Among patients with severe isolated aortic stenosis younger than 65, the rate of transcatheter aortic valve replacement (TAVR) now almost matches that of surgical aortic valve replacement (SAVR), despite guideline recommendations to the contrary, a study in a national U.S. population shows.

The 2020 American Heart Association/American College of Cardiology (AHA/ACC) valve guideline recommends SAVR for patients younger than 65 with severe aortic stenosis, the researchers note, but their study showed “near equal utilization between TAVR and SAVR in these younger patients by 2021,” at 48% and 52% respectively.

Toishi Sharma, MD, and colleagues presented these findings in an oral poster session at Transcatheter Cardiovascular Therapeutics 2022, and the study was simultaneously published as a Research Letter in the Journal of the American College of Cardiology (JACC).

“To our knowledge, the current findings represent the first national temporal trends study stratifying [aortic stenosis] therapies according to guideline-recommended age groups: our observations demonstrate the dramatic growth of TAVR in all age groups, including young patients,” the researchers conclude.

They analyzed changes in rates of TAVR and SAVR in a U.S. sample stratified by age: younger than 65 years, 65-80, and older than 80 years.

These findings have implications for lifetime management of younger patients who undergo TAVR, they write, “including issues related to lifetime coronary access, valve durability, and the potential for subsequent TAVR procedures over time.”
 

Three age groups

In a study published in JACC, this group examined changes in uptake of TAVR versus SAVR in 4,161 patients with aortic stenosis in Vermont, New Hampshire, and Maine, senior author Harold L. Dauerman, MD, said in an interview.

The greatest rate of rise of TAVR was in the group younger than 65, but that study ended in 2019, said Dr. Dauerman, from the University of Vermont Health Network, Burlington.

The 2020 guideline stratifies TAVR and SAVR recommendations such that “less than 65 should primarily be a surgical approach and greater than 80 primarily a TAVR approach, while 65 to 80 is a gray zone, and shared decision-making becomes important,” he noted.

The group hypothesized that recent trials and technology have led to a national increase in TAVR in people younger than 65.

From the Vizient clinical database, including more than 250 U.S. academic centers that perform both TAVR and SAVR, the researchers identified 142,953 patients who underwent TAVR or SAVR for isolated aortic stenosis from Oct. 1, 2015, to Dec. 31, 2021. From 2015 to 2021, the valve replacement rates in the three age groups changed as follows:

• Age less than 65: TAVR rose from 17% to 48%; SAVR fell from 83% to 52%.
• Age 65-80: TAVR rose from 46% to 87%; SAVR fell from 54% to 12%.
• Age greater than 80: TAVR rose from 83% to 99%; SAVR fell from 16% to 1%.

“All ages have grown in the last 7 years in TAVR,” Dr. Dauerman summarized. “The one that’s surprising, and in contradiction to the guideline, is the growth of TAVR in young patients less than 65.”

Among patients younger than 65, prior bypass surgery and congestive heart failure predicted the use of TAVR instead of surgery, whereas bicuspid aortic valve disease was the biggest predictor of surgery instead of TAVR.

Most studies on TAVR valve durability are limited to patients in the randomized trials who were primarily in their mid-70s to mid-80s, some of whom died before a 10-year follow-up, Dr. Dauerman noted.

European guidelines recommend surgery for patients younger than 70, and it would be interesting to see if clinicians there follow this recommendation or if TAVR is now the preferred approach, he added.

There is a need for further, longer study of TAVR in younger patients, he said, to determine whether there are long-term clinical issues of concern.
 

Strategy depends on more than age

The “findings are not too surprising,” John Carroll, MD, who was not involved in this research, said in an email.

University of Colorado Hospital

“Age is only one of multiple patient characteristics that enter into consideration of TAVR versus SAVR,” said Dr. Carroll, from Anschutz Medical Campus, University of Colorado, Aurora.

“As the article reports,” he noted, “those less than 65 having TAVR are more likely to have comorbid conditions that likely made the risk of SAVR higher.”

Dr. Carroll was lead author of a review article published in 2020 based on data from the ACC–Society of Thoracic Surgeons (STS)–Transcatheter Valve Therapy (TVT) registry on 276,316 patients who had TAVR in the United States from 2011-2019.

He pointed out that Figure 2 in that review shows that “SAVR is often performed in conjunction with other surgical procedures – another major reason why SAVR remains an important treatment for valvular heart disease.”

“We are awaiting long-term data comparing TAVR to SAVR durability,” Dr. Carroll added, echoing Dr. Dauerman. “So far [there are] no major differences, but it remains a key need to fully understand TAVR and the various models in commercial use.”

“Both TAVR and SAVR used in adults are tissue valves (SAVR with mechanical valves is used in younger patients),” Dr. Carroll noted, “and all tissue valves will eventually fail if the patient lives long enough.”

Patient management strategies need to consider what treatment options exist when the first valve fails. “If the first valve is SAVR, there is now extensive experience with placing a TAVR valve inside a failing SAVR valve, so called Valve-in-Valve or TAVR-in-SAVR. This is the preferred treatment in most patients with failing SAVR valves,” he said.

“On the other hand,” he continued, “we are just beginning to see more and more patients with failing TAVR valves, and the TAVR-in-TAVR procedure is less well understood.”

“Issues such as acute coronary occlusion and long-term difficulty in accessing coronary arteries are being encountered in some patients having TAVR-in-TAVR,” Dr. Carroll noted, which he discusses in a recent editorial he coauthored about the complexities of redo TAVR, published in JACC: Cardiovascular Interventions.

The study received no funding. Dr. Dauerman has research grants and is a consultant for Medtronic and Boston Scientific. Dr. Carroll is a local principal investigator in trials sponsored by Medtronic, Abbott, and Edwards Lifesciences.

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

Among patients with severe isolated aortic stenosis younger than 65, the rate of transcatheter aortic valve replacement (TAVR) now almost matches that of surgical aortic valve replacement (SAVR), despite guideline recommendations to the contrary, a study in a national U.S. population shows.

The 2020 American Heart Association/American College of Cardiology (AHA/ACC) valve guideline recommends SAVR for patients younger than 65 with severe aortic stenosis, the researchers note, but their study showed “near equal utilization between TAVR and SAVR in these younger patients by 2021,” at 48% and 52% respectively.

Toishi Sharma, MD, and colleagues presented these findings in an oral poster session at Transcatheter Cardiovascular Therapeutics 2022, and the study was simultaneously published as a Research Letter in the Journal of the American College of Cardiology (JACC).

“To our knowledge, the current findings represent the first national temporal trends study stratifying [aortic stenosis] therapies according to guideline-recommended age groups: our observations demonstrate the dramatic growth of TAVR in all age groups, including young patients,” the researchers conclude.

They analyzed changes in rates of TAVR and SAVR in a U.S. sample stratified by age: younger than 65 years, 65-80, and older than 80 years.

These findings have implications for lifetime management of younger patients who undergo TAVR, they write, “including issues related to lifetime coronary access, valve durability, and the potential for subsequent TAVR procedures over time.”
 

Three age groups

In a study published in JACC, this group examined changes in uptake of TAVR versus SAVR in 4,161 patients with aortic stenosis in Vermont, New Hampshire, and Maine, senior author Harold L. Dauerman, MD, said in an interview.

The greatest rate of rise of TAVR was in the group younger than 65, but that study ended in 2019, said Dr. Dauerman, from the University of Vermont Health Network, Burlington.

The 2020 guideline stratifies TAVR and SAVR recommendations such that “less than 65 should primarily be a surgical approach and greater than 80 primarily a TAVR approach, while 65 to 80 is a gray zone, and shared decision-making becomes important,” he noted.

The group hypothesized that recent trials and technology have led to a national increase in TAVR in people younger than 65.

From the Vizient clinical database, including more than 250 U.S. academic centers that perform both TAVR and SAVR, the researchers identified 142,953 patients who underwent TAVR or SAVR for isolated aortic stenosis from Oct. 1, 2015, to Dec. 31, 2021. From 2015 to 2021, the valve replacement rates in the three age groups changed as follows:

• Age less than 65: TAVR rose from 17% to 48%; SAVR fell from 83% to 52%.
• Age 65-80: TAVR rose from 46% to 87%; SAVR fell from 54% to 12%.
• Age greater than 80: TAVR rose from 83% to 99%; SAVR fell from 16% to 1%.

“All ages have grown in the last 7 years in TAVR,” Dr. Dauerman summarized. “The one that’s surprising, and in contradiction to the guideline, is the growth of TAVR in young patients less than 65.”

Among patients younger than 65, prior bypass surgery and congestive heart failure predicted the use of TAVR instead of surgery, whereas bicuspid aortic valve disease was the biggest predictor of surgery instead of TAVR.

Most studies on TAVR valve durability are limited to patients in the randomized trials who were primarily in their mid-70s to mid-80s, some of whom died before a 10-year follow-up, Dr. Dauerman noted.

European guidelines recommend surgery for patients younger than 70, and it would be interesting to see if clinicians there follow this recommendation or if TAVR is now the preferred approach, he added.

There is a need for further, longer study of TAVR in younger patients, he said, to determine whether there are long-term clinical issues of concern.
 

Strategy depends on more than age

The “findings are not too surprising,” John Carroll, MD, who was not involved in this research, said in an email.

