Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.

Three factors predict 6-month mortality in patients with DILI

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Thu, 09/19/2019 - 17:15

 

Medical comorbidity burden is significantly associated with 6-month and overall mortality in individuals with suspected drug-induced liver injury (DILI). In addition, a model consisting of Charlson Comorbidity Index, model for end-stage liver disease score, and serum albumin strongly predicts 6-month mortality in patients with suspected DILI.

Those are key findings from a study which set out to investigate the association between comorbidity burden and outcomes of patients with DILI and to develop a model to calculate risk of death within 6 months.

“Drug-induced liver injury is an important cause of liver-related morbidity and mortality that is likely under-recognized,” investigators led by Marwan S. Ghabril, MD, of the division of gastroenterology and hepatology at Indiana University, Indianapolis, wrote in a study published in Gastroenterology. “Its diagnosis depends on high index of suspicion, compatible temporal relationship, and thorough exclusion of competing etiologies. DILI by an implicated drug commonly occurs in patients with one or several comorbid conditions such as hypertension, diabetes mellitus, cardiovascular disease, renal disease, and malignancy. However, the impact of comorbidity burden on mortality in patients with suspected DILI has not been previously investigated.”

For the current analysis and model development, the researchers drew from 306 patients enrolled in the multicenter Drug-Induced Liver Injury Network Prospective Study at Indiana University between 2003 and 2017 (discovery cohort; Drug Saf. 2009;32:55-68). To validate their model, they used data from 247 patients who were enrolled in the same study at the University of North Carolina (validation cohort). The primary outcome of interest was mortality within 6 months of onset of liver injury.



The mean ages of the discovery and validation cohorts were 49 years and 51 years, respectively. Dr. Ghabril and colleagues found that 6-month mortality was 8.5% in the discovery cohort and 4.5% in the validation cohort. “The most common class of implicated agent was antimicrobials with no significant differences between groups,” they wrote. “However, herbal and dietary supplements were predominantly implicated in patients with none to mild comorbidity, while cardiovascular agents were predominantly implicated in patients with significant comorbidity.”

Among patients in the discovery cohort, the presence of significant comorbidities, defined as a Charlson Comorbidity Index score greater than 2, was independently associated with 6-month mortality (odds ratio, 5.22), as was model for end-stage liver disease score (OR, 1.11) and serum level of albumin at presentation (OR, 0.39). When the researchers created a morbidity risk model based on those three clinical variables, it performed well, identifying patients who died within 6 months with a C statistic value of 0.89 in the discovery cohort and 0.91 in the validation cohort. This spurred the development of a web-based risk calculator, which clinicians can access at http://gihep.com/calculators/hepatology/dili-cam/.

“Since DILI is not a unique cause of liver injury, it is conceivable that models incorporating comorbidity burden and severity of liver injury could prove useful in improving the prediction of mortality in a variety of liver injuries and diseases, and as such warrants further studies,” the researchers wrote.

The study was funded by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Ghabril reported having no financial disclosures, but two coauthors reported having numerous financial ties to industry.

SOURCE: Ghabril M et al. Gastroenterology. 2019 Jul 11. doi: 10/1053/j.gastro.2019.07.006.

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Medical comorbidity burden is significantly associated with 6-month and overall mortality in individuals with suspected drug-induced liver injury (DILI). In addition, a model consisting of Charlson Comorbidity Index, model for end-stage liver disease score, and serum albumin strongly predicts 6-month mortality in patients with suspected DILI.

Those are key findings from a study which set out to investigate the association between comorbidity burden and outcomes of patients with DILI and to develop a model to calculate risk of death within 6 months.

“Drug-induced liver injury is an important cause of liver-related morbidity and mortality that is likely under-recognized,” investigators led by Marwan S. Ghabril, MD, of the division of gastroenterology and hepatology at Indiana University, Indianapolis, wrote in a study published in Gastroenterology. “Its diagnosis depends on high index of suspicion, compatible temporal relationship, and thorough exclusion of competing etiologies. DILI by an implicated drug commonly occurs in patients with one or several comorbid conditions such as hypertension, diabetes mellitus, cardiovascular disease, renal disease, and malignancy. However, the impact of comorbidity burden on mortality in patients with suspected DILI has not been previously investigated.”

For the current analysis and model development, the researchers drew from 306 patients enrolled in the multicenter Drug-Induced Liver Injury Network Prospective Study at Indiana University between 2003 and 2017 (discovery cohort; Drug Saf. 2009;32:55-68). To validate their model, they used data from 247 patients who were enrolled in the same study at the University of North Carolina (validation cohort). The primary outcome of interest was mortality within 6 months of onset of liver injury.



The mean ages of the discovery and validation cohorts were 49 years and 51 years, respectively. Dr. Ghabril and colleagues found that 6-month mortality was 8.5% in the discovery cohort and 4.5% in the validation cohort. “The most common class of implicated agent was antimicrobials with no significant differences between groups,” they wrote. “However, herbal and dietary supplements were predominantly implicated in patients with none to mild comorbidity, while cardiovascular agents were predominantly implicated in patients with significant comorbidity.”

Among patients in the discovery cohort, the presence of significant comorbidities, defined as a Charlson Comorbidity Index score greater than 2, was independently associated with 6-month mortality (odds ratio, 5.22), as was model for end-stage liver disease score (OR, 1.11) and serum level of albumin at presentation (OR, 0.39). When the researchers created a morbidity risk model based on those three clinical variables, it performed well, identifying patients who died within 6 months with a C statistic value of 0.89 in the discovery cohort and 0.91 in the validation cohort. This spurred the development of a web-based risk calculator, which clinicians can access at http://gihep.com/calculators/hepatology/dili-cam/.

“Since DILI is not a unique cause of liver injury, it is conceivable that models incorporating comorbidity burden and severity of liver injury could prove useful in improving the prediction of mortality in a variety of liver injuries and diseases, and as such warrants further studies,” the researchers wrote.

The study was funded by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Ghabril reported having no financial disclosures, but two coauthors reported having numerous financial ties to industry.

SOURCE: Ghabril M et al. Gastroenterology. 2019 Jul 11. doi: 10/1053/j.gastro.2019.07.006.

 

Medical comorbidity burden is significantly associated with 6-month and overall mortality in individuals with suspected drug-induced liver injury (DILI). In addition, a model consisting of Charlson Comorbidity Index, model for end-stage liver disease score, and serum albumin strongly predicts 6-month mortality in patients with suspected DILI.

Those are key findings from a study which set out to investigate the association between comorbidity burden and outcomes of patients with DILI and to develop a model to calculate risk of death within 6 months.

“Drug-induced liver injury is an important cause of liver-related morbidity and mortality that is likely under-recognized,” investigators led by Marwan S. Ghabril, MD, of the division of gastroenterology and hepatology at Indiana University, Indianapolis, wrote in a study published in Gastroenterology. “Its diagnosis depends on high index of suspicion, compatible temporal relationship, and thorough exclusion of competing etiologies. DILI by an implicated drug commonly occurs in patients with one or several comorbid conditions such as hypertension, diabetes mellitus, cardiovascular disease, renal disease, and malignancy. However, the impact of comorbidity burden on mortality in patients with suspected DILI has not been previously investigated.”

For the current analysis and model development, the researchers drew from 306 patients enrolled in the multicenter Drug-Induced Liver Injury Network Prospective Study at Indiana University between 2003 and 2017 (discovery cohort; Drug Saf. 2009;32:55-68). To validate their model, they used data from 247 patients who were enrolled in the same study at the University of North Carolina (validation cohort). The primary outcome of interest was mortality within 6 months of onset of liver injury.



The mean ages of the discovery and validation cohorts were 49 years and 51 years, respectively. Dr. Ghabril and colleagues found that 6-month mortality was 8.5% in the discovery cohort and 4.5% in the validation cohort. “The most common class of implicated agent was antimicrobials with no significant differences between groups,” they wrote. “However, herbal and dietary supplements were predominantly implicated in patients with none to mild comorbidity, while cardiovascular agents were predominantly implicated in patients with significant comorbidity.”

Among patients in the discovery cohort, the presence of significant comorbidities, defined as a Charlson Comorbidity Index score greater than 2, was independently associated with 6-month mortality (odds ratio, 5.22), as was model for end-stage liver disease score (OR, 1.11) and serum level of albumin at presentation (OR, 0.39). When the researchers created a morbidity risk model based on those three clinical variables, it performed well, identifying patients who died within 6 months with a C statistic value of 0.89 in the discovery cohort and 0.91 in the validation cohort. This spurred the development of a web-based risk calculator, which clinicians can access at http://gihep.com/calculators/hepatology/dili-cam/.

“Since DILI is not a unique cause of liver injury, it is conceivable that models incorporating comorbidity burden and severity of liver injury could prove useful in improving the prediction of mortality in a variety of liver injuries and diseases, and as such warrants further studies,” the researchers wrote.

The study was funded by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Ghabril reported having no financial disclosures, but two coauthors reported having numerous financial ties to industry.

SOURCE: Ghabril M et al. Gastroenterology. 2019 Jul 11. doi: 10/1053/j.gastro.2019.07.006.

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Laser treatment of basal cell carcinoma continues to be refined

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Wed, 09/18/2019 - 10:14

 

– Using laser and light sources to treat nonaggressive basal cell carcinoma (BCC) is emerging as a promising treatment option, especially for those with multiple tumors and those who are poor surgical candidates, Arisa E. Ortiz, MD, said at the annual Masters of Aesthetics Symposium.

Dr. Arisa E. Ortiz

“Topical therapies often result in recurrence, so there really is a need for an alternative [to surgery] that’s effective, efficient, and carries a low risk of side effects,” said Dr. Ortiz, who is director of laser and cosmetic dermatology at the University of California, San Diego,

“The prototypic feature of BCC is the presence of telangiectatic vessels,” she explained, and the postulated mechanism of action is selective photothermolysis of the tumor vasculature. “These vessels are slightly larger in caliber, compared with normal skin – 40 micrometers versus 15 micrometers – and more fragile. You can tailor your pulse duration to the size of the vessels. Theoretically, by targeting the vasculature then you get tumor regression with sparing of normal tissue.”

Initial studies of this approach have used the 595-nm pulsed-dye laser, which is well absorbed by oxyhemoglobin, but more recent studies have used the 1064-nm Nd:YAG to reach deep arterial vessels. In a prospective, open-label study, 10 patients with 13 BCCs less than 1.5 cm in diameter received one treatment with a 10-ms pulsed 1064-nm Nd:YAG laser delivered on the trunk or extremities at a fluence of 80-120 J/cm2 (Lasers Surg Med. 2015;47[2]:106-10). Dr. Ortiz and her colleagues observed a 92% clearance rate overall.

She described other earlier studies of the approach as flawed, because they relied on confirmation of clearance rates with clinical exam or biopsy rather than with surgical excision. “Also, some of the protocols weren’t standardized, multiple treatments were required, and subjects with suboptimal response were currently on anticoagulation,” she said. “Intravascular coagulation is important for effective treatment with vascular lasers, so anticoagulation may interfere with efficacy.”

In a more recent multicenter study, Dr. Ortiz and her colleagues treated 33 BCCs once with the long-pulsed 1064-nm Nd:YAG laser delivered with a 5-6 mm spot size at a fluence of 125-140 J/cm2 and a 7-10 ms pulse duration (Laser Surgery Med. Feb 13 2018. doi: 10.1002/lsm.22803). Standard surgical excision with 5-mm margins was performed 4 weeks after laser treatment. Among 31 subjects who completed the study, 28 of 31 BCC tumors (90%) cleared after one treatment.



“The treatments were performed without anesthesia, because we didn’t want the vasculature to be affected, but in clinical practice I am now using lidocaine with no epinephrine,” Dr. Ortiz said. She characterized the results as “at least comparable to, if not superior to” common modalities including methyl aminolevulinate–PDT (72.8%), imiquimod cream (83.4%), and fluorouracil cream (80.1%). “One criticism I hear is that with such high fluences, you’re probably getting some bulk heating,” she said. “Maybe so, but it seems to work and there’s no scarring, which suggests otherwise.”

Advantages of using a 1064-nm Nd:YAG for treating nonaggressive BCCs are that it requires just one treatment, it takes about 5 minutes, and there is no significant downtime, with no limitations in posttreatment activity. “Potentially there is a relatively decreased risk for complications, including infection and bleeding,” she added. “It’s a good alternative for treating patients with multiple tumors or those who are poor surgical candidates.”

She and her colleagues are currently performing a long-term follow-up study of 35 BCC lesions. Only one has potentially recurred, but that recurrence has not yet been confirmed.

Dr. Ortiz treats BCCs with a standard 5-mm margin and uses lidocaine without epinephrine to avoid vasoconstriction. She typically uses a 1064-nm Cutera excel V laser delivered at a pulse duration of 8 ms and a fluence of 140 J/cm2, with no cooling. “Theoretically, any 1064-nm pulsed-dye laser could work, but the way the pulse is delivered is different, depending on which device” is used, she said.

“I always like waiting between passes to avoid any bulk heating. The immediate endpoint to strive for is slight graying and slight contraction,” she said. Billing codes for malignant destruction/electrodesiccation and curettage can be used (codes 17260-17266 for the trunk and 17280-17283 for the face).

In order to determine the mechanism of cell death and to optimize results, Dr. Ortiz said that further studies need to be conducted in vitro and in vivo. In order to determine treatment efficacy, clinical studies involving various heat sources and low concentrations of lidocaine are also required.

Dr. Ortiz disclosed having financial relationships with numerous pharmaceutical and device companies. She is also cochair of the MOAS.

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– Using laser and light sources to treat nonaggressive basal cell carcinoma (BCC) is emerging as a promising treatment option, especially for those with multiple tumors and those who are poor surgical candidates, Arisa E. Ortiz, MD, said at the annual Masters of Aesthetics Symposium.

Dr. Arisa E. Ortiz

“Topical therapies often result in recurrence, so there really is a need for an alternative [to surgery] that’s effective, efficient, and carries a low risk of side effects,” said Dr. Ortiz, who is director of laser and cosmetic dermatology at the University of California, San Diego,

“The prototypic feature of BCC is the presence of telangiectatic vessels,” she explained, and the postulated mechanism of action is selective photothermolysis of the tumor vasculature. “These vessels are slightly larger in caliber, compared with normal skin – 40 micrometers versus 15 micrometers – and more fragile. You can tailor your pulse duration to the size of the vessels. Theoretically, by targeting the vasculature then you get tumor regression with sparing of normal tissue.”

Initial studies of this approach have used the 595-nm pulsed-dye laser, which is well absorbed by oxyhemoglobin, but more recent studies have used the 1064-nm Nd:YAG to reach deep arterial vessels. In a prospective, open-label study, 10 patients with 13 BCCs less than 1.5 cm in diameter received one treatment with a 10-ms pulsed 1064-nm Nd:YAG laser delivered on the trunk or extremities at a fluence of 80-120 J/cm2 (Lasers Surg Med. 2015;47[2]:106-10). Dr. Ortiz and her colleagues observed a 92% clearance rate overall.

She described other earlier studies of the approach as flawed, because they relied on confirmation of clearance rates with clinical exam or biopsy rather than with surgical excision. “Also, some of the protocols weren’t standardized, multiple treatments were required, and subjects with suboptimal response were currently on anticoagulation,” she said. “Intravascular coagulation is important for effective treatment with vascular lasers, so anticoagulation may interfere with efficacy.”

In a more recent multicenter study, Dr. Ortiz and her colleagues treated 33 BCCs once with the long-pulsed 1064-nm Nd:YAG laser delivered with a 5-6 mm spot size at a fluence of 125-140 J/cm2 and a 7-10 ms pulse duration (Laser Surgery Med. Feb 13 2018. doi: 10.1002/lsm.22803). Standard surgical excision with 5-mm margins was performed 4 weeks after laser treatment. Among 31 subjects who completed the study, 28 of 31 BCC tumors (90%) cleared after one treatment.



