy (MetaNeb, Hill-Rom) may provide a benefit for high-risk patients in terms of reducing their pulmonary complications and their hospital stay,” said Toan Huynh, MD, lead investigator and director of trauma research at Carolinas HealthCare System, Charlotte, N.C., at the Critical Care Congress sponsored by the Society for Critical Care Medicine.

Currently, aggressive management of high-risk patients with strategies such as optimal analgesia, early ambulation, secretion mobilization, and lung expansion are used to try to reduce the incidence of postoperative pulmonary complications, noted Dr. Huynh, in an interview.

ollega/Thinkstock

In this study, Dr. Huynh and his colleagues from the University of Pennsylvania, Philadelphia, and the Lahey Hospital & Medical Center, Burlington, Mass., sought to evaluate the efficacy of the MetaNeb system, which delivers continuous high-frequency oscillation, continuous positive expiratory pressure, and in-line aerosol flow in one combined unit. To estimate usual postoperative pulmonary complication rates, they first queried CPT and ICD-9-CM codes to identify a total of 210 patients who had undergone thoracic, upper-abdominal, or aortic open surgical procedures. Then, in the second stage of the study, the investigators prospectively enrolled 209 subjects who underwent those types of surgery with the MetaNeb system in addition to a standard postoperative respiratory regimen. All patients were high risk as defined by having either an American Society of Anesthesiologists classification of at least 3 or an ASA classification of 2 along with one or more comorbidities, such as COPD or recent smoking history.

Among the patients managed with MetaNeb, 33 (15.8%) experienced one or more pulmonary complications, compared with 48 (22.9%) in the retrospective cohort (P = 0.06). For intubated patients, at least one complication was seen in 22 patients (36.7%) in the MetaNeb group, compared with 37 (69.8%) in the comparison group (P less than .05). Time on mechanical ventilation was 8.5 hours in the MetaNeb group versus 23.7 hours in the comparison group (P less than .05).

Use of the device was also associated with decreased length of hospital stay, but the difference between lengths of stay was not statistically significant. Hospital length of stay was 6.8 days in the MetaNeb versus 8.4 days in the comparison groups.“In the current day and age of value-based health care, I think any kind of reduction in expenditure related to health care costs would be compelling for clinicians,” Dr. Huynh said in the interview.

Further study may be needed to better define the role of the combined modality system in clinical practice, according to Dr. Huynh.

“This is sort of a ‘before and after’ nonrandomized trial,” Dr. Huynh explained. “I think, ideally, if we can do a truly controlled, randomized trial, that will be much more powerful.”

The study was sponsored by Hill-Rom, which manufactures the device under study. Dr. Huynh said he and coinvestigators had no financial conflicts related to the research.

 

A device that combines lung expansion, mucus clearance, and aerosol delivery appears to reduce postoperative pulmonary complications, according to results of a nonrandomized study including high-risk patients undergoing elective surgical procedures.

“For certain types of surgical procedures, this therapy (MetaNeb, Hill-Rom) may provide a benefit for high-risk patients in terms of reducing their pulmonary complications and their hospital stay,” said Toan Huynh, MD, lead investigator and director of trauma research at Carolinas HealthCare System, Charlotte, N.C., at the Critical Care Congress sponsored by the Society for Critical Care Medicine.

Currently, aggressive management of high-risk patients with strategies such as optimal analgesia, early ambulation, secretion mobilization, and lung expansion are used to try to reduce the incidence of postoperative pulmonary complications, noted Dr. Huynh, in an interview.

ollega/Thinkstock

In this study, Dr. Huynh and his colleagues from the University of Pennsylvania, Philadelphia, and the Lahey Hospital & Medical Center, Burlington, Mass., sought to evaluate the efficacy of the MetaNeb system, which delivers continuous high-frequency oscillation, continuous positive expiratory pressure, and in-line aerosol flow in one combined unit. To estimate usual postoperative pulmonary complication rates, they first queried CPT and ICD-9-CM codes to identify a total of 210 patients who had undergone thoracic, upper-abdominal, or aortic open surgical procedures. Then, in the second stage of the study, the investigators prospectively enrolled 209 subjects who underwent those types of surgery with the MetaNeb system in addition to a standard postoperative respiratory regimen. All patients were high risk as defined by having either an American Society of Anesthesiologists classification of at least 3 or an ASA classification of 2 along with one or more comorbidities, such as COPD or recent smoking history.