University of Colorado Hospital

“Age is only one of multiple patient characteristics that enter into consideration of TAVR versus SAVR,” said Dr. Carroll, from Anschutz Medical Campus, University of Colorado, Aurora.

“As the article reports,” he noted, “those less than 65 having TAVR are more likely to have comorbid conditions that likely made the risk of SAVR higher.”

Dr. Carroll was lead author of a review article published in 2020 based on data from the ACC–Society of Thoracic Surgeons (STS)–Transcatheter Valve Therapy (TVT) registry on 276,316 patients who had TAVR in the United States from 2011-2019.

He pointed out that Figure 2 in that review shows that “SAVR is often performed in conjunction with other surgical procedures – another major reason why SAVR remains an important treatment for valvular heart disease.”

“We are awaiting long-term data comparing TAVR to SAVR durability,” Dr. Carroll added, echoing Dr. Dauerman. “So far [there are] no major differences, but it remains a key need to fully understand TAVR and the various models in commercial use.”

“Both TAVR and SAVR used in adults are tissue valves (SAVR with mechanical valves is used in younger patients),” Dr. Carroll noted, “and all tissue valves will eventually fail if the patient lives long enough.”

Patient management strategies need to consider what treatment options exist when the first valve fails. “If the first valve is SAVR, there is now extensive experience with placing a TAVR valve inside a failing SAVR valve, so called Valve-in-Valve or TAVR-in-SAVR. This is the preferred treatment in most patients with failing SAVR valves,” he said.

“On the other hand,” he continued, “we are just beginning to see more and more patients with failing TAVR valves, and the TAVR-in-TAVR procedure is less well understood.”

“Issues such as acute coronary occlusion and long-term difficulty in accessing coronary arteries are being encountered in some patients having TAVR-in-TAVR,” Dr. Carroll noted, which he discusses in a recent editorial he coauthored about the complexities of redo TAVR, published in JACC: Cardiovascular Interventions.

The study received no funding. Dr. Dauerman has research grants and is a consultant for Medtronic and Boston Scientific. Dr. Carroll is a local principal investigator in trials sponsored by Medtronic, Abbott, and Edwards Lifesciences.

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

Among patients with severe isolated aortic stenosis younger than 65, the rate of transcatheter aortic valve replacement (TAVR) now almost matches that of surgical aortic valve replacement (SAVR), despite guideline recommendations to the contrary, a study in a national U.S. population shows.

The 2020 American Heart Association/American College of Cardiology (AHA/ACC) valve guideline recommends SAVR for patients younger than 65 with severe aortic stenosis, the researchers note, but their study showed “near equal utilization between TAVR and SAVR in these younger patients by 2021,” at 48% and 52% respectively.

Toishi Sharma, MD, and colleagues presented these findings in an oral poster session at Transcatheter Cardiovascular Therapeutics 2022, and the study was simultaneously published as a Research Letter in the Journal of the American College of Cardiology (JACC).

“To our knowledge, the current findings represent the first national temporal trends study stratifying [aortic stenosis] therapies according to guideline-recommended age groups: our observations demonstrate the dramatic growth of TAVR in all age groups, including young patients,” the researchers conclude.

They analyzed changes in rates of TAVR and SAVR in a U.S. sample stratified by age: younger than 65 years, 65-80, and older than 80 years.

These findings have implications for lifetime management of younger patients who undergo TAVR, they write, “including issues related to lifetime coronary access, valve durability, and the potential for subsequent TAVR procedures over time.”
 

Three age groups

In a study published in JACC, this group examined changes in uptake of TAVR versus SAVR in 4,161 patients with aortic stenosis in Vermont, New Hampshire, and Maine, senior author Harold L. Dauerman, MD, said in an interview.

The greatest rate of rise of TAVR was in the group younger than 65, but that study ended in 2019, said Dr. Dauerman, from the University of Vermont Health Network, Burlington.

The 2020 guideline stratifies TAVR and SAVR recommendations such that “less than 65 should primarily be a surgical approach and greater than 80 primarily a TAVR approach, while 65 to 80 is a gray zone, and shared decision-making becomes important,” he noted.

The group hypothesized that recent trials and technology have led to a national increase in TAVR in people younger than 65.

From the Vizient clinical database, including more than 250 U.S. academic centers that perform both TAVR and SAVR, the researchers identified 142,953 patients who underwent TAVR or SAVR for isolated aortic stenosis from Oct. 1, 2015, to Dec. 31, 2021. From 2015 to 2021, the valve replacement rates in the three age groups changed as follows:

• Age less than 65: TAVR rose from 17% to 48%; SAVR fell from 83% to 52%.
• Age 65-80: TAVR rose from 46% to 87%; SAVR fell from 54% to 12%.
• Age greater than 80: TAVR rose from 83% to 99%; SAVR fell from 16% to 1%.

“All ages have grown in the last 7 years in TAVR,” Dr. Dauerman summarized. “The one that’s surprising, and in contradiction to the guideline, is the growth of TAVR in young patients less than 65.”

Among patients younger than 65, prior bypass surgery and congestive heart failure predicted the use of TAVR instead of surgery, whereas bicuspid aortic valve disease was the biggest predictor of surgery instead of TAVR.

Most studies on TAVR valve durability are limited to patients in the randomized trials who were primarily in their mid-70s to mid-80s, some of whom died before a 10-year follow-up, Dr. Dauerman noted.

European guidelines recommend surgery for patients younger than 70, and it would be interesting to see if clinicians there follow this recommendation or if TAVR is now the preferred approach, he added.

There is a need for further, longer study of TAVR in younger patients, he said, to determine whether there are long-term clinical issues of concern.
 

Strategy depends on more than age

The “findings are not too surprising,” John Carroll, MD, who was not involved in this research, said in an email.

University of Colorado Hospital

“Age is only one of multiple patient characteristics that enter into consideration of TAVR versus SAVR,” said Dr. Carroll, from Anschutz Medical Campus, University of Colorado, Aurora.

“As the article reports,” he noted, “those less than 65 having TAVR are more likely to have comorbid conditions that likely made the risk of SAVR higher.”

Dr. Carroll was lead author of a review article published in 2020 based on data from the ACC–Society of Thoracic Surgeons (STS)–Transcatheter Valve Therapy (TVT) registry on 276,316 patients who had TAVR in the United States from 2011-2019.

He pointed out that Figure 2 in that review shows that “SAVR is often performed in conjunction with other surgical procedures – another major reason why SAVR remains an important treatment for valvular heart disease.”

“We are awaiting long-term data comparing TAVR to SAVR durability,” Dr. Carroll added, echoing Dr. Dauerman. “So far [there are] no major differences, but it remains a key need to fully understand TAVR and the various models in commercial use.”

“Both TAVR and SAVR used in adults are tissue valves (SAVR with mechanical valves is used in younger patients),” Dr. Carroll noted, “and all tissue valves will eventually fail if the patient lives long enough.”

Patient management strategies need to consider what treatment options exist when the first valve fails. “If the first valve is SAVR, there is now extensive experience with placing a TAVR valve inside a failing SAVR valve, so called Valve-in-Valve or TAVR-in-SAVR. This is the preferred treatment in most patients with failing SAVR valves,” he said.

“On the other hand,” he continued, “we are just beginning to see more and more patients with failing TAVR valves, and the TAVR-in-TAVR procedure is less well understood.”

“Issues such as acute coronary occlusion and long-term difficulty in accessing coronary arteries are being encountered in some patients having TAVR-in-TAVR,” Dr. Carroll noted, which he discusses in a recent editorial he coauthored about the complexities of redo TAVR, published in JACC: Cardiovascular Interventions.

The study received no funding. Dr. Dauerman has research grants and is a consultant for Medtronic and Boston Scientific. Dr. Carroll is a local principal investigator in trials sponsored by Medtronic, Abbott, and Edwards Lifesciences.

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

Researchers have developed a blood test that can detect hepatocellular carcinoma (HCC) at an early stage, increasing the likelihood of potentially curative therapy and improved patient prognosis.

HCC accounts for the majority of primary liver cancers and mainly occurs in patients with cirrhosis or chronic hepatitis B virus infection. The prognosis of HCC is poor, largely owing to advanced disease stage at diagnosis.

The current guidelines recommend surveillance with twice-yearly liver ultrasound, with or without serum alpha-fetoprotein, for patients at risk for HCC, although the diagnostic performance is suboptimal.

The new “liquid biopsy” uses HCC-associated extracellular vesicles (EVs) to establish an HCC EV ECG score for distinguishing patients with early-stage HCC from at-risk controls with cirrhosis from a 400-mcL plasma sample.

“We’re the first team looking at extracellular vesicles as a detection biomarker for early-stage liver cancer, and our study showed it had outstanding performance,” study investigator Ju Dong Yang, MD, with Cedars-Sinai Medical Center, Los Angeles, said in a news release.

The study was published online in Hepatology.

In a phase 2 biomarker (case-control) study, the investigators tested their blood test in a training cohort of 106 individuals (45 patients with treatment-naive early-stage HCC and 61 with cirrhosis) and an independent validation cohort with 72 participants (35 patients with treatment-naive early-stage HCC and 37 with cirrhosis).

