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Endobronchial ultrasound with aspiration yields most lung lesions
, according to a multisite study of current and former smokers with suspected lung cancer.
Bronchoscopy has long played a role in the identification of lung lesions, but the yield varies according to many factors associated with the lesion and the type of bronchoscopy, and recent studies suggest that the yield may be lower than previously thought, wrote Gerard A. Silvestri, MD, of Medical University of South Carolina, Charleston, and colleagues.
In a study published in Chest, the researchers sought to assess the yield of bronchoscopy based on procedure and characteristics, as well as the physician-calculated pretest probability of cancer.
They conducted a secondary analysis of 687 patients from the AEGIS trial, a prospective 28-site study of current and former smokers who underwent bronchoscopy for suspected lung cancer. Patients under 21, those without a history of smoking, and those with a concurrent cancer or history of lung cancer were excluded. The average age of the participants was 63 years, and two-thirds were male. Of these, 474 had diagnostic bronchoscopies and 213 had nondiagnostic bronchoscopies.
The overall diagnostic yield was 69%. However, the diagnostic yield significantly higher (80%) with the use of EBUS-TBNA, compared with 55% for standard bronchoscopy with biopsy +/– fluoroscopy, 57% for electromagnetic navigation, and 74% for combination procedures.
Patients with diagnostic bronchoscopies were significantly more likely than were those who had nondiagnostic bronchoscopies to have lesions greater than 3 cm (67% vs. 45%), to have central locations (75% vs. 50%), and to have lymphadenopathy (57% vs. 55%).
In addition, yields were significantly higher (77%) for patients whose preprocedure physician-assessed probability of cancer was at least 60%, compared with yields in those whose preprocedure physician-assessed probability of cancer was less than 10% or 10%-60% (44% and 42%, respectively).
The study findings were limited by several factors including the high prevalence of cancer in the study population, a 1-year follow-up that may have missed slow-growing cancers, and lack of data on the presence or absence of a bronchus sign, the researchers noted. However, the results were strengthened by the large size, mixture of sites, and use of multiple technologies and presentations, they said.
The study is the largest to assess diagnostic yields and various bronchoscopy techniques and supports EBUS-TBNA as the most reliable, but patient selection and improved procedural training can help improve diagnostic yields, the researchers emphasized.
“While the overall yield of bronchoscopy is reasonable, EBUS-TBNA is the only technique that reliably provides a diagnosis in those suspected of having lung cancer, likely because the biopsy is targeting a central lymph node and there is direct visualization of the needle passing into the target,” they said. However,“better bronchoscopic technology is needed and there are devices in the development pipeline that promise improved diagnostic yield, though these products will require evaluation through prospective comparative effectiveness trials prior to widespread adoption,” they noted. Clinicians should be prepared to pursue alternatives to bronchoscopy if a diagnosis is unlikely, they concluded.
Dr. Silvestri disclosed research grant awards to his university from Olympus America, Auris robotics, Veracyte, and Veran Medical, as well as consulting fees from Olympus and Auris robotics.
SOURCE: Silvestri GA et al. CHEST. 2020 Jan 21. doi: 10.1016/j.chest.2019.12.024.
, according to a multisite study of current and former smokers with suspected lung cancer.
Bronchoscopy has long played a role in the identification of lung lesions, but the yield varies according to many factors associated with the lesion and the type of bronchoscopy, and recent studies suggest that the yield may be lower than previously thought, wrote Gerard A. Silvestri, MD, of Medical University of South Carolina, Charleston, and colleagues.
In a study published in Chest, the researchers sought to assess the yield of bronchoscopy based on procedure and characteristics, as well as the physician-calculated pretest probability of cancer.
They conducted a secondary analysis of 687 patients from the AEGIS trial, a prospective 28-site study of current and former smokers who underwent bronchoscopy for suspected lung cancer. Patients under 21, those without a history of smoking, and those with a concurrent cancer or history of lung cancer were excluded. The average age of the participants was 63 years, and two-thirds were male. Of these, 474 had diagnostic bronchoscopies and 213 had nondiagnostic bronchoscopies.
The overall diagnostic yield was 69%. However, the diagnostic yield significantly higher (80%) with the use of EBUS-TBNA, compared with 55% for standard bronchoscopy with biopsy +/– fluoroscopy, 57% for electromagnetic navigation, and 74% for combination procedures.
Patients with diagnostic bronchoscopies were significantly more likely than were those who had nondiagnostic bronchoscopies to have lesions greater than 3 cm (67% vs. 45%), to have central locations (75% vs. 50%), and to have lymphadenopathy (57% vs. 55%).
