Conference Coverage

MANCHESTER, ENGLAND – An age-appropriate version of the Lupus Low Disease Activity State (LLDAS) has been developed by an international task force that will hopefully enable childhood-onset systemic lupus erythematosus (cSLE) to be treated to target in the near future.

The new childhood LLDAS (cLLDAS) has been purposefully developed to align with that already used for adults, Eve Smith, MBChB, PhD, explained at the annual meeting of the British Society for Rheumatology.

“There’s a lot of compelling data that’s accumulating from adult lupus and increasingly from childhood lupus that [treat to target] might be a good idea,” said Dr. Smith, who is a senior clinical fellow and honorary consultant at the University of Liverpool (England) and Alder Hey Children’s NHS Foundation Trust Hospital, also in Liverpool.
 

Urgent need to improve childhood lupus outcomes

“We urgently need to do something to try and improve outcomes for children,” Dr. Smith said.

“We know that childhood lupus patients have got higher disease activity as compared to adults; they have a greater medication burden, particularly steroids; and they tend to have more severe organ manifestations,” she added.

Moreover, data show that one-fifth of pediatric patients with lupus have already accrued early damage, and there is much higher mortality associated with childhood lupus than there is with adult lupus.

“So, really we want to use treat to target as a way to try and improve on these aspects,” Dr. Smith said.

The treat-to-target (T2T) approach is not a new idea in lupus, with a lot of work already done in adult patients. One large study of more than 3,300 patients conducted in 13 countries has shown that patients who never achieve LLDAS are more likely to have high levels of damage, greater glucocorticoid use, worse quality of life, and higher mortality than are those who do.

Conversely, data have also shown that achieving a LLDAS is associated with a reduction in the risk for new damage, flares, and hospitalization, as well as reducing health care costs and improving patients’ overall health-related quality of life.

T2T is a recognized approach in European adult SLE guidelines, Dr. Smith said, although the approach has not really been fully realized as of yet, even in adult practice.
 

The cSLE T2T international task force and cLLDAS definition

With evidence accumulating on the benefits of getting children with SLE to a low disease activity state, Dr. Smith and colleague Michael Beresford, MBChB, PhD, Brough Chair, Professor of Child Health at the University of Liverpool, put out a call to develop a task force to look into the feasibility of a T2T approach.

“We had a really enthusiastic response internationally, which we were really encouraged by,” Dr. Smith said, “and we now lead a task force of 20 experts from across all five continents, and we have really strong patient involvement.”

Through a consensus process, an international cSLE T2T Task Force agreed on overarching principles and points to consider that will “lay the foundation for future T2T approaches in cSLE,” according to the recommendations statement, which was endorsed by the Paediatric Rheumatology European Society.

Next, they looked to develop an age-appropriate definition for low disease activity.

“We’re deliberately wanting to maintain sufficient unity with the adult definition, so that we could facilitate life-course studies,” said Dr. Smith, who presented the results of a literature review and series of Delphi surveys at the meeting.

The conceptual definition of cLLDAS is similar to adults in describing it as a sustained state that is associated with a low likelihood of adverse outcome, Dr. Smith said, but with the added wording of “considering disease activity, damage, and medication toxicity.”

The definition is achieved when the SLE Disease Activity Index-2K is ≤ 4 and there is no activity in major organ systems; there are no new features of lupus disease activity since the last assessment; there is a score of ≤ 1 on Physician Global Assessment; steroid doses are ≤ 0.15 mg/kg/day or a maximum of 7.5 mg/day (whichever is lower); and immunosuppressive treatment is stable, with any changes to medication only because of side effects, adherence, changes in weight, or when in the process of reaching a target dose.

“It’s all very well having a definition, but you need to think about how that will work in practice,” Dr. Smith said. This is something that the task force is thinking about very carefully.

The task force next aims to validate the cLLDAS definition, form an extensive research agenda to inform the T2T methods, and develop innovative methods to apply the approach in practice.

The work is supported by the Wellcome Trust, National Institutes for Health Research, Versus Arthritis, and the University of Liverpool, Alder Hey Children’s NHS Foundation Trust and the Alder Hey Charity. Dr. Smith reported no relevant financial relationships.
 

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

MANCHESTER, ENGLAND – An age-appropriate version of the Lupus Low Disease Activity State (LLDAS) has been developed by an international task force that will hopefully enable childhood-onset systemic lupus erythematosus (cSLE) to be treated to target in the near future.

The new childhood LLDAS (cLLDAS) has been purposefully developed to align with that already used for adults, Eve Smith, MBChB, PhD, explained at the annual meeting of the British Society for Rheumatology.

“There’s a lot of compelling data that’s accumulating from adult lupus and increasingly from childhood lupus that [treat to target] might be a good idea,” said Dr. Smith, who is a senior clinical fellow and honorary consultant at the University of Liverpool (England) and Alder Hey Children’s NHS Foundation Trust Hospital, also in Liverpool.
 

Urgent need to improve childhood lupus outcomes

“We urgently need to do something to try and improve outcomes for children,” Dr. Smith said.

“We know that childhood lupus patients have got higher disease activity as compared to adults; they have a greater medication burden, particularly steroids; and they tend to have more severe organ manifestations,” she added.

Moreover, data show that one-fifth of pediatric patients with lupus have already accrued early damage, and there is much higher mortality associated with childhood lupus than there is with adult lupus.

“So, really we want to use treat to target as a way to try and improve on these aspects,” Dr. Smith said.

The treat-to-target (T2T) approach is not a new idea in lupus, with a lot of work already done in adult patients. One large study of more than 3,300 patients conducted in 13 countries has shown that patients who never achieve LLDAS are more likely to have high levels of damage, greater glucocorticoid use, worse quality of life, and higher mortality than are those who do.

Conversely, data have also shown that achieving a LLDAS is associated with a reduction in the risk for new damage, flares, and hospitalization, as well as reducing health care costs and improving patients’ overall health-related quality of life.

T2T is a recognized approach in European adult SLE guidelines, Dr. Smith said, although the approach has not really been fully realized as of yet, even in adult practice.
 

The cSLE T2T international task force and cLLDAS definition

With evidence accumulating on the benefits of getting children with SLE to a low disease activity state, Dr. Smith and colleague Michael Beresford, MBChB, PhD, Brough Chair, Professor of Child Health at the University of Liverpool, put out a call to develop a task force to look into the feasibility of a T2T approach.

“We had a really enthusiastic response internationally, which we were really encouraged by,” Dr. Smith said, “and we now lead a task force of 20 experts from across all five continents, and we have really strong patient involvement.”

Through a consensus process, an international cSLE T2T Task Force agreed on overarching principles and points to consider that will “lay the foundation for future T2T approaches in cSLE,” according to the recommendations statement, which was endorsed by the Paediatric Rheumatology European Society.

Next, they looked to develop an age-appropriate definition for low disease activity.

“We’re deliberately wanting to maintain sufficient unity with the adult definition, so that we could facilitate life-course studies,” said Dr. Smith, who presented the results of a literature review and series of Delphi surveys at the meeting.

The conceptual definition of cLLDAS is similar to adults in describing it as a sustained state that is associated with a low likelihood of adverse outcome, Dr. Smith said, but with the added wording of “considering disease activity, damage, and medication toxicity.”

The definition is achieved when the SLE Disease Activity Index-2K is ≤ 4 and there is no activity in major organ systems; there are no new features of lupus disease activity since the last assessment; there is a score of ≤ 1 on Physician Global Assessment; steroid doses are ≤ 0.15 mg/kg/day or a maximum of 7.5 mg/day (whichever is lower); and immunosuppressive treatment is stable, with any changes to medication only because of side effects, adherence, changes in weight, or when in the process of reaching a target dose.

“It’s all very well having a definition, but you need to think about how that will work in practice,” Dr. Smith said. This is something that the task force is thinking about very carefully.

The task force next aims to validate the cLLDAS definition, form an extensive research agenda to inform the T2T methods, and develop innovative methods to apply the approach in practice.

The work is supported by the Wellcome Trust, National Institutes for Health Research, Versus Arthritis, and the University of Liverpool, Alder Hey Children’s NHS Foundation Trust and the Alder Hey Charity. Dr. Smith reported no relevant financial relationships.
 

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

MANCHESTER, ENGLAND – An age-appropriate version of the Lupus Low Disease Activity State (LLDAS) has been developed by an international task force that will hopefully enable childhood-onset systemic lupus erythematosus (cSLE) to be treated to target in the near future.

The new childhood LLDAS (cLLDAS) has been purposefully developed to align with that already used for adults, Eve Smith, MBChB, PhD, explained at the annual meeting of the British Society for Rheumatology.

“There’s a lot of compelling data that’s accumulating from adult lupus and increasingly from childhood lupus that [treat to target] might be a good idea,” said Dr. Smith, who is a senior clinical fellow and honorary consultant at the University of Liverpool (England) and Alder Hey Children’s NHS Foundation Trust Hospital, also in Liverpool.
 

Urgent need to improve childhood lupus outcomes

“We urgently need to do something to try and improve outcomes for children,” Dr. Smith said.

“We know that childhood lupus patients have got higher disease activity as compared to adults; they have a greater medication burden, particularly steroids; and they tend to have more severe organ manifestations,” she added.

Moreover, data show that one-fifth of pediatric patients with lupus have already accrued early damage, and there is much higher mortality associated with childhood lupus than there is with adult lupus.

“So, really we want to use treat to target as a way to try and improve on these aspects,” Dr. Smith said.

The treat-to-target (T2T) approach is not a new idea in lupus, with a lot of work already done in adult patients. One large study of more than 3,300 patients conducted in 13 countries has shown that patients who never achieve LLDAS are more likely to have high levels of damage, greater glucocorticoid use, worse quality of life, and higher mortality than are those who do.

Conversely, data have also shown that achieving a LLDAS is associated with a reduction in the risk for new damage, flares, and hospitalization, as well as reducing health care costs and improving patients’ overall health-related quality of life.

T2T is a recognized approach in European adult SLE guidelines, Dr. Smith said, although the approach has not really been fully realized as of yet, even in adult practice.
 

The cSLE T2T international task force and cLLDAS definition

With evidence accumulating on the benefits of getting children with SLE to a low disease activity state, Dr. Smith and colleague Michael Beresford, MBChB, PhD, Brough Chair, Professor of Child Health at the University of Liverpool, put out a call to develop a task force to look into the feasibility of a T2T approach.

“We had a really enthusiastic response internationally, which we were really encouraged by,” Dr. Smith said, “and we now lead a task force of 20 experts from across all five continents, and we have really strong patient involvement.”

Through a consensus process, an international cSLE T2T Task Force agreed on overarching principles and points to consider that will “lay the foundation for future T2T approaches in cSLE,” according to the recommendations statement, which was endorsed by the Paediatric Rheumatology European Society.

Next, they looked to develop an age-appropriate definition for low disease activity.

“We’re deliberately wanting to maintain sufficient unity with the adult definition, so that we could facilitate life-course studies,” said Dr. Smith, who presented the results of a literature review and series of Delphi surveys at the meeting.

The conceptual definition of cLLDAS is similar to adults in describing it as a sustained state that is associated with a low likelihood of adverse outcome, Dr. Smith said, but with the added wording of “considering disease activity, damage, and medication toxicity.”

The definition is achieved when the SLE Disease Activity Index-2K is ≤ 4 and there is no activity in major organ systems; there are no new features of lupus disease activity since the last assessment; there is a score of ≤ 1 on Physician Global Assessment; steroid doses are ≤ 0.15 mg/kg/day or a maximum of 7.5 mg/day (whichever is lower); and immunosuppressive treatment is stable, with any changes to medication only because of side effects, adherence, changes in weight, or when in the process of reaching a target dose.

“It’s all very well having a definition, but you need to think about how that will work in practice,” Dr. Smith said. This is something that the task force is thinking about very carefully.

The task force next aims to validate the cLLDAS definition, form an extensive research agenda to inform the T2T methods, and develop innovative methods to apply the approach in practice.

The work is supported by the Wellcome Trust, National Institutes for Health Research, Versus Arthritis, and the University of Liverpool, Alder Hey Children’s NHS Foundation Trust and the Alder Hey Charity. Dr. Smith reported no relevant financial relationships.
 

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

SEATTLE – The use of Mohs surgery may improve survival for patients with early-stage Merkel cell carcinoma (MCC), results from a large, retrospective study show.

Compared with conventional wide local excision, survival was significantly improved among patients treated with Mohs, and a subgroup analysis showed that the survival benefit remained for patients with risk factors.

“At 10 years, overall survival was about 21% higher for those treated with Mohs surgery versus those treated with conventional surgery,” said lead author Shayan Cheraghlou, MD, a dermatology resident at the New York University School of Medicine. “On multivariable analysis, which controlled for tumor and patient factors, Mohs was associated with an over 40% reduction in the hazard for death.”

The findings were presented at the annual meeting of the American College of Mohs Surgery.

MCC is a rare, aggressive, neuroendocrine cutaneous malignancy that carries a high mortality rate. The estimated 5-year survival for patients with localized disease is about 50%, Dr. Cheraghlou noted. “That extrapolates to about 55% for T1 tumors and down to about 30% for T4 tumors.”

Although it’s considered to be a rare cancer, the incidence of MCC has been rapidly rising, and in fact it doubled during the period from the 1990s to the 2010s.

Most commonly treated with wide local excision with or without adjuvant radiation therapy, Mohs as monotherapy may offer an alternative treatment option for patients with MCC. It is generally accepted that the optimal treatment for tumors without regional lymph node involvement is surgical, but the data regarding the optimal surgical approach are mixed. Current National Comprehensive Cancer Network guidelines state that either Mohs surgery or wide local excision can be used.

“However, these guidelines do not indicate a preference for one modality over the other,” said Dr. Cheraghlou, “and present them as interchangeable treatment options.”

A growing body of literature supports Mohs surgery for many types of rare tumors, including MCC. For example, as previously reported at the 2021 ACMS meeting, one study found that Mohs surgery compared favorably with the standard treatment approach when it came to recurrence rates for patients with MCC. The 5-year disease-specific survival rate was 91.2% for patients with stage I disease and 68.6% for patients with stage IIa. These rates were comparable with rates for historical control patients who were treated with wide local excision, with or without radiation (81%-87% for stage I disease, and 63%-67% for stage II).

Study details

In the current study, Dr. Cheraghlou and colleagues sought to evaluate the association of the type of surgical approach with patient survival after excision of early-stage MCC. They conducted a retrospective cohort study using the National Cancer Database to identify cases of MCC with T1/T2 tumors. A total of 2,313 patients who were diagnosed from 2004 to 2018 with pathologically confirmed negative lymph node involvement and who were treated with Mohs surgery or wide lesion excision were included in the analysis.

“About 90% were T1 tumors, about 40% were located on the head and neck, and the vast majority – about 60% – were treated with wide local excision,” he explained. “Only about 5% received Mohs surgery for treatment of the primary tumor.”

But when the researchers assessed survival outcomes, they found that treatment with Mohs surgery was associated with significantly improved overall survival.

The unadjusted 3-, 5-, and 10-year survival rates for patients treated with Mohs was 87.4% (SE: 3.4%), 84.5% (SE: 3.9%), and 81.8% (SE: 4.6%), respectively, while for wide lesion excision, the rates were 86.1% (SE: 0.9%), 76.9% (SE: 1.2%), and 60.9% (SE: 2.0%), respectively.

For patients who underwent treatment with narrow margin excision, survival rates were similar as for those treated with wide lesion excision, with 3-, 5-, and 10-year survival rates of 84.8% (SE: 1.4%), 78.3% (SE: 1.7%), and 60.8% (SE: 3.6%), respectively.

On multivariable survival analysis, Mohs surgery was associated with significantly improved survival, compared with wide lesion excision (hazard ratio, 0.594; P = .038). This was also true after multivariable analysis for patients who had one or more NCCN risk factors, for whom improved survival was also seen with Mohs (HR, 0.530; P = .026).

The results did not differ after a sensitivity analysis that included T3 and T4 tumors.

Given that the use of Mohs was so infrequent, compared with standard surgery, the researchers investigated the factors that were associated with the use of Mohs. High-volume MCC centers were significantly more likely to utilize Mohs than wide lesion excision (odds ratio, 1.993; P < .001), compared with other facilities.

“This study has important implications going forward,” Dr. Cheraghlou concluded. “We think it’s important how few patients were treated with Mohs for Merkel cell, and it was slightly more likely to happen in a high-volume center.”

The reasoning for that may be that high-volume centers are more likely to have a surgeon trained to perform Mohs surgery for MCC. “Or perhaps they are more attuned to the benefits of this procedure,” he said. “We can’t tell that from our data, but its notable that it’s such a small proportion of patients – especially when we consider that it is associated with improved survival for the patients who receive it.”