The HCC EV ECG score had “excellent accuracy” for discriminating between HCC and cirrhosis, with an area under the receiver operating characteristic curve (AUROC) of 0.95 and 0.93 in the training and validation cohorts, respectively, they report.

The diagnostic performance “remained excellent” among the subpopulations of HCC etiology and those with tumors within the Milan criteria.

Adding the serum alpha-fetoprotein level to the HCC EV ECG score did not improve its performance.

The researchers say that further validation of the blood test in a larger phase 2 study and a subsequent phase 3 study are needed to confirm its utility in clinical settings.

“We are planning on doing larger-scale studies to further validate this test and bring it into routine clinical practice here – and globally,” Dr. Yang said.

“In addition to its excellent performance, this marker has the advantages of being user friendly, cost efficient, and having a fast turnaround time – within 6 hours from sample collection to result,” Dan Theodorescu, MD, PhD, director of Cedars-Sinai Cancer, who is not an author on the study, said in the news release.

“Once this marker has been validated in subsequent studies, it can be easily adopted by existing PCR [polymerase chain reaction] facilities,” Dr. Theodorescu added.

The study was supported by an American College of Gastroenterology Junior Faculty Development Award, a Department of Defense Peer Reviewed Cancer Research Program Career Development Award, and the National Institutes of Health. Dr. Yang provides a consulting service for Exact Sciences, Gilead Sciences, and Eisai. Dr. Theodorescu reports no relevant financial relationships.

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

Researchers have developed a blood test that can detect hepatocellular carcinoma (HCC) at an early stage, increasing the likelihood of potentially curative therapy and improved patient prognosis.

HCC accounts for the majority of primary liver cancers and mainly occurs in patients with cirrhosis or chronic hepatitis B virus infection. The prognosis of HCC is poor, largely owing to advanced disease stage at diagnosis.

The current guidelines recommend surveillance with twice-yearly liver ultrasound, with or without serum alpha-fetoprotein, for patients at risk for HCC, although the diagnostic performance is suboptimal.

The new “liquid biopsy” uses HCC-associated extracellular vesicles (EVs) to establish an HCC EV ECG score for distinguishing patients with early-stage HCC from at-risk controls with cirrhosis from a 400-mcL plasma sample.

“We’re the first team looking at extracellular vesicles as a detection biomarker for early-stage liver cancer, and our study showed it had outstanding performance,” study investigator Ju Dong Yang, MD, with Cedars-Sinai Medical Center, Los Angeles, said in a news release.

The study was published online in Hepatology.

In a phase 2 biomarker (case-control) study, the investigators tested their blood test in a training cohort of 106 individuals (45 patients with treatment-naive early-stage HCC and 61 with cirrhosis) and an independent validation cohort with 72 participants (35 patients with treatment-naive early-stage HCC and 37 with cirrhosis).

The HCC EV ECG score had “excellent accuracy” for discriminating between HCC and cirrhosis, with an area under the receiver operating characteristic curve (AUROC) of 0.95 and 0.93 in the training and validation cohorts, respectively, they report.

The diagnostic performance “remained excellent” among the subpopulations of HCC etiology and those with tumors within the Milan criteria.

Adding the serum alpha-fetoprotein level to the HCC EV ECG score did not improve its performance.

The researchers say that further validation of the blood test in a larger phase 2 study and a subsequent phase 3 study are needed to confirm its utility in clinical settings.

“We are planning on doing larger-scale studies to further validate this test and bring it into routine clinical practice here – and globally,” Dr. Yang said.

“In addition to its excellent performance, this marker has the advantages of being user friendly, cost efficient, and having a fast turnaround time – within 6 hours from sample collection to result,” Dan Theodorescu, MD, PhD, director of Cedars-Sinai Cancer, who is not an author on the study, said in the news release.

“Once this marker has been validated in subsequent studies, it can be easily adopted by existing PCR [polymerase chain reaction] facilities,” Dr. Theodorescu added.

The study was supported by an American College of Gastroenterology Junior Faculty Development Award, a Department of Defense Peer Reviewed Cancer Research Program Career Development Award, and the National Institutes of Health. Dr. Yang provides a consulting service for Exact Sciences, Gilead Sciences, and Eisai. Dr. Theodorescu reports no relevant financial relationships.

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

Researchers have developed a blood test that can detect hepatocellular carcinoma (HCC) at an early stage, increasing the likelihood of potentially curative therapy and improved patient prognosis.

HCC accounts for the majority of primary liver cancers and mainly occurs in patients with cirrhosis or chronic hepatitis B virus infection. The prognosis of HCC is poor, largely owing to advanced disease stage at diagnosis.

The current guidelines recommend surveillance with twice-yearly liver ultrasound, with or without serum alpha-fetoprotein, for patients at risk for HCC, although the diagnostic performance is suboptimal.

The new “liquid biopsy” uses HCC-associated extracellular vesicles (EVs) to establish an HCC EV ECG score for distinguishing patients with early-stage HCC from at-risk controls with cirrhosis from a 400-mcL plasma sample.

“We’re the first team looking at extracellular vesicles as a detection biomarker for early-stage liver cancer, and our study showed it had outstanding performance,” study investigator Ju Dong Yang, MD, with Cedars-Sinai Medical Center, Los Angeles, said in a news release.

The study was published online in Hepatology.

In a phase 2 biomarker (case-control) study, the investigators tested their blood test in a training cohort of 106 individuals (45 patients with treatment-naive early-stage HCC and 61 with cirrhosis) and an independent validation cohort with 72 participants (35 patients with treatment-naive early-stage HCC and 37 with cirrhosis).

The HCC EV ECG score had “excellent accuracy” for discriminating between HCC and cirrhosis, with an area under the receiver operating characteristic curve (AUROC) of 0.95 and 0.93 in the training and validation cohorts, respectively, they report.

The diagnostic performance “remained excellent” among the subpopulations of HCC etiology and those with tumors within the Milan criteria.

Adding the serum alpha-fetoprotein level to the HCC EV ECG score did not improve its performance.

The researchers say that further validation of the blood test in a larger phase 2 study and a subsequent phase 3 study are needed to confirm its utility in clinical settings.

“We are planning on doing larger-scale studies to further validate this test and bring it into routine clinical practice here – and globally,” Dr. Yang said.

“In addition to its excellent performance, this marker has the advantages of being user friendly, cost efficient, and having a fast turnaround time – within 6 hours from sample collection to result,” Dan Theodorescu, MD, PhD, director of Cedars-Sinai Cancer, who is not an author on the study, said in the news release.

“Once this marker has been validated in subsequent studies, it can be easily adopted by existing PCR [polymerase chain reaction] facilities,” Dr. Theodorescu added.

The study was supported by an American College of Gastroenterology Junior Faculty Development Award, a Department of Defense Peer Reviewed Cancer Research Program Career Development Award, and the National Institutes of Health. Dr. Yang provides a consulting service for Exact Sciences, Gilead Sciences, and Eisai. Dr. Theodorescu reports no relevant financial relationships.

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

Key clinical point: The use of probiotic supplementation reduced disease severity in adult patients with atopic dermatitis (AD).

Major finding: Probiotic supplementation vs placebo led to a significant reduction in the Scoring AD index (mean difference −7.90; 95% CI −7.25 to−6.92), but no significant improvements in skin severity and itch severity.

Study details: Findings are from a meta-analysis of six randomized controlled trials including 241 adults with AD, of which 128 received probiotics and 113 received placebo.

Disclosures: This study was funded by a grant from Universitas Airlangga, Indonesia. The authors declared no conflicts of interest.

Source: Umborowati MA et al. The role of probiotics in the treatment of adult atopic dermatitis: a meta-analysis of randomized controlled trials. J Health Popul Nutr. 2022;41:37 (Aug 17). Doi: 10.1186/s41043-022-00318-6

Key clinical point: The use of probiotic supplementation reduced disease severity in adult patients with atopic dermatitis (AD).

Major finding: Probiotic supplementation vs placebo led to a significant reduction in the Scoring AD index (mean difference −7.90; 95% CI −7.25 to−6.92), but no significant improvements in skin severity and itch severity.

Study details: Findings are from a meta-analysis of six randomized controlled trials including 241 adults with AD, of which 128 received probiotics and 113 received placebo.

Disclosures: This study was funded by a grant from Universitas Airlangga, Indonesia. The authors declared no conflicts of interest.

Source: Umborowati MA et al. The role of probiotics in the treatment of adult atopic dermatitis: a meta-analysis of randomized controlled trials. J Health Popul Nutr. 2022;41:37 (Aug 17). Doi: 10.1186/s41043-022-00318-6

Key clinical point: The use of probiotic supplementation reduced disease severity in adult patients with atopic dermatitis (AD).

Major finding: Probiotic supplementation vs placebo led to a significant reduction in the Scoring AD index (mean difference −7.90; 95% CI −7.25 to−6.92), but no significant improvements in skin severity and itch severity.

Study details: Findings are from a meta-analysis of six randomized controlled trials including 241 adults with AD, of which 128 received probiotics and 113 received placebo.

Disclosures: This study was funded by a grant from Universitas Airlangga, Indonesia. The authors declared no conflicts of interest.

