IBD: Inpatient opioids linked with outpatient use

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Patients with inflammatory bowel disease (IBD) who receive opioids while hospitalized are three times as likely to be prescribed opioids after discharge, based on a retrospective analysis of more than 800 patients.

Awareness of this dose-dependent relationship and IBD-related risks of opioid use should encourage physicians to consider alternative analgesics, according to lead author Rahul S. Dalal, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

“Recent evidence has demonstrated that opioid use is associated with severe infections and increased mortality among IBD patients,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Despite these concerns, opioids are commonly prescribed to IBD patients in the outpatient setting and to as many as 70% of IBD patients who are hospitalized.”

To look for a possible relationship between inpatient and outpatient opioid use, the investigators reviewed electronic medical records of 862 IBD patients who were treated at three urban hospitals in the University of Pennsylvania Health System. The primary outcome was opioid prescription within 12 months of discharge, including prescriptions at time of hospital dismissal.

During hospitalization, about two-thirds (67.6%) of patients received intravenous opioids. Of the total population, slightly more than half (54.6%) received intravenous hydromorphone and about one-quarter (25.9%) received intravenous morphine. Following discharge, almost half of the population (44.7%) was prescribed opioids, and about 3 out of 4 patients (77.9%) received an additional opioid prescription within the same year.

After accounting for confounders such as IBD severity, preadmission opioid use, pain scores, and psychiatric conditions, data analysis showed that inpatients who received intravenous opioids had a threefold (odds ratio [OR], 3.3) increased likelihood of receiving postdischarge opioid prescription, compared with patients who received no opioids while hospitalized. This association was stronger among those who had IBD flares (OR, 5.4). Furthermore, intravenous dose was positively correlated with postdischarge opioid prescription.

Avoiding intravenous opioids had no impact on the relationship between inpatient and outpatient opioid use. Among inpatients who received only oral or transdermal opioids, a similarly increased likelihood of postdischarge opioid prescription was observed (OR, 4.2), although this was a small cohort (n = 67).

Compared with other physicians, gastroenterologists were the least likely to prescribe opioids. Considering that gastroenterologists were also most likely aware of IBD-related risks of opioid use, the investigators concluded that more interdisciplinary communication and education are needed.

“Alternative analgesics such as acetaminophen, dicyclomine, hyoscyamine, and celecoxib could be advised, as many of these therapies have been deemed relatively safe and effective in this population,” they wrote.The investigators disclosed relationships with Abbott, Gilead, Romark, and others.

SOURCE: Dalal RS et al. Clin Gastro Hepatol. 2019 Dec 27. doi: 10.1016/j.cgh.2019.12.024.

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Patients with inflammatory bowel disease (IBD) who receive opioids while hospitalized are three times as likely to be prescribed opioids after discharge, based on a retrospective analysis of more than 800 patients.

Awareness of this dose-dependent relationship and IBD-related risks of opioid use should encourage physicians to consider alternative analgesics, according to lead author Rahul S. Dalal, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

“Recent evidence has demonstrated that opioid use is associated with severe infections and increased mortality among IBD patients,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Despite these concerns, opioids are commonly prescribed to IBD patients in the outpatient setting and to as many as 70% of IBD patients who are hospitalized.”

To look for a possible relationship between inpatient and outpatient opioid use, the investigators reviewed electronic medical records of 862 IBD patients who were treated at three urban hospitals in the University of Pennsylvania Health System. The primary outcome was opioid prescription within 12 months of discharge, including prescriptions at time of hospital dismissal.

During hospitalization, about two-thirds (67.6%) of patients received intravenous opioids. Of the total population, slightly more than half (54.6%) received intravenous hydromorphone and about one-quarter (25.9%) received intravenous morphine. Following discharge, almost half of the population (44.7%) was prescribed opioids, and about 3 out of 4 patients (77.9%) received an additional opioid prescription within the same year.

After accounting for confounders such as IBD severity, preadmission opioid use, pain scores, and psychiatric conditions, data analysis showed that inpatients who received intravenous opioids had a threefold (odds ratio [OR], 3.3) increased likelihood of receiving postdischarge opioid prescription, compared with patients who received no opioids while hospitalized. This association was stronger among those who had IBD flares (OR, 5.4). Furthermore, intravenous dose was positively correlated with postdischarge opioid prescription.

Avoiding intravenous opioids had no impact on the relationship between inpatient and outpatient opioid use. Among inpatients who received only oral or transdermal opioids, a similarly increased likelihood of postdischarge opioid prescription was observed (OR, 4.2), although this was a small cohort (n = 67).

Compared with other physicians, gastroenterologists were the least likely to prescribe opioids. Considering that gastroenterologists were also most likely aware of IBD-related risks of opioid use, the investigators concluded that more interdisciplinary communication and education are needed.

“Alternative analgesics such as acetaminophen, dicyclomine, hyoscyamine, and celecoxib could be advised, as many of these therapies have been deemed relatively safe and effective in this population,” they wrote.The investigators disclosed relationships with Abbott, Gilead, Romark, and others.

SOURCE: Dalal RS et al. Clin Gastro Hepatol. 2019 Dec 27. doi: 10.1016/j.cgh.2019.12.024.

Patients with inflammatory bowel disease (IBD) who receive opioids while hospitalized are three times as likely to be prescribed opioids after discharge, based on a retrospective analysis of more than 800 patients.

Awareness of this dose-dependent relationship and IBD-related risks of opioid use should encourage physicians to consider alternative analgesics, according to lead author Rahul S. Dalal, MD, of Brigham and Women’s Hospital, Boston, and colleagues.

“Recent evidence has demonstrated that opioid use is associated with severe infections and increased mortality among IBD patients,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Despite these concerns, opioids are commonly prescribed to IBD patients in the outpatient setting and to as many as 70% of IBD patients who are hospitalized.”

To look for a possible relationship between inpatient and outpatient opioid use, the investigators reviewed electronic medical records of 862 IBD patients who were treated at three urban hospitals in the University of Pennsylvania Health System. The primary outcome was opioid prescription within 12 months of discharge, including prescriptions at time of hospital dismissal.

During hospitalization, about two-thirds (67.6%) of patients received intravenous opioids. Of the total population, slightly more than half (54.6%) received intravenous hydromorphone and about one-quarter (25.9%) received intravenous morphine. Following discharge, almost half of the population (44.7%) was prescribed opioids, and about 3 out of 4 patients (77.9%) received an additional opioid prescription within the same year.

After accounting for confounders such as IBD severity, preadmission opioid use, pain scores, and psychiatric conditions, data analysis showed that inpatients who received intravenous opioids had a threefold (odds ratio [OR], 3.3) increased likelihood of receiving postdischarge opioid prescription, compared with patients who received no opioids while hospitalized. This association was stronger among those who had IBD flares (OR, 5.4). Furthermore, intravenous dose was positively correlated with postdischarge opioid prescription.

Avoiding intravenous opioids had no impact on the relationship between inpatient and outpatient opioid use. Among inpatients who received only oral or transdermal opioids, a similarly increased likelihood of postdischarge opioid prescription was observed (OR, 4.2), although this was a small cohort (n = 67).

Compared with other physicians, gastroenterologists were the least likely to prescribe opioids. Considering that gastroenterologists were also most likely aware of IBD-related risks of opioid use, the investigators concluded that more interdisciplinary communication and education are needed.

“Alternative analgesics such as acetaminophen, dicyclomine, hyoscyamine, and celecoxib could be advised, as many of these therapies have been deemed relatively safe and effective in this population,” they wrote.The investigators disclosed relationships with Abbott, Gilead, Romark, and others.

SOURCE: Dalal RS et al. Clin Gastro Hepatol. 2019 Dec 27. doi: 10.1016/j.cgh.2019.12.024.

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Key clinical point: Patients with inflammatory bowel disease (IBD) who receive opioids while hospitalized are three times as likely to be prescribed opioids after discharge.

Major finding: Patients who were given intravenous opioids while hospitalized were three times as likely to receive a postdischarge opioid prescription, compared with patients who did not receive inpatient intravenous opioids (odds ratio, 3.3).

Study details: A retrospective cohort study involving 862 patients with inflammatory bowel disease.

Disclosures: The investigators disclosed relationships Abbott, Gilead, Romark, and others.

Source: Dalal RS et al. Clin Gastro Hepatol. 2019 Dec 27. doi: 10.1016/j.cgh.2019.12.024.

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Score predicts surgery’s benefits for obesity, diabetes

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Researchers have devised a risk calculator for patients with obesity and type 2 diabetes that can estimate their 10-year risk for death and cardiovascular disease events if their clinical status continues relatively unchanged, or if they opt to undergo bariatric surgery.

Mitchel L. Zoler/MDedge News
Dr. Ali Aminian

The Individualized Diabetes Complications risk score “can provide personalized, evidence-based risk information for patients with type 2 diabetes and obesity about their future cardiovascular disease outcomes and mortality with and without metabolic surgery,” Ali Aminian, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Although the calculator needs validation in a prospective, randomized study to document its impact on practice, it is now available on two separate websites and as a downloadable app, said Dr. Aminian, a surgeon at the Cleveland Clinic.

The calculator inputs data for 26 distinct, “readily available” demographic and clinical entries, and based on that, estimates the patient’s 10-year risk for all-cause death, diabetic kidney disease, cerebrovascular disease, heart failure, and coronary artery disease if no surgery occurs or after some type of metabolic or bariatric surgery. The calculator does not currently have the ability to individualize predicted risks based on the specific type of metabolic surgery performed, but that is planned as a future refinement of the score.

“We validated the model in the nonsurgical patients, which showed it was very accurate. The next step is to run a randomized trial to see how useful the calculator is” for assisting in patients’ decision making, Dr. Aminian said.

The data for deriving the risk calculator, and for a preliminary validation of it, came from 13,722 patients with obesity (body mass index, 30 kg/m2 or greater) and type 2 diabetes, who were managed at the Cleveland Clinic during 1998-2017, drawn from more than 287,000 such patients in the clinic’s database. The study focused on 2,287 patients who underwent metabolic (bariatric) surgery and 11,435 patients from the same database who did not have surgery and matched by propensity scoring on a 5:1 basis with those who had surgery. The two cohorts this created matched well for age (about 54 years), sex (about two-thirds women), BMI (about 44 kg/m2), and the prevalence of various comorbidities at baseline.

Dr. Aminian and associates then analyzed the incidence of all-cause mortality and various cardiovascular disease endpoints, as well as nephropathy during follow-up, through December 2018. Patients who had undergone metabolic surgery showed statistically significant reductions in the incidence of each of those events, compared with patients who did not have surgery (JAMA. 2019;322[13]:1271-82).The investigators used these findings to create their model for calculating a patient’s risk score. For example, to calculate an estimate for the 10-year risk from all-cause mortality, the results showed that the most powerful risk factors were age, baseline body mass index, heart failure, need for insulin, and smoking status. For the endpoint of nephropathy, the most important factors were estimated glomerular filtration rate at baseline and age. Identified risk factors could account for about 80% of the 10-year risk for all-cause death and for about 75% of the risk for developing nephropathy during 10 years, based on the area-under-the-curve values the model produced.

The calculator is available at a website maintained by the Cleveland Clinic, at a site of the American Society for Metabolic and Bariatric Surgery, and in app stores, he said.

The work was partially funded by Medtronic. Dr. Aminian has received grants from Medtronic.

The AGA Practice guide on Obesity and Weight management, Education and Resources (POWER) white paper provides physicians with a comprehensive, multidisciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at www.gastro.org/obesity.

SOURCE: Aminian A et al. Obesity Week 2019, Abstract A101.

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Researchers have devised a risk calculator for patients with obesity and type 2 diabetes that can estimate their 10-year risk for death and cardiovascular disease events if their clinical status continues relatively unchanged, or if they opt to undergo bariatric surgery.

Mitchel L. Zoler/MDedge News
Dr. Ali Aminian

The Individualized Diabetes Complications risk score “can provide personalized, evidence-based risk information for patients with type 2 diabetes and obesity about their future cardiovascular disease outcomes and mortality with and without metabolic surgery,” Ali Aminian, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Although the calculator needs validation in a prospective, randomized study to document its impact on practice, it is now available on two separate websites and as a downloadable app, said Dr. Aminian, a surgeon at the Cleveland Clinic.

The calculator inputs data for 26 distinct, “readily available” demographic and clinical entries, and based on that, estimates the patient’s 10-year risk for all-cause death, diabetic kidney disease, cerebrovascular disease, heart failure, and coronary artery disease if no surgery occurs or after some type of metabolic or bariatric surgery. The calculator does not currently have the ability to individualize predicted risks based on the specific type of metabolic surgery performed, but that is planned as a future refinement of the score.

“We validated the model in the nonsurgical patients, which showed it was very accurate. The next step is to run a randomized trial to see how useful the calculator is” for assisting in patients’ decision making, Dr. Aminian said.

The data for deriving the risk calculator, and for a preliminary validation of it, came from 13,722 patients with obesity (body mass index, 30 kg/m2 or greater) and type 2 diabetes, who were managed at the Cleveland Clinic during 1998-2017, drawn from more than 287,000 such patients in the clinic’s database. The study focused on 2,287 patients who underwent metabolic (bariatric) surgery and 11,435 patients from the same database who did not have surgery and matched by propensity scoring on a 5:1 basis with those who had surgery. The two cohorts this created matched well for age (about 54 years), sex (about two-thirds women), BMI (about 44 kg/m2), and the prevalence of various comorbidities at baseline.

Dr. Aminian and associates then analyzed the incidence of all-cause mortality and various cardiovascular disease endpoints, as well as nephropathy during follow-up, through December 2018. Patients who had undergone metabolic surgery showed statistically significant reductions in the incidence of each of those events, compared with patients who did not have surgery (JAMA. 2019;322[13]:1271-82).The investigators used these findings to create their model for calculating a patient’s risk score. For example, to calculate an estimate for the 10-year risk from all-cause mortality, the results showed that the most powerful risk factors were age, baseline body mass index, heart failure, need for insulin, and smoking status. For the endpoint of nephropathy, the most important factors were estimated glomerular filtration rate at baseline and age. Identified risk factors could account for about 80% of the 10-year risk for all-cause death and for about 75% of the risk for developing nephropathy during 10 years, based on the area-under-the-curve values the model produced.

The calculator is available at a website maintained by the Cleveland Clinic, at a site of the American Society for Metabolic and Bariatric Surgery, and in app stores, he said.

The work was partially funded by Medtronic. Dr. Aminian has received grants from Medtronic.

The AGA Practice guide on Obesity and Weight management, Education and Resources (POWER) white paper provides physicians with a comprehensive, multidisciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at www.gastro.org/obesity.

SOURCE: Aminian A et al. Obesity Week 2019, Abstract A101.

Researchers have devised a risk calculator for patients with obesity and type 2 diabetes that can estimate their 10-year risk for death and cardiovascular disease events if their clinical status continues relatively unchanged, or if they opt to undergo bariatric surgery.

Mitchel L. Zoler/MDedge News
Dr. Ali Aminian

The Individualized Diabetes Complications risk score “can provide personalized, evidence-based risk information for patients with type 2 diabetes and obesity about their future cardiovascular disease outcomes and mortality with and without metabolic surgery,” Ali Aminian, MD, said at a meeting presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Although the calculator needs validation in a prospective, randomized study to document its impact on practice, it is now available on two separate websites and as a downloadable app, said Dr. Aminian, a surgeon at the Cleveland Clinic.

