Are you interested in vascular surgery? Consider applying for a travel scholarship that will help defray costs of attending the 2020 Vascular Annual Meeting June 17 to 20 in Toronto, Canada. The Society for Vascular Surgery offers travel scholarships for medical students or general surgery residents. The Vascular Annual Meeting – June 17 to 20 – includes a dedicated resident/student educational and networking program that will include a mock interview session, mentor program, residency fair and more. Learn more.

Are you interested in vascular surgery? Consider applying for a travel scholarship that will help defray costs of attending the 2020 Vascular Annual Meeting June 17 to 20 in Toronto, Canada. The Society for Vascular Surgery offers travel scholarships for medical students or general surgery residents. The Vascular Annual Meeting – June 17 to 20 – includes a dedicated resident/student educational and networking program that will include a mock interview session, mentor program, residency fair and more. Learn more.

Are you interested in vascular surgery? Consider applying for a travel scholarship that will help defray costs of attending the 2020 Vascular Annual Meeting June 17 to 20 in Toronto, Canada. The Society for Vascular Surgery offers travel scholarships for medical students or general surgery residents. The Vascular Annual Meeting – June 17 to 20 – includes a dedicated resident/student educational and networking program that will include a mock interview session, mentor program, residency fair and more. Learn more.

ORLANDO – Oral arginine supplementation significantly increased plasma arginine levels and improved acute pain-related outcomes in Nigerian children with sickle cell disease in a randomized, placebo-controlled, phase 2 trial.

Andrew Bowser/MDedge News

Of 68 children with a mean age of 10 years who were hospitalized with vaso-occlusive crisis involving severe pain and treated with standard pain management, 35 were randomized to receive adjuvant oral L-arginine at a dose of 100 mg/kg every 8 hours for 5 days or until discharge, and 33 received placebo. Those in the arginine arm experienced a 125% increase in their plasma arginine level, compared with a 29% increase in the placebo arm, Richard Onalo, FC Paed, reported during a press briefing at the annual meeting of the American Society of Hematology.

“This was statistically significant,” Dr. Onalo, of the department of pediatrics at the University of Abuja, Nigeria, said of the difference between the two arms. “Also, the global bioavailability ratio increased by 59% in the arginine arm.”

Low plasma arginine levels are associated with acute pain requiring hospitalization in Nigerian children with sickle cell disease, and have also been shown in a prior study in the United States to predict pediatric vaso-occlusion, Dr. Onalo said, adding that arginine supplementation, which has known opioid-sparing effects, was found in another phase 2, randomized, placebo-controlled U.S. study to significantly decrease pain scores.

In the current study, the increase in arginine bioavailability inversely correlated with Medication Quantification Scale scores, which were 73 vs. 120 in the arginine and placebo arms, respectively (r = -0.35; P = .02), indicating reduced analgesic use in the arginine arm, he said.

“Clinically, the patients in the arginine arm also tended to have a faster resolution in their pain score,” he said.

Despite similar baseline Numerical Pain Scale (PS) scores (8.7 and 8.4 on a 0-10 scale), day 5 pain scores were 1.2 vs. 2.0, and the mean daily rate of decline was 1.5 vs. 1.1 cm/day.

Crisis resolution was achieved by 25% of the patients in the arginine arm in about 72 hours, compared with about 120 hours in the placebo arms.

“By day 5, 54% of patients on arginine were already home, as compared with just 24% in the placebo arm, and this was found to be clinically and statistically significant,” Dr. Onalo said, noting that mean hospital length of stay was 110 hours vs. 156 hours in the arginine and placebo arms, respectively.

A non–statistically significant decrease in mean total opioid dose was also observed in the arginine vs. placebo arms (3.8 vs 5.1 mg/kg; P = .11).

Arginine supplementation in this study was safe; no serious treatment-related adverse events occurred, and there were no significant differences between the groups in the incidence of adverse events. Dr. Onalo noted, however, that a trend toward more vomiting was observed in the arginine versus the placebo arm (20% vs. 3%, P = .07).

Severe vaso-occlusive pain episodes are a major cause of morbidity and mortality in sickle cell disease, and based on the prior findings – and the lack of data regarding the role of arginine for treating acute sickle cell-related vaso-occlusive pain episodes in sub-Saharan Africa – Dr. Onalo and colleagues set out to assess its role in that setting.

“Also, we are interested in finding a molecule that can be used easily by the patient at home, and also can be [self-administered],” he said.

Children enrolled in the double-blind study had a severe vaso-occlusive pain episode, defined by a PS score of at least 7 on a scale of 0-10, at one of two major hospitals in Abuja, Nigeria. All patients received pain management, including opioid and nonopioid analgesics, per institutional practice.

The findings reinforce the role of arginine in vaso-occlusive pain episodes, and suggest that oral arginine is a promising adjuvant therapy for vaso-occlusive crisis management in patients with sickle cell disease, he said.

“We recommend a phase 3 multicenter clinical trial,” he added.

As for a potential role for arginine in this setting in the United States, prevention trials in the U.S. have thus far been negative, said Julie Panepinto, MD, the press briefing moderator and a pediatric hematologist-oncologist at Children’s Hospital of Wisconsin, Milwaukee.

Sharon Worcester/MDedge News

“This is my first knowledge of use in the acute setting,” said Dr. Panepinto, also a professor at the Medical College of Wisconsin in Milwaukee. “There is going to be some future work looking at use of arginine in the U.S. for patients presenting with pain.”

For now, however, it’s too early to say that all patients should be started on arginine, she said, adding that more information is needed, including about appropriate dosing.

Nonetheless, it’s encouraging to see positive findings, she noted.

“We’ve been looking at and thinking about arginine for a long time, so I think this is a really exciting study ... that should lead us to future work to really understand better how to use the medication,” she said.

Dr. Onalo reported having no disclosures. Dr. Panepinto has received research funding from the National Institutes of Health and the Health Resources and Services Administration.

[email protected]

SOURCE: Onalo R et al. ASH 2019, Abstract 613.

ORLANDO – Oral arginine supplementation significantly increased plasma arginine levels and improved acute pain-related outcomes in Nigerian children with sickle cell disease in a randomized, placebo-controlled, phase 2 trial.

Andrew Bowser/MDedge News

Of 68 children with a mean age of 10 years who were hospitalized with vaso-occlusive crisis involving severe pain and treated with standard pain management, 35 were randomized to receive adjuvant oral L-arginine at a dose of 100 mg/kg every 8 hours for 5 days or until discharge, and 33 received placebo. Those in the arginine arm experienced a 125% increase in their plasma arginine level, compared with a 29% increase in the placebo arm, Richard Onalo, FC Paed, reported during a press briefing at the annual meeting of the American Society of Hematology.

“This was statistically significant,” Dr. Onalo, of the department of pediatrics at the University of Abuja, Nigeria, said of the difference between the two arms. “Also, the global bioavailability ratio increased by 59% in the arginine arm.”

Low plasma arginine levels are associated with acute pain requiring hospitalization in Nigerian children with sickle cell disease, and have also been shown in a prior study in the United States to predict pediatric vaso-occlusion, Dr. Onalo said, adding that arginine supplementation, which has known opioid-sparing effects, was found in another phase 2, randomized, placebo-controlled U.S. study to significantly decrease pain scores.

In the current study, the increase in arginine bioavailability inversely correlated with Medication Quantification Scale scores, which were 73 vs. 120 in the arginine and placebo arms, respectively (r = -0.35; P = .02), indicating reduced analgesic use in the arginine arm, he said.

“Clinically, the patients in the arginine arm also tended to have a faster resolution in their pain score,” he said.

Despite similar baseline Numerical Pain Scale (PS) scores (8.7 and 8.4 on a 0-10 scale), day 5 pain scores were 1.2 vs. 2.0, and the mean daily rate of decline was 1.5 vs. 1.1 cm/day.

Crisis resolution was achieved by 25% of the patients in the arginine arm in about 72 hours, compared with about 120 hours in the placebo arms.

“By day 5, 54% of patients on arginine were already home, as compared with just 24% in the placebo arm, and this was found to be clinically and statistically significant,” Dr. Onalo said, noting that mean hospital length of stay was 110 hours vs. 156 hours in the arginine and placebo arms, respectively.

A non–statistically significant decrease in mean total opioid dose was also observed in the arginine vs. placebo arms (3.8 vs 5.1 mg/kg; P = .11).

Arginine supplementation in this study was safe; no serious treatment-related adverse events occurred, and there were no significant differences between the groups in the incidence of adverse events. Dr. Onalo noted, however, that a trend toward more vomiting was observed in the arginine versus the placebo arm (20% vs. 3%, P = .07).

Severe vaso-occlusive pain episodes are a major cause of morbidity and mortality in sickle cell disease, and based on the prior findings – and the lack of data regarding the role of arginine for treating acute sickle cell-related vaso-occlusive pain episodes in sub-Saharan Africa – Dr. Onalo and colleagues set out to assess its role in that setting.

“Also, we are interested in finding a molecule that can be used easily by the patient at home, and also can be [self-administered],” he said.

Children enrolled in the double-blind study had a severe vaso-occlusive pain episode, defined by a PS score of at least 7 on a scale of 0-10, at one of two major hospitals in Abuja, Nigeria. All patients received pain management, including opioid and nonopioid analgesics, per institutional practice.

The findings reinforce the role of arginine in vaso-occlusive pain episodes, and suggest that oral arginine is a promising adjuvant therapy for vaso-occlusive crisis management in patients with sickle cell disease, he said.

“We recommend a phase 3 multicenter clinical trial,” he added.

As for a potential role for arginine in this setting in the United States, prevention trials in the U.S. have thus far been negative, said Julie Panepinto, MD, the press briefing moderator and a pediatric hematologist-oncologist at Children’s Hospital of Wisconsin, Milwaukee.

Sharon Worcester/MDedge News

“This is my first knowledge of use in the acute setting,” said Dr. Panepinto, also a professor at the Medical College of Wisconsin in Milwaukee. “There is going to be some future work looking at use of arginine in the U.S. for patients presenting with pain.”

For now, however, it’s too early to say that all patients should be started on arginine, she said, adding that more information is needed, including about appropriate dosing.

Nonetheless, it’s encouraging to see positive findings, she noted.

“We’ve been looking at and thinking about arginine for a long time, so I think this is a really exciting study ... that should lead us to future work to really understand better how to use the medication,” she said.

