Image by Kevin MacKenzie

The US Food and Drug Administration (FDA) has approved a ready-to-use formulation of bivalirudin for use as an anticoagulant in patients undergoing percutaneous coronary intervention.

Baxter International Inc. expects to launch this frozen, premixed formulation of bivalirudin—Bivalirudin in 0.9% Sodium Chloride Injection—in the US early this year.

The product will be available in 2 commonly prescribed dosage forms and strengths: 250 mg of bivalirudin per 50 mL (5 mg/mL) and 500 mg of bivalirudin per 100 mL (5 mg/mL).

This frozen, premixed, ready-to-use bivalirudin makes use of Baxter’s proprietary frozen GALAXY container technology, a non-PVC and non-DEHP system specifically designed to create a ready-to-use format for unstable molecules.

Baxter’s premixed medications are manufactured to current Good Manufacturing Practice regulations established and monitored by the FDA.

Image by Kevin MacKenzie

The US Food and Drug Administration (FDA) has approved a ready-to-use formulation of bivalirudin for use as an anticoagulant in patients undergoing percutaneous coronary intervention.

Baxter International Inc. expects to launch this frozen, premixed formulation of bivalirudin—Bivalirudin in 0.9% Sodium Chloride Injection—in the US early this year.

The product will be available in 2 commonly prescribed dosage forms and strengths: 250 mg of bivalirudin per 50 mL (5 mg/mL) and 500 mg of bivalirudin per 100 mL (5 mg/mL).

This frozen, premixed, ready-to-use bivalirudin makes use of Baxter’s proprietary frozen GALAXY container technology, a non-PVC and non-DEHP system specifically designed to create a ready-to-use format for unstable molecules.

Baxter’s premixed medications are manufactured to current Good Manufacturing Practice regulations established and monitored by the FDA.

Image by Kevin MacKenzie

The US Food and Drug Administration (FDA) has approved a ready-to-use formulation of bivalirudin for use as an anticoagulant in patients undergoing percutaneous coronary intervention.

Baxter International Inc. expects to launch this frozen, premixed formulation of bivalirudin—Bivalirudin in 0.9% Sodium Chloride Injection—in the US early this year.

The product will be available in 2 commonly prescribed dosage forms and strengths: 250 mg of bivalirudin per 50 mL (5 mg/mL) and 500 mg of bivalirudin per 100 mL (5 mg/mL).

This frozen, premixed, ready-to-use bivalirudin makes use of Baxter’s proprietary frozen GALAXY container technology, a non-PVC and non-DEHP system specifically designed to create a ready-to-use format for unstable molecules.

Baxter’s premixed medications are manufactured to current Good Manufacturing Practice regulations established and monitored by the FDA.

AML cells

The European Commission (EC) has granted orphan designation to gilteritinib for the treatment of patients with acute myeloid leukemia (AML).

Gilteritinib is an investigational compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication, FLT3 tyrosine kinase domain, and the AXL receptor.

Astellas Pharma Inc. is currently investigating gilteritinib in phase 3 trials of AML patients.

Results from a phase 1/2 study of gilteritinib in AML were published in The Lancet Oncology last June.

The study enrolled 252 adults with relapsed/refractory AML. They received gilteritinib once daily in 1 of 7 dose-escalation (n=23) or dose-expansion (n=229) cohorts.

The maximum tolerated dose was 300 mg/day. There were 2 dose-limiting toxicities in the 450 mg dose-escalation cohort—grade 3 diarrhea and grade 3 elevated aspartate aminotransferase.

Common treatment-related adverse events were diarrhea (37%), anemia (34%), fatigue (33%), elevated aspartate aminotransferase (26%), and increased alanine aminotransferase (19%).

Serious adverse events related to treatment included febrile neutropenia (n=5), sepsis (n=2), acute renal failure (n=5), pyrexia (n=3), and bacteremia (n=1).

There were 7 deaths considered possibly or probably related to treatment—pulmonary embolism (200 mg/day), respiratory failure (120 mg/day), hemoptysis (80 mg/day), intracranial hemorrhage (20 mg/day), ventricular fibrillation (120 mg/day), septic shock (80 mg/day), and neutropenia (120 mg/day).

The overall response rate was 40% (100/249), and the complete response (CR) rate was 8% (n=19).

Four percent of patients (n=10) had a CR with incomplete platelet recovery, 18% (n=46) had a CR with incomplete hematological recovery, and 10% (n=25) had a partial response.

About orphan designation

Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.

Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval.

The designation also provides incentives for companies seeking protocol assistance from the European Medicines Agency during the product development phase and direct access to the centralized authorization procedure.

AML cells

The European Commission (EC) has granted orphan designation to gilteritinib for the treatment of patients with acute myeloid leukemia (AML).

Gilteritinib is an investigational compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication, FLT3 tyrosine kinase domain, and the AXL receptor.

Astellas Pharma Inc. is currently investigating gilteritinib in phase 3 trials of AML patients.

Results from a phase 1/2 study of gilteritinib in AML were published in The Lancet Oncology last June.

The study enrolled 252 adults with relapsed/refractory AML. They received gilteritinib once daily in 1 of 7 dose-escalation (n=23) or dose-expansion (n=229) cohorts.

The maximum tolerated dose was 300 mg/day. There were 2 dose-limiting toxicities in the 450 mg dose-escalation cohort—grade 3 diarrhea and grade 3 elevated aspartate aminotransferase.

Common treatment-related adverse events were diarrhea (37%), anemia (34%), fatigue (33%), elevated aspartate aminotransferase (26%), and increased alanine aminotransferase (19%).

Serious adverse events related to treatment included febrile neutropenia (n=5), sepsis (n=2), acute renal failure (n=5), pyrexia (n=3), and bacteremia (n=1).

There were 7 deaths considered possibly or probably related to treatment—pulmonary embolism (200 mg/day), respiratory failure (120 mg/day), hemoptysis (80 mg/day), intracranial hemorrhage (20 mg/day), ventricular fibrillation (120 mg/day), septic shock (80 mg/day), and neutropenia (120 mg/day).

The overall response rate was 40% (100/249), and the complete response (CR) rate was 8% (n=19).

Four percent of patients (n=10) had a CR with incomplete platelet recovery, 18% (n=46) had a CR with incomplete hematological recovery, and 10% (n=25) had a partial response.

About orphan designation

Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.

Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval.

The designation also provides incentives for companies seeking protocol assistance from the European Medicines Agency during the product development phase and direct access to the centralized authorization procedure.

AML cells

The European Commission (EC) has granted orphan designation to gilteritinib for the treatment of patients with acute myeloid leukemia (AML).

Gilteritinib is an investigational compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication, FLT3 tyrosine kinase domain, and the AXL receptor.

Astellas Pharma Inc. is currently investigating gilteritinib in phase 3 trials of AML patients.

Results from a phase 1/2 study of gilteritinib in AML were published in The Lancet Oncology last June.

The study enrolled 252 adults with relapsed/refractory AML. They received gilteritinib once daily in 1 of 7 dose-escalation (n=23) or dose-expansion (n=229) cohorts.

The maximum tolerated dose was 300 mg/day. There were 2 dose-limiting toxicities in the 450 mg dose-escalation cohort—grade 3 diarrhea and grade 3 elevated aspartate aminotransferase.

Common treatment-related adverse events were diarrhea (37%), anemia (34%), fatigue (33%), elevated aspartate aminotransferase (26%), and increased alanine aminotransferase (19%).

Serious adverse events related to treatment included febrile neutropenia (n=5), sepsis (n=2), acute renal failure (n=5), pyrexia (n=3), and bacteremia (n=1).

There were 7 deaths considered possibly or probably related to treatment—pulmonary embolism (200 mg/day), respiratory failure (120 mg/day), hemoptysis (80 mg/day), intracranial hemorrhage (20 mg/day), ventricular fibrillation (120 mg/day), septic shock (80 mg/day), and neutropenia (120 mg/day).

The overall response rate was 40% (100/249), and the complete response (CR) rate was 8% (n=19).

Four percent of patients (n=10) had a CR with incomplete platelet recovery, 18% (n=46) had a CR with incomplete hematological recovery, and 10% (n=25) had a partial response.

About orphan designation

Orphan designation provides regulatory and financial incentives for companies to develop and market therapies that treat life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union, and where no satisfactory treatment is available.

Orphan designation provides a 10-year period of marketing exclusivity if the drug receives regulatory approval.

The designation also provides incentives for companies seeking protocol assistance from the European Medicines Agency during the product development phase and direct access to the centralized authorization procedure.

People with rheumatologic diseases and cancer appear to be at no higher risk of having an adverse event or disease flare if they receive checkpoint inhibitor therapy, compared with the general population, experience from the Mayo Clinic suggests.

In a brief report published in Arthritis and Rheumatology, a team from the Mayo Clinic in Rochester, Minn., reported on 16 patients with rheumatologic diseases who received cancer immunotherapy. They found that only a minority experienced a flare of their disease or another immune-related event.

The rate of severe immune-related adverse effects (IRAEs) with a single immune checkpoint inhibitor (ICI) has been reported to be less than 2% among the average population. However, less is known about patients with underlying rheumatologic disease, largely because initial trials of ICIs had excluded patients with autoimmune diseases for fear the treatment would induce a disease flare, the researchers noted.