The calculator inputs data for 26 distinct, “readily available” demographic and clinical entries, and based on that, estimates the patient’s 10-year risk for all-cause death, diabetic kidney disease, cerebrovascular disease, heart failure, and coronary artery disease if no surgery occurs or after some type of metabolic or bariatric surgery. The calculator does not currently have the ability to individualize predicted risks based on the specific type of metabolic surgery performed, but that is planned as a future refinement of the score.

“We validated the model in the nonsurgical patients, which showed it was very accurate. The next step is to run a randomized trial to see how useful the calculator is” for assisting in patients’ decision making, Dr. Aminian said.

The data for deriving the risk calculator, and for a preliminary validation of it, came from 13,722 patients with obesity (body mass index, 30 kg/m2 or greater) and type 2 diabetes, who were managed at the Cleveland Clinic during 1998-2017, drawn from more than 287,000 such patients in the clinic’s database. The study focused on 2,287 patients who underwent metabolic (bariatric) surgery and 11,435 patients from the same database who did not have surgery and matched by propensity scoring on a 5:1 basis with those who had surgery. The two cohorts this created matched well for age (about 54 years), sex (about two-thirds women), BMI (about 44 kg/m2), and the prevalence of various comorbidities at baseline.

Dr. Aminian and associates then analyzed the incidence of all-cause mortality and various cardiovascular disease endpoints, as well as nephropathy during follow-up, through December 2018. Patients who had undergone metabolic surgery showed statistically significant reductions in the incidence of each of those events, compared with patients who did not have surgery (JAMA. 2019;322[13]:1271-82).The investigators used these findings to create their model for calculating a patient’s risk score. For example, to calculate an estimate for the 10-year risk from all-cause mortality, the results showed that the most powerful risk factors were age, baseline body mass index, heart failure, need for insulin, and smoking status. For the endpoint of nephropathy, the most important factors were estimated glomerular filtration rate at baseline and age. Identified risk factors could account for about 80% of the 10-year risk for all-cause death and for about 75% of the risk for developing nephropathy during 10 years, based on the area-under-the-curve values the model produced.

The calculator is available at a website maintained by the Cleveland Clinic, at a site of the American Society for Metabolic and Bariatric Surgery, and in app stores, he said.

The work was partially funded by Medtronic. Dr. Aminian has received grants from Medtronic.

The AGA Practice guide on Obesity and Weight management, Education and Resources (POWER) white paper provides physicians with a comprehensive, multidisciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at www.gastro.org/obesity.

SOURCE: Aminian A et al. Obesity Week 2019, Abstract A101.

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Bariatric surgery lacks impact on teens’ long-term mental health

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Young people treated with bariatric surgery for severe obesity did not experience better mental health in the 5 years following their procedures, Swedish researchers said, and indeed fared worse than their nontreated peers on certain measures.

The results of this study do not necessarily argue “that metabolic and bariatric surgery during adolescence causes mental health problems,” the investigators wrote in the Lancet Child and Adolescent Health, but “it is reasonable to conclude that metabolic and bariatric surgery does not result in a substantial alleviation of mental health problems in adolescents with severe obesity,” and that “long-term mental health support should be required in programs providing adolescent metabolic and bariatric surgery.”

Kajsa Järvholm, PhD, of Skåne University Hospital, in Malmö, Sweden, and colleagues reported results from a prospective nonrandomized study that recruited 81 adolescents in Sweden aged 13-18 years (mean age, 16.5) who had a body mass index of 40 or higher, or BMI of 35 with obesity-related comorbidities and who underwent Roux-en-Y gastric bypass for weight loss. Subjects were matched by age, sex, and BMI to 80 controls (mean age, 15.8 years) who were assigned to conventional nonsurgical treatment. All patients were assessed at 1, 2, and 5 years.

Although mental health treatment, including use of psychiatric drugs, did not differ between the groups at baseline, during the follow-up period the subjects who underwent surgery saw 15% more impatient and outpatient mental health treatment, compared with controls, a significant difference. About a quarter of patients in the surgically treated group required specialized mental health treatment for the first time after their surgeries.

Though the surgical group lost much more weight – mean BMI was 32.3 at 5 years, compared with 41.7 for controls – none of the mental health changes from baseline were significantly associated with percentage change of BMI at 5 years.

The findings from the study are consistent with results from studies in adults in which bariatric surgery improves many health outcomes but does not alter the need for mental health treatment. Although 5 years is a longer follow-up than in previous studies in young patients – a key strength of the study – Dr. Järvholm and colleagues acknowledged some weaknesses, including a nonrandomized design, lack of a comparison group of nonobese youths for mental health measures, a small sample size, and a surgical procedure that is now out of favor in adolescents.

The study was funded by Swedish government and health foundations. Dr. Järvholm disclosed pharmaceutical industry funding not related to the study, and three coauthors also disclosed industry relationships.

SOURCE: Järvholm K et al. Lancet Child Adolesc Health. 2020. doi: 10.1016/s2352-4642(20)30024-9.

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Young people treated with bariatric surgery for severe obesity did not experience better mental health in the 5 years following their procedures, Swedish researchers said, and indeed fared worse than their nontreated peers on certain measures.

The results of this study do not necessarily argue “that metabolic and bariatric surgery during adolescence causes mental health problems,” the investigators wrote in the Lancet Child and Adolescent Health, but “it is reasonable to conclude that metabolic and bariatric surgery does not result in a substantial alleviation of mental health problems in adolescents with severe obesity,” and that “long-term mental health support should be required in programs providing adolescent metabolic and bariatric surgery.”

Kajsa Järvholm, PhD, of Skåne University Hospital, in Malmö, Sweden, and colleagues reported results from a prospective nonrandomized study that recruited 81 adolescents in Sweden aged 13-18 years (mean age, 16.5) who had a body mass index of 40 or higher, or BMI of 35 with obesity-related comorbidities and who underwent Roux-en-Y gastric bypass for weight loss. Subjects were matched by age, sex, and BMI to 80 controls (mean age, 15.8 years) who were assigned to conventional nonsurgical treatment. All patients were assessed at 1, 2, and 5 years.

Although mental health treatment, including use of psychiatric drugs, did not differ between the groups at baseline, during the follow-up period the subjects who underwent surgery saw 15% more impatient and outpatient mental health treatment, compared with controls, a significant difference. About a quarter of patients in the surgically treated group required specialized mental health treatment for the first time after their surgeries.

Though the surgical group lost much more weight – mean BMI was 32.3 at 5 years, compared with 41.7 for controls – none of the mental health changes from baseline were significantly associated with percentage change of BMI at 5 years.

The findings from the study are consistent with results from studies in adults in which bariatric surgery improves many health outcomes but does not alter the need for mental health treatment. Although 5 years is a longer follow-up than in previous studies in young patients – a key strength of the study – Dr. Järvholm and colleagues acknowledged some weaknesses, including a nonrandomized design, lack of a comparison group of nonobese youths for mental health measures, a small sample size, and a surgical procedure that is now out of favor in adolescents.

The study was funded by Swedish government and health foundations. Dr. Järvholm disclosed pharmaceutical industry funding not related to the study, and three coauthors also disclosed industry relationships.

SOURCE: Järvholm K et al. Lancet Child Adolesc Health. 2020. doi: 10.1016/s2352-4642(20)30024-9.

Young people treated with bariatric surgery for severe obesity did not experience better mental health in the 5 years following their procedures, Swedish researchers said, and indeed fared worse than their nontreated peers on certain measures.

The results of this study do not necessarily argue “that metabolic and bariatric surgery during adolescence causes mental health problems,” the investigators wrote in the Lancet Child and Adolescent Health, but “it is reasonable to conclude that metabolic and bariatric surgery does not result in a substantial alleviation of mental health problems in adolescents with severe obesity,” and that “long-term mental health support should be required in programs providing adolescent metabolic and bariatric surgery.”

Kajsa Järvholm, PhD, of Skåne University Hospital, in Malmö, Sweden, and colleagues reported results from a prospective nonrandomized study that recruited 81 adolescents in Sweden aged 13-18 years (mean age, 16.5) who had a body mass index of 40 or higher, or BMI of 35 with obesity-related comorbidities and who underwent Roux-en-Y gastric bypass for weight loss. Subjects were matched by age, sex, and BMI to 80 controls (mean age, 15.8 years) who were assigned to conventional nonsurgical treatment. All patients were assessed at 1, 2, and 5 years.

Although mental health treatment, including use of psychiatric drugs, did not differ between the groups at baseline, during the follow-up period the subjects who underwent surgery saw 15% more impatient and outpatient mental health treatment, compared with controls, a significant difference. About a quarter of patients in the surgically treated group required specialized mental health treatment for the first time after their surgeries.

Though the surgical group lost much more weight – mean BMI was 32.3 at 5 years, compared with 41.7 for controls – none of the mental health changes from baseline were significantly associated with percentage change of BMI at 5 years.

The findings from the study are consistent with results from studies in adults in which bariatric surgery improves many health outcomes but does not alter the need for mental health treatment. Although 5 years is a longer follow-up than in previous studies in young patients – a key strength of the study – Dr. Järvholm and colleagues acknowledged some weaknesses, including a nonrandomized design, lack of a comparison group of nonobese youths for mental health measures, a small sample size, and a surgical procedure that is now out of favor in adolescents.

The study was funded by Swedish government and health foundations. Dr. Järvholm disclosed pharmaceutical industry funding not related to the study, and three coauthors also disclosed industry relationships.

SOURCE: Järvholm K et al. Lancet Child Adolesc Health. 2020. doi: 10.1016/s2352-4642(20)30024-9.

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FROM THE LANCET CHILD & ADOLESCENT HEALTH

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Key clinical point: Bariatric surgery was not associated with improvement in obese adolescents’ long-term mental health, despite significant weight loss.

Major finding: During 5 years of follow up, surgically treated patients experienced 15% more mental health care usage than controls.

Study details: A prospective, nonrandomized study involving 161 adolescents with a BMI of 40 or greater (or 35 with comorbidities).

Disclosures: The Swedish government and Swedish health research foundations sponsored the study.

Source: Järvholm K et al. Lancet Child Adolesc Health. 2020. doi: 10.1016/s2352-4642(20)30024-9.

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Quality reporting of improvement activities in 2020

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2020 has begun and therefore so has a new year of quality reporting requirements. Quality reporting under the Centers for Medicare and Medicaid Services (CMS) Merit-based Incentive Payment System (MIPS) may seem like a burden, but it doesn’t need to be. You can likely get credit for the things you are already doing in your practice with little to no augmentation needed.

Dr. Brijen J. Shah

First, there are a few pieces of information to keep in mind when tracking your data and preparing your staff for their 2020 strategy.

1. Group Participation – For 2020 there is an increase in the MIPS participation threshold for those participating as part of a group. At least 50% of the MIPS eligible clinicians in the reporting group must participate in the same continuous 90-day period to receive credit for a quality improvement activity. That’s a significant increase from 2019 when only one (1) MIPS eligible clinician in a group was required to participate. Connect with your staff now to make sure your group meets the new 50% participation requirement.

2. Improvement Activities for Group Participation – Improvement Activities that are approved for credit by CMS are given a weight based on their requirements. Approved activities are weighted as either medium or high, and this impacts how many activities a practitioner must report on. In 2020, CMS increased the participation threshold for group reporting from a single clinician to 50% of the clinicians in the practice for the Improvement Activities category along with other changes such as modifying the definition of rural area to mean a ZIP code designated as rural by the Federal Office of Rural Health Policy using the most recent file available, updating the improvement activities and removing some criteria for Patient-Centered Medical Home designation. Work with your staff now to make sure at least 50% of the MIPS-eligible clinicians in your group are participating in the same Improvement Activities.

3. Quantity of Improvement Activities Required – CMS requires most individuals or groups report on any of the following options during any continuous 90-day period (or as specified in the activity description) in the same performance year, provided that all participating clinicians are reporting on the same activities:
a. 2 high-weighted activities, or
b. 1 high-weighted and 2 medium-weighted activities, or
c. 4 medium-weighted activities

Be sure to pay attention to the weight of the activity you (if you’re reporting as an individual) or your group is reporting so you don’t have any surprises at the end of the reporting period.

There are a variety of options for activities you can report on and some may be a lower lift than you expect.

Does your practice treat Medicaid patients? If so, do you know their average wait time for an initial visit? If that number is 10 days or less, you can report on this activity. If you aren’t quite hitting this benchmark, then consider implementing a scheduling protocol for this population of your patients in the new year.

 

 

Engagement of new Medicaid patients and follow-up

Seeing new and follow-up Medicaid patients in a timely manner, including individuals dually eligible for Medicaid and Medicare. A timely manner is defined as within 10 business days for this activity.
Subcategory name: Achieving Health Equity
Activity weighting: High

Are you responsible for onboarding and training new clinicians to your rural practice? If so, you could report on the next activity. Eligible clinicians would be responsible for training of new clinicians including physicians, advanced practice providers and clinical nursing specialists. These clinicians must practice in small, underserved, or rural areas. What is considered a small, rural, or underserved practice for the purpose of MIPS?

Small practice

  • Defined as a practice with 15 or fewer eligible clinicians-based billing under the same TIN

Rural/underserved practice

  • Defined as a practice in a zip code included in the most recent set of Health Professional Shortage Areas (HPSAs), as determined by the Health Resources and Services Administration (HRSA).
  • HPSAs are designations that indicate health care provider shortages in primary care, dental health or mental health can be geographic population based or facility based.
 

 

Provide education opportunities for new clinicians

MIPS-eligible clinicians acting as a preceptor for clinicians-in-training (such as medical residents/fellows, medical students, physician assistants, nurse practitioners, or clinical nurse specialists) and accepting such clinicians for clinical rotations in community practices in small, underserved, or rural areas.
Subcategory name: Achieving Health Equity
Activity weighting: High
There are also activities you can report on under the beneficiary engagement category that you may already be doing in your practice. First, the collection of patient experience and satisfaction data and the development of an improvement plan as necessary counts as one activity. Second, the engagement of the patient’s support team in the development of a plan of care, which needs to include goals and be documented in the electronic health record.

Collection and follow-up on patient experience and satisfaction data on beneficiary engagement

Collection and follow-up on patient experience and satisfaction data on beneficiary engagement, including development of improvement plan.
Subcategory name: Beneficiary Engagement
Activity weighting: High

Engagement of Patients, Family, and Caregivers in Developing a Plan of Care

Engage patients, family, and caregivers in developing a plan of care and prioritizing their goals for action, documented in the electronic health record (EHR) technology.
Subcategory name: Beneficiary Engagement
Activity weighting: Medium
Another data collection category is patient access to care. If you collect and use patient data on their satisfaction and experience related to access to care and commit to developing an improvement plan as necessary, you can receive credit for this reporting category.

Collection and use of patient experience and satisfaction data on access

Collection of patient experience and satisfaction data on access to care and development of an improvement plan, such as outlining steps for improving communications with patients to help understanding of urgent access needs.
Subcategory name: Expanded Practice Access
Activity weighting: Medium

One of the hallmarks of a medical practice in any specialty is improvement. We are always striving to improve something, whether it be the patient experience, patient outcomes, the bottom line, or the education of clinical staff. You can leverage the practice improvement plans you have put into place for credit.