Dr. Onalo reported having no disclosures. Dr. Panepinto has received research funding from the National Institutes of Health and the Health Resources and Services Administration.

[email protected]

SOURCE: Onalo R et al. ASH 2019, Abstract 613.

ORLANDO – Oral arginine supplementation significantly increased plasma arginine levels and improved acute pain-related outcomes in Nigerian children with sickle cell disease in a randomized, placebo-controlled, phase 2 trial.

Andrew Bowser/MDedge News

Of 68 children with a mean age of 10 years who were hospitalized with vaso-occlusive crisis involving severe pain and treated with standard pain management, 35 were randomized to receive adjuvant oral L-arginine at a dose of 100 mg/kg every 8 hours for 5 days or until discharge, and 33 received placebo. Those in the arginine arm experienced a 125% increase in their plasma arginine level, compared with a 29% increase in the placebo arm, Richard Onalo, FC Paed, reported during a press briefing at the annual meeting of the American Society of Hematology.

“This was statistically significant,” Dr. Onalo, of the department of pediatrics at the University of Abuja, Nigeria, said of the difference between the two arms. “Also, the global bioavailability ratio increased by 59% in the arginine arm.”

Low plasma arginine levels are associated with acute pain requiring hospitalization in Nigerian children with sickle cell disease, and have also been shown in a prior study in the United States to predict pediatric vaso-occlusion, Dr. Onalo said, adding that arginine supplementation, which has known opioid-sparing effects, was found in another phase 2, randomized, placebo-controlled U.S. study to significantly decrease pain scores.

In the current study, the increase in arginine bioavailability inversely correlated with Medication Quantification Scale scores, which were 73 vs. 120 in the arginine and placebo arms, respectively (r = -0.35; P = .02), indicating reduced analgesic use in the arginine arm, he said.

“Clinically, the patients in the arginine arm also tended to have a faster resolution in their pain score,” he said.

Despite similar baseline Numerical Pain Scale (PS) scores (8.7 and 8.4 on a 0-10 scale), day 5 pain scores were 1.2 vs. 2.0, and the mean daily rate of decline was 1.5 vs. 1.1 cm/day.

Crisis resolution was achieved by 25% of the patients in the arginine arm in about 72 hours, compared with about 120 hours in the placebo arms.

“By day 5, 54% of patients on arginine were already home, as compared with just 24% in the placebo arm, and this was found to be clinically and statistically significant,” Dr. Onalo said, noting that mean hospital length of stay was 110 hours vs. 156 hours in the arginine and placebo arms, respectively.

A non–statistically significant decrease in mean total opioid dose was also observed in the arginine vs. placebo arms (3.8 vs 5.1 mg/kg; P = .11).

Arginine supplementation in this study was safe; no serious treatment-related adverse events occurred, and there were no significant differences between the groups in the incidence of adverse events. Dr. Onalo noted, however, that a trend toward more vomiting was observed in the arginine versus the placebo arm (20% vs. 3%, P = .07).

Severe vaso-occlusive pain episodes are a major cause of morbidity and mortality in sickle cell disease, and based on the prior findings – and the lack of data regarding the role of arginine for treating acute sickle cell-related vaso-occlusive pain episodes in sub-Saharan Africa – Dr. Onalo and colleagues set out to assess its role in that setting.

“Also, we are interested in finding a molecule that can be used easily by the patient at home, and also can be [self-administered],” he said.

Children enrolled in the double-blind study had a severe vaso-occlusive pain episode, defined by a PS score of at least 7 on a scale of 0-10, at one of two major hospitals in Abuja, Nigeria. All patients received pain management, including opioid and nonopioid analgesics, per institutional practice.

The findings reinforce the role of arginine in vaso-occlusive pain episodes, and suggest that oral arginine is a promising adjuvant therapy for vaso-occlusive crisis management in patients with sickle cell disease, he said.

“We recommend a phase 3 multicenter clinical trial,” he added.

As for a potential role for arginine in this setting in the United States, prevention trials in the U.S. have thus far been negative, said Julie Panepinto, MD, the press briefing moderator and a pediatric hematologist-oncologist at Children’s Hospital of Wisconsin, Milwaukee.

Sharon Worcester/MDedge News

“This is my first knowledge of use in the acute setting,” said Dr. Panepinto, also a professor at the Medical College of Wisconsin in Milwaukee. “There is going to be some future work looking at use of arginine in the U.S. for patients presenting with pain.”

For now, however, it’s too early to say that all patients should be started on arginine, she said, adding that more information is needed, including about appropriate dosing.

Nonetheless, it’s encouraging to see positive findings, she noted.

“We’ve been looking at and thinking about arginine for a long time, so I think this is a really exciting study ... that should lead us to future work to really understand better how to use the medication,” she said.

Dr. Onalo reported having no disclosures. Dr. Panepinto has received research funding from the National Institutes of Health and the Health Resources and Services Administration.

[email protected]

SOURCE: Onalo R et al. ASH 2019, Abstract 613.

ORLANDO – Preclinical research suggests nuclear factor I X is a fetal hemoglobin repressor, a finding that could have implications for the treatment of sickle cell disease.

Researchers found that knocking down nuclear factor I X (NFIX) in adult erythroblasts induced fetal hemoglobin expression in a vast majority of cells, and the total amount of fetal hemoglobin in those cells was about 40%. The target level of fetal hemoglobin for sickle cell patients to become asymptomatic is 30%, according to study investigator Jeffrey R. Shearstone, PhD, of Syros Pharmaceuticals in Cambridge, Mass. He made these remarks during a press conference at the annual meeting of the American Society of Hematology. Mudit Chaand, PhD, also of Syros, is scheduled to present the study at the meeting on Dec. 9, 2019.

“While this is obviously a preclinical, investigational study, to see levels of induction in primary cells and cell lines of 40% is very encouraging and shows that [NFIX] is a very potent fetal hemoglobin repressor,” Dr. Shearstone said. “We see this discovery as, potentially, a new avenue for therapeutic intervention in sickle cell disease, but there’s still a lot of work to be done.”

Syros researchers began this study by comparing erythroblasts derived from cord blood, which have high levels of fetal hemoglobin, and erythroblasts derived from bone marrow, which have low levels of fetal hemoglobin. The team’s goal was to identify transcription factors that might regulate the repression of fetal hemoglobin in adult cells.

Chromatin accessibility mapping pointed to NFIX as a hemoglobin repressor. The researchers observed increased accessibility at the NFIX promoter and elevated NFIX messenger RNA in adult cells.

To confirm NFIX’s role as a repressor of fetal hemoglobin, the researchers used short hairpin RNA to knock down NFIX in primary erythroblasts and cell lines.

“By knocking down NFIX, we saw a very robust induction of fetal hemoglobin,” Dr. Shearstone said. “We saw nearly 100% of cells in which NFIX was knocked down express fetal hemoglobin. This level of induction compared very favorably to probably the two most potent known repressors of fetal hemoglobin, ZBTB7A and BCL11A.”

Specifically, 86%-97% of cells with NFIX knockdown expressed fetal hemoglobin, compared with 16% of control cells, 88% of cells with BCL11A knockdown, and 91% of cells with ZBTB7A knockdown.

The total amount of fetal hemoglobin in erythroblasts with NFIX knockdown was 39%-40%.

The researchers plan to conduct additional studies to validate these results, examine how NFIX directly binds at the fetal globin promoter, determine if NFIX interacts with any previously identified fetal hemoglobin repressors, and investigate how NFIX can be shut down in patients with sickle cell disease. The researchers’ ultimate goal is to develop a small molecule that would target NFIX.

All researchers involved in this work are employees of Syros Pharmaceuticals.

[email protected]

SOURCE: Shearstone JR et al. ASH 2019, Abstract 821.

ORLANDO – Preclinical research suggests nuclear factor I X is a fetal hemoglobin repressor, a finding that could have implications for the treatment of sickle cell disease.

Researchers found that knocking down nuclear factor I X (NFIX) in adult erythroblasts induced fetal hemoglobin expression in a vast majority of cells, and the total amount of fetal hemoglobin in those cells was about 40%. The target level of fetal hemoglobin for sickle cell patients to become asymptomatic is 30%, according to study investigator Jeffrey R. Shearstone, PhD, of Syros Pharmaceuticals in Cambridge, Mass. He made these remarks during a press conference at the annual meeting of the American Society of Hematology. Mudit Chaand, PhD, also of Syros, is scheduled to present the study at the meeting on Dec. 9, 2019.

“While this is obviously a preclinical, investigational study, to see levels of induction in primary cells and cell lines of 40% is very encouraging and shows that [NFIX] is a very potent fetal hemoglobin repressor,” Dr. Shearstone said. “We see this discovery as, potentially, a new avenue for therapeutic intervention in sickle cell disease, but there’s still a lot of work to be done.”

Syros researchers began this study by comparing erythroblasts derived from cord blood, which have high levels of fetal hemoglobin, and erythroblasts derived from bone marrow, which have low levels of fetal hemoglobin. The team’s goal was to identify transcription factors that might regulate the repression of fetal hemoglobin in adult cells.

Chromatin accessibility mapping pointed to NFIX as a hemoglobin repressor. The researchers observed increased accessibility at the NFIX promoter and elevated NFIX messenger RNA in adult cells.

To confirm NFIX’s role as a repressor of fetal hemoglobin, the researchers used short hairpin RNA to knock down NFIX in primary erythroblasts and cell lines.

“By knocking down NFIX, we saw a very robust induction of fetal hemoglobin,” Dr. Shearstone said. “We saw nearly 100% of cells in which NFIX was knocked down express fetal hemoglobin. This level of induction compared very favorably to probably the two most potent known repressors of fetal hemoglobin, ZBTB7A and BCL11A.”

Specifically, 86%-97% of cells with NFIX knockdown expressed fetal hemoglobin, compared with 16% of control cells, 88% of cells with BCL11A knockdown, and 91% of cells with ZBTB7A knockdown.

The total amount of fetal hemoglobin in erythroblasts with NFIX knockdown was 39%-40%.

The researchers plan to conduct additional studies to validate these results, examine how NFIX directly binds at the fetal globin promoter, determine if NFIX interacts with any previously identified fetal hemoglobin repressors, and investigate how NFIX can be shut down in patients with sickle cell disease. The researchers’ ultimate goal is to develop a small molecule that would target NFIX.