“The treatments were performed without anesthesia, because we didn’t want the vasculature to be affected, but in clinical practice I am now using lidocaine with no epinephrine,” Dr. Ortiz said. She characterized the results as “at least comparable to, if not superior to” common modalities including methyl aminolevulinate–PDT (72.8%), imiquimod cream (83.4%), and fluorouracil cream (80.1%). “One criticism I hear is that with such high fluences, you’re probably getting some bulk heating,” she said. “Maybe so, but it seems to work and there’s no scarring, which suggests otherwise.”

Advantages of using a 1064-nm Nd:YAG for treating nonaggressive BCCs are that it requires just one treatment, it takes about 5 minutes, and there is no significant downtime, with no limitations in posttreatment activity. “Potentially there is a relatively decreased risk for complications, including infection and bleeding,” she added. “It’s a good alternative for treating patients with multiple tumors or those who are poor surgical candidates.”

She and her colleagues are currently performing a long-term follow-up study of 35 BCC lesions. Only one has potentially recurred, but that recurrence has not yet been confirmed.

Dr. Ortiz treats BCCs with a standard 5-mm margin and uses lidocaine without epinephrine to avoid vasoconstriction. She typically uses a 1064-nm Cutera excel V laser delivered at a pulse duration of 8 ms and a fluence of 140 J/cm2, with no cooling. “Theoretically, any 1064-nm pulsed-dye laser could work, but the way the pulse is delivered is different, depending on which device” is used, she said.

“I always like waiting between passes to avoid any bulk heating. The immediate endpoint to strive for is slight graying and slight contraction,” she said. Billing codes for malignant destruction/electrodesiccation and curettage can be used (codes 17260-17266 for the trunk and 17280-17283 for the face).

In order to determine the mechanism of cell death and to optimize results, Dr. Ortiz said that further studies need to be conducted in vitro and in vivo. In order to determine treatment efficacy, clinical studies involving various heat sources and low concentrations of lidocaine are also required.

Dr. Ortiz disclosed having financial relationships with numerous pharmaceutical and device companies. She is also cochair of the MOAS.

 

– Using laser and light sources to treat nonaggressive basal cell carcinoma (BCC) is emerging as a promising treatment option, especially for those with multiple tumors and those who are poor surgical candidates, Arisa E. Ortiz, MD, said at the annual Masters of Aesthetics Symposium.

Dr. Arisa E. Ortiz

“Topical therapies often result in recurrence, so there really is a need for an alternative [to surgery] that’s effective, efficient, and carries a low risk of side effects,” said Dr. Ortiz, who is director of laser and cosmetic dermatology at the University of California, San Diego,

“The prototypic feature of BCC is the presence of telangiectatic vessels,” she explained, and the postulated mechanism of action is selective photothermolysis of the tumor vasculature. “These vessels are slightly larger in caliber, compared with normal skin – 40 micrometers versus 15 micrometers – and more fragile. You can tailor your pulse duration to the size of the vessels. Theoretically, by targeting the vasculature then you get tumor regression with sparing of normal tissue.”

Initial studies of this approach have used the 595-nm pulsed-dye laser, which is well absorbed by oxyhemoglobin, but more recent studies have used the 1064-nm Nd:YAG to reach deep arterial vessels. In a prospective, open-label study, 10 patients with 13 BCCs less than 1.5 cm in diameter received one treatment with a 10-ms pulsed 1064-nm Nd:YAG laser delivered on the trunk or extremities at a fluence of 80-120 J/cm2 (Lasers Surg Med. 2015;47[2]:106-10). Dr. Ortiz and her colleagues observed a 92% clearance rate overall.

She described other earlier studies of the approach as flawed, because they relied on confirmation of clearance rates with clinical exam or biopsy rather than with surgical excision. “Also, some of the protocols weren’t standardized, multiple treatments were required, and subjects with suboptimal response were currently on anticoagulation,” she said. “Intravascular coagulation is important for effective treatment with vascular lasers, so anticoagulation may interfere with efficacy.”

In a more recent multicenter study, Dr. Ortiz and her colleagues treated 33 BCCs once with the long-pulsed 1064-nm Nd:YAG laser delivered with a 5-6 mm spot size at a fluence of 125-140 J/cm2 and a 7-10 ms pulse duration (Laser Surgery Med. Feb 13 2018. doi: 10.1002/lsm.22803). Standard surgical excision with 5-mm margins was performed 4 weeks after laser treatment. Among 31 subjects who completed the study, 28 of 31 BCC tumors (90%) cleared after one treatment.



“The treatments were performed without anesthesia, because we didn’t want the vasculature to be affected, but in clinical practice I am now using lidocaine with no epinephrine,” Dr. Ortiz said. She characterized the results as “at least comparable to, if not superior to” common modalities including methyl aminolevulinate–PDT (72.8%), imiquimod cream (83.4%), and fluorouracil cream (80.1%). “One criticism I hear is that with such high fluences, you’re probably getting some bulk heating,” she said. “Maybe so, but it seems to work and there’s no scarring, which suggests otherwise.”

Advantages of using a 1064-nm Nd:YAG for treating nonaggressive BCCs are that it requires just one treatment, it takes about 5 minutes, and there is no significant downtime, with no limitations in posttreatment activity. “Potentially there is a relatively decreased risk for complications, including infection and bleeding,” she added. “It’s a good alternative for treating patients with multiple tumors or those who are poor surgical candidates.”

She and her colleagues are currently performing a long-term follow-up study of 35 BCC lesions. Only one has potentially recurred, but that recurrence has not yet been confirmed.

Dr. Ortiz treats BCCs with a standard 5-mm margin and uses lidocaine without epinephrine to avoid vasoconstriction. She typically uses a 1064-nm Cutera excel V laser delivered at a pulse duration of 8 ms and a fluence of 140 J/cm2, with no cooling. “Theoretically, any 1064-nm pulsed-dye laser could work, but the way the pulse is delivered is different, depending on which device” is used, she said.

“I always like waiting between passes to avoid any bulk heating. The immediate endpoint to strive for is slight graying and slight contraction,” she said. Billing codes for malignant destruction/electrodesiccation and curettage can be used (codes 17260-17266 for the trunk and 17280-17283 for the face).

In order to determine the mechanism of cell death and to optimize results, Dr. Ortiz said that further studies need to be conducted in vitro and in vivo. In order to determine treatment efficacy, clinical studies involving various heat sources and low concentrations of lidocaine are also required.

Dr. Ortiz disclosed having financial relationships with numerous pharmaceutical and device companies. She is also cochair of the MOAS.

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Wildfire smoke has acute cardiorespiratory impact, but long-term effects still under study

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Fri, 09/27/2019 - 14:12

The 2019 wildfire season is underway in many locales across the United States, exposing millions of individuals to smoky conditions that will have health consequences ranging from stinging eyes to scratchy throats to a trip to the ED for asthma or chronic obstructive pulmonary disease (COPD) exacerbation. Questions about long-term health impacts are on the minds of many, including physicians and their patients who live with cardiorespiratory conditions.

US Forest Service photo courtesy of Peter Buschmann.
The Woolsey Fire as seen from Topanga, Calif., on Nov. 9, 2018. The wildfire burned more than 96,000 acres and destroyed more than 1,600 structures.

John R. Balmes, MD, a pulmonologist at the University of California, San Francisco, and an expert on the respiratory and cardiovascular effects of air pollutants, suggested that the best available published literature points to “pretty strong evidence for acute effects of wildfire smoke on respiratory health, meaning people with preexisting asthma and COPD are at risk for exacerbations, and probably for respiratory tract infections as well.” He said, “It’s a little less clear, but there’s good biological plausibility for increased risk of respiratory tract infections because when your alveolar macrophages are overloaded with carbon particles that are toxic to those cells, they don’t function as well as a first line of defense against bacterial infection, for example.”

 

The new normal of wildfires

Dr. John R. Balmes

Warmer, drier summers in recent years in the western United States and many other regions, attributed by climate experts to global climate change, have produced catastrophic wildfires (PNAS;2016 Oct 18;113[42]11770-5; Science 2006 Aug 18;313:940-3). The Camp Fire in Northern California broke out in November 2018, took the lives of at least 85 people, and cost more than $16 billion in damage. Smoke from that blaze reached hazardous levels in San Francisco, Sacramento, Fresno, and many other smaller towns. Other forest fires in that year caused heavy smoke conditions in Portland, Seattle, Vancouver, and Anchorage. Such events are expected to be repeated often in the coming years (Int J Environ Res Public Health. 2019 Jul 6;16[13]).

Courtesy Dr. Wayne Cascio
On Nov. 10, 2018, wildfire smoke from the devastating Camp Fire obscured views of the Golden Gate Bridge from Lands End Trail in San Francisco.

Wildfire smoke can contain a wide range of substances, chemicals, and gases with known and unknown cardiorespiratory implications. “Smoke is composed primarily of carbon dioxide, water vapor, carbon monoxide, particulate matter, hydrocarbons and other organic chemicals, nitrogen oxides, trace minerals and several thousand other compounds,” according to the U.S. Environmental Protection Agency (Wildfire smoke: A guide for public health officials 2019. Washington, D.C.: EPA, 2019). The EPA report noted, “Particles with diameters less than 10 mcm (particulate matter, or PM10) can be inhaled into the lungs and affect the lungs, heart, and blood vessels. The smallest particles, those less than 2.5 mcm in diameter (PM2.5), are the greatest risk to public health because they can reach deep into the lungs and may even make it into the bloodstream.”

 

 

Research on health impact

In early June of 2008, Wayne Cascio, MD, awoke in his Greenville, N.C., home to the stench of smoke emanating from a large peat fire burning some 65 miles away. By the time he reached the parking lot at East Carolina University in Greenville to begin his workday as chief of cardiology, the haze of smoke had thickened to the point where he could only see a few feet in front of him.

Dr. Wayne Cascio

Over the next several weeks, the fire scorched 41,000 acres and produced haze and air pollution that far exceeded National Ambient Air Quality Standards for particulate matter and blanketed rural communities in the state’s eastern region. The price tag for management of the blaze reached $20 million. Because of his interest in the health effects of wildfire smoke and because of his relationship with investigators at the EPA, Dr. Cascio initiated an epidemiology study to investigate the effects of exposure on cardiorespiratory outcomes in the population affected by the fire (Environ Health Perspect. 2011 Oct;119[10]:1415-20).

By combining satellite data with syndromic surveillance drawn from hospital records in 41 counties contained in the North Carolina Disease Event Tracking and Epidemiologic Collection Tool, he and his colleagues found that exposure to the peat wildfire smoke led to increases in the cumulative risk ratio for asthma (relative risk, 1.65), chronic obstructive pulmonary disease (RR, 1.73), and pneumonia and acute bronchitis (RR, 1.59). ED visits related to cardiopulmonary symptoms and heart failure also were significantly increased (RR, 1.23 and 1.37, respectively). “That was really the first study to strongly identify a cardiac endpoint related to wildfire smoke exposure,” said Dr. Cascio, who now directs the EPA’s National Health and Environmental Effects Research Laboratory. “It really pointed out how little we knew about the health effects of wildfire up until that time.”

Those early findings have been replicated in subsequent research about the acute health effects of exposure to wildfire smoke, which contains PM2.5 and other toxic substances from structures, electronic devices, and automobiles destroyed in the path of flames, including heavy metals and asbestos. Most of the work has focused on smoke-related cardiovascular and respiratory ED visits and hospitalizations.

A study of the 2008 California wildfire impact on ED visits accounted for ozone levels in addition to PM2.5 in the smoke. During the active fire periods, PM2.5 was significantly associated with exacerbations of asthma and COPD and these effects remained after controlling for ozone levels. PM2.5 inhalation during the wildfires was associated with increased risk of an ED visit for asthma (RR, 1.112; 95% confidence interval, 1.087-1.138) for a 10 mcg/m3 increase in PM2.5 and COPD (RR, 1.05; 95% CI, 1.019-1.0825), as well as for combined respiratory visits (RR, 1.035; 95% CI, 1.023-1.046) (Environ Int. 2109 Aug;129:291-8).

Researchers who evaluated the health impacts of wildfires in California during the 2015 fire season found an increase in all-cause cardiovascular and respiratory ED visits, especially among those aged 65 years and older during smoke days. The population-based study included 1,196,233 ED visits during May 1–Sept. 30 that year. PM2.5 concentrations were categorized as light, medium, or dense. Relative risk rose with the amount of smoke in the air. Rates of all-cause cardiovascular ED visits were elevated across levels of smoke density, with the greatest increase on dense smoke days and among those aged 65 years or older (RR,1.15; 95% CI, 1.09-1.22). All-cause cerebrovascular visits were associated with dense smoke days, especially among those aged 65 years and older (RR, 1.22; 95% CI, 1.00-1.49). Respiratory conditions also were increased on dense smoke days (RR, 1.18; 95% CI, 1.08-1.28) (J Am Heart Assoc. 2018 Apr 11;7:e007492. doi: 10.1161/JAHA.117.007492).

 

 

Long-term effects unknown

When it comes to the long-term effects of wildfire smoke on human health outcomes, much less is known. In a recent literature review, Colleen E. Reid, PhD, and Melissa May Maestas, PhD, found only one study that investigated long-term respiratory health impacts of wildfire smoke, and only a few studies that have estimated future health impacts of wildfires under likely climate change scenarios (Curr Opin Pulm Med. 2019 Mar;25:179-87).

Dr. Colleen E. Reid

“We know that there are immediate respiratory health effects from wildfire smoke,” said Dr. Reid of the department of geography at the University of Colorado Boulder. “What’s less known is everything else. That’s challenging, because people want to know about the long-term health effects.”

Evidence from the scientific literature suggests that exposure to air pollution adversely affects cardiovascular health, but whether exposure to wildfire smoke confers a similar risk is less clear. “Until just a few years ago we haven’t been able to study wildfire exposure measures on a large scale,” said EPA scientist Ana G. Rappold, PhD, a statistician there in the environmental public health division of the National Health and Environmental Effects Research Laboratory. “It’s also hard to predict wildfires, so it’s hard to plan for an epidemiologic study if you don’t know where they’re going to occur.”

Dr. Ana G. Rappold

Dr. Rappold and colleagues examined cardiopulmonary hospitalizations among adults aged 65 years and older in 692 U.S. counties within 200 km of 123 large wildfires during 2008-2010 (Environ Health Perspect. 2019;127[3]:37006. doi: 10.1289/EHP3860). They observed that an increased risk of PM2.5-related cardiopulmonary hospitalizations was similar on smoke and nonsmoke days across multiple lags and exposure metrics, while risk for asthma-related hospitalizations was higher during smoke days. “One hypothesis is that this was an older study population, so naturally if you’re inhaling smoke, the first organ that’s impacted in an older population is the lungs,” Dr. Rappold said. “If you go to the hospital for asthma, wheezing, or bronchitis, you are taken out of the risk pool for cardiovascular and other diseases. That could explain why in other studies we don’t see a clear cardiovascular signal as we have for air pollution studies in general. Another aspect to this study is, the exposure metric was PM2.5, but smoke contains many other components, particularly gases, which are respiratory irritants. It could be that this triggers a higher risk for respiratory [effects] than regular episodes of high PM2.5 exposure, just because of the additional gases that people are exposed to.”

Another complicating factor is the paucity of data about solutions to long-term exposure to wildfire smoke. “If you’re impacted by high-exposure levels for 60 days, that is not something we have experienced before,” Dr. Rappold noted. “What are the solutions for that community? What works? Can we show that by implementing community-level resilience plans with HEPA [high-efficiency particulate air] filters or other interventions, do the overall outcomes improve? Doctors are the first ones to talk with their patients about their symptoms and about how to take care of their conditions. They can clearly make a difference in emphasizing reducing exposures in a way that fits their patients individually, either reducing the amount of time spent outside, the duration of exposure, and the level of exposure. Maybe change activities based on the intensity of exposure. Don’t go for a run outside when it’s smoky, because your ventilation rate is higher and you will breathe in more smoke. Become aware of those things.”