Among the patients managed with MetaNeb, 33 (15.8%) experienced one or more pulmonary complications, compared with 48 (22.9%) in the retrospective cohort (P = 0.06). For intubated patients, at least one complication was seen in 22 patients (36.7%) in the MetaNeb group, compared with 37 (69.8%) in the comparison group (P less than .05). Time on mechanical ventilation was 8.5 hours in the MetaNeb group versus 23.7 hours in the comparison group (P less than .05).

Use of the device was also associated with decreased length of hospital stay, but the difference between lengths of stay was not statistically significant. Hospital length of stay was 6.8 days in the MetaNeb versus 8.4 days in the comparison groups.“In the current day and age of value-based health care, I think any kind of reduction in expenditure related to health care costs would be compelling for clinicians,” Dr. Huynh said in the interview.

Further study may be needed to better define the role of the combined modality system in clinical practice, according to Dr. Huynh.

“This is sort of a ‘before and after’ nonrandomized trial,” Dr. Huynh explained. “I think, ideally, if we can do a truly controlled, randomized trial, that will be much more powerful.”

The study was sponsored by Hill-Rom, which manufactures the device under study. Dr. Huynh said he and coinvestigators had no financial conflicts related to the research.

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AT THE CRITICAL CARE CONGRESS

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Key clinical point: A device that combines lung expansion, secretion clearance, and aerosol delivery (MetaNeb) appears to reduce postoperative pulmonary complications and resource use.Major finding: Pulmonary complications occurred in 36.7% of intubated patients, compared with 69.8% for a prospectively evaluated reference population (P less than 0.05).

Data source: A prospective, nonrandomized, two-stage study including 417 subjects who underwent thoracic, upper-abdominal, or aortic open surgical procedure at one of three centers.

Disclosures: The study was sponsored by Hill-Rom, which manufactures the MetaNeb device. Investigators had no financial conflicts related to the study.

Source: Huynh T et al. Critical Care Congress, Abstract 17.

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Adenotonsillectomy reduced hypertension in OSA subgroup

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Hypertensive children with obstructive sleep apnea (OSA) who underwent adenotonsillectomy experienced significant improvements in their blood pressure after surgery, according to a retrospective analysis.

This is one of the few studies to have ever examined whether adenotonsillectomy for children with OSA had any effects on blood pressure (BP) and was based on “one of the largest cohorts for evaluating postoperative BP changes in nonobese children with OSA,” noted Cho-Hsueh Lee, MD, and colleagues. The report was published in JAMA Otolaryngology–Head & Neck Surgery. Among the previous studies that evaluated BP in children with OSA before and after having this surgery, the results varied, they added.

Purestock/ThinkStock
“Our subgroup analysis results revealed that hypertensive children with OSA had significant improvements in all BP measures after surgery,” wrote Dr. Lee, of the department of otolaryngology at National Taiwan University Hospital in Taipei, and coauthors. “These findings highlight the need to screen children with OSA to determine their hypertensive status and appropriately treat these children to ease their OSA symptoms and potentially prevent future adverse cardiovascular outcomes.”

The researchers analyzed the medical records of 240 nonobese children with clinical symptoms and polysomnography-confirmed OSA (having an apnea-hypopnea index of greater than 1) who underwent adenotonsillectomy. Prior to surgery, 169 patients (70.4%) of the patients were classified as nonhypertensive, while 71 (29.6%) were classified as hypertensive. The children had a mean age of 7.3 years, and 160 were males.

Patients participated in full-night polysomnography (PSG) before surgery and at 3-6 months after adenotonsillectomy in the National Taiwan University Hospital Sleep Center. Apnea episodes were defined as a 90% decrease in airflow for two consecutive breaths. Sleep center staff measured the study participants’ systolic and diastolic BP in a sleep center using an electronic sphygmomanometer, in the evening, prior to the PSG study, and in the morning. Pediatric hypertension was based on the nocturnal BP measurement and was defined as having mean systolic and diastolic BP greater or equal to the 95th percentile for age, sex, and height.