All researchers involved in this work are employees of Syros Pharmaceuticals.

[email protected]

SOURCE: Shearstone JR et al. ASH 2019, Abstract 821.

ORLANDO – Preclinical research suggests nuclear factor I X is a fetal hemoglobin repressor, a finding that could have implications for the treatment of sickle cell disease.

Researchers found that knocking down nuclear factor I X (NFIX) in adult erythroblasts induced fetal hemoglobin expression in a vast majority of cells, and the total amount of fetal hemoglobin in those cells was about 40%. The target level of fetal hemoglobin for sickle cell patients to become asymptomatic is 30%, according to study investigator Jeffrey R. Shearstone, PhD, of Syros Pharmaceuticals in Cambridge, Mass. He made these remarks during a press conference at the annual meeting of the American Society of Hematology. Mudit Chaand, PhD, also of Syros, is scheduled to present the study at the meeting on Dec. 9, 2019.

“While this is obviously a preclinical, investigational study, to see levels of induction in primary cells and cell lines of 40% is very encouraging and shows that [NFIX] is a very potent fetal hemoglobin repressor,” Dr. Shearstone said. “We see this discovery as, potentially, a new avenue for therapeutic intervention in sickle cell disease, but there’s still a lot of work to be done.”

Syros researchers began this study by comparing erythroblasts derived from cord blood, which have high levels of fetal hemoglobin, and erythroblasts derived from bone marrow, which have low levels of fetal hemoglobin. The team’s goal was to identify transcription factors that might regulate the repression of fetal hemoglobin in adult cells.

Chromatin accessibility mapping pointed to NFIX as a hemoglobin repressor. The researchers observed increased accessibility at the NFIX promoter and elevated NFIX messenger RNA in adult cells.

To confirm NFIX’s role as a repressor of fetal hemoglobin, the researchers used short hairpin RNA to knock down NFIX in primary erythroblasts and cell lines.

“By knocking down NFIX, we saw a very robust induction of fetal hemoglobin,” Dr. Shearstone said. “We saw nearly 100% of cells in which NFIX was knocked down express fetal hemoglobin. This level of induction compared very favorably to probably the two most potent known repressors of fetal hemoglobin, ZBTB7A and BCL11A.”

Specifically, 86%-97% of cells with NFIX knockdown expressed fetal hemoglobin, compared with 16% of control cells, 88% of cells with BCL11A knockdown, and 91% of cells with ZBTB7A knockdown.

The total amount of fetal hemoglobin in erythroblasts with NFIX knockdown was 39%-40%.

The researchers plan to conduct additional studies to validate these results, examine how NFIX directly binds at the fetal globin promoter, determine if NFIX interacts with any previously identified fetal hemoglobin repressors, and investigate how NFIX can be shut down in patients with sickle cell disease. The researchers’ ultimate goal is to develop a small molecule that would target NFIX.

All researchers involved in this work are employees of Syros Pharmaceuticals.

[email protected]

SOURCE: Shearstone JR et al. ASH 2019, Abstract 821.

The Affinity Program of expanded benefits gives SVS members more options for disability insurance. Many members are part of a group plan in which the employer or group pays the premium. These plans may meet the needs of members, but sometimes they may not. With the options offered through the Affinity Program, members could avoid offsets that reduce tax-free benefits or ones that limit the time period in which they are covered. The program can connect interested members with three companies: Principal Life Insurance Company, Securian and Lloyd’s of London. These group plans are unlike many others, providing tax-free benefits that could potentially protect hundreds of thousands of dollars. Click here for details.

The Affinity Program of expanded benefits gives SVS members more options for disability insurance. Many members are part of a group plan in which the employer or group pays the premium. These plans may meet the needs of members, but sometimes they may not. With the options offered through the Affinity Program, members could avoid offsets that reduce tax-free benefits or ones that limit the time period in which they are covered. The program can connect interested members with three companies: Principal Life Insurance Company, Securian and Lloyd’s of London. These group plans are unlike many others, providing tax-free benefits that could potentially protect hundreds of thousands of dollars. Click here for details.

The Affinity Program of expanded benefits gives SVS members more options for disability insurance. Many members are part of a group plan in which the employer or group pays the premium. These plans may meet the needs of members, but sometimes they may not. With the options offered through the Affinity Program, members could avoid offsets that reduce tax-free benefits or ones that limit the time period in which they are covered. The program can connect interested members with three companies: Principal Life Insurance Company, Securian and Lloyd’s of London. These group plans are unlike many others, providing tax-free benefits that could potentially protect hundreds of thousands of dollars. Click here for details.

ORLANDO – There is an urgent need for new therapies to treat relapsed or refractory peripheral T-cell lymphoma, but results of a phase 2 study suggest that monotherapy with the immune checkpoint inhibitor nivolumab (Opdivo) is not the hoped-for salvage treatment.

Neil Osterweil/MDedge News

An interim analysis of data on 12 patients with peripheral T-cell lymphoma (PTCL) treated with nivolumab monotherapy showed an overall response rate of 33%, consisting of 2 complete responses and 2 partial responses. But the responses were short lived, and one patient had hyperprogressive disease – dramatic progression within one cycle of treatment – while two more had progression within two cycles, leading to a trial halt, reported N. Nora Bennani, MD, from the Mayo Clinic in Rochester, Minn.

“These findings likely reflect the distinct biology of PTCL and should be considered when designing future studies using checkpoint inhibitors in these diseases,” she said at the annual meeting of the American Society of Hematology.

The rationale for using an immune checkpoint inhibitor directed against the programmed death–1 protein and its ligands (PD and PD-L1/2) is that malignant cells in PTCL induce a profoundly immunosuppressive tumor microenvironment. Checkpoint inhibitors have shown strong activity against relapsed Hodgkin lymphoma, and the Mayo Clinic researchers speculated that an anti-PD-1 agent could have a similar effect in PTCL.

They had originally planned to enroll 29 patients into a phase 2 trial with nivolumab delivered 240 mg every 2 weeks for eight cycles, followed by a dose of 480 mg given every 4 weeks until disease progression or intolerable toxicities.

Patients were eligible if they had biopsy-confirmed relapsed or refractory PTCL, measurable disease on cross-sectional imaging of at least 1.5 cm, and prior systemic chemoimmunotherapy and/or autologous stem cell transplantation.

The interim analysis included 12 patients who received at least one dose of nivolumab. Of the 12 patients, 6 had angioimmunoblastic T-cell lymphoma (AITL), 3 had PTCL not otherwise specified, and 1 each had ALK-negative anaplastic large cell lymphoma (ALK-ALCL), enteropathy-associated T-cell lymphoma (EATL), or hepatosplenic gamma/delta T-cell lymphoma.

All patients had Ann Arbor stage III/IV disease, and 11 had extranodal involvement.

As noted, there were 4 responses among the 12 patients, consisting of 1 complete response in the patient with ALK-ALCL and 1 in a patient with AITL, and 2 partial responses – 1 in a patient with PTCL-NOS, and 1 in the patient with EATL.

The median progression-free survival for all 12 patients was short at 2.7 months, and the median overall survival was estimated at 6.7 months.

“It was staggering to see this: The duration of response was significantly short, less than 2 months,” Dr. Bennani said.

Nonhematologic toxicities were seen in 5 of the 12 patients (42%), and hematologic adverse events occurred in 3 (25%). All patients are now off treatment, 10 because of disease progression, 1 because of acute pancreatitis, and the aforementioned patient with hyperprogressive disease.

The patient with hyperprogressive disease had significant progression in tonsillar and cervical lymphadenopathy within 7-10 days of nivolumab infusion, with biopsy-proven AITL in the involved nodes.

“I believe that, in this patient population, combination therapies will be key. I think checkpoint blockers alone are not going to be sufficient to see meaningful outcomes in these patients,” Dr. Bennani said in an interview.

“An overall response rate of 33% is significant, because most other agents that were FDA approved in this patient population have response rates around 30%,” she said, adding that it’s possible that the patients with rapid progression had disease too advanced to be effectively treated with a checkpoint inhibitor.

“Ideally however, if we want to move forward, it will need to be with combinations of checkpoint inhibitors with HDAC [histone deacetylase] inhibitors, hypomethylating agents, or even PI3 kinase inhibitors,” she said.

­The study was supported by Bristol-Myers Squibb. Dr. Bennani reported research funding and advisory board activities for Bristol-Myers Squibb and others.

SOURCE: Bennani NN et al. ASH 2019, Abstract 467.

ORLANDO – There is an urgent need for new therapies to treat relapsed or refractory peripheral T-cell lymphoma, but results of a phase 2 study suggest that monotherapy with the immune checkpoint inhibitor nivolumab (Opdivo) is not the hoped-for salvage treatment.

Neil Osterweil/MDedge News

An interim analysis of data on 12 patients with peripheral T-cell lymphoma (PTCL) treated with nivolumab monotherapy showed an overall response rate of 33%, consisting of 2 complete responses and 2 partial responses. But the responses were short lived, and one patient had hyperprogressive disease – dramatic progression within one cycle of treatment – while two more had progression within two cycles, leading to a trial halt, reported N. Nora Bennani, MD, from the Mayo Clinic in Rochester, Minn.

“These findings likely reflect the distinct biology of PTCL and should be considered when designing future studies using checkpoint inhibitors in these diseases,” she said at the annual meeting of the American Society of Hematology.

The rationale for using an immune checkpoint inhibitor directed against the programmed death–1 protein and its ligands (PD and PD-L1/2) is that malignant cells in PTCL induce a profoundly immunosuppressive tumor microenvironment. Checkpoint inhibitors have shown strong activity against relapsed Hodgkin lymphoma, and the Mayo Clinic researchers speculated that an anti-PD-1 agent could have a similar effect in PTCL.

They had originally planned to enroll 29 patients into a phase 2 trial with nivolumab delivered 240 mg every 2 weeks for eight cycles, followed by a dose of 480 mg given every 4 weeks until disease progression or intolerable toxicities.

Patients were eligible if they had biopsy-confirmed relapsed or refractory PTCL, measurable disease on cross-sectional imaging of at least 1.5 cm, and prior systemic chemoimmunotherapy and/or autologous stem cell transplantation.