Small studies have suggested that people with inflammatory arthritis or connective tissue diseases have higher rates of IRAEs with immunotherapy, but it is unclear how often these events represented flares of their disease or new autoimmune events, and whether the events had any predictive significance for cancer survival.

In this study, researchers performed a retrospective review of medical records and identified 16 patients with rheumatologic diseases who had received checkpoint inhibitor therapy at the Mayo Clinic between 2011 and 2016.

The most common rheumatologic diseases among the 16 patients were rheumatoid arthritis, polymyalgia rheumatica, Sjögren’s syndrome, and systemic lupus erythematosus, and the most common cancers were malignant melanoma, pulmonary malignancies, and non-Hodgkin lymphoma. Seven of the patients were receiving immunosuppressive therapy or glucocorticoids for their rheumatologic disease upon initiation of a checkpoint inhibitor.

Ten patients had received a prior disease-modifying antirheumatic drug, but only two patients were still taking this at the time of ICI initiation.

Results showed that six of the patients (38%) had an IRAE or flare of their rheumatologic disease, two were graded as mild. All of the patients responded well to glucocorticoids and discontinuation of therapy. The most common event was colitis and just one patient had a flare of rheumatologic disease.

“This is consistent with what is currently known about the management of IRAEs,” the research team wrote. “This study adds further support to the emerging notion that the rate of IRAEs is not necessarily higher in this group compared to the general population.”

The type and severity of rheumatologic disease may play an important role in both the risk of disease flare and IRAEs, a factor that they were unable to assess in the current study, the researchers wrote.

“Further large, prospective studies are needed to address the link between the type, severity, and concurrent rheumatologic disease activity on the risk of flare and IRAE. It is possible that patients with more severe or active disease are at higher risk for these complications,” they wrote.

While patients in the study did not appear to have significantly increased incidence or severity of adverse effects, the research team advised that “treatment decisions must factor in clinical judgement.”

They noted that some studies had proposed predictive biomarkers, pretreatment workup, and monitoring, but this advice was based on a small body of evidence.

“Larger, prospective studies will be necessary to validate these findings and establish evidence-based guidelines for appropriate identification and rating of the rheumatologic IRAEs as well as their treatment, such that patients can continue to receive potentially life-saving cancer treatments,” they wrote.

One of the researchers reported advisory board membership with Bristol-Myers Squibb.

[email protected]

SOURCE: Richter M et al. Arthritis Rheumatol. 2018 Jan 24. doi: 10.1002/art.40397.

People with rheumatologic diseases and cancer appear to be at no higher risk of having an adverse event or disease flare if they receive checkpoint inhibitor therapy, compared with the general population, experience from the Mayo Clinic suggests.

In a brief report published in Arthritis and Rheumatology, a team from the Mayo Clinic in Rochester, Minn., reported on 16 patients with rheumatologic diseases who received cancer immunotherapy. They found that only a minority experienced a flare of their disease or another immune-related event.

The rate of severe immune-related adverse effects (IRAEs) with a single immune checkpoint inhibitor (ICI) has been reported to be less than 2% among the average population. However, less is known about patients with underlying rheumatologic disease, largely because initial trials of ICIs had excluded patients with autoimmune diseases for fear the treatment would induce a disease flare, the researchers noted.

Small studies have suggested that people with inflammatory arthritis or connective tissue diseases have higher rates of IRAEs with immunotherapy, but it is unclear how often these events represented flares of their disease or new autoimmune events, and whether the events had any predictive significance for cancer survival.

In this study, researchers performed a retrospective review of medical records and identified 16 patients with rheumatologic diseases who had received checkpoint inhibitor therapy at the Mayo Clinic between 2011 and 2016.

The most common rheumatologic diseases among the 16 patients were rheumatoid arthritis, polymyalgia rheumatica, Sjögren’s syndrome, and systemic lupus erythematosus, and the most common cancers were malignant melanoma, pulmonary malignancies, and non-Hodgkin lymphoma. Seven of the patients were receiving immunosuppressive therapy or glucocorticoids for their rheumatologic disease upon initiation of a checkpoint inhibitor.

Ten patients had received a prior disease-modifying antirheumatic drug, but only two patients were still taking this at the time of ICI initiation.

Results showed that six of the patients (38%) had an IRAE or flare of their rheumatologic disease, two were graded as mild. All of the patients responded well to glucocorticoids and discontinuation of therapy. The most common event was colitis and just one patient had a flare of rheumatologic disease.

“This is consistent with what is currently known about the management of IRAEs,” the research team wrote. “This study adds further support to the emerging notion that the rate of IRAEs is not necessarily higher in this group compared to the general population.”

The type and severity of rheumatologic disease may play an important role in both the risk of disease flare and IRAEs, a factor that they were unable to assess in the current study, the researchers wrote.

“Further large, prospective studies are needed to address the link between the type, severity, and concurrent rheumatologic disease activity on the risk of flare and IRAE. It is possible that patients with more severe or active disease are at higher risk for these complications,” they wrote.

While patients in the study did not appear to have significantly increased incidence or severity of adverse effects, the research team advised that “treatment decisions must factor in clinical judgement.”

They noted that some studies had proposed predictive biomarkers, pretreatment workup, and monitoring, but this advice was based on a small body of evidence.

“Larger, prospective studies will be necessary to validate these findings and establish evidence-based guidelines for appropriate identification and rating of the rheumatologic IRAEs as well as their treatment, such that patients can continue to receive potentially life-saving cancer treatments,” they wrote.

One of the researchers reported advisory board membership with Bristol-Myers Squibb.

[email protected]

SOURCE: Richter M et al. Arthritis Rheumatol. 2018 Jan 24. doi: 10.1002/art.40397.

People with rheumatologic diseases and cancer appear to be at no higher risk of having an adverse event or disease flare if they receive checkpoint inhibitor therapy, compared with the general population, experience from the Mayo Clinic suggests.

In a brief report published in Arthritis and Rheumatology, a team from the Mayo Clinic in Rochester, Minn., reported on 16 patients with rheumatologic diseases who received cancer immunotherapy. They found that only a minority experienced a flare of their disease or another immune-related event.

The rate of severe immune-related adverse effects (IRAEs) with a single immune checkpoint inhibitor (ICI) has been reported to be less than 2% among the average population. However, less is known about patients with underlying rheumatologic disease, largely because initial trials of ICIs had excluded patients with autoimmune diseases for fear the treatment would induce a disease flare, the researchers noted.

Small studies have suggested that people with inflammatory arthritis or connective tissue diseases have higher rates of IRAEs with immunotherapy, but it is unclear how often these events represented flares of their disease or new autoimmune events, and whether the events had any predictive significance for cancer survival.

In this study, researchers performed a retrospective review of medical records and identified 16 patients with rheumatologic diseases who had received checkpoint inhibitor therapy at the Mayo Clinic between 2011 and 2016.

The most common rheumatologic diseases among the 16 patients were rheumatoid arthritis, polymyalgia rheumatica, Sjögren’s syndrome, and systemic lupus erythematosus, and the most common cancers were malignant melanoma, pulmonary malignancies, and non-Hodgkin lymphoma. Seven of the patients were receiving immunosuppressive therapy or glucocorticoids for their rheumatologic disease upon initiation of a checkpoint inhibitor.

Ten patients had received a prior disease-modifying antirheumatic drug, but only two patients were still taking this at the time of ICI initiation.

Results showed that six of the patients (38%) had an IRAE or flare of their rheumatologic disease, two were graded as mild. All of the patients responded well to glucocorticoids and discontinuation of therapy. The most common event was colitis and just one patient had a flare of rheumatologic disease.

“This is consistent with what is currently known about the management of IRAEs,” the research team wrote. “This study adds further support to the emerging notion that the rate of IRAEs is not necessarily higher in this group compared to the general population.”

The type and severity of rheumatologic disease may play an important role in both the risk of disease flare and IRAEs, a factor that they were unable to assess in the current study, the researchers wrote.

“Further large, prospective studies are needed to address the link between the type, severity, and concurrent rheumatologic disease activity on the risk of flare and IRAE. It is possible that patients with more severe or active disease are at higher risk for these complications,” they wrote.

While patients in the study did not appear to have significantly increased incidence or severity of adverse effects, the research team advised that “treatment decisions must factor in clinical judgement.”

They noted that some studies had proposed predictive biomarkers, pretreatment workup, and monitoring, but this advice was based on a small body of evidence.

“Larger, prospective studies will be necessary to validate these findings and establish evidence-based guidelines for appropriate identification and rating of the rheumatologic IRAEs as well as their treatment, such that patients can continue to receive potentially life-saving cancer treatments,” they wrote.

One of the researchers reported advisory board membership with Bristol-Myers Squibb.

[email protected]

SOURCE: Richter M et al. Arthritis Rheumatol. 2018 Jan 24. doi: 10.1002/art.40397.

Silverman, M., et al, Ann Intern Med 166(11):765, June 6, 2017

BACKGROUND: Overuse of antibiotics increases healthcare costs and contributes to the emergence of resistance, but these agents continue to be prescribed heavily for nonbacterial acute upper respiratory infections. Factors influencing physicians may include patient expectations, decision fatigue, fear of complications and unintended financial incentives.