He added that efforts to increase the utilization of Mohs may yield improved local control and overall survival for these patients. “And perhaps with more data, future versions of guidelines may indicate a preference for Mohs over conventional incisions.”
 

No changes to current practice

Asked to comment on the study, Anthony J. Olszanski, RPh, MD, associate professor, department of hematology/oncology, Fox Chase Cancer Center, Philadelphia, noted that while the results are intriguing, they must be interpreted with caution.

“This study was retrospective in nature, and unrecognized biases can influence results,” he said. “Additionally, given the relative rarity of Merkel cell carcinoma, the sample size is expectantly small.”

But importantly, Dr. Olszanski emphasized, Mohs may more often have been recommended for patients with lesions that appear less aggressive. “Many patients undergoing wide lesion excision may have been referred by Mohs surgeons secondary to features or characteristics of lesions which were worrisome,” he explained. “The results of this study do not opine on why Mohs would impact overall survival over wide lesion excision, a point worthy of consideration. Presently, both modalities can be considered for patients with T1/T2 MCC. The results of this study should not change current practice and would lend themselves to a more robust study.”

No external funding of the study was reported. Dr. Cheraghlou has disclosed no relevant financial relationships. Dr. Olszanski has received financial support from Merck and BMS for participated on advisory boards.

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

SEATTLE – The use of Mohs surgery may improve survival for patients with early-stage Merkel cell carcinoma (MCC), results from a large, retrospective study show.

Compared with conventional wide local excision, survival was significantly improved among patients treated with Mohs, and a subgroup analysis showed that the survival benefit remained for patients with risk factors.

“At 10 years, overall survival was about 21% higher for those treated with Mohs surgery versus those treated with conventional surgery,” said lead author Shayan Cheraghlou, MD, a dermatology resident at the New York University School of Medicine. “On multivariable analysis, which controlled for tumor and patient factors, Mohs was associated with an over 40% reduction in the hazard for death.”

The findings were presented at the annual meeting of the American College of Mohs Surgery.

MCC is a rare, aggressive, neuroendocrine cutaneous malignancy that carries a high mortality rate. The estimated 5-year survival for patients with localized disease is about 50%, Dr. Cheraghlou noted. “That extrapolates to about 55% for T1 tumors and down to about 30% for T4 tumors.”

Although it’s considered to be a rare cancer, the incidence of MCC has been rapidly rising, and in fact it doubled during the period from the 1990s to the 2010s.

Most commonly treated with wide local excision with or without adjuvant radiation therapy, Mohs as monotherapy may offer an alternative treatment option for patients with MCC. It is generally accepted that the optimal treatment for tumors without regional lymph node involvement is surgical, but the data regarding the optimal surgical approach are mixed. Current National Comprehensive Cancer Network guidelines state that either Mohs surgery or wide local excision can be used.

“However, these guidelines do not indicate a preference for one modality over the other,” said Dr. Cheraghlou, “and present them as interchangeable treatment options.”

A growing body of literature supports Mohs surgery for many types of rare tumors, including MCC. For example, as previously reported at the 2021 ACMS meeting, one study found that Mohs surgery compared favorably with the standard treatment approach when it came to recurrence rates for patients with MCC. The 5-year disease-specific survival rate was 91.2% for patients with stage I disease and 68.6% for patients with stage IIa. These rates were comparable with rates for historical control patients who were treated with wide local excision, with or without radiation (81%-87% for stage I disease, and 63%-67% for stage II).

Study details

In the current study, Dr. Cheraghlou and colleagues sought to evaluate the association of the type of surgical approach with patient survival after excision of early-stage MCC. They conducted a retrospective cohort study using the National Cancer Database to identify cases of MCC with T1/T2 tumors. A total of 2,313 patients who were diagnosed from 2004 to 2018 with pathologically confirmed negative lymph node involvement and who were treated with Mohs surgery or wide lesion excision were included in the analysis.

“About 90% were T1 tumors, about 40% were located on the head and neck, and the vast majority – about 60% – were treated with wide local excision,” he explained. “Only about 5% received Mohs surgery for treatment of the primary tumor.”

But when the researchers assessed survival outcomes, they found that treatment with Mohs surgery was associated with significantly improved overall survival.

The unadjusted 3-, 5-, and 10-year survival rates for patients treated with Mohs was 87.4% (SE: 3.4%), 84.5% (SE: 3.9%), and 81.8% (SE: 4.6%), respectively, while for wide lesion excision, the rates were 86.1% (SE: 0.9%), 76.9% (SE: 1.2%), and 60.9% (SE: 2.0%), respectively.

For patients who underwent treatment with narrow margin excision, survival rates were similar as for those treated with wide lesion excision, with 3-, 5-, and 10-year survival rates of 84.8% (SE: 1.4%), 78.3% (SE: 1.7%), and 60.8% (SE: 3.6%), respectively.

On multivariable survival analysis, Mohs surgery was associated with significantly improved survival, compared with wide lesion excision (hazard ratio, 0.594; P = .038). This was also true after multivariable analysis for patients who had one or more NCCN risk factors, for whom improved survival was also seen with Mohs (HR, 0.530; P = .026).

The results did not differ after a sensitivity analysis that included T3 and T4 tumors.

Given that the use of Mohs was so infrequent, compared with standard surgery, the researchers investigated the factors that were associated with the use of Mohs. High-volume MCC centers were significantly more likely to utilize Mohs than wide lesion excision (odds ratio, 1.993; P < .001), compared with other facilities.

“This study has important implications going forward,” Dr. Cheraghlou concluded. “We think it’s important how few patients were treated with Mohs for Merkel cell, and it was slightly more likely to happen in a high-volume center.”

The reasoning for that may be that high-volume centers are more likely to have a surgeon trained to perform Mohs surgery for MCC. “Or perhaps they are more attuned to the benefits of this procedure,” he said. “We can’t tell that from our data, but its notable that it’s such a small proportion of patients – especially when we consider that it is associated with improved survival for the patients who receive it.”

He added that efforts to increase the utilization of Mohs may yield improved local control and overall survival for these patients. “And perhaps with more data, future versions of guidelines may indicate a preference for Mohs over conventional incisions.”
 

No changes to current practice

Asked to comment on the study, Anthony J. Olszanski, RPh, MD, associate professor, department of hematology/oncology, Fox Chase Cancer Center, Philadelphia, noted that while the results are intriguing, they must be interpreted with caution.

“This study was retrospective in nature, and unrecognized biases can influence results,” he said. “Additionally, given the relative rarity of Merkel cell carcinoma, the sample size is expectantly small.”

But importantly, Dr. Olszanski emphasized, Mohs may more often have been recommended for patients with lesions that appear less aggressive. “Many patients undergoing wide lesion excision may have been referred by Mohs surgeons secondary to features or characteristics of lesions which were worrisome,” he explained. “The results of this study do not opine on why Mohs would impact overall survival over wide lesion excision, a point worthy of consideration. Presently, both modalities can be considered for patients with T1/T2 MCC. The results of this study should not change current practice and would lend themselves to a more robust study.”

No external funding of the study was reported. Dr. Cheraghlou has disclosed no relevant financial relationships. Dr. Olszanski has received financial support from Merck and BMS for participated on advisory boards.

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

SEATTLE – The use of Mohs surgery may improve survival for patients with early-stage Merkel cell carcinoma (MCC), results from a large, retrospective study show.

Compared with conventional wide local excision, survival was significantly improved among patients treated with Mohs, and a subgroup analysis showed that the survival benefit remained for patients with risk factors.

“At 10 years, overall survival was about 21% higher for those treated with Mohs surgery versus those treated with conventional surgery,” said lead author Shayan Cheraghlou, MD, a dermatology resident at the New York University School of Medicine. “On multivariable analysis, which controlled for tumor and patient factors, Mohs was associated with an over 40% reduction in the hazard for death.”

The findings were presented at the annual meeting of the American College of Mohs Surgery.

MCC is a rare, aggressive, neuroendocrine cutaneous malignancy that carries a high mortality rate. The estimated 5-year survival for patients with localized disease is about 50%, Dr. Cheraghlou noted. “That extrapolates to about 55% for T1 tumors and down to about 30% for T4 tumors.”

Although it’s considered to be a rare cancer, the incidence of MCC has been rapidly rising, and in fact it doubled during the period from the 1990s to the 2010s.

Most commonly treated with wide local excision with or without adjuvant radiation therapy, Mohs as monotherapy may offer an alternative treatment option for patients with MCC. It is generally accepted that the optimal treatment for tumors without regional lymph node involvement is surgical, but the data regarding the optimal surgical approach are mixed. Current National Comprehensive Cancer Network guidelines state that either Mohs surgery or wide local excision can be used.

“However, these guidelines do not indicate a preference for one modality over the other,” said Dr. Cheraghlou, “and present them as interchangeable treatment options.”

A growing body of literature supports Mohs surgery for many types of rare tumors, including MCC. For example, as previously reported at the 2021 ACMS meeting, one study found that Mohs surgery compared favorably with the standard treatment approach when it came to recurrence rates for patients with MCC. The 5-year disease-specific survival rate was 91.2% for patients with stage I disease and 68.6% for patients with stage IIa. These rates were comparable with rates for historical control patients who were treated with wide local excision, with or without radiation (81%-87% for stage I disease, and 63%-67% for stage II).

Study details

In the current study, Dr. Cheraghlou and colleagues sought to evaluate the association of the type of surgical approach with patient survival after excision of early-stage MCC. They conducted a retrospective cohort study using the National Cancer Database to identify cases of MCC with T1/T2 tumors. A total of 2,313 patients who were diagnosed from 2004 to 2018 with pathologically confirmed negative lymph node involvement and who were treated with Mohs surgery or wide lesion excision were included in the analysis.

“About 90% were T1 tumors, about 40% were located on the head and neck, and the vast majority – about 60% – were treated with wide local excision,” he explained. “Only about 5% received Mohs surgery for treatment of the primary tumor.”

But when the researchers assessed survival outcomes, they found that treatment with Mohs surgery was associated with significantly improved overall survival.

The unadjusted 3-, 5-, and 10-year survival rates for patients treated with Mohs was 87.4% (SE: 3.4%), 84.5% (SE: 3.9%), and 81.8% (SE: 4.6%), respectively, while for wide lesion excision, the rates were 86.1% (SE: 0.9%), 76.9% (SE: 1.2%), and 60.9% (SE: 2.0%), respectively.

For patients who underwent treatment with narrow margin excision, survival rates were similar as for those treated with wide lesion excision, with 3-, 5-, and 10-year survival rates of 84.8% (SE: 1.4%), 78.3% (SE: 1.7%), and 60.8% (SE: 3.6%), respectively.

On multivariable survival analysis, Mohs surgery was associated with significantly improved survival, compared with wide lesion excision (hazard ratio, 0.594; P = .038). This was also true after multivariable analysis for patients who had one or more NCCN risk factors, for whom improved survival was also seen with Mohs (HR, 0.530; P = .026).

The results did not differ after a sensitivity analysis that included T3 and T4 tumors.

Given that the use of Mohs was so infrequent, compared with standard surgery, the researchers investigated the factors that were associated with the use of Mohs. High-volume MCC centers were significantly more likely to utilize Mohs than wide lesion excision (odds ratio, 1.993; P < .001), compared with other facilities.

“This study has important implications going forward,” Dr. Cheraghlou concluded. “We think it’s important how few patients were treated with Mohs for Merkel cell, and it was slightly more likely to happen in a high-volume center.”

The reasoning for that may be that high-volume centers are more likely to have a surgeon trained to perform Mohs surgery for MCC. “Or perhaps they are more attuned to the benefits of this procedure,” he said. “We can’t tell that from our data, but its notable that it’s such a small proportion of patients – especially when we consider that it is associated with improved survival for the patients who receive it.”

He added that efforts to increase the utilization of Mohs may yield improved local control and overall survival for these patients. “And perhaps with more data, future versions of guidelines may indicate a preference for Mohs over conventional incisions.”
 

No changes to current practice

Asked to comment on the study, Anthony J. Olszanski, RPh, MD, associate professor, department of hematology/oncology, Fox Chase Cancer Center, Philadelphia, noted that while the results are intriguing, they must be interpreted with caution.

“This study was retrospective in nature, and unrecognized biases can influence results,” he said. “Additionally, given the relative rarity of Merkel cell carcinoma, the sample size is expectantly small.”

But importantly, Dr. Olszanski emphasized, Mohs may more often have been recommended for patients with lesions that appear less aggressive. “Many patients undergoing wide lesion excision may have been referred by Mohs surgeons secondary to features or characteristics of lesions which were worrisome,” he explained. “The results of this study do not opine on why Mohs would impact overall survival over wide lesion excision, a point worthy of consideration. Presently, both modalities can be considered for patients with T1/T2 MCC. The results of this study should not change current practice and would lend themselves to a more robust study.”

No external funding of the study was reported. Dr. Cheraghlou has disclosed no relevant financial relationships. Dr. Olszanski has received financial support from Merck and BMS for participated on advisory boards.

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

BARCELONA – Clinically important arrhythmias, especially nonsustained ventricular tachycardia (NSVT), may be more prevalent in patients with hypertrophic cardiomyopathy (HCM) than widely believed, suggests a study that questions current risk stratification practices in HCM.

In the registry study, such arrythmias were observed in about six times as many HCM patients during 30 days of ambulatory electrocardiographic monitoring as would have been identified based on the first 24 hours of the monitoring period: 65% vs. 11% of the cohort.

Also, about 62% of the patients showed NSVT at “extended” 30-day monitoring, compared with an 8% prevalence of the arrhythmia based on the more conventional ECG monitoring period of 24 hours.

Nonsustained ventricular tachycardia, an important arrhythmia used every day in clinical practice to make decisions, is “much, much more prevalent than we thought” in patients with HCM, Juan Caro Codón, MD, the study’s principal investigator, said in an interview. “We should invest in further research regarding extended ECG monitoring in these patients.”

Dr. Caro Codón, of La Paz University Hospital, Madrid, presented the findings from the TEMPO-HCM study at the European Heart Rhythm Association 2023 Congress, held in Barcelona and virtually.

Its results, he said, have implications for stratifying HCM patients according to their risk for sudden cardiac death in deciding who should be offered an implantable cardioverter-defibrillator (ICD).

The life-incidence of atrial fibrillation (AF) in patients like those in the current analysis has previously been found to be about 20%, and the life-prevalence of NSVT about 20%-30%, using traditional 24- or 48-hour Holter monitoring, Dr. Caro Codón said.

“These arrhythmias are clinically relevant events because they are linked to very meaningful clinical endpoints,” including stroke and thromboembolism, he said, “but also for sudden cardiac death.”

Extended ECG monitoring has been shown useful in the setting of cryptogenic stroke and after AF ablation, but similar findings have been scarce in HCM. Patients using personal wearable monitors such as smart watches, Dr. Caro Codón said, have come to his clinic with concerns that the devices may have signaled a problem. But the lack of relevant data leaves them without a sufficient answer.

In other findings, invited discussant Isabelle van Gelder, MD, PhD, observed after Dr. Caro Codón’s presentation that the number of patients with AF almost doubled based on extended monitoring, compared with the first 24 hours of monitoring.

Based on European Society of Cardiology guidelines from 2020, “Once clinical AF has been documented, there is a class IIA recommendation to start anticoagulation,” said Dr. van Gelder, University of Groningen, the Netherlands. “Therefore, your data really are a call for more data on screening for AF in hypertrophic cardiomyopathy patients.”
 

Prospective multicenter registry

The TEMPO-HCM registry includes patients with HCM and a clinical indication for standard Holter monitoring at five hospitals in Spain. It excludes patients with an HCM-like phenotype but who lack the telltale genotype, as well as those already implanted with an ICD.

Those in the current analysis underwent 30-day ECG monitoring with a small, wearable device that Dr. Caro Codón described as about 7 cm long, worn in what is essentially a T-shirt with a pocket. Patients could remove the shirt and device to bathe or go swimming, for example, and still be monitored for most of the day.

The analysis included the registry’s first 100 patients (mean age, 57 years; 78% male). Hypertension was present in 47%, 58% were on beta-blockers, 16% had prior AF or atrial flutter, and 19% were taking anticoagulants. Only 8% were on antiarrhythmic drugs, Dr. Caro Codón reported.

The patients had good functional status (68% and 29% were in NYHA class 1 and 2, respectively) and their left ventricular ejection fraction averaged 66%. Of the 71 patients who underwent MRI, 28.2% showed late gadolinium enhancement suggesting myocardial scarring.
 

More arrhythmias on 30-day monitoring

The primary endpoint of clinically relevant arrhythmia (AF, atrial flutter, or NSVT) was identified during the first 24 hours of monitoring in 11% of patients. The prevalence rose to 65% (P < .001) based on 30-day monitoring.