The interim analysis included 12 patients who received at least one dose of nivolumab. Of the 12 patients, 6 had angioimmunoblastic T-cell lymphoma (AITL), 3 had PTCL not otherwise specified, and 1 each had ALK-negative anaplastic large cell lymphoma (ALK-ALCL), enteropathy-associated T-cell lymphoma (EATL), or hepatosplenic gamma/delta T-cell lymphoma.

All patients had Ann Arbor stage III/IV disease, and 11 had extranodal involvement.

As noted, there were 4 responses among the 12 patients, consisting of 1 complete response in the patient with ALK-ALCL and 1 in a patient with AITL, and 2 partial responses – 1 in a patient with PTCL-NOS, and 1 in the patient with EATL.

The median progression-free survival for all 12 patients was short at 2.7 months, and the median overall survival was estimated at 6.7 months.

“It was staggering to see this: The duration of response was significantly short, less than 2 months,” Dr. Bennani said.

Nonhematologic toxicities were seen in 5 of the 12 patients (42%), and hematologic adverse events occurred in 3 (25%). All patients are now off treatment, 10 because of disease progression, 1 because of acute pancreatitis, and the aforementioned patient with hyperprogressive disease.

The patient with hyperprogressive disease had significant progression in tonsillar and cervical lymphadenopathy within 7-10 days of nivolumab infusion, with biopsy-proven AITL in the involved nodes.

“I believe that, in this patient population, combination therapies will be key. I think checkpoint blockers alone are not going to be sufficient to see meaningful outcomes in these patients,” Dr. Bennani said in an interview.

“An overall response rate of 33% is significant, because most other agents that were FDA approved in this patient population have response rates around 30%,” she said, adding that it’s possible that the patients with rapid progression had disease too advanced to be effectively treated with a checkpoint inhibitor.

“Ideally however, if we want to move forward, it will need to be with combinations of checkpoint inhibitors with HDAC [histone deacetylase] inhibitors, hypomethylating agents, or even PI3 kinase inhibitors,” she said.

­The study was supported by Bristol-Myers Squibb. Dr. Bennani reported research funding and advisory board activities for Bristol-Myers Squibb and others.

SOURCE: Bennani NN et al. ASH 2019, Abstract 467.

ORLANDO – There is an urgent need for new therapies to treat relapsed or refractory peripheral T-cell lymphoma, but results of a phase 2 study suggest that monotherapy with the immune checkpoint inhibitor nivolumab (Opdivo) is not the hoped-for salvage treatment.

Neil Osterweil/MDedge News

An interim analysis of data on 12 patients with peripheral T-cell lymphoma (PTCL) treated with nivolumab monotherapy showed an overall response rate of 33%, consisting of 2 complete responses and 2 partial responses. But the responses were short lived, and one patient had hyperprogressive disease – dramatic progression within one cycle of treatment – while two more had progression within two cycles, leading to a trial halt, reported N. Nora Bennani, MD, from the Mayo Clinic in Rochester, Minn.

“These findings likely reflect the distinct biology of PTCL and should be considered when designing future studies using checkpoint inhibitors in these diseases,” she said at the annual meeting of the American Society of Hematology.

The rationale for using an immune checkpoint inhibitor directed against the programmed death–1 protein and its ligands (PD and PD-L1/2) is that malignant cells in PTCL induce a profoundly immunosuppressive tumor microenvironment. Checkpoint inhibitors have shown strong activity against relapsed Hodgkin lymphoma, and the Mayo Clinic researchers speculated that an anti-PD-1 agent could have a similar effect in PTCL.

They had originally planned to enroll 29 patients into a phase 2 trial with nivolumab delivered 240 mg every 2 weeks for eight cycles, followed by a dose of 480 mg given every 4 weeks until disease progression or intolerable toxicities.

Patients were eligible if they had biopsy-confirmed relapsed or refractory PTCL, measurable disease on cross-sectional imaging of at least 1.5 cm, and prior systemic chemoimmunotherapy and/or autologous stem cell transplantation.

The interim analysis included 12 patients who received at least one dose of nivolumab. Of the 12 patients, 6 had angioimmunoblastic T-cell lymphoma (AITL), 3 had PTCL not otherwise specified, and 1 each had ALK-negative anaplastic large cell lymphoma (ALK-ALCL), enteropathy-associated T-cell lymphoma (EATL), or hepatosplenic gamma/delta T-cell lymphoma.

All patients had Ann Arbor stage III/IV disease, and 11 had extranodal involvement.

As noted, there were 4 responses among the 12 patients, consisting of 1 complete response in the patient with ALK-ALCL and 1 in a patient with AITL, and 2 partial responses – 1 in a patient with PTCL-NOS, and 1 in the patient with EATL.

The median progression-free survival for all 12 patients was short at 2.7 months, and the median overall survival was estimated at 6.7 months.

“It was staggering to see this: The duration of response was significantly short, less than 2 months,” Dr. Bennani said.

Nonhematologic toxicities were seen in 5 of the 12 patients (42%), and hematologic adverse events occurred in 3 (25%). All patients are now off treatment, 10 because of disease progression, 1 because of acute pancreatitis, and the aforementioned patient with hyperprogressive disease.

The patient with hyperprogressive disease had significant progression in tonsillar and cervical lymphadenopathy within 7-10 days of nivolumab infusion, with biopsy-proven AITL in the involved nodes.

“I believe that, in this patient population, combination therapies will be key. I think checkpoint blockers alone are not going to be sufficient to see meaningful outcomes in these patients,” Dr. Bennani said in an interview.

“An overall response rate of 33% is significant, because most other agents that were FDA approved in this patient population have response rates around 30%,” she said, adding that it’s possible that the patients with rapid progression had disease too advanced to be effectively treated with a checkpoint inhibitor.

“Ideally however, if we want to move forward, it will need to be with combinations of checkpoint inhibitors with HDAC [histone deacetylase] inhibitors, hypomethylating agents, or even PI3 kinase inhibitors,” she said.

­The study was supported by Bristol-Myers Squibb. Dr. Bennani reported research funding and advisory board activities for Bristol-Myers Squibb and others.

SOURCE: Bennani NN et al. ASH 2019, Abstract 467.

Two priorities of NAMDRC have moved into the formal congressional arena. The issues focus on access to pulmonary rehabilitation and CMS’s move to include home mechanical ventilation in competitive bidding.

Pulmonary Rehabilitation – The Problem: One of the major concerns to CMS and Congress is the fact that different payment methodologies for the same service result in different payment amounts dependent upon the actual site of service. To address the phenomenon of hospitals purchasing certain physician practices to game the payment system, Congress included in the 2015 Budget Act a provision that would remove incentives for such hospital purchases by stating that new hospital outpatient services must be within 250 yards of the main hospital campus in order to receive payment based on the hospital outpatient prospective payment system methodology. If a hospital opens such services beyond that 250-yard threshold, the hospital would be reimbursed at the physician fee schedule amount for the same service. Likewise, if an off campus program moved its grandfathered location because of expansion, loss of lease, etc, the physician fee schedule would again kick in.

For pulmonary rehabilitation services, this is extremely problematic and is tying the hands of hospitals providing this service. The physician fee schedule payment for pulmonary rehabilitation is less than $30 for 1 hour of service, and it is, therefore, not surprising that the service is simply not provided in physician offices. In fact, Medicare data show that all physician specialties bill less than $1M for code G0424, and we believe that most of that is likely billing error. Pulmonologists bill less than $500K for code G0424, and putting that number in context, the entire Medicare program is approaching $700B in outlays.

Pulmonary Rehabilitation – The Solution: As a solution to this problem, HR 4838 has been introduced in the House of Representatives. There is no specific reference to pulmonary rehabilitation in the bill as our approach is based not only on substance but political considerations, as well. Using CMS’ own acknowledgment of “unintended consequences,” this legislation would exempt all CPT codes from the restrictions imposed by Section 603 of the 2015 Budget Act when the physician billings for that code are under $2M for the most recent year for which data are available. CMS has signaled to us that such a limitation would apply only to pulmonary and cardiac rehab services, but others may be affected, as well. By putting a dollar limit rather than identifying a specific service for such a “carve out,” it is a more politically viable approach.

Bills such as this rarely see the light of day; however, such provisions are often attached to larger, more substantive bills. For nearly 2 decades, the common legislative vehicle for such provisions is a larger Medicare bill, often including “must pass Medicare extender” provisions that are slated to expire on a particular date. Our goal is to include HR 4838 in such a package of extenders some time between now and the end of this Congress in 2020.

Home Mechanical Ventilation – The Problem: CMS has proposed inclusion of home mechanical ventilation in competitive bidding for durable medical equipment. Such a regulatory proposal is fraught with downside risk, most notably that such a policy would follow the history of liquid oxygen. Liquid 02 has virtually disappeared from the marketplace since it was included in competitive bidding as suppliers simply refused to provide liquid oxygen systems as their own bidding dropped the price to prohibitively low levels. Also, because there is a statutory requirement that such payment be made on the basis of “frequent and substantial servicing,” and that stipulation could trigger wide variations in actual bidding because some states require involvement of respiratory therapists in such services, while others do not.

It is critical to understand that the driving force behind all of this is the reality that CMS’ own coverage policies for home mechanical ventilation are seriously flawed and outdated, creating perverse incentives for physicians to order easily accessible systems rather than clinically appropriate ones. NAMDRC and its sister societies have been pushing CMS to revise those policies with no success.

Home Mechanical Ventilation – The Solution: Our solution is twofold. HR 4945 bill was introduced on November 1, 2019. First, the proposed legislation would create a blanket exemption for home mechanical ventilation from competitive bidding. Second, it requires CMS to convene a technical expert panel to craft up-to-date policies for home mechanical ventilation.

The political strategy here is slightly different. While passage of the bill is certainly our first choice, we believe that introduction of the bill is a red flag signal to CMS for the need to revise its coverage policies as those policies are the root cause of the growth of home mechanical ventilation outlays.

Two priorities of NAMDRC have moved into the formal congressional arena. The issues focus on access to pulmonary rehabilitation and CMS’s move to include home mechanical ventilation in competitive bidding.

Pulmonary Rehabilitation – The Problem: One of the major concerns to CMS and Congress is the fact that different payment methodologies for the same service result in different payment amounts dependent upon the actual site of service. To address the phenomenon of hospitals purchasing certain physician practices to game the payment system, Congress included in the 2015 Budget Act a provision that would remove incentives for such hospital purchases by stating that new hospital outpatient services must be within 250 yards of the main hospital campus in order to receive payment based on the hospital outpatient prospective payment system methodology. If a hospital opens such services beyond that 250-yard threshold, the hospital would be reimbursed at the physician fee schedule amount for the same service. Likewise, if an off campus program moved its grandfathered location because of expansion, loss of lease, etc, the physician fee schedule would again kick in.