“Postoperatively, hypertensive children had a significant decrease in all BP measures, including nocturnal and morning [systolic] BP ... A total of 47 hypertensive patients (66.2%) became nonhypertensive after surgery,” the researchers said.

For patients who were hypertensive before surgery, the average nocturnal (before PSG) preop systolic BP was 114.3 mm Hg, versus 107.5 mm Hg after surgery. The mean nocturnal diastolic BP for this same group of patients decreased to 65.1 mm Hg from 74.3 mm Hg. Similarly, the average morning (after PSG) systolic BP and diastolic BP were 106.0 mm Hg and 64.4 mm Hg after these patients underwent adenotonsillectomy, compared with 111.8 mm Hg and 71.7 mm Hg prior to surgery, respectively.

The adenotonsillectomy didn’t improve all patients’ BP. For some who were nonhypertensive before surgery, blood pressure increased, with 36 (21.3%) of this group having become hypersensitive after surgery, the researchers acknowledged.

Overall, the cohort experienced significant improvements in several PSG measures, including the average apnea-hypopnea index, which decreased from 12.1 events per hour to 1.7. The total arousal index also declined, going from 6.1 events per hour to 4.2. In addition, the mean oxygen saturation improved from 96.8% to 97.7%.

The investigators described several limitations of the study, including their inability to collect patients’ arterial stiffness, carotid intima thickness, and other cardiovascular measures beyond BP.

They recommended a follow-up study. “Although we observed improvements in BP measures within 6 months after surgery for hypertensive children with OSA, the long-term effects of surgery on BP remain uncertain,” they explained.

The study was supported by grants from the Ministry of Science and Technology, Republic of China (Taiwan). The researchers disclosed no potential conflicts of interest.

SOURCE: Lee, C-H et al. JAMA Otolaryngol Head Neck Surg. 2018 Feb 15. doi: 10.1001/jamaoto.2017.3127.

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Dr. Susan Millard
Susan Millard, MD, FCCP, comments: This pediatric study from Taiwan is important because it shows that hypertension is a significant issue in nonobese children and can be modulated by treatment for OSA. The only concern I have is that blood pressure normative reference data was adopted to Taiwanese children from the National High Blood Pressure Education Program working group in the United States. Our sleep clinic at Helen DeVos Children’s Hospital often receives referrals from Pediatric Cardiology and Pediatric Nephrology for sleep studies for hypertensive patients. Hopefully, because of this publication, primary care providers will also consider OSA in their work-up for pediatric hypertension!
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Dr. Susan Millard
Susan Millard, MD, FCCP, comments: This pediatric study from Taiwan is important because it shows that hypertension is a significant issue in nonobese children and can be modulated by treatment for OSA. The only concern I have is that blood pressure normative reference data was adopted to Taiwanese children from the National High Blood Pressure Education Program working group in the United States. Our sleep clinic at Helen DeVos Children’s Hospital often receives referrals from Pediatric Cardiology and Pediatric Nephrology for sleep studies for hypertensive patients. Hopefully, because of this publication, primary care providers will also consider OSA in their work-up for pediatric hypertension!
Body

Dr. Susan Millard
Susan Millard, MD, FCCP, comments: This pediatric study from Taiwan is important because it shows that hypertension is a significant issue in nonobese children and can be modulated by treatment for OSA. The only concern I have is that blood pressure normative reference data was adopted to Taiwanese children from the National High Blood Pressure Education Program working group in the United States. Our sleep clinic at Helen DeVos Children’s Hospital often receives referrals from Pediatric Cardiology and Pediatric Nephrology for sleep studies for hypertensive patients. Hopefully, because of this publication, primary care providers will also consider OSA in their work-up for pediatric hypertension!
Name
Susan Millard, MD, FCCP
Name
Susan Millard, MD, FCCP

 

Hypertensive children with obstructive sleep apnea (OSA) who underwent adenotonsillectomy experienced significant improvements in their blood pressure after surgery, according to a retrospective analysis.