METHODS: In this retrospective analysis of administrative healthcare data, the authors from the University of Western Ontario included 185,014 patients aged 66 or older (mean age 74.6 years) presenting to 8990 primary care physicians who were diagnosed with a first episode of nonbacterial acute upper respiratory infection that did not otherwise warrant antibiotic treatment. More than 90% of the episodes were managed by one physician and involved one visit. The primary outcome was antibiotic prescription within 30 days. Episode, patient and physician factors, in the context of antibiotic prescription, were evaluated.

RESULTS: Overall, 46.2% of the patients were prescribed antibiotics (broad-spectrum agents in 69.9% of these cases). Patients receiving an antibiotic prescription were more likely than those not prescribed an antibiotic to be diagnosed with acute bronchitis (45.3% vs. 19.3%) or acute sinusitis (17.1% vs. 10.6%). Patients were more likely to receive antibiotic prescriptions when physicians were mid- and late-career vs. early-career, trained outside of Canada or the United States, and seeing more than 25 patients per day. Broad-spectrum agents were more frequently prescribed by mid- and late-career physicians and those trained in Canada or the United States.

CONCLUSIONS: Almost one-half of these elderly patients with nonbacterial acute upper respiratory infections received unnecessary antibiotic prescriptions. This study sheds light on the prevalence and predictors of such prescribing. 58 references ([email protected] for reprints)

Silverman, M., et al, Ann Intern Med 166(11):765, June 6, 2017

BACKGROUND: Overuse of antibiotics increases healthcare costs and contributes to the emergence of resistance, but these agents continue to be prescribed heavily for nonbacterial acute upper respiratory infections. Factors influencing physicians may include patient expectations, decision fatigue, fear of complications and unintended financial incentives.

METHODS: In this retrospective analysis of administrative healthcare data, the authors from the University of Western Ontario included 185,014 patients aged 66 or older (mean age 74.6 years) presenting to 8990 primary care physicians who were diagnosed with a first episode of nonbacterial acute upper respiratory infection that did not otherwise warrant antibiotic treatment. More than 90% of the episodes were managed by one physician and involved one visit. The primary outcome was antibiotic prescription within 30 days. Episode, patient and physician factors, in the context of antibiotic prescription, were evaluated.

RESULTS: Overall, 46.2% of the patients were prescribed antibiotics (broad-spectrum agents in 69.9% of these cases). Patients receiving an antibiotic prescription were more likely than those not prescribed an antibiotic to be diagnosed with acute bronchitis (45.3% vs. 19.3%) or acute sinusitis (17.1% vs. 10.6%). Patients were more likely to receive antibiotic prescriptions when physicians were mid- and late-career vs. early-career, trained outside of Canada or the United States, and seeing more than 25 patients per day. Broad-spectrum agents were more frequently prescribed by mid- and late-career physicians and those trained in Canada or the United States.

CONCLUSIONS: Almost one-half of these elderly patients with nonbacterial acute upper respiratory infections received unnecessary antibiotic prescriptions. This study sheds light on the prevalence and predictors of such prescribing. 58 references ([email protected] for reprints)

Silverman, M., et al, Ann Intern Med 166(11):765, June 6, 2017

BACKGROUND: Overuse of antibiotics increases healthcare costs and contributes to the emergence of resistance, but these agents continue to be prescribed heavily for nonbacterial acute upper respiratory infections. Factors influencing physicians may include patient expectations, decision fatigue, fear of complications and unintended financial incentives.

METHODS: In this retrospective analysis of administrative healthcare data, the authors from the University of Western Ontario included 185,014 patients aged 66 or older (mean age 74.6 years) presenting to 8990 primary care physicians who were diagnosed with a first episode of nonbacterial acute upper respiratory infection that did not otherwise warrant antibiotic treatment. More than 90% of the episodes were managed by one physician and involved one visit. The primary outcome was antibiotic prescription within 30 days. Episode, patient and physician factors, in the context of antibiotic prescription, were evaluated.

RESULTS: Overall, 46.2% of the patients were prescribed antibiotics (broad-spectrum agents in 69.9% of these cases). Patients receiving an antibiotic prescription were more likely than those not prescribed an antibiotic to be diagnosed with acute bronchitis (45.3% vs. 19.3%) or acute sinusitis (17.1% vs. 10.6%). Patients were more likely to receive antibiotic prescriptions when physicians were mid- and late-career vs. early-career, trained outside of Canada or the United States, and seeing more than 25 patients per day. Broad-spectrum agents were more frequently prescribed by mid- and late-career physicians and those trained in Canada or the United States.

CONCLUSIONS: Almost one-half of these elderly patients with nonbacterial acute upper respiratory infections received unnecessary antibiotic prescriptions. This study sheds light on the prevalence and predictors of such prescribing. 58 references ([email protected] for reprints)

The Society of Hospital Medicine recently opened the 2018 State of Hospital Medicine (SoHM) Survey and is now seeking participants from hospital medicine groups to contribute to the collective understanding of the state of the specialty.

Results from the biennial survey will be analyzed and compiled into the 2018 SoHM Report to provide current data on hospitalist compensation and production, as well as cutting-edge knowledge covering practice demographics, staffing levels, turnover, staff growth, and financial support. The SoHM Survey closes on Feb. 16, 2018.

“The SoHM Survey lays the foundation for the creation of one of the most expansive tools for hospital medicine professionals,” said Beth Hawley, MBA, FACHE, chief operating officer of SHM. “With the help of participants from hospital medicine groups nationwide, it creates an up-to-date snapshot of trends in the specialty to help inform staffing and management decisions.”

The 2018 SoHM Survey includes new questions about open hospitalist physician positions during the year, including what percentage of approved staffing was unfilled and how the group filled the coverage. Other new topics ask about the number of work Relative Value Units generated by participating hospital medicine groups and who selects the billing codes for the groups.

Over the past year and a half, five distinct efforts were completed to collect user feedback for both the survey and report development processes. Efforts ranged from in-person focus groups at SHM’s Annual Conference to online user surveys. After information was collected and summarized, SHM’s Practice Analysis Committee ranked every question to trim down the Survey from 70 questions in 2016 to 52 questions in 2018.

The 2018 SoHM Report will be available this fall in print only, as a bundle of print and digital, or as digital only, with special discounts available for SHM members.

Committee members are available for one-on-one guidance as participants complete the Survey. For more information and to participate, visit www.hospitalmedicine.org/sohm.




 

The Society of Hospital Medicine recently opened the 2018 State of Hospital Medicine (SoHM) Survey and is now seeking participants from hospital medicine groups to contribute to the collective understanding of the state of the specialty.

Results from the biennial survey will be analyzed and compiled into the 2018 SoHM Report to provide current data on hospitalist compensation and production, as well as cutting-edge knowledge covering practice demographics, staffing levels, turnover, staff growth, and financial support. The SoHM Survey closes on Feb. 16, 2018.

“The SoHM Survey lays the foundation for the creation of one of the most expansive tools for hospital medicine professionals,” said Beth Hawley, MBA, FACHE, chief operating officer of SHM. “With the help of participants from hospital medicine groups nationwide, it creates an up-to-date snapshot of trends in the specialty to help inform staffing and management decisions.”

The 2018 SoHM Survey includes new questions about open hospitalist physician positions during the year, including what percentage of approved staffing was unfilled and how the group filled the coverage. Other new topics ask about the number of work Relative Value Units generated by participating hospital medicine groups and who selects the billing codes for the groups.

Over the past year and a half, five distinct efforts were completed to collect user feedback for both the survey and report development processes. Efforts ranged from in-person focus groups at SHM’s Annual Conference to online user surveys. After information was collected and summarized, SHM’s Practice Analysis Committee ranked every question to trim down the Survey from 70 questions in 2016 to 52 questions in 2018.

The 2018 SoHM Report will be available this fall in print only, as a bundle of print and digital, or as digital only, with special discounts available for SHM members.

Committee members are available for one-on-one guidance as participants complete the Survey. For more information and to participate, visit www.hospitalmedicine.org/sohm.




 

The Society of Hospital Medicine recently opened the 2018 State of Hospital Medicine (SoHM) Survey and is now seeking participants from hospital medicine groups to contribute to the collective understanding of the state of the specialty.

Results from the biennial survey will be analyzed and compiled into the 2018 SoHM Report to provide current data on hospitalist compensation and production, as well as cutting-edge knowledge covering practice demographics, staffing levels, turnover, staff growth, and financial support. The SoHM Survey closes on Feb. 16, 2018.

“The SoHM Survey lays the foundation for the creation of one of the most expansive tools for hospital medicine professionals,” said Beth Hawley, MBA, FACHE, chief operating officer of SHM. “With the help of participants from hospital medicine groups nationwide, it creates an up-to-date snapshot of trends in the specialty to help inform staffing and management decisions.”

The 2018 SoHM Survey includes new questions about open hospitalist physician positions during the year, including what percentage of approved staffing was unfilled and how the group filled the coverage. Other new topics ask about the number of work Relative Value Units generated by participating hospital medicine groups and who selects the billing codes for the groups.

Over the past year and a half, five distinct efforts were completed to collect user feedback for both the survey and report development processes. Efforts ranged from in-person focus groups at SHM’s Annual Conference to online user surveys. After information was collected and summarized, SHM’s Practice Analysis Committee ranked every question to trim down the Survey from 70 questions in 2016 to 52 questions in 2018.