For pulmonary rehabilitation services, this is extremely problematic and is tying the hands of hospitals providing this service. The physician fee schedule payment for pulmonary rehabilitation is less than $30 for 1 hour of service, and it is, therefore, not surprising that the service is simply not provided in physician offices. In fact, Medicare data show that all physician specialties bill less than $1M for code G0424, and we believe that most of that is likely billing error. Pulmonologists bill less than $500K for code G0424, and putting that number in context, the entire Medicare program is approaching $700B in outlays.

Pulmonary Rehabilitation – The Solution: As a solution to this problem, HR 4838 has been introduced in the House of Representatives. There is no specific reference to pulmonary rehabilitation in the bill as our approach is based not only on substance but political considerations, as well. Using CMS’ own acknowledgment of “unintended consequences,” this legislation would exempt all CPT codes from the restrictions imposed by Section 603 of the 2015 Budget Act when the physician billings for that code are under $2M for the most recent year for which data are available. CMS has signaled to us that such a limitation would apply only to pulmonary and cardiac rehab services, but others may be affected, as well. By putting a dollar limit rather than identifying a specific service for such a “carve out,” it is a more politically viable approach.

Bills such as this rarely see the light of day; however, such provisions are often attached to larger, more substantive bills. For nearly 2 decades, the common legislative vehicle for such provisions is a larger Medicare bill, often including “must pass Medicare extender” provisions that are slated to expire on a particular date. Our goal is to include HR 4838 in such a package of extenders some time between now and the end of this Congress in 2020.

Home Mechanical Ventilation – The Problem: CMS has proposed inclusion of home mechanical ventilation in competitive bidding for durable medical equipment. Such a regulatory proposal is fraught with downside risk, most notably that such a policy would follow the history of liquid oxygen. Liquid 02 has virtually disappeared from the marketplace since it was included in competitive bidding as suppliers simply refused to provide liquid oxygen systems as their own bidding dropped the price to prohibitively low levels. Also, because there is a statutory requirement that such payment be made on the basis of “frequent and substantial servicing,” and that stipulation could trigger wide variations in actual bidding because some states require involvement of respiratory therapists in such services, while others do not.

It is critical to understand that the driving force behind all of this is the reality that CMS’ own coverage policies for home mechanical ventilation are seriously flawed and outdated, creating perverse incentives for physicians to order easily accessible systems rather than clinically appropriate ones. NAMDRC and its sister societies have been pushing CMS to revise those policies with no success.

Home Mechanical Ventilation – The Solution: Our solution is twofold. HR 4945 bill was introduced on November 1, 2019. First, the proposed legislation would create a blanket exemption for home mechanical ventilation from competitive bidding. Second, it requires CMS to convene a technical expert panel to craft up-to-date policies for home mechanical ventilation.

The political strategy here is slightly different. While passage of the bill is certainly our first choice, we believe that introduction of the bill is a red flag signal to CMS for the need to revise its coverage policies as those policies are the root cause of the growth of home mechanical ventilation outlays.

Two priorities of NAMDRC have moved into the formal congressional arena. The issues focus on access to pulmonary rehabilitation and CMS’s move to include home mechanical ventilation in competitive bidding.

Pulmonary Rehabilitation – The Problem: One of the major concerns to CMS and Congress is the fact that different payment methodologies for the same service result in different payment amounts dependent upon the actual site of service. To address the phenomenon of hospitals purchasing certain physician practices to game the payment system, Congress included in the 2015 Budget Act a provision that would remove incentives for such hospital purchases by stating that new hospital outpatient services must be within 250 yards of the main hospital campus in order to receive payment based on the hospital outpatient prospective payment system methodology. If a hospital opens such services beyond that 250-yard threshold, the hospital would be reimbursed at the physician fee schedule amount for the same service. Likewise, if an off campus program moved its grandfathered location because of expansion, loss of lease, etc, the physician fee schedule would again kick in.

For pulmonary rehabilitation services, this is extremely problematic and is tying the hands of hospitals providing this service. The physician fee schedule payment for pulmonary rehabilitation is less than $30 for 1 hour of service, and it is, therefore, not surprising that the service is simply not provided in physician offices. In fact, Medicare data show that all physician specialties bill less than $1M for code G0424, and we believe that most of that is likely billing error. Pulmonologists bill less than $500K for code G0424, and putting that number in context, the entire Medicare program is approaching $700B in outlays.

Pulmonary Rehabilitation – The Solution: As a solution to this problem, HR 4838 has been introduced in the House of Representatives. There is no specific reference to pulmonary rehabilitation in the bill as our approach is based not only on substance but political considerations, as well. Using CMS’ own acknowledgment of “unintended consequences,” this legislation would exempt all CPT codes from the restrictions imposed by Section 603 of the 2015 Budget Act when the physician billings for that code are under $2M for the most recent year for which data are available. CMS has signaled to us that such a limitation would apply only to pulmonary and cardiac rehab services, but others may be affected, as well. By putting a dollar limit rather than identifying a specific service for such a “carve out,” it is a more politically viable approach.

Bills such as this rarely see the light of day; however, such provisions are often attached to larger, more substantive bills. For nearly 2 decades, the common legislative vehicle for such provisions is a larger Medicare bill, often including “must pass Medicare extender” provisions that are slated to expire on a particular date. Our goal is to include HR 4838 in such a package of extenders some time between now and the end of this Congress in 2020.

Home Mechanical Ventilation – The Problem: CMS has proposed inclusion of home mechanical ventilation in competitive bidding for durable medical equipment. Such a regulatory proposal is fraught with downside risk, most notably that such a policy would follow the history of liquid oxygen. Liquid 02 has virtually disappeared from the marketplace since it was included in competitive bidding as suppliers simply refused to provide liquid oxygen systems as their own bidding dropped the price to prohibitively low levels. Also, because there is a statutory requirement that such payment be made on the basis of “frequent and substantial servicing,” and that stipulation could trigger wide variations in actual bidding because some states require involvement of respiratory therapists in such services, while others do not.

It is critical to understand that the driving force behind all of this is the reality that CMS’ own coverage policies for home mechanical ventilation are seriously flawed and outdated, creating perverse incentives for physicians to order easily accessible systems rather than clinically appropriate ones. NAMDRC and its sister societies have been pushing CMS to revise those policies with no success.

Home Mechanical Ventilation – The Solution: Our solution is twofold. HR 4945 bill was introduced on November 1, 2019. First, the proposed legislation would create a blanket exemption for home mechanical ventilation from competitive bidding. Second, it requires CMS to convene a technical expert panel to craft up-to-date policies for home mechanical ventilation.

The political strategy here is slightly different. While passage of the bill is certainly our first choice, we believe that introduction of the bill is a red flag signal to CMS for the need to revise its coverage policies as those policies are the root cause of the growth of home mechanical ventilation outlays.

When most think of Mark J. Rosen, MD, Master FCCP, so many words come to mind: master educator, astute and caring clinician, researcher, mentor, leader. We recall his generosity, kindness, honesty, brilliance, and sense of humor.

Mark loved CHEST. He gave so much to the organization and was happy to do so. He was one of the rare Past Presidents who contributed even more after his presidency than during or before. Mark left an enormous footprint on CHEST’s educational programs, including the CHEST Annual Meeting, Pulmonary Board Review, and SEEK. He was instrumental in building our international educational programs and a key player in empowering our Chinese colleagues in establishing pulmonary fellowships in their country. Much of what we have all accomplished at CHEST and in pulmonary medicine is directly related to the wonderful mentors we have had in the organization, and Mark was certainly one of the most prominent.

Mark always believed the core strength of the college was education. The CHEST Foundation is endowing the Rosen International Scholarship and raising $100,000 to support deserving international clinicians. This endowed fund will directly support international CHEST members’ travel to the CHEST Annual Meeting affording CHEST’s world-class educational and mentorship opportunities to members who could not otherwise attend.

To support the Mark J. Rosen, MD, FCCP Endowment, his legacy, and international CHEST members, visit chestfoundation.org/donate today.

When most think of Mark J. Rosen, MD, Master FCCP, so many words come to mind: master educator, astute and caring clinician, researcher, mentor, leader. We recall his generosity, kindness, honesty, brilliance, and sense of humor.

Mark loved CHEST. He gave so much to the organization and was happy to do so. He was one of the rare Past Presidents who contributed even more after his presidency than during or before. Mark left an enormous footprint on CHEST’s educational programs, including the CHEST Annual Meeting, Pulmonary Board Review, and SEEK. He was instrumental in building our international educational programs and a key player in empowering our Chinese colleagues in establishing pulmonary fellowships in their country. Much of what we have all accomplished at CHEST and in pulmonary medicine is directly related to the wonderful mentors we have had in the organization, and Mark was certainly one of the most prominent.

Mark always believed the core strength of the college was education. The CHEST Foundation is endowing the Rosen International Scholarship and raising $100,000 to support deserving international clinicians. This endowed fund will directly support international CHEST members’ travel to the CHEST Annual Meeting affording CHEST’s world-class educational and mentorship opportunities to members who could not otherwise attend.

To support the Mark J. Rosen, MD, FCCP Endowment, his legacy, and international CHEST members, visit chestfoundation.org/donate today.

When most think of Mark J. Rosen, MD, Master FCCP, so many words come to mind: master educator, astute and caring clinician, researcher, mentor, leader. We recall his generosity, kindness, honesty, brilliance, and sense of humor.

Mark loved CHEST. He gave so much to the organization and was happy to do so. He was one of the rare Past Presidents who contributed even more after his presidency than during or before. Mark left an enormous footprint on CHEST’s educational programs, including the CHEST Annual Meeting, Pulmonary Board Review, and SEEK. He was instrumental in building our international educational programs and a key player in empowering our Chinese colleagues in establishing pulmonary fellowships in their country. Much of what we have all accomplished at CHEST and in pulmonary medicine is directly related to the wonderful mentors we have had in the organization, and Mark was certainly one of the most prominent.