 

 

Leadership engagement in regular guidance and demonstrated commitment for implementing practice improvement changes

Ensure full engagement of clinical and administrative leadership in practice improvement that could include one or more of the following: Make responsibility for guidance of practice change a component of clinical and administrative leadership roles; Allocate time for clinical and administrative leadership for practice improvement efforts, including participation in regular team meetings; and/or Incorporate population health, quality and patient experience metrics in regular reviews of practice performance.
Subcategory name: Patient Safety and Practice Assessment
Activity weighting: Medium

Prescription drug use is a topic on every providers’ radar right now. Proper prescribing and monitoring of patients are crucial to their safety and quality of care. In the field of gastroenterology, step-therapy adds a new level of complication to the use of prescription drugs. Ensuring the proper medication protocols allows you to provide appropriate and timely treatment for your patients.

Annual registration in the Prescription Drug Monitoring Program

Annual registration by eligible clinician or group in the prescription drug–monitoring program of the state where they practice. Activities that simply involve registration are not sufficient. MIPS-eligible clinicians and groups must participate for a minimum of 6 months.

Subcategory name: Patient Safety and Practice Assessment
Activity weighting: Medium

As you can see, there are a variety of improvement activities that you can report on for 2020. This article has outlined several of them that you may already be doing in your practice, but many more can be found by visiting https://qpp.cms.gov/mips/improvement-activities?py=2020 along with information on how to report and the necessary forms for submission.

Dr. Shah is associate professor, Mount Sinai Medical Center, New York, member of the AGA Quality Leadership Council. He has no disclosures.

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2020 has begun and therefore so has a new year of quality reporting requirements. Quality reporting under the Centers for Medicare and Medicaid Services (CMS) Merit-based Incentive Payment System (MIPS) may seem like a burden, but it doesn’t need to be. You can likely get credit for the things you are already doing in your practice with little to no augmentation needed.

Dr. Brijen J. Shah

First, there are a few pieces of information to keep in mind when tracking your data and preparing your staff for their 2020 strategy.

1. Group Participation – For 2020 there is an increase in the MIPS participation threshold for those participating as part of a group. At least 50% of the MIPS eligible clinicians in the reporting group must participate in the same continuous 90-day period to receive credit for a quality improvement activity. That’s a significant increase from 2019 when only one (1) MIPS eligible clinician in a group was required to participate. Connect with your staff now to make sure your group meets the new 50% participation requirement.

2. Improvement Activities for Group Participation – Improvement Activities that are approved for credit by CMS are given a weight based on their requirements. Approved activities are weighted as either medium or high, and this impacts how many activities a practitioner must report on. In 2020, CMS increased the participation threshold for group reporting from a single clinician to 50% of the clinicians in the practice for the Improvement Activities category along with other changes such as modifying the definition of rural area to mean a ZIP code designated as rural by the Federal Office of Rural Health Policy using the most recent file available, updating the improvement activities and removing some criteria for Patient-Centered Medical Home designation. Work with your staff now to make sure at least 50% of the MIPS-eligible clinicians in your group are participating in the same Improvement Activities.

3. Quantity of Improvement Activities Required – CMS requires most individuals or groups report on any of the following options during any continuous 90-day period (or as specified in the activity description) in the same performance year, provided that all participating clinicians are reporting on the same activities:
a. 2 high-weighted activities, or
b. 1 high-weighted and 2 medium-weighted activities, or
c. 4 medium-weighted activities

Be sure to pay attention to the weight of the activity you (if you’re reporting as an individual) or your group is reporting so you don’t have any surprises at the end of the reporting period.

There are a variety of options for activities you can report on and some may be a lower lift than you expect.

Does your practice treat Medicaid patients? If so, do you know their average wait time for an initial visit? If that number is 10 days or less, you can report on this activity. If you aren’t quite hitting this benchmark, then consider implementing a scheduling protocol for this population of your patients in the new year.

 

 

Engagement of new Medicaid patients and follow-up

Seeing new and follow-up Medicaid patients in a timely manner, including individuals dually eligible for Medicaid and Medicare. A timely manner is defined as within 10 business days for this activity.
Subcategory name: Achieving Health Equity
Activity weighting: High

Are you responsible for onboarding and training new clinicians to your rural practice? If so, you could report on the next activity. Eligible clinicians would be responsible for training of new clinicians including physicians, advanced practice providers and clinical nursing specialists. These clinicians must practice in small, underserved, or rural areas. What is considered a small, rural, or underserved practice for the purpose of MIPS?

Small practice

  • Defined as a practice with 15 or fewer eligible clinicians-based billing under the same TIN

Rural/underserved practice

  • Defined as a practice in a zip code included in the most recent set of Health Professional Shortage Areas (HPSAs), as determined by the Health Resources and Services Administration (HRSA).
  • HPSAs are designations that indicate health care provider shortages in primary care, dental health or mental health can be geographic population based or facility based.
 

 

Provide education opportunities for new clinicians

MIPS-eligible clinicians acting as a preceptor for clinicians-in-training (such as medical residents/fellows, medical students, physician assistants, nurse practitioners, or clinical nurse specialists) and accepting such clinicians for clinical rotations in community practices in small, underserved, or rural areas.
Subcategory name: Achieving Health Equity
Activity weighting: High
There are also activities you can report on under the beneficiary engagement category that you may already be doing in your practice. First, the collection of patient experience and satisfaction data and the development of an improvement plan as necessary counts as one activity. Second, the engagement of the patient’s support team in the development of a plan of care, which needs to include goals and be documented in the electronic health record.

Collection and follow-up on patient experience and satisfaction data on beneficiary engagement

Collection and follow-up on patient experience and satisfaction data on beneficiary engagement, including development of improvement plan.
Subcategory name: Beneficiary Engagement
Activity weighting: High

Engagement of Patients, Family, and Caregivers in Developing a Plan of Care

Engage patients, family, and caregivers in developing a plan of care and prioritizing their goals for action, documented in the electronic health record (EHR) technology.
Subcategory name: Beneficiary Engagement
Activity weighting: Medium
Another data collection category is patient access to care. If you collect and use patient data on their satisfaction and experience related to access to care and commit to developing an improvement plan as necessary, you can receive credit for this reporting category.

Collection and use of patient experience and satisfaction data on access

Collection of patient experience and satisfaction data on access to care and development of an improvement plan, such as outlining steps for improving communications with patients to help understanding of urgent access needs.
Subcategory name: Expanded Practice Access
Activity weighting: Medium

One of the hallmarks of a medical practice in any specialty is improvement. We are always striving to improve something, whether it be the patient experience, patient outcomes, the bottom line, or the education of clinical staff. You can leverage the practice improvement plans you have put into place for credit.

 

 

Leadership engagement in regular guidance and demonstrated commitment for implementing practice improvement changes

Ensure full engagement of clinical and administrative leadership in practice improvement that could include one or more of the following: Make responsibility for guidance of practice change a component of clinical and administrative leadership roles; Allocate time for clinical and administrative leadership for practice improvement efforts, including participation in regular team meetings; and/or Incorporate population health, quality and patient experience metrics in regular reviews of practice performance.
Subcategory name: Patient Safety and Practice Assessment
Activity weighting: Medium

Prescription drug use is a topic on every providers’ radar right now. Proper prescribing and monitoring of patients are crucial to their safety and quality of care. In the field of gastroenterology, step-therapy adds a new level of complication to the use of prescription drugs. Ensuring the proper medication protocols allows you to provide appropriate and timely treatment for your patients.

Annual registration in the Prescription Drug Monitoring Program

Annual registration by eligible clinician or group in the prescription drug–monitoring program of the state where they practice. Activities that simply involve registration are not sufficient. MIPS-eligible clinicians and groups must participate for a minimum of 6 months.

Subcategory name: Patient Safety and Practice Assessment
Activity weighting: Medium

As you can see, there are a variety of improvement activities that you can report on for 2020. This article has outlined several of them that you may already be doing in your practice, but many more can be found by visiting https://qpp.cms.gov/mips/improvement-activities?py=2020 along with information on how to report and the necessary forms for submission.

Dr. Shah is associate professor, Mount Sinai Medical Center, New York, member of the AGA Quality Leadership Council. He has no disclosures.

2020 has begun and therefore so has a new year of quality reporting requirements. Quality reporting under the Centers for Medicare and Medicaid Services (CMS) Merit-based Incentive Payment System (MIPS) may seem like a burden, but it doesn’t need to be. You can likely get credit for the things you are already doing in your practice with little to no augmentation needed.

Dr. Brijen J. Shah

First, there are a few pieces of information to keep in mind when tracking your data and preparing your staff for their 2020 strategy.

1. Group Participation – For 2020 there is an increase in the MIPS participation threshold for those participating as part of a group. At least 50% of the MIPS eligible clinicians in the reporting group must participate in the same continuous 90-day period to receive credit for a quality improvement activity. That’s a significant increase from 2019 when only one (1) MIPS eligible clinician in a group was required to participate. Connect with your staff now to make sure your group meets the new 50% participation requirement.

2. Improvement Activities for Group Participation – Improvement Activities that are approved for credit by CMS are given a weight based on their requirements. Approved activities are weighted as either medium or high, and this impacts how many activities a practitioner must report on. In 2020, CMS increased the participation threshold for group reporting from a single clinician to 50% of the clinicians in the practice for the Improvement Activities category along with other changes such as modifying the definition of rural area to mean a ZIP code designated as rural by the Federal Office of Rural Health Policy using the most recent file available, updating the improvement activities and removing some criteria for Patient-Centered Medical Home designation. Work with your staff now to make sure at least 50% of the MIPS-eligible clinicians in your group are participating in the same Improvement Activities.

3. Quantity of Improvement Activities Required – CMS requires most individuals or groups report on any of the following options during any continuous 90-day period (or as specified in the activity description) in the same performance year, provided that all participating clinicians are reporting on the same activities:
a. 2 high-weighted activities, or
b. 1 high-weighted and 2 medium-weighted activities, or
c. 4 medium-weighted activities

Be sure to pay attention to the weight of the activity you (if you’re reporting as an individual) or your group is reporting so you don’t have any surprises at the end of the reporting period.

There are a variety of options for activities you can report on and some may be a lower lift than you expect.

Does your practice treat Medicaid patients? If so, do you know their average wait time for an initial visit? If that number is 10 days or less, you can report on this activity. If you aren’t quite hitting this benchmark, then consider implementing a scheduling protocol for this population of your patients in the new year.

 

 

Engagement of new Medicaid patients and follow-up

Seeing new and follow-up Medicaid patients in a timely manner, including individuals dually eligible for Medicaid and Medicare. A timely manner is defined as within 10 business days for this activity.
Subcategory name: Achieving Health Equity
Activity weighting: High

Are you responsible for onboarding and training new clinicians to your rural practice? If so, you could report on the next activity. Eligible clinicians would be responsible for training of new clinicians including physicians, advanced practice providers and clinical nursing specialists. These clinicians must practice in small, underserved, or rural areas. What is considered a small, rural, or underserved practice for the purpose of MIPS?

Small practice

  • Defined as a practice with 15 or fewer eligible clinicians-based billing under the same TIN

Rural/underserved practice

  • Defined as a practice in a zip code included in the most recent set of Health Professional Shortage Areas (HPSAs), as determined by the Health Resources and Services Administration (HRSA).
  • HPSAs are designations that indicate health care provider shortages in primary care, dental health or mental health can be geographic population based or facility based.
 

 

Provide education opportunities for new clinicians

MIPS-eligible clinicians acting as a preceptor for clinicians-in-training (such as medical residents/fellows, medical students, physician assistants, nurse practitioners, or clinical nurse specialists) and accepting such clinicians for clinical rotations in community practices in small, underserved, or rural areas.
Subcategory name: Achieving Health Equity
Activity weighting: High
There are also activities you can report on under the beneficiary engagement category that you may already be doing in your practice. First, the collection of patient experience and satisfaction data and the development of an improvement plan as necessary counts as one activity. Second, the engagement of the patient’s support team in the development of a plan of care, which needs to include goals and be documented in the electronic health record.

Collection and follow-up on patient experience and satisfaction data on beneficiary engagement

Collection and follow-up on patient experience and satisfaction data on beneficiary engagement, including development of improvement plan.
Subcategory name: Beneficiary Engagement
Activity weighting: High

Engagement of Patients, Family, and Caregivers in Developing a Plan of Care

Engage patients, family, and caregivers in developing a plan of care and prioritizing their goals for action, documented in the electronic health record (EHR) technology.
Subcategory name: Beneficiary Engagement
Activity weighting: Medium
Another data collection category is patient access to care. If you collect and use patient data on their satisfaction and experience related to access to care and commit to developing an improvement plan as necessary, you can receive credit for this reporting category.

Collection and use of patient experience and satisfaction data on access

Collection of patient experience and satisfaction data on access to care and development of an improvement plan, such as outlining steps for improving communications with patients to help understanding of urgent access needs.
Subcategory name: Expanded Practice Access
Activity weighting: Medium

One of the hallmarks of a medical practice in any specialty is improvement. We are always striving to improve something, whether it be the patient experience, patient outcomes, the bottom line, or the education of clinical staff. You can leverage the practice improvement plans you have put into place for credit.

 

 

Leadership engagement in regular guidance and demonstrated commitment for implementing practice improvement changes

Ensure full engagement of clinical and administrative leadership in practice improvement that could include one or more of the following: Make responsibility for guidance of practice change a component of clinical and administrative leadership roles; Allocate time for clinical and administrative leadership for practice improvement efforts, including participation in regular team meetings; and/or Incorporate population health, quality and patient experience metrics in regular reviews of practice performance.
Subcategory name: Patient Safety and Practice Assessment
Activity weighting: Medium

Prescription drug use is a topic on every providers’ radar right now. Proper prescribing and monitoring of patients are crucial to their safety and quality of care. In the field of gastroenterology, step-therapy adds a new level of complication to the use of prescription drugs. Ensuring the proper medication protocols allows you to provide appropriate and timely treatment for your patients.

Annual registration in the Prescription Drug Monitoring Program

Annual registration by eligible clinician or group in the prescription drug–monitoring program of the state where they practice. Activities that simply involve registration are not sufficient. MIPS-eligible clinicians and groups must participate for a minimum of 6 months.

Subcategory name: Patient Safety and Practice Assessment
Activity weighting: Medium

As you can see, there are a variety of improvement activities that you can report on for 2020. This article has outlined several of them that you may already be doing in your practice, but many more can be found by visiting https://qpp.cms.gov/mips/improvement-activities?py=2020 along with information on how to report and the necessary forms for submission.

Dr. Shah is associate professor, Mount Sinai Medical Center, New York, member of the AGA Quality Leadership Council. He has no disclosures.

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Wuhan virus: What clinicians need to know

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As the Wuhan coronavirus story unfolds, the most important thing for clinicians in the United States to do is ask patients who appear to have the flu if they, or someone they have been in contact with, recently returned from China, according to infectious disease experts.

China News Service/CC BY 3.0
Medical staff in Wuhan railway station during the Wuhan coronavirus outbreak, Jan. 24, 2020.

“We are asking that of everyone with fever and respiratory symptoms who comes to our clinics, hospital, or emergency room. It’s a powerful screening tool,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

In addition to fever, common signs of infection include cough, shortness of breath, and breathing difficulties. Some patients have had diarrhea, vomiting, and other gastrointestinal symptoms. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death. The incubation period appears to be up to 2 weeks, according to the World Health Organization (WHO).