 

 

Advising vulnerable patients

While research in this field advances, the unforgiving wildfire season looms, assuring more destruction of property and threats to cardiorespiratory health. “There are a lot of questions that research will have an opportunity to address as we go forward, including the utility and the benefit of N95 masks, the utility of HEPA filters used in the house, and even with HVAC [heating, ventilation, and air conditioning] systems,” Dr. Cascio said. “Can we really clean up the indoor air well enough to protect us from wildfire smoke?”



The way he sees it, the time is ripe for clinicians and officials in public and private practice settings to refine how they distribute information to people living in areas affected by wildfire smoke. “We can’t force people do anything, but at least if they’re informed, then they understand they can make an informed decision about how they might want to affect what they do that would limit their exposure,” he said. “As a patient, my health care system sends text and email messages to me. So, why couldn’t the hospital send out a text message or an email to all of the patients with COPD, coronary disease, and heart failure when an area is impacted by smoke, saying, ‘Check your air quality and take action if air quality is poor?’ Physicians don’t have time to do this kind of education in the office for all of their patients. I know that from experience. But if one were to only focus on those at highest risk, and encourage them to follow our guidelines, which might include doing HEPA filter treatment in the home, we probably would reduce the number of clinical events in a cost-effective way.”

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The 2019 wildfire season is underway in many locales across the United States, exposing millions of individuals to smoky conditions that will have health consequences ranging from stinging eyes to scratchy throats to a trip to the ED for asthma or chronic obstructive pulmonary disease (COPD) exacerbation. Questions about long-term health impacts are on the minds of many, including physicians and their patients who live with cardiorespiratory conditions.

US Forest Service photo courtesy of Peter Buschmann.
The Woolsey Fire as seen from Topanga, Calif., on Nov. 9, 2018. The wildfire burned more than 96,000 acres and destroyed more than 1,600 structures.

John R. Balmes, MD, a pulmonologist at the University of California, San Francisco, and an expert on the respiratory and cardiovascular effects of air pollutants, suggested that the best available published literature points to “pretty strong evidence for acute effects of wildfire smoke on respiratory health, meaning people with preexisting asthma and COPD are at risk for exacerbations, and probably for respiratory tract infections as well.” He said, “It’s a little less clear, but there’s good biological plausibility for increased risk of respiratory tract infections because when your alveolar macrophages are overloaded with carbon particles that are toxic to those cells, they don’t function as well as a first line of defense against bacterial infection, for example.”

 

The new normal of wildfires

Dr. John R. Balmes

Warmer, drier summers in recent years in the western United States and many other regions, attributed by climate experts to global climate change, have produced catastrophic wildfires (PNAS;2016 Oct 18;113[42]11770-5; Science 2006 Aug 18;313:940-3). The Camp Fire in Northern California broke out in November 2018, took the lives of at least 85 people, and cost more than $16 billion in damage. Smoke from that blaze reached hazardous levels in San Francisco, Sacramento, Fresno, and many other smaller towns. Other forest fires in that year caused heavy smoke conditions in Portland, Seattle, Vancouver, and Anchorage. Such events are expected to be repeated often in the coming years (Int J Environ Res Public Health. 2019 Jul 6;16[13]).

Courtesy Dr. Wayne Cascio
On Nov. 10, 2018, wildfire smoke from the devastating Camp Fire obscured views of the Golden Gate Bridge from Lands End Trail in San Francisco.

Wildfire smoke can contain a wide range of substances, chemicals, and gases with known and unknown cardiorespiratory implications. “Smoke is composed primarily of carbon dioxide, water vapor, carbon monoxide, particulate matter, hydrocarbons and other organic chemicals, nitrogen oxides, trace minerals and several thousand other compounds,” according to the U.S. Environmental Protection Agency (Wildfire smoke: A guide for public health officials 2019. Washington, D.C.: EPA, 2019). The EPA report noted, “Particles with diameters less than 10 mcm (particulate matter, or PM10) can be inhaled into the lungs and affect the lungs, heart, and blood vessels. The smallest particles, those less than 2.5 mcm in diameter (PM2.5), are the greatest risk to public health because they can reach deep into the lungs and may even make it into the bloodstream.”

 

 

Research on health impact

In early June of 2008, Wayne Cascio, MD, awoke in his Greenville, N.C., home to the stench of smoke emanating from a large peat fire burning some 65 miles away. By the time he reached the parking lot at East Carolina University in Greenville to begin his workday as chief of cardiology, the haze of smoke had thickened to the point where he could only see a few feet in front of him.

Dr. Wayne Cascio

Over the next several weeks, the fire scorched 41,000 acres and produced haze and air pollution that far exceeded National Ambient Air Quality Standards for particulate matter and blanketed rural communities in the state’s eastern region. The price tag for management of the blaze reached $20 million. Because of his interest in the health effects of wildfire smoke and because of his relationship with investigators at the EPA, Dr. Cascio initiated an epidemiology study to investigate the effects of exposure on cardiorespiratory outcomes in the population affected by the fire (Environ Health Perspect. 2011 Oct;119[10]:1415-20).

By combining satellite data with syndromic surveillance drawn from hospital records in 41 counties contained in the North Carolina Disease Event Tracking and Epidemiologic Collection Tool, he and his colleagues found that exposure to the peat wildfire smoke led to increases in the cumulative risk ratio for asthma (relative risk, 1.65), chronic obstructive pulmonary disease (RR, 1.73), and pneumonia and acute bronchitis (RR, 1.59). ED visits related to cardiopulmonary symptoms and heart failure also were significantly increased (RR, 1.23 and 1.37, respectively). “That was really the first study to strongly identify a cardiac endpoint related to wildfire smoke exposure,” said Dr. Cascio, who now directs the EPA’s National Health and Environmental Effects Research Laboratory. “It really pointed out how little we knew about the health effects of wildfire up until that time.”

Those early findings have been replicated in subsequent research about the acute health effects of exposure to wildfire smoke, which contains PM2.5 and other toxic substances from structures, electronic devices, and automobiles destroyed in the path of flames, including heavy metals and asbestos. Most of the work has focused on smoke-related cardiovascular and respiratory ED visits and hospitalizations.

A study of the 2008 California wildfire impact on ED visits accounted for ozone levels in addition to PM2.5 in the smoke. During the active fire periods, PM2.5 was significantly associated with exacerbations of asthma and COPD and these effects remained after controlling for ozone levels. PM2.5 inhalation during the wildfires was associated with increased risk of an ED visit for asthma (RR, 1.112; 95% confidence interval, 1.087-1.138) for a 10 mcg/m3 increase in PM2.5 and COPD (RR, 1.05; 95% CI, 1.019-1.0825), as well as for combined respiratory visits (RR, 1.035; 95% CI, 1.023-1.046) (Environ Int. 2109 Aug;129:291-8).

Researchers who evaluated the health impacts of wildfires in California during the 2015 fire season found an increase in all-cause cardiovascular and respiratory ED visits, especially among those aged 65 years and older during smoke days. The population-based study included 1,196,233 ED visits during May 1–Sept. 30 that year. PM2.5 concentrations were categorized as light, medium, or dense. Relative risk rose with the amount of smoke in the air. Rates of all-cause cardiovascular ED visits were elevated across levels of smoke density, with the greatest increase on dense smoke days and among those aged 65 years or older (RR,1.15; 95% CI, 1.09-1.22). All-cause cerebrovascular visits were associated with dense smoke days, especially among those aged 65 years and older (RR, 1.22; 95% CI, 1.00-1.49). Respiratory conditions also were increased on dense smoke days (RR, 1.18; 95% CI, 1.08-1.28) (J Am Heart Assoc. 2018 Apr 11;7:e007492. doi: 10.1161/JAHA.117.007492).

 

 

Long-term effects unknown

When it comes to the long-term effects of wildfire smoke on human health outcomes, much less is known. In a recent literature review, Colleen E. Reid, PhD, and Melissa May Maestas, PhD, found only one study that investigated long-term respiratory health impacts of wildfire smoke, and only a few studies that have estimated future health impacts of wildfires under likely climate change scenarios (Curr Opin Pulm Med. 2019 Mar;25:179-87).

Dr. Colleen E. Reid

“We know that there are immediate respiratory health effects from wildfire smoke,” said Dr. Reid of the department of geography at the University of Colorado Boulder. “What’s less known is everything else. That’s challenging, because people want to know about the long-term health effects.”

Evidence from the scientific literature suggests that exposure to air pollution adversely affects cardiovascular health, but whether exposure to wildfire smoke confers a similar risk is less clear. “Until just a few years ago we haven’t been able to study wildfire exposure measures on a large scale,” said EPA scientist Ana G. Rappold, PhD, a statistician there in the environmental public health division of the National Health and Environmental Effects Research Laboratory. “It’s also hard to predict wildfires, so it’s hard to plan for an epidemiologic study if you don’t know where they’re going to occur.”

Dr. Ana G. Rappold

Dr. Rappold and colleagues examined cardiopulmonary hospitalizations among adults aged 65 years and older in 692 U.S. counties within 200 km of 123 large wildfires during 2008-2010 (Environ Health Perspect. 2019;127[3]:37006. doi: 10.1289/EHP3860). They observed that an increased risk of PM2.5-related cardiopulmonary hospitalizations was similar on smoke and nonsmoke days across multiple lags and exposure metrics, while risk for asthma-related hospitalizations was higher during smoke days. “One hypothesis is that this was an older study population, so naturally if you’re inhaling smoke, the first organ that’s impacted in an older population is the lungs,” Dr. Rappold said. “If you go to the hospital for asthma, wheezing, or bronchitis, you are taken out of the risk pool for cardiovascular and other diseases. That could explain why in other studies we don’t see a clear cardiovascular signal as we have for air pollution studies in general. Another aspect to this study is, the exposure metric was PM2.5, but smoke contains many other components, particularly gases, which are respiratory irritants. It could be that this triggers a higher risk for respiratory [effects] than regular episodes of high PM2.5 exposure, just because of the additional gases that people are exposed to.”

Another complicating factor is the paucity of data about solutions to long-term exposure to wildfire smoke. “If you’re impacted by high-exposure levels for 60 days, that is not something we have experienced before,” Dr. Rappold noted. “What are the solutions for that community? What works? Can we show that by implementing community-level resilience plans with HEPA [high-efficiency particulate air] filters or other interventions, do the overall outcomes improve? Doctors are the first ones to talk with their patients about their symptoms and about how to take care of their conditions. They can clearly make a difference in emphasizing reducing exposures in a way that fits their patients individually, either reducing the amount of time spent outside, the duration of exposure, and the level of exposure. Maybe change activities based on the intensity of exposure. Don’t go for a run outside when it’s smoky, because your ventilation rate is higher and you will breathe in more smoke. Become aware of those things.”

 

 

Advising vulnerable patients

While research in this field advances, the unforgiving wildfire season looms, assuring more destruction of property and threats to cardiorespiratory health. “There are a lot of questions that research will have an opportunity to address as we go forward, including the utility and the benefit of N95 masks, the utility of HEPA filters used in the house, and even with HVAC [heating, ventilation, and air conditioning] systems,” Dr. Cascio said. “Can we really clean up the indoor air well enough to protect us from wildfire smoke?”



The way he sees it, the time is ripe for clinicians and officials in public and private practice settings to refine how they distribute information to people living in areas affected by wildfire smoke. “We can’t force people do anything, but at least if they’re informed, then they understand they can make an informed decision about how they might want to affect what they do that would limit their exposure,” he said. “As a patient, my health care system sends text and email messages to me. So, why couldn’t the hospital send out a text message or an email to all of the patients with COPD, coronary disease, and heart failure when an area is impacted by smoke, saying, ‘Check your air quality and take action if air quality is poor?’ Physicians don’t have time to do this kind of education in the office for all of their patients. I know that from experience. But if one were to only focus on those at highest risk, and encourage them to follow our guidelines, which might include doing HEPA filter treatment in the home, we probably would reduce the number of clinical events in a cost-effective way.”

The 2019 wildfire season is underway in many locales across the United States, exposing millions of individuals to smoky conditions that will have health consequences ranging from stinging eyes to scratchy throats to a trip to the ED for asthma or chronic obstructive pulmonary disease (COPD) exacerbation. Questions about long-term health impacts are on the minds of many, including physicians and their patients who live with cardiorespiratory conditions.

US Forest Service photo courtesy of Peter Buschmann.
The Woolsey Fire as seen from Topanga, Calif., on Nov. 9, 2018. The wildfire burned more than 96,000 acres and destroyed more than 1,600 structures.

John R. Balmes, MD, a pulmonologist at the University of California, San Francisco, and an expert on the respiratory and cardiovascular effects of air pollutants, suggested that the best available published literature points to “pretty strong evidence for acute effects of wildfire smoke on respiratory health, meaning people with preexisting asthma and COPD are at risk for exacerbations, and probably for respiratory tract infections as well.” He said, “It’s a little less clear, but there’s good biological plausibility for increased risk of respiratory tract infections because when your alveolar macrophages are overloaded with carbon particles that are toxic to those cells, they don’t function as well as a first line of defense against bacterial infection, for example.”

 

The new normal of wildfires

Dr. John R. Balmes

Warmer, drier summers in recent years in the western United States and many other regions, attributed by climate experts to global climate change, have produced catastrophic wildfires (PNAS;2016 Oct 18;113[42]11770-5; Science 2006 Aug 18;313:940-3). The Camp Fire in Northern California broke out in November 2018, took the lives of at least 85 people, and cost more than $16 billion in damage. Smoke from that blaze reached hazardous levels in San Francisco, Sacramento, Fresno, and many other smaller towns. Other forest fires in that year caused heavy smoke conditions in Portland, Seattle, Vancouver, and Anchorage. Such events are expected to be repeated often in the coming years (Int J Environ Res Public Health. 2019 Jul 6;16[13]).

Courtesy Dr. Wayne Cascio
On Nov. 10, 2018, wildfire smoke from the devastating Camp Fire obscured views of the Golden Gate Bridge from Lands End Trail in San Francisco.

Wildfire smoke can contain a wide range of substances, chemicals, and gases with known and unknown cardiorespiratory implications. “Smoke is composed primarily of carbon dioxide, water vapor, carbon monoxide, particulate matter, hydrocarbons and other organic chemicals, nitrogen oxides, trace minerals and several thousand other compounds,” according to the U.S. Environmental Protection Agency (Wildfire smoke: A guide for public health officials 2019. Washington, D.C.: EPA, 2019). The EPA report noted, “Particles with diameters less than 10 mcm (particulate matter, or PM10) can be inhaled into the lungs and affect the lungs, heart, and blood vessels. The smallest particles, those less than 2.5 mcm in diameter (PM2.5), are the greatest risk to public health because they can reach deep into the lungs and may even make it into the bloodstream.”

 

 

Research on health impact

In early June of 2008, Wayne Cascio, MD, awoke in his Greenville, N.C., home to the stench of smoke emanating from a large peat fire burning some 65 miles away. By the time he reached the parking lot at East Carolina University in Greenville to begin his workday as chief of cardiology, the haze of smoke had thickened to the point where he could only see a few feet in front of him.

Dr. Wayne Cascio

Over the next several weeks, the fire scorched 41,000 acres and produced haze and air pollution that far exceeded National Ambient Air Quality Standards for particulate matter and blanketed rural communities in the state’s eastern region. The price tag for management of the blaze reached $20 million. Because of his interest in the health effects of wildfire smoke and because of his relationship with investigators at the EPA, Dr. Cascio initiated an epidemiology study to investigate the effects of exposure on cardiorespiratory outcomes in the population affected by the fire (Environ Health Perspect. 2011 Oct;119[10]:1415-20).