Mark always believed the core strength of the college was education. The CHEST Foundation is endowing the Rosen International Scholarship and raising $100,000 to support deserving international clinicians. This endowed fund will directly support international CHEST members’ travel to the CHEST Annual Meeting affording CHEST’s world-class educational and mentorship opportunities to members who could not otherwise attend.

To support the Mark J. Rosen, MD, FCCP Endowment, his legacy, and international CHEST members, visit chestfoundation.org/donate today.

CHEST leadership recently met for its fall quarterly face to face meeting prior to the CHEST Annual Meeting in New Orleans this October. Like all of CHEST board meetings, the agenda was packed with important topics and a great deal of meaningful discussion. I left the meeting more energized about CHEST and its current and future offerings for our membership. Below are a few highlights from the meeting.

The meeting was opened with an update from the outgoing CHEST President Clayton Cowl, MD, MS, FCCP. He highlighted some of the organization’s major achievements over the past year, including: Confirming and signing a new contract with our new EVP/CEO Robert Musacchio, PhD; hiring a new Chief Learning Officer, a new Editor in Chief for the CHEST® journal, and a new Chief Legal Counsel; and expansion of the international strategy with CHEST Congress in Bangkok and a CHEST Regional meeting in Athens with plans for CHEST Congress 2020 in Bologna, Italy. In addition, CHEST convened a Digital Strategy Task Force, which made recommendations to improve how members, patients, and staff interact with our organization.

EVP/CEO Robert Musacchio reviewed some additional organizational accomplishments and areas of focus for the future. These included redefining the One CHEST operating model and a continued focus on international business development with plans for CHEST Congress 2020 in Italy and exploration of future meetings in Singapore and The Philippines. CHEST continues to develop an improved membership strategy focused on improving experiences for our membership and improving member engagement to help secure the future of CHEST. Finally, CHEST remains focused on innovation though new experiences for our members, including new games, virtual patient tours, and enduring activities and products. Many of these experiences were highlighted and on display at the recent CHEST annual meeting.

Doreen Addrizzo-Harris, MD, FCCP, the CHEST Foundation outgoing President, recapped a very successful year for the CHEST Foundation with plans for increasing the impact and visibility of the CHEST Foundation going forward.. John Howington, MD, FCCP, Chair of the Finance Committee, updated the board on the financial health of the organization. Overall, CHEST had a solid financial report based on budgeted revenue and strong expense management by our executive leadership team.

John Studdard, MD, FCCP, the immediate Past President and Chair of the Governance Committee, led the Governance Committee report and discussion. The Governance Committee is composed of members of both the College Board of Regents (BOR) and Foundation Board of Trustees (BOT) and is responsible for the overall health of both boards and ensuring that the boards are consistently performing at a high level. Dr. Studdard presented slates for 2019-20 Board of Trustees and Board of Regents for discussion and approval. Five new members for the Board of Regents and four new members for the Board of Trustees were approved for the upcoming year. In addition, David Schulman, MD, MS, FCCP, and Robert De Marco, MD, FCCP, were elected as President-Designate of the BOR and BOT, respectively.

Several committees presented to the Board to review this year’s progress, future plans, and potential barriers to success. The Council of Global Governors continued to see growth in our international membership, though a potential ongoing barrier to future growth will be developing an efficient mode of communication between the Global Governors and our international members. Discussion around using the expertise within the Digital Strategy Task Force was offered as one method to improve international member communication and engagement. The Education Committee continues to be one of CHEST’s most popular committees with an unprecedented 130 nominations with exceptional credentials for the 2019-20 election cycle. The Education Committee has expanded the size of three of its subcommittees to better include and engage these individuals in CHEST education projects. The Training and Transitions Committee continues to see increased engagement from trainees and training programs. CHEST 2019 had an increased number of trainee submissions, as well as the number of accepted submissions to the meeting. The committee will continue to evolve their strategy for engaging trainees and early career professionals. Finally, Christopher Hergott, MD, FCCP, Chair of the Membership Committee, reviewed several strategies and recommendations to expand our membership offerings and improve the value that we bring to our all of our members.

Finally, it was time to say thank you and farewell to out our outgoing Board members. Clayton Cowl, MD, MS, FCCP, and Stephanie Levine, MD, FCCP, recognized the following board members for their service to CHEST over the last several years: Jack Buckley, MD, FCCP; John Studdard, MD, FCCP; David Zielinski, MD, FCCP; and Burt Lesnick, MD, FCCP.

CHEST leadership recently met for its fall quarterly face to face meeting prior to the CHEST Annual Meeting in New Orleans this October. Like all of CHEST board meetings, the agenda was packed with important topics and a great deal of meaningful discussion. I left the meeting more energized about CHEST and its current and future offerings for our membership. Below are a few highlights from the meeting.

The meeting was opened with an update from the outgoing CHEST President Clayton Cowl, MD, MS, FCCP. He highlighted some of the organization’s major achievements over the past year, including: Confirming and signing a new contract with our new EVP/CEO Robert Musacchio, PhD; hiring a new Chief Learning Officer, a new Editor in Chief for the CHEST® journal, and a new Chief Legal Counsel; and expansion of the international strategy with CHEST Congress in Bangkok and a CHEST Regional meeting in Athens with plans for CHEST Congress 2020 in Bologna, Italy. In addition, CHEST convened a Digital Strategy Task Force, which made recommendations to improve how members, patients, and staff interact with our organization.

EVP/CEO Robert Musacchio reviewed some additional organizational accomplishments and areas of focus for the future. These included redefining the One CHEST operating model and a continued focus on international business development with plans for CHEST Congress 2020 in Italy and exploration of future meetings in Singapore and The Philippines. CHEST continues to develop an improved membership strategy focused on improving experiences for our membership and improving member engagement to help secure the future of CHEST. Finally, CHEST remains focused on innovation though new experiences for our members, including new games, virtual patient tours, and enduring activities and products. Many of these experiences were highlighted and on display at the recent CHEST annual meeting.

Doreen Addrizzo-Harris, MD, FCCP, the CHEST Foundation outgoing President, recapped a very successful year for the CHEST Foundation with plans for increasing the impact and visibility of the CHEST Foundation going forward.. John Howington, MD, FCCP, Chair of the Finance Committee, updated the board on the financial health of the organization. Overall, CHEST had a solid financial report based on budgeted revenue and strong expense management by our executive leadership team.

John Studdard, MD, FCCP, the immediate Past President and Chair of the Governance Committee, led the Governance Committee report and discussion. The Governance Committee is composed of members of both the College Board of Regents (BOR) and Foundation Board of Trustees (BOT) and is responsible for the overall health of both boards and ensuring that the boards are consistently performing at a high level. Dr. Studdard presented slates for 2019-20 Board of Trustees and Board of Regents for discussion and approval. Five new members for the Board of Regents and four new members for the Board of Trustees were approved for the upcoming year. In addition, David Schulman, MD, MS, FCCP, and Robert De Marco, MD, FCCP, were elected as President-Designate of the BOR and BOT, respectively.

Several committees presented to the Board to review this year’s progress, future plans, and potential barriers to success. The Council of Global Governors continued to see growth in our international membership, though a potential ongoing barrier to future growth will be developing an efficient mode of communication between the Global Governors and our international members. Discussion around using the expertise within the Digital Strategy Task Force was offered as one method to improve international member communication and engagement. The Education Committee continues to be one of CHEST’s most popular committees with an unprecedented 130 nominations with exceptional credentials for the 2019-20 election cycle. The Education Committee has expanded the size of three of its subcommittees to better include and engage these individuals in CHEST education projects. The Training and Transitions Committee continues to see increased engagement from trainees and training programs. CHEST 2019 had an increased number of trainee submissions, as well as the number of accepted submissions to the meeting. The committee will continue to evolve their strategy for engaging trainees and early career professionals. Finally, Christopher Hergott, MD, FCCP, Chair of the Membership Committee, reviewed several strategies and recommendations to expand our membership offerings and improve the value that we bring to our all of our members.

Finally, it was time to say thank you and farewell to out our outgoing Board members. Clayton Cowl, MD, MS, FCCP, and Stephanie Levine, MD, FCCP, recognized the following board members for their service to CHEST over the last several years: Jack Buckley, MD, FCCP; John Studdard, MD, FCCP; David Zielinski, MD, FCCP; and Burt Lesnick, MD, FCCP.

CHEST leadership recently met for its fall quarterly face to face meeting prior to the CHEST Annual Meeting in New Orleans this October. Like all of CHEST board meetings, the agenda was packed with important topics and a great deal of meaningful discussion. I left the meeting more energized about CHEST and its current and future offerings for our membership. Below are a few highlights from the meeting.

The meeting was opened with an update from the outgoing CHEST President Clayton Cowl, MD, MS, FCCP. He highlighted some of the organization’s major achievements over the past year, including: Confirming and signing a new contract with our new EVP/CEO Robert Musacchio, PhD; hiring a new Chief Learning Officer, a new Editor in Chief for the CHEST® journal, and a new Chief Legal Counsel; and expansion of the international strategy with CHEST Congress in Bangkok and a CHEST Regional meeting in Athens with plans for CHEST Congress 2020 in Bologna, Italy. In addition, CHEST convened a Digital Strategy Task Force, which made recommendations to improve how members, patients, and staff interact with our organization.

EVP/CEO Robert Musacchio reviewed some additional organizational accomplishments and areas of focus for the future. These included redefining the One CHEST operating model and a continued focus on international business development with plans for CHEST Congress 2020 in Italy and exploration of future meetings in Singapore and The Philippines. CHEST continues to develop an improved membership strategy focused on improving experiences for our membership and improving member engagement to help secure the future of CHEST. Finally, CHEST remains focused on innovation though new experiences for our members, including new games, virtual patient tours, and enduring activities and products. Many of these experiences were highlighted and on display at the recent CHEST annual meeting.

Doreen Addrizzo-Harris, MD, FCCP, the CHEST Foundation outgoing President, recapped a very successful year for the CHEST Foundation with plans for increasing the impact and visibility of the CHEST Foundation going forward.. John Howington, MD, FCCP, Chair of the Finance Committee, updated the board on the financial health of the organization. Overall, CHEST had a solid financial report based on budgeted revenue and strong expense management by our executive leadership team.