If patients exhibit symptoms and either they or a close contact has returned from China recently, take standard airborne precautions and send specimens – a serum sample, oral and nasal pharyngeal swabs, and lower respiratory tract specimens if available – to the local health department, which will forward them to the Centers for Disease Control and Prevention (CDC) for testing. Turnaround time is 24-48 hours.

Dr. William Shaffner


The 2019 Novel Coronavirus (2019-nCoV), identified as the cause of an outbreak of respiratory illness first detected in December in association with a live animal market in Wuhan, China, has been implicated in almost 2,000 cases and 56 deaths in that country. Cases have been reported in 13 countries besides China. Five cases of 2019-nCoV infection have been confirmed in the United States, all in people recently returned from Wuhan. As the virus spreads in China, however, it’s almost certain more cases will show up in the United States. Travel history is key, Dr. Schaffner and others said.
 

Plan and rehearse

The first step to prepare is to use the CDC’s Interim Guidance for Healthcare Professionals to make a written plan specific to your practice to respond to a potential case. The plan must include notifying the local health department, the CDC liaison for testing, and tracking down patient contacts.

“It’s not good enough to just download CDC’s guidance; use it to make your own local plan and know what to do 24/7,” said Daniel Lucey, MD, an infectious disease expert at Georgetown University Medical Center, Washington, D.C.

“Know who is on call at the health department on weekends and nights,” he said. Know where the patient is going to be isolated; figure out what to do if there’s more than one, and tests come back positive. Have masks on hand, and rehearse the response. “Make a coronavirus team, and absolutely have the nurses involved,” as well as other providers who may come into contact with a case, he added.

Dr. Daniel Lucey


“You want to be able to do as well as your counterparts in Washington state and Chicago,” where the first two U.S. cases emerged. “They were prepared. They knew what to do,” Dr. Lucey said.

Those first two U.S. patients – a man in Everett, Wash., and a Chicago woman – developed symptoms after returning from Wuhan, a city of 11 million just over 400 miles inland from the port city of Shanghai. On Jan. 26 three more cases were confirmed by the CDC, two in California and one in Arizona, and each had recently traveled to Wuhan.  All five patients remain hospitalized, and there’s no evidence they spread the infection further. There is also no evidence of human-to-human transmission of other cases exported from China to any other countries, according to the WHO.

WHO declined to declare a global health emergency – a Public Health Emergency of International Concern, in its parlance – on Jan. 23. The step would have triggered travel and trade restrictions in member states, including the United States. For now, at least, the group said it wasn’t warranted at this point.
 
 

 

Fatality rates

The focus right now is China. The outbreak has spread beyond Wuhan to other parts of the country, and there’s evidence of fourth-generation spread.



Transportation into and out of Wuhan and other cities has been curtailed, Lunar New Year festivals have been canceled, and the Shanghai Disneyland has been closed, among other measures taken by Chinese officials.

The government could be taking drastic measures in part to prevent the public criticism it took in the early 2000’s for the delayed response and lack of transparency during the global outbreak of another wildlife market coronavirus epidemic, severe acute respiratory syndrome (SARS). In a press conference Jan. 22, WHO officials commended the government’s containment efforts but did not say they recommended them.

According to WHO, serious cases in China have mostly been in people over 40 years old with significant comorbidities and have skewed towards men. Spread seems to be limited to family members, health care providers, and other close contacts, probably by respiratory droplets. If that pattern holds, WHO officials said, the outbreak is containable.

The fatality rate appears to be around 3%, a good deal lower than the 10% reported for SARS and much lower than the nearly 40% reported for Middle East respiratory syndrome (MERS), another recent coronavirus mutation from the animal trade.

The Wuhan virus fatality rate might drop as milder cases are detected and added to the denominator. “It definitely appears to be less severe than SARS and MERS,” said Amesh Adalja, MD, an infectious disease physician in Pittsburgh and emerging infectious disease researcher at Johns Hopkins University, Baltimore.

SARS: Lessons learned

In general, the world is much better equipped for coronavirus outbreaks than when SARS, in particular, emerged in 2003.

Dr. Amesh Adalja

WHO officials in their press conference lauded China for it openness with the current outbreak, and for isolating and sequencing the virus immediately, which gave the world a diagnostic test in the first days of the outbreak, something that wasn’t available for SARS. China and other countries also are cooperating and working closely to contain the Wuhan virus.

“What we know today might change tomorrow, so we have to keep tuned in to new information, but we learned a lot from SARS,” Dr. Shaffner said. Overall, it’s likely “the impact on the United States of this new coronavirus is going to be trivial,” he predicted.

Dr. Lucey, however, recalled that the SARS outbreak in Toronto in 2003 started with one missed case. A woman returned asymptomatic from Hong Kong and spread the infection to her family members before she died. Her cause of death wasn’t immediately recognized, nor was the reason her family members were sick, since they hadn’t been to Hong Kong recently.

The infection ultimately spread to more than 200 people, about half of them health care workers. A few people died.

If a virus is sufficiently contagious, “it just takes one. You don’t want to be the one who misses that first patient,” Dr. Lucey said.

Currently, there are no antivirals or vaccines for coronaviruses; researchers are working on both, but for now, care is supportive.

aotto@mdedge.com

This article was updated with new case numbers on 1/26/20.

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As the Wuhan coronavirus story unfolds, the most important thing for clinicians in the United States to do is ask patients who appear to have the flu if they, or someone they have been in contact with, recently returned from China, according to infectious disease experts.

China News Service/CC BY 3.0
Medical staff in Wuhan railway station during the Wuhan coronavirus outbreak, Jan. 24, 2020.

“We are asking that of everyone with fever and respiratory symptoms who comes to our clinics, hospital, or emergency room. It’s a powerful screening tool,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

In addition to fever, common signs of infection include cough, shortness of breath, and breathing difficulties. Some patients have had diarrhea, vomiting, and other gastrointestinal symptoms. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death. The incubation period appears to be up to 2 weeks, according to the World Health Organization (WHO).

If patients exhibit symptoms and either they or a close contact has returned from China recently, take standard airborne precautions and send specimens – a serum sample, oral and nasal pharyngeal swabs, and lower respiratory tract specimens if available – to the local health department, which will forward them to the Centers for Disease Control and Prevention (CDC) for testing. Turnaround time is 24-48 hours.

Dr. William Shaffner


The 2019 Novel Coronavirus (2019-nCoV), identified as the cause of an outbreak of respiratory illness first detected in December in association with a live animal market in Wuhan, China, has been implicated in almost 2,000 cases and 56 deaths in that country. Cases have been reported in 13 countries besides China. Five cases of 2019-nCoV infection have been confirmed in the United States, all in people recently returned from Wuhan. As the virus spreads in China, however, it’s almost certain more cases will show up in the United States. Travel history is key, Dr. Schaffner and others said.
 

Plan and rehearse

The first step to prepare is to use the CDC’s Interim Guidance for Healthcare Professionals to make a written plan specific to your practice to respond to a potential case. The plan must include notifying the local health department, the CDC liaison for testing, and tracking down patient contacts.

“It’s not good enough to just download CDC’s guidance; use it to make your own local plan and know what to do 24/7,” said Daniel Lucey, MD, an infectious disease expert at Georgetown University Medical Center, Washington, D.C.

“Know who is on call at the health department on weekends and nights,” he said. Know where the patient is going to be isolated; figure out what to do if there’s more than one, and tests come back positive. Have masks on hand, and rehearse the response. “Make a coronavirus team, and absolutely have the nurses involved,” as well as other providers who may come into contact with a case, he added.

Dr. Daniel Lucey


“You want to be able to do as well as your counterparts in Washington state and Chicago,” where the first two U.S. cases emerged. “They were prepared. They knew what to do,” Dr. Lucey said.

Those first two U.S. patients – a man in Everett, Wash., and a Chicago woman – developed symptoms after returning from Wuhan, a city of 11 million just over 400 miles inland from the port city of Shanghai. On Jan. 26 three more cases were confirmed by the CDC, two in California and one in Arizona, and each had recently traveled to Wuhan.  All five patients remain hospitalized, and there’s no evidence they spread the infection further. There is also no evidence of human-to-human transmission of other cases exported from China to any other countries, according to the WHO.

WHO declined to declare a global health emergency – a Public Health Emergency of International Concern, in its parlance – on Jan. 23. The step would have triggered travel and trade restrictions in member states, including the United States. For now, at least, the group said it wasn’t warranted at this point.
 
 

 

Fatality rates

The focus right now is China. The outbreak has spread beyond Wuhan to other parts of the country, and there’s evidence of fourth-generation spread.



Transportation into and out of Wuhan and other cities has been curtailed, Lunar New Year festivals have been canceled, and the Shanghai Disneyland has been closed, among other measures taken by Chinese officials.

The government could be taking drastic measures in part to prevent the public criticism it took in the early 2000’s for the delayed response and lack of transparency during the global outbreak of another wildlife market coronavirus epidemic, severe acute respiratory syndrome (SARS). In a press conference Jan. 22, WHO officials commended the government’s containment efforts but did not say they recommended them.

According to WHO, serious cases in China have mostly been in people over 40 years old with significant comorbidities and have skewed towards men. Spread seems to be limited to family members, health care providers, and other close contacts, probably by respiratory droplets. If that pattern holds, WHO officials said, the outbreak is containable.

The fatality rate appears to be around 3%, a good deal lower than the 10% reported for SARS and much lower than the nearly 40% reported for Middle East respiratory syndrome (MERS), another recent coronavirus mutation from the animal trade.

The Wuhan virus fatality rate might drop as milder cases are detected and added to the denominator. “It definitely appears to be less severe than SARS and MERS,” said Amesh Adalja, MD, an infectious disease physician in Pittsburgh and emerging infectious disease researcher at Johns Hopkins University, Baltimore.

SARS: Lessons learned

In general, the world is much better equipped for coronavirus outbreaks than when SARS, in particular, emerged in 2003.

Dr. Amesh Adalja

WHO officials in their press conference lauded China for it openness with the current outbreak, and for isolating and sequencing the virus immediately, which gave the world a diagnostic test in the first days of the outbreak, something that wasn’t available for SARS. China and other countries also are cooperating and working closely to contain the Wuhan virus.

“What we know today might change tomorrow, so we have to keep tuned in to new information, but we learned a lot from SARS,” Dr. Shaffner said. Overall, it’s likely “the impact on the United States of this new coronavirus is going to be trivial,” he predicted.

Dr. Lucey, however, recalled that the SARS outbreak in Toronto in 2003 started with one missed case. A woman returned asymptomatic from Hong Kong and spread the infection to her family members before she died. Her cause of death wasn’t immediately recognized, nor was the reason her family members were sick, since they hadn’t been to Hong Kong recently.

The infection ultimately spread to more than 200 people, about half of them health care workers. A few people died.

If a virus is sufficiently contagious, “it just takes one. You don’t want to be the one who misses that first patient,” Dr. Lucey said.

Currently, there are no antivirals or vaccines for coronaviruses; researchers are working on both, but for now, care is supportive.

aotto@mdedge.com

This article was updated with new case numbers on 1/26/20.

As the Wuhan coronavirus story unfolds, the most important thing for clinicians in the United States to do is ask patients who appear to have the flu if they, or someone they have been in contact with, recently returned from China, according to infectious disease experts.

China News Service/CC BY 3.0
Medical staff in Wuhan railway station during the Wuhan coronavirus outbreak, Jan. 24, 2020.

“We are asking that of everyone with fever and respiratory symptoms who comes to our clinics, hospital, or emergency room. It’s a powerful screening tool,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

In addition to fever, common signs of infection include cough, shortness of breath, and breathing difficulties. Some patients have had diarrhea, vomiting, and other gastrointestinal symptoms. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death. The incubation period appears to be up to 2 weeks, according to the World Health Organization (WHO).

If patients exhibit symptoms and either they or a close contact has returned from China recently, take standard airborne precautions and send specimens – a serum sample, oral and nasal pharyngeal swabs, and lower respiratory tract specimens if available – to the local health department, which will forward them to the Centers for Disease Control and Prevention (CDC) for testing. Turnaround time is 24-48 hours.

Dr. William Shaffner


The 2019 Novel Coronavirus (2019-nCoV), identified as the cause of an outbreak of respiratory illness first detected in December in association with a live animal market in Wuhan, China, has been implicated in almost 2,000 cases and 56 deaths in that country. Cases have been reported in 13 countries besides China. Five cases of 2019-nCoV infection have been confirmed in the United States, all in people recently returned from Wuhan. As the virus spreads in China, however, it’s almost certain more cases will show up in the United States. Travel history is key, Dr. Schaffner and others said.
 

Plan and rehearse

The first step to prepare is to use the CDC’s Interim Guidance for Healthcare Professionals to make a written plan specific to your practice to respond to a potential case. The plan must include notifying the local health department, the CDC liaison for testing, and tracking down patient contacts.

“It’s not good enough to just download CDC’s guidance; use it to make your own local plan and know what to do 24/7,” said Daniel Lucey, MD, an infectious disease expert at Georgetown University Medical Center, Washington, D.C.

“Know who is on call at the health department on weekends and nights,” he said. Know where the patient is going to be isolated; figure out what to do if there’s more than one, and tests come back positive. Have masks on hand, and rehearse the response. “Make a coronavirus team, and absolutely have the nurses involved,” as well as other providers who may come into contact with a case, he added.

Dr. Daniel Lucey


“You want to be able to do as well as your counterparts in Washington state and Chicago,” where the first two U.S. cases emerged. “They were prepared. They knew what to do,” Dr. Lucey said.

Those first two U.S. patients – a man in Everett, Wash., and a Chicago woman – developed symptoms after returning from Wuhan, a city of 11 million just over 400 miles inland from the port city of Shanghai. On Jan. 26 three more cases were confirmed by the CDC, two in California and one in Arizona, and each had recently traveled to Wuhan.  All five patients remain hospitalized, and there’s no evidence they spread the infection further. There is also no evidence of human-to-human transmission of other cases exported from China to any other countries, according to the WHO.

WHO declined to declare a global health emergency – a Public Health Emergency of International Concern, in its parlance – on Jan. 23. The step would have triggered travel and trade restrictions in member states, including the United States. For now, at least, the group said it wasn’t warranted at this point.
 
 

 

Fatality rates

The focus right now is China. The outbreak has spread beyond Wuhan to other parts of the country, and there’s evidence of fourth-generation spread.



Transportation into and out of Wuhan and other cities has been curtailed, Lunar New Year festivals have been canceled, and the Shanghai Disneyland has been closed, among other measures taken by Chinese officials.

The government could be taking drastic measures in part to prevent the public criticism it took in the early 2000’s for the delayed response and lack of transparency during the global outbreak of another wildlife market coronavirus epidemic, severe acute respiratory syndrome (SARS). In a press conference Jan. 22, WHO officials commended the government’s containment efforts but did not say they recommended them.

According to WHO, serious cases in China have mostly been in people over 40 years old with significant comorbidities and have skewed towards men. Spread seems to be limited to family members, health care providers, and other close contacts, probably by respiratory droplets. If that pattern holds, WHO officials said, the outbreak is containable.

The fatality rate appears to be around 3%, a good deal lower than the 10% reported for SARS and much lower than the nearly 40% reported for Middle East respiratory syndrome (MERS), another recent coronavirus mutation from the animal trade.