The 2018 SoHM Report will be available this fall in print only, as a bundle of print and digital, or as digital only, with special discounts available for SHM members.

Committee members are available for one-on-one guidance as participants complete the Survey. For more information and to participate, visit www.hospitalmedicine.org/sohm.




 

This is the first article in a series on the cost of medications.

While it’s not news that some pharmaceuticals are exorbitantly expensive and therefore unavailable to our patients, I have learned that there are ways around the obstacle of cost for at least some medications. I want to tell you what I’ve learned about the high cost of two medications: aripiprazole, the generic of Abilify, and modafinil, the generic of Provigil, but the lessons learned may apply to other psychotropics – and Smokey Robinson and the Miracles said it best in a line from their 1960 hit song, “You’d better shop around.”

Gina L. Henderson/Frontline Medical News

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).

This is the first article in a series on the cost of medications.

While it’s not news that some pharmaceuticals are exorbitantly expensive and therefore unavailable to our patients, I have learned that there are ways around the obstacle of cost for at least some medications. I want to tell you what I’ve learned about the high cost of two medications: aripiprazole, the generic of Abilify, and modafinil, the generic of Provigil, but the lessons learned may apply to other psychotropics – and Smokey Robinson and the Miracles said it best in a line from their 1960 hit song, “You’d better shop around.”

Gina L. Henderson/Frontline Medical News

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).

This is the first article in a series on the cost of medications.

While it’s not news that some pharmaceuticals are exorbitantly expensive and therefore unavailable to our patients, I have learned that there are ways around the obstacle of cost for at least some medications. I want to tell you what I’ve learned about the high cost of two medications: aripiprazole, the generic of Abilify, and modafinil, the generic of Provigil, but the lessons learned may apply to other psychotropics – and Smokey Robinson and the Miracles said it best in a line from their 1960 hit song, “You’d better shop around.”

Gina L. Henderson/Frontline Medical News

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).

The prior authorization approval process required by health insurance companies for patients’ medical treatments, also called preapproval, eats up countless hours of time and costs, over $80,000 per year, per provider. The average provider deals with 35 of these prior authorization requests per day, and each request takes an average of 20 minutes. Physicians, pharmacists, hospitals, medical groups, and health insurance companies are working together to come up with a solution.

The American Hospital Association, America’s Health Insurance Plans, American Medical Association, American Pharmacists Association, Blue Cross Blue Shield Association, and Medical Group Management Association announced a consensus statement delineating where they agree the health care industry can improve the prior authorization process.

Most of the solutions outlined in the document are intuitive – they include reducing the number of health care professionals subject to prior authorization requirements based on their performance; adherence to evidence-based medical practices or participation in a value-based agreement with the health insurance provider; reviewing the services and medications that require prior authorization and eliminating requirements for therapies that no longer warrant them; improving communications between health insurance providers, health care professionals, and patients to provide clarity on prior authorization requirements and changes; protecting continuity of care for patients; improving formulary information and coverage restrictions at point-of-care; and adopting national electronic standards for prior authorization.

Jack Resneck Jr., MD, chair-elect of the AMA board of trustees, described the document as a “good initial step” toward reducing the difficulties imposed by prior authorizations.

Prior authorization requests are particularly burdensome for medications that are expensive, a headache that doctors working with patients who have rheumatoid arthritis or lupus know well.

As insurance and provider groups work to improve the prior authorization process “it will be vital that they consider the issue from the perspective of general practitioners as well as specialists, the latter of whom prescribe more of the specialty tier medications that are subject to more protocols before patients can access these often life-improving medications,” Stephen Marmaras, director of policy and advocacy at Global Healthy Living Foundation, said in an interview. “Ultimately, improved communication between both parties – the physician offices and the payers – will allow us to identify barriers existing in current appeals processes and work toward collectively building solutions that benefit patients, particularly those with chronic disease who rely on stable access to medications.”

Sean Fahey, MD, chair of the American College of Rheumatology’s insurance subcommittee, said that, while the consensus statement is “a step in the right direction, like a lot of things, the devil is in the details.

“There’s good concepts in the statement without a whole lot of specifics,” Dr. Fahey said. Most changes will be addressed at the state level, because the federal legislature is very hesitant to legislate decisions for nongovernment insurance.

“A lot of the ideas set forth in this consensus statement are wonderful,” said Dr. Fahey. “Unfortunately for our patients, many of their medications are ludicrously expensive. … Every time you write a prescription for one of these medications, after appropriate therapy, you have to do [a preauthorization] just to get the medicine that people want and need. It’s frustrating that the issue of drug cost is driving the whole process. For a $60,000 a year price you’re going to have to do a preauthorization every single time, as opposed to a drug that’s $100 a year.”

Still, the statement is “an important step” toward ultimately making vital medications “more accessible for patients,” Dr. Fahey said.

[email protected]

The prior authorization approval process required by health insurance companies for patients’ medical treatments, also called preapproval, eats up countless hours of time and costs, over $80,000 per year, per provider. The average provider deals with 35 of these prior authorization requests per day, and each request takes an average of 20 minutes. Physicians, pharmacists, hospitals, medical groups, and health insurance companies are working together to come up with a solution.

The American Hospital Association, America’s Health Insurance Plans, American Medical Association, American Pharmacists Association, Blue Cross Blue Shield Association, and Medical Group Management Association announced a consensus statement delineating where they agree the health care industry can improve the prior authorization process.

Most of the solutions outlined in the document are intuitive – they include reducing the number of health care professionals subject to prior authorization requirements based on their performance; adherence to evidence-based medical practices or participation in a value-based agreement with the health insurance provider; reviewing the services and medications that require prior authorization and eliminating requirements for therapies that no longer warrant them; improving communications between health insurance providers, health care professionals, and patients to provide clarity on prior authorization requirements and changes; protecting continuity of care for patients; improving formulary information and coverage restrictions at point-of-care; and adopting national electronic standards for prior authorization.

Jack Resneck Jr., MD, chair-elect of the AMA board of trustees, described the document as a “good initial step” toward reducing the difficulties imposed by prior authorizations.

Prior authorization requests are particularly burdensome for medications that are expensive, a headache that doctors working with patients who have rheumatoid arthritis or lupus know well.

As insurance and provider groups work to improve the prior authorization process “it will be vital that they consider the issue from the perspective of general practitioners as well as specialists, the latter of whom prescribe more of the specialty tier medications that are subject to more protocols before patients can access these often life-improving medications,” Stephen Marmaras, director of policy and advocacy at Global Healthy Living Foundation, said in an interview. “Ultimately, improved communication between both parties – the physician offices and the payers – will allow us to identify barriers existing in current appeals processes and work toward collectively building solutions that benefit patients, particularly those with chronic disease who rely on stable access to medications.”

Sean Fahey, MD, chair of the American College of Rheumatology’s insurance subcommittee, said that, while the consensus statement is “a step in the right direction, like a lot of things, the devil is in the details.

“There’s good concepts in the statement without a whole lot of specifics,” Dr. Fahey said. Most changes will be addressed at the state level, because the federal legislature is very hesitant to legislate decisions for nongovernment insurance.

“A lot of the ideas set forth in this consensus statement are wonderful,” said Dr. Fahey. “Unfortunately for our patients, many of their medications are ludicrously expensive. … Every time you write a prescription for one of these medications, after appropriate therapy, you have to do [a preauthorization] just to get the medicine that people want and need. It’s frustrating that the issue of drug cost is driving the whole process. For a $60,000 a year price you’re going to have to do a preauthorization every single time, as opposed to a drug that’s $100 a year.”

Still, the statement is “an important step” toward ultimately making vital medications “more accessible for patients,” Dr. Fahey said.

[email protected]

The prior authorization approval process required by health insurance companies for patients’ medical treatments, also called preapproval, eats up countless hours of time and costs, over $80,000 per year, per provider. The average provider deals with 35 of these prior authorization requests per day, and each request takes an average of 20 minutes. Physicians, pharmacists, hospitals, medical groups, and health insurance companies are working together to come up with a solution.

The American Hospital Association, America’s Health Insurance Plans, American Medical Association, American Pharmacists Association, Blue Cross Blue Shield Association, and Medical Group Management Association announced a consensus statement delineating where they agree the health care industry can improve the prior authorization process.

Most of the solutions outlined in the document are intuitive – they include reducing the number of health care professionals subject to prior authorization requirements based on their performance; adherence to evidence-based medical practices or participation in a value-based agreement with the health insurance provider; reviewing the services and medications that require prior authorization and eliminating requirements for therapies that no longer warrant them; improving communications between health insurance providers, health care professionals, and patients to provide clarity on prior authorization requirements and changes; protecting continuity of care for patients; improving formulary information and coverage restrictions at point-of-care; and adopting national electronic standards for prior authorization.

Jack Resneck Jr., MD, chair-elect of the AMA board of trustees, described the document as a “good initial step” toward reducing the difficulties imposed by prior authorizations.

Prior authorization requests are particularly burdensome for medications that are expensive, a headache that doctors working with patients who have rheumatoid arthritis or lupus know well.