John Studdard, MD, FCCP, the immediate Past President and Chair of the Governance Committee, led the Governance Committee report and discussion. The Governance Committee is composed of members of both the College Board of Regents (BOR) and Foundation Board of Trustees (BOT) and is responsible for the overall health of both boards and ensuring that the boards are consistently performing at a high level. Dr. Studdard presented slates for 2019-20 Board of Trustees and Board of Regents for discussion and approval. Five new members for the Board of Regents and four new members for the Board of Trustees were approved for the upcoming year. In addition, David Schulman, MD, MS, FCCP, and Robert De Marco, MD, FCCP, were elected as President-Designate of the BOR and BOT, respectively.

Several committees presented to the Board to review this year’s progress, future plans, and potential barriers to success. The Council of Global Governors continued to see growth in our international membership, though a potential ongoing barrier to future growth will be developing an efficient mode of communication between the Global Governors and our international members. Discussion around using the expertise within the Digital Strategy Task Force was offered as one method to improve international member communication and engagement. The Education Committee continues to be one of CHEST’s most popular committees with an unprecedented 130 nominations with exceptional credentials for the 2019-20 election cycle. The Education Committee has expanded the size of three of its subcommittees to better include and engage these individuals in CHEST education projects. The Training and Transitions Committee continues to see increased engagement from trainees and training programs. CHEST 2019 had an increased number of trainee submissions, as well as the number of accepted submissions to the meeting. The committee will continue to evolve their strategy for engaging trainees and early career professionals. Finally, Christopher Hergott, MD, FCCP, Chair of the Membership Committee, reviewed several strategies and recommendations to expand our membership offerings and improve the value that we bring to our all of our members.

Finally, it was time to say thank you and farewell to out our outgoing Board members. Clayton Cowl, MD, MS, FCCP, and Stephanie Levine, MD, FCCP, recognized the following board members for their service to CHEST over the last several years: Jack Buckley, MD, FCCP; John Studdard, MD, FCCP; David Zielinski, MD, FCCP; and Burt Lesnick, MD, FCCP.

Point-of-care ultrasound (POCUS) is an essential part of ICU care. It has been demonstrated to improve patient safety and outcomes through procedural guidance (Brass P, et al. Cochrane Database Syst Rev. 2015 Jan 9;1:CD006962) and aid in accurate and timely diagnosis of cardiopulmonary failure (Lichtenstein DA, Mezière GA. Chest. 2008 Jul;134[1]:117-25). Due in part to increasing affordability and portability of ultrasound technologies, the use of POCUS has become seemingly ubiquitous and will continue to increase in coming years. According to expert groups representing 12 critical care societies worldwide, general critical care ultrasound and basic critical care echocardiography should be mandatory training for ICU physicians (Expert Round Table on Ultrasound in ICU. Intensive Care Med. 2011 Jul;37[7]:1077-83).

Currently, POCUS is not universally taught to pulmonary and critical care fellows (PCCM); and when training does exist, curriculums are not standardized. This is in part due to the broadly worded requirements set forth from the ACGME for pulmonary disease and critical care medicine. The totality of ACGME common program requirements as it regards to ultrasound training are as follows: 1. “Fellows must demonstrate competence in procedural and technical skills, including ... use of ultrasound techniques to perform thoracentesis and place intravascular and intracavitary tubes and catheters”; and 2. “Fellows must demonstrate knowledge of imaging techniques commonly employed in the evaluation of patients with pulmonary disease or critical illness, including the use of ultrasound” (ACGME Program Requirements for Graduate Medical Education in Pulmonary Disease and Critical Care Medicine).

In comparison, recently updated ACGME common program requirements for ultrasound in emergency medicine and anesthesiology residencies are robust and detailed. Requirements for anesthesia residency training include: ” ... competency in using surface ultrasound ... and transthoracic echocardiography to guide the performance of invasive procedures and to evaluate organ function and pathology ... understanding the principles of ultrasound, including the physics of ultrasound transmission, ultrasound transducer construction, and transducer selection for specific applications, to include being able to obtain images with an understanding of limitations and artifacts ... obtaining standard views of the heart and inferior vena cava with transthoracic echocardiography allowing the evaluation of myocardial function, estimation of central venous pressure, and gross pericardial/cardiac pathology (eg, large pericardial effusion) ... using transthoracic ultrasound for the detection of pneumothorax and pleural effusion ... using surface ultrasound to guide vascular access (both central and peripheral) ... describing techniques, views, and findings in standard language” (ACGME Program Requirements for Graduate Medical Education In Anesthesiology).

Herein lies a stark contrast in what is required of programs that train physicians to care for unstable patients and the critically ill. Current requirements leave graduates of PCCM training programs vulnerable to completing ACGME milestones without being adequately prepared to evaluate patients in a modern ICU setting. Increasingly, hospitals credentialing committees expect PCCM graduates to be suitably trained in ultrasound. Regrettably, there is no assurance that is true, or standardized, with current PCCM fellowship training requirements.

There is not a national standard for competency assessment or requirements for credentialing in POCUS for critical care physicians at this time. However, multiple national and international critical care societies, including CHEST, have consensus statements and recommendations outlining the areas of competence expected in critical care ultrasound (Mayo PH, et al. Chest. 2009 Apr;135[4];1050-60, Expert Round Table on Ultrasound in ICU. Intensive Care Med. 2011 Jul;37(7):1077-83). The PCCM ACGME requirements should be updated to reflect such recommendations, thereby placing greater emphasis on ultrasound teaching requirements and standardized curriculums. Despite the current ACGME program requirements, it is incumbent upon critical care training programs to provide competency-based education of this now “standard of care” technology.

Barriers to universal POCUS training exist. Fellowship programs may lack trained, ultrasound confident faculty, time, and funding to successfully develop and sustain an ultrasound curriculum. (Eisen LA, et al. Crit Care Med. 2010;38[10]:1978-83; Patrawalla P, et al. J Intensive Care Med. 2019 Feb 12: [Epub ahead of print].)

Although access to adequate quality and quantity of ultrasound machines is less often a problem than in the past, many institutions lack archival and image review software that allows for quality assurance of image acquisition, and some still may not have a faculty member with expertise and ability to champion the cause.

In attempts to mitigate the local faculty gaps, national and regional solutions have been developed for ultrasonography education. CHEST has educated more than 1,400 learners in the Ultrasound Essentials course since 2013. Also, grassroots efforts have led to the development of courses specifically designed to teach incoming PCCM fellows. Using a collaborative and cost-effective model, these regional programs pool faculty and experts in the field to train multiple fellowship programs simultaneously. The first of these was created over a decade ago in New York City (Patrawalla P, et al. J Intensive Care Med. 2019 Feb 12:[Epub ahead of print].)

Currently, there are at least four regional annual ultrasound courses directed at teaching PCCM fellows. These courses are typically held over multiple days and encompass the basics of critical care ultrasound, including vascular, thoracic, abdominal, cardiac, and procedural imaging. By estimation, these four courses provide a basic ultrasonography education to approximately two-thirds of first year pulmonary and critical care fellows in the United States. In addition to training fellows, these programs also serve as a platform for the development of local faculty experts, so that training can continue at their institutions.

Introductory courses are highly effective (Dinh VA, et al. Crit Care Res Pract. 2015 Aug 5:675041 Patrawalla P, et al. J Intensive Care Med. 2019 Feb 12: [Epub ahead of print]), but ongoing education, assessment, and quality assurance is required to achieve sustained competence. Ideally, training in POCUS should entail a dedicated, intensive introduction to the competencies of critical care ultrasound (such as the above regional courses or CHEST ultrasound courses), followed by a formal curriculum within the PCCM fellowship programs. This curriculum should afford the trainee exposure to critically ill patients in an environment with adequate ultrasound equipment and a method to record studies. The trainee then interprets the acquired studies in clinical context. Preferably, the program will afford the trainee real-time quality assurance for image acquisition and interpretation by a program champion. Quality assurance can be provided on site or remotely using fixed interval review sessions. Lastly, the program should have internal milestones to evaluate when a trainee has reached competency to perform these tasks independently. The completion of training should include a letter to any future employee attesting to the trainee’s acquisition of these skills and ability to apply them safely while caring for the critically ill. This robust education is occurring in many centers across the country. PCCM fellowship programs owe it to their trainees, and patients, that competency-based critical care ultrasound training is robust, standardized, and supported.
 

Point-of-care ultrasound (POCUS) is an essential part of ICU care. It has been demonstrated to improve patient safety and outcomes through procedural guidance (Brass P, et al. Cochrane Database Syst Rev. 2015 Jan 9;1:CD006962) and aid in accurate and timely diagnosis of cardiopulmonary failure (Lichtenstein DA, Mezière GA. Chest. 2008 Jul;134[1]:117-25). Due in part to increasing affordability and portability of ultrasound technologies, the use of POCUS has become seemingly ubiquitous and will continue to increase in coming years. According to expert groups representing 12 critical care societies worldwide, general critical care ultrasound and basic critical care echocardiography should be mandatory training for ICU physicians (Expert Round Table on Ultrasound in ICU. Intensive Care Med. 2011 Jul;37[7]:1077-83).

Currently, POCUS is not universally taught to pulmonary and critical care fellows (PCCM); and when training does exist, curriculums are not standardized. This is in part due to the broadly worded requirements set forth from the ACGME for pulmonary disease and critical care medicine. The totality of ACGME common program requirements as it regards to ultrasound training are as follows: 1. “Fellows must demonstrate competence in procedural and technical skills, including ... use of ultrasound techniques to perform thoracentesis and place intravascular and intracavitary tubes and catheters”; and 2. “Fellows must demonstrate knowledge of imaging techniques commonly employed in the evaluation of patients with pulmonary disease or critical illness, including the use of ultrasound” (ACGME Program Requirements for Graduate Medical Education in Pulmonary Disease and Critical Care Medicine).

In comparison, recently updated ACGME common program requirements for ultrasound in emergency medicine and anesthesiology residencies are robust and detailed. Requirements for anesthesia residency training include: ” ... competency in using surface ultrasound ... and transthoracic echocardiography to guide the performance of invasive procedures and to evaluate organ function and pathology ... understanding the principles of ultrasound, including the physics of ultrasound transmission, ultrasound transducer construction, and transducer selection for specific applications, to include being able to obtain images with an understanding of limitations and artifacts ... obtaining standard views of the heart and inferior vena cava with transthoracic echocardiography allowing the evaluation of myocardial function, estimation of central venous pressure, and gross pericardial/cardiac pathology (eg, large pericardial effusion) ... using transthoracic ultrasound for the detection of pneumothorax and pleural effusion ... using surface ultrasound to guide vascular access (both central and peripheral) ... describing techniques, views, and findings in standard language” (ACGME Program Requirements for Graduate Medical Education In Anesthesiology).