The Wuhan virus fatality rate might drop as milder cases are detected and added to the denominator. “It definitely appears to be less severe than SARS and MERS,” said Amesh Adalja, MD, an infectious disease physician in Pittsburgh and emerging infectious disease researcher at Johns Hopkins University, Baltimore.

SARS: Lessons learned

In general, the world is much better equipped for coronavirus outbreaks than when SARS, in particular, emerged in 2003.

Dr. Amesh Adalja

WHO officials in their press conference lauded China for it openness with the current outbreak, and for isolating and sequencing the virus immediately, which gave the world a diagnostic test in the first days of the outbreak, something that wasn’t available for SARS. China and other countries also are cooperating and working closely to contain the Wuhan virus.

“What we know today might change tomorrow, so we have to keep tuned in to new information, but we learned a lot from SARS,” Dr. Shaffner said. Overall, it’s likely “the impact on the United States of this new coronavirus is going to be trivial,” he predicted.

Dr. Lucey, however, recalled that the SARS outbreak in Toronto in 2003 started with one missed case. A woman returned asymptomatic from Hong Kong and spread the infection to her family members before she died. Her cause of death wasn’t immediately recognized, nor was the reason her family members were sick, since they hadn’t been to Hong Kong recently.

The infection ultimately spread to more than 200 people, about half of them health care workers. A few people died.

If a virus is sufficiently contagious, “it just takes one. You don’t want to be the one who misses that first patient,” Dr. Lucey said.

Currently, there are no antivirals or vaccines for coronaviruses; researchers are working on both, but for now, care is supportive.

aotto@mdedge.com

This article was updated with new case numbers on 1/26/20.

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Catheter cryoablation effective for persistent AFib in pivotal trial

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A catheter device for ablating atrial fibrillation has, for the first time, successfully completed a Food and Drug Administration–sanctioned pivotal trial in patients with persistent atrial arrhythmia, setting the stage for the device to become the first to receive U.S. labeling for catheter ablation in this atrial fibrillation population.

The Arctic Front Advance cryoballoon, used on 165 patients with persistent atrial fibrillation (AFib) enrolled in the trial, produced a 55% rate of treatment success, including freedom from recurrent AFib during 12 months of follow-up, and produced one prespecified serious adverse event in the primary safety endpoint.

Mitchel L. Zoler/MDedge News
Dr. Hugh Calkins


Both results easily surpassed the prespecified performance goals set by negotiation with the FDA, Hugh Calkins, MD, said at the annual International AF Symposium. The trial design included no control group and instead assessed safety and efficacy against prespecified standards set by the regulatory agency.

The cryoballoon “showed excellent performance. I don’t see how this could possibly be turned down by the FDA,” said Dr. Calkins, professor of medicine and director of the cardiac arrhythmia service at Johns Hopkins Medicine in Baltimore.

Cardiac electrophysiologists have for years routinely performed catheter ablation procedures on patients with persistent AFib even though the devices, based on ablation by radiofrequency or by chilling, have been labeled for use only in treating patients with paroxysmal AFib. Although this off-label use has not resulted in any problems with health insurance coverage, Dr. Calkins said, it has kept manufacturers from marketing their ablation devices for use in persistent AFib patients.

If the reported data result in labeling for the tested cryoballoon for persistant AFib patients, “it will have a big impact,” he predicted. “People have used cryoballoons for ablating persistent AFib for years, but this would put more fuel in the fire, both the [very positive] safety and efficacy data, and getting an FDA label, which is worth a lot,” he said in an interview.

But Dr. Calkins stopped short of anticipating that the results would convince operators experienced and focused on performing radiofrequency ablation to switch to cryo devices for treating persistent AFib patients. “People are pretty stuck in their ways,” he noted, and reports are expected soon from pivotal trials that are now testing various radiofrequency devices, as well as other types of cryo devices, in persistent AFib patients, so the range of device options labeled for this population may soon grow even more.

The STOP Persistent AF trial ran at 25 sites in the United States, Canada, and Japan during March 2017-August 2019, and included 165 adults with symptomatic, persistent AFib who had not responded to at least one antiarrhythmic drug and had a history of AFib episodes lasting at least 7 days but with no episodes persisting for 6 months or longer. The study excluded patients with prior ablation or left atrial surgery, a recent cerebrovascular event, substantially reduced left ventricular function, or substantial left atrial enlargement.

The enrolled patients were an average 65 years of age and 70% were men. Patients had been diagnosed with paroxysmal AFib an average of 5 years before study entry and with persistent AFib a little over 6 months before entry. The most recent AFib episode of enrolled patients averaged about 60 days, on average they had been unsuccessfully treated with just over one antiarrhythmic drug, and on average they had previously undergone about two cardioversions, after which their arrhythmia recurred.

The primary efficacy endpoint – a 55% rate of acute procedural success plus freedom from AFib recurrence during the 9 months following a 90-day blanking period immediately after ablation plus no added or increased antiarrhythmic drugs – significantly exceeded the prespecified performance goal of a 40% rate, Dr. Calkins reported. The study used the standard measure of recurrence as any 30-second or longer AFib episode detected during a weekly ECG telemonitoring session or during 48-hour ambulatory ECG monitoring at 6- and 12-month follow-ups or during in-office 12-lead ECG assessment at 3-, 6-, and 12-month follow-up. Twelve-month follow-up occurred for 145 of the enrolled patients.

The only prespecified primary safety event was one episode of cardiac perforation, which occurred during a repeat procedure. This rate of one safety event among 165 patients (0.6%) fell well within the prespecified safety performance goal of no more than 13%. In addition to this perforation, five additional serious adverse events (3%) occurred that were attributable to the cryoballoon treatment, including two cases of vascular pseudoaneurysm, one puncture-site hematoma, one case of pericarditis, and one episode of atrial tachycardia. Four additional serious adverse events occurred that were attributable to the ablation procedure (one acute cardiac failure, one postprocedure ileus, one respiratory failure, and one urinary tract infection), for an overall serious event rate of 5%.

During follow-up, 13% of patients had a repeat ablation procedure, following an initial ablation limited to pulmonary-vein isolation (PVI). The overall rate of 1-year efficacy, including the relatively low rate of need for redo ablation, “are an impressive endorsement of a PVI-only strategy” for initial ablation, Dr. Calkins said. “I’m a strong believer in PVI only for the first ablation for both paroxysmal and persistent AFib.”

He also noted that the 30-second threshold for scoring recurrent arrhythmia episodes following the 90-day blanking period after ablation was a very conservative measure of treatment failure, but it continues to define recurrence in this and many other current AFib ablation studies because it is the historical criteria for measuring ablation success or failure. It is especially important to maintain this criteria in a study that relied on prespecified performance criteria rather than a control arm for judging efficacy, Dr. Calkins said.

The study also included three quality-of-life measures. Patient scores on the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire rose by an average of nearly 26 points from baseline to 12 months, a statistically significant and clinically meaningful increase. Scores on both the physical and mental domains of the Short Form-12 (SF-12) improved from baseline by an average of about five points on each subscale, also statistically significant and clinically meaningful changes. Patients also reported statistically significant and in some cases substantial reductions in the prevalence rates of each of five different AFib symptoms: dizziness, dyspnea, fatigue, palpitations, and rapid heartbeat.

The study was funded by Medtronic, the company that markets the tested cryoballoon (Arctic Front Advance). Dr. Calkins has been a consultant to and has received honoraria from Medtronic, as well as from Abbott, AtriCure, Boehringer Ingelheim, Boston Scientific, and Johnson & Johnson.
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A catheter device for ablating atrial fibrillation has, for the first time, successfully completed a Food and Drug Administration–sanctioned pivotal trial in patients with persistent atrial arrhythmia, setting the stage for the device to become the first to receive U.S. labeling for catheter ablation in this atrial fibrillation population.

The Arctic Front Advance cryoballoon, used on 165 patients with persistent atrial fibrillation (AFib) enrolled in the trial, produced a 55% rate of treatment success, including freedom from recurrent AFib during 12 months of follow-up, and produced one prespecified serious adverse event in the primary safety endpoint.

Mitchel L. Zoler/MDedge News
Dr. Hugh Calkins


Both results easily surpassed the prespecified performance goals set by negotiation with the FDA, Hugh Calkins, MD, said at the annual International AF Symposium. The trial design included no control group and instead assessed safety and efficacy against prespecified standards set by the regulatory agency.

The cryoballoon “showed excellent performance. I don’t see how this could possibly be turned down by the FDA,” said Dr. Calkins, professor of medicine and director of the cardiac arrhythmia service at Johns Hopkins Medicine in Baltimore.

Cardiac electrophysiologists have for years routinely performed catheter ablation procedures on patients with persistent AFib even though the devices, based on ablation by radiofrequency or by chilling, have been labeled for use only in treating patients with paroxysmal AFib. Although this off-label use has not resulted in any problems with health insurance coverage, Dr. Calkins said, it has kept manufacturers from marketing their ablation devices for use in persistent AFib patients.

If the reported data result in labeling for the tested cryoballoon for persistant AFib patients, “it will have a big impact,” he predicted. “People have used cryoballoons for ablating persistent AFib for years, but this would put more fuel in the fire, both the [very positive] safety and efficacy data, and getting an FDA label, which is worth a lot,” he said in an interview.

But Dr. Calkins stopped short of anticipating that the results would convince operators experienced and focused on performing radiofrequency ablation to switch to cryo devices for treating persistent AFib patients. “People are pretty stuck in their ways,” he noted, and reports are expected soon from pivotal trials that are now testing various radiofrequency devices, as well as other types of cryo devices, in persistent AFib patients, so the range of device options labeled for this population may soon grow even more.

The STOP Persistent AF trial ran at 25 sites in the United States, Canada, and Japan during March 2017-August 2019, and included 165 adults with symptomatic, persistent AFib who had not responded to at least one antiarrhythmic drug and had a history of AFib episodes lasting at least 7 days but with no episodes persisting for 6 months or longer. The study excluded patients with prior ablation or left atrial surgery, a recent cerebrovascular event, substantially reduced left ventricular function, or substantial left atrial enlargement.

The enrolled patients were an average 65 years of age and 70% were men. Patients had been diagnosed with paroxysmal AFib an average of 5 years before study entry and with persistent AFib a little over 6 months before entry. The most recent AFib episode of enrolled patients averaged about 60 days, on average they had been unsuccessfully treated with just over one antiarrhythmic drug, and on average they had previously undergone about two cardioversions, after which their arrhythmia recurred.

The primary efficacy endpoint – a 55% rate of acute procedural success plus freedom from AFib recurrence during the 9 months following a 90-day blanking period immediately after ablation plus no added or increased antiarrhythmic drugs – significantly exceeded the prespecified performance goal of a 40% rate, Dr. Calkins reported. The study used the standard measure of recurrence as any 30-second or longer AFib episode detected during a weekly ECG telemonitoring session or during 48-hour ambulatory ECG monitoring at 6- and 12-month follow-ups or during in-office 12-lead ECG assessment at 3-, 6-, and 12-month follow-up. Twelve-month follow-up occurred for 145 of the enrolled patients.

The only prespecified primary safety event was one episode of cardiac perforation, which occurred during a repeat procedure. This rate of one safety event among 165 patients (0.6%) fell well within the prespecified safety performance goal of no more than 13%. In addition to this perforation, five additional serious adverse events (3%) occurred that were attributable to the cryoballoon treatment, including two cases of vascular pseudoaneurysm, one puncture-site hematoma, one case of pericarditis, and one episode of atrial tachycardia. Four additional serious adverse events occurred that were attributable to the ablation procedure (one acute cardiac failure, one postprocedure ileus, one respiratory failure, and one urinary tract infection), for an overall serious event rate of 5%.

During follow-up, 13% of patients had a repeat ablation procedure, following an initial ablation limited to pulmonary-vein isolation (PVI). The overall rate of 1-year efficacy, including the relatively low rate of need for redo ablation, “are an impressive endorsement of a PVI-only strategy” for initial ablation, Dr. Calkins said. “I’m a strong believer in PVI only for the first ablation for both paroxysmal and persistent AFib.”

He also noted that the 30-second threshold for scoring recurrent arrhythmia episodes following the 90-day blanking period after ablation was a very conservative measure of treatment failure, but it continues to define recurrence in this and many other current AFib ablation studies because it is the historical criteria for measuring ablation success or failure. It is especially important to maintain this criteria in a study that relied on prespecified performance criteria rather than a control arm for judging efficacy, Dr. Calkins said.

The study also included three quality-of-life measures. Patient scores on the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire rose by an average of nearly 26 points from baseline to 12 months, a statistically significant and clinically meaningful increase. Scores on both the physical and mental domains of the Short Form-12 (SF-12) improved from baseline by an average of about five points on each subscale, also statistically significant and clinically meaningful changes. Patients also reported statistically significant and in some cases substantial reductions in the prevalence rates of each of five different AFib symptoms: dizziness, dyspnea, fatigue, palpitations, and rapid heartbeat.

The study was funded by Medtronic, the company that markets the tested cryoballoon (Arctic Front Advance). Dr. Calkins has been a consultant to and has received honoraria from Medtronic, as well as from Abbott, AtriCure, Boehringer Ingelheim, Boston Scientific, and Johnson & Johnson.

A catheter device for ablating atrial fibrillation has, for the first time, successfully completed a Food and Drug Administration–sanctioned pivotal trial in patients with persistent atrial arrhythmia, setting the stage for the device to become the first to receive U.S. labeling for catheter ablation in this atrial fibrillation population.

The Arctic Front Advance cryoballoon, used on 165 patients with persistent atrial fibrillation (AFib) enrolled in the trial, produced a 55% rate of treatment success, including freedom from recurrent AFib during 12 months of follow-up, and produced one prespecified serious adverse event in the primary safety endpoint.

Mitchel L. Zoler/MDedge News
Dr. Hugh Calkins


Both results easily surpassed the prespecified performance goals set by negotiation with the FDA, Hugh Calkins, MD, said at the annual International AF Symposium. The trial design included no control group and instead assessed safety and efficacy against prespecified standards set by the regulatory agency.

The cryoballoon “showed excellent performance. I don’t see how this could possibly be turned down by the FDA,” said Dr. Calkins, professor of medicine and director of the cardiac arrhythmia service at Johns Hopkins Medicine in Baltimore.

Cardiac electrophysiologists have for years routinely performed catheter ablation procedures on patients with persistent AFib even though the devices, based on ablation by radiofrequency or by chilling, have been labeled for use only in treating patients with paroxysmal AFib. Although this off-label use has not resulted in any problems with health insurance coverage, Dr. Calkins said, it has kept manufacturers from marketing their ablation devices for use in persistent AFib patients.

If the reported data result in labeling for the tested cryoballoon for persistant AFib patients, “it will have a big impact,” he predicted. “People have used cryoballoons for ablating persistent AFib for years, but this would put more fuel in the fire, both the [very positive] safety and efficacy data, and getting an FDA label, which is worth a lot,” he said in an interview.

But Dr. Calkins stopped short of anticipating that the results would convince operators experienced and focused on performing radiofrequency ablation to switch to cryo devices for treating persistent AFib patients. “People are pretty stuck in their ways,” he noted, and reports are expected soon from pivotal trials that are now testing various radiofrequency devices, as well as other types of cryo devices, in persistent AFib patients, so the range of device options labeled for this population may soon grow even more.