Source: Umborowati MA et al. The role of probiotics in the treatment of adult atopic dermatitis: a meta-analysis of randomized controlled trials. J Health Popul Nutr. 2022;41:37 (Aug 17). Doi: 10.1186/s41043-022-00318-6

Key clinical point: Patients who received dupilumab for atopic dermatitis (AD) had moderate-to-severe disease, long medical history, and high prevalence of coexisting type 2 inflammatory diseases.

Major finding: A majority of patients (66.6%) were diagnosed with AD in childhood, and most patients presented with bordering moderate-to-severe AD (Eczema Area and Severity Index > 21), high prevalence of pruritus (99.6%), and coexisting atopic and type 2 inflammatory diseases (51.8%).

Study details: Findings are from an analysis of PROLEAD, a national, multicenter, prospective, non-interventional study, including 817 patients with moderate-to-severe AD who received dupilumab.

Disclosures: This study was funded by Sanofi. Three authors declared being employees of or holding stocks in Sanofi. The other authors reported ties with several sources, including Sanofi.

Source: Thaci D et al. Dupilumab treatment of atopic dermatitis in routine clinical care: Baseline characteristics of patients in the PROLEAD prospective, observational study. Dermatol Ther (Heidelb). 2022;12(9):2145-2160 (Aug 19). Doi: 10.1007/s13555-022-00791-1

Key clinical point: Patients who received dupilumab for atopic dermatitis (AD) had moderate-to-severe disease, long medical history, and high prevalence of coexisting type 2 inflammatory diseases.

Major finding: A majority of patients (66.6%) were diagnosed with AD in childhood, and most patients presented with bordering moderate-to-severe AD (Eczema Area and Severity Index > 21), high prevalence of pruritus (99.6%), and coexisting atopic and type 2 inflammatory diseases (51.8%).

Study details: Findings are from an analysis of PROLEAD, a national, multicenter, prospective, non-interventional study, including 817 patients with moderate-to-severe AD who received dupilumab.

Disclosures: This study was funded by Sanofi. Three authors declared being employees of or holding stocks in Sanofi. The other authors reported ties with several sources, including Sanofi.

Source: Thaci D et al. Dupilumab treatment of atopic dermatitis in routine clinical care: Baseline characteristics of patients in the PROLEAD prospective, observational study. Dermatol Ther (Heidelb). 2022;12(9):2145-2160 (Aug 19). Doi: 10.1007/s13555-022-00791-1

Key clinical point: Patients who received dupilumab for atopic dermatitis (AD) had moderate-to-severe disease, long medical history, and high prevalence of coexisting type 2 inflammatory diseases.

Major finding: A majority of patients (66.6%) were diagnosed with AD in childhood, and most patients presented with bordering moderate-to-severe AD (Eczema Area and Severity Index > 21), high prevalence of pruritus (99.6%), and coexisting atopic and type 2 inflammatory diseases (51.8%).

Study details: Findings are from an analysis of PROLEAD, a national, multicenter, prospective, non-interventional study, including 817 patients with moderate-to-severe AD who received dupilumab.

Disclosures: This study was funded by Sanofi. Three authors declared being employees of or holding stocks in Sanofi. The other authors reported ties with several sources, including Sanofi.

Source: Thaci D et al. Dupilumab treatment of atopic dermatitis in routine clinical care: Baseline characteristics of patients in the PROLEAD prospective, observational study. Dermatol Ther (Heidelb). 2022;12(9):2145-2160 (Aug 19). Doi: 10.1007/s13555-022-00791-1

Key clinical point: Atopic dermatitis (AD) did not increase the incidence risk for most neuropsychiatric disorders in a pediatric cohort.

Major finding: The risks for attention deficit hyperactivity disorder (hazard ratio [HR] 1.02; 95% CI 0.97-1.06), autism (HR 1.02; 95% CI 0.98-1.06), anxiety (HR 1.01; 95% CI 0.99-1.03), and bipolar disorder (HR 1.08; 95% CI 0.85-1.36) were comparable in the AD and non-AD groups. Participants with vs without AD were less likely to develop depression (HR 0.93; 95% CI 0.91-0.95) or schizophrenia (HR 0.72; 95% CI 0.54-0.95) but more likely to develop obsessive compulsive disorder (HR 1.26; 95% CI 1.16-1.37). However, the risks varied with disease severity and patient’s age.

Study details: Findings are from a retrospective population-based cohort study including 409,431 children with AD and 1,809,029 matched children without AD.

Disclosures: This study was supported by a contract from Pfizer, Inc. One author declared being an employee of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Wan J et al. Atopic dermatitis and risk of major neuropsychiatric disorders in children: A population-based cohort study. J Eur Acad Dermatol Venereol. 2022 (Aug 26). Doi: 10.1111/jdv.18564

Key clinical point: Atopic dermatitis (AD) did not increase the incidence risk for most neuropsychiatric disorders in a pediatric cohort.

Major finding: The risks for attention deficit hyperactivity disorder (hazard ratio [HR] 1.02; 95% CI 0.97-1.06), autism (HR 1.02; 95% CI 0.98-1.06), anxiety (HR 1.01; 95% CI 0.99-1.03), and bipolar disorder (HR 1.08; 95% CI 0.85-1.36) were comparable in the AD and non-AD groups. Participants with vs without AD were less likely to develop depression (HR 0.93; 95% CI 0.91-0.95) or schizophrenia (HR 0.72; 95% CI 0.54-0.95) but more likely to develop obsessive compulsive disorder (HR 1.26; 95% CI 1.16-1.37). However, the risks varied with disease severity and patient’s age.

Study details: Findings are from a retrospective population-based cohort study including 409,431 children with AD and 1,809,029 matched children without AD.

Disclosures: This study was supported by a contract from Pfizer, Inc. One author declared being an employee of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Wan J et al. Atopic dermatitis and risk of major neuropsychiatric disorders in children: A population-based cohort study. J Eur Acad Dermatol Venereol. 2022 (Aug 26). Doi: 10.1111/jdv.18564

Key clinical point: Atopic dermatitis (AD) did not increase the incidence risk for most neuropsychiatric disorders in a pediatric cohort.

Major finding: The risks for attention deficit hyperactivity disorder (hazard ratio [HR] 1.02; 95% CI 0.97-1.06), autism (HR 1.02; 95% CI 0.98-1.06), anxiety (HR 1.01; 95% CI 0.99-1.03), and bipolar disorder (HR 1.08; 95% CI 0.85-1.36) were comparable in the AD and non-AD groups. Participants with vs without AD were less likely to develop depression (HR 0.93; 95% CI 0.91-0.95) or schizophrenia (HR 0.72; 95% CI 0.54-0.95) but more likely to develop obsessive compulsive disorder (HR 1.26; 95% CI 1.16-1.37). However, the risks varied with disease severity and patient’s age.

Study details: Findings are from a retrospective population-based cohort study including 409,431 children with AD and 1,809,029 matched children without AD.

Disclosures: This study was supported by a contract from Pfizer, Inc. One author declared being an employee of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Wan J et al. Atopic dermatitis and risk of major neuropsychiatric disorders in children: A population-based cohort study. J Eur Acad Dermatol Venereol. 2022 (Aug 26). Doi: 10.1111/jdv.18564

Key clinical point: Initiation of daily application of a specialized emollient from the first to the eighth week of life reduced the risk for atopic dermatitis (AD) incidence for 12 months in infants with high risk for AD.

Major finding: At 12 months, the cumulative incidence of AD was significantly lower in the emollient vs standard routine skin care group (32.8% vs 46.4%; relative risk 0.707; P = .036). The rate of patient-reported skin infections was similar between both the treatment groups during the 8-week intervention period (5.0% vs 5.7%).

Study details: Findings are from the STOP AD trial including 321 newborn infants at high risk for AD who were randomly assigned to receive twice-daily emollient for the first 8 weeks of life or standard routine skin care.

Disclosures: This study was supported by The City of Dublin Skin and Cancer Hospital Charity and the Skin Research Institute of Singapore. Some authors declared being managing directors, employees, shareholders, or consultants or receiving research funding, speaker fees, or consulting fees from several sources.

Source: Ní Chaoimh C, Lad D, et al. Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants - the STOP AD randomised controlled trial. Allergy. 2022 (Aug 23). Doi: 10.1111/all.15491

Key clinical point: Initiation of daily application of a specialized emollient from the first to the eighth week of life reduced the risk for atopic dermatitis (AD) incidence for 12 months in infants with high risk for AD.

Major finding: At 12 months, the cumulative incidence of AD was significantly lower in the emollient vs standard routine skin care group (32.8% vs 46.4%; relative risk 0.707; P = .036). The rate of patient-reported skin infections was similar between both the treatment groups during the 8-week intervention period (5.0% vs 5.7%).

Study details: Findings are from the STOP AD trial including 321 newborn infants at high risk for AD who were randomly assigned to receive twice-daily emollient for the first 8 weeks of life or standard routine skin care.

Disclosures: This study was supported by The City of Dublin Skin and Cancer Hospital Charity and the Skin Research Institute of Singapore. Some authors declared being managing directors, employees, shareholders, or consultants or receiving research funding, speaker fees, or consulting fees from several sources.