As insurance and provider groups work to improve the prior authorization process “it will be vital that they consider the issue from the perspective of general practitioners as well as specialists, the latter of whom prescribe more of the specialty tier medications that are subject to more protocols before patients can access these often life-improving medications,” Stephen Marmaras, director of policy and advocacy at Global Healthy Living Foundation, said in an interview. “Ultimately, improved communication between both parties – the physician offices and the payers – will allow us to identify barriers existing in current appeals processes and work toward collectively building solutions that benefit patients, particularly those with chronic disease who rely on stable access to medications.”

Sean Fahey, MD, chair of the American College of Rheumatology’s insurance subcommittee, said that, while the consensus statement is “a step in the right direction, like a lot of things, the devil is in the details.

“There’s good concepts in the statement without a whole lot of specifics,” Dr. Fahey said. Most changes will be addressed at the state level, because the federal legislature is very hesitant to legislate decisions for nongovernment insurance.

“A lot of the ideas set forth in this consensus statement are wonderful,” said Dr. Fahey. “Unfortunately for our patients, many of their medications are ludicrously expensive. … Every time you write a prescription for one of these medications, after appropriate therapy, you have to do [a preauthorization] just to get the medicine that people want and need. It’s frustrating that the issue of drug cost is driving the whole process. For a $60,000 a year price you’re going to have to do a preauthorization every single time, as opposed to a drug that’s $100 a year.”

Still, the statement is “an important step” toward ultimately making vital medications “more accessible for patients,” Dr. Fahey said.

[email protected]

The Diagnosis: Nevus Sebaceous

The patient presented with a typical solitary scalp lesion characteristic of nevus sebaceous (NS). The lesion was present at birth as a flat and smooth hairless plaque; however, over time it became more thickened and noticeable, which prompted the parents to seek medical advice.

Nevus sebaceous, also known as NS of Jadassohn, is a benign congenital hamartoma of the sebaceous gland that usually is present at birth and frequently involves the scalp and/or the face. The classic NS lesion is solitary and appears as a well-circumscribed, waxy, yellow-orange or tan, hairless plaque. Despite the presence of these lesions at birth, they may not be noted until early childhood or rarely until adulthood. Generally, the lesion tends to thicken and become more verrucous and velvety over time, particularly around the time of reaching puberty.¹ Clinically, NS lesions vary in size from 1 cm to several centimeters. Lesions initially tend to grow proportionately with the child until puberty when they become notably thicker, greasier, and verrucous or nodular under hormonal influences. The yellow discoloration of the lesion is due to sebaceous gland secretion, and the characteristic color usually becomes less evident with age.

Nevus sebaceous occurs in approximately 0.3% of newborns and tends to be sporadic in nature; however, rare familial forms have been reported.^2,3 Nevus sebaceous can present as multiple nevi that tend to be extensive and distributed along the Blaschko lines, and they usually are associated with neurologic, ocular, or skeletal defects. Involvement of the central nervous system frequently is associated with large sebaceous nevi located on the face or scalp. This association has been termed NS syndrome.⁴ Neurologic abnormalities associated with NS syndrome include seizures, mental retardation, and hemimegalencephaly.⁵ Ocular findings most communally associated with the syndrome are choristomas and colobomas.^6-8

There are several benign and malignant epithelial neoplasms that may develop within sebaceous nevi. Benign tumors include trichoblastoma, syringocystadenoma papilliferum, trichilemmoma, sebaceoma, nodular hidradenoma, and hidrocystoma.^1,8,9 Malignant neoplasms include basal cell carcinoma (BCC), apocrine carcinoma, sebaceous carcinoma, and squamous cell carcinoma. The lifetime risk of malignancy in NS is unknown. In an extensive literature review by Moody et al¹⁰ of 4923 cases of NS for the development of secondary benign and malignant neoplasms, 16% developed benign tumors while 8% developed malignant tumors such as BCC. However, subsequent studies suggested that the incidence of BCC may have been overestimated due to misinterpretation of trichoblastoma and may be less than 1%.^11-13

Usually the diagnosis of NS is made clinically and rarely a biopsy for histopathologic confirmation may be needed when the diagnosis is uncertain. Typically, these histopathologic findings include immature hair follicles, hyperplastic immature sebaceous glands, dilated apocrine glands, and epidermal hyperplasia.⁹ For patients with suspected NS syndrome, additional neurologic and ophthalmologic evaluations should be performed including neuroimaging studies, skeletal radiography, and analysis of liver and renal function.¹⁴

The current standard of care in treating NS is full-thickness excision. However, the decision should be individualized based on patient age, extension and location of the lesion, concerns about the cosmetic appearance, and the risk for malignancy. 

The 2 main reasons to excise NS include concern about malignancy and undesirable cosmetic appearance. Once a malignant lesion develops within NS, it generally is agreed that the tumor and the entire nevus should be removed; however, recommendations vary for excising NS prophylactically to decrease the risk for malignant growths. Because the risk for malignant transformation seems to be lower than previously thought, observation can be a reasonable choice for lesions that are not associated with cosmetic concern.^12,13

Photodynamic therapy, CO2 laser resurfacing, and dermabrasion have been reported as alternative therapeutic approaches. However, there is a growing concern on how effective these treatment modalities are in completely removing the lesion and whether the risk for recurrence and potential for neoplasm development remains.^1,9

This patient was healthy with normal development and growth and no signs of neurologic or ocular involvement. The parents were counseled about the risk for malignancy and the long-term cosmetic appearance of the lesion. They opted for surgical excision of the lesion at 18 months of age.

The Diagnosis: Nevus Sebaceous

The patient presented with a typical solitary scalp lesion characteristic of nevus sebaceous (NS). The lesion was present at birth as a flat and smooth hairless plaque; however, over time it became more thickened and noticeable, which prompted the parents to seek medical advice.

Nevus sebaceous, also known as NS of Jadassohn, is a benign congenital hamartoma of the sebaceous gland that usually is present at birth and frequently involves the scalp and/or the face. The classic NS lesion is solitary and appears as a well-circumscribed, waxy, yellow-orange or tan, hairless plaque. Despite the presence of these lesions at birth, they may not be noted until early childhood or rarely until adulthood. Generally, the lesion tends to thicken and become more verrucous and velvety over time, particularly around the time of reaching puberty.¹ Clinically, NS lesions vary in size from 1 cm to several centimeters. Lesions initially tend to grow proportionately with the child until puberty when they become notably thicker, greasier, and verrucous or nodular under hormonal influences. The yellow discoloration of the lesion is due to sebaceous gland secretion, and the characteristic color usually becomes less evident with age.

Nevus sebaceous occurs in approximately 0.3% of newborns and tends to be sporadic in nature; however, rare familial forms have been reported.^2,3 Nevus sebaceous can present as multiple nevi that tend to be extensive and distributed along the Blaschko lines, and they usually are associated with neurologic, ocular, or skeletal defects. Involvement of the central nervous system frequently is associated with large sebaceous nevi located on the face or scalp. This association has been termed NS syndrome.⁴ Neurologic abnormalities associated with NS syndrome include seizures, mental retardation, and hemimegalencephaly.⁵ Ocular findings most communally associated with the syndrome are choristomas and colobomas.^6-8

There are several benign and malignant epithelial neoplasms that may develop within sebaceous nevi. Benign tumors include trichoblastoma, syringocystadenoma papilliferum, trichilemmoma, sebaceoma, nodular hidradenoma, and hidrocystoma.^1,8,9 Malignant neoplasms include basal cell carcinoma (BCC), apocrine carcinoma, sebaceous carcinoma, and squamous cell carcinoma. The lifetime risk of malignancy in NS is unknown. In an extensive literature review by Moody et al¹⁰ of 4923 cases of NS for the development of secondary benign and malignant neoplasms, 16% developed benign tumors while 8% developed malignant tumors such as BCC. However, subsequent studies suggested that the incidence of BCC may have been overestimated due to misinterpretation of trichoblastoma and may be less than 1%.^11-13

Usually the diagnosis of NS is made clinically and rarely a biopsy for histopathologic confirmation may be needed when the diagnosis is uncertain. Typically, these histopathologic findings include immature hair follicles, hyperplastic immature sebaceous glands, dilated apocrine glands, and epidermal hyperplasia.⁹ For patients with suspected NS syndrome, additional neurologic and ophthalmologic evaluations should be performed including neuroimaging studies, skeletal radiography, and analysis of liver and renal function.¹⁴

The current standard of care in treating NS is full-thickness excision. However, the decision should be individualized based on patient age, extension and location of the lesion, concerns about the cosmetic appearance, and the risk for malignancy. 

The 2 main reasons to excise NS include concern about malignancy and undesirable cosmetic appearance. Once a malignant lesion develops within NS, it generally is agreed that the tumor and the entire nevus should be removed; however, recommendations vary for excising NS prophylactically to decrease the risk for malignant growths. Because the risk for malignant transformation seems to be lower than previously thought, observation can be a reasonable choice for lesions that are not associated with cosmetic concern.^12,13

Photodynamic therapy, CO2 laser resurfacing, and dermabrasion have been reported as alternative therapeutic approaches. However, there is a growing concern on how effective these treatment modalities are in completely removing the lesion and whether the risk for recurrence and potential for neoplasm development remains.^1,9

This patient was healthy with normal development and growth and no signs of neurologic or ocular involvement. The parents were counseled about the risk for malignancy and the long-term cosmetic appearance of the lesion. They opted for surgical excision of the lesion at 18 months of age.