The STOP Persistent AF trial ran at 25 sites in the United States, Canada, and Japan during March 2017-August 2019, and included 165 adults with symptomatic, persistent AFib who had not responded to at least one antiarrhythmic drug and had a history of AFib episodes lasting at least 7 days but with no episodes persisting for 6 months or longer. The study excluded patients with prior ablation or left atrial surgery, a recent cerebrovascular event, substantially reduced left ventricular function, or substantial left atrial enlargement.

The enrolled patients were an average 65 years of age and 70% were men. Patients had been diagnosed with paroxysmal AFib an average of 5 years before study entry and with persistent AFib a little over 6 months before entry. The most recent AFib episode of enrolled patients averaged about 60 days, on average they had been unsuccessfully treated with just over one antiarrhythmic drug, and on average they had previously undergone about two cardioversions, after which their arrhythmia recurred.

The primary efficacy endpoint – a 55% rate of acute procedural success plus freedom from AFib recurrence during the 9 months following a 90-day blanking period immediately after ablation plus no added or increased antiarrhythmic drugs – significantly exceeded the prespecified performance goal of a 40% rate, Dr. Calkins reported. The study used the standard measure of recurrence as any 30-second or longer AFib episode detected during a weekly ECG telemonitoring session or during 48-hour ambulatory ECG monitoring at 6- and 12-month follow-ups or during in-office 12-lead ECG assessment at 3-, 6-, and 12-month follow-up. Twelve-month follow-up occurred for 145 of the enrolled patients.

The only prespecified primary safety event was one episode of cardiac perforation, which occurred during a repeat procedure. This rate of one safety event among 165 patients (0.6%) fell well within the prespecified safety performance goal of no more than 13%. In addition to this perforation, five additional serious adverse events (3%) occurred that were attributable to the cryoballoon treatment, including two cases of vascular pseudoaneurysm, one puncture-site hematoma, one case of pericarditis, and one episode of atrial tachycardia. Four additional serious adverse events occurred that were attributable to the ablation procedure (one acute cardiac failure, one postprocedure ileus, one respiratory failure, and one urinary tract infection), for an overall serious event rate of 5%.

During follow-up, 13% of patients had a repeat ablation procedure, following an initial ablation limited to pulmonary-vein isolation (PVI). The overall rate of 1-year efficacy, including the relatively low rate of need for redo ablation, “are an impressive endorsement of a PVI-only strategy” for initial ablation, Dr. Calkins said. “I’m a strong believer in PVI only for the first ablation for both paroxysmal and persistent AFib.”

He also noted that the 30-second threshold for scoring recurrent arrhythmia episodes following the 90-day blanking period after ablation was a very conservative measure of treatment failure, but it continues to define recurrence in this and many other current AFib ablation studies because it is the historical criteria for measuring ablation success or failure. It is especially important to maintain this criteria in a study that relied on prespecified performance criteria rather than a control arm for judging efficacy, Dr. Calkins said.

The study also included three quality-of-life measures. Patient scores on the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire rose by an average of nearly 26 points from baseline to 12 months, a statistically significant and clinically meaningful increase. Scores on both the physical and mental domains of the Short Form-12 (SF-12) improved from baseline by an average of about five points on each subscale, also statistically significant and clinically meaningful changes. Patients also reported statistically significant and in some cases substantial reductions in the prevalence rates of each of five different AFib symptoms: dizziness, dyspnea, fatigue, palpitations, and rapid heartbeat.

The study was funded by Medtronic, the company that markets the tested cryoballoon (Arctic Front Advance). Dr. Calkins has been a consultant to and has received honoraria from Medtronic, as well as from Abbott, AtriCure, Boehringer Ingelheim, Boston Scientific, and Johnson & Johnson.
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REPORTING FROM THE AF SYMPOSIUM 2020

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Key clinical point: Catheter ablation using a cryoballoon was safe and effective for patients with persistent atrial fibrillation in a pivotal trial.

Major finding: The rate of freedom from treatment failure after 12 months was 55%, significantly exceeding the prespecified performance goal of 40%.

Study details: A multicenter, international study with 165 enrolled patients.

Disclosures: The study was funded by Medtronic, the company that markets the tested cryoballoon (Arctic Front Advance). Dr. Calkins has been a consultant to and has received honoraria from Medtronic, as well as from Abbott, AtriCure, Boehringer Ingelheim, Boston Scientific, and Johnson & Johnson.

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New appointments at Cleveland Clinic, Fox Chase

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Melissa Walt, PsyD, a clinical psychologist, recently joined the Taussig Cancer Institute at Cleveland Clinic. In this role, Dr. Walt focuses on the psychological treatment of cancer patients, helping them adjust to their diagnosis and navigate life with cancer.

Dr. Melissa Walt

Dr. Walt was previously a staff psychologist at the outpatient behavioral health/mental health clinic at the VA Southern Nevada Healthcare System in North Las Vegas. She obtained her doctorate degree from Adler University in Chicago, completed a residency at the VA Southern Nevada Healthcare System, and completed a fellowship at Memphis VA Medical Center.

Sheela Ahmed, MD, has joined Fox Chase Cancer Center in Philadelphia and works in the department of medicine as an associate clinical professor in the division of pulmonary, sleep, and critical care medicine. She is board certified in internal, pulmonary, critical care, and sleep medicine.

Dr. Sheela Ahmed


Dr. Ahmed was previously a pulmonary, critical care, and sleep physician at WellSpan Health in York, Pa. She received her medical degree from Patna (India) Medical College and Hospital. Dr. Ahmed completed a residency at the Postgraduate Institute of Medical Education and Research in Chandigarh, India, and a fellowship at St. Thomas Hospital in London and North Manchester (England) General Hospital. She also completed a residency and fellowship at Oregon Health and Science University in Portland.

Usman Ali, MD, has joined Fox Chase as an assistant professor in the division of hospital medicine within the department of medicine. Dr. Ali is board certified to practice medicine in Pennsylvania and New Jersey, and he is certified by the Educational Commission for Foreign Medical Graduates.
Dr. Usman Ali


Dr. Ali previously worked as a contracted hospitalist at Fox Chase. He obtained his medical degree from Jawaharlal Nehru Medical College in Aligarh, India, and completed a residency at the Institute of Ophthalmology in Aligarh. Dr. Ali also completed a residency at Capital Health System in Pennington, N.J., and a fellowship at Mount Sinai Beth Israel Medical Center in New York City.

Dylan R. Sherry, MD, has joined the pain and palliative care program in the department of hematology/oncology at Fox Chase as an assistant professor on the academic clinician track. Dr. Sherry is board certified in internal medicine and board eligible in hospice and palliative medicine.
Dr. Dylan R. Sherry


Dr. Sherry was previously a hospitalist at Abington Memorial Hospital, now Abington Hospital–Jefferson Health, in Abington Township, Pa. He received his medical degree from Case Western Reserve University in Cleveland. He completed his residency and fellowship at Beth Israel Deaconess Medical Center in Boston.
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Melissa Walt, PsyD, a clinical psychologist, recently joined the Taussig Cancer Institute at Cleveland Clinic. In this role, Dr. Walt focuses on the psychological treatment of cancer patients, helping them adjust to their diagnosis and navigate life with cancer.

Dr. Melissa Walt

Dr. Walt was previously a staff psychologist at the outpatient behavioral health/mental health clinic at the VA Southern Nevada Healthcare System in North Las Vegas. She obtained her doctorate degree from Adler University in Chicago, completed a residency at the VA Southern Nevada Healthcare System, and completed a fellowship at Memphis VA Medical Center.

Sheela Ahmed, MD, has joined Fox Chase Cancer Center in Philadelphia and works in the department of medicine as an associate clinical professor in the division of pulmonary, sleep, and critical care medicine. She is board certified in internal, pulmonary, critical care, and sleep medicine.

Dr. Sheela Ahmed


Dr. Ahmed was previously a pulmonary, critical care, and sleep physician at WellSpan Health in York, Pa. She received her medical degree from Patna (India) Medical College and Hospital. Dr. Ahmed completed a residency at the Postgraduate Institute of Medical Education and Research in Chandigarh, India, and a fellowship at St. Thomas Hospital in London and North Manchester (England) General Hospital. She also completed a residency and fellowship at Oregon Health and Science University in Portland.

Usman Ali, MD, has joined Fox Chase as an assistant professor in the division of hospital medicine within the department of medicine. Dr. Ali is board certified to practice medicine in Pennsylvania and New Jersey, and he is certified by the Educational Commission for Foreign Medical Graduates.
Dr. Usman Ali


Dr. Ali previously worked as a contracted hospitalist at Fox Chase. He obtained his medical degree from Jawaharlal Nehru Medical College in Aligarh, India, and completed a residency at the Institute of Ophthalmology in Aligarh. Dr. Ali also completed a residency at Capital Health System in Pennington, N.J., and a fellowship at Mount Sinai Beth Israel Medical Center in New York City.

Dylan R. Sherry, MD, has joined the pain and palliative care program in the department of hematology/oncology at Fox Chase as an assistant professor on the academic clinician track. Dr. Sherry is board certified in internal medicine and board eligible in hospice and palliative medicine.
Dr. Dylan R. Sherry


Dr. Sherry was previously a hospitalist at Abington Memorial Hospital, now Abington Hospital–Jefferson Health, in Abington Township, Pa. He received his medical degree from Case Western Reserve University in Cleveland. He completed his residency and fellowship at Beth Israel Deaconess Medical Center in Boston.


Melissa Walt, PsyD, a clinical psychologist, recently joined the Taussig Cancer Institute at Cleveland Clinic. In this role, Dr. Walt focuses on the psychological treatment of cancer patients, helping them adjust to their diagnosis and navigate life with cancer.

Dr. Melissa Walt

Dr. Walt was previously a staff psychologist at the outpatient behavioral health/mental health clinic at the VA Southern Nevada Healthcare System in North Las Vegas. She obtained her doctorate degree from Adler University in Chicago, completed a residency at the VA Southern Nevada Healthcare System, and completed a fellowship at Memphis VA Medical Center.

Sheela Ahmed, MD, has joined Fox Chase Cancer Center in Philadelphia and works in the department of medicine as an associate clinical professor in the division of pulmonary, sleep, and critical care medicine. She is board certified in internal, pulmonary, critical care, and sleep medicine.

Dr. Sheela Ahmed


Dr. Ahmed was previously a pulmonary, critical care, and sleep physician at WellSpan Health in York, Pa. She received her medical degree from Patna (India) Medical College and Hospital. Dr. Ahmed completed a residency at the Postgraduate Institute of Medical Education and Research in Chandigarh, India, and a fellowship at St. Thomas Hospital in London and North Manchester (England) General Hospital. She also completed a residency and fellowship at Oregon Health and Science University in Portland.

Usman Ali, MD, has joined Fox Chase as an assistant professor in the division of hospital medicine within the department of medicine. Dr. Ali is board certified to practice medicine in Pennsylvania and New Jersey, and he is certified by the Educational Commission for Foreign Medical Graduates.
Dr. Usman Ali


Dr. Ali previously worked as a contracted hospitalist at Fox Chase. He obtained his medical degree from Jawaharlal Nehru Medical College in Aligarh, India, and completed a residency at the Institute of Ophthalmology in Aligarh. Dr. Ali also completed a residency at Capital Health System in Pennington, N.J., and a fellowship at Mount Sinai Beth Israel Medical Center in New York City.

Dylan R. Sherry, MD, has joined the pain and palliative care program in the department of hematology/oncology at Fox Chase as an assistant professor on the academic clinician track. Dr. Sherry is board certified in internal medicine and board eligible in hospice and palliative medicine.
Dr. Dylan R. Sherry


Dr. Sherry was previously a hospitalist at Abington Memorial Hospital, now Abington Hospital–Jefferson Health, in Abington Township, Pa. He received his medical degree from Case Western Reserve University in Cleveland. He completed his residency and fellowship at Beth Israel Deaconess Medical Center in Boston.
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EVALI update warns of chemicals in vaping products

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A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).

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Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.

“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.

Of the 82% of patients who reported using a THC-containing e-cigarette or vaping product, 33% reported only THC-containing product use. In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.

Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.

The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.

The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.

Nicotine-only vaping products

In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.

A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.

In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).

Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.

The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.

In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.

The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.

SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.

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A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).

ArminStautBerlin/Thinkstock

Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.

“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.

Of the 82% of patients who reported using a THC-containing e-cigarette or vaping product, 33% reported only THC-containing product use. In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.

Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.

The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.

The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.

Nicotine-only vaping products

In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.

A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.

In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).

Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.

The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.

In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.

The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.

SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.

 

A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).

ArminStautBerlin/Thinkstock

Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.

“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.

Of the 82% of patients who reported using a THC-containing e-cigarette or vaping product, 33% reported only THC-containing product use. In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.

Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.

The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.

The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.

Nicotine-only vaping products

In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.

A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.

In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).

Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.

The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.

In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.

The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.

SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.

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Pubertal suppression reduces risk of later suicidal ideation in transgender people

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Transgender adults who, as adolescents, desired and received pubertal suppression had reduced odds of suicidal ideation, compared with those who wanted but didn’t receive pubertal suppression during their teen years.

Stuart Jenner/Thinkstock

Raw frequency of lifetime suicidal ideation was 90% in transgender adults who wanted, but did not receive, pubertal suppression in adolescence, compared with 75% in those who did receive pubertal suppression in adolescence, according to a new analysis of a nationwide survey of transgender people reported in Pediatrics. After controlling for demographic variables, the lifetime adjusted odds ratio for suicidal ideation was 0.3 for those receiving pubertal suppression, compared with those who wanted but didn’t receive pubertal suppression.

The study was the first to examine this association, and findings were drawn from the 2015 U.S. Transgender Survey, the largest known dataset of transgender adults, wrote the study’s lead author Jack Turban, MD, and coinvestigators.

“Suicidality is of particular concern for this population because the estimated lifetime prevalence of suicide attempts among transgender people is as high as 40%,” noted Dr. Turban, a psychiatry resident at Harvard Medical School and Massachusetts General Hospital, Boston, and McLean Hospital, Belmont, Mass., and coauthors. Anxiety, depression, and suicidality all are more common among transgender youth, who make up almost 2% of the nation’s adolescent population, they said.

Among transgender youth, the researchers explained, a spectrum exists: “Some have minimal body dysphoria and do not desire pubertal suppression, whereas others report significant dysphoria around the physical changes related to puberty.” Accordingly, they said, “We examined only those youth who desired pubertal suppression,” because this is the population of youth about whom clinicians need to make treatment decisions.

For individuals who might experience distress from the irreversible bodily changes of endogenous puberty, suppression via gonadotropin releasing hormone analogues (GnRHas) “allows these adolescents more time to decide if they wish to either induce exogenous gender-congruent puberty or allow endogenous puberty to progress,” wrote Dr. Turban and his collaborators.

The U.S. Transgender Survey dataset includes response from over 27,000 transgender adults with nationwide representation. However, this study included only participants who were younger than 17 years in 1998, when GnRHas for pubertal suppression became available. Filtering this group further to just those respondents between the ages of 18 and 36 years whose survey responses indicated they had ever wanted pubertal suppression yielded 3,494 individuals. Of these individuals, just 2.5% (89 participants) had ever received pubertal suppression.

“Results from this study suggest that the majority of transgender adults in the United States who have wanted pubertal suppression did not receive it,” noted the authors. Even among the youngest respondents – who received care during puberty most recently – just 5% of the 18-year-olds in 2015 desiring pubertal suppression actually received the treatment.