Source: Ní Chaoimh C, Lad D, et al. Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants - the STOP AD randomised controlled trial. Allergy. 2022 (Aug 23). Doi: 10.1111/all.15491

Key clinical point: Initiation of daily application of a specialized emollient from the first to the eighth week of life reduced the risk for atopic dermatitis (AD) incidence for 12 months in infants with high risk for AD.

Major finding: At 12 months, the cumulative incidence of AD was significantly lower in the emollient vs standard routine skin care group (32.8% vs 46.4%; relative risk 0.707; P = .036). The rate of patient-reported skin infections was similar between both the treatment groups during the 8-week intervention period (5.0% vs 5.7%).

Study details: Findings are from the STOP AD trial including 321 newborn infants at high risk for AD who were randomly assigned to receive twice-daily emollient for the first 8 weeks of life or standard routine skin care.

Disclosures: This study was supported by The City of Dublin Skin and Cancer Hospital Charity and the Skin Research Institute of Singapore. Some authors declared being managing directors, employees, shareholders, or consultants or receiving research funding, speaker fees, or consulting fees from several sources.

Source: Ní Chaoimh C, Lad D, et al. Early initiation of short-term emollient use for the prevention of atopic dermatitis in high risk infants - the STOP AD randomised controlled trial. Allergy. 2022 (Aug 23). Doi: 10.1111/all.15491

In some cases, bruising or bleeding from bleeding disorders may look like signs of child abuse, but new guidance may help clinicians distinguish one from the other.

On Sept. 19 the American Academy of Pediatrics published two reports – a clinical report and a technical report – in the October 2022 issue of Pediatrics on evaluating for bleeding disorders when child abuse is suspected.

The reports were written by the AAP Section on Hematology/Oncology and the AAP Council on Child Abuse and Neglect.
 

One doesn’t rule out the other

The reports emphasize that laboratory testing of bleeding cannot always rule out abuse, just as a history of trauma (accidental or nonaccidental) may not rule out a bleeding disorder or other medical condition.

In the clinical report, led by James Anderst, MD, MSCI, with the division of child adversity and resilience, Children’s Mercy Hospital, University of Missouri–Kansas City, the researchers note that infants are at especially high risk of abusive bruising/bleeding, but bleeding disorders may also present in infancy.

The authors give an example of a situation when taking a thorough history won’t necessarily rule out a bleeding disorder: Male infants who have been circumcised with no significant bleeding issues may still have a bleeding disorder. Therefore, laboratory evaluations are often needed to detect disordered bleeding.

Children’s medications should be documented, the authors note, because certain drugs, such as nonsteroidal anti-inflammatory drugs, some antibiotics, antiepileptics, and herbal supplements, can affect tests that might be used to detect bleeding disorders.

Likewise, asking about restrictive or unusual diets or alternative therapies is important as some could increase the likelihood of bleeding/bruising.

Signs that bleeding disorder is not likely

The authors advise that, if a child has any of the following, an evaluation for a bleeding disorder is generally not needed:

• Caregivers’ description of trauma sufficiently explains the bruising.
• The child or an independent witness can provide a history of abuse or nonabusive trauma that explains the bruising.
• The outline of the bruising follows an object or hand pattern.
• The location of the bruising is on the ears, neck, or genitals.

“Bruising to the ears, neck, or genitals is rarely seen in either accidental injuries or in children with bleeding disorders,” the authors write.

Specification of which locations for injuries are more indicative of abuse in both mobile and immobile children was among the most important information from the paper, Seattle pediatrician Timothy Joos, MD, said in an interview.

Also very helpful, he said, was the listing of which tests should be done if bruising looks like potential abuse.

The authors write that if bruising is concerning for abuse that necessitates evaluation for bleeding disorders, the following tests should be done: PT (prothrombin time); aPTT (activated partial thromboplastin time); von Willebrand Factor (VWF) activity (Ristocetin cofactor); factor VIII activity level; factor IX activity level; and a complete blood count, including platelets.

“I think that’s what a lot of us suspected, but there’s not a lot of summary evidence regarding that until now,” Dr. Joos said.

Case-by-case decisions on when to test

The decision on whether to evaluate for a bleeding disorder may be made case by case.

If there is no obvious known trauma or intracranial hemorrhage (ICH), particularly subdural hematoma (SDH) in a nonmobile child, abuse should be suspected, the authors write.

They acknowledge that children can have ICH, such as a small SDH or an epidural hematoma, under the point of impact from a short fall.

“However,” the authors write, “short falls rarely result in significant brain injury.”

Conditions may affect screening tests

Screening tests for bleeding disorders can be falsely positive or falsely negative, the authors caution in the technical report, led by Shannon Carpenter, MD, MS, with the department of pediatrics, University of Missouri–Kansas City.

• If coagulation laboratory test specimens sit in a hot metal box all day, for instance, factor levels may be falsely low, the authors explain.
• Conversely, factors such as VWF and factor VIII are acute-phase reactants and factor levels will be deceptively high if blood specimens are taken in a stressful time.
• Patients who have a traumatic brain injury often show temporary coagulopathy that does not signal a congenital disorder.

Vitamin K deficiency

The technical report explains that if an infant, typically younger than 6 months, presents with bleeding/bruising that raises flags for abuse and has a long PT, clinicians should confirm vitamin K was provided at birth and/or testing for vitamin K deficiency should be performed.

Not all states require vitamin K to be administered at birth and some parents refuse it. Deficiency can lead to bleeding in the skin or from mucosal surfaces from circumcision, generalized ecchymoses, and large intramuscular hemorrhages or ICH.

When infants don’t get vitamin K at birth, vitamin K deficiency bleeding (VKDB) is seen most often in the first days of life, the technical report states. It can also occur 1-3 months after birth.

“Late VKDB occurs from the first month to 3 months after birth,” the authors write. “This deficiency is more prevalent in breast-fed babies, because human milk contains less vitamin K than does cow milk.”

Overall, the authors write, extensive lab tests are usually not necessary, given the rarity of most bleeding disorders and specific clinical factors that decrease the odds that a bleeding disorder caused the child’s findings.

Dr. Joos said the decisions described in this paper are the kind that can keep pediatricians up at night.

“Any kind of guidance is helpful in these difficult cases,” he said. “These are scenarios that can often happen in the middle of the night, and you’re often struggling with evidence or past experience that can help you make some of these decisions.”

Authors of the reports and Dr. Joos declared no relevant financial relationships.

In some cases, bruising or bleeding from bleeding disorders may look like signs of child abuse, but new guidance may help clinicians distinguish one from the other.

On Sept. 19 the American Academy of Pediatrics published two reports – a clinical report and a technical report – in the October 2022 issue of Pediatrics on evaluating for bleeding disorders when child abuse is suspected.

The reports were written by the AAP Section on Hematology/Oncology and the AAP Council on Child Abuse and Neglect.
 

One doesn’t rule out the other

The reports emphasize that laboratory testing of bleeding cannot always rule out abuse, just as a history of trauma (accidental or nonaccidental) may not rule out a bleeding disorder or other medical condition.

In the clinical report, led by James Anderst, MD, MSCI, with the division of child adversity and resilience, Children’s Mercy Hospital, University of Missouri–Kansas City, the researchers note that infants are at especially high risk of abusive bruising/bleeding, but bleeding disorders may also present in infancy.

The authors give an example of a situation when taking a thorough history won’t necessarily rule out a bleeding disorder: Male infants who have been circumcised with no significant bleeding issues may still have a bleeding disorder. Therefore, laboratory evaluations are often needed to detect disordered bleeding.

Children’s medications should be documented, the authors note, because certain drugs, such as nonsteroidal anti-inflammatory drugs, some antibiotics, antiepileptics, and herbal supplements, can affect tests that might be used to detect bleeding disorders.

Likewise, asking about restrictive or unusual diets or alternative therapies is important as some could increase the likelihood of bleeding/bruising.

Signs that bleeding disorder is not likely

The authors advise that, if a child has any of the following, an evaluation for a bleeding disorder is generally not needed:

• Caregivers’ description of trauma sufficiently explains the bruising.
• The child or an independent witness can provide a history of abuse or nonabusive trauma that explains the bruising.
• The outline of the bruising follows an object or hand pattern.
• The location of the bruising is on the ears, neck, or genitals.

“Bruising to the ears, neck, or genitals is rarely seen in either accidental injuries or in children with bleeding disorders,” the authors write.

Specification of which locations for injuries are more indicative of abuse in both mobile and immobile children was among the most important information from the paper, Seattle pediatrician Timothy Joos, MD, said in an interview.

Also very helpful, he said, was the listing of which tests should be done if bruising looks like potential abuse.

The authors write that if bruising is concerning for abuse that necessitates evaluation for bleeding disorders, the following tests should be done: PT (prothrombin time); aPTT (activated partial thromboplastin time); von Willebrand Factor (VWF) activity (Ristocetin cofactor); factor VIII activity level; factor IX activity level; and a complete blood count, including platelets.

“I think that’s what a lot of us suspected, but there’s not a lot of summary evidence regarding that until now,” Dr. Joos said.

Case-by-case decisions on when to test

The decision on whether to evaluate for a bleeding disorder may be made case by case.

If there is no obvious known trauma or intracranial hemorrhage (ICH), particularly subdural hematoma (SDH) in a nonmobile child, abuse should be suspected, the authors write.