Similarly, prevalences of the composite primary endpoint components grew on extended monitoring, but the increases reached statistical significance only for NSVT; its prevalence went from 8% to 62% (P < .001). Prevalences rose nonsignificantly from 6% to 10% for AF and 0% to 1% for sustained ventricular tachycardia.

The incidence of NSVT during monitoring climbed fastest from day 0 through about day 19 and then rose more slowly through day 30, Dr. Caro Codón said. “It actually didn’t reach a plateau during this time period, so there is the possibility that if we had continued monitoring patients, the difference between both periods may have been even higher.”

Three variables predicted the incidence of nonsustained VT during monitoring, he said: age, atrial wall thickness, and whether there was late gadolinium enhancement at MRI.

An exploratory analysis looked at the 5-year risk of sudden cardiac death using the European Society of Cardiology HCM-SCD risk calculator recommended in guidelines. Risk assessment based on the 30-day extended monitoring period, compared with the first 24 hours of monitoring alone, predicted a significantly higher 5-year risk of sudden death, Dr. Caro Codón said.

“Even more importantly,” he added, “over 20%” of patients would have been reclassified into a higher-risk group and possibly considered for an ICD based on extended monitoring, compared to 24-hour monitoring.

However, given that more than 50% of patients were found to have NSVT during extended monitoring, Dr. Caro Codón proposed that decisions on whether to implant an ICD should not be so “binary” based on the presence or absence of symptoms, and proposed further investigations be conducted into the complete phenotype of these arrhythmias.

The study has limitations, he observed, including a relatively small size; but it was able to detect important differences between 24-hour and 30-day monitoring outcomes even with only 100 patients. It was also limited by a lack of clinical follow-up for information on endpoints like stroke, thromboembolism, and sudden cardiac death.

Extended monitoring detected more cases of NSVT in the study’s relatively low-risk HCM patients who would not generally have an indication for ICD implantation, observed Dr. van Gelder. Also, at present the prognostic value of NSVT for SCD “seems to be more important at younger age” – that is, younger than 30 years – in patients with HCM.

Dr. van Gelder echoed Dr. Caro Codón’s call for more data from prolonged monitoring to help stratify patients according to risk; she proposed NSVT frequency, duration, and rate as possible targets.

The study was supported by an unrestricted grant from Nuubo, which provided the ECG monitoring systems. Dr. Caro Codón and Dr. van Gelder reported no relevant financial relationships.

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

BARCELONA – Clinically important arrhythmias, especially nonsustained ventricular tachycardia (NSVT), may be more prevalent in patients with hypertrophic cardiomyopathy (HCM) than widely believed, suggests a study that questions current risk stratification practices in HCM.

In the registry study, such arrythmias were observed in about six times as many HCM patients during 30 days of ambulatory electrocardiographic monitoring as would have been identified based on the first 24 hours of the monitoring period: 65% vs. 11% of the cohort.

Also, about 62% of the patients showed NSVT at “extended” 30-day monitoring, compared with an 8% prevalence of the arrhythmia based on the more conventional ECG monitoring period of 24 hours.

Nonsustained ventricular tachycardia, an important arrhythmia used every day in clinical practice to make decisions, is “much, much more prevalent than we thought” in patients with HCM, Juan Caro Codón, MD, the study’s principal investigator, said in an interview. “We should invest in further research regarding extended ECG monitoring in these patients.”

Dr. Caro Codón, of La Paz University Hospital, Madrid, presented the findings from the TEMPO-HCM study at the European Heart Rhythm Association 2023 Congress, held in Barcelona and virtually.

Its results, he said, have implications for stratifying HCM patients according to their risk for sudden cardiac death in deciding who should be offered an implantable cardioverter-defibrillator (ICD).

The life-incidence of atrial fibrillation (AF) in patients like those in the current analysis has previously been found to be about 20%, and the life-prevalence of NSVT about 20%-30%, using traditional 24- or 48-hour Holter monitoring, Dr. Caro Codón said.

“These arrhythmias are clinically relevant events because they are linked to very meaningful clinical endpoints,” including stroke and thromboembolism, he said, “but also for sudden cardiac death.”

Extended ECG monitoring has been shown useful in the setting of cryptogenic stroke and after AF ablation, but similar findings have been scarce in HCM. Patients using personal wearable monitors such as smart watches, Dr. Caro Codón said, have come to his clinic with concerns that the devices may have signaled a problem. But the lack of relevant data leaves them without a sufficient answer.

In other findings, invited discussant Isabelle van Gelder, MD, PhD, observed after Dr. Caro Codón’s presentation that the number of patients with AF almost doubled based on extended monitoring, compared with the first 24 hours of monitoring.

Based on European Society of Cardiology guidelines from 2020, “Once clinical AF has been documented, there is a class IIA recommendation to start anticoagulation,” said Dr. van Gelder, University of Groningen, the Netherlands. “Therefore, your data really are a call for more data on screening for AF in hypertrophic cardiomyopathy patients.”
 

Prospective multicenter registry

The TEMPO-HCM registry includes patients with HCM and a clinical indication for standard Holter monitoring at five hospitals in Spain. It excludes patients with an HCM-like phenotype but who lack the telltale genotype, as well as those already implanted with an ICD.

Those in the current analysis underwent 30-day ECG monitoring with a small, wearable device that Dr. Caro Codón described as about 7 cm long, worn in what is essentially a T-shirt with a pocket. Patients could remove the shirt and device to bathe or go swimming, for example, and still be monitored for most of the day.

The analysis included the registry’s first 100 patients (mean age, 57 years; 78% male). Hypertension was present in 47%, 58% were on beta-blockers, 16% had prior AF or atrial flutter, and 19% were taking anticoagulants. Only 8% were on antiarrhythmic drugs, Dr. Caro Codón reported.

The patients had good functional status (68% and 29% were in NYHA class 1 and 2, respectively) and their left ventricular ejection fraction averaged 66%. Of the 71 patients who underwent MRI, 28.2% showed late gadolinium enhancement suggesting myocardial scarring.
 

More arrhythmias on 30-day monitoring

The primary endpoint of clinically relevant arrhythmia (AF, atrial flutter, or NSVT) was identified during the first 24 hours of monitoring in 11% of patients. The prevalence rose to 65% (P < .001) based on 30-day monitoring.

Similarly, prevalences of the composite primary endpoint components grew on extended monitoring, but the increases reached statistical significance only for NSVT; its prevalence went from 8% to 62% (P < .001). Prevalences rose nonsignificantly from 6% to 10% for AF and 0% to 1% for sustained ventricular tachycardia.

The incidence of NSVT during monitoring climbed fastest from day 0 through about day 19 and then rose more slowly through day 30, Dr. Caro Codón said. “It actually didn’t reach a plateau during this time period, so there is the possibility that if we had continued monitoring patients, the difference between both periods may have been even higher.”

Three variables predicted the incidence of nonsustained VT during monitoring, he said: age, atrial wall thickness, and whether there was late gadolinium enhancement at MRI.

An exploratory analysis looked at the 5-year risk of sudden cardiac death using the European Society of Cardiology HCM-SCD risk calculator recommended in guidelines. Risk assessment based on the 30-day extended monitoring period, compared with the first 24 hours of monitoring alone, predicted a significantly higher 5-year risk of sudden death, Dr. Caro Codón said.

“Even more importantly,” he added, “over 20%” of patients would have been reclassified into a higher-risk group and possibly considered for an ICD based on extended monitoring, compared to 24-hour monitoring.

However, given that more than 50% of patients were found to have NSVT during extended monitoring, Dr. Caro Codón proposed that decisions on whether to implant an ICD should not be so “binary” based on the presence or absence of symptoms, and proposed further investigations be conducted into the complete phenotype of these arrhythmias.

The study has limitations, he observed, including a relatively small size; but it was able to detect important differences between 24-hour and 30-day monitoring outcomes even with only 100 patients. It was also limited by a lack of clinical follow-up for information on endpoints like stroke, thromboembolism, and sudden cardiac death.

Extended monitoring detected more cases of NSVT in the study’s relatively low-risk HCM patients who would not generally have an indication for ICD implantation, observed Dr. van Gelder. Also, at present the prognostic value of NSVT for SCD “seems to be more important at younger age” – that is, younger than 30 years – in patients with HCM.

Dr. van Gelder echoed Dr. Caro Codón’s call for more data from prolonged monitoring to help stratify patients according to risk; she proposed NSVT frequency, duration, and rate as possible targets.

The study was supported by an unrestricted grant from Nuubo, which provided the ECG monitoring systems. Dr. Caro Codón and Dr. van Gelder reported no relevant financial relationships.

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

BARCELONA – Clinically important arrhythmias, especially nonsustained ventricular tachycardia (NSVT), may be more prevalent in patients with hypertrophic cardiomyopathy (HCM) than widely believed, suggests a study that questions current risk stratification practices in HCM.

In the registry study, such arrythmias were observed in about six times as many HCM patients during 30 days of ambulatory electrocardiographic monitoring as would have been identified based on the first 24 hours of the monitoring period: 65% vs. 11% of the cohort.

Also, about 62% of the patients showed NSVT at “extended” 30-day monitoring, compared with an 8% prevalence of the arrhythmia based on the more conventional ECG monitoring period of 24 hours.

Nonsustained ventricular tachycardia, an important arrhythmia used every day in clinical practice to make decisions, is “much, much more prevalent than we thought” in patients with HCM, Juan Caro Codón, MD, the study’s principal investigator, said in an interview. “We should invest in further research regarding extended ECG monitoring in these patients.”

Dr. Caro Codón, of La Paz University Hospital, Madrid, presented the findings from the TEMPO-HCM study at the European Heart Rhythm Association 2023 Congress, held in Barcelona and virtually.

Its results, he said, have implications for stratifying HCM patients according to their risk for sudden cardiac death in deciding who should be offered an implantable cardioverter-defibrillator (ICD).

The life-incidence of atrial fibrillation (AF) in patients like those in the current analysis has previously been found to be about 20%, and the life-prevalence of NSVT about 20%-30%, using traditional 24- or 48-hour Holter monitoring, Dr. Caro Codón said.

“These arrhythmias are clinically relevant events because they are linked to very meaningful clinical endpoints,” including stroke and thromboembolism, he said, “but also for sudden cardiac death.”

Extended ECG monitoring has been shown useful in the setting of cryptogenic stroke and after AF ablation, but similar findings have been scarce in HCM. Patients using personal wearable monitors such as smart watches, Dr. Caro Codón said, have come to his clinic with concerns that the devices may have signaled a problem. But the lack of relevant data leaves them without a sufficient answer.

In other findings, invited discussant Isabelle van Gelder, MD, PhD, observed after Dr. Caro Codón’s presentation that the number of patients with AF almost doubled based on extended monitoring, compared with the first 24 hours of monitoring.

Based on European Society of Cardiology guidelines from 2020, “Once clinical AF has been documented, there is a class IIA recommendation to start anticoagulation,” said Dr. van Gelder, University of Groningen, the Netherlands. “Therefore, your data really are a call for more data on screening for AF in hypertrophic cardiomyopathy patients.”
 

Prospective multicenter registry

The TEMPO-HCM registry includes patients with HCM and a clinical indication for standard Holter monitoring at five hospitals in Spain. It excludes patients with an HCM-like phenotype but who lack the telltale genotype, as well as those already implanted with an ICD.

Those in the current analysis underwent 30-day ECG monitoring with a small, wearable device that Dr. Caro Codón described as about 7 cm long, worn in what is essentially a T-shirt with a pocket. Patients could remove the shirt and device to bathe or go swimming, for example, and still be monitored for most of the day.

The analysis included the registry’s first 100 patients (mean age, 57 years; 78% male). Hypertension was present in 47%, 58% were on beta-blockers, 16% had prior AF or atrial flutter, and 19% were taking anticoagulants. Only 8% were on antiarrhythmic drugs, Dr. Caro Codón reported.

The patients had good functional status (68% and 29% were in NYHA class 1 and 2, respectively) and their left ventricular ejection fraction averaged 66%. Of the 71 patients who underwent MRI, 28.2% showed late gadolinium enhancement suggesting myocardial scarring.
 

More arrhythmias on 30-day monitoring

The primary endpoint of clinically relevant arrhythmia (AF, atrial flutter, or NSVT) was identified during the first 24 hours of monitoring in 11% of patients. The prevalence rose to 65% (P < .001) based on 30-day monitoring.

Similarly, prevalences of the composite primary endpoint components grew on extended monitoring, but the increases reached statistical significance only for NSVT; its prevalence went from 8% to 62% (P < .001). Prevalences rose nonsignificantly from 6% to 10% for AF and 0% to 1% for sustained ventricular tachycardia.

The incidence of NSVT during monitoring climbed fastest from day 0 through about day 19 and then rose more slowly through day 30, Dr. Caro Codón said. “It actually didn’t reach a plateau during this time period, so there is the possibility that if we had continued monitoring patients, the difference between both periods may have been even higher.”

Three variables predicted the incidence of nonsustained VT during monitoring, he said: age, atrial wall thickness, and whether there was late gadolinium enhancement at MRI.

An exploratory analysis looked at the 5-year risk of sudden cardiac death using the European Society of Cardiology HCM-SCD risk calculator recommended in guidelines. Risk assessment based on the 30-day extended monitoring period, compared with the first 24 hours of monitoring alone, predicted a significantly higher 5-year risk of sudden death, Dr. Caro Codón said.

“Even more importantly,” he added, “over 20%” of patients would have been reclassified into a higher-risk group and possibly considered for an ICD based on extended monitoring, compared to 24-hour monitoring.

However, given that more than 50% of patients were found to have NSVT during extended monitoring, Dr. Caro Codón proposed that decisions on whether to implant an ICD should not be so “binary” based on the presence or absence of symptoms, and proposed further investigations be conducted into the complete phenotype of these arrhythmias.

The study has limitations, he observed, including a relatively small size; but it was able to detect important differences between 24-hour and 30-day monitoring outcomes even with only 100 patients. It was also limited by a lack of clinical follow-up for information on endpoints like stroke, thromboembolism, and sudden cardiac death.

Extended monitoring detected more cases of NSVT in the study’s relatively low-risk HCM patients who would not generally have an indication for ICD implantation, observed Dr. van Gelder. Also, at present the prognostic value of NSVT for SCD “seems to be more important at younger age” – that is, younger than 30 years – in patients with HCM.

Dr. van Gelder echoed Dr. Caro Codón’s call for more data from prolonged monitoring to help stratify patients according to risk; she proposed NSVT frequency, duration, and rate as possible targets.

The study was supported by an unrestricted grant from Nuubo, which provided the ECG monitoring systems. Dr. Caro Codón and Dr. van Gelder reported no relevant financial relationships.

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

Many patients with asymptomatic renal stones can qualify for an active surveillance program, Swiss researchers report at the American Urological Association 2023 Annual Meeting.

Kevin Stritt, MD, chief resident in the urology department at Lausanne University Hospital, said kidney stones often pass without symptoms. But until now, data on the frequency of asymptomatic, spontaneous passage of stones have been lacking.

The new data come from the NOSTONE trial, a prospective, multicenter, double-blind, placebo-controlled randomized trial to assess the efficacy of hydrochlorothiazide in the prevention of recurrence in patients with recurrent calcium-containing kidney stones.

Dr. Stritt and colleagues evaluated the natural history of asymptomatic renal stones during a median follow-up of 35 months. “We found for the first time that a relevant number of kidney stone passages [39%] were asymptomatic, spontaneous stone passages,” Dr. Stritt told this news organization.

All asymptomatic spontaneous stone passages were analyzed in a comparison of the total number of kidney stones on low-dose, nonintravenous contrast CT imaging at the beginning and end of the 3-year follow-up.

Of the 403 stones passed spontaneously, 61% (245) were symptomatic stone passages and 39% (158) were asymptomatic stone passages, Dr. Stritt told this news organization.

Asymptomatic stones were a median size of 2.4 mm, and symptomatic stones were 2.15 mm, which was not significantly different (P = .366), according to the researchers. Dr. Stritt said the spontaneous passage of asymptomatic stones was largely influenced by a higher number of stones on CT imaging at randomization (P = .001) and a lower total stone volume (P = .001).

Ephrem Olweny, MD, an assistant professor of urology and section chief of endourology at Rush University Medical Center in Chicago, said previous studies have found that the rate of spontaneous passage of kidney stones ranges from 3% to 29%.

“But this secondary analysis of data from a prior multicenter prospective randomized trial offers higher-quality data that will be of value in guiding patient counseling,” Dr. Olweny said.

“Observation should be initially offered to these patients. However, patients should be informed that 52% are likely to develop symptoms, and some may indeed opt for preemptive surgical removal,” he added.

David Schulsinger, MD, an associate professor in the department of urology at Stony Brook (N.Y.) University Hospital, said the incidence of kidney stones has been increasing worldwide, affecting approximately 12% of men and 6% of women. Dehydration and diets high in sodium and calcium are major factors, he said.