Among other associations, individuals who were younger, those with feminine gender identity, those with male sex assigned at birth, and those reporting heterosexual sexual orientation were more likely to have received pubertal suppression.

Receiving GnRHas also was more likely for individuals with higher household income and more family support of their gender identity. Without insurance, studies have indicated that the annual cost of GnRHA treatment can be $4,000-$25,000. Another study noted that at the Boston Children’s Hospital Gender Management Service before 2012, fewer than 20% of patients were able to get insurance coverage for pubertal suppression, according to Dr. Turban and colleagues.

The study looked at suicidality over the past year and lifetime suicidality, as well as severe psychological distress and binge drinking over the past month. Investigators also asked about lifetime history of illicit drug use, hypothesizing that those who received pubertal suppression would have “superior mental health outcomes” when compared to those who desired – but didn’t receive – pubertal suppression, wrote Dr. Turban and coauthors.

Suicidality within the past 12 months and severe psychological distress were both significantly more common among those who did not receive pubertal suppression, but these associations lost significance after multivariable analysis. There was no difference in odds of suicide attempts, although the study may have been underpowered to detect some of these associations, said the investigators.

After statistical analysis to control for demographic variables, pubertal suppression still was associated with decreased odds of having suicidal ideation over the lifespan.

Dr. Turban and colleagues acknowledged that reverse causation may have been in play, because adolescents with better mental health might have been considered better candidates for GnRHa therapy. But the study’s large sample size and wide geographic reach are strengths, they said, concluding that overall, the findings lend support to existing recommendations from the Endocrine Society and the World Professional Association for Transgender Health that pubertal suppression therapy be available to those adolescents who desire it.

Investigators were supported by the U.S. Health Resources and Services Administration, the Patient-Centered Outcomes Research Institute, and the American Academy of Child & Adolescent Psychiatry. The authors reported that they had no financial conflicts of interest.

SOURCE: Turban JL et al. Pediatrics. 2020;145(2):e20191725.

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Access to good medical care for transgender adolescents remains very limited. When it is available, puberty blockers are an excellent, conservative option for trans adolescents entering puberty so that they have time to consider longer-term treatment options with their providers and families. As demonstrated by the data in this study, good attention to transgender children can substantially improve their mental health.

The biggest barrier to health care for trans adolescents is access to knowledgeable providers – even more than affordability, which is improving with better coverage by payers. As noted in the study by Turban et al., the lack of access to care remains a huge problem.

It is not surprising that, when we neglect health care, we get bad outcomes. In that sense, the study by Turban et al. is quite intuitive. The few adolescents with access to the appropriate health care had better immediate outcomes. Still, as a scientist I take nothing for granted, and a study confirming what seems logical is important confirmation.

Joshua D. Safer, MD, who is the executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System, and professor of medicine at Icahn School of Medicine at Mount Sinai, both in New York, was asked to comment on the article by Turban et al. He said he had no relevant financial disclosures.

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Access to good medical care for transgender adolescents remains very limited. When it is available, puberty blockers are an excellent, conservative option for trans adolescents entering puberty so that they have time to consider longer-term treatment options with their providers and families. As demonstrated by the data in this study, good attention to transgender children can substantially improve their mental health.

The biggest barrier to health care for trans adolescents is access to knowledgeable providers – even more than affordability, which is improving with better coverage by payers. As noted in the study by Turban et al., the lack of access to care remains a huge problem.

It is not surprising that, when we neglect health care, we get bad outcomes. In that sense, the study by Turban et al. is quite intuitive. The few adolescents with access to the appropriate health care had better immediate outcomes. Still, as a scientist I take nothing for granted, and a study confirming what seems logical is important confirmation.

Joshua D. Safer, MD, who is the executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System, and professor of medicine at Icahn School of Medicine at Mount Sinai, both in New York, was asked to comment on the article by Turban et al. He said he had no relevant financial disclosures.

Body

 

Access to good medical care for transgender adolescents remains very limited. When it is available, puberty blockers are an excellent, conservative option for trans adolescents entering puberty so that they have time to consider longer-term treatment options with their providers and families. As demonstrated by the data in this study, good attention to transgender children can substantially improve their mental health.

The biggest barrier to health care for trans adolescents is access to knowledgeable providers – even more than affordability, which is improving with better coverage by payers. As noted in the study by Turban et al., the lack of access to care remains a huge problem.

It is not surprising that, when we neglect health care, we get bad outcomes. In that sense, the study by Turban et al. is quite intuitive. The few adolescents with access to the appropriate health care had better immediate outcomes. Still, as a scientist I take nothing for granted, and a study confirming what seems logical is important confirmation.

Joshua D. Safer, MD, who is the executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System, and professor of medicine at Icahn School of Medicine at Mount Sinai, both in New York, was asked to comment on the article by Turban et al. He said he had no relevant financial disclosures.

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Transgender adults who, as adolescents, desired and received pubertal suppression had reduced odds of suicidal ideation, compared with those who wanted but didn’t receive pubertal suppression during their teen years.

Stuart Jenner/Thinkstock

Raw frequency of lifetime suicidal ideation was 90% in transgender adults who wanted, but did not receive, pubertal suppression in adolescence, compared with 75% in those who did receive pubertal suppression in adolescence, according to a new analysis of a nationwide survey of transgender people reported in Pediatrics. After controlling for demographic variables, the lifetime adjusted odds ratio for suicidal ideation was 0.3 for those receiving pubertal suppression, compared with those who wanted but didn’t receive pubertal suppression.

The study was the first to examine this association, and findings were drawn from the 2015 U.S. Transgender Survey, the largest known dataset of transgender adults, wrote the study’s lead author Jack Turban, MD, and coinvestigators.

“Suicidality is of particular concern for this population because the estimated lifetime prevalence of suicide attempts among transgender people is as high as 40%,” noted Dr. Turban, a psychiatry resident at Harvard Medical School and Massachusetts General Hospital, Boston, and McLean Hospital, Belmont, Mass., and coauthors. Anxiety, depression, and suicidality all are more common among transgender youth, who make up almost 2% of the nation’s adolescent population, they said.

Among transgender youth, the researchers explained, a spectrum exists: “Some have minimal body dysphoria and do not desire pubertal suppression, whereas others report significant dysphoria around the physical changes related to puberty.” Accordingly, they said, “We examined only those youth who desired pubertal suppression,” because this is the population of youth about whom clinicians need to make treatment decisions.

For individuals who might experience distress from the irreversible bodily changes of endogenous puberty, suppression via gonadotropin releasing hormone analogues (GnRHas) “allows these adolescents more time to decide if they wish to either induce exogenous gender-congruent puberty or allow endogenous puberty to progress,” wrote Dr. Turban and his collaborators.

The U.S. Transgender Survey dataset includes response from over 27,000 transgender adults with nationwide representation. However, this study included only participants who were younger than 17 years in 1998, when GnRHas for pubertal suppression became available. Filtering this group further to just those respondents between the ages of 18 and 36 years whose survey responses indicated they had ever wanted pubertal suppression yielded 3,494 individuals. Of these individuals, just 2.5% (89 participants) had ever received pubertal suppression.

“Results from this study suggest that the majority of transgender adults in the United States who have wanted pubertal suppression did not receive it,” noted the authors. Even among the youngest respondents – who received care during puberty most recently – just 5% of the 18-year-olds in 2015 desiring pubertal suppression actually received the treatment.

Among other associations, individuals who were younger, those with feminine gender identity, those with male sex assigned at birth, and those reporting heterosexual sexual orientation were more likely to have received pubertal suppression.

Receiving GnRHas also was more likely for individuals with higher household income and more family support of their gender identity. Without insurance, studies have indicated that the annual cost of GnRHA treatment can be $4,000-$25,000. Another study noted that at the Boston Children’s Hospital Gender Management Service before 2012, fewer than 20% of patients were able to get insurance coverage for pubertal suppression, according to Dr. Turban and colleagues.

The study looked at suicidality over the past year and lifetime suicidality, as well as severe psychological distress and binge drinking over the past month. Investigators also asked about lifetime history of illicit drug use, hypothesizing that those who received pubertal suppression would have “superior mental health outcomes” when compared to those who desired – but didn’t receive – pubertal suppression, wrote Dr. Turban and coauthors.

Suicidality within the past 12 months and severe psychological distress were both significantly more common among those who did not receive pubertal suppression, but these associations lost significance after multivariable analysis. There was no difference in odds of suicide attempts, although the study may have been underpowered to detect some of these associations, said the investigators.

After statistical analysis to control for demographic variables, pubertal suppression still was associated with decreased odds of having suicidal ideation over the lifespan.

Dr. Turban and colleagues acknowledged that reverse causation may have been in play, because adolescents with better mental health might have been considered better candidates for GnRHa therapy. But the study’s large sample size and wide geographic reach are strengths, they said, concluding that overall, the findings lend support to existing recommendations from the Endocrine Society and the World Professional Association for Transgender Health that pubertal suppression therapy be available to those adolescents who desire it.

Investigators were supported by the U.S. Health Resources and Services Administration, the Patient-Centered Outcomes Research Institute, and the American Academy of Child & Adolescent Psychiatry. The authors reported that they had no financial conflicts of interest.

SOURCE: Turban JL et al. Pediatrics. 2020;145(2):e20191725.

 

Transgender adults who, as adolescents, desired and received pubertal suppression had reduced odds of suicidal ideation, compared with those who wanted but didn’t receive pubertal suppression during their teen years.

Stuart Jenner/Thinkstock

Raw frequency of lifetime suicidal ideation was 90% in transgender adults who wanted, but did not receive, pubertal suppression in adolescence, compared with 75% in those who did receive pubertal suppression in adolescence, according to a new analysis of a nationwide survey of transgender people reported in Pediatrics. After controlling for demographic variables, the lifetime adjusted odds ratio for suicidal ideation was 0.3 for those receiving pubertal suppression, compared with those who wanted but didn’t receive pubertal suppression.

The study was the first to examine this association, and findings were drawn from the 2015 U.S. Transgender Survey, the largest known dataset of transgender adults, wrote the study’s lead author Jack Turban, MD, and coinvestigators.

“Suicidality is of particular concern for this population because the estimated lifetime prevalence of suicide attempts among transgender people is as high as 40%,” noted Dr. Turban, a psychiatry resident at Harvard Medical School and Massachusetts General Hospital, Boston, and McLean Hospital, Belmont, Mass., and coauthors. Anxiety, depression, and suicidality all are more common among transgender youth, who make up almost 2% of the nation’s adolescent population, they said.

Among transgender youth, the researchers explained, a spectrum exists: “Some have minimal body dysphoria and do not desire pubertal suppression, whereas others report significant dysphoria around the physical changes related to puberty.” Accordingly, they said, “We examined only those youth who desired pubertal suppression,” because this is the population of youth about whom clinicians need to make treatment decisions.

For individuals who might experience distress from the irreversible bodily changes of endogenous puberty, suppression via gonadotropin releasing hormone analogues (GnRHas) “allows these adolescents more time to decide if they wish to either induce exogenous gender-congruent puberty or allow endogenous puberty to progress,” wrote Dr. Turban and his collaborators.

The U.S. Transgender Survey dataset includes response from over 27,000 transgender adults with nationwide representation. However, this study included only participants who were younger than 17 years in 1998, when GnRHas for pubertal suppression became available. Filtering this group further to just those respondents between the ages of 18 and 36 years whose survey responses indicated they had ever wanted pubertal suppression yielded 3,494 individuals. Of these individuals, just 2.5% (89 participants) had ever received pubertal suppression.

“Results from this study suggest that the majority of transgender adults in the United States who have wanted pubertal suppression did not receive it,” noted the authors. Even among the youngest respondents – who received care during puberty most recently – just 5% of the 18-year-olds in 2015 desiring pubertal suppression actually received the treatment.

Among other associations, individuals who were younger, those with feminine gender identity, those with male sex assigned at birth, and those reporting heterosexual sexual orientation were more likely to have received pubertal suppression.

Receiving GnRHas also was more likely for individuals with higher household income and more family support of their gender identity. Without insurance, studies have indicated that the annual cost of GnRHA treatment can be $4,000-$25,000. Another study noted that at the Boston Children’s Hospital Gender Management Service before 2012, fewer than 20% of patients were able to get insurance coverage for pubertal suppression, according to Dr. Turban and colleagues.

The study looked at suicidality over the past year and lifetime suicidality, as well as severe psychological distress and binge drinking over the past month. Investigators also asked about lifetime history of illicit drug use, hypothesizing that those who received pubertal suppression would have “superior mental health outcomes” when compared to those who desired – but didn’t receive – pubertal suppression, wrote Dr. Turban and coauthors.

Suicidality within the past 12 months and severe psychological distress were both significantly more common among those who did not receive pubertal suppression, but these associations lost significance after multivariable analysis. There was no difference in odds of suicide attempts, although the study may have been underpowered to detect some of these associations, said the investigators.

After statistical analysis to control for demographic variables, pubertal suppression still was associated with decreased odds of having suicidal ideation over the lifespan.

Dr. Turban and colleagues acknowledged that reverse causation may have been in play, because adolescents with better mental health might have been considered better candidates for GnRHa therapy. But the study’s large sample size and wide geographic reach are strengths, they said, concluding that overall, the findings lend support to existing recommendations from the Endocrine Society and the World Professional Association for Transgender Health that pubertal suppression therapy be available to those adolescents who desire it.

Investigators were supported by the U.S. Health Resources and Services Administration, the Patient-Centered Outcomes Research Institute, and the American Academy of Child & Adolescent Psychiatry. The authors reported that they had no financial conflicts of interest.

SOURCE: Turban JL et al. Pediatrics. 2020;145(2):e20191725.

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The Lowdown on Low-Dose Naltrexone

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Low-dose naltrexone (LDN) has shown efficacy in off-label treatment of a variety of inflammatory diseases ranging from Crohn disease to multiple sclerosis.1 There are limited data about the use of LDN in dermatology, but reports regarding how it works as an anti-inflammatory agent have been published.1,2

Naltrexone is an opioid receptor antagonist that originally was approved by the US Food and Drug Administration to treat addiction to alcohol, opiates, and heroin.2 The dose of naltrexone to treat addiction ranges from 50 to 100 mg/d, and at these levels the effects of opioids are blocked for 24 hours; however, the dosing for LDN is much lower, ranging from 1.5 to 4.5 mg/d.3 At this low dose, naltrexone partially binds to various opioid receptors, leading to a temporary blockade.4 One of the downstream effects of this opioid receptor blockade is a paradoxical increase in endogenous endorphins.3

In addition to opioid blockage, lower doses of naltrexone have anti-inflammatory effects by inhibiting nonopioid receptors. Naltrexone blocks toll-like receptor 4, which is found on keratinocytes and also on macrophages such as microglia.5 These macrophages also contain inflammatory compounds such as tumor necrosis factor α and IL-6. Low-dose naltrexone can suppress levels of these inflammatory markers. It is important to note that these anti-inflammatory effects have not been observed at the standard higher doses of naltrexone.1

When to Use

Low-dose naltrexone is a treatment option for inflammatory dermatologic conditions. A recent review of the literature outlined the use of LDN in a variety of inflammatory skin conditions. Improvement was noted in patients with Hailey-Hailey disease, lichen planopilaris, and various types of pruritus (ie, aquagenic, cholestatic, uremic, atopic dermatitis related).3 A case report of LDN successfully treating a patient with psoriasis also has been published.6 We often use LDN at the University of Wisconsin (Madison, Wisconsin) to treat patients with psoriasis. Ekelem et al3 also discussed patients with skin conditions that either had no response or worsened with naltrexone treatment, including various types of pruritus (ie, uremic, mycosis fungoides related, other causes of pruritus). Importantly, in the majority of cases without an improved response, the dose used was 50 mg/d.3 Higher doses of naltrexone are not known to have anti-inflammatory effects.