By combining satellite data with syndromic surveillance drawn from hospital records in 41 counties contained in the North Carolina Disease Event Tracking and Epidemiologic Collection Tool, he and his colleagues found that exposure to the peat wildfire smoke led to increases in the cumulative risk ratio for asthma (relative risk, 1.65), chronic obstructive pulmonary disease (RR, 1.73), and pneumonia and acute bronchitis (RR, 1.59). ED visits related to cardiopulmonary symptoms and heart failure also were significantly increased (RR, 1.23 and 1.37, respectively). “That was really the first study to strongly identify a cardiac endpoint related to wildfire smoke exposure,” said Dr. Cascio, who now directs the EPA’s National Health and Environmental Effects Research Laboratory. “It really pointed out how little we knew about the health effects of wildfire up until that time.”

Those early findings have been replicated in subsequent research about the acute health effects of exposure to wildfire smoke, which contains PM2.5 and other toxic substances from structures, electronic devices, and automobiles destroyed in the path of flames, including heavy metals and asbestos. Most of the work has focused on smoke-related cardiovascular and respiratory ED visits and hospitalizations.

A study of the 2008 California wildfire impact on ED visits accounted for ozone levels in addition to PM2.5 in the smoke. During the active fire periods, PM2.5 was significantly associated with exacerbations of asthma and COPD and these effects remained after controlling for ozone levels. PM2.5 inhalation during the wildfires was associated with increased risk of an ED visit for asthma (RR, 1.112; 95% confidence interval, 1.087-1.138) for a 10 mcg/m3 increase in PM2.5 and COPD (RR, 1.05; 95% CI, 1.019-1.0825), as well as for combined respiratory visits (RR, 1.035; 95% CI, 1.023-1.046) (Environ Int. 2109 Aug;129:291-8).

Researchers who evaluated the health impacts of wildfires in California during the 2015 fire season found an increase in all-cause cardiovascular and respiratory ED visits, especially among those aged 65 years and older during smoke days. The population-based study included 1,196,233 ED visits during May 1–Sept. 30 that year. PM2.5 concentrations were categorized as light, medium, or dense. Relative risk rose with the amount of smoke in the air. Rates of all-cause cardiovascular ED visits were elevated across levels of smoke density, with the greatest increase on dense smoke days and among those aged 65 years or older (RR,1.15; 95% CI, 1.09-1.22). All-cause cerebrovascular visits were associated with dense smoke days, especially among those aged 65 years and older (RR, 1.22; 95% CI, 1.00-1.49). Respiratory conditions also were increased on dense smoke days (RR, 1.18; 95% CI, 1.08-1.28) (J Am Heart Assoc. 2018 Apr 11;7:e007492. doi: 10.1161/JAHA.117.007492).

 

 

Long-term effects unknown

When it comes to the long-term effects of wildfire smoke on human health outcomes, much less is known. In a recent literature review, Colleen E. Reid, PhD, and Melissa May Maestas, PhD, found only one study that investigated long-term respiratory health impacts of wildfire smoke, and only a few studies that have estimated future health impacts of wildfires under likely climate change scenarios (Curr Opin Pulm Med. 2019 Mar;25:179-87).

Dr. Colleen E. Reid

“We know that there are immediate respiratory health effects from wildfire smoke,” said Dr. Reid of the department of geography at the University of Colorado Boulder. “What’s less known is everything else. That’s challenging, because people want to know about the long-term health effects.”

Evidence from the scientific literature suggests that exposure to air pollution adversely affects cardiovascular health, but whether exposure to wildfire smoke confers a similar risk is less clear. “Until just a few years ago we haven’t been able to study wildfire exposure measures on a large scale,” said EPA scientist Ana G. Rappold, PhD, a statistician there in the environmental public health division of the National Health and Environmental Effects Research Laboratory. “It’s also hard to predict wildfires, so it’s hard to plan for an epidemiologic study if you don’t know where they’re going to occur.”

Dr. Ana G. Rappold

Dr. Rappold and colleagues examined cardiopulmonary hospitalizations among adults aged 65 years and older in 692 U.S. counties within 200 km of 123 large wildfires during 2008-2010 (Environ Health Perspect. 2019;127[3]:37006. doi: 10.1289/EHP3860). They observed that an increased risk of PM2.5-related cardiopulmonary hospitalizations was similar on smoke and nonsmoke days across multiple lags and exposure metrics, while risk for asthma-related hospitalizations was higher during smoke days. “One hypothesis is that this was an older study population, so naturally if you’re inhaling smoke, the first organ that’s impacted in an older population is the lungs,” Dr. Rappold said. “If you go to the hospital for asthma, wheezing, or bronchitis, you are taken out of the risk pool for cardiovascular and other diseases. That could explain why in other studies we don’t see a clear cardiovascular signal as we have for air pollution studies in general. Another aspect to this study is, the exposure metric was PM2.5, but smoke contains many other components, particularly gases, which are respiratory irritants. It could be that this triggers a higher risk for respiratory [effects] than regular episodes of high PM2.5 exposure, just because of the additional gases that people are exposed to.”

Another complicating factor is the paucity of data about solutions to long-term exposure to wildfire smoke. “If you’re impacted by high-exposure levels for 60 days, that is not something we have experienced before,” Dr. Rappold noted. “What are the solutions for that community? What works? Can we show that by implementing community-level resilience plans with HEPA [high-efficiency particulate air] filters or other interventions, do the overall outcomes improve? Doctors are the first ones to talk with their patients about their symptoms and about how to take care of their conditions. They can clearly make a difference in emphasizing reducing exposures in a way that fits their patients individually, either reducing the amount of time spent outside, the duration of exposure, and the level of exposure. Maybe change activities based on the intensity of exposure. Don’t go for a run outside when it’s smoky, because your ventilation rate is higher and you will breathe in more smoke. Become aware of those things.”

 

 

Advising vulnerable patients

While research in this field advances, the unforgiving wildfire season looms, assuring more destruction of property and threats to cardiorespiratory health. “There are a lot of questions that research will have an opportunity to address as we go forward, including the utility and the benefit of N95 masks, the utility of HEPA filters used in the house, and even with HVAC [heating, ventilation, and air conditioning] systems,” Dr. Cascio said. “Can we really clean up the indoor air well enough to protect us from wildfire smoke?”



The way he sees it, the time is ripe for clinicians and officials in public and private practice settings to refine how they distribute information to people living in areas affected by wildfire smoke. “We can’t force people do anything, but at least if they’re informed, then they understand they can make an informed decision about how they might want to affect what they do that would limit their exposure,” he said. “As a patient, my health care system sends text and email messages to me. So, why couldn’t the hospital send out a text message or an email to all of the patients with COPD, coronary disease, and heart failure when an area is impacted by smoke, saying, ‘Check your air quality and take action if air quality is poor?’ Physicians don’t have time to do this kind of education in the office for all of their patients. I know that from experience. But if one were to only focus on those at highest risk, and encourage them to follow our guidelines, which might include doing HEPA filter treatment in the home, we probably would reduce the number of clinical events in a cost-effective way.”

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NDMA found in samples of ranitidine, FDA says

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Mon, 09/16/2019 - 16:44

According to the Food and Drug Administration, Zantac and other ranitidine medicines contain low levels of a nitrosamine impurity known as N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen.

“NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a prepared statement issued on Sept. 13, 2019. “The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”

Dr. Woodcock said that the agency is working with industry partners to determine whether the low levels of NDMA in ranitidine pose a risk to patients, and it plans to post that information when it becomes available. For now, “patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health,” she said. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”

Dr. Janet Woodcock

Dr. Woodcock emphasized that the FDA is not suggesting that individuals stop taking ranitidine at this time. “However, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options,” she said. “People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”

She advised consumers and health care professionals to report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the problem.

Visit the AGA GI Patient Center for education to share with your patients about GERD, including symptoms, testing, lifestyle modifications and drug treatments at https://www.gastro.org/practice-guidance/gi-patient-center/topic/gastroesophageal-reflux-disease-gerd.

 

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According to the Food and Drug Administration, Zantac and other ranitidine medicines contain low levels of a nitrosamine impurity known as N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen.

“NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a prepared statement issued on Sept. 13, 2019. “The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”

Dr. Woodcock said that the agency is working with industry partners to determine whether the low levels of NDMA in ranitidine pose a risk to patients, and it plans to post that information when it becomes available. For now, “patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health,” she said. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”

Dr. Janet Woodcock

Dr. Woodcock emphasized that the FDA is not suggesting that individuals stop taking ranitidine at this time. “However, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options,” she said. “People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”

She advised consumers and health care professionals to report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the problem.

Visit the AGA GI Patient Center for education to share with your patients about GERD, including symptoms, testing, lifestyle modifications and drug treatments at https://www.gastro.org/practice-guidance/gi-patient-center/topic/gastroesophageal-reflux-disease-gerd.

 

According to the Food and Drug Administration, Zantac and other ranitidine medicines contain low levels of a nitrosamine impurity known as N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen.

“NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a prepared statement issued on Sept. 13, 2019. “The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”

Dr. Woodcock said that the agency is working with industry partners to determine whether the low levels of NDMA in ranitidine pose a risk to patients, and it plans to post that information when it becomes available. For now, “patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health,” she said. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”

Dr. Janet Woodcock

Dr. Woodcock emphasized that the FDA is not suggesting that individuals stop taking ranitidine at this time. “However, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options,” she said. “People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”

She advised consumers and health care professionals to report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the problem.

Visit the AGA GI Patient Center for education to share with your patients about GERD, including symptoms, testing, lifestyle modifications and drug treatments at https://www.gastro.org/practice-guidance/gi-patient-center/topic/gastroesophageal-reflux-disease-gerd.

 

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NDMA found in samples of ranitidine, FDA says

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Mon, 09/16/2019 - 10:13

 

According to the Food and Drug Administration, Zantac and other ranitidine medicines contain low levels of a nitrosamine impurity known as N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen.

“NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a prepared statement issued on Sept. 13, 2019. “The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”



Dr. Woodcock said that the agency is working with industry partners to determine whether the low levels of NDMA in ranitidine pose a risk to patients, and it plans to post that information when it becomes available. For now, “patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health,” she said. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”

 

Dr. Woodcock emphasized that the FDA is not suggesting that individuals stop taking ranitidine at this time. “However, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options,” she said. “People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”

Dr. Janet Woodcock

She advised consumers and health care professionals to report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the problem.

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According to the Food and Drug Administration, Zantac and other ranitidine medicines contain low levels of a nitrosamine impurity known as N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen.

“NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a prepared statement issued on Sept. 13, 2019. “The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”



Dr. Woodcock said that the agency is working with industry partners to determine whether the low levels of NDMA in ranitidine pose a risk to patients, and it plans to post that information when it becomes available. For now, “patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health,” she said. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”

 

Dr. Woodcock emphasized that the FDA is not suggesting that individuals stop taking ranitidine at this time. “However, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options,” she said. “People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”

Dr. Janet Woodcock

She advised consumers and health care professionals to report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the problem.

 

According to the Food and Drug Administration, Zantac and other ranitidine medicines contain low levels of a nitrosamine impurity known as N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen.

“NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a prepared statement issued on Sept. 13, 2019. “The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”



Dr. Woodcock said that the agency is working with industry partners to determine whether the low levels of NDMA in ranitidine pose a risk to patients, and it plans to post that information when it becomes available. For now, “patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health,” she said. “Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”

 

Dr. Woodcock emphasized that the FDA is not suggesting that individuals stop taking ranitidine at this time. “However, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options,” she said. “People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”

Dr. Janet Woodcock

She advised consumers and health care professionals to report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the problem.

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Expert spotlights telltale clinical signs of xeroderma pigmentosum

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Tue, 09/10/2019 - 15:54

 

– If a child presents with acute photosensitivity at a young age, onset of freckling before the age of 2 years, and severe sun damage of the lips and eyes, think xeroderma pigmentosum (XP), a rare autosomal recessive disorder.

Doug Brunk/MDedge News
Dr. John J. DiGiovanna

Other telltale symptoms of XP include the presence of skin cancer at an early age and a large number of skin cancers.

At the annual meeting of the Society for Pediatric Dermatology, John J. DiGiovanna, MD, described XP as a disorder of genomic instability, which has no cure. It’s caused by a mutation in genes XPA through XPG and the XP variant (XPV) gene. “The genome controls our genes, and UV rays damage DNA,” said Dr. DiGiovanna, who is a senior research physician at the National Cancer Institute’s Laboratory of Cancer and Biology and Genetics, Bethesda, Md. “This damage from UV radiation is similar to damage from chemical agents that form DNA adducts, such as cigarette smoke and certain chemotherapy agents such as cisplatinum.”

XP patients present with or without acute burning after minimal sun exposure, while children with both subtypes develop “freckling” by the time they reach 2 years of age. Dr. DiGiovanna pointed out that lentigo maligna lesions associated with XP resemble freckles at first glance, yet they vary in size, intensity, and border. Meanwhile, freckles in healthy patients are similar in size, are light tan in color, and have a regular border.

“The burning with minimal sun exposure that occurs during childhood leads to pigmentary changes, atrophy, xerosis, and telangiectasias,” he said. A follow-up analysis of 106 XP patients admitted to the National Institutes of Health between 1971 and 2009 found that patients were diagnosed with their first nonmelanoma skin cancer at a median age of 9 years, compared with age 67 among those in the general population (J Med Genet 2011 Mar;48[3]:168-76). “This is a 58-year decrease in age at risk, which is a 10,000-fold increase in skin cancer,” said Dr. DiGiovanna, who was one of the study authors.

Melanoma also occurs at an earlier age among XP patients – a median age of 22 years, compared with a median of 55 years in the general population. “In the general population, melanoma occurs at a younger age than nonmelanoma skin cancer, while in the XP population, melanoma occurs at an older age,” he said. “This is giving us a good biologic lesson that the melanoma induction mechanism must be different from nonmelanoma skin cancer.”

He recalled one XP patient who was followed by NIH researchers for 4 decades. She worked in a doctor’s office and drove a car, but developed progressive neurologic degeneration and died at the age of 40. “This was not due to unrepaired UV damage, but there are other agents which damage other neurons,” Dr. DiGiovanna explained. “Over time, what you get is a decrease in brain volume, an increase in the brain ventricles, and a loss of brain tissue. At postmortem examination, her brain was of infantile size, compared with that of an equivalent 40-year-old. This is a disease of neuronal loss, and it’s progressive. Only about 20%-25% of XP patients experience neural degeneration.”

Management of XP involves strict sun avoidance, including use of a portable UV meter and many layers of UV protection, including application of sunscreen, wearing protective clothing, sunglasses, hats, and face shields, and the use of UV-blocking window film, LED lights, and a vitamin D diet or oral supplementation. Affected individuals also require frequent skin monitoring by the patients and their family members, frequent dermatologic exams by clinicians, biopsy of suspicious lesions, removal of any skin cancers found, field treatments with agents such as 5-fluorouracil and imiquimod, and chemoprevention with oral retinoids for patients who are actively developing large numbers of new lesions (N Engl J Med. 1988 Jun23;318[25]:1633-7).

“Probably the most important thing you can do is refer them to patient support groups,” Dr. DiGiovanna said. “They are present in many countries and can help them manage the day-to-day issues of their condition.” Support groups based in North America include the XP Family Support Group, XP Society, and XP Grupo Luz De Esperanza.

Dr. DiGiovanna reported having no financial disclosures.

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– If a child presents with acute photosensitivity at a young age, onset of freckling before the age of 2 years, and severe sun damage of the lips and eyes, think xeroderma pigmentosum (XP), a rare autosomal recessive disorder.