Patients with a history of stones have a 50% risk of recurrence in the next 5 years, and an 80% risk in their lifetime, he added.

Dr. Schulsinger said the message from the Swiss study is that urologists can be “comfortable” watching small stones, those averaging 2.4 mm or less in size. “But if a patient has a 7- or  8-mm stone, you might be more inclined to manage that patient a little bit more aggressively.”

Roughly half of patients with stones less than 2 mm will pass it in about 8 days, he said. 

Dr. Olweny noted that the study was a secondary analysis of data from a randomized controlled trial that evaluated the efficacy of thiazides in preventing the recurrence of calcium stones. “The original study was not specifically designed to look at asymptomatic stone passage rates for small renal stones, and therefore, the observed rates may not reflect the most precise estimates,” he said.

Dr. Stritt said his group has not studied the size limit of stones that pass spontaneously without symptoms. “This study could serve to construct recurrence prediction models based on medical history and stone burden on CT imaging. More well-designed research on this topic is urgently needed,” he said. “These results should encourage urologists to counsel patients about the possibility of an active surveillance strategy when smaller kidney stones are present.”

The author and independent commentators have reported no relevant financial relationships.

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

Many patients with asymptomatic renal stones can qualify for an active surveillance program, Swiss researchers report at the American Urological Association 2023 Annual Meeting.

Kevin Stritt, MD, chief resident in the urology department at Lausanne University Hospital, said kidney stones often pass without symptoms. But until now, data on the frequency of asymptomatic, spontaneous passage of stones have been lacking.

The new data come from the NOSTONE trial, a prospective, multicenter, double-blind, placebo-controlled randomized trial to assess the efficacy of hydrochlorothiazide in the prevention of recurrence in patients with recurrent calcium-containing kidney stones.

Dr. Stritt and colleagues evaluated the natural history of asymptomatic renal stones during a median follow-up of 35 months. “We found for the first time that a relevant number of kidney stone passages [39%] were asymptomatic, spontaneous stone passages,” Dr. Stritt told this news organization.

All asymptomatic spontaneous stone passages were analyzed in a comparison of the total number of kidney stones on low-dose, nonintravenous contrast CT imaging at the beginning and end of the 3-year follow-up.

Of the 403 stones passed spontaneously, 61% (245) were symptomatic stone passages and 39% (158) were asymptomatic stone passages, Dr. Stritt told this news organization.

Asymptomatic stones were a median size of 2.4 mm, and symptomatic stones were 2.15 mm, which was not significantly different (P = .366), according to the researchers. Dr. Stritt said the spontaneous passage of asymptomatic stones was largely influenced by a higher number of stones on CT imaging at randomization (P = .001) and a lower total stone volume (P = .001).

Ephrem Olweny, MD, an assistant professor of urology and section chief of endourology at Rush University Medical Center in Chicago, said previous studies have found that the rate of spontaneous passage of kidney stones ranges from 3% to 29%.

“But this secondary analysis of data from a prior multicenter prospective randomized trial offers higher-quality data that will be of value in guiding patient counseling,” Dr. Olweny said.

“Observation should be initially offered to these patients. However, patients should be informed that 52% are likely to develop symptoms, and some may indeed opt for preemptive surgical removal,” he added.

David Schulsinger, MD, an associate professor in the department of urology at Stony Brook (N.Y.) University Hospital, said the incidence of kidney stones has been increasing worldwide, affecting approximately 12% of men and 6% of women. Dehydration and diets high in sodium and calcium are major factors, he said.

Patients with a history of stones have a 50% risk of recurrence in the next 5 years, and an 80% risk in their lifetime, he added.

Dr. Schulsinger said the message from the Swiss study is that urologists can be “comfortable” watching small stones, those averaging 2.4 mm or less in size. “But if a patient has a 7- or  8-mm stone, you might be more inclined to manage that patient a little bit more aggressively.”

Roughly half of patients with stones less than 2 mm will pass it in about 8 days, he said. 

Dr. Olweny noted that the study was a secondary analysis of data from a randomized controlled trial that evaluated the efficacy of thiazides in preventing the recurrence of calcium stones. “The original study was not specifically designed to look at asymptomatic stone passage rates for small renal stones, and therefore, the observed rates may not reflect the most precise estimates,” he said.

Dr. Stritt said his group has not studied the size limit of stones that pass spontaneously without symptoms. “This study could serve to construct recurrence prediction models based on medical history and stone burden on CT imaging. More well-designed research on this topic is urgently needed,” he said. “These results should encourage urologists to counsel patients about the possibility of an active surveillance strategy when smaller kidney stones are present.”

The author and independent commentators have reported no relevant financial relationships.

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

Many patients with asymptomatic renal stones can qualify for an active surveillance program, Swiss researchers report at the American Urological Association 2023 Annual Meeting.

Kevin Stritt, MD, chief resident in the urology department at Lausanne University Hospital, said kidney stones often pass without symptoms. But until now, data on the frequency of asymptomatic, spontaneous passage of stones have been lacking.

The new data come from the NOSTONE trial, a prospective, multicenter, double-blind, placebo-controlled randomized trial to assess the efficacy of hydrochlorothiazide in the prevention of recurrence in patients with recurrent calcium-containing kidney stones.

Dr. Stritt and colleagues evaluated the natural history of asymptomatic renal stones during a median follow-up of 35 months. “We found for the first time that a relevant number of kidney stone passages [39%] were asymptomatic, spontaneous stone passages,” Dr. Stritt told this news organization.

All asymptomatic spontaneous stone passages were analyzed in a comparison of the total number of kidney stones on low-dose, nonintravenous contrast CT imaging at the beginning and end of the 3-year follow-up.

Of the 403 stones passed spontaneously, 61% (245) were symptomatic stone passages and 39% (158) were asymptomatic stone passages, Dr. Stritt told this news organization.

Asymptomatic stones were a median size of 2.4 mm, and symptomatic stones were 2.15 mm, which was not significantly different (P = .366), according to the researchers. Dr. Stritt said the spontaneous passage of asymptomatic stones was largely influenced by a higher number of stones on CT imaging at randomization (P = .001) and a lower total stone volume (P = .001).

Ephrem Olweny, MD, an assistant professor of urology and section chief of endourology at Rush University Medical Center in Chicago, said previous studies have found that the rate of spontaneous passage of kidney stones ranges from 3% to 29%.

“But this secondary analysis of data from a prior multicenter prospective randomized trial offers higher-quality data that will be of value in guiding patient counseling,” Dr. Olweny said.

“Observation should be initially offered to these patients. However, patients should be informed that 52% are likely to develop symptoms, and some may indeed opt for preemptive surgical removal,” he added.

David Schulsinger, MD, an associate professor in the department of urology at Stony Brook (N.Y.) University Hospital, said the incidence of kidney stones has been increasing worldwide, affecting approximately 12% of men and 6% of women. Dehydration and diets high in sodium and calcium are major factors, he said.

Patients with a history of stones have a 50% risk of recurrence in the next 5 years, and an 80% risk in their lifetime, he added.

Dr. Schulsinger said the message from the Swiss study is that urologists can be “comfortable” watching small stones, those averaging 2.4 mm or less in size. “But if a patient has a 7- or  8-mm stone, you might be more inclined to manage that patient a little bit more aggressively.”

Roughly half of patients with stones less than 2 mm will pass it in about 8 days, he said. 

Dr. Olweny noted that the study was a secondary analysis of data from a randomized controlled trial that evaluated the efficacy of thiazides in preventing the recurrence of calcium stones. “The original study was not specifically designed to look at asymptomatic stone passage rates for small renal stones, and therefore, the observed rates may not reflect the most precise estimates,” he said.

Dr. Stritt said his group has not studied the size limit of stones that pass spontaneously without symptoms. “This study could serve to construct recurrence prediction models based on medical history and stone burden on CT imaging. More well-designed research on this topic is urgently needed,” he said. “These results should encourage urologists to counsel patients about the possibility of an active surveillance strategy when smaller kidney stones are present.”

The author and independent commentators have reported no relevant financial relationships.

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

CHICAGO – It’s been 125 years since the founding of the American Gastroenterological Association (AGA). It’s gone from a small organization in which gastroenterology wasn’t even a known medical specialty, to an organization that grants millions of dollars in research funding each year.

University of California San Diego

Congratulating the organization on its 125th anniversary, AGA president John M. Carethers, MD, AGAF, reflected on its history and outlined many accomplishments and challenges. He spoke with optimism about gastroenterology’s future during his presidential address on May 8 at the annual Digestive Disease Week® (DDW) meeting in Chicago.

“I congratulate the AGA on its quasquicentennial, or 125th anniversary,” said Dr. Carethers, who is distinguished professor of medicine and vice chancellor for health sciences at the University of California, San Diego.

The AGA was founded in 1897 by Detroit-based physician Charles Aaron, MD. His passion was gastroenterology, but at that point, it wasn’t an established medical discipline. Dr. Aaron, Max Einhorn, MD, and 8 other colleagues formed the American Gastroenterological Association. Today, with nearly 16,000 members, the organization has become a driving force in improving the care of patients with gastrointestinal conditions.

Among AGA’s accomplishments since its founding: In 1940, the American Board of Internal Medicine certified gastroenterology as a subspecialty. Three years later, the first issue of Gastroenterology, the AGA’s flagship journal, was published. And, in 1971, the very first Digestive Disease Week® meeting took place.

In terms of medical advances that have been made since those early years, the list is vast: From the description of ileitis in 1932 by Burril B. Crohn, MD, in 1932 to the discovery of the hepatitis B surface antigen in 1965 and the more recent discovery of germline mutations in DNA mismatch repair genes as a cause of Lynch syndrome.

Dr. Carethers outlined goals for the future, including building a leadership team that is “reflective of our practice here in the United States,” Dr. Carethers said. Creating a culturally and gender diverse leadership team will only strengthen the organization and the practice of gastroenterology. The AGA’s first female president, Sarah Jordan, MD, was named in 1942, and since then, the AGA has been led by women and men from different ethnic backgrounds, including himself, who is AGA’s first president of African American heritage.

The AGA has committed to a number of diversity and equity objectives, including the AGA Equity Project, an initiative launched in 2020 whose goal is to achieve equity and eradicate disparities in digestive diseases with a focus on justice and equity, research and funding, workforce and leadership, recognition of the achievements of people of color, unconscious bias, and engagement with early career members.

“I am not only excited about the diversity and equity objectives within our specialty ... but also the innovation and things to come for our specialty,” Dr. Carethers said.

Securing funding for early-stage innovations in medicine can be difficult across medical disciplines, including gastroenterology. So, last year, the AGA, with Varia Ventures, launched the GI Opportunity Fund 1 to support early-stage GI-based companies. The goal is to raise $25 million for the initial fund. Through the AGA’s Center for GI Innovation and Technology and the AGA Tech Summit, early-stage companies may have new funding opportunities.

And, through the AGA Research Foundation, the organization will continue to support clinical research. Last year, $2.6 million in grants were awarded to investigators.

Dr. Carethers is a board director at Avantor, a life sciences supply company.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

CHICAGO – It’s been 125 years since the founding of the American Gastroenterological Association (AGA). It’s gone from a small organization in which gastroenterology wasn’t even a known medical specialty, to an organization that grants millions of dollars in research funding each year.

University of California San Diego

Congratulating the organization on its 125th anniversary, AGA president John M. Carethers, MD, AGAF, reflected on its history and outlined many accomplishments and challenges. He spoke with optimism about gastroenterology’s future during his presidential address on May 8 at the annual Digestive Disease Week® (DDW) meeting in Chicago.

“I congratulate the AGA on its quasquicentennial, or 125th anniversary,” said Dr. Carethers, who is distinguished professor of medicine and vice chancellor for health sciences at the University of California, San Diego.

The AGA was founded in 1897 by Detroit-based physician Charles Aaron, MD. His passion was gastroenterology, but at that point, it wasn’t an established medical discipline. Dr. Aaron, Max Einhorn, MD, and 8 other colleagues formed the American Gastroenterological Association. Today, with nearly 16,000 members, the organization has become a driving force in improving the care of patients with gastrointestinal conditions.

Among AGA’s accomplishments since its founding: In 1940, the American Board of Internal Medicine certified gastroenterology as a subspecialty. Three years later, the first issue of Gastroenterology, the AGA’s flagship journal, was published. And, in 1971, the very first Digestive Disease Week® meeting took place.

In terms of medical advances that have been made since those early years, the list is vast: From the description of ileitis in 1932 by Burril B. Crohn, MD, in 1932 to the discovery of the hepatitis B surface antigen in 1965 and the more recent discovery of germline mutations in DNA mismatch repair genes as a cause of Lynch syndrome.

Dr. Carethers outlined goals for the future, including building a leadership team that is “reflective of our practice here in the United States,” Dr. Carethers said. Creating a culturally and gender diverse leadership team will only strengthen the organization and the practice of gastroenterology. The AGA’s first female president, Sarah Jordan, MD, was named in 1942, and since then, the AGA has been led by women and men from different ethnic backgrounds, including himself, who is AGA’s first president of African American heritage.

The AGA has committed to a number of diversity and equity objectives, including the AGA Equity Project, an initiative launched in 2020 whose goal is to achieve equity and eradicate disparities in digestive diseases with a focus on justice and equity, research and funding, workforce and leadership, recognition of the achievements of people of color, unconscious bias, and engagement with early career members.

“I am not only excited about the diversity and equity objectives within our specialty ... but also the innovation and things to come for our specialty,” Dr. Carethers said.

Securing funding for early-stage innovations in medicine can be difficult across medical disciplines, including gastroenterology. So, last year, the AGA, with Varia Ventures, launched the GI Opportunity Fund 1 to support early-stage GI-based companies. The goal is to raise $25 million for the initial fund. Through the AGA’s Center for GI Innovation and Technology and the AGA Tech Summit, early-stage companies may have new funding opportunities.

And, through the AGA Research Foundation, the organization will continue to support clinical research. Last year, $2.6 million in grants were awarded to investigators.

Dr. Carethers is a board director at Avantor, a life sciences supply company.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

CHICAGO – It’s been 125 years since the founding of the American Gastroenterological Association (AGA). It’s gone from a small organization in which gastroenterology wasn’t even a known medical specialty, to an organization that grants millions of dollars in research funding each year.

University of California San Diego

Congratulating the organization on its 125th anniversary, AGA president John M. Carethers, MD, AGAF, reflected on its history and outlined many accomplishments and challenges. He spoke with optimism about gastroenterology’s future during his presidential address on May 8 at the annual Digestive Disease Week® (DDW) meeting in Chicago.

“I congratulate the AGA on its quasquicentennial, or 125th anniversary,” said Dr. Carethers, who is distinguished professor of medicine and vice chancellor for health sciences at the University of California, San Diego.

The AGA was founded in 1897 by Detroit-based physician Charles Aaron, MD. His passion was gastroenterology, but at that point, it wasn’t an established medical discipline. Dr. Aaron, Max Einhorn, MD, and 8 other colleagues formed the American Gastroenterological Association. Today, with nearly 16,000 members, the organization has become a driving force in improving the care of patients with gastrointestinal conditions.

Among AGA’s accomplishments since its founding: In 1940, the American Board of Internal Medicine certified gastroenterology as a subspecialty. Three years later, the first issue of Gastroenterology, the AGA’s flagship journal, was published. And, in 1971, the very first Digestive Disease Week® meeting took place.

In terms of medical advances that have been made since those early years, the list is vast: From the description of ileitis in 1932 by Burril B. Crohn, MD, in 1932 to the discovery of the hepatitis B surface antigen in 1965 and the more recent discovery of germline mutations in DNA mismatch repair genes as a cause of Lynch syndrome.

Dr. Carethers outlined goals for the future, including building a leadership team that is “reflective of our practice here in the United States,” Dr. Carethers said. Creating a culturally and gender diverse leadership team will only strengthen the organization and the practice of gastroenterology. The AGA’s first female president, Sarah Jordan, MD, was named in 1942, and since then, the AGA has been led by women and men from different ethnic backgrounds, including himself, who is AGA’s first president of African American heritage.

The AGA has committed to a number of diversity and equity objectives, including the AGA Equity Project, an initiative launched in 2020 whose goal is to achieve equity and eradicate disparities in digestive diseases with a focus on justice and equity, research and funding, workforce and leadership, recognition of the achievements of people of color, unconscious bias, and engagement with early career members.

“I am not only excited about the diversity and equity objectives within our specialty ... but also the innovation and things to come for our specialty,” Dr. Carethers said.

Securing funding for early-stage innovations in medicine can be difficult across medical disciplines, including gastroenterology. So, last year, the AGA, with Varia Ventures, launched the GI Opportunity Fund 1 to support early-stage GI-based companies. The goal is to raise $25 million for the initial fund. Through the AGA’s Center for GI Innovation and Technology and the AGA Tech Summit, early-stage companies may have new funding opportunities.