Herein lies a stark contrast in what is required of programs that train physicians to care for unstable patients and the critically ill. Current requirements leave graduates of PCCM training programs vulnerable to completing ACGME milestones without being adequately prepared to evaluate patients in a modern ICU setting. Increasingly, hospitals credentialing committees expect PCCM graduates to be suitably trained in ultrasound. Regrettably, there is no assurance that is true, or standardized, with current PCCM fellowship training requirements.

There is not a national standard for competency assessment or requirements for credentialing in POCUS for critical care physicians at this time. However, multiple national and international critical care societies, including CHEST, have consensus statements and recommendations outlining the areas of competence expected in critical care ultrasound (Mayo PH, et al. Chest. 2009 Apr;135[4];1050-60, Expert Round Table on Ultrasound in ICU. Intensive Care Med. 2011 Jul;37(7):1077-83). The PCCM ACGME requirements should be updated to reflect such recommendations, thereby placing greater emphasis on ultrasound teaching requirements and standardized curriculums. Despite the current ACGME program requirements, it is incumbent upon critical care training programs to provide competency-based education of this now “standard of care” technology.

Barriers to universal POCUS training exist. Fellowship programs may lack trained, ultrasound confident faculty, time, and funding to successfully develop and sustain an ultrasound curriculum. (Eisen LA, et al. Crit Care Med. 2010;38[10]:1978-83; Patrawalla P, et al. J Intensive Care Med. 2019 Feb 12: [Epub ahead of print].)

Although access to adequate quality and quantity of ultrasound machines is less often a problem than in the past, many institutions lack archival and image review software that allows for quality assurance of image acquisition, and some still may not have a faculty member with expertise and ability to champion the cause.

In attempts to mitigate the local faculty gaps, national and regional solutions have been developed for ultrasonography education. CHEST has educated more than 1,400 learners in the Ultrasound Essentials course since 2013. Also, grassroots efforts have led to the development of courses specifically designed to teach incoming PCCM fellows. Using a collaborative and cost-effective model, these regional programs pool faculty and experts in the field to train multiple fellowship programs simultaneously. The first of these was created over a decade ago in New York City (Patrawalla P, et al. J Intensive Care Med. 2019 Feb 12:[Epub ahead of print].)

Currently, there are at least four regional annual ultrasound courses directed at teaching PCCM fellows. These courses are typically held over multiple days and encompass the basics of critical care ultrasound, including vascular, thoracic, abdominal, cardiac, and procedural imaging. By estimation, these four courses provide a basic ultrasonography education to approximately two-thirds of first year pulmonary and critical care fellows in the United States. In addition to training fellows, these programs also serve as a platform for the development of local faculty experts, so that training can continue at their institutions.

Introductory courses are highly effective (Dinh VA, et al. Crit Care Res Pract. 2015 Aug 5:675041 Patrawalla P, et al. J Intensive Care Med. 2019 Feb 12: [Epub ahead of print]), but ongoing education, assessment, and quality assurance is required to achieve sustained competence. Ideally, training in POCUS should entail a dedicated, intensive introduction to the competencies of critical care ultrasound (such as the above regional courses or CHEST ultrasound courses), followed by a formal curriculum within the PCCM fellowship programs. This curriculum should afford the trainee exposure to critically ill patients in an environment with adequate ultrasound equipment and a method to record studies. The trainee then interprets the acquired studies in clinical context. Preferably, the program will afford the trainee real-time quality assurance for image acquisition and interpretation by a program champion. Quality assurance can be provided on site or remotely using fixed interval review sessions. Lastly, the program should have internal milestones to evaluate when a trainee has reached competency to perform these tasks independently. The completion of training should include a letter to any future employee attesting to the trainee’s acquisition of these skills and ability to apply them safely while caring for the critically ill. This robust education is occurring in many centers across the country. PCCM fellowship programs owe it to their trainees, and patients, that competency-based critical care ultrasound training is robust, standardized, and supported.
 

Point-of-care ultrasound (POCUS) is an essential part of ICU care. It has been demonstrated to improve patient safety and outcomes through procedural guidance (Brass P, et al. Cochrane Database Syst Rev. 2015 Jan 9;1:CD006962) and aid in accurate and timely diagnosis of cardiopulmonary failure (Lichtenstein DA, Mezière GA. Chest. 2008 Jul;134[1]:117-25). Due in part to increasing affordability and portability of ultrasound technologies, the use of POCUS has become seemingly ubiquitous and will continue to increase in coming years. According to expert groups representing 12 critical care societies worldwide, general critical care ultrasound and basic critical care echocardiography should be mandatory training for ICU physicians (Expert Round Table on Ultrasound in ICU. Intensive Care Med. 2011 Jul;37[7]:1077-83).

Currently, POCUS is not universally taught to pulmonary and critical care fellows (PCCM); and when training does exist, curriculums are not standardized. This is in part due to the broadly worded requirements set forth from the ACGME for pulmonary disease and critical care medicine. The totality of ACGME common program requirements as it regards to ultrasound training are as follows: 1. “Fellows must demonstrate competence in procedural and technical skills, including ... use of ultrasound techniques to perform thoracentesis and place intravascular and intracavitary tubes and catheters”; and 2. “Fellows must demonstrate knowledge of imaging techniques commonly employed in the evaluation of patients with pulmonary disease or critical illness, including the use of ultrasound” (ACGME Program Requirements for Graduate Medical Education in Pulmonary Disease and Critical Care Medicine).

In comparison, recently updated ACGME common program requirements for ultrasound in emergency medicine and anesthesiology residencies are robust and detailed. Requirements for anesthesia residency training include: ” ... competency in using surface ultrasound ... and transthoracic echocardiography to guide the performance of invasive procedures and to evaluate organ function and pathology ... understanding the principles of ultrasound, including the physics of ultrasound transmission, ultrasound transducer construction, and transducer selection for specific applications, to include being able to obtain images with an understanding of limitations and artifacts ... obtaining standard views of the heart and inferior vena cava with transthoracic echocardiography allowing the evaluation of myocardial function, estimation of central venous pressure, and gross pericardial/cardiac pathology (eg, large pericardial effusion) ... using transthoracic ultrasound for the detection of pneumothorax and pleural effusion ... using surface ultrasound to guide vascular access (both central and peripheral) ... describing techniques, views, and findings in standard language” (ACGME Program Requirements for Graduate Medical Education In Anesthesiology).

Herein lies a stark contrast in what is required of programs that train physicians to care for unstable patients and the critically ill. Current requirements leave graduates of PCCM training programs vulnerable to completing ACGME milestones without being adequately prepared to evaluate patients in a modern ICU setting. Increasingly, hospitals credentialing committees expect PCCM graduates to be suitably trained in ultrasound. Regrettably, there is no assurance that is true, or standardized, with current PCCM fellowship training requirements.

There is not a national standard for competency assessment or requirements for credentialing in POCUS for critical care physicians at this time. However, multiple national and international critical care societies, including CHEST, have consensus statements and recommendations outlining the areas of competence expected in critical care ultrasound (Mayo PH, et al. Chest. 2009 Apr;135[4];1050-60, Expert Round Table on Ultrasound in ICU. Intensive Care Med. 2011 Jul;37(7):1077-83). The PCCM ACGME requirements should be updated to reflect such recommendations, thereby placing greater emphasis on ultrasound teaching requirements and standardized curriculums. Despite the current ACGME program requirements, it is incumbent upon critical care training programs to provide competency-based education of this now “standard of care” technology.

Barriers to universal POCUS training exist. Fellowship programs may lack trained, ultrasound confident faculty, time, and funding to successfully develop and sustain an ultrasound curriculum. (Eisen LA, et al. Crit Care Med. 2010;38[10]:1978-83; Patrawalla P, et al. J Intensive Care Med. 2019 Feb 12: [Epub ahead of print].)

Although access to adequate quality and quantity of ultrasound machines is less often a problem than in the past, many institutions lack archival and image review software that allows for quality assurance of image acquisition, and some still may not have a faculty member with expertise and ability to champion the cause.

In attempts to mitigate the local faculty gaps, national and regional solutions have been developed for ultrasonography education. CHEST has educated more than 1,400 learners in the Ultrasound Essentials course since 2013. Also, grassroots efforts have led to the development of courses specifically designed to teach incoming PCCM fellows. Using a collaborative and cost-effective model, these regional programs pool faculty and experts in the field to train multiple fellowship programs simultaneously. The first of these was created over a decade ago in New York City (Patrawalla P, et al. J Intensive Care Med. 2019 Feb 12:[Epub ahead of print].)

Currently, there are at least four regional annual ultrasound courses directed at teaching PCCM fellows. These courses are typically held over multiple days and encompass the basics of critical care ultrasound, including vascular, thoracic, abdominal, cardiac, and procedural imaging. By estimation, these four courses provide a basic ultrasonography education to approximately two-thirds of first year pulmonary and critical care fellows in the United States. In addition to training fellows, these programs also serve as a platform for the development of local faculty experts, so that training can continue at their institutions.

Introductory courses are highly effective (Dinh VA, et al. Crit Care Res Pract. 2015 Aug 5:675041 Patrawalla P, et al. J Intensive Care Med. 2019 Feb 12: [Epub ahead of print]), but ongoing education, assessment, and quality assurance is required to achieve sustained competence. Ideally, training in POCUS should entail a dedicated, intensive introduction to the competencies of critical care ultrasound (such as the above regional courses or CHEST ultrasound courses), followed by a formal curriculum within the PCCM fellowship programs. This curriculum should afford the trainee exposure to critically ill patients in an environment with adequate ultrasound equipment and a method to record studies. The trainee then interprets the acquired studies in clinical context. Preferably, the program will afford the trainee real-time quality assurance for image acquisition and interpretation by a program champion. Quality assurance can be provided on site or remotely using fixed interval review sessions. Lastly, the program should have internal milestones to evaluate when a trainee has reached competency to perform these tasks independently. The completion of training should include a letter to any future employee attesting to the trainee’s acquisition of these skills and ability to apply them safely while caring for the critically ill. This robust education is occurring in many centers across the country. PCCM fellowship programs owe it to their trainees, and patients, that competency-based critical care ultrasound training is robust, standardized, and supported.