Doug Brunk/MDedge News
Dr. John J. DiGiovanna

Other telltale symptoms of XP include the presence of skin cancer at an early age and a large number of skin cancers.

At the annual meeting of the Society for Pediatric Dermatology, John J. DiGiovanna, MD, described XP as a disorder of genomic instability, which has no cure. It’s caused by a mutation in genes XPA through XPG and the XP variant (XPV) gene. “The genome controls our genes, and UV rays damage DNA,” said Dr. DiGiovanna, who is a senior research physician at the National Cancer Institute’s Laboratory of Cancer and Biology and Genetics, Bethesda, Md. “This damage from UV radiation is similar to damage from chemical agents that form DNA adducts, such as cigarette smoke and certain chemotherapy agents such as cisplatinum.”

XP patients present with or without acute burning after minimal sun exposure, while children with both subtypes develop “freckling” by the time they reach 2 years of age. Dr. DiGiovanna pointed out that lentigo maligna lesions associated with XP resemble freckles at first glance, yet they vary in size, intensity, and border. Meanwhile, freckles in healthy patients are similar in size, are light tan in color, and have a regular border.

“The burning with minimal sun exposure that occurs during childhood leads to pigmentary changes, atrophy, xerosis, and telangiectasias,” he said. A follow-up analysis of 106 XP patients admitted to the National Institutes of Health between 1971 and 2009 found that patients were diagnosed with their first nonmelanoma skin cancer at a median age of 9 years, compared with age 67 among those in the general population (J Med Genet 2011 Mar;48[3]:168-76). “This is a 58-year decrease in age at risk, which is a 10,000-fold increase in skin cancer,” said Dr. DiGiovanna, who was one of the study authors.

Melanoma also occurs at an earlier age among XP patients – a median age of 22 years, compared with a median of 55 years in the general population. “In the general population, melanoma occurs at a younger age than nonmelanoma skin cancer, while in the XP population, melanoma occurs at an older age,” he said. “This is giving us a good biologic lesson that the melanoma induction mechanism must be different from nonmelanoma skin cancer.”

He recalled one XP patient who was followed by NIH researchers for 4 decades. She worked in a doctor’s office and drove a car, but developed progressive neurologic degeneration and died at the age of 40. “This was not due to unrepaired UV damage, but there are other agents which damage other neurons,” Dr. DiGiovanna explained. “Over time, what you get is a decrease in brain volume, an increase in the brain ventricles, and a loss of brain tissue. At postmortem examination, her brain was of infantile size, compared with that of an equivalent 40-year-old. This is a disease of neuronal loss, and it’s progressive. Only about 20%-25% of XP patients experience neural degeneration.”

Management of XP involves strict sun avoidance, including use of a portable UV meter and many layers of UV protection, including application of sunscreen, wearing protective clothing, sunglasses, hats, and face shields, and the use of UV-blocking window film, LED lights, and a vitamin D diet or oral supplementation. Affected individuals also require frequent skin monitoring by the patients and their family members, frequent dermatologic exams by clinicians, biopsy of suspicious lesions, removal of any skin cancers found, field treatments with agents such as 5-fluorouracil and imiquimod, and chemoprevention with oral retinoids for patients who are actively developing large numbers of new lesions (N Engl J Med. 1988 Jun23;318[25]:1633-7).

“Probably the most important thing you can do is refer them to patient support groups,” Dr. DiGiovanna said. “They are present in many countries and can help them manage the day-to-day issues of their condition.” Support groups based in North America include the XP Family Support Group, XP Society, and XP Grupo Luz De Esperanza.

Dr. DiGiovanna reported having no financial disclosures.

 

– If a child presents with acute photosensitivity at a young age, onset of freckling before the age of 2 years, and severe sun damage of the lips and eyes, think xeroderma pigmentosum (XP), a rare autosomal recessive disorder.

Doug Brunk/MDedge News
Dr. John J. DiGiovanna

Other telltale symptoms of XP include the presence of skin cancer at an early age and a large number of skin cancers.

At the annual meeting of the Society for Pediatric Dermatology, John J. DiGiovanna, MD, described XP as a disorder of genomic instability, which has no cure. It’s caused by a mutation in genes XPA through XPG and the XP variant (XPV) gene. “The genome controls our genes, and UV rays damage DNA,” said Dr. DiGiovanna, who is a senior research physician at the National Cancer Institute’s Laboratory of Cancer and Biology and Genetics, Bethesda, Md. “This damage from UV radiation is similar to damage from chemical agents that form DNA adducts, such as cigarette smoke and certain chemotherapy agents such as cisplatinum.”

XP patients present with or without acute burning after minimal sun exposure, while children with both subtypes develop “freckling” by the time they reach 2 years of age. Dr. DiGiovanna pointed out that lentigo maligna lesions associated with XP resemble freckles at first glance, yet they vary in size, intensity, and border. Meanwhile, freckles in healthy patients are similar in size, are light tan in color, and have a regular border.

“The burning with minimal sun exposure that occurs during childhood leads to pigmentary changes, atrophy, xerosis, and telangiectasias,” he said. A follow-up analysis of 106 XP patients admitted to the National Institutes of Health between 1971 and 2009 found that patients were diagnosed with their first nonmelanoma skin cancer at a median age of 9 years, compared with age 67 among those in the general population (J Med Genet 2011 Mar;48[3]:168-76). “This is a 58-year decrease in age at risk, which is a 10,000-fold increase in skin cancer,” said Dr. DiGiovanna, who was one of the study authors.

Melanoma also occurs at an earlier age among XP patients – a median age of 22 years, compared with a median of 55 years in the general population. “In the general population, melanoma occurs at a younger age than nonmelanoma skin cancer, while in the XP population, melanoma occurs at an older age,” he said. “This is giving us a good biologic lesson that the melanoma induction mechanism must be different from nonmelanoma skin cancer.”

He recalled one XP patient who was followed by NIH researchers for 4 decades. She worked in a doctor’s office and drove a car, but developed progressive neurologic degeneration and died at the age of 40. “This was not due to unrepaired UV damage, but there are other agents which damage other neurons,” Dr. DiGiovanna explained. “Over time, what you get is a decrease in brain volume, an increase in the brain ventricles, and a loss of brain tissue. At postmortem examination, her brain was of infantile size, compared with that of an equivalent 40-year-old. This is a disease of neuronal loss, and it’s progressive. Only about 20%-25% of XP patients experience neural degeneration.”

Management of XP involves strict sun avoidance, including use of a portable UV meter and many layers of UV protection, including application of sunscreen, wearing protective clothing, sunglasses, hats, and face shields, and the use of UV-blocking window film, LED lights, and a vitamin D diet or oral supplementation. Affected individuals also require frequent skin monitoring by the patients and their family members, frequent dermatologic exams by clinicians, biopsy of suspicious lesions, removal of any skin cancers found, field treatments with agents such as 5-fluorouracil and imiquimod, and chemoprevention with oral retinoids for patients who are actively developing large numbers of new lesions (N Engl J Med. 1988 Jun23;318[25]:1633-7).

“Probably the most important thing you can do is refer them to patient support groups,” Dr. DiGiovanna said. “They are present in many countries and can help them manage the day-to-day issues of their condition.” Support groups based in North America include the XP Family Support Group, XP Society, and XP Grupo Luz De Esperanza.

Dr. DiGiovanna reported having no financial disclosures.

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Expert shares tips for laser hair removal prior to gender reassignment surgery

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Fri, 06/11/2021 - 10:18

 

As the gender reassignment surgery market continues to grow in North America, more people are turning to dermatologists for laser hair removal prior to undergoing the procedures.

“In the last year, in terms of hair removal, this has been the biggest change in my practice,” Mathew M. Avram, MD, JD, said at the annual Masters of Aesthetics Symposium.

R. Rox Anderson, MD, director of the Wellman Center for Photomedicine at Massachusetts General Hospital, and Melanie Grossman, MD, who practices in New York City, developed laser hair removal in the 1990s, and today laser hair removal stands as the most common laser treatment in medicine, said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston. He described it as “safe and effective in skilled hands,” requiring about six treatments. Indications are for hypertrichosis, hirsutism (sometimes in the setting of polycystic ovary syndrome), pseudofolliculitis barbae, pilonidal cysts, and gender reassignment surgery.

Laser hair removal works by the extended theory of selective photothermolysis. “You’re targeting by proxy,” Dr. Avram explained. “The laser targets eumelanin in darkly pigmented hairs, with the secondary target being the follicular stem cells. Pigment is a prerequisite for effective treatment. So if there is no pigment in the hair, with current technology, it’s not going to work.”

He advises clinicians to avoid a cookbook approach to fluences when performing laser hair removal. Even though higher fluences have been correlated with greater permanent hair removal, they are also more likely to cause unexpected side effects. “The recommended treatment fluences are often provided with each individual laser device for nonexperienced operators, but I would not recommend doing that,” he said. “You want to evaluate for the desired clinical endpoint of perifollicular erythema and edema. The highest possible tolerated fluence, which yields this endpoint, without any adverse effects, is often the best fluence for treatment.” In 2016, Dr. Avram and his colleagues published a paper that focuses on desirable and therapeutic endpoints when performing laser and light treatments (J Am Acad Dermatol 2016;74[5]:821-33).


The best candidates for laser hair removal are those with light skin color and dark hair. “The more pigment that’s in the hair, the more it’s going to absorb the energy,” he said. Coarse, thick hair responds better than thin vellus hairs, and blond, gray hairs do not respond. A new silver nanoparticle technology is being developed that may improve efficacy for people with blond or gray hair in the future. “Modest initial data showed that it works, but it requires several treatments,” Dr. Avram said.

A past president of the American Society for Laser Medicine and Surgery, Dr. Avram went on to note that laser hair removal is often delegated to nonphysicians and is the most common cause of lawsuits for laser injury. “The rates of lawsuits rise dramatically when delegated to nonphysicians,” he said. “They even rise higher when performed by nonphysicians without supervision such as in medi-spas. Some of the side effects when performed by nonexperienced users can include temporary hyperpigmentation and longterm hypopigmentation.”

One of his clinical pearls is to never perform laser hair removal on suntanned individuals (“you will get obvious, bizarre-appearing hypopigmentation,” he said) and to exercise caution in patients with darker skin types. “If you do a test spot, give it a couple of weeks to see if hyperpigmentation develops,” he advised. “However, their sun exposure may change, and the area you treat with a test spot may be different than the entire area you intend to treat, so don’t think that a test spot is going to guarantee a particular result. You also have to be aware of paradoxical hypertrichosis, where you get more hair growth rather than less.”

Laser hair removal is mandatory prior to neovaginoplasty surgery. Surgeons use skin from the penile shaft and the midscrotum to create the new vagina, Dr. Avram said, so all hair must be removed prior to surgery so that the inside of the new vagina will be free of hair.

“You can use laser or electrolysis for this,” he said. “Electrolysis takes a lot more treatments and is going to be much more tedious than laser hair removal.” Areas to be targeted include all hair on the scrotum and all hair on the penile shaft, plus one inch around the base. “In the perineum, you want to remove hair from the bottom of the scrotum to one inch above the anus in order to clear a 2.5-inch-wide strip,” he said.

For a phalloplasty, surgeons use skin from the underside of arm to create a urethra. This means that all hair should be removed from the crease of the wrist to 15-18 cm up the arm. “You treat the underside of the arm at 4 cm distally and 5.5 cm proximally,” Dr. Avram said. “It should be 15-18 cm in length, and you cannot have any hair that remains within the new urethra.”

To create a penis, surgeons use skin from the prone arm and around. This requires removing hair at 10 cm distally, 13 cm proximally, and 14 cm in length.

Dr. Avram emphasized the importance of patient and staff education and use of preferred pronouns when performing laser hair removal on patients prior to their gender reassignment surgery. “It requires an explanation that this requires multiple treatments and will not remove all hair,” he said. “You can work with an experienced electrologist for nonresponsive hair.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis, Invasix, and Zalea and intellectual property rights with Cytrellis.

[email protected]

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As the gender reassignment surgery market continues to grow in North America, more people are turning to dermatologists for laser hair removal prior to undergoing the procedures.

“In the last year, in terms of hair removal, this has been the biggest change in my practice,” Mathew M. Avram, MD, JD, said at the annual Masters of Aesthetics Symposium.

R. Rox Anderson, MD, director of the Wellman Center for Photomedicine at Massachusetts General Hospital, and Melanie Grossman, MD, who practices in New York City, developed laser hair removal in the 1990s, and today laser hair removal stands as the most common laser treatment in medicine, said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston. He described it as “safe and effective in skilled hands,” requiring about six treatments. Indications are for hypertrichosis, hirsutism (sometimes in the setting of polycystic ovary syndrome), pseudofolliculitis barbae, pilonidal cysts, and gender reassignment surgery.

Laser hair removal works by the extended theory of selective photothermolysis. “You’re targeting by proxy,” Dr. Avram explained. “The laser targets eumelanin in darkly pigmented hairs, with the secondary target being the follicular stem cells. Pigment is a prerequisite for effective treatment. So if there is no pigment in the hair, with current technology, it’s not going to work.”

He advises clinicians to avoid a cookbook approach to fluences when performing laser hair removal. Even though higher fluences have been correlated with greater permanent hair removal, they are also more likely to cause unexpected side effects. “The recommended treatment fluences are often provided with each individual laser device for nonexperienced operators, but I would not recommend doing that,” he said. “You want to evaluate for the desired clinical endpoint of perifollicular erythema and edema. The highest possible tolerated fluence, which yields this endpoint, without any adverse effects, is often the best fluence for treatment.” In 2016, Dr. Avram and his colleagues published a paper that focuses on desirable and therapeutic endpoints when performing laser and light treatments (J Am Acad Dermatol 2016;74[5]:821-33).


The best candidates for laser hair removal are those with light skin color and dark hair. “The more pigment that’s in the hair, the more it’s going to absorb the energy,” he said. Coarse, thick hair responds better than thin vellus hairs, and blond, gray hairs do not respond. A new silver nanoparticle technology is being developed that may improve efficacy for people with blond or gray hair in the future. “Modest initial data showed that it works, but it requires several treatments,” Dr. Avram said.

A past president of the American Society for Laser Medicine and Surgery, Dr. Avram went on to note that laser hair removal is often delegated to nonphysicians and is the most common cause of lawsuits for laser injury. “The rates of lawsuits rise dramatically when delegated to nonphysicians,” he said. “They even rise higher when performed by nonphysicians without supervision such as in medi-spas. Some of the side effects when performed by nonexperienced users can include temporary hyperpigmentation and longterm hypopigmentation.”

One of his clinical pearls is to never perform laser hair removal on suntanned individuals (“you will get obvious, bizarre-appearing hypopigmentation,” he said) and to exercise caution in patients with darker skin types. “If you do a test spot, give it a couple of weeks to see if hyperpigmentation develops,” he advised. “However, their sun exposure may change, and the area you treat with a test spot may be different than the entire area you intend to treat, so don’t think that a test spot is going to guarantee a particular result. You also have to be aware of paradoxical hypertrichosis, where you get more hair growth rather than less.”

Laser hair removal is mandatory prior to neovaginoplasty surgery. Surgeons use skin from the penile shaft and the midscrotum to create the new vagina, Dr. Avram said, so all hair must be removed prior to surgery so that the inside of the new vagina will be free of hair.

“You can use laser or electrolysis for this,” he said. “Electrolysis takes a lot more treatments and is going to be much more tedious than laser hair removal.” Areas to be targeted include all hair on the scrotum and all hair on the penile shaft, plus one inch around the base. “In the perineum, you want to remove hair from the bottom of the scrotum to one inch above the anus in order to clear a 2.5-inch-wide strip,” he said.