And, through the AGA Research Foundation, the organization will continue to support clinical research. Last year, $2.6 million in grants were awarded to investigators.

Dr. Carethers is a board director at Avantor, a life sciences supply company.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

CHICAGO – The total annual waste generated by a single, large academic endoscopy unit over 2 months could cover about two football fields, according to Madhav Desai, MD, MPH, assistant professor of medicine at the University of Minnesota, Minneapolis. About 20% of the waste, most of which went to landfills, was potentially recyclable, he said in a presentation given at the annual Digestive Disease Week® meeting.

Gastrointestinal endoscopies are critical for the screening, diagnosis, and treatment of a variety of gastrointestinal conditions. But like other medical procedures, endoscopies are a source of environmental waste, including plastic, sharps, personal protective equipment (PPE), and cleaning supplies, and also energy waste.

Walter Alexander/MDedge News

“This all goes back to the damage that mankind is inflicting on the environment in general, with the health care sector as one of the top contributors to plastic waste generation, landfills and water wastage,” Dr. Desai said. “Endoscopies, with their numerous benefits, substantially increase waste generation through landfill waste and liquid consumption and waste through the cleaning of endoscopes. We have a responsibility to look into this topic.”

To prospectively assess total waste generation from their institution, Dr. Desai, who was with the Kansas City (Mo.) Veterans Administration Medical Center, when the research was conducted, collected data on the items used in 450 consecutive procedures from May to June 2022. The data included procedure type, accessory use, intravenous tubing, numbers of biopsy jars, linens, PPE, and more, beginning at the point of patient entry to the endoscopy unit until discharge. They also collected data on waste generation related to reprocessing after each procedure and daily energy use (including endoscopy equipment, lights, and computers). With an eye toward finding opportunities to improve and maximize waste recycling, they stratified waste into the three categories of biohazardous, nonbiohazardous, or potentially recyclable.

“We found that the total waste generated during the time period was 1,398.6 kg, with more than half of it, 61.6%, going directly to landfill,” Dr. Desai said in an interview. “That’s an amount that an average family in the U.S. would use for 2 months. That’s a huge amount.”
 

Most waste consists of sharps

Exactly one-third was biohazard waste and 5.1% was sharps, they found. A single procedure, on average, sent 2.19 kg of waste to landfill. Extrapolated to 1 year, the waste total amounts to 9,189 kg (equivalent to just over 10 U.S. tons) and per 100 procedures to 219 kg (about 483 pounds).

They estimated 20% of the landfill waste was potentially recyclable (such as plastic CO₂ tubing, O₂ connector, syringes, etc.), which could reduce the total landfill burden by 8.6 kg per day or 2,580 kg per year (or 61 kg per 100 procedures). Reprocessing endoscopes generated 194 gallons of liquid waste (735.26 kg) per day or 1,385 gallons per 100 procedures.

Turning to energy consumption, Dr. Desai reported that daily use in the endoscopy unit was 277.1 kW-hours (equivalent to 8.2 gallons of gasoline), adding up to about 1,980 kW per 100 procedures. “That 100-procedure amount is the equivalent of the energy used for an average fuel efficiency car to travel 1,200 miles, the distance from Seattle to San Diego,” he said.

“One next step,” Dr. Desai said, “is getting help from GI societies to come together and have endoscopy units track their own performance. You need benchmarks so that you can determine how good an endoscopist you are with respect to waste.”

He commented further:“We all owe it to the environment. And, we have all witnessed what Mother Nature can do to you.”

Working on the potentially recyclable materials that account for 20% of the total waste would be a simple initial step to reduce waste going to landfills, Dr. Desai and colleagues concluded in the meeting abstract. “These data could serve as an actionable model for health systems to reduce total waste generation and move toward environmentally sustainable endoscopy units,” they wrote.

The authors reported no disclosures.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

CHICAGO – The total annual waste generated by a single, large academic endoscopy unit over 2 months could cover about two football fields, according to Madhav Desai, MD, MPH, assistant professor of medicine at the University of Minnesota, Minneapolis. About 20% of the waste, most of which went to landfills, was potentially recyclable, he said in a presentation given at the annual Digestive Disease Week® meeting.

Gastrointestinal endoscopies are critical for the screening, diagnosis, and treatment of a variety of gastrointestinal conditions. But like other medical procedures, endoscopies are a source of environmental waste, including plastic, sharps, personal protective equipment (PPE), and cleaning supplies, and also energy waste.

Walter Alexander/MDedge News

“This all goes back to the damage that mankind is inflicting on the environment in general, with the health care sector as one of the top contributors to plastic waste generation, landfills and water wastage,” Dr. Desai said. “Endoscopies, with their numerous benefits, substantially increase waste generation through landfill waste and liquid consumption and waste through the cleaning of endoscopes. We have a responsibility to look into this topic.”

To prospectively assess total waste generation from their institution, Dr. Desai, who was with the Kansas City (Mo.) Veterans Administration Medical Center, when the research was conducted, collected data on the items used in 450 consecutive procedures from May to June 2022. The data included procedure type, accessory use, intravenous tubing, numbers of biopsy jars, linens, PPE, and more, beginning at the point of patient entry to the endoscopy unit until discharge. They also collected data on waste generation related to reprocessing after each procedure and daily energy use (including endoscopy equipment, lights, and computers). With an eye toward finding opportunities to improve and maximize waste recycling, they stratified waste into the three categories of biohazardous, nonbiohazardous, or potentially recyclable.

“We found that the total waste generated during the time period was 1,398.6 kg, with more than half of it, 61.6%, going directly to landfill,” Dr. Desai said in an interview. “That’s an amount that an average family in the U.S. would use for 2 months. That’s a huge amount.”
 

Most waste consists of sharps

Exactly one-third was biohazard waste and 5.1% was sharps, they found. A single procedure, on average, sent 2.19 kg of waste to landfill. Extrapolated to 1 year, the waste total amounts to 9,189 kg (equivalent to just over 10 U.S. tons) and per 100 procedures to 219 kg (about 483 pounds).

They estimated 20% of the landfill waste was potentially recyclable (such as plastic CO₂ tubing, O₂ connector, syringes, etc.), which could reduce the total landfill burden by 8.6 kg per day or 2,580 kg per year (or 61 kg per 100 procedures). Reprocessing endoscopes generated 194 gallons of liquid waste (735.26 kg) per day or 1,385 gallons per 100 procedures.

Turning to energy consumption, Dr. Desai reported that daily use in the endoscopy unit was 277.1 kW-hours (equivalent to 8.2 gallons of gasoline), adding up to about 1,980 kW per 100 procedures. “That 100-procedure amount is the equivalent of the energy used for an average fuel efficiency car to travel 1,200 miles, the distance from Seattle to San Diego,” he said.

“One next step,” Dr. Desai said, “is getting help from GI societies to come together and have endoscopy units track their own performance. You need benchmarks so that you can determine how good an endoscopist you are with respect to waste.”

He commented further:“We all owe it to the environment. And, we have all witnessed what Mother Nature can do to you.”

Working on the potentially recyclable materials that account for 20% of the total waste would be a simple initial step to reduce waste going to landfills, Dr. Desai and colleagues concluded in the meeting abstract. “These data could serve as an actionable model for health systems to reduce total waste generation and move toward environmentally sustainable endoscopy units,” they wrote.

The authors reported no disclosures.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

CHICAGO – The total annual waste generated by a single, large academic endoscopy unit over 2 months could cover about two football fields, according to Madhav Desai, MD, MPH, assistant professor of medicine at the University of Minnesota, Minneapolis. About 20% of the waste, most of which went to landfills, was potentially recyclable, he said in a presentation given at the annual Digestive Disease Week® meeting.

Gastrointestinal endoscopies are critical for the screening, diagnosis, and treatment of a variety of gastrointestinal conditions. But like other medical procedures, endoscopies are a source of environmental waste, including plastic, sharps, personal protective equipment (PPE), and cleaning supplies, and also energy waste.

Walter Alexander/MDedge News

“This all goes back to the damage that mankind is inflicting on the environment in general, with the health care sector as one of the top contributors to plastic waste generation, landfills and water wastage,” Dr. Desai said. “Endoscopies, with their numerous benefits, substantially increase waste generation through landfill waste and liquid consumption and waste through the cleaning of endoscopes. We have a responsibility to look into this topic.”

To prospectively assess total waste generation from their institution, Dr. Desai, who was with the Kansas City (Mo.) Veterans Administration Medical Center, when the research was conducted, collected data on the items used in 450 consecutive procedures from May to June 2022. The data included procedure type, accessory use, intravenous tubing, numbers of biopsy jars, linens, PPE, and more, beginning at the point of patient entry to the endoscopy unit until discharge. They also collected data on waste generation related to reprocessing after each procedure and daily energy use (including endoscopy equipment, lights, and computers). With an eye toward finding opportunities to improve and maximize waste recycling, they stratified waste into the three categories of biohazardous, nonbiohazardous, or potentially recyclable.

“We found that the total waste generated during the time period was 1,398.6 kg, with more than half of it, 61.6%, going directly to landfill,” Dr. Desai said in an interview. “That’s an amount that an average family in the U.S. would use for 2 months. That’s a huge amount.”
 

Most waste consists of sharps

Exactly one-third was biohazard waste and 5.1% was sharps, they found. A single procedure, on average, sent 2.19 kg of waste to landfill. Extrapolated to 1 year, the waste total amounts to 9,189 kg (equivalent to just over 10 U.S. tons) and per 100 procedures to 219 kg (about 483 pounds).

They estimated 20% of the landfill waste was potentially recyclable (such as plastic CO₂ tubing, O₂ connector, syringes, etc.), which could reduce the total landfill burden by 8.6 kg per day or 2,580 kg per year (or 61 kg per 100 procedures). Reprocessing endoscopes generated 194 gallons of liquid waste (735.26 kg) per day or 1,385 gallons per 100 procedures.

Turning to energy consumption, Dr. Desai reported that daily use in the endoscopy unit was 277.1 kW-hours (equivalent to 8.2 gallons of gasoline), adding up to about 1,980 kW per 100 procedures. “That 100-procedure amount is the equivalent of the energy used for an average fuel efficiency car to travel 1,200 miles, the distance from Seattle to San Diego,” he said.

“One next step,” Dr. Desai said, “is getting help from GI societies to come together and have endoscopy units track their own performance. You need benchmarks so that you can determine how good an endoscopist you are with respect to waste.”

He commented further:“We all owe it to the environment. And, we have all witnessed what Mother Nature can do to you.”

Working on the potentially recyclable materials that account for 20% of the total waste would be a simple initial step to reduce waste going to landfills, Dr. Desai and colleagues concluded in the meeting abstract. “These data could serve as an actionable model for health systems to reduce total waste generation and move toward environmentally sustainable endoscopy units,” they wrote.

The authors reported no disclosures.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

PHOENIX – When Jeffrey Dover, MD, addressed audience members gathered for a session on cutting-edge technologies at the annual conference of the American Society for Laser Medicine and Surgery, he reflected on a conversation he had with R. Rox Anderson, MD, almost 40 years ago, about eventually finding a cure for acne.

“Despite the fact that we have over-the-counter therapies, prescription therapies, and all kinds of devices available to treat acne, there are still barriers to care that get in the way of treatment,” said Dr. Dover, director of SkinCare Physicians in Chestnut Hill, Mass. “If we had a device based on innovative light science that could meet the needs of the acne patient to get rid of these barriers, wouldn’t that be something wonderful?”

Dr. Jeffrey Dover

The answer to this question, he said, is now “yes,” because of advances in lasers that target sebaceous glands.

In a seminal paper published in 2012, Fernanda H. Sakamoto, MD, PhD, Dr. Anderson, and colleagues demonstrated the potential for a free electron laser to target sebaceous glands . Following several years of refinement, there are now two 1,726-nm laser devices – the AviClear and the Accure Laser System – cleared by the Food and Drug Administration for the treatment of mild to severe acne, which have “very impressive results,” Dr. Dover said.

“With the 1,726-nm laser, there is some selective absorption in sebum in skin, which beats out absorption in the other chromophores,” he said. “But it’s not a big difference like it is, for example, for pulsed-dye lasers and vascular targets. ... This means that the therapeutic window is relatively small and protecting the rest of the epidermis and dermis is crucial to be able to target these lesions or the sebaceous gland without unnecessary damage. If we can protect the epidermis and heat just the sebaceous glands, we should be able to get Accutane-like results if we get durability [by] shrinking sebaceous glands.”

Effective cooling, whether contact cooling, bulk cooling, or air cooling, is crucial to success, he continued. “It’s got to be robust and highly specific to protect the skin, so you don’t end up with side effects that are worse than the disease.”

The AviClear laser delivers seven 3-mm spots, which takes into account the thermal relaxation times of the sebaceous glands. The algorithm delivers a treatment imprint at roughly 0.3 Hz and a 1.5-mm depth of penetration, and the device relies on contact cooling. In pivotal data submitted to the FDA, 104 individuals with moderate to severe acne received three treatments with the AviClear 1 month apart, with follow-up at 1, 3, 6, and 12 months post treatment. They had no other treatment regimens, and the primary endpoint was the percentage of patients who achieved a 50% reduction in inflammatory lesion count 3 months after the final treatment. The secondary endpoint was an Investigator’s Global Assessment (IGA) improvement of 2 or greater.

Dr. Dover, who helped design the study, said that, at 3 months, 80% of those treated achieved a 50% or greater reduction in inflammatory lesion count (P < .001). As for secondary endpoints, 36% of individuals were assessed as having clear or almost clear skin; 47% achieved a 2-point or greater improvement in IGA score, compared with baseline, and 87% achieved a 1-point or greater improvement in IGA score, compared with baseline. By 6 months, 88% of individuals achieved a 50% or greater reduction in inflammatory lesion count; this improved to 92% by 12 months (P < .001).

“All of these procedures were done with no topical anesthetic, no intralesional anesthetic, and they tolerated these quite well,” he said. “There was no down time that required medical intervention after the treatments. All posttreatment erythema and swelling resolved quickly,” and 75% of the patients were “very satisfied” with the treatments.

The Accure Laser System features a proprietary technology that precisely controls thermal gradient depth. “So instead of guessing whether you are delivering the correct amount of heat, it actually tells you,” said Dr. Dover, a past president of the ASLMS and the American Society for Dermatologic Surgery. “It correlates surface and at-depth temperatures, and there’s an infrared camera for real-time accurate temperature monitoring.” The device features highly controlled air cooling and a pulsing pattern that ensures treatment of sebaceous glands of all sizes and at all depths. The clinical end marker is peak epidermal temperature.

In a study supported by Accure, the manufacturer, researchers evaluated the efficacy of the Accure Laser System in 35 subjects with types I to VI skin, who received four monthly treatments 30-45 minutes each, and were followed 12, 26, 39, and 52 weeks following their last treatment. To date, data out to 52 weeks is available for 17 study participants. According to Dr. Dover, the researchers found 80% clearance at 12 weeks following the last treatment, with continued improvement at 52 weeks. One hundred percent of subjects responded. Side effects included erythema, edema, crusting, blisters, and inflammatory papules. “None of these were medically significant,” he said.

As dermatologists begin to incorporate the AviClear and Accure devices into their practices, Dr. Dover said that he is reminded of the conversation he had some 40 years ago with Dr. Anderson about finding a cure for acne, and he feels a bit awestruck. “These 1,726-nm lasers are effective for treating acne. I personally think they are going to revolutionize the way we treat at least some of our patients with acne. They may both be effective for treating facial acne scars. Time will tell. Further study of both scarring and acne are needed to fully categorize the benefit and to optimize treatments.”

To date no direct clinical comparisons have been made between the AviClear and Accure devices.

Dr. Dover reported that he is a consultant for Cutera, the manufacturer for AviClear. He also performs research for the company.





 

PHOENIX – When Jeffrey Dover, MD, addressed audience members gathered for a session on cutting-edge technologies at the annual conference of the American Society for Laser Medicine and Surgery, he reflected on a conversation he had with R. Rox Anderson, MD, almost 40 years ago, about eventually finding a cure for acne.

“Despite the fact that we have over-the-counter therapies, prescription therapies, and all kinds of devices available to treat acne, there are still barriers to care that get in the way of treatment,” said Dr. Dover, director of SkinCare Physicians in Chestnut Hill, Mass. “If we had a device based on innovative light science that could meet the needs of the acne patient to get rid of these barriers, wouldn’t that be something wonderful?”

Dr. Jeffrey Dover

The answer to this question, he said, is now “yes,” because of advances in lasers that target sebaceous glands.

In a seminal paper published in 2012, Fernanda H. Sakamoto, MD, PhD, Dr. Anderson, and colleagues demonstrated the potential for a free electron laser to target sebaceous glands . Following several years of refinement, there are now two 1,726-nm laser devices – the AviClear and the Accure Laser System – cleared by the Food and Drug Administration for the treatment of mild to severe acne, which have “very impressive results,” Dr. Dover said.