They acknowledge that children can have ICH, such as a small SDH or an epidural hematoma, under the point of impact from a short fall.

“However,” the authors write, “short falls rarely result in significant brain injury.”

Conditions may affect screening tests

Screening tests for bleeding disorders can be falsely positive or falsely negative, the authors caution in the technical report, led by Shannon Carpenter, MD, MS, with the department of pediatrics, University of Missouri–Kansas City.

• If coagulation laboratory test specimens sit in a hot metal box all day, for instance, factor levels may be falsely low, the authors explain.
• Conversely, factors such as VWF and factor VIII are acute-phase reactants and factor levels will be deceptively high if blood specimens are taken in a stressful time.
• Patients who have a traumatic brain injury often show temporary coagulopathy that does not signal a congenital disorder.

Vitamin K deficiency

The technical report explains that if an infant, typically younger than 6 months, presents with bleeding/bruising that raises flags for abuse and has a long PT, clinicians should confirm vitamin K was provided at birth and/or testing for vitamin K deficiency should be performed.

Not all states require vitamin K to be administered at birth and some parents refuse it. Deficiency can lead to bleeding in the skin or from mucosal surfaces from circumcision, generalized ecchymoses, and large intramuscular hemorrhages or ICH.

When infants don’t get vitamin K at birth, vitamin K deficiency bleeding (VKDB) is seen most often in the first days of life, the technical report states. It can also occur 1-3 months after birth.

“Late VKDB occurs from the first month to 3 months after birth,” the authors write. “This deficiency is more prevalent in breast-fed babies, because human milk contains less vitamin K than does cow milk.”

Overall, the authors write, extensive lab tests are usually not necessary, given the rarity of most bleeding disorders and specific clinical factors that decrease the odds that a bleeding disorder caused the child’s findings.

Dr. Joos said the decisions described in this paper are the kind that can keep pediatricians up at night.

“Any kind of guidance is helpful in these difficult cases,” he said. “These are scenarios that can often happen in the middle of the night, and you’re often struggling with evidence or past experience that can help you make some of these decisions.”

Authors of the reports and Dr. Joos declared no relevant financial relationships.

In some cases, bruising or bleeding from bleeding disorders may look like signs of child abuse, but new guidance may help clinicians distinguish one from the other.

On Sept. 19 the American Academy of Pediatrics published two reports – a clinical report and a technical report – in the October 2022 issue of Pediatrics on evaluating for bleeding disorders when child abuse is suspected.

The reports were written by the AAP Section on Hematology/Oncology and the AAP Council on Child Abuse and Neglect.
 

One doesn’t rule out the other

The reports emphasize that laboratory testing of bleeding cannot always rule out abuse, just as a history of trauma (accidental or nonaccidental) may not rule out a bleeding disorder or other medical condition.

In the clinical report, led by James Anderst, MD, MSCI, with the division of child adversity and resilience, Children’s Mercy Hospital, University of Missouri–Kansas City, the researchers note that infants are at especially high risk of abusive bruising/bleeding, but bleeding disorders may also present in infancy.

The authors give an example of a situation when taking a thorough history won’t necessarily rule out a bleeding disorder: Male infants who have been circumcised with no significant bleeding issues may still have a bleeding disorder. Therefore, laboratory evaluations are often needed to detect disordered bleeding.

Children’s medications should be documented, the authors note, because certain drugs, such as nonsteroidal anti-inflammatory drugs, some antibiotics, antiepileptics, and herbal supplements, can affect tests that might be used to detect bleeding disorders.

Likewise, asking about restrictive or unusual diets or alternative therapies is important as some could increase the likelihood of bleeding/bruising.

Signs that bleeding disorder is not likely

The authors advise that, if a child has any of the following, an evaluation for a bleeding disorder is generally not needed:

• Caregivers’ description of trauma sufficiently explains the bruising.
• The child or an independent witness can provide a history of abuse or nonabusive trauma that explains the bruising.
• The outline of the bruising follows an object or hand pattern.
• The location of the bruising is on the ears, neck, or genitals.

“Bruising to the ears, neck, or genitals is rarely seen in either accidental injuries or in children with bleeding disorders,” the authors write.

Specification of which locations for injuries are more indicative of abuse in both mobile and immobile children was among the most important information from the paper, Seattle pediatrician Timothy Joos, MD, said in an interview.

Also very helpful, he said, was the listing of which tests should be done if bruising looks like potential abuse.

The authors write that if bruising is concerning for abuse that necessitates evaluation for bleeding disorders, the following tests should be done: PT (prothrombin time); aPTT (activated partial thromboplastin time); von Willebrand Factor (VWF) activity (Ristocetin cofactor); factor VIII activity level; factor IX activity level; and a complete blood count, including platelets.

“I think that’s what a lot of us suspected, but there’s not a lot of summary evidence regarding that until now,” Dr. Joos said.

Case-by-case decisions on when to test

The decision on whether to evaluate for a bleeding disorder may be made case by case.

If there is no obvious known trauma or intracranial hemorrhage (ICH), particularly subdural hematoma (SDH) in a nonmobile child, abuse should be suspected, the authors write.

They acknowledge that children can have ICH, such as a small SDH or an epidural hematoma, under the point of impact from a short fall.

“However,” the authors write, “short falls rarely result in significant brain injury.”

Conditions may affect screening tests

Screening tests for bleeding disorders can be falsely positive or falsely negative, the authors caution in the technical report, led by Shannon Carpenter, MD, MS, with the department of pediatrics, University of Missouri–Kansas City.

• If coagulation laboratory test specimens sit in a hot metal box all day, for instance, factor levels may be falsely low, the authors explain.
• Conversely, factors such as VWF and factor VIII are acute-phase reactants and factor levels will be deceptively high if blood specimens are taken in a stressful time.
• Patients who have a traumatic brain injury often show temporary coagulopathy that does not signal a congenital disorder.

Vitamin K deficiency

The technical report explains that if an infant, typically younger than 6 months, presents with bleeding/bruising that raises flags for abuse and has a long PT, clinicians should confirm vitamin K was provided at birth and/or testing for vitamin K deficiency should be performed.

Not all states require vitamin K to be administered at birth and some parents refuse it. Deficiency can lead to bleeding in the skin or from mucosal surfaces from circumcision, generalized ecchymoses, and large intramuscular hemorrhages or ICH.

When infants don’t get vitamin K at birth, vitamin K deficiency bleeding (VKDB) is seen most often in the first days of life, the technical report states. It can also occur 1-3 months after birth.

“Late VKDB occurs from the first month to 3 months after birth,” the authors write. “This deficiency is more prevalent in breast-fed babies, because human milk contains less vitamin K than does cow milk.”

Overall, the authors write, extensive lab tests are usually not necessary, given the rarity of most bleeding disorders and specific clinical factors that decrease the odds that a bleeding disorder caused the child’s findings.

Dr. Joos said the decisions described in this paper are the kind that can keep pediatricians up at night.

“Any kind of guidance is helpful in these difficult cases,” he said. “These are scenarios that can often happen in the middle of the night, and you’re often struggling with evidence or past experience that can help you make some of these decisions.”

Authors of the reports and Dr. Joos declared no relevant financial relationships.

I want to tell you a story about forgetfulness and haste, and how the combination of the two can lead to frightening consequences. A few years ago, I was lying in bed about to turn out the light when I realized I’d forgotten to take “my pill.”

Like some 161 million other American adults, I was then a consumer of a prescription medication. Being conscientious, I got up, retrieved said pill, and tossed it back. Being lazy, I didn’t bother to grab a glass of water to help the thing go down. Instead, I promptly returned to bed, threw a pillow over my head, and prepared for sleep.

Within seconds, I began to feel a burning sensation in my chest. After about a minute, that burn became a crippling pain. Not wanting to alarm my wife, I went into the living room, where I spent the next 30 minutes doubled over in agony. Was I having a heart attack? I phoned my sister, a hospitalist in Texas. She advised me to take myself to the ED to get checked out.

If only I’d known then about “Duke.” He could have told me how critical body posture is when people swallow pills.
 

Who’s Duke?

Duke is a computer representation of a 34-year-old, anatomically normal human male created by computer scientists at the IT’IS Foundation, a nonprofit group based in Switzerland that works on a variety of projects in health care technology. Using Duke, Rajat Mittal, PhD, a professor of medicine at the Johns Hopkins University, Baltimore, created a computer model called “StomachSim” to explore the process of digestion.

Their research, published in the journal Physics of Fluids, turned up several surprising findings about the dynamics of swallowing pills – the most common way medication is used worldwide.

Dr. Mittal said he chose to study the stomach because the functions of most other organ systems, from the heart to the brain, have already attracted plenty of attention from scientists.

“As I was looking to initiate research in some new directions, the implications of stomach biomechanics on important conditions such as diabetes, obesity, and gastroparesis became apparent to me,” he said. “It was clear that bioengineering research in this arena lags other more ‘sexy’ areas such as cardiovascular flows by at least 20 years, and there seemed to be a great opportunity to do impactful work.”
 

Your posture may help a pill work better

Several well-known things affect a pill’s ability to disperse its contents into the gut and be used by the body, such as the stomach’s contents (a heavy breakfast, a mix of liquids like juice, milk, and coffee) and the motion of the organ’s walls. But Dr. Mittal’s group learned that Duke’s posture also played a major role.