This is one of the few studies to have ever examined whether adenotonsillectomy for children with OSA had any effects on blood pressure (BP) and was based on “one of the largest cohorts for evaluating postoperative BP changes in nonobese children with OSA,” noted Cho-Hsueh Lee, MD, and colleagues. The report was published in JAMA Otolaryngology–Head & Neck Surgery. Among the previous studies that evaluated BP in children with OSA before and after having this surgery, the results varied, they added.

Purestock/ThinkStock
“Our subgroup analysis results revealed that hypertensive children with OSA had significant improvements in all BP measures after surgery,” wrote Dr. Lee, of the department of otolaryngology at National Taiwan University Hospital in Taipei, and coauthors. “These findings highlight the need to screen children with OSA to determine their hypertensive status and appropriately treat these children to ease their OSA symptoms and potentially prevent future adverse cardiovascular outcomes.”

The researchers analyzed the medical records of 240 nonobese children with clinical symptoms and polysomnography-confirmed OSA (having an apnea-hypopnea index of greater than 1) who underwent adenotonsillectomy. Prior to surgery, 169 patients (70.4%) of the patients were classified as nonhypertensive, while 71 (29.6%) were classified as hypertensive. The children had a mean age of 7.3 years, and 160 were males.

Patients participated in full-night polysomnography (PSG) before surgery and at 3-6 months after adenotonsillectomy in the National Taiwan University Hospital Sleep Center. Apnea episodes were defined as a 90% decrease in airflow for two consecutive breaths. Sleep center staff measured the study participants’ systolic and diastolic BP in a sleep center using an electronic sphygmomanometer, in the evening, prior to the PSG study, and in the morning. Pediatric hypertension was based on the nocturnal BP measurement and was defined as having mean systolic and diastolic BP greater or equal to the 95th percentile for age, sex, and height.

“Postoperatively, hypertensive children had a significant decrease in all BP measures, including nocturnal and morning [systolic] BP ... A total of 47 hypertensive patients (66.2%) became nonhypertensive after surgery,” the researchers said.

For patients who were hypertensive before surgery, the average nocturnal (before PSG) preop systolic BP was 114.3 mm Hg, versus 107.5 mm Hg after surgery. The mean nocturnal diastolic BP for this same group of patients decreased to 65.1 mm Hg from 74.3 mm Hg. Similarly, the average morning (after PSG) systolic BP and diastolic BP were 106.0 mm Hg and 64.4 mm Hg after these patients underwent adenotonsillectomy, compared with 111.8 mm Hg and 71.7 mm Hg prior to surgery, respectively.

The adenotonsillectomy didn’t improve all patients’ BP. For some who were nonhypertensive before surgery, blood pressure increased, with 36 (21.3%) of this group having become hypersensitive after surgery, the researchers acknowledged.

Overall, the cohort experienced significant improvements in several PSG measures, including the average apnea-hypopnea index, which decreased from 12.1 events per hour to 1.7. The total arousal index also declined, going from 6.1 events per hour to 4.2. In addition, the mean oxygen saturation improved from 96.8% to 97.7%.

The investigators described several limitations of the study, including their inability to collect patients’ arterial stiffness, carotid intima thickness, and other cardiovascular measures beyond BP.

They recommended a follow-up study. “Although we observed improvements in BP measures within 6 months after surgery for hypertensive children with OSA, the long-term effects of surgery on BP remain uncertain,” they explained.

The study was supported by grants from the Ministry of Science and Technology, Republic of China (Taiwan). The researchers disclosed no potential conflicts of interest.

SOURCE: Lee, C-H et al. JAMA Otolaryngol Head Neck Surg. 2018 Feb 15. doi: 10.1001/jamaoto.2017.3127.

 

Hypertensive children with obstructive sleep apnea (OSA) who underwent adenotonsillectomy experienced significant improvements in their blood pressure after surgery, according to a retrospective analysis.

This is one of the few studies to have ever examined whether adenotonsillectomy for children with OSA had any effects on blood pressure (BP) and was based on “one of the largest cohorts for evaluating postoperative BP changes in nonobese children with OSA,” noted Cho-Hsueh Lee, MD, and colleagues. The report was published in JAMA Otolaryngology–Head & Neck Surgery. Among the previous studies that evaluated BP in children with OSA before and after having this surgery, the results varied, they added.