For a phalloplasty, surgeons use skin from the underside of arm to create a urethra. This means that all hair should be removed from the crease of the wrist to 15-18 cm up the arm. “You treat the underside of the arm at 4 cm distally and 5.5 cm proximally,” Dr. Avram said. “It should be 15-18 cm in length, and you cannot have any hair that remains within the new urethra.”

To create a penis, surgeons use skin from the prone arm and around. This requires removing hair at 10 cm distally, 13 cm proximally, and 14 cm in length.

Dr. Avram emphasized the importance of patient and staff education and use of preferred pronouns when performing laser hair removal on patients prior to their gender reassignment surgery. “It requires an explanation that this requires multiple treatments and will not remove all hair,” he said. “You can work with an experienced electrologist for nonresponsive hair.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis, Invasix, and Zalea and intellectual property rights with Cytrellis.

[email protected]

 

As the gender reassignment surgery market continues to grow in North America, more people are turning to dermatologists for laser hair removal prior to undergoing the procedures.

“In the last year, in terms of hair removal, this has been the biggest change in my practice,” Mathew M. Avram, MD, JD, said at the annual Masters of Aesthetics Symposium.

R. Rox Anderson, MD, director of the Wellman Center for Photomedicine at Massachusetts General Hospital, and Melanie Grossman, MD, who practices in New York City, developed laser hair removal in the 1990s, and today laser hair removal stands as the most common laser treatment in medicine, said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston. He described it as “safe and effective in skilled hands,” requiring about six treatments. Indications are for hypertrichosis, hirsutism (sometimes in the setting of polycystic ovary syndrome), pseudofolliculitis barbae, pilonidal cysts, and gender reassignment surgery.

Laser hair removal works by the extended theory of selective photothermolysis. “You’re targeting by proxy,” Dr. Avram explained. “The laser targets eumelanin in darkly pigmented hairs, with the secondary target being the follicular stem cells. Pigment is a prerequisite for effective treatment. So if there is no pigment in the hair, with current technology, it’s not going to work.”

He advises clinicians to avoid a cookbook approach to fluences when performing laser hair removal. Even though higher fluences have been correlated with greater permanent hair removal, they are also more likely to cause unexpected side effects. “The recommended treatment fluences are often provided with each individual laser device for nonexperienced operators, but I would not recommend doing that,” he said. “You want to evaluate for the desired clinical endpoint of perifollicular erythema and edema. The highest possible tolerated fluence, which yields this endpoint, without any adverse effects, is often the best fluence for treatment.” In 2016, Dr. Avram and his colleagues published a paper that focuses on desirable and therapeutic endpoints when performing laser and light treatments (J Am Acad Dermatol 2016;74[5]:821-33).


The best candidates for laser hair removal are those with light skin color and dark hair. “The more pigment that’s in the hair, the more it’s going to absorb the energy,” he said. Coarse, thick hair responds better than thin vellus hairs, and blond, gray hairs do not respond. A new silver nanoparticle technology is being developed that may improve efficacy for people with blond or gray hair in the future. “Modest initial data showed that it works, but it requires several treatments,” Dr. Avram said.

A past president of the American Society for Laser Medicine and Surgery, Dr. Avram went on to note that laser hair removal is often delegated to nonphysicians and is the most common cause of lawsuits for laser injury. “The rates of lawsuits rise dramatically when delegated to nonphysicians,” he said. “They even rise higher when performed by nonphysicians without supervision such as in medi-spas. Some of the side effects when performed by nonexperienced users can include temporary hyperpigmentation and longterm hypopigmentation.”

One of his clinical pearls is to never perform laser hair removal on suntanned individuals (“you will get obvious, bizarre-appearing hypopigmentation,” he said) and to exercise caution in patients with darker skin types. “If you do a test spot, give it a couple of weeks to see if hyperpigmentation develops,” he advised. “However, their sun exposure may change, and the area you treat with a test spot may be different than the entire area you intend to treat, so don’t think that a test spot is going to guarantee a particular result. You also have to be aware of paradoxical hypertrichosis, where you get more hair growth rather than less.”

Laser hair removal is mandatory prior to neovaginoplasty surgery. Surgeons use skin from the penile shaft and the midscrotum to create the new vagina, Dr. Avram said, so all hair must be removed prior to surgery so that the inside of the new vagina will be free of hair.

“You can use laser or electrolysis for this,” he said. “Electrolysis takes a lot more treatments and is going to be much more tedious than laser hair removal.” Areas to be targeted include all hair on the scrotum and all hair on the penile shaft, plus one inch around the base. “In the perineum, you want to remove hair from the bottom of the scrotum to one inch above the anus in order to clear a 2.5-inch-wide strip,” he said.

For a phalloplasty, surgeons use skin from the underside of arm to create a urethra. This means that all hair should be removed from the crease of the wrist to 15-18 cm up the arm. “You treat the underside of the arm at 4 cm distally and 5.5 cm proximally,” Dr. Avram said. “It should be 15-18 cm in length, and you cannot have any hair that remains within the new urethra.”

To create a penis, surgeons use skin from the prone arm and around. This requires removing hair at 10 cm distally, 13 cm proximally, and 14 cm in length.

Dr. Avram emphasized the importance of patient and staff education and use of preferred pronouns when performing laser hair removal on patients prior to their gender reassignment surgery. “It requires an explanation that this requires multiple treatments and will not remove all hair,” he said. “You can work with an experienced electrologist for nonresponsive hair.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis, Invasix, and Zalea and intellectual property rights with Cytrellis.

[email protected]

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No ‘one size fits all’ approach to managing severe pediatric psoriasis

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Sat, 09/07/2019 - 15:27

 

– The way Kelly M. Cordoro sees it, the most difficult part of managing pediatric patients with severe psoriasis is not in the logistics of prescribing a drug, it’s deciding which drug to use for which patient.

Dr. Kelly M. Cordoro

“You can look up the dosing and frequency of these drugs; all of that’s available,” she said at the annual meeting of the Society for Pediatric Dermatology. “But how do we think about which drug for which patient? What are the considerations?”

Dr. Cordoro, professor of dermatology and pediatrics at the University of California, San Francisco, described psoriasis as an autoamplifying inflammatory cascade involving innate and adaptive immunity and noted that various components of that cascade represent treatment targets. “We don’t have a true comprehension of the pathophysiology of psoriasis, but as we learn the pathways, we’re targeting them,” she said. “You can target keratinocyte proliferation with drugs like retinoids and phototherapy. You can broadly target T cells, neutrophils, and dendritic cells with methotrexate, cyclosporine, and phototherapy. The newer drugs target the cytokine milieu, including TNF [tumor necrosis factor]–alpha, IL [interleukin]–17A, IL-12, and IL-23.”

There is no one right answer for which drug to prescribe, she continued, except in the cases of certain comorbidities, contraindications, and genetic variants. “For example, if a patient has psoriatic arthritis, then you have methotrexate and all of the biologics that might be disease modifying,” she said. “If a patient has inflammatory bowel disease, it’s critical to know that IL-17 inhibitors will flare that disease, but anti-TNF and IL-12 and IL-23 inhibitors are okay. If a patient has liver and kidney disease, you want to avoid methotrexate and cyclosporine. If there’s a female of childbearing potential you want to be very cautious with using retinoids. I think the harder question for us is, How about the rest of the patients?”

In addition to a drug’s mechanism of action, patient- and family-related factors play a role in deciding which agent to use. For example, does the patient prefer an oral or an injectable agent? Is the patient able to travel to a phototherapy center? Is it feasible for the family to manage visits for lab work and direct clinical monitoring? Does the family have a high level of health literacy and are you communicating with them in ways that facilitate shared decision making?


“The best way to choose a systemic therapy is to develop an individualized assessment of overall disease burden,” said Dr. Cordoro, who is also division chief of pediatric dermatology at UCSF. “Include psychological burden and subjective data in addition to objective measures like body surface area. Look for triggers. Infants are more commonly affected by viral infections and, in a subset, monogenic forms of psoriasis such as deficiency of interleukin 1 receptor antagonist [DIRA]. In general, we try to take a conservative approach in the developing child. As children hit early adolescence and become post pubertal, you have to start thinking about the psychosocial impact [of psoriasis], and we have to start treating patients with the consideration that chronic uncontrolled inflammation can potentially lead to comorbidities down the road. We see this in adults with severe psoriasis and early onset cardiovascular disease, the so-called psoriatic march from chronic inflammation to cardiovascular disease.”

Dr. Cordoro advises clinicians to rethink the conventional “therapeutic ladder” concept and embrace the idea of “finding the right tool for the job right now.” If a patient presents with a flare from a known trigger such as a strep infection, “maybe you want to treat with something more conservative,” she said. “Once you treat, and if the trigger has been managed, they might be better. But some patients will need the most aggressive treatment right out of the gate.”

Tried and true systemic therapies for psoriasis include methotrexate, cyclosporine, acitretin, and phototherapy, but none is approved by the Food and Drug Administration for use in children. “These drugs have decades of experience behind them,” Dr. Cordoro said. “Methotrexate is slow to start but has a sustained profile, so if you can get the patient to respond, that response tends to persist. Methotrexate also prevents the formation of antidrug antibodies, which is important if you are considering use of a biologic agent later on.”

Cyclosporine is best if you need a rapid rescue drug to get the disease under control before moving on to other options. “One in four patients relapse once cyclosporine is discontinued, so the benefit may not be as sustained as with methotrexate,” she said. “Acitretin is a really nice choice when you can’t or don’t want to immunosuppress the patient, and phototherapy is good if you can get it. The advantages of systemic therapies are that they’re easy on, easy off, and you can combine medications in severe situations. Almost all of these drugs can be combined with another, with few exceptions. I would caution that over immunosuppression is the biggest risk ... so this must be done carefully and only when necessary.”

Biologic agents such as TNF inhibitors and IL-12/23 inhibitors are playing an increasing role in pediatric psoriasis. They can be expensive and difficult for some insurance plans to cover, but offer the convenience of better efficacy and less frequent lab monitoring than conventional systemics. In the United States, etanercept and ustekinumab are approved for moderate to severe pediatric plaque psoriasis in patients as young as age 4 and 12 years, respectively. TNF inhibitors have accumulated the most data in children, while data are accumulating in trials of IL-17 inhibitors, IL-23 inhibitors, and PDE4 inhibitors.

“These drugs have reassuring safety profiles; low rates of infection and adverse reactions,” Dr. Cordoro said of biologic agents. “They’ve changed the landscape completely because now the expectation is complete or near-complete clearance. In contrast to the systemic agents, which may be started and stopped repeatedly, you need to think about continuous therapy, because these drugs are immunogenic,” she noted. “Whether antibodies against them become neutralizing or not is a different case. If a patient does have antibodies, it does not mean you have to stop the drug. Dose escalation can help. Increasing frequency of use of the drug can help, but patients will develop antibodies and it may result in loss of efficacy or reactions to the drug,” she added.

“When you’re thinking about using a biologic agent, think about patients who are chronic, moderate to severe, and who will need more long-term therapy. Most importantly, treatment should be individualized, as there is no ‘one size fits all’ approach.”

Dr. Cordoro disclosed that she is a member of the Celgene Corporation Scientific Steering Committee.

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– The way Kelly M. Cordoro sees it, the most difficult part of managing pediatric patients with severe psoriasis is not in the logistics of prescribing a drug, it’s deciding which drug to use for which patient.

Dr. Kelly M. Cordoro

“You can look up the dosing and frequency of these drugs; all of that’s available,” she said at the annual meeting of the Society for Pediatric Dermatology. “But how do we think about which drug for which patient? What are the considerations?”

Dr. Cordoro, professor of dermatology and pediatrics at the University of California, San Francisco, described psoriasis as an autoamplifying inflammatory cascade involving innate and adaptive immunity and noted that various components of that cascade represent treatment targets. “We don’t have a true comprehension of the pathophysiology of psoriasis, but as we learn the pathways, we’re targeting them,” she said. “You can target keratinocyte proliferation with drugs like retinoids and phototherapy. You can broadly target T cells, neutrophils, and dendritic cells with methotrexate, cyclosporine, and phototherapy. The newer drugs target the cytokine milieu, including TNF [tumor necrosis factor]–alpha, IL [interleukin]–17A, IL-12, and IL-23.”

There is no one right answer for which drug to prescribe, she continued, except in the cases of certain comorbidities, contraindications, and genetic variants. “For example, if a patient has psoriatic arthritis, then you have methotrexate and all of the biologics that might be disease modifying,” she said. “If a patient has inflammatory bowel disease, it’s critical to know that IL-17 inhibitors will flare that disease, but anti-TNF and IL-12 and IL-23 inhibitors are okay. If a patient has liver and kidney disease, you want to avoid methotrexate and cyclosporine. If there’s a female of childbearing potential you want to be very cautious with using retinoids. I think the harder question for us is, How about the rest of the patients?”

In addition to a drug’s mechanism of action, patient- and family-related factors play a role in deciding which agent to use. For example, does the patient prefer an oral or an injectable agent? Is the patient able to travel to a phototherapy center? Is it feasible for the family to manage visits for lab work and direct clinical monitoring? Does the family have a high level of health literacy and are you communicating with them in ways that facilitate shared decision making?


“The best way to choose a systemic therapy is to develop an individualized assessment of overall disease burden,” said Dr. Cordoro, who is also division chief of pediatric dermatology at UCSF. “Include psychological burden and subjective data in addition to objective measures like body surface area. Look for triggers. Infants are more commonly affected by viral infections and, in a subset, monogenic forms of psoriasis such as deficiency of interleukin 1 receptor antagonist [DIRA]. In general, we try to take a conservative approach in the developing child. As children hit early adolescence and become post pubertal, you have to start thinking about the psychosocial impact [of psoriasis], and we have to start treating patients with the consideration that chronic uncontrolled inflammation can potentially lead to comorbidities down the road. We see this in adults with severe psoriasis and early onset cardiovascular disease, the so-called psoriatic march from chronic inflammation to cardiovascular disease.”

Dr. Cordoro advises clinicians to rethink the conventional “therapeutic ladder” concept and embrace the idea of “finding the right tool for the job right now.” If a patient presents with a flare from a known trigger such as a strep infection, “maybe you want to treat with something more conservative,” she said. “Once you treat, and if the trigger has been managed, they might be better. But some patients will need the most aggressive treatment right out of the gate.”

Tried and true systemic therapies for psoriasis include methotrexate, cyclosporine, acitretin, and phototherapy, but none is approved by the Food and Drug Administration for use in children. “These drugs have decades of experience behind them,” Dr. Cordoro said. “Methotrexate is slow to start but has a sustained profile, so if you can get the patient to respond, that response tends to persist. Methotrexate also prevents the formation of antidrug antibodies, which is important if you are considering use of a biologic agent later on.”

Cyclosporine is best if you need a rapid rescue drug to get the disease under control before moving on to other options. “One in four patients relapse once cyclosporine is discontinued, so the benefit may not be as sustained as with methotrexate,” she said. “Acitretin is a really nice choice when you can’t or don’t want to immunosuppress the patient, and phototherapy is good if you can get it. The advantages of systemic therapies are that they’re easy on, easy off, and you can combine medications in severe situations. Almost all of these drugs can be combined with another, with few exceptions. I would caution that over immunosuppression is the biggest risk ... so this must be done carefully and only when necessary.”

Biologic agents such as TNF inhibitors and IL-12/23 inhibitors are playing an increasing role in pediatric psoriasis. They can be expensive and difficult for some insurance plans to cover, but offer the convenience of better efficacy and less frequent lab monitoring than conventional systemics. In the United States, etanercept and ustekinumab are approved for moderate to severe pediatric plaque psoriasis in patients as young as age 4 and 12 years, respectively. TNF inhibitors have accumulated the most data in children, while data are accumulating in trials of IL-17 inhibitors, IL-23 inhibitors, and PDE4 inhibitors.