“With the 1,726-nm laser, there is some selective absorption in sebum in skin, which beats out absorption in the other chromophores,” he said. “But it’s not a big difference like it is, for example, for pulsed-dye lasers and vascular targets. ... This means that the therapeutic window is relatively small and protecting the rest of the epidermis and dermis is crucial to be able to target these lesions or the sebaceous gland without unnecessary damage. If we can protect the epidermis and heat just the sebaceous glands, we should be able to get Accutane-like results if we get durability [by] shrinking sebaceous glands.”

Effective cooling, whether contact cooling, bulk cooling, or air cooling, is crucial to success, he continued. “It’s got to be robust and highly specific to protect the skin, so you don’t end up with side effects that are worse than the disease.”

The AviClear laser delivers seven 3-mm spots, which takes into account the thermal relaxation times of the sebaceous glands. The algorithm delivers a treatment imprint at roughly 0.3 Hz and a 1.5-mm depth of penetration, and the device relies on contact cooling. In pivotal data submitted to the FDA, 104 individuals with moderate to severe acne received three treatments with the AviClear 1 month apart, with follow-up at 1, 3, 6, and 12 months post treatment. They had no other treatment regimens, and the primary endpoint was the percentage of patients who achieved a 50% reduction in inflammatory lesion count 3 months after the final treatment. The secondary endpoint was an Investigator’s Global Assessment (IGA) improvement of 2 or greater.

Dr. Dover, who helped design the study, said that, at 3 months, 80% of those treated achieved a 50% or greater reduction in inflammatory lesion count (P < .001). As for secondary endpoints, 36% of individuals were assessed as having clear or almost clear skin; 47% achieved a 2-point or greater improvement in IGA score, compared with baseline, and 87% achieved a 1-point or greater improvement in IGA score, compared with baseline. By 6 months, 88% of individuals achieved a 50% or greater reduction in inflammatory lesion count; this improved to 92% by 12 months (P < .001).

“All of these procedures were done with no topical anesthetic, no intralesional anesthetic, and they tolerated these quite well,” he said. “There was no down time that required medical intervention after the treatments. All posttreatment erythema and swelling resolved quickly,” and 75% of the patients were “very satisfied” with the treatments.

The Accure Laser System features a proprietary technology that precisely controls thermal gradient depth. “So instead of guessing whether you are delivering the correct amount of heat, it actually tells you,” said Dr. Dover, a past president of the ASLMS and the American Society for Dermatologic Surgery. “It correlates surface and at-depth temperatures, and there’s an infrared camera for real-time accurate temperature monitoring.” The device features highly controlled air cooling and a pulsing pattern that ensures treatment of sebaceous glands of all sizes and at all depths. The clinical end marker is peak epidermal temperature.

In a study supported by Accure, the manufacturer, researchers evaluated the efficacy of the Accure Laser System in 35 subjects with types I to VI skin, who received four monthly treatments 30-45 minutes each, and were followed 12, 26, 39, and 52 weeks following their last treatment. To date, data out to 52 weeks is available for 17 study participants. According to Dr. Dover, the researchers found 80% clearance at 12 weeks following the last treatment, with continued improvement at 52 weeks. One hundred percent of subjects responded. Side effects included erythema, edema, crusting, blisters, and inflammatory papules. “None of these were medically significant,” he said.

As dermatologists begin to incorporate the AviClear and Accure devices into their practices, Dr. Dover said that he is reminded of the conversation he had some 40 years ago with Dr. Anderson about finding a cure for acne, and he feels a bit awestruck. “These 1,726-nm lasers are effective for treating acne. I personally think they are going to revolutionize the way we treat at least some of our patients with acne. They may both be effective for treating facial acne scars. Time will tell. Further study of both scarring and acne are needed to fully categorize the benefit and to optimize treatments.”

To date no direct clinical comparisons have been made between the AviClear and Accure devices.

Dr. Dover reported that he is a consultant for Cutera, the manufacturer for AviClear. He also performs research for the company.





 

PHOENIX – When Jeffrey Dover, MD, addressed audience members gathered for a session on cutting-edge technologies at the annual conference of the American Society for Laser Medicine and Surgery, he reflected on a conversation he had with R. Rox Anderson, MD, almost 40 years ago, about eventually finding a cure for acne.

“Despite the fact that we have over-the-counter therapies, prescription therapies, and all kinds of devices available to treat acne, there are still barriers to care that get in the way of treatment,” said Dr. Dover, director of SkinCare Physicians in Chestnut Hill, Mass. “If we had a device based on innovative light science that could meet the needs of the acne patient to get rid of these barriers, wouldn’t that be something wonderful?”

Dr. Jeffrey Dover

The answer to this question, he said, is now “yes,” because of advances in lasers that target sebaceous glands.

In a seminal paper published in 2012, Fernanda H. Sakamoto, MD, PhD, Dr. Anderson, and colleagues demonstrated the potential for a free electron laser to target sebaceous glands . Following several years of refinement, there are now two 1,726-nm laser devices – the AviClear and the Accure Laser System – cleared by the Food and Drug Administration for the treatment of mild to severe acne, which have “very impressive results,” Dr. Dover said.

“With the 1,726-nm laser, there is some selective absorption in sebum in skin, which beats out absorption in the other chromophores,” he said. “But it’s not a big difference like it is, for example, for pulsed-dye lasers and vascular targets. ... This means that the therapeutic window is relatively small and protecting the rest of the epidermis and dermis is crucial to be able to target these lesions or the sebaceous gland without unnecessary damage. If we can protect the epidermis and heat just the sebaceous glands, we should be able to get Accutane-like results if we get durability [by] shrinking sebaceous glands.”

Effective cooling, whether contact cooling, bulk cooling, or air cooling, is crucial to success, he continued. “It’s got to be robust and highly specific to protect the skin, so you don’t end up with side effects that are worse than the disease.”

The AviClear laser delivers seven 3-mm spots, which takes into account the thermal relaxation times of the sebaceous glands. The algorithm delivers a treatment imprint at roughly 0.3 Hz and a 1.5-mm depth of penetration, and the device relies on contact cooling. In pivotal data submitted to the FDA, 104 individuals with moderate to severe acne received three treatments with the AviClear 1 month apart, with follow-up at 1, 3, 6, and 12 months post treatment. They had no other treatment regimens, and the primary endpoint was the percentage of patients who achieved a 50% reduction in inflammatory lesion count 3 months after the final treatment. The secondary endpoint was an Investigator’s Global Assessment (IGA) improvement of 2 or greater.

Dr. Dover, who helped design the study, said that, at 3 months, 80% of those treated achieved a 50% or greater reduction in inflammatory lesion count (P < .001). As for secondary endpoints, 36% of individuals were assessed as having clear or almost clear skin; 47% achieved a 2-point or greater improvement in IGA score, compared with baseline, and 87% achieved a 1-point or greater improvement in IGA score, compared with baseline. By 6 months, 88% of individuals achieved a 50% or greater reduction in inflammatory lesion count; this improved to 92% by 12 months (P < .001).

“All of these procedures were done with no topical anesthetic, no intralesional anesthetic, and they tolerated these quite well,” he said. “There was no down time that required medical intervention after the treatments. All posttreatment erythema and swelling resolved quickly,” and 75% of the patients were “very satisfied” with the treatments.

The Accure Laser System features a proprietary technology that precisely controls thermal gradient depth. “So instead of guessing whether you are delivering the correct amount of heat, it actually tells you,” said Dr. Dover, a past president of the ASLMS and the American Society for Dermatologic Surgery. “It correlates surface and at-depth temperatures, and there’s an infrared camera for real-time accurate temperature monitoring.” The device features highly controlled air cooling and a pulsing pattern that ensures treatment of sebaceous glands of all sizes and at all depths. The clinical end marker is peak epidermal temperature.

In a study supported by Accure, the manufacturer, researchers evaluated the efficacy of the Accure Laser System in 35 subjects with types I to VI skin, who received four monthly treatments 30-45 minutes each, and were followed 12, 26, 39, and 52 weeks following their last treatment. To date, data out to 52 weeks is available for 17 study participants. According to Dr. Dover, the researchers found 80% clearance at 12 weeks following the last treatment, with continued improvement at 52 weeks. One hundred percent of subjects responded. Side effects included erythema, edema, crusting, blisters, and inflammatory papules. “None of these were medically significant,” he said.

As dermatologists begin to incorporate the AviClear and Accure devices into their practices, Dr. Dover said that he is reminded of the conversation he had some 40 years ago with Dr. Anderson about finding a cure for acne, and he feels a bit awestruck. “These 1,726-nm lasers are effective for treating acne. I personally think they are going to revolutionize the way we treat at least some of our patients with acne. They may both be effective for treating facial acne scars. Time will tell. Further study of both scarring and acne are needed to fully categorize the benefit and to optimize treatments.”

To date no direct clinical comparisons have been made between the AviClear and Accure devices.

Dr. Dover reported that he is a consultant for Cutera, the manufacturer for AviClear. He also performs research for the company.





 

WASHINGTON – A nonpharmacologic, interdisciplinary program significantly improved chronic pain in children and the quality of life for their families, based on data from 115 individuals.

Up to 40% of children experience chronic pain that affects their physical, psychosocial, and educational functioning, said Jessica Campanile, BA, a medical student at the University of Pennsylvania, Philadelphia, in a presentation at the Pediatric Academic Societies annual meeting.

Although interdisciplinary pediatric pain rehabilitation programs have shown positive outcomes, very few use only nonpharmacologic treatments, said Ms. Campanile. In addition, few studies have explored the effects of a hospital-based program on the patients and their families.

Ms. Campanile and colleagues conducted a retrospective cohort study of participants in an outpatient pain rehabilitation program at the Children’s Hospital of Philadelphia between April 2016 and December 2019. Patients were evaluated by a pediatric rheumatologist, psychologist, and physical and occupational therapists.

Patients engaged in 2-3 hours of physical therapy (PT) and 2-3 hours of occupational therapy (OT) in a 1:1 ratio at least 5 days a week. Physical activities included stepping into and out of a tub, carrying laundry, and desensitizing to allodynia as needed. Participants also received individual and group cognitive-behavior therapy interventions from psychologists, and psychological support during PT and OT sessions if needed. Parents/caregivers were invited to separate individual and group therapy sessions as part of the program. The median age at admission to the program was 15 years, and 79% of the participants were female. Patients participated the program for a median of 17 days, and 87% were outpatients who came to the hospital for the program.

Pain was assessed based on the 0-10 verbal pain intensity scale, energy was assessed on a scale of 0-100, and functional disability was assessed on a scale of 0-60, with higher scores indicating more pain, more energy, and more self-perceived disability, respectively.

Overall, scores on measures of pain, disability, allodynia, and energy improved significantly from baseline to discharge from the program. Verbal pain intensity scores decreased on average from 7 to 5, disability scores decreased from 26 to 9, the proportion of patients reporting allodynia decreased from 86% to 61%, and the energy level score increased from 70 to 77. The trend continued at the first follow-up visit, conducted 2-3 months after discharge from the program. Notably, pain intensity further decreased from a median of 5 at program completion to a median of 2 at the first follow-up, Ms. Campanile said. Improvements in allodynia also were sustained at the first follow-up.

Quality of life measures related to physical, emotional, social, and cognitive function also improved significantly from baseline to completion of the program.

In addition, scores on a quality of life family impact survey improved significantly; in particular, parent health-related quality of life scores (Parent HRQoL) improved from 60 at baseline to 71 at the end of the program on a scale of 0 to 100. The study findings were limited by several factors including the relatively short duration and use of a convenience sample from a retrospective cohort, with data limited to electronic health records, Ms. Campanile said. The study also was not powered to examine differential treatments based on psychiatric conditions, and any psychiatric conditions were based on self-reports.

However, the results support the value of a nonpharmacologic interdisciplinary program as “a robust treatment for youth with chronic idiopathic pain, for both patients and the family unit,” she said.

“This study also supports the need for and benefit of additional counseling for patients and their caregivers prior to and during enrollment in a pain rehabilitation program,” she concluded.
 

Study supports effectiveness of drug-free pain management

“The management of pain in any age group can be challenging, especially with current concerns for opioid dependence and abuse,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Chronic pain affects daily life for all populations, but for children, adolescents, and their families, it can have a long-lasting impact on growth and development, psychosocial and physical well-being,” Dr. Haut said. “Determining and testing nonpharmacologic alternative methods of pain control are extremely important.”

Given the debilitating effects of chronic pain, and the potential side effects and dependence that have been associated with use of pharmacologic modes of pain control, unique and creative solutions have begun to emerge and need further attention and study, she said.

However, “despite published research supporting the use of alternative and complementary approaches to pain control in children and adolescents, nonpharmacologic, collaborative, interprofessional approaches to pain control have not been widely shared in the literature,” she said.

“Barriers to this type of program include first and foremost a potential lack of financial and workforce-related resources,” Dr. Haut said. “Patient and family attendance at frequent health visits, daily or even every other day, may also hinder success, but opportunities for telehealth and family training to learn physical and occupational skills within this type of program may be beginning solutions.”

Additional research should be conducted at multiple children’s hospitals, with a larger number of children and adolescents at varying ages, with pain related to different diagnoses, and with the inclusion of collaborative methodology, said Dr. Haut. “The current study had some limitations, including the small sample size, predominantly female sex, and a short participation time frame utilizing retrospective review. Completing prospective research over a longer time frame can also yield generalizable results applicable to varied populations.”

The study received no outside funding. Ms. Campanile had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose, and serves on the editorial advisory board of Pediatric News.

WASHINGTON – A nonpharmacologic, interdisciplinary program significantly improved chronic pain in children and the quality of life for their families, based on data from 115 individuals.

Up to 40% of children experience chronic pain that affects their physical, psychosocial, and educational functioning, said Jessica Campanile, BA, a medical student at the University of Pennsylvania, Philadelphia, in a presentation at the Pediatric Academic Societies annual meeting.

Although interdisciplinary pediatric pain rehabilitation programs have shown positive outcomes, very few use only nonpharmacologic treatments, said Ms. Campanile. In addition, few studies have explored the effects of a hospital-based program on the patients and their families.

Ms. Campanile and colleagues conducted a retrospective cohort study of participants in an outpatient pain rehabilitation program at the Children’s Hospital of Philadelphia between April 2016 and December 2019. Patients were evaluated by a pediatric rheumatologist, psychologist, and physical and occupational therapists.

Patients engaged in 2-3 hours of physical therapy (PT) and 2-3 hours of occupational therapy (OT) in a 1:1 ratio at least 5 days a week. Physical activities included stepping into and out of a tub, carrying laundry, and desensitizing to allodynia as needed. Participants also received individual and group cognitive-behavior therapy interventions from psychologists, and psychological support during PT and OT sessions if needed. Parents/caregivers were invited to separate individual and group therapy sessions as part of the program. The median age at admission to the program was 15 years, and 79% of the participants were female. Patients participated the program for a median of 17 days, and 87% were outpatients who came to the hospital for the program.

Pain was assessed based on the 0-10 verbal pain intensity scale, energy was assessed on a scale of 0-100, and functional disability was assessed on a scale of 0-60, with higher scores indicating more pain, more energy, and more self-perceived disability, respectively.

Overall, scores on measures of pain, disability, allodynia, and energy improved significantly from baseline to discharge from the program. Verbal pain intensity scores decreased on average from 7 to 5, disability scores decreased from 26 to 9, the proportion of patients reporting allodynia decreased from 86% to 61%, and the energy level score increased from 70 to 77. The trend continued at the first follow-up visit, conducted 2-3 months after discharge from the program. Notably, pain intensity further decreased from a median of 5 at program completion to a median of 2 at the first follow-up, Ms. Campanile said. Improvements in allodynia also were sustained at the first follow-up.

Quality of life measures related to physical, emotional, social, and cognitive function also improved significantly from baseline to completion of the program.

In addition, scores on a quality of life family impact survey improved significantly; in particular, parent health-related quality of life scores (Parent HRQoL) improved from 60 at baseline to 71 at the end of the program on a scale of 0 to 100. The study findings were limited by several factors including the relatively short duration and use of a convenience sample from a retrospective cohort, with data limited to electronic health records, Ms. Campanile said. The study also was not powered to examine differential treatments based on psychiatric conditions, and any psychiatric conditions were based on self-reports.

However, the results support the value of a nonpharmacologic interdisciplinary program as “a robust treatment for youth with chronic idiopathic pain, for both patients and the family unit,” she said.

“This study also supports the need for and benefit of additional counseling for patients and their caregivers prior to and during enrollment in a pain rehabilitation program,” she concluded.
 