Purestock/ThinkStock
“Our subgroup analysis results revealed that hypertensive children with OSA had significant improvements in all BP measures after surgery,” wrote Dr. Lee, of the department of otolaryngology at National Taiwan University Hospital in Taipei, and coauthors. “These findings highlight the need to screen children with OSA to determine their hypertensive status and appropriately treat these children to ease their OSA symptoms and potentially prevent future adverse cardiovascular outcomes.”

The researchers analyzed the medical records of 240 nonobese children with clinical symptoms and polysomnography-confirmed OSA (having an apnea-hypopnea index of greater than 1) who underwent adenotonsillectomy. Prior to surgery, 169 patients (70.4%) of the patients were classified as nonhypertensive, while 71 (29.6%) were classified as hypertensive. The children had a mean age of 7.3 years, and 160 were males.

Patients participated in full-night polysomnography (PSG) before surgery and at 3-6 months after adenotonsillectomy in the National Taiwan University Hospital Sleep Center. Apnea episodes were defined as a 90% decrease in airflow for two consecutive breaths. Sleep center staff measured the study participants’ systolic and diastolic BP in a sleep center using an electronic sphygmomanometer, in the evening, prior to the PSG study, and in the morning. Pediatric hypertension was based on the nocturnal BP measurement and was defined as having mean systolic and diastolic BP greater or equal to the 95th percentile for age, sex, and height.

“Postoperatively, hypertensive children had a significant decrease in all BP measures, including nocturnal and morning [systolic] BP ... A total of 47 hypertensive patients (66.2%) became nonhypertensive after surgery,” the researchers said.

For patients who were hypertensive before surgery, the average nocturnal (before PSG) preop systolic BP was 114.3 mm Hg, versus 107.5 mm Hg after surgery. The mean nocturnal diastolic BP for this same group of patients decreased to 65.1 mm Hg from 74.3 mm Hg. Similarly, the average morning (after PSG) systolic BP and diastolic BP were 106.0 mm Hg and 64.4 mm Hg after these patients underwent adenotonsillectomy, compared with 111.8 mm Hg and 71.7 mm Hg prior to surgery, respectively.

The adenotonsillectomy didn’t improve all patients’ BP. For some who were nonhypertensive before surgery, blood pressure increased, with 36 (21.3%) of this group having become hypersensitive after surgery, the researchers acknowledged.

Overall, the cohort experienced significant improvements in several PSG measures, including the average apnea-hypopnea index, which decreased from 12.1 events per hour to 1.7. The total arousal index also declined, going from 6.1 events per hour to 4.2. In addition, the mean oxygen saturation improved from 96.8% to 97.7%.

The investigators described several limitations of the study, including their inability to collect patients’ arterial stiffness, carotid intima thickness, and other cardiovascular measures beyond BP.

They recommended a follow-up study. “Although we observed improvements in BP measures within 6 months after surgery for hypertensive children with OSA, the long-term effects of surgery on BP remain uncertain,” they explained.

The study was supported by grants from the Ministry of Science and Technology, Republic of China (Taiwan). The researchers disclosed no potential conflicts of interest.

SOURCE: Lee, C-H et al. JAMA Otolaryngol Head Neck Surg. 2018 Feb 15. doi: 10.1001/jamaoto.2017.3127.

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FROM JAMA OTOLARYNGOLOGY-HEAD & NECK SURGERY

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Key clinical point: Hypertensive children with obstructive sleep apnea (OSA) who had an adenotonsillectomy experienced significant improvements in their blood pressure after surgery.

Major finding: Sixty-six percent of hypertensive patients with OSA became nonhypertensive after adenotonsillectomy.

Study details: A retrospective analysis of 240 nonobese children with OSA who underwent adenotonsillectomy.

Disclosures: The study was supported by grants from the Ministry of Science and Technology, Republic of China (Taiwan). The researchers disclosed no potential conflicts of interest.

Source: Lee, C-H et al. JAMA Otolaryngol Head Neck Surg. 2018 Feb 15. doi: 10.1001/jamaoto.2017.3127.

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