The researchers ran Duke through computer simulations in varying postures: upright, leaning right, leaning left, and leaning back, while keeping all the other parts of their analyses (like the things mentioned above) the same.

They found that posture determined as much as 83% of how quickly a pill disperses into the intestines. The most efficient position was leaning right. The least was leaning left, which prevented the pill from reaching the antrum, or bottom section of the stomach, and thus kept all but traces of the dissolved drug from entering the duodenum, where the stomach joins the small intestine. (Interestingly, Jews who observe Passover are advised to recline to the left during the meal as a symbol of freedom and leisure.)

That makes sense if you think about the stomach’s shape, which looks kind of like a bean, curving from the left to the right side of the body. Because of gravity, your position will change where the pill lands.

In the end, the researchers found that posture can be as significant a factor in how a pill dissolves as gastroparesis, a condition in which the stomach loses the ability to empty properly.
 

How this could help people

Among the groups most likely to benefit from such studies, Dr. Mittal said, are the elderly – who both take a lot of pills and are more prone to trouble swallowing because of age-related changes in their esophagus – and the bedridden, who can’t easily shift their posture. The findings may also lead to improvements in the ability to treat people with gastroparesis, a particular problem for people with diabetes.

Future studies with Duke and similar simulations will look at how the GI system digests proteins, carbohydrates, and fatty meals, Dr. Mittal said.

In the meantime, Dr. Mittal offered the following advice: “Standing or sitting upright after taking a pill is fine. If you have to take a pill lying down, stay on your back or on your right side. Avoid lying on your left side after taking a pill.”

As for what happened to me, any gastroenterologist reading this has figured out that my condition was not heart-related. Instead, I likely was having a bout of pill esophagitis, irritation that can result from medications that aggravate the mucosa of the food tube. Although painful, esophagitis isn’t life-threatening. After about an hour, the pain began to subside, and by the next morning I was fine, with only a faint ache in my chest to remind me of my earlier torment. (Researchers noted an increase in the condition early in the COVID-19 pandemic, linked to the antibiotic doxycycline.)

And, in the interest of accuracy, my pill problem began above the stomach. Nothing in the Hopkins research suggests that the alignment of the esophagus plays a role in how drugs disperse in the gut – unless, of course, it prevents those pills from reaching the stomach in the first place.

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

I want to tell you a story about forgetfulness and haste, and how the combination of the two can lead to frightening consequences. A few years ago, I was lying in bed about to turn out the light when I realized I’d forgotten to take “my pill.”

Like some 161 million other American adults, I was then a consumer of a prescription medication. Being conscientious, I got up, retrieved said pill, and tossed it back. Being lazy, I didn’t bother to grab a glass of water to help the thing go down. Instead, I promptly returned to bed, threw a pillow over my head, and prepared for sleep.

Within seconds, I began to feel a burning sensation in my chest. After about a minute, that burn became a crippling pain. Not wanting to alarm my wife, I went into the living room, where I spent the next 30 minutes doubled over in agony. Was I having a heart attack? I phoned my sister, a hospitalist in Texas. She advised me to take myself to the ED to get checked out.

If only I’d known then about “Duke.” He could have told me how critical body posture is when people swallow pills.
 

Who’s Duke?

Duke is a computer representation of a 34-year-old, anatomically normal human male created by computer scientists at the IT’IS Foundation, a nonprofit group based in Switzerland that works on a variety of projects in health care technology. Using Duke, Rajat Mittal, PhD, a professor of medicine at the Johns Hopkins University, Baltimore, created a computer model called “StomachSim” to explore the process of digestion.

Their research, published in the journal Physics of Fluids, turned up several surprising findings about the dynamics of swallowing pills – the most common way medication is used worldwide.

Dr. Mittal said he chose to study the stomach because the functions of most other organ systems, from the heart to the brain, have already attracted plenty of attention from scientists.

“As I was looking to initiate research in some new directions, the implications of stomach biomechanics on important conditions such as diabetes, obesity, and gastroparesis became apparent to me,” he said. “It was clear that bioengineering research in this arena lags other more ‘sexy’ areas such as cardiovascular flows by at least 20 years, and there seemed to be a great opportunity to do impactful work.”
 

Your posture may help a pill work better

Several well-known things affect a pill’s ability to disperse its contents into the gut and be used by the body, such as the stomach’s contents (a heavy breakfast, a mix of liquids like juice, milk, and coffee) and the motion of the organ’s walls. But Dr. Mittal’s group learned that Duke’s posture also played a major role.

The researchers ran Duke through computer simulations in varying postures: upright, leaning right, leaning left, and leaning back, while keeping all the other parts of their analyses (like the things mentioned above) the same.

They found that posture determined as much as 83% of how quickly a pill disperses into the intestines. The most efficient position was leaning right. The least was leaning left, which prevented the pill from reaching the antrum, or bottom section of the stomach, and thus kept all but traces of the dissolved drug from entering the duodenum, where the stomach joins the small intestine. (Interestingly, Jews who observe Passover are advised to recline to the left during the meal as a symbol of freedom and leisure.)

That makes sense if you think about the stomach’s shape, which looks kind of like a bean, curving from the left to the right side of the body. Because of gravity, your position will change where the pill lands.

In the end, the researchers found that posture can be as significant a factor in how a pill dissolves as gastroparesis, a condition in which the stomach loses the ability to empty properly.
 

How this could help people

Among the groups most likely to benefit from such studies, Dr. Mittal said, are the elderly – who both take a lot of pills and are more prone to trouble swallowing because of age-related changes in their esophagus – and the bedridden, who can’t easily shift their posture. The findings may also lead to improvements in the ability to treat people with gastroparesis, a particular problem for people with diabetes.

Future studies with Duke and similar simulations will look at how the GI system digests proteins, carbohydrates, and fatty meals, Dr. Mittal said.

In the meantime, Dr. Mittal offered the following advice: “Standing or sitting upright after taking a pill is fine. If you have to take a pill lying down, stay on your back or on your right side. Avoid lying on your left side after taking a pill.”

As for what happened to me, any gastroenterologist reading this has figured out that my condition was not heart-related. Instead, I likely was having a bout of pill esophagitis, irritation that can result from medications that aggravate the mucosa of the food tube. Although painful, esophagitis isn’t life-threatening. After about an hour, the pain began to subside, and by the next morning I was fine, with only a faint ache in my chest to remind me of my earlier torment. (Researchers noted an increase in the condition early in the COVID-19 pandemic, linked to the antibiotic doxycycline.)

And, in the interest of accuracy, my pill problem began above the stomach. Nothing in the Hopkins research suggests that the alignment of the esophagus plays a role in how drugs disperse in the gut – unless, of course, it prevents those pills from reaching the stomach in the first place.

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

I want to tell you a story about forgetfulness and haste, and how the combination of the two can lead to frightening consequences. A few years ago, I was lying in bed about to turn out the light when I realized I’d forgotten to take “my pill.”

Like some 161 million other American adults, I was then a consumer of a prescription medication. Being conscientious, I got up, retrieved said pill, and tossed it back. Being lazy, I didn’t bother to grab a glass of water to help the thing go down. Instead, I promptly returned to bed, threw a pillow over my head, and prepared for sleep.

Within seconds, I began to feel a burning sensation in my chest. After about a minute, that burn became a crippling pain. Not wanting to alarm my wife, I went into the living room, where I spent the next 30 minutes doubled over in agony. Was I having a heart attack? I phoned my sister, a hospitalist in Texas. She advised me to take myself to the ED to get checked out.

If only I’d known then about “Duke.” He could have told me how critical body posture is when people swallow pills.
 

Who’s Duke?

Duke is a computer representation of a 34-year-old, anatomically normal human male created by computer scientists at the IT’IS Foundation, a nonprofit group based in Switzerland that works on a variety of projects in health care technology. Using Duke, Rajat Mittal, PhD, a professor of medicine at the Johns Hopkins University, Baltimore, created a computer model called “StomachSim” to explore the process of digestion.

Their research, published in the journal Physics of Fluids, turned up several surprising findings about the dynamics of swallowing pills – the most common way medication is used worldwide.

Dr. Mittal said he chose to study the stomach because the functions of most other organ systems, from the heart to the brain, have already attracted plenty of attention from scientists.

“As I was looking to initiate research in some new directions, the implications of stomach biomechanics on important conditions such as diabetes, obesity, and gastroparesis became apparent to me,” he said. “It was clear that bioengineering research in this arena lags other more ‘sexy’ areas such as cardiovascular flows by at least 20 years, and there seemed to be a great opportunity to do impactful work.”
 

Your posture may help a pill work better

Several well-known things affect a pill’s ability to disperse its contents into the gut and be used by the body, such as the stomach’s contents (a heavy breakfast, a mix of liquids like juice, milk, and coffee) and the motion of the organ’s walls. But Dr. Mittal’s group learned that Duke’s posture also played a major role.

The researchers ran Duke through computer simulations in varying postures: upright, leaning right, leaning left, and leaning back, while keeping all the other parts of their analyses (like the things mentioned above) the same.