Study supports effectiveness of drug-free pain management

“The management of pain in any age group can be challenging, especially with current concerns for opioid dependence and abuse,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Chronic pain affects daily life for all populations, but for children, adolescents, and their families, it can have a long-lasting impact on growth and development, psychosocial and physical well-being,” Dr. Haut said. “Determining and testing nonpharmacologic alternative methods of pain control are extremely important.”

Given the debilitating effects of chronic pain, and the potential side effects and dependence that have been associated with use of pharmacologic modes of pain control, unique and creative solutions have begun to emerge and need further attention and study, she said.

However, “despite published research supporting the use of alternative and complementary approaches to pain control in children and adolescents, nonpharmacologic, collaborative, interprofessional approaches to pain control have not been widely shared in the literature,” she said.

“Barriers to this type of program include first and foremost a potential lack of financial and workforce-related resources,” Dr. Haut said. “Patient and family attendance at frequent health visits, daily or even every other day, may also hinder success, but opportunities for telehealth and family training to learn physical and occupational skills within this type of program may be beginning solutions.”

Additional research should be conducted at multiple children’s hospitals, with a larger number of children and adolescents at varying ages, with pain related to different diagnoses, and with the inclusion of collaborative methodology, said Dr. Haut. “The current study had some limitations, including the small sample size, predominantly female sex, and a short participation time frame utilizing retrospective review. Completing prospective research over a longer time frame can also yield generalizable results applicable to varied populations.”

The study received no outside funding. Ms. Campanile had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose, and serves on the editorial advisory board of Pediatric News.

WASHINGTON – A nonpharmacologic, interdisciplinary program significantly improved chronic pain in children and the quality of life for their families, based on data from 115 individuals.

Up to 40% of children experience chronic pain that affects their physical, psychosocial, and educational functioning, said Jessica Campanile, BA, a medical student at the University of Pennsylvania, Philadelphia, in a presentation at the Pediatric Academic Societies annual meeting.

Although interdisciplinary pediatric pain rehabilitation programs have shown positive outcomes, very few use only nonpharmacologic treatments, said Ms. Campanile. In addition, few studies have explored the effects of a hospital-based program on the patients and their families.

Ms. Campanile and colleagues conducted a retrospective cohort study of participants in an outpatient pain rehabilitation program at the Children’s Hospital of Philadelphia between April 2016 and December 2019. Patients were evaluated by a pediatric rheumatologist, psychologist, and physical and occupational therapists.

Patients engaged in 2-3 hours of physical therapy (PT) and 2-3 hours of occupational therapy (OT) in a 1:1 ratio at least 5 days a week. Physical activities included stepping into and out of a tub, carrying laundry, and desensitizing to allodynia as needed. Participants also received individual and group cognitive-behavior therapy interventions from psychologists, and psychological support during PT and OT sessions if needed. Parents/caregivers were invited to separate individual and group therapy sessions as part of the program. The median age at admission to the program was 15 years, and 79% of the participants were female. Patients participated the program for a median of 17 days, and 87% were outpatients who came to the hospital for the program.

Pain was assessed based on the 0-10 verbal pain intensity scale, energy was assessed on a scale of 0-100, and functional disability was assessed on a scale of 0-60, with higher scores indicating more pain, more energy, and more self-perceived disability, respectively.

Overall, scores on measures of pain, disability, allodynia, and energy improved significantly from baseline to discharge from the program. Verbal pain intensity scores decreased on average from 7 to 5, disability scores decreased from 26 to 9, the proportion of patients reporting allodynia decreased from 86% to 61%, and the energy level score increased from 70 to 77. The trend continued at the first follow-up visit, conducted 2-3 months after discharge from the program. Notably, pain intensity further decreased from a median of 5 at program completion to a median of 2 at the first follow-up, Ms. Campanile said. Improvements in allodynia also were sustained at the first follow-up.

Quality of life measures related to physical, emotional, social, and cognitive function also improved significantly from baseline to completion of the program.

In addition, scores on a quality of life family impact survey improved significantly; in particular, parent health-related quality of life scores (Parent HRQoL) improved from 60 at baseline to 71 at the end of the program on a scale of 0 to 100. The study findings were limited by several factors including the relatively short duration and use of a convenience sample from a retrospective cohort, with data limited to electronic health records, Ms. Campanile said. The study also was not powered to examine differential treatments based on psychiatric conditions, and any psychiatric conditions were based on self-reports.

However, the results support the value of a nonpharmacologic interdisciplinary program as “a robust treatment for youth with chronic idiopathic pain, for both patients and the family unit,” she said.

“This study also supports the need for and benefit of additional counseling for patients and their caregivers prior to and during enrollment in a pain rehabilitation program,” she concluded.
 

Study supports effectiveness of drug-free pain management

“The management of pain in any age group can be challenging, especially with current concerns for opioid dependence and abuse,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Chronic pain affects daily life for all populations, but for children, adolescents, and their families, it can have a long-lasting impact on growth and development, psychosocial and physical well-being,” Dr. Haut said. “Determining and testing nonpharmacologic alternative methods of pain control are extremely important.”

Given the debilitating effects of chronic pain, and the potential side effects and dependence that have been associated with use of pharmacologic modes of pain control, unique and creative solutions have begun to emerge and need further attention and study, she said.

However, “despite published research supporting the use of alternative and complementary approaches to pain control in children and adolescents, nonpharmacologic, collaborative, interprofessional approaches to pain control have not been widely shared in the literature,” she said.

“Barriers to this type of program include first and foremost a potential lack of financial and workforce-related resources,” Dr. Haut said. “Patient and family attendance at frequent health visits, daily or even every other day, may also hinder success, but opportunities for telehealth and family training to learn physical and occupational skills within this type of program may be beginning solutions.”

Additional research should be conducted at multiple children’s hospitals, with a larger number of children and adolescents at varying ages, with pain related to different diagnoses, and with the inclusion of collaborative methodology, said Dr. Haut. “The current study had some limitations, including the small sample size, predominantly female sex, and a short participation time frame utilizing retrospective review. Completing prospective research over a longer time frame can also yield generalizable results applicable to varied populations.”

The study received no outside funding. Ms. Campanile had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose, and serves on the editorial advisory board of Pediatric News.

SEATTLE – Taking sulfonylureas sold as “street Valium” can lead to severe hypoglycemia that may result in emergency department visits, the latest of a handful of case reports suggest.

“Physicians should be aware of this possibility and consider intentional or unintentional sulfonylurea abuse, with or without other drugs,” Amanda McKenna, MD, a first-year endocrinology fellow at the Mayo Clinic, Jacksonville, Fla., and colleagues say in a poster presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.

The new case, seen in Florida, involves a 33-year-old man with a history of narcotic dependence and anxiety but not diabetes. At the time of presentation, the patient was unconscious and diaphoretic. The patient’s blood glucose level was 18 mg/dL. He had purchased two unmarked, light blue pills on the street which he thought were Valiums but turned out to be glyburide.

Sulfonylureas have no potential for abuse, but they physically resemble Valiums and are easier for illicit drug dealers to obtain because they’re not a controlled substance, and they can be sold for considerably more money, Dr. McKenna said in an interview.

“He thought he was getting Valium, but what he really purchased was glyburide. ... When he took it, he developed sweating and weakness. He probably thought he was having a bad trip, but it was really low blood sugar,” she said.
 

Similar cases go back nearly two decades

Similar cases have been reported as far back as 2004 in different parts of the United States. A 2004 article reports five cases in which people in San Francisco were “admitted to the hospital for hypoglycemia as a result of a drug purchased on the streets as a presumed benzodiazepine.”

Two more cases of “glyburide poisoning by ingestion of ‘street Valium,’ ” also from San Francisco, were reported in 2012. And in another case presented at the 2022 Endocrine Society meeting, sulfonylurea had been cut with cocaine, presumably to increase the volume.

The lead author of the 2012 article, Craig Smollin, MD, medical director of the California Poison Control System, San Francisco Division, and professor of emergency medicine at the University of California, San Francisco, told this news organization that his team has seen “a handful of cases over the years” but that “it is hard to say how common it is because hypoglycemia is common in this patient population for a variety of reasons.”
 

Persistent hypoglycemia led to the source

In the current case, paramedics treated the patient with D50W, and his blood glucose level increased from 18 mg/dL to 109 mg/dL. He regained consciousness but then developed recurrent hypoglycemia, and his blood glucose level dropped back to 15 mg/dL in the ED. Urine toxicology results were positive for benzodiazepines, cannabis, and cocaine.

Laboratory results showed elevations in levels of insulin (47.4 mIU/mL), C-peptide (5.4 ng/mL), and glucose (44 mg/dL). He was again treated with D50W, and his blood glucose level returned to normal over 20 hours. Once alert and oriented, he reported no personal or family history of diabetes. A 72-hour fast showed no evidence of insulinoma. A sulfonylurea screen was positive for glyburide. He was discharged home in stable condition. How many more cases have been missed?

Dr. McKenna pointed out that a typical urine toxicology screen for drugs wouldn’t detect a sulfonylurea. “The screen for hypoglycemic agents is a blood test, not a urine screen, so it’s completely different in the workup, and you really have to be thinking about that. It typically takes a while to come back,” she said.

She added that if the hypoglycemia resolves and testing isn’t conducted, the cause of the low blood sugar level might be missed. “If the hypoglycemia doesn’t persist, the [ED] physician wouldn’t consult endocrine. ... Is this happening more than we think?”
 

Ocreotide: A ‘unique antidote’

In their article, Dr. Smollin and colleagues describe the use of ocreotide, a long-acting somatostatin agonist that reverses the insulin-releasing effect of sulfonylureas on pancreatic beta cells, resulting in diminished insulin secretion. Unlike glucose supplementation, ocreotide doesn’t stimulate additional insulin release. It is of longer duration than glucagon, the authors say.

“The management of sulfonylurea overdose includes administration of glucose but also may include the use of octreotide, a unique antidote for sulfonylurea induced hypoglycemia,” Dr. Smollin said.

However, he also cautioned, “there is a broad differential diagnosis for hypoglycemia, and clinicians must consider many alternative diagnoses.”

Dr. McKenna and Dr. Smollin have disclosed no relevant financial relationships.

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

SEATTLE – Taking sulfonylureas sold as “street Valium” can lead to severe hypoglycemia that may result in emergency department visits, the latest of a handful of case reports suggest.

“Physicians should be aware of this possibility and consider intentional or unintentional sulfonylurea abuse, with or without other drugs,” Amanda McKenna, MD, a first-year endocrinology fellow at the Mayo Clinic, Jacksonville, Fla., and colleagues say in a poster presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.

The new case, seen in Florida, involves a 33-year-old man with a history of narcotic dependence and anxiety but not diabetes. At the time of presentation, the patient was unconscious and diaphoretic. The patient’s blood glucose level was 18 mg/dL. He had purchased two unmarked, light blue pills on the street which he thought were Valiums but turned out to be glyburide.

Sulfonylureas have no potential for abuse, but they physically resemble Valiums and are easier for illicit drug dealers to obtain because they’re not a controlled substance, and they can be sold for considerably more money, Dr. McKenna said in an interview.

“He thought he was getting Valium, but what he really purchased was glyburide. ... When he took it, he developed sweating and weakness. He probably thought he was having a bad trip, but it was really low blood sugar,” she said.
 

Similar cases go back nearly two decades

Similar cases have been reported as far back as 2004 in different parts of the United States. A 2004 article reports five cases in which people in San Francisco were “admitted to the hospital for hypoglycemia as a result of a drug purchased on the streets as a presumed benzodiazepine.”

Two more cases of “glyburide poisoning by ingestion of ‘street Valium,’ ” also from San Francisco, were reported in 2012. And in another case presented at the 2022 Endocrine Society meeting, sulfonylurea had been cut with cocaine, presumably to increase the volume.

The lead author of the 2012 article, Craig Smollin, MD, medical director of the California Poison Control System, San Francisco Division, and professor of emergency medicine at the University of California, San Francisco, told this news organization that his team has seen “a handful of cases over the years” but that “it is hard to say how common it is because hypoglycemia is common in this patient population for a variety of reasons.”
 

Persistent hypoglycemia led to the source

In the current case, paramedics treated the patient with D50W, and his blood glucose level increased from 18 mg/dL to 109 mg/dL. He regained consciousness but then developed recurrent hypoglycemia, and his blood glucose level dropped back to 15 mg/dL in the ED. Urine toxicology results were positive for benzodiazepines, cannabis, and cocaine.

Laboratory results showed elevations in levels of insulin (47.4 mIU/mL), C-peptide (5.4 ng/mL), and glucose (44 mg/dL). He was again treated with D50W, and his blood glucose level returned to normal over 20 hours. Once alert and oriented, he reported no personal or family history of diabetes. A 72-hour fast showed no evidence of insulinoma. A sulfonylurea screen was positive for glyburide. He was discharged home in stable condition. How many more cases have been missed?

Dr. McKenna pointed out that a typical urine toxicology screen for drugs wouldn’t detect a sulfonylurea. “The screen for hypoglycemic agents is a blood test, not a urine screen, so it’s completely different in the workup, and you really have to be thinking about that. It typically takes a while to come back,” she said.

She added that if the hypoglycemia resolves and testing isn’t conducted, the cause of the low blood sugar level might be missed. “If the hypoglycemia doesn’t persist, the [ED] physician wouldn’t consult endocrine. ... Is this happening more than we think?”
 

Ocreotide: A ‘unique antidote’

In their article, Dr. Smollin and colleagues describe the use of ocreotide, a long-acting somatostatin agonist that reverses the insulin-releasing effect of sulfonylureas on pancreatic beta cells, resulting in diminished insulin secretion. Unlike glucose supplementation, ocreotide doesn’t stimulate additional insulin release. It is of longer duration than glucagon, the authors say.

“The management of sulfonylurea overdose includes administration of glucose but also may include the use of octreotide, a unique antidote for sulfonylurea induced hypoglycemia,” Dr. Smollin said.

However, he also cautioned, “there is a broad differential diagnosis for hypoglycemia, and clinicians must consider many alternative diagnoses.”

Dr. McKenna and Dr. Smollin have disclosed no relevant financial relationships.

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

SEATTLE – Taking sulfonylureas sold as “street Valium” can lead to severe hypoglycemia that may result in emergency department visits, the latest of a handful of case reports suggest.

“Physicians should be aware of this possibility and consider intentional or unintentional sulfonylurea abuse, with or without other drugs,” Amanda McKenna, MD, a first-year endocrinology fellow at the Mayo Clinic, Jacksonville, Fla., and colleagues say in a poster presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.

The new case, seen in Florida, involves a 33-year-old man with a history of narcotic dependence and anxiety but not diabetes. At the time of presentation, the patient was unconscious and diaphoretic. The patient’s blood glucose level was 18 mg/dL. He had purchased two unmarked, light blue pills on the street which he thought were Valiums but turned out to be glyburide.

Sulfonylureas have no potential for abuse, but they physically resemble Valiums and are easier for illicit drug dealers to obtain because they’re not a controlled substance, and they can be sold for considerably more money, Dr. McKenna said in an interview.

“He thought he was getting Valium, but what he really purchased was glyburide. ... When he took it, he developed sweating and weakness. He probably thought he was having a bad trip, but it was really low blood sugar,” she said.
 

Similar cases go back nearly two decades

Similar cases have been reported as far back as 2004 in different parts of the United States. A 2004 article reports five cases in which people in San Francisco were “admitted to the hospital for hypoglycemia as a result of a drug purchased on the streets as a presumed benzodiazepine.”

Two more cases of “glyburide poisoning by ingestion of ‘street Valium,’ ” also from San Francisco, were reported in 2012. And in another case presented at the 2022 Endocrine Society meeting, sulfonylurea had been cut with cocaine, presumably to increase the volume.

The lead author of the 2012 article, Craig Smollin, MD, medical director of the California Poison Control System, San Francisco Division, and professor of emergency medicine at the University of California, San Francisco, told this news organization that his team has seen “a handful of cases over the years” but that “it is hard to say how common it is because hypoglycemia is common in this patient population for a variety of reasons.”
 

Persistent hypoglycemia led to the source

In the current case, paramedics treated the patient with D50W, and his blood glucose level increased from 18 mg/dL to 109 mg/dL. He regained consciousness but then developed recurrent hypoglycemia, and his blood glucose level dropped back to 15 mg/dL in the ED. Urine toxicology results were positive for benzodiazepines, cannabis, and cocaine.

Laboratory results showed elevations in levels of insulin (47.4 mIU/mL), C-peptide (5.4 ng/mL), and glucose (44 mg/dL). He was again treated with D50W, and his blood glucose level returned to normal over 20 hours. Once alert and oriented, he reported no personal or family history of diabetes. A 72-hour fast showed no evidence of insulinoma. A sulfonylurea screen was positive for glyburide. He was discharged home in stable condition. How many more cases have been missed?