“These drugs have reassuring safety profiles; low rates of infection and adverse reactions,” Dr. Cordoro said of biologic agents. “They’ve changed the landscape completely because now the expectation is complete or near-complete clearance. In contrast to the systemic agents, which may be started and stopped repeatedly, you need to think about continuous therapy, because these drugs are immunogenic,” she noted. “Whether antibodies against them become neutralizing or not is a different case. If a patient does have antibodies, it does not mean you have to stop the drug. Dose escalation can help. Increasing frequency of use of the drug can help, but patients will develop antibodies and it may result in loss of efficacy or reactions to the drug,” she added.

“When you’re thinking about using a biologic agent, think about patients who are chronic, moderate to severe, and who will need more long-term therapy. Most importantly, treatment should be individualized, as there is no ‘one size fits all’ approach.”

Dr. Cordoro disclosed that she is a member of the Celgene Corporation Scientific Steering Committee.

 

– The way Kelly M. Cordoro sees it, the most difficult part of managing pediatric patients with severe psoriasis is not in the logistics of prescribing a drug, it’s deciding which drug to use for which patient.

Dr. Kelly M. Cordoro

“You can look up the dosing and frequency of these drugs; all of that’s available,” she said at the annual meeting of the Society for Pediatric Dermatology. “But how do we think about which drug for which patient? What are the considerations?”

Dr. Cordoro, professor of dermatology and pediatrics at the University of California, San Francisco, described psoriasis as an autoamplifying inflammatory cascade involving innate and adaptive immunity and noted that various components of that cascade represent treatment targets. “We don’t have a true comprehension of the pathophysiology of psoriasis, but as we learn the pathways, we’re targeting them,” she said. “You can target keratinocyte proliferation with drugs like retinoids and phototherapy. You can broadly target T cells, neutrophils, and dendritic cells with methotrexate, cyclosporine, and phototherapy. The newer drugs target the cytokine milieu, including TNF [tumor necrosis factor]–alpha, IL [interleukin]–17A, IL-12, and IL-23.”

There is no one right answer for which drug to prescribe, she continued, except in the cases of certain comorbidities, contraindications, and genetic variants. “For example, if a patient has psoriatic arthritis, then you have methotrexate and all of the biologics that might be disease modifying,” she said. “If a patient has inflammatory bowel disease, it’s critical to know that IL-17 inhibitors will flare that disease, but anti-TNF and IL-12 and IL-23 inhibitors are okay. If a patient has liver and kidney disease, you want to avoid methotrexate and cyclosporine. If there’s a female of childbearing potential you want to be very cautious with using retinoids. I think the harder question for us is, How about the rest of the patients?”

In addition to a drug’s mechanism of action, patient- and family-related factors play a role in deciding which agent to use. For example, does the patient prefer an oral or an injectable agent? Is the patient able to travel to a phototherapy center? Is it feasible for the family to manage visits for lab work and direct clinical monitoring? Does the family have a high level of health literacy and are you communicating with them in ways that facilitate shared decision making?


“The best way to choose a systemic therapy is to develop an individualized assessment of overall disease burden,” said Dr. Cordoro, who is also division chief of pediatric dermatology at UCSF. “Include psychological burden and subjective data in addition to objective measures like body surface area. Look for triggers. Infants are more commonly affected by viral infections and, in a subset, monogenic forms of psoriasis such as deficiency of interleukin 1 receptor antagonist [DIRA]. In general, we try to take a conservative approach in the developing child. As children hit early adolescence and become post pubertal, you have to start thinking about the psychosocial impact [of psoriasis], and we have to start treating patients with the consideration that chronic uncontrolled inflammation can potentially lead to comorbidities down the road. We see this in adults with severe psoriasis and early onset cardiovascular disease, the so-called psoriatic march from chronic inflammation to cardiovascular disease.”

Dr. Cordoro advises clinicians to rethink the conventional “therapeutic ladder” concept and embrace the idea of “finding the right tool for the job right now.” If a patient presents with a flare from a known trigger such as a strep infection, “maybe you want to treat with something more conservative,” she said. “Once you treat, and if the trigger has been managed, they might be better. But some patients will need the most aggressive treatment right out of the gate.”

Tried and true systemic therapies for psoriasis include methotrexate, cyclosporine, acitretin, and phototherapy, but none is approved by the Food and Drug Administration for use in children. “These drugs have decades of experience behind them,” Dr. Cordoro said. “Methotrexate is slow to start but has a sustained profile, so if you can get the patient to respond, that response tends to persist. Methotrexate also prevents the formation of antidrug antibodies, which is important if you are considering use of a biologic agent later on.”

Cyclosporine is best if you need a rapid rescue drug to get the disease under control before moving on to other options. “One in four patients relapse once cyclosporine is discontinued, so the benefit may not be as sustained as with methotrexate,” she said. “Acitretin is a really nice choice when you can’t or don’t want to immunosuppress the patient, and phototherapy is good if you can get it. The advantages of systemic therapies are that they’re easy on, easy off, and you can combine medications in severe situations. Almost all of these drugs can be combined with another, with few exceptions. I would caution that over immunosuppression is the biggest risk ... so this must be done carefully and only when necessary.”

Biologic agents such as TNF inhibitors and IL-12/23 inhibitors are playing an increasing role in pediatric psoriasis. They can be expensive and difficult for some insurance plans to cover, but offer the convenience of better efficacy and less frequent lab monitoring than conventional systemics. In the United States, etanercept and ustekinumab are approved for moderate to severe pediatric plaque psoriasis in patients as young as age 4 and 12 years, respectively. TNF inhibitors have accumulated the most data in children, while data are accumulating in trials of IL-17 inhibitors, IL-23 inhibitors, and PDE4 inhibitors.

“These drugs have reassuring safety profiles; low rates of infection and adverse reactions,” Dr. Cordoro said of biologic agents. “They’ve changed the landscape completely because now the expectation is complete or near-complete clearance. In contrast to the systemic agents, which may be started and stopped repeatedly, you need to think about continuous therapy, because these drugs are immunogenic,” she noted. “Whether antibodies against them become neutralizing or not is a different case. If a patient does have antibodies, it does not mean you have to stop the drug. Dose escalation can help. Increasing frequency of use of the drug can help, but patients will develop antibodies and it may result in loss of efficacy or reactions to the drug,” she added.

“When you’re thinking about using a biologic agent, think about patients who are chronic, moderate to severe, and who will need more long-term therapy. Most importantly, treatment should be individualized, as there is no ‘one size fits all’ approach.”

Dr. Cordoro disclosed that she is a member of the Celgene Corporation Scientific Steering Committee.

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Novel dermal microcoring device holds promise for moderate to severe wrinkles

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Changed
Sat, 09/07/2019 - 15:28

 

An investigative dermal microcoring device designed for improvement of moderate to severe facial wrinkles and tightening is poised to become a game-changer in the minimally invasive aesthetics field.

Courtesy Jill S. Waibel, MD
This photo shows the patient's mid and lower cheek and jawline before treatment.

A brainchild of dermatologists and plastic surgeons at Massachusetts General Hospital, Boston, the device features a proprietary needle design that makes a series of high throughput microexcisions in epidermal and dermal tissue, with minimal downtime and without using thermal energy.

“The idea is to get more significant improvement of tissue laxity by fractionally removing the skin,” Mathew M. Avram, MD, JD, explained at the annual Masters of Aesthetics Symposium. “You can do a facelift by cutting the skin on the side and pulling it back. This is skin tightening and improvement of wrinkles with a thousand micro punches. It’s called fractional tissue extraction.”

Instead of relying on laser, heat, light, or radiofrequency, the device uses needle mechanics to extract microsized cores of full-thickness skin below the size threshold that causes scarring. “Then, you have biomechanical remodeling; you close the channels right away,” said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital. “If you remove skin that is smaller than 500 micrometers in size, no scar is left behind.”

Courtesy Jill S. Waibel, MD
This is the patient at day 90 after one treatment with an investigative dermal microcoring device being developed by Cytrellis. The device removed 5% of the treated skin.

In trials of the device being carried out by Cytrellis Biosystems, more than 100 patients have been treated one to two times. During a separate presentation, one of the device investigators, Jill S. Waibel, MD, said that areas of treatment have included the upper and lower cheeks, perioral areas, and the submentum. On average, the amount of skin removed during each treatment session ranges from 5% to 8.5% and the mean down time is 3.8 days. According to combined data from two studies of 30 patients who had 60 areas treated and were followed at 90 or 180 days, subjects experienced an average 1.1 grade improvement on the Lemperle Rating Scale and showed an 80% improvement in moderate or severe wrinkles. In addition, 91% of investigators rated treatment areas as “improved” or “very much improved” on the Global Aesthetic Improvement Scale, and 88% of subjects were “satisfied” or “extremely satisfied” with the results.

“The safety profile of this device is amazing,” said Dr. Waibel, a dermatologist and owner of the Miami Dermatology and Laser Institute. “It provides an entirely new mode of treatment for skin laxity through highly approachable tissue removal with minimal to no pain or downtime. You can visually see the cores close through Optical Coherence Tomography before patients even leave the office. There have also been virtually no side effects except in one patient at another site who had minor postinflammatory hyperpigmentation.”


The device allows for local and scarless treatment of wrinkles in the areas in which they form, she continued, so results are natural and true to the underlying anatomy. “While its target testing has been in more severely lax patients, I think it has a great future for younger patients who want to stave off a future face lift,” Dr. Waibel said. “Initial treatments required preoperative lidocaine injections. However, recent trials using more tolerable analgesic methods have shown that this may not even be necessary. This is very exciting new technology and I have high hopes for the future of this device.”

Histological analysis from baseline to 60-90 days post treatment showed homogenization of elastosis, which signals reorganization of the papillary dermis, Dr. Avram said. It also showed a decrease in the grenz zone, rete ridge flattening, a slight increase in the collagen-to-elastin ratio, and no scarring. Pending clearance, he said, the device could be commercially available in 2020.

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis, Invasix, and Zalea and intellectual property rights with Cytrellis.

Dr. Waibel disclosed that she has conducted clinical research for AbbVie, Aquavit, Cytrellis, Lumenis, Lutronic, Michelson Diagnostics, RegenX, Sciton, Sebacia, and Syneron/Candela. She is also a consultant for RegenX, Strata, and Syneron/Candela and is a member of the advisory board for Dominion Technologies, Sciton, and Sebacia.

[email protected]

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An investigative dermal microcoring device designed for improvement of moderate to severe facial wrinkles and tightening is poised to become a game-changer in the minimally invasive aesthetics field.

Courtesy Jill S. Waibel, MD
This photo shows the patient's mid and lower cheek and jawline before treatment.

A brainchild of dermatologists and plastic surgeons at Massachusetts General Hospital, Boston, the device features a proprietary needle design that makes a series of high throughput microexcisions in epidermal and dermal tissue, with minimal downtime and without using thermal energy.

“The idea is to get more significant improvement of tissue laxity by fractionally removing the skin,” Mathew M. Avram, MD, JD, explained at the annual Masters of Aesthetics Symposium. “You can do a facelift by cutting the skin on the side and pulling it back. This is skin tightening and improvement of wrinkles with a thousand micro punches. It’s called fractional tissue extraction.”

Instead of relying on laser, heat, light, or radiofrequency, the device uses needle mechanics to extract microsized cores of full-thickness skin below the size threshold that causes scarring. “Then, you have biomechanical remodeling; you close the channels right away,” said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital. “If you remove skin that is smaller than 500 micrometers in size, no scar is left behind.”

Courtesy Jill S. Waibel, MD
This is the patient at day 90 after one treatment with an investigative dermal microcoring device being developed by Cytrellis. The device removed 5% of the treated skin.

In trials of the device being carried out by Cytrellis Biosystems, more than 100 patients have been treated one to two times. During a separate presentation, one of the device investigators, Jill S. Waibel, MD, said that areas of treatment have included the upper and lower cheeks, perioral areas, and the submentum. On average, the amount of skin removed during each treatment session ranges from 5% to 8.5% and the mean down time is 3.8 days. According to combined data from two studies of 30 patients who had 60 areas treated and were followed at 90 or 180 days, subjects experienced an average 1.1 grade improvement on the Lemperle Rating Scale and showed an 80% improvement in moderate or severe wrinkles. In addition, 91% of investigators rated treatment areas as “improved” or “very much improved” on the Global Aesthetic Improvement Scale, and 88% of subjects were “satisfied” or “extremely satisfied” with the results.

“The safety profile of this device is amazing,” said Dr. Waibel, a dermatologist and owner of the Miami Dermatology and Laser Institute. “It provides an entirely new mode of treatment for skin laxity through highly approachable tissue removal with minimal to no pain or downtime. You can visually see the cores close through Optical Coherence Tomography before patients even leave the office. There have also been virtually no side effects except in one patient at another site who had minor postinflammatory hyperpigmentation.”


The device allows for local and scarless treatment of wrinkles in the areas in which they form, she continued, so results are natural and true to the underlying anatomy. “While its target testing has been in more severely lax patients, I think it has a great future for younger patients who want to stave off a future face lift,” Dr. Waibel said. “Initial treatments required preoperative lidocaine injections. However, recent trials using more tolerable analgesic methods have shown that this may not even be necessary. This is very exciting new technology and I have high hopes for the future of this device.”

Histological analysis from baseline to 60-90 days post treatment showed homogenization of elastosis, which signals reorganization of the papillary dermis, Dr. Avram said. It also showed a decrease in the grenz zone, rete ridge flattening, a slight increase in the collagen-to-elastin ratio, and no scarring. Pending clearance, he said, the device could be commercially available in 2020.

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis, Invasix, and Zalea and intellectual property rights with Cytrellis.

Dr. Waibel disclosed that she has conducted clinical research for AbbVie, Aquavit, Cytrellis, Lumenis, Lutronic, Michelson Diagnostics, RegenX, Sciton, Sebacia, and Syneron/Candela. She is also a consultant for RegenX, Strata, and Syneron/Candela and is a member of the advisory board for Dominion Technologies, Sciton, and Sebacia.

[email protected]

 

An investigative dermal microcoring device designed for improvement of moderate to severe facial wrinkles and tightening is poised to become a game-changer in the minimally invasive aesthetics field.

Courtesy Jill S. Waibel, MD
This photo shows the patient's mid and lower cheek and jawline before treatment.

A brainchild of dermatologists and plastic surgeons at Massachusetts General Hospital, Boston, the device features a proprietary needle design that makes a series of high throughput microexcisions in epidermal and dermal tissue, with minimal downtime and without using thermal energy.

“The idea is to get more significant improvement of tissue laxity by fractionally removing the skin,” Mathew M. Avram, MD, JD, explained at the annual Masters of Aesthetics Symposium. “You can do a facelift by cutting the skin on the side and pulling it back. This is skin tightening and improvement of wrinkles with a thousand micro punches. It’s called fractional tissue extraction.”

Instead of relying on laser, heat, light, or radiofrequency, the device uses needle mechanics to extract microsized cores of full-thickness skin below the size threshold that causes scarring. “Then, you have biomechanical remodeling; you close the channels right away,” said Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital. “If you remove skin that is smaller than 500 micrometers in size, no scar is left behind.”

Courtesy Jill S. Waibel, MD
This is the patient at day 90 after one treatment with an investigative dermal microcoring device being developed by Cytrellis. The device removed 5% of the treated skin.

In trials of the device being carried out by Cytrellis Biosystems, more than 100 patients have been treated one to two times. During a separate presentation, one of the device investigators, Jill S. Waibel, MD, said that areas of treatment have included the upper and lower cheeks, perioral areas, and the submentum. On average, the amount of skin removed during each treatment session ranges from 5% to 8.5% and the mean down time is 3.8 days. According to combined data from two studies of 30 patients who had 60 areas treated and were followed at 90 or 180 days, subjects experienced an average 1.1 grade improvement on the Lemperle Rating Scale and showed an 80% improvement in moderate or severe wrinkles. In addition, 91% of investigators rated treatment areas as “improved” or “very much improved” on the Global Aesthetic Improvement Scale, and 88% of subjects were “satisfied” or “extremely satisfied” with the results.