They found that posture determined as much as 83% of how quickly a pill disperses into the intestines. The most efficient position was leaning right. The least was leaning left, which prevented the pill from reaching the antrum, or bottom section of the stomach, and thus kept all but traces of the dissolved drug from entering the duodenum, where the stomach joins the small intestine. (Interestingly, Jews who observe Passover are advised to recline to the left during the meal as a symbol of freedom and leisure.)

That makes sense if you think about the stomach’s shape, which looks kind of like a bean, curving from the left to the right side of the body. Because of gravity, your position will change where the pill lands.

In the end, the researchers found that posture can be as significant a factor in how a pill dissolves as gastroparesis, a condition in which the stomach loses the ability to empty properly.
 

How this could help people

Among the groups most likely to benefit from such studies, Dr. Mittal said, are the elderly – who both take a lot of pills and are more prone to trouble swallowing because of age-related changes in their esophagus – and the bedridden, who can’t easily shift their posture. The findings may also lead to improvements in the ability to treat people with gastroparesis, a particular problem for people with diabetes.

Future studies with Duke and similar simulations will look at how the GI system digests proteins, carbohydrates, and fatty meals, Dr. Mittal said.

In the meantime, Dr. Mittal offered the following advice: “Standing or sitting upright after taking a pill is fine. If you have to take a pill lying down, stay on your back or on your right side. Avoid lying on your left side after taking a pill.”

As for what happened to me, any gastroenterologist reading this has figured out that my condition was not heart-related. Instead, I likely was having a bout of pill esophagitis, irritation that can result from medications that aggravate the mucosa of the food tube. Although painful, esophagitis isn’t life-threatening. After about an hour, the pain began to subside, and by the next morning I was fine, with only a faint ache in my chest to remind me of my earlier torment. (Researchers noted an increase in the condition early in the COVID-19 pandemic, linked to the antibiotic doxycycline.)

And, in the interest of accuracy, my pill problem began above the stomach. Nothing in the Hopkins research suggests that the alignment of the esophagus plays a role in how drugs disperse in the gut – unless, of course, it prevents those pills from reaching the stomach in the first place.

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

Key clinical point: Astegolimab, despite being well-tolerated, did not lessen the severity of the disease in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the adjusted mean percent changes in the mean Eczema Area and Severity Index score were comparable in the astegolimab (−51.47%) and placebo (−58.24%) groups ( = .5624). A lower proportion of patients who received astegolimab vs placebo reported ≥1 adverse event of grade 1 or 2 severity (41.2% vs 58.1%).

Study details: Findings are from a phase 2 trial including 65 adult patients with moderate-to-severe AD and inadequate response to topical medications who were randomly assigned to receive 490 mg astegolimab or placebo every 4 weeks for 16 weeks and were further followed-up for 8 weeks.

Disclosures: This study was supported by Genentech, Inc. Six authors declared serving as employees of Genentech, Inc., a member of the Roche group, and owning stocks in Roche. The other authors reported ties with several sources, including Roche.

Source: Maurer M et al. Phase 2 randomized clinical trial of astegolimab in patients with moderate to severe atopic dermatitis. J Allergy Clin Immunol. 2022 (Aug 27). Doi: 10.1016/j.jaci.2022.08.015

Key clinical point: Astegolimab, despite being well-tolerated, did not lessen the severity of the disease in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the adjusted mean percent changes in the mean Eczema Area and Severity Index score were comparable in the astegolimab (−51.47%) and placebo (−58.24%) groups ( = .5624). A lower proportion of patients who received astegolimab vs placebo reported ≥1 adverse event of grade 1 or 2 severity (41.2% vs 58.1%).

Study details: Findings are from a phase 2 trial including 65 adult patients with moderate-to-severe AD and inadequate response to topical medications who were randomly assigned to receive 490 mg astegolimab or placebo every 4 weeks for 16 weeks and were further followed-up for 8 weeks.

Disclosures: This study was supported by Genentech, Inc. Six authors declared serving as employees of Genentech, Inc., a member of the Roche group, and owning stocks in Roche. The other authors reported ties with several sources, including Roche.

Source: Maurer M et al. Phase 2 randomized clinical trial of astegolimab in patients with moderate to severe atopic dermatitis. J Allergy Clin Immunol. 2022 (Aug 27). Doi: 10.1016/j.jaci.2022.08.015

Key clinical point: Astegolimab, despite being well-tolerated, did not lessen the severity of the disease in patients with moderate-to-severe atopic dermatitis (AD).

Major finding: At week 16, the adjusted mean percent changes in the mean Eczema Area and Severity Index score were comparable in the astegolimab (−51.47%) and placebo (−58.24%) groups ( = .5624). A lower proportion of patients who received astegolimab vs placebo reported ≥1 adverse event of grade 1 or 2 severity (41.2% vs 58.1%).

Study details: Findings are from a phase 2 trial including 65 adult patients with moderate-to-severe AD and inadequate response to topical medications who were randomly assigned to receive 490 mg astegolimab or placebo every 4 weeks for 16 weeks and were further followed-up for 8 weeks.

Disclosures: This study was supported by Genentech, Inc. Six authors declared serving as employees of Genentech, Inc., a member of the Roche group, and owning stocks in Roche. The other authors reported ties with several sources, including Roche.

Source: Maurer M et al. Phase 2 randomized clinical trial of astegolimab in patients with moderate to severe atopic dermatitis. J Allergy Clin Immunol. 2022 (Aug 27). Doi: 10.1016/j.jaci.2022.08.015

Key clinical point: A cream containing 1% ectoine and 0.1% hyaluronic acid (EHA) demonstrated superior efficacy than a vehicle cream and was well-tolerated in children aged 2-18 years with mild-to-moderate atopic dermatitis (AD).

Major finding: At week 4, patients receiving EHA cream achieved a significantly higher clinical improvement in SCORing AD (mean difference [MD] −6.62; P < .001) and Investigator’s Global Assessment scores (MD −0.69; P < .001) than those receiving vehicle cream. Mild adverse events like skin erythema, pruritus, and burning skin were reported by 23.5% of patients receiving EHA cream and 5.7% of patients receiving vehicle cream.

Study details: Findings are from an observer-blind, multicenter clinical trial including 57 children aged 2-18 years with mild-to-moderate AD who were randomly assigned to receive EHA or vehicle cream twice daily for 4 weeks.

Disclosures: This study was funded by BODERM SA. The authors declared no conflicts of interest.

Source: Alexopoulos A et al. A randomized, observer-blind, vehicle-control, multi-center clinical investigation for assessing the efficacy and tolerability of a 1% ectoine and hyaluronic acid 0.1%-containing medical device in pediatric patients with mild-to-moderate atopic dermatitis. Pediatr Dermatol. 2022 (Aug 29). Doi: 10.1111/pde.15117

Key clinical point: A cream containing 1% ectoine and 0.1% hyaluronic acid (EHA) demonstrated superior efficacy than a vehicle cream and was well-tolerated in children aged 2-18 years with mild-to-moderate atopic dermatitis (AD).

Major finding: At week 4, patients receiving EHA cream achieved a significantly higher clinical improvement in SCORing AD (mean difference [MD] −6.62; P < .001) and Investigator’s Global Assessment scores (MD −0.69; P < .001) than those receiving vehicle cream. Mild adverse events like skin erythema, pruritus, and burning skin were reported by 23.5% of patients receiving EHA cream and 5.7% of patients receiving vehicle cream.

Study details: Findings are from an observer-blind, multicenter clinical trial including 57 children aged 2-18 years with mild-to-moderate AD who were randomly assigned to receive EHA or vehicle cream twice daily for 4 weeks.

Disclosures: This study was funded by BODERM SA. The authors declared no conflicts of interest.

Source: Alexopoulos A et al. A randomized, observer-blind, vehicle-control, multi-center clinical investigation for assessing the efficacy and tolerability of a 1% ectoine and hyaluronic acid 0.1%-containing medical device in pediatric patients with mild-to-moderate atopic dermatitis. Pediatr Dermatol. 2022 (Aug 29). Doi: 10.1111/pde.15117

Key clinical point: A cream containing 1% ectoine and 0.1% hyaluronic acid (EHA) demonstrated superior efficacy than a vehicle cream and was well-tolerated in children aged 2-18 years with mild-to-moderate atopic dermatitis (AD).

Major finding: At week 4, patients receiving EHA cream achieved a significantly higher clinical improvement in SCORing AD (mean difference [MD] −6.62; P < .001) and Investigator’s Global Assessment scores (MD −0.69; P < .001) than those receiving vehicle cream. Mild adverse events like skin erythema, pruritus, and burning skin were reported by 23.5% of patients receiving EHA cream and 5.7% of patients receiving vehicle cream.

Study details: Findings are from an observer-blind, multicenter clinical trial including 57 children aged 2-18 years with mild-to-moderate AD who were randomly assigned to receive EHA or vehicle cream twice daily for 4 weeks.

Disclosures: This study was funded by BODERM SA. The authors declared no conflicts of interest.

Source: Alexopoulos A et al. A randomized, observer-blind, vehicle-control, multi-center clinical investigation for assessing the efficacy and tolerability of a 1% ectoine and hyaluronic acid 0.1%-containing medical device in pediatric patients with mild-to-moderate atopic dermatitis. Pediatr Dermatol. 2022 (Aug 29). Doi: 10.1111/pde.15117