The Diagnosis: Nevus Sebaceous

The patient presented with a typical solitary scalp lesion characteristic of nevus sebaceous (NS). The lesion was present at birth as a flat and smooth hairless plaque; however, over time it became more thickened and noticeable, which prompted the parents to seek medical advice.

Nevus sebaceous, also known as NS of Jadassohn, is a benign congenital hamartoma of the sebaceous gland that usually is present at birth and frequently involves the scalp and/or the face. The classic NS lesion is solitary and appears as a well-circumscribed, waxy, yellow-orange or tan, hairless plaque. Despite the presence of these lesions at birth, they may not be noted until early childhood or rarely until adulthood. Generally, the lesion tends to thicken and become more verrucous and velvety over time, particularly around the time of reaching puberty.¹ Clinically, NS lesions vary in size from 1 cm to several centimeters. Lesions initially tend to grow proportionately with the child until puberty when they become notably thicker, greasier, and verrucous or nodular under hormonal influences. The yellow discoloration of the lesion is due to sebaceous gland secretion, and the characteristic color usually becomes less evident with age.

Nevus sebaceous occurs in approximately 0.3% of newborns and tends to be sporadic in nature; however, rare familial forms have been reported.^2,3 Nevus sebaceous can present as multiple nevi that tend to be extensive and distributed along the Blaschko lines, and they usually are associated with neurologic, ocular, or skeletal defects. Involvement of the central nervous system frequently is associated with large sebaceous nevi located on the face or scalp. This association has been termed NS syndrome.⁴ Neurologic abnormalities associated with NS syndrome include seizures, mental retardation, and hemimegalencephaly.⁵ Ocular findings most communally associated with the syndrome are choristomas and colobomas.^6-8

There are several benign and malignant epithelial neoplasms that may develop within sebaceous nevi. Benign tumors include trichoblastoma, syringocystadenoma papilliferum, trichilemmoma, sebaceoma, nodular hidradenoma, and hidrocystoma.^1,8,9 Malignant neoplasms include basal cell carcinoma (BCC), apocrine carcinoma, sebaceous carcinoma, and squamous cell carcinoma. The lifetime risk of malignancy in NS is unknown. In an extensive literature review by Moody et al¹⁰ of 4923 cases of NS for the development of secondary benign and malignant neoplasms, 16% developed benign tumors while 8% developed malignant tumors such as BCC. However, subsequent studies suggested that the incidence of BCC may have been overestimated due to misinterpretation of trichoblastoma and may be less than 1%.^11-13

Usually the diagnosis of NS is made clinically and rarely a biopsy for histopathologic confirmation may be needed when the diagnosis is uncertain. Typically, these histopathologic findings include immature hair follicles, hyperplastic immature sebaceous glands, dilated apocrine glands, and epidermal hyperplasia.⁹ For patients with suspected NS syndrome, additional neurologic and ophthalmologic evaluations should be performed including neuroimaging studies, skeletal radiography, and analysis of liver and renal function.¹⁴

The current standard of care in treating NS is full-thickness excision. However, the decision should be individualized based on patient age, extension and location of the lesion, concerns about the cosmetic appearance, and the risk for malignancy. 

The 2 main reasons to excise NS include concern about malignancy and undesirable cosmetic appearance. Once a malignant lesion develops within NS, it generally is agreed that the tumor and the entire nevus should be removed; however, recommendations vary for excising NS prophylactically to decrease the risk for malignant growths. Because the risk for malignant transformation seems to be lower than previously thought, observation can be a reasonable choice for lesions that are not associated with cosmetic concern.^12,13

Photodynamic therapy, CO2 laser resurfacing, and dermabrasion have been reported as alternative therapeutic approaches. However, there is a growing concern on how effective these treatment modalities are in completely removing the lesion and whether the risk for recurrence and potential for neoplasm development remains.^1,9

This patient was healthy with normal development and growth and no signs of neurologic or ocular involvement. The parents were counseled about the risk for malignancy and the long-term cosmetic appearance of the lesion. They opted for surgical excision of the lesion at 18 months of age.

Surgical left atrial appendage occlusion may be just as good as anticoagulation at preventing thromboembolic events in older people with atrial fibrillation, with less risk of bleeding into the brain, according to a database review of more than 10,000 patients.

Among elderly atrial fibrillation patients who underwent heart surgery with no oral follow-up oral anticoagulation, those who had the left atrial appendage surgically occluded were 74% less likely than were those who did not to be readmitted for a major thromboembolic event within 3 years, and 68% less likely to be readmitted for a hemorrhagic stroke, researchers at Duke University in Durham, N.C., found.

“The current study demonstrated that S-LAAO [surgical left atrial appendage occlusion] was associated with a significantly lower rate of thromboembolism among patients without oral anticoagulation. In the cohort of patients discharged with oral anticoagulation, S-LAAO was not associated with [reduced] thromboembolism but was associated with a lower risk for hemorrhagic stroke presumably related to eventual discontinuation of oral anticoagulation among S-LAAO patients,” reported Daniel Friedman, MD, and his coinvestigators. The study was published Jan. 23 in JAMA.

In short, the findings suggest that shutting down the left atrial appendage in older patients offers the same stroke protection as anticoagulation, but without the bleeding risk. Given the low rates of anticoagulant use, physicians have been considering that approach for a while. Even so, it’s only been a weak (IIb) recommendation so far in AF guidelines because of the lack of evidence.

That might change soon, but “additional randomized studies comparing S-LAAO without anticoagulation [versus] systemic anticoagulation alone will be needed to define the optimal use of S-LAAO,” said Dr. Friedman, a cardiothoracic surgeon at Duke, and his colleagues. Those studies are in the works.

The team found 10,524 older patients in the Society of Thoracic Surgeons Adult Cardiac Surgery Database during 2011-2012, and linked them to Medicare data so they could be followed for up to 3 years. About a third of the subjects had stand-alone coronary artery bypass grafting; the rest had mitral or aortic valve repairs with or without CABG.

The investigators compared outcomes among the 37% (3,892) who had S-LAAO with outcomes among those who did not. Participants were a median of 76 years of age, 61% were men, and they were all at high risk for AF stroke.

After a mean follow-up of 2.6 years, subjects who received S-LAAO without postoperative anticoagulation had a significantly lower risk of readmission for thromboembolism – stroke, transient ischemic attack, or systemic embolism – compared with those who received neither S-LAAO nor anticoagulation (unadjusted rate 4.2% versus 6.0%; adjusted subdistribution hazard ratio [sHR] 0.26, 95% CI, 0.17-0.40, P less than .001).

There was no extra embolic stroke protection from S-LAAO in patients who were discharged on anticoagulation (sHR 0.88, 95% CI, 0.56-1.39; P = .59), but the risk of returning with a hemorrhagic stroke was considerably less (sHR 0.32, 95% CI, 0.17-0.57, P less than .001).

The S-LAAO group more commonly had nonparoxysmal AF, a higher ejection fraction, a lower mortality risk score, and lower rates of common stroke risks, such as diabetes, hypertension, and prior stroke. The Duke team adjusted for those and a long list of other confounders, including smoking, age, preoperative warfarin, and academic hospital status.

There were important limitations. No one knows what surgeons did to close the LAA, or how well it worked, and most patients discharged on anticoagulation were sent home on warfarin, not the newer direct oral anticoagulants.

The investigators noted that “the strongest data to date for LAAO come from randomized trials comparing warfarin with percutaneous LAAO using the WATCHMAN device” from Boston Scientific.

The reduction in cardiovascular mortality in those trials appeared to be driven by a reduction in hemorrhagic stroke and occurred despite increased rates of ischemic stroke, they said.

The current study, however, showed that S-LAAO was associated with a significantly lower rate of thromboembolism in patients without oral anticoagulation, the authors said.

The work was funded, in part, by the Food and Drug Administration. Dr. Friedman reported grants from Boston Scientific and Abbott. Other authors reported financial relations with those and several other companies.

[email protected]

SOURCE: Friedman DJ, et. al. JAMA. 2018;319(4):365-74. doi: 10.1001/jama.2017.20125.

Surgical left atrial appendage occlusion may be just as good as anticoagulation at preventing thromboembolic events in older people with atrial fibrillation, with less risk of bleeding into the brain, according to a database review of more than 10,000 patients.

Among elderly atrial fibrillation patients who underwent heart surgery with no oral follow-up oral anticoagulation, those who had the left atrial appendage surgically occluded were 74% less likely than were those who did not to be readmitted for a major thromboembolic event within 3 years, and 68% less likely to be readmitted for a hemorrhagic stroke, researchers at Duke University in Durham, N.C., found.

“The current study demonstrated that S-LAAO [surgical left atrial appendage occlusion] was associated with a significantly lower rate of thromboembolism among patients without oral anticoagulation. In the cohort of patients discharged with oral anticoagulation, S-LAAO was not associated with [reduced] thromboembolism but was associated with a lower risk for hemorrhagic stroke presumably related to eventual discontinuation of oral anticoagulation among S-LAAO patients,” reported Daniel Friedman, MD, and his coinvestigators. The study was published Jan. 23 in JAMA.

In short, the findings suggest that shutting down the left atrial appendage in older patients offers the same stroke protection as anticoagulation, but without the bleeding risk. Given the low rates of anticoagulant use, physicians have been considering that approach for a while. Even so, it’s only been a weak (IIb) recommendation so far in AF guidelines because of the lack of evidence.