“The safety profile of this device is amazing,” said Dr. Waibel, a dermatologist and owner of the Miami Dermatology and Laser Institute. “It provides an entirely new mode of treatment for skin laxity through highly approachable tissue removal with minimal to no pain or downtime. You can visually see the cores close through Optical Coherence Tomography before patients even leave the office. There have also been virtually no side effects except in one patient at another site who had minor postinflammatory hyperpigmentation.”


The device allows for local and scarless treatment of wrinkles in the areas in which they form, she continued, so results are natural and true to the underlying anatomy. “While its target testing has been in more severely lax patients, I think it has a great future for younger patients who want to stave off a future face lift,” Dr. Waibel said. “Initial treatments required preoperative lidocaine injections. However, recent trials using more tolerable analgesic methods have shown that this may not even be necessary. This is very exciting new technology and I have high hopes for the future of this device.”

Histological analysis from baseline to 60-90 days post treatment showed homogenization of elastosis, which signals reorganization of the papillary dermis, Dr. Avram said. It also showed a decrease in the grenz zone, rete ridge flattening, a slight increase in the collagen-to-elastin ratio, and no scarring. Pending clearance, he said, the device could be commercially available in 2020.

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, Sciton, Soliton, and Zalea. He also reported having ownership and/or shareholder interest in Cytrellis, Invasix, and Zalea and intellectual property rights with Cytrellis.

Dr. Waibel disclosed that she has conducted clinical research for AbbVie, Aquavit, Cytrellis, Lumenis, Lutronic, Michelson Diagnostics, RegenX, Sciton, Sebacia, and Syneron/Candela. She is also a consultant for RegenX, Strata, and Syneron/Candela and is a member of the advisory board for Dominion Technologies, Sciton, and Sebacia.

[email protected]

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Thread lifts making a comeback, but long-term effects remain unclear

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Fri, 06/11/2021 - 10:18

 

– The use of threads to improve skin laxity is making a comeback, thanks largely to advances in absorbable sutures.

Dr. Arisa E. Ortiz

“Thread lifts were popularized in the 1990s, but I think they were misrepresented as an alternative to a surgical face-lift, which remains the gold standard,” Arisa E. Ortiz, MD, said at the annual Masters of Aesthetics Symposium. “A thread lift is certainly not like a traditional face-lift; it’s much more subtle.”

In the 1990s, clinicians used nonabsorbable sutures for thread lifts, including polypropylene-barbed threads, which caused adverse events ranging from extrusion and migration to thread expulsion, dimpling, granuloma formation, and prolonged pain. As a result, the Food and Drug Administration withdrew its approval of contour thread aesthetic procedures in 2009. Since then, the development of absorbable threads made from polydioxanone (PDO) and poly-l-lactic acid (PLLA) has led to renewed interest in thread-lift procedures, yet the long-term effects remain unclear.

“There are some nice benefits to thread lifts,” said Dr. Ortiz, who is director of laser and cosmetic dermatology at the University of California, San Diego. “You get immediate results, which is always nice for patients, but with tissue tightening using energy-based devices, results are unpredictable and it can take 6 months to see the results. With resorbable sutures, we’re seeing fewer complications, and the amount of lifting is more predictable because you’re physically lifting the tissue. In some cases, threads are able to lift tissue more than energy-based devices. There is minimal recovery, it requires local anesthesia, and it’s less expensive than a surgical face-lift, which can run $10,000-$15,000 or more.”



For skin lifting, clinicians implant threads subcutaneously. When tugged in the opposite direction, the barbs anchor in adipose tissue, increasing tensile strength while suspended in the dermis and overlying tissue. This produces a fibrous adhesion capsule that helps to solidify anchorage of the suture long term. Fibrosis has been shown to increase local collagen production. PDO and PLLA are known collagen stimulants and are postulated to stimulate a long-term benefit in rejuvenation, Dr. Ortiz said, but overall evidence regarding their use in thread lifts is weak.

“Existing studies have a very short follow-up period and there is really no standardized protocol, so we don’t know really know a lot about them yet,” she said. Lana Tong, MD, and Evan A. Rieder, MD, of New York University recently published a systematic review of the literature on the topic (Dermatol Surg. 2019 45[7]:931-40).

PDO is biodegradable by hydrolysis over 4-8 months and is used as absorbable suture material for prolonged tension–bearing areas. “It causes neocollagenesis with a foreign-body reaction,” Dr. Ortiz said. Meanwhile, PLLA is a collagen stimulator used for prolonged volume restoration. “It’s used an aesthetic filler, but a known complication with PLLA injections is the formation of subcutaneous nodules and late onset granulomas,” she said.

Early in 2019, Korean researchers published results of a study that set out to evaluate the collagen-producing effects of powdered PDO injection, compared with PLLA injection, in a murine model (J Cosmet Dermatol. 2019 Feb 27. doi: 10.1111/jocd.12894). “It showed both PDO and PLLA induced granulomatous reactions and collagen formation, but this decreased at 12 weeks,” said Dr. Ortiz, who was not involved with the work. “PDO had slightly more collagen formation than PLLA.”

Indications for thread lifts, she continued, are for jawline lift, cheek enhancement, brow lift, wrinkle reduction, body contouring, acne scarring, and texturing. “Choose patients with good skin quality: not too thick/heavy, and not too thin. Patients with moderate skin sagging are going to better candidates than those with severe skin sagging.”

One type of absorbable suspension suture, the Silhouette InstaLift, is made of polyglycolide/l-lactide and is FDA cleared for temporary midface suspension targeting the elevation of cheek laxity. “It is a bidirectional implant with four, six, or eight cones per side,” Dr. Ortiz said. “They provide immediate suspension of the tissue until collagen production ensues. These tend to last a year or 2, but there are no controlled studies to confirm that. I’ve found that if you’re able to lift tissue in an upward direction rather than posteriorly you get a better result, but you’re limited by the length of these sutures. They’re not as customizable as some of the shorter sutures.”

In terms of adverse events following thread lift procedures, patients usually feel tender for about a week or 2. “They can have some bruising, mostly from the anesthesia,” she said.

To prevent temporary dimpling, Dr. Ortiz undermines with an 18-gauge needle and inserts perpendicular to the skin surface. “Extrusions can still occur,” she said. To prevent this, she pulls on the end and makes sure it’s buried subcutaneously.

Dr. Ortiz reported having financial relationships with numerous pharmaceutical and device companies, though none related to the content of her presentation. She is also cochair of the Masters of Aesthetics symposium.

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– The use of threads to improve skin laxity is making a comeback, thanks largely to advances in absorbable sutures.

Dr. Arisa E. Ortiz

“Thread lifts were popularized in the 1990s, but I think they were misrepresented as an alternative to a surgical face-lift, which remains the gold standard,” Arisa E. Ortiz, MD, said at the annual Masters of Aesthetics Symposium. “A thread lift is certainly not like a traditional face-lift; it’s much more subtle.”

In the 1990s, clinicians used nonabsorbable sutures for thread lifts, including polypropylene-barbed threads, which caused adverse events ranging from extrusion and migration to thread expulsion, dimpling, granuloma formation, and prolonged pain. As a result, the Food and Drug Administration withdrew its approval of contour thread aesthetic procedures in 2009. Since then, the development of absorbable threads made from polydioxanone (PDO) and poly-l-lactic acid (PLLA) has led to renewed interest in thread-lift procedures, yet the long-term effects remain unclear.

“There are some nice benefits to thread lifts,” said Dr. Ortiz, who is director of laser and cosmetic dermatology at the University of California, San Diego. “You get immediate results, which is always nice for patients, but with tissue tightening using energy-based devices, results are unpredictable and it can take 6 months to see the results. With resorbable sutures, we’re seeing fewer complications, and the amount of lifting is more predictable because you’re physically lifting the tissue. In some cases, threads are able to lift tissue more than energy-based devices. There is minimal recovery, it requires local anesthesia, and it’s less expensive than a surgical face-lift, which can run $10,000-$15,000 or more.”



For skin lifting, clinicians implant threads subcutaneously. When tugged in the opposite direction, the barbs anchor in adipose tissue, increasing tensile strength while suspended in the dermis and overlying tissue. This produces a fibrous adhesion capsule that helps to solidify anchorage of the suture long term. Fibrosis has been shown to increase local collagen production. PDO and PLLA are known collagen stimulants and are postulated to stimulate a long-term benefit in rejuvenation, Dr. Ortiz said, but overall evidence regarding their use in thread lifts is weak.

“Existing studies have a very short follow-up period and there is really no standardized protocol, so we don’t know really know a lot about them yet,” she said. Lana Tong, MD, and Evan A. Rieder, MD, of New York University recently published a systematic review of the literature on the topic (Dermatol Surg. 2019 45[7]:931-40).

PDO is biodegradable by hydrolysis over 4-8 months and is used as absorbable suture material for prolonged tension–bearing areas. “It causes neocollagenesis with a foreign-body reaction,” Dr. Ortiz said. Meanwhile, PLLA is a collagen stimulator used for prolonged volume restoration. “It’s used an aesthetic filler, but a known complication with PLLA injections is the formation of subcutaneous nodules and late onset granulomas,” she said.

Early in 2019, Korean researchers published results of a study that set out to evaluate the collagen-producing effects of powdered PDO injection, compared with PLLA injection, in a murine model (J Cosmet Dermatol. 2019 Feb 27. doi: 10.1111/jocd.12894). “It showed both PDO and PLLA induced granulomatous reactions and collagen formation, but this decreased at 12 weeks,” said Dr. Ortiz, who was not involved with the work. “PDO had slightly more collagen formation than PLLA.”

Indications for thread lifts, she continued, are for jawline lift, cheek enhancement, brow lift, wrinkle reduction, body contouring, acne scarring, and texturing. “Choose patients with good skin quality: not too thick/heavy, and not too thin. Patients with moderate skin sagging are going to better candidates than those with severe skin sagging.”

One type of absorbable suspension suture, the Silhouette InstaLift, is made of polyglycolide/l-lactide and is FDA cleared for temporary midface suspension targeting the elevation of cheek laxity. “It is a bidirectional implant with four, six, or eight cones per side,” Dr. Ortiz said. “They provide immediate suspension of the tissue until collagen production ensues. These tend to last a year or 2, but there are no controlled studies to confirm that. I’ve found that if you’re able to lift tissue in an upward direction rather than posteriorly you get a better result, but you’re limited by the length of these sutures. They’re not as customizable as some of the shorter sutures.”

In terms of adverse events following thread lift procedures, patients usually feel tender for about a week or 2. “They can have some bruising, mostly from the anesthesia,” she said.

To prevent temporary dimpling, Dr. Ortiz undermines with an 18-gauge needle and inserts perpendicular to the skin surface. “Extrusions can still occur,” she said. To prevent this, she pulls on the end and makes sure it’s buried subcutaneously.

Dr. Ortiz reported having financial relationships with numerous pharmaceutical and device companies, though none related to the content of her presentation. She is also cochair of the Masters of Aesthetics symposium.

 

– The use of threads to improve skin laxity is making a comeback, thanks largely to advances in absorbable sutures.

Dr. Arisa E. Ortiz

“Thread lifts were popularized in the 1990s, but I think they were misrepresented as an alternative to a surgical face-lift, which remains the gold standard,” Arisa E. Ortiz, MD, said at the annual Masters of Aesthetics Symposium. “A thread lift is certainly not like a traditional face-lift; it’s much more subtle.”

In the 1990s, clinicians used nonabsorbable sutures for thread lifts, including polypropylene-barbed threads, which caused adverse events ranging from extrusion and migration to thread expulsion, dimpling, granuloma formation, and prolonged pain. As a result, the Food and Drug Administration withdrew its approval of contour thread aesthetic procedures in 2009. Since then, the development of absorbable threads made from polydioxanone (PDO) and poly-l-lactic acid (PLLA) has led to renewed interest in thread-lift procedures, yet the long-term effects remain unclear.

“There are some nice benefits to thread lifts,” said Dr. Ortiz, who is director of laser and cosmetic dermatology at the University of California, San Diego. “You get immediate results, which is always nice for patients, but with tissue tightening using energy-based devices, results are unpredictable and it can take 6 months to see the results. With resorbable sutures, we’re seeing fewer complications, and the amount of lifting is more predictable because you’re physically lifting the tissue. In some cases, threads are able to lift tissue more than energy-based devices. There is minimal recovery, it requires local anesthesia, and it’s less expensive than a surgical face-lift, which can run $10,000-$15,000 or more.”



For skin lifting, clinicians implant threads subcutaneously. When tugged in the opposite direction, the barbs anchor in adipose tissue, increasing tensile strength while suspended in the dermis and overlying tissue. This produces a fibrous adhesion capsule that helps to solidify anchorage of the suture long term. Fibrosis has been shown to increase local collagen production. PDO and PLLA are known collagen stimulants and are postulated to stimulate a long-term benefit in rejuvenation, Dr. Ortiz said, but overall evidence regarding their use in thread lifts is weak.

“Existing studies have a very short follow-up period and there is really no standardized protocol, so we don’t know really know a lot about them yet,” she said. Lana Tong, MD, and Evan A. Rieder, MD, of New York University recently published a systematic review of the literature on the topic (Dermatol Surg. 2019 45[7]:931-40).

PDO is biodegradable by hydrolysis over 4-8 months and is used as absorbable suture material for prolonged tension–bearing areas. “It causes neocollagenesis with a foreign-body reaction,” Dr. Ortiz said. Meanwhile, PLLA is a collagen stimulator used for prolonged volume restoration. “It’s used an aesthetic filler, but a known complication with PLLA injections is the formation of subcutaneous nodules and late onset granulomas,” she said.

Early in 2019, Korean researchers published results of a study that set out to evaluate the collagen-producing effects of powdered PDO injection, compared with PLLA injection, in a murine model (J Cosmet Dermatol. 2019 Feb 27. doi: 10.1111/jocd.12894). “It showed both PDO and PLLA induced granulomatous reactions and collagen formation, but this decreased at 12 weeks,” said Dr. Ortiz, who was not involved with the work. “PDO had slightly more collagen formation than PLLA.”

Indications for thread lifts, she continued, are for jawline lift, cheek enhancement, brow lift, wrinkle reduction, body contouring, acne scarring, and texturing. “Choose patients with good skin quality: not too thick/heavy, and not too thin. Patients with moderate skin sagging are going to better candidates than those with severe skin sagging.”

One type of absorbable suspension suture, the Silhouette InstaLift, is made of polyglycolide/l-lactide and is FDA cleared for temporary midface suspension targeting the elevation of cheek laxity. “It is a bidirectional implant with four, six, or eight cones per side,” Dr. Ortiz said. “They provide immediate suspension of the tissue until collagen production ensues. These tend to last a year or 2, but there are no controlled studies to confirm that. I’ve found that if you’re able to lift tissue in an upward direction rather than posteriorly you get a better result, but you’re limited by the length of these sutures. They’re not as customizable as some of the shorter sutures.”

In terms of adverse events following thread lift procedures, patients usually feel tender for about a week or 2. “They can have some bruising, mostly from the anesthesia,” she said.

To prevent temporary dimpling, Dr. Ortiz undermines with an 18-gauge needle and inserts perpendicular to the skin surface. “Extrusions can still occur,” she said. To prevent this, she pulls on the end and makes sure it’s buried subcutaneously.

Dr. Ortiz reported having financial relationships with numerous pharmaceutical and device companies, though none related to the content of her presentation. She is also cochair of the Masters of Aesthetics symposium.

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