Dr. McKenna pointed out that a typical urine toxicology screen for drugs wouldn’t detect a sulfonylurea. “The screen for hypoglycemic agents is a blood test, not a urine screen, so it’s completely different in the workup, and you really have to be thinking about that. It typically takes a while to come back,” she said.

She added that if the hypoglycemia resolves and testing isn’t conducted, the cause of the low blood sugar level might be missed. “If the hypoglycemia doesn’t persist, the [ED] physician wouldn’t consult endocrine. ... Is this happening more than we think?”
 

Ocreotide: A ‘unique antidote’

In their article, Dr. Smollin and colleagues describe the use of ocreotide, a long-acting somatostatin agonist that reverses the insulin-releasing effect of sulfonylureas on pancreatic beta cells, resulting in diminished insulin secretion. Unlike glucose supplementation, ocreotide doesn’t stimulate additional insulin release. It is of longer duration than glucagon, the authors say.

“The management of sulfonylurea overdose includes administration of glucose but also may include the use of octreotide, a unique antidote for sulfonylurea induced hypoglycemia,” Dr. Smollin said.

However, he also cautioned, “there is a broad differential diagnosis for hypoglycemia, and clinicians must consider many alternative diagnoses.”

Dr. McKenna and Dr. Smollin have disclosed no relevant financial relationships.

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

WASHINGTON – Congenital diaphragmatic hernia affects many areas of pediatrics. In a trio of posters presented at the Pediatric Academic Societies annual meeting, researchers at Children’s Hospital of Philadelphia addressed initial ventilation and infant outcomes in the neonatal intensive care unit, prenatal brain immaturity and later cognitive development, and antibiotic use.

Initial ventilation mode shows little impact on NICU outcomes

In one study, K. Taylor Wild, MD, and colleagues investigated whether high-frequency oscillatory ventilation (HFOV) as an initial mode of ventilation in the delivery room improved gas exchange and neonatal ICU (NICU) outcomes in infants with congenital diaphragmatic hernia (CDH), compared with conventional mechanical ventilation (CMV). In 2019, HFOV became standard practice at CHOP.

The researchers reviewed data on infants with severe CDH who were born at CHOP between 2014 and 2022. Of these, 75 were placed on HFOV and 114 on CMV. The mean gestational age at birth in both groups was approximately 38 weeks, and the mean birth weight was approximately 3 kg.

Compared with CMV, use of HFOV in the delivery room was associated with significantly higher pH (7.05 vs. 7.16, P = .03) and significantly lower CO₂ (85.2 vs. 64.5, P = .005). However, after adjusting for CDH severity, no significant differences appeared in length of stay and overall survival to discharge. The higher rates of extracorporeal membrane oxygenation (ECMO) use in the HFOV group, compared with the CMV group (48% vs. 29.9%), may reflect more severe disease, the researchers noted.
 

Prenatal brain immaturity associates with developmental delay

In a second study, Sandy Johng, MD, and colleagues found a significant association between prenatal brain immaturity in babies with CDH and developmental scores at age 12 months and older. The researchers reviewed data from a single-center patient registry for 48 infants for whom prenatal neuroimaging results were available. Based on the imaging, a fetal Total Maturation Score (fTMS) was generated and used as a measure of prenatal brain immaturity.

Results from the Bayley Scales of Infant Development-III (BSID-III) – a composite of cognitive, motor, and language scores – were available for 26 neonates at ages 12 months and under as well as at 12 months and older.

In a linear regression model, the researchers found a significant association between difference in fTMS and BSID-III composite language scores in infants 12 months and older. After adjusting for ECMO treatment, an increase in fTMS of one unit was associated with a 6.5-point increase in language scores at age 12 months and older (P < .01). No significant differences were observed between fTMS difference and language scores in infants under 12 months, or in cognitive or motor scores at any age, the researchers noted. The findings were limited by the small sample size, but the study is the first to show an association between prenatal imaging and neurodevelopmental outcomes for infants with CDH. Results suggest that the risk for neurodevelopmental impairment in this population may start in utero, the researchers concluded.
 

Antibiotic use stays stable

In a third study, Sabrina Flohr, MPH, and colleagues reviewed antibiotic use among infants with CDH who are at increased risk for infection. In many cases, distinguishing between infection and inherent clinical illness is challenging and may lead to unnecessarily high rates of antibiotic use, the researchers noted.

They reviewed data from 381 infants with CDH born at CHOP between January 2013 and November 2022 who were treated and survived in the NICU. Overall, 97.1% of the newborns received antibiotics for a median of 13 days. Nearly two-thirds (63.5%) received antibiotics in the first 72 hours, and 98.1% received them after 72 hours. Ampicillin and gentamicin were the antibiotics used most often in the first 72 hours (approximately 50% for both). After 72 hours, the most commonly used antibiotics were cefazolin (91.6%), vancomycin (67.7%), and cefepime (65.7%).

The results show that antibiotic use among newborns with CDH did not change significantly over time, and the choices of later antibiotics likely reflect perioperative prophylaxis and broad-spectrum treatment, the researchers noted.
 

Studies show larger trends

“These are three interesting studies regarding congenital diaphragmatic hernia from a center that does a high volume of repairs,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“Each individual case can be consuming, but it is important to look for an aggregate of cases to see the larger trends in practices and outcomes,” said Dr. Joos, who was not involved in any of the studies.

The findings of the ventilation study surprised Dr. Joos. “Although high-frequency oscillatory ventilation improves initial gas exchange in the delivery room, compared with conventional mechanical ventilation, it was not associated with any larger NICU outcome,” he said. “This surprised me because my intuition would be that the HFOV would lead to less barotrauma and therefore better outcomes with the underformed lungs associated with this disorder.”

The imaging study demonstrates the need for more research on the association between CDH and neurologic outcomes, said Dr. Joos.

“Prenatal neuroimaging that shows delayed maturation with congenital diaphragmatic hernia correlates with lower language scores in early childhood, and suggests that this may be a predictor of neurologic outcome independent of the postnatal course,” he said.

Data from the antibiotics study reflect current trends, said Dr. Joos. “Antibiotics use is extremely common during the postnatal course of CDH and surgical repair,” he said. “The choice of antibiotics mirrors what we see in other neonatal conditions with regard to treatment for possible early neonatal sepsis, postsurgical prophylaxis, and later broad-spectrum empiric coverage,” he noted.

“I look forward to more studies to come out of large-volume centers like CHOP or aggregated results from many centers to help figure out best practices for this rare but very complicated and often devastating malformation,” he said.

The three posters received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but he serves on the Editorial Advisory Board of Pediatric News.

WASHINGTON – Congenital diaphragmatic hernia affects many areas of pediatrics. In a trio of posters presented at the Pediatric Academic Societies annual meeting, researchers at Children’s Hospital of Philadelphia addressed initial ventilation and infant outcomes in the neonatal intensive care unit, prenatal brain immaturity and later cognitive development, and antibiotic use.

Initial ventilation mode shows little impact on NICU outcomes

In one study, K. Taylor Wild, MD, and colleagues investigated whether high-frequency oscillatory ventilation (HFOV) as an initial mode of ventilation in the delivery room improved gas exchange and neonatal ICU (NICU) outcomes in infants with congenital diaphragmatic hernia (CDH), compared with conventional mechanical ventilation (CMV). In 2019, HFOV became standard practice at CHOP.

The researchers reviewed data on infants with severe CDH who were born at CHOP between 2014 and 2022. Of these, 75 were placed on HFOV and 114 on CMV. The mean gestational age at birth in both groups was approximately 38 weeks, and the mean birth weight was approximately 3 kg.

Compared with CMV, use of HFOV in the delivery room was associated with significantly higher pH (7.05 vs. 7.16, P = .03) and significantly lower CO₂ (85.2 vs. 64.5, P = .005). However, after adjusting for CDH severity, no significant differences appeared in length of stay and overall survival to discharge. The higher rates of extracorporeal membrane oxygenation (ECMO) use in the HFOV group, compared with the CMV group (48% vs. 29.9%), may reflect more severe disease, the researchers noted.
 

Prenatal brain immaturity associates with developmental delay

In a second study, Sandy Johng, MD, and colleagues found a significant association between prenatal brain immaturity in babies with CDH and developmental scores at age 12 months and older. The researchers reviewed data from a single-center patient registry for 48 infants for whom prenatal neuroimaging results were available. Based on the imaging, a fetal Total Maturation Score (fTMS) was generated and used as a measure of prenatal brain immaturity.

Results from the Bayley Scales of Infant Development-III (BSID-III) – a composite of cognitive, motor, and language scores – were available for 26 neonates at ages 12 months and under as well as at 12 months and older.

In a linear regression model, the researchers found a significant association between difference in fTMS and BSID-III composite language scores in infants 12 months and older. After adjusting for ECMO treatment, an increase in fTMS of one unit was associated with a 6.5-point increase in language scores at age 12 months and older (P < .01). No significant differences were observed between fTMS difference and language scores in infants under 12 months, or in cognitive or motor scores at any age, the researchers noted. The findings were limited by the small sample size, but the study is the first to show an association between prenatal imaging and neurodevelopmental outcomes for infants with CDH. Results suggest that the risk for neurodevelopmental impairment in this population may start in utero, the researchers concluded.
 

Antibiotic use stays stable

In a third study, Sabrina Flohr, MPH, and colleagues reviewed antibiotic use among infants with CDH who are at increased risk for infection. In many cases, distinguishing between infection and inherent clinical illness is challenging and may lead to unnecessarily high rates of antibiotic use, the researchers noted.

They reviewed data from 381 infants with CDH born at CHOP between January 2013 and November 2022 who were treated and survived in the NICU. Overall, 97.1% of the newborns received antibiotics for a median of 13 days. Nearly two-thirds (63.5%) received antibiotics in the first 72 hours, and 98.1% received them after 72 hours. Ampicillin and gentamicin were the antibiotics used most often in the first 72 hours (approximately 50% for both). After 72 hours, the most commonly used antibiotics were cefazolin (91.6%), vancomycin (67.7%), and cefepime (65.7%).

The results show that antibiotic use among newborns with CDH did not change significantly over time, and the choices of later antibiotics likely reflect perioperative prophylaxis and broad-spectrum treatment, the researchers noted.
 

Studies show larger trends

“These are three interesting studies regarding congenital diaphragmatic hernia from a center that does a high volume of repairs,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“Each individual case can be consuming, but it is important to look for an aggregate of cases to see the larger trends in practices and outcomes,” said Dr. Joos, who was not involved in any of the studies.

The findings of the ventilation study surprised Dr. Joos. “Although high-frequency oscillatory ventilation improves initial gas exchange in the delivery room, compared with conventional mechanical ventilation, it was not associated with any larger NICU outcome,” he said. “This surprised me because my intuition would be that the HFOV would lead to less barotrauma and therefore better outcomes with the underformed lungs associated with this disorder.”

The imaging study demonstrates the need for more research on the association between CDH and neurologic outcomes, said Dr. Joos.

“Prenatal neuroimaging that shows delayed maturation with congenital diaphragmatic hernia correlates with lower language scores in early childhood, and suggests that this may be a predictor of neurologic outcome independent of the postnatal course,” he said.

Data from the antibiotics study reflect current trends, said Dr. Joos. “Antibiotics use is extremely common during the postnatal course of CDH and surgical repair,” he said. “The choice of antibiotics mirrors what we see in other neonatal conditions with regard to treatment for possible early neonatal sepsis, postsurgical prophylaxis, and later broad-spectrum empiric coverage,” he noted.

“I look forward to more studies to come out of large-volume centers like CHOP or aggregated results from many centers to help figure out best practices for this rare but very complicated and often devastating malformation,” he said.

The three posters received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but he serves on the Editorial Advisory Board of Pediatric News.

WASHINGTON – Congenital diaphragmatic hernia affects many areas of pediatrics. In a trio of posters presented at the Pediatric Academic Societies annual meeting, researchers at Children’s Hospital of Philadelphia addressed initial ventilation and infant outcomes in the neonatal intensive care unit, prenatal brain immaturity and later cognitive development, and antibiotic use.

Initial ventilation mode shows little impact on NICU outcomes

In one study, K. Taylor Wild, MD, and colleagues investigated whether high-frequency oscillatory ventilation (HFOV) as an initial mode of ventilation in the delivery room improved gas exchange and neonatal ICU (NICU) outcomes in infants with congenital diaphragmatic hernia (CDH), compared with conventional mechanical ventilation (CMV). In 2019, HFOV became standard practice at CHOP.

The researchers reviewed data on infants with severe CDH who were born at CHOP between 2014 and 2022. Of these, 75 were placed on HFOV and 114 on CMV. The mean gestational age at birth in both groups was approximately 38 weeks, and the mean birth weight was approximately 3 kg.

Compared with CMV, use of HFOV in the delivery room was associated with significantly higher pH (7.05 vs. 7.16, P = .03) and significantly lower CO₂ (85.2 vs. 64.5, P = .005). However, after adjusting for CDH severity, no significant differences appeared in length of stay and overall survival to discharge. The higher rates of extracorporeal membrane oxygenation (ECMO) use in the HFOV group, compared with the CMV group (48% vs. 29.9%), may reflect more severe disease, the researchers noted.
 

Prenatal brain immaturity associates with developmental delay

In a second study, Sandy Johng, MD, and colleagues found a significant association between prenatal brain immaturity in babies with CDH and developmental scores at age 12 months and older. The researchers reviewed data from a single-center patient registry for 48 infants for whom prenatal neuroimaging results were available. Based on the imaging, a fetal Total Maturation Score (fTMS) was generated and used as a measure of prenatal brain immaturity.

Results from the Bayley Scales of Infant Development-III (BSID-III) – a composite of cognitive, motor, and language scores – were available for 26 neonates at ages 12 months and under as well as at 12 months and older.

In a linear regression model, the researchers found a significant association between difference in fTMS and BSID-III composite language scores in infants 12 months and older. After adjusting for ECMO treatment, an increase in fTMS of one unit was associated with a 6.5-point increase in language scores at age 12 months and older (P < .01). No significant differences were observed between fTMS difference and language scores in infants under 12 months, or in cognitive or motor scores at any age, the researchers noted. The findings were limited by the small sample size, but the study is the first to show an association between prenatal imaging and neurodevelopmental outcomes for infants with CDH. Results suggest that the risk for neurodevelopmental impairment in this population may start in utero, the researchers concluded.
 

Antibiotic use stays stable

In a third study, Sabrina Flohr, MPH, and colleagues reviewed antibiotic use among infants with CDH who are at increased risk for infection. In many cases, distinguishing between infection and inherent clinical illness is challenging and may lead to unnecessarily high rates of antibiotic use, the researchers noted.

They reviewed data from 381 infants with CDH born at CHOP between January 2013 and November 2022 who were treated and survived in the NICU. Overall, 97.1% of the newborns received antibiotics for a median of 13 days. Nearly two-thirds (63.5%) received antibiotics in the first 72 hours, and 98.1% received them after 72 hours. Ampicillin and gentamicin were the antibiotics used most often in the first 72 hours (approximately 50% for both). After 72 hours, the most commonly used antibiotics were cefazolin (91.6%), vancomycin (67.7%), and cefepime (65.7%).

The results show that antibiotic use among newborns with CDH did not change significantly over time, and the choices of later antibiotics likely reflect perioperative prophylaxis and broad-spectrum treatment, the researchers noted.
 

Studies show larger trends

“These are three interesting studies regarding congenital diaphragmatic hernia from a center that does a high volume of repairs,” said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.

“Each individual case can be consuming, but it is important to look for an aggregate of cases to see the larger trends in practices and outcomes,” said Dr. Joos, who was not involved in any of the studies.

The findings of the ventilation study surprised Dr. Joos. “Although high-frequency oscillatory ventilation improves initial gas exchange in the delivery room, compared with conventional mechanical ventilation, it was not associated with any larger NICU outcome,” he said. “This surprised me because my intuition would be that the HFOV would lead to less barotrauma and therefore better outcomes with the underformed lungs associated with this disorder.”

The imaging study demonstrates the need for more research on the association between CDH and neurologic outcomes, said Dr. Joos.

“Prenatal neuroimaging that shows delayed maturation with congenital diaphragmatic hernia correlates with lower language scores in early childhood, and suggests that this may be a predictor of neurologic outcome independent of the postnatal course,” he said.

Data from the antibiotics study reflect current trends, said Dr. Joos. “Antibiotics use is extremely common during the postnatal course of CDH and surgical repair,” he said. “The choice of antibiotics mirrors what we see in other neonatal conditions with regard to treatment for possible early neonatal sepsis, postsurgical prophylaxis, and later broad-spectrum empiric coverage,” he noted.

“I look forward to more studies to come out of large-volume centers like CHOP or aggregated results from many centers to help figure out best practices for this rare but very complicated and often devastating malformation,” he said.

The three posters received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose, but he serves on the Editorial Advisory Board of Pediatric News.