That might change soon, but “additional randomized studies comparing S-LAAO without anticoagulation [versus] systemic anticoagulation alone will be needed to define the optimal use of S-LAAO,” said Dr. Friedman, a cardiothoracic surgeon at Duke, and his colleagues. Those studies are in the works.

The team found 10,524 older patients in the Society of Thoracic Surgeons Adult Cardiac Surgery Database during 2011-2012, and linked them to Medicare data so they could be followed for up to 3 years. About a third of the subjects had stand-alone coronary artery bypass grafting; the rest had mitral or aortic valve repairs with or without CABG.

The investigators compared outcomes among the 37% (3,892) who had S-LAAO with outcomes among those who did not. Participants were a median of 76 years of age, 61% were men, and they were all at high risk for AF stroke.

After a mean follow-up of 2.6 years, subjects who received S-LAAO without postoperative anticoagulation had a significantly lower risk of readmission for thromboembolism – stroke, transient ischemic attack, or systemic embolism – compared with those who received neither S-LAAO nor anticoagulation (unadjusted rate 4.2% versus 6.0%; adjusted subdistribution hazard ratio [sHR] 0.26, 95% CI, 0.17-0.40, P less than .001).

There was no extra embolic stroke protection from S-LAAO in patients who were discharged on anticoagulation (sHR 0.88, 95% CI, 0.56-1.39; P = .59), but the risk of returning with a hemorrhagic stroke was considerably less (sHR 0.32, 95% CI, 0.17-0.57, P less than .001).

The S-LAAO group more commonly had nonparoxysmal AF, a higher ejection fraction, a lower mortality risk score, and lower rates of common stroke risks, such as diabetes, hypertension, and prior stroke. The Duke team adjusted for those and a long list of other confounders, including smoking, age, preoperative warfarin, and academic hospital status.

There were important limitations. No one knows what surgeons did to close the LAA, or how well it worked, and most patients discharged on anticoagulation were sent home on warfarin, not the newer direct oral anticoagulants.

The investigators noted that “the strongest data to date for LAAO come from randomized trials comparing warfarin with percutaneous LAAO using the WATCHMAN device” from Boston Scientific.

The reduction in cardiovascular mortality in those trials appeared to be driven by a reduction in hemorrhagic stroke and occurred despite increased rates of ischemic stroke, they said.

The current study, however, showed that S-LAAO was associated with a significantly lower rate of thromboembolism in patients without oral anticoagulation, the authors said.

The work was funded, in part, by the Food and Drug Administration. Dr. Friedman reported grants from Boston Scientific and Abbott. Other authors reported financial relations with those and several other companies.

[email protected]

SOURCE: Friedman DJ, et. al. JAMA. 2018;319(4):365-74. doi: 10.1001/jama.2017.20125.

Surgical left atrial appendage occlusion may be just as good as anticoagulation at preventing thromboembolic events in older people with atrial fibrillation, with less risk of bleeding into the brain, according to a database review of more than 10,000 patients.

Among elderly atrial fibrillation patients who underwent heart surgery with no oral follow-up oral anticoagulation, those who had the left atrial appendage surgically occluded were 74% less likely than were those who did not to be readmitted for a major thromboembolic event within 3 years, and 68% less likely to be readmitted for a hemorrhagic stroke, researchers at Duke University in Durham, N.C., found.

“The current study demonstrated that S-LAAO [surgical left atrial appendage occlusion] was associated with a significantly lower rate of thromboembolism among patients without oral anticoagulation. In the cohort of patients discharged with oral anticoagulation, S-LAAO was not associated with [reduced] thromboembolism but was associated with a lower risk for hemorrhagic stroke presumably related to eventual discontinuation of oral anticoagulation among S-LAAO patients,” reported Daniel Friedman, MD, and his coinvestigators. The study was published Jan. 23 in JAMA.

In short, the findings suggest that shutting down the left atrial appendage in older patients offers the same stroke protection as anticoagulation, but without the bleeding risk. Given the low rates of anticoagulant use, physicians have been considering that approach for a while. Even so, it’s only been a weak (IIb) recommendation so far in AF guidelines because of the lack of evidence.

That might change soon, but “additional randomized studies comparing S-LAAO without anticoagulation [versus] systemic anticoagulation alone will be needed to define the optimal use of S-LAAO,” said Dr. Friedman, a cardiothoracic surgeon at Duke, and his colleagues. Those studies are in the works.

The team found 10,524 older patients in the Society of Thoracic Surgeons Adult Cardiac Surgery Database during 2011-2012, and linked them to Medicare data so they could be followed for up to 3 years. About a third of the subjects had stand-alone coronary artery bypass grafting; the rest had mitral or aortic valve repairs with or without CABG.

The investigators compared outcomes among the 37% (3,892) who had S-LAAO with outcomes among those who did not. Participants were a median of 76 years of age, 61% were men, and they were all at high risk for AF stroke.

After a mean follow-up of 2.6 years, subjects who received S-LAAO without postoperative anticoagulation had a significantly lower risk of readmission for thromboembolism – stroke, transient ischemic attack, or systemic embolism – compared with those who received neither S-LAAO nor anticoagulation (unadjusted rate 4.2% versus 6.0%; adjusted subdistribution hazard ratio [sHR] 0.26, 95% CI, 0.17-0.40, P less than .001).

There was no extra embolic stroke protection from S-LAAO in patients who were discharged on anticoagulation (sHR 0.88, 95% CI, 0.56-1.39; P = .59), but the risk of returning with a hemorrhagic stroke was considerably less (sHR 0.32, 95% CI, 0.17-0.57, P less than .001).

The S-LAAO group more commonly had nonparoxysmal AF, a higher ejection fraction, a lower mortality risk score, and lower rates of common stroke risks, such as diabetes, hypertension, and prior stroke. The Duke team adjusted for those and a long list of other confounders, including smoking, age, preoperative warfarin, and academic hospital status.

There were important limitations. No one knows what surgeons did to close the LAA, or how well it worked, and most patients discharged on anticoagulation were sent home on warfarin, not the newer direct oral anticoagulants.

The investigators noted that “the strongest data to date for LAAO come from randomized trials comparing warfarin with percutaneous LAAO using the WATCHMAN device” from Boston Scientific.

The reduction in cardiovascular mortality in those trials appeared to be driven by a reduction in hemorrhagic stroke and occurred despite increased rates of ischemic stroke, they said.

The current study, however, showed that S-LAAO was associated with a significantly lower rate of thromboembolism in patients without oral anticoagulation, the authors said.

The work was funded, in part, by the Food and Drug Administration. Dr. Friedman reported grants from Boston Scientific and Abbott. Other authors reported financial relations with those and several other companies.

[email protected]

SOURCE: Friedman DJ, et. al. JAMA. 2018;319(4):365-74. doi: 10.1001/jama.2017.20125.

To the Editor:

Trigeminal motor neuropathy is a rare condition presenting with muscle weakness and atrophy in the distribution of the trigeminal nerve without sensory changes. We present a challenging case with clinical features that mimic progressive hemifacial atrophy (PHA), a disease characterized by slowly progressive, unilateral facial atrophy that can be accompanied by inflammation and sclerosis as early features.

A 55-year-old man presented with right-sided ptosis and progressive right-sided facial atrophy of 4 years’ duration. A clinical diagnosis of PHA was made by the rheumatology department, and the patient was referred to the dermatology department for further evaluation. Examination at presentation revealed right-sided subcutaneous atrophy of the cheek, temple, and forehead extending to the scalp with absence of sclerosis, pigmentary alteration, or typical linear morphea lesions (Figures 1 and 2). The patient had no sensory changes in the affected area.

Workup by the dermatology department included magnetic resonance imaging (MRI) of the face and scalp, which demonstrated denervation muscle atrophy exclusively in the distribution of the third branch of the right trigeminal nerve, including severe atrophy of the right temporalis and masseter muscles and moderate atrophy of the pterygoid muscles. No signs of inflammation, fibrosis, or atrophy of the skin or subcutaneous fat were found, ruling out a diagnosis of PHA.

The patient was referred to the neurology department where he was found to have a normal neurologic examination with the exception of right-sided ptosis and temporalis and masseter muscle atrophy. Notably, the patient had normal sensation in the distribution of the trigeminal nerve and normal strength of the masseter and temporalis muscles.

An extensive workup by the neurology department was completed, including magnetic resonance angiography, eyeblink testing, and testing for causes of neuropathies (eg, infectious, autoimmune, vitamin deficiencies, toxin related). Of note, magnetic resonance angiography showed no abnormalities within the cavernous sinus or trigeminal cave but showed potential vascular compression of the trigeminal nerve, which was believed to be an incidental finding. The remainder of the workup was unremarkable. Based on muscle denervation atrophy in the distribution of the third branch of the trigeminal nerve in the absence of sensory symptoms or deficits, the patient’s presentation was consistent with trigeminal motor neuropathy.

In reported cases, the pathogenesis of trigeminal motor neuropathy is attributed to tumors, trauma, stroke, viral infection, and autoimmune reaction.^1-6 In other reported cases the cause is unknown,^6-8 as was the case in our patient. Magnetic resonance angiography revealed potential vascular compression of the trigeminal nerve, which has been previously reported to cause trigeminal neuropathy.⁹ However, patients with trigeminal neuropathy presented with sensory changes in the distribution of the trigeminal nerve as opposed to motor symptoms and muscle atrophy.