Low-dose naltrexone can be considered as a treatment option in patients with contraindications to other systemic anti-inflammatory treatments; for example, patients with a history of malignancy may prefer to avoid treatment with biologic agents. Low-dose naltrexone also can be considered as a treatment option in patients who are uncomfortable with the side-effect profiles of other systemic anti-inflammatory treatments, such as the risk for leukemias and lymphomas associated with biologic agents, the risk for liver toxicity with methotrexate, or the risk for hyperlipidemia with acitretin.

 

 

How to Monitor

The following monitoring information is adapted from the practice of Apple Bodemer, MD, a board-certified dermatologist at the University of Wisconsin (Madison, Wisconsin) who also is fellowship trained in integrative medicine.

There is a paucity of published data about LDN dosing for inflammatory skin diseases. However, prescribers should be aware that LDN can alter thyroid hormone levels, especially in patients with autoimmune thyroid disease. If a thyroid-stimulating hormone (TSH) level within reference range has not been noted in the last year, consider screening with a TSH test and also assessing for a personal or family history of thyroid disease. If the TSH level is within reference range, there generally is no need to monitor while treating with LDN. Consider checking TSH levels every 4 months in patients with thyroid disease while they are on LDN therapy and be sure to educate them about symptoms of hyperthyroidism.

Side Effects

Low-dose naltrexone has a minimal side-effect profile with self-limited side effects that often resolve within approximately 1 week. One of the most commonly reported side effects is sleep disturbance with vivid dreams, which has been reported in 37% of participants.1 If your patients experience this side effect, you can reassure them that it improves with time. You also can switch to morning dosing to try and alleviate sleep disturbances at night. Another possible side effect is gastrointestinal tract upset. Importantly, there is no known abuse potential for LDN.1 To stop LDN, patients should be stable for 6 to 12 months, and there is no need to wean them off it.

Cost and Availability

Because use of LDN in dermatology is considered off label and it is not approved by the US Food and Drug Administration to treat any medical conditions, it must be prescribed through a compounding pharmacy, usually without insurance coverage. The monthly cost is approximately $30 depending on the pharmacy (unpublished data), which may be cost prohibitive for patients, so it is important to counsel them about price before starting treatment.

Final Thoughts

Low-dose naltrexone is an alternative treatment option that can be considered in patients with inflammatory skin diseases. It has a favorable side-effect profile, especially compared to other systemic anti-inflammatory agents; however, additional studies are needed to learn more about its safety and efficacy. If patients ask you about LDN, the information provided here can guide you with how it works and how to prescribe it.

References
  1. Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014;33:451-459.
  2. Brown N, Panksepp J. Low-dose naltrexone for disease prevention and quality of life. Med Hypotheses. 2009;72:333-337.
  3. Ekelem C, Juhasz M, Khera P, et al. Utility of naltrexone treatment for chronic inflammatory dermatologic conditions: a systematic review. JAMA Dermatol. 2019;155:229-236.
  4. Bihari B. Efficacy of low dose naltrexone as an immune stabilizing agent for the treatment of HIV/AIDS. AIDS Patient Care. 1995;9:3.
  5. Lee B, Elston DM. The uses of naltrexone in dermatologic conditions [published online December 21, 2018]. J Am Acad Dermatol. 2019;80:1746-1752.
  6. Bridgman AC, Kirchhof MG. Treatment of psoriasis vulgaris using low-dose naltrexone. JAAD Case Rep. 2018;4:827-829.
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From the Department of Dermatology, University of Wisconsin Hospital and Clinics, Madison.

The author reports no conflict of interest.

Correspondence: Nadine Shabeeb, MD, MPH, One S Park, 7th Floor, Madison, WI 53715 (nshabeeb@uwhealth.org).

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Low-dose naltrexone (LDN) has shown efficacy in off-label treatment of a variety of inflammatory diseases ranging from Crohn disease to multiple sclerosis.1 There are limited data about the use of LDN in dermatology, but reports regarding how it works as an anti-inflammatory agent have been published.1,2

Naltrexone is an opioid receptor antagonist that originally was approved by the US Food and Drug Administration to treat addiction to alcohol, opiates, and heroin.2 The dose of naltrexone to treat addiction ranges from 50 to 100 mg/d, and at these levels the effects of opioids are blocked for 24 hours; however, the dosing for LDN is much lower, ranging from 1.5 to 4.5 mg/d.3 At this low dose, naltrexone partially binds to various opioid receptors, leading to a temporary blockade.4 One of the downstream effects of this opioid receptor blockade is a paradoxical increase in endogenous endorphins.3

In addition to opioid blockage, lower doses of naltrexone have anti-inflammatory effects by inhibiting nonopioid receptors. Naltrexone blocks toll-like receptor 4, which is found on keratinocytes and also on macrophages such as microglia.5 These macrophages also contain inflammatory compounds such as tumor necrosis factor α and IL-6. Low-dose naltrexone can suppress levels of these inflammatory markers. It is important to note that these anti-inflammatory effects have not been observed at the standard higher doses of naltrexone.1

When to Use

Low-dose naltrexone is a treatment option for inflammatory dermatologic conditions. A recent review of the literature outlined the use of LDN in a variety of inflammatory skin conditions. Improvement was noted in patients with Hailey-Hailey disease, lichen planopilaris, and various types of pruritus (ie, aquagenic, cholestatic, uremic, atopic dermatitis related).3 A case report of LDN successfully treating a patient with psoriasis also has been published.6 We often use LDN at the University of Wisconsin (Madison, Wisconsin) to treat patients with psoriasis. Ekelem et al3 also discussed patients with skin conditions that either had no response or worsened with naltrexone treatment, including various types of pruritus (ie, uremic, mycosis fungoides related, other causes of pruritus). Importantly, in the majority of cases without an improved response, the dose used was 50 mg/d.3 Higher doses of naltrexone are not known to have anti-inflammatory effects.

Low-dose naltrexone can be considered as a treatment option in patients with contraindications to other systemic anti-inflammatory treatments; for example, patients with a history of malignancy may prefer to avoid treatment with biologic agents. Low-dose naltrexone also can be considered as a treatment option in patients who are uncomfortable with the side-effect profiles of other systemic anti-inflammatory treatments, such as the risk for leukemias and lymphomas associated with biologic agents, the risk for liver toxicity with methotrexate, or the risk for hyperlipidemia with acitretin.

 

 

How to Monitor

The following monitoring information is adapted from the practice of Apple Bodemer, MD, a board-certified dermatologist at the University of Wisconsin (Madison, Wisconsin) who also is fellowship trained in integrative medicine.

There is a paucity of published data about LDN dosing for inflammatory skin diseases. However, prescribers should be aware that LDN can alter thyroid hormone levels, especially in patients with autoimmune thyroid disease. If a thyroid-stimulating hormone (TSH) level within reference range has not been noted in the last year, consider screening with a TSH test and also assessing for a personal or family history of thyroid disease. If the TSH level is within reference range, there generally is no need to monitor while treating with LDN. Consider checking TSH levels every 4 months in patients with thyroid disease while they are on LDN therapy and be sure to educate them about symptoms of hyperthyroidism.

Side Effects

Low-dose naltrexone has a minimal side-effect profile with self-limited side effects that often resolve within approximately 1 week. One of the most commonly reported side effects is sleep disturbance with vivid dreams, which has been reported in 37% of participants.1 If your patients experience this side effect, you can reassure them that it improves with time. You also can switch to morning dosing to try and alleviate sleep disturbances at night. Another possible side effect is gastrointestinal tract upset. Importantly, there is no known abuse potential for LDN.1 To stop LDN, patients should be stable for 6 to 12 months, and there is no need to wean them off it.

Cost and Availability

Because use of LDN in dermatology is considered off label and it is not approved by the US Food and Drug Administration to treat any medical conditions, it must be prescribed through a compounding pharmacy, usually without insurance coverage. The monthly cost is approximately $30 depending on the pharmacy (unpublished data), which may be cost prohibitive for patients, so it is important to counsel them about price before starting treatment.

Final Thoughts

Low-dose naltrexone is an alternative treatment option that can be considered in patients with inflammatory skin diseases. It has a favorable side-effect profile, especially compared to other systemic anti-inflammatory agents; however, additional studies are needed to learn more about its safety and efficacy. If patients ask you about LDN, the information provided here can guide you with how it works and how to prescribe it.

Low-dose naltrexone (LDN) has shown efficacy in off-label treatment of a variety of inflammatory diseases ranging from Crohn disease to multiple sclerosis.1 There are limited data about the use of LDN in dermatology, but reports regarding how it works as an anti-inflammatory agent have been published.1,2

Naltrexone is an opioid receptor antagonist that originally was approved by the US Food and Drug Administration to treat addiction to alcohol, opiates, and heroin.2 The dose of naltrexone to treat addiction ranges from 50 to 100 mg/d, and at these levels the effects of opioids are blocked for 24 hours; however, the dosing for LDN is much lower, ranging from 1.5 to 4.5 mg/d.3 At this low dose, naltrexone partially binds to various opioid receptors, leading to a temporary blockade.4 One of the downstream effects of this opioid receptor blockade is a paradoxical increase in endogenous endorphins.3

In addition to opioid blockage, lower doses of naltrexone have anti-inflammatory effects by inhibiting nonopioid receptors. Naltrexone blocks toll-like receptor 4, which is found on keratinocytes and also on macrophages such as microglia.5 These macrophages also contain inflammatory compounds such as tumor necrosis factor α and IL-6. Low-dose naltrexone can suppress levels of these inflammatory markers. It is important to note that these anti-inflammatory effects have not been observed at the standard higher doses of naltrexone.1

When to Use

Low-dose naltrexone is a treatment option for inflammatory dermatologic conditions. A recent review of the literature outlined the use of LDN in a variety of inflammatory skin conditions. Improvement was noted in patients with Hailey-Hailey disease, lichen planopilaris, and various types of pruritus (ie, aquagenic, cholestatic, uremic, atopic dermatitis related).3 A case report of LDN successfully treating a patient with psoriasis also has been published.6 We often use LDN at the University of Wisconsin (Madison, Wisconsin) to treat patients with psoriasis. Ekelem et al3 also discussed patients with skin conditions that either had no response or worsened with naltrexone treatment, including various types of pruritus (ie, uremic, mycosis fungoides related, other causes of pruritus). Importantly, in the majority of cases without an improved response, the dose used was 50 mg/d.3 Higher doses of naltrexone are not known to have anti-inflammatory effects.

Low-dose naltrexone can be considered as a treatment option in patients with contraindications to other systemic anti-inflammatory treatments; for example, patients with a history of malignancy may prefer to avoid treatment with biologic agents. Low-dose naltrexone also can be considered as a treatment option in patients who are uncomfortable with the side-effect profiles of other systemic anti-inflammatory treatments, such as the risk for leukemias and lymphomas associated with biologic agents, the risk for liver toxicity with methotrexate, or the risk for hyperlipidemia with acitretin.

 

 

How to Monitor

The following monitoring information is adapted from the practice of Apple Bodemer, MD, a board-certified dermatologist at the University of Wisconsin (Madison, Wisconsin) who also is fellowship trained in integrative medicine.

There is a paucity of published data about LDN dosing for inflammatory skin diseases. However, prescribers should be aware that LDN can alter thyroid hormone levels, especially in patients with autoimmune thyroid disease. If a thyroid-stimulating hormone (TSH) level within reference range has not been noted in the last year, consider screening with a TSH test and also assessing for a personal or family history of thyroid disease. If the TSH level is within reference range, there generally is no need to monitor while treating with LDN. Consider checking TSH levels every 4 months in patients with thyroid disease while they are on LDN therapy and be sure to educate them about symptoms of hyperthyroidism.

Side Effects

Low-dose naltrexone has a minimal side-effect profile with self-limited side effects that often resolve within approximately 1 week. One of the most commonly reported side effects is sleep disturbance with vivid dreams, which has been reported in 37% of participants.1 If your patients experience this side effect, you can reassure them that it improves with time. You also can switch to morning dosing to try and alleviate sleep disturbances at night. Another possible side effect is gastrointestinal tract upset. Importantly, there is no known abuse potential for LDN.1 To stop LDN, patients should be stable for 6 to 12 months, and there is no need to wean them off it.

Cost and Availability

Because use of LDN in dermatology is considered off label and it is not approved by the US Food and Drug Administration to treat any medical conditions, it must be prescribed through a compounding pharmacy, usually without insurance coverage. The monthly cost is approximately $30 depending on the pharmacy (unpublished data), which may be cost prohibitive for patients, so it is important to counsel them about price before starting treatment.

Final Thoughts

Low-dose naltrexone is an alternative treatment option that can be considered in patients with inflammatory skin diseases. It has a favorable side-effect profile, especially compared to other systemic anti-inflammatory agents; however, additional studies are needed to learn more about its safety and efficacy. If patients ask you about LDN, the information provided here can guide you with how it works and how to prescribe it.

References
  1. Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014;33:451-459.
  2. Brown N, Panksepp J. Low-dose naltrexone for disease prevention and quality of life. Med Hypotheses. 2009;72:333-337.
  3. Ekelem C, Juhasz M, Khera P, et al. Utility of naltrexone treatment for chronic inflammatory dermatologic conditions: a systematic review. JAMA Dermatol. 2019;155:229-236.
  4. Bihari B. Efficacy of low dose naltrexone as an immune stabilizing agent for the treatment of HIV/AIDS. AIDS Patient Care. 1995;9:3.
  5. Lee B, Elston DM. The uses of naltrexone in dermatologic conditions [published online December 21, 2018]. J Am Acad Dermatol. 2019;80:1746-1752.
  6. Bridgman AC, Kirchhof MG. Treatment of psoriasis vulgaris using low-dose naltrexone. JAAD Case Rep. 2018;4:827-829.
References
  1. Younger J, Parkitny L, McLain D. The use of low-dose naltrexone (LDN) as a novel anti-inflammatory treatment for chronic pain. Clin Rheumatol. 2014;33:451-459.
  2. Brown N, Panksepp J. Low-dose naltrexone for disease prevention and quality of life. Med Hypotheses. 2009;72:333-337.
  3. Ekelem C, Juhasz M, Khera P, et al. Utility of naltrexone treatment for chronic inflammatory dermatologic conditions: a systematic review. JAMA Dermatol. 2019;155:229-236.
  4. Bihari B. Efficacy of low dose naltrexone as an immune stabilizing agent for the treatment of HIV/AIDS. AIDS Patient Care. 1995;9:3.
  5. Lee B, Elston DM. The uses of naltrexone in dermatologic conditions [published online December 21, 2018]. J Am Acad Dermatol. 2019;80:1746-1752.
  6. Bridgman AC, Kirchhof MG. Treatment of psoriasis vulgaris using low-dose naltrexone. JAAD Case Rep. 2018;4:827-829.
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  • Low-dose naltrexone is an alternative antiinflammatory treatment to consider in patients with inflammatory skin diseases, with a minimal side-effect profile.
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