We present a case of trigeminal motor neuropathy presenting as PHA. Progressive hemifacial atrophy is a rare, slowly progressive disease characterized by unilateral atrophy of the skin, subcutis, muscle, and bony structures of the face. Onset usually is during childhood, though later onset has been reported.¹⁰ The pathogenesis of PHA is not well understood, though trauma, infection, immune-mediated causes, sympathetic dysfunction, and metabolic dysfunction have been proposed.¹¹ Diagnosis of PHA typically is based on clinical presentation, but histology and imaging are useful. In contrast to trigeminal motor neuropathy, MRI findings in PHA demonstrate involvement of the skin.¹²

Differentiation between PHA and trigeminal motor neuropathy is important because treatment differs. Treatment of trigeminal motor neuropathy depends on the etiology and may include removal of underlying neoplasms, while treatment of PHA depends on disease activity. The initial goal when treating PHA is to improve symptoms and slow disease progression; immunosuppressants may be considered. Facial reconstruction is an option when PHA is stable.

In this case, the features differentiating trigeminal motor neuropathy from PHA include age of onset and MRI as well as clinical findings of muscle atrophy limited to the distribution of the third branch of the trigeminal nerve. Although PHA is a rare disorder, this case demonstrates the importance of including trigeminal motor neuropathy in the differential diagnosis.

To the Editor:

Trigeminal motor neuropathy is a rare condition presenting with muscle weakness and atrophy in the distribution of the trigeminal nerve without sensory changes. We present a challenging case with clinical features that mimic progressive hemifacial atrophy (PHA), a disease characterized by slowly progressive, unilateral facial atrophy that can be accompanied by inflammation and sclerosis as early features.

A 55-year-old man presented with right-sided ptosis and progressive right-sided facial atrophy of 4 years’ duration. A clinical diagnosis of PHA was made by the rheumatology department, and the patient was referred to the dermatology department for further evaluation. Examination at presentation revealed right-sided subcutaneous atrophy of the cheek, temple, and forehead extending to the scalp with absence of sclerosis, pigmentary alteration, or typical linear morphea lesions (Figures 1 and 2). The patient had no sensory changes in the affected area.

Workup by the dermatology department included magnetic resonance imaging (MRI) of the face and scalp, which demonstrated denervation muscle atrophy exclusively in the distribution of the third branch of the right trigeminal nerve, including severe atrophy of the right temporalis and masseter muscles and moderate atrophy of the pterygoid muscles. No signs of inflammation, fibrosis, or atrophy of the skin or subcutaneous fat were found, ruling out a diagnosis of PHA.

The patient was referred to the neurology department where he was found to have a normal neurologic examination with the exception of right-sided ptosis and temporalis and masseter muscle atrophy. Notably, the patient had normal sensation in the distribution of the trigeminal nerve and normal strength of the masseter and temporalis muscles.

An extensive workup by the neurology department was completed, including magnetic resonance angiography, eyeblink testing, and testing for causes of neuropathies (eg, infectious, autoimmune, vitamin deficiencies, toxin related). Of note, magnetic resonance angiography showed no abnormalities within the cavernous sinus or trigeminal cave but showed potential vascular compression of the trigeminal nerve, which was believed to be an incidental finding. The remainder of the workup was unremarkable. Based on muscle denervation atrophy in the distribution of the third branch of the trigeminal nerve in the absence of sensory symptoms or deficits, the patient’s presentation was consistent with trigeminal motor neuropathy.

In reported cases, the pathogenesis of trigeminal motor neuropathy is attributed to tumors, trauma, stroke, viral infection, and autoimmune reaction.^1-6 In other reported cases the cause is unknown,^6-8 as was the case in our patient. Magnetic resonance angiography revealed potential vascular compression of the trigeminal nerve, which has been previously reported to cause trigeminal neuropathy.⁹ However, patients with trigeminal neuropathy presented with sensory changes in the distribution of the trigeminal nerve as opposed to motor symptoms and muscle atrophy.

We present a case of trigeminal motor neuropathy presenting as PHA. Progressive hemifacial atrophy is a rare, slowly progressive disease characterized by unilateral atrophy of the skin, subcutis, muscle, and bony structures of the face. Onset usually is during childhood, though later onset has been reported.¹⁰ The pathogenesis of PHA is not well understood, though trauma, infection, immune-mediated causes, sympathetic dysfunction, and metabolic dysfunction have been proposed.¹¹ Diagnosis of PHA typically is based on clinical presentation, but histology and imaging are useful. In contrast to trigeminal motor neuropathy, MRI findings in PHA demonstrate involvement of the skin.¹²

Differentiation between PHA and trigeminal motor neuropathy is important because treatment differs. Treatment of trigeminal motor neuropathy depends on the etiology and may include removal of underlying neoplasms, while treatment of PHA depends on disease activity. The initial goal when treating PHA is to improve symptoms and slow disease progression; immunosuppressants may be considered. Facial reconstruction is an option when PHA is stable.

In this case, the features differentiating trigeminal motor neuropathy from PHA include age of onset and MRI as well as clinical findings of muscle atrophy limited to the distribution of the third branch of the trigeminal nerve. Although PHA is a rare disorder, this case demonstrates the importance of including trigeminal motor neuropathy in the differential diagnosis.

To the Editor:

Trigeminal motor neuropathy is a rare condition presenting with muscle weakness and atrophy in the distribution of the trigeminal nerve without sensory changes. We present a challenging case with clinical features that mimic progressive hemifacial atrophy (PHA), a disease characterized by slowly progressive, unilateral facial atrophy that can be accompanied by inflammation and sclerosis as early features.

A 55-year-old man presented with right-sided ptosis and progressive right-sided facial atrophy of 4 years’ duration. A clinical diagnosis of PHA was made by the rheumatology department, and the patient was referred to the dermatology department for further evaluation. Examination at presentation revealed right-sided subcutaneous atrophy of the cheek, temple, and forehead extending to the scalp with absence of sclerosis, pigmentary alteration, or typical linear morphea lesions (Figures 1 and 2). The patient had no sensory changes in the affected area.

Workup by the dermatology department included magnetic resonance imaging (MRI) of the face and scalp, which demonstrated denervation muscle atrophy exclusively in the distribution of the third branch of the right trigeminal nerve, including severe atrophy of the right temporalis and masseter muscles and moderate atrophy of the pterygoid muscles. No signs of inflammation, fibrosis, or atrophy of the skin or subcutaneous fat were found, ruling out a diagnosis of PHA.

The patient was referred to the neurology department where he was found to have a normal neurologic examination with the exception of right-sided ptosis and temporalis and masseter muscle atrophy. Notably, the patient had normal sensation in the distribution of the trigeminal nerve and normal strength of the masseter and temporalis muscles.

An extensive workup by the neurology department was completed, including magnetic resonance angiography, eyeblink testing, and testing for causes of neuropathies (eg, infectious, autoimmune, vitamin deficiencies, toxin related). Of note, magnetic resonance angiography showed no abnormalities within the cavernous sinus or trigeminal cave but showed potential vascular compression of the trigeminal nerve, which was believed to be an incidental finding. The remainder of the workup was unremarkable. Based on muscle denervation atrophy in the distribution of the third branch of the trigeminal nerve in the absence of sensory symptoms or deficits, the patient’s presentation was consistent with trigeminal motor neuropathy.

In reported cases, the pathogenesis of trigeminal motor neuropathy is attributed to tumors, trauma, stroke, viral infection, and autoimmune reaction.^1-6 In other reported cases the cause is unknown,^6-8 as was the case in our patient. Magnetic resonance angiography revealed potential vascular compression of the trigeminal nerve, which has been previously reported to cause trigeminal neuropathy.⁹ However, patients with trigeminal neuropathy presented with sensory changes in the distribution of the trigeminal nerve as opposed to motor symptoms and muscle atrophy.

We present a case of trigeminal motor neuropathy presenting as PHA. Progressive hemifacial atrophy is a rare, slowly progressive disease characterized by unilateral atrophy of the skin, subcutis, muscle, and bony structures of the face. Onset usually is during childhood, though later onset has been reported.¹⁰ The pathogenesis of PHA is not well understood, though trauma, infection, immune-mediated causes, sympathetic dysfunction, and metabolic dysfunction have been proposed.¹¹ Diagnosis of PHA typically is based on clinical presentation, but histology and imaging are useful. In contrast to trigeminal motor neuropathy, MRI findings in PHA demonstrate involvement of the skin.¹²

Differentiation between PHA and trigeminal motor neuropathy is important because treatment differs. Treatment of trigeminal motor neuropathy depends on the etiology and may include removal of underlying neoplasms, while treatment of PHA depends on disease activity. The initial goal when treating PHA is to improve symptoms and slow disease progression; immunosuppressants may be considered. Facial reconstruction is an option when PHA is stable.

In this case, the features differentiating trigeminal motor neuropathy from PHA include age of onset and MRI as well as clinical findings of muscle atrophy limited to the distribution of the third branch of the trigeminal nerve. Although PHA is a rare disorder, this case demonstrates the importance of including trigeminal motor neuropathy in the differential diagnosis.