In addition, yields were significantly higher (77%) for patients whose preprocedure physician-assessed probability of cancer was at least 60%, compared with yields in those whose preprocedure physician-assessed probability of cancer was less than 10% or 10%-60% (44% and 42%, respectively).
The study findings were limited by several factors including the high prevalence of cancer in the study population, a 1-year follow-up that may have missed slow-growing cancers, and lack of data on the presence or absence of a bronchus sign, the researchers noted. However, the results were strengthened by the large size, mixture of sites, and use of multiple technologies and presentations, they said.
The study is the largest to assess diagnostic yields and various bronchoscopy techniques and supports EBUS-TBNA as the most reliable, but patient selection and improved procedural training can help improve diagnostic yields, the researchers emphasized.
“While the overall yield of bronchoscopy is reasonable, EBUS-TBNA is the only technique that reliably provides a diagnosis in those suspected of having lung cancer, likely because the biopsy is targeting a central lymph node and there is direct visualization of the needle passing into the target,” they said. However,“better bronchoscopic technology is needed and there are devices in the development pipeline that promise improved diagnostic yield, though these products will require evaluation through prospective comparative effectiveness trials prior to widespread adoption,” they noted. Clinicians should be prepared to pursue alternatives to bronchoscopy if a diagnosis is unlikely, they concluded.
Dr. Silvestri disclosed research grant awards to his university from Olympus America, Auris robotics, Veracyte, and Veran Medical, as well as consulting fees from Olympus and Auris robotics.
SOURCE: Silvestri GA et al. CHEST. 2020 Jan 21. doi: 10.1016/j.chest.2019.12.024.
, according to a multisite study of current and former smokers with suspected lung cancer.
Bronchoscopy has long played a role in the identification of lung lesions, but the yield varies according to many factors associated with the lesion and the type of bronchoscopy, and recent studies suggest that the yield may be lower than previously thought, wrote Gerard A. Silvestri, MD, of Medical University of South Carolina, Charleston, and colleagues.
In a study published in Chest, the researchers sought to assess the yield of bronchoscopy based on procedure and characteristics, as well as the physician-calculated pretest probability of cancer.
They conducted a secondary analysis of 687 patients from the AEGIS trial, a prospective 28-site study of current and former smokers who underwent bronchoscopy for suspected lung cancer. Patients under 21, those without a history of smoking, and those with a concurrent cancer or history of lung cancer were excluded. The average age of the participants was 63 years, and two-thirds were male. Of these, 474 had diagnostic bronchoscopies and 213 had nondiagnostic bronchoscopies.
The overall diagnostic yield was 69%. However, the diagnostic yield significantly higher (80%) with the use of EBUS-TBNA, compared with 55% for standard bronchoscopy with biopsy +/– fluoroscopy, 57% for electromagnetic navigation, and 74% for combination procedures.
Patients with diagnostic bronchoscopies were significantly more likely than were those who had nondiagnostic bronchoscopies to have lesions greater than 3 cm (67% vs. 45%), to have central locations (75% vs. 50%), and to have lymphadenopathy (57% vs. 55%).
In addition, yields were significantly higher (77%) for patients whose preprocedure physician-assessed probability of cancer was at least 60%, compared with yields in those whose preprocedure physician-assessed probability of cancer was less than 10% or 10%-60% (44% and 42%, respectively).
The study findings were limited by several factors including the high prevalence of cancer in the study population, a 1-year follow-up that may have missed slow-growing cancers, and lack of data on the presence or absence of a bronchus sign, the researchers noted. However, the results were strengthened by the large size, mixture of sites, and use of multiple technologies and presentations, they said.
The study is the largest to assess diagnostic yields and various bronchoscopy techniques and supports EBUS-TBNA as the most reliable, but patient selection and improved procedural training can help improve diagnostic yields, the researchers emphasized.
“While the overall yield of bronchoscopy is reasonable, EBUS-TBNA is the only technique that reliably provides a diagnosis in those suspected of having lung cancer, likely because the biopsy is targeting a central lymph node and there is direct visualization of the needle passing into the target,” they said. However,“better bronchoscopic technology is needed and there are devices in the development pipeline that promise improved diagnostic yield, though these products will require evaluation through prospective comparative effectiveness trials prior to widespread adoption,” they noted. Clinicians should be prepared to pursue alternatives to bronchoscopy if a diagnosis is unlikely, they concluded.
Dr. Silvestri disclosed research grant awards to his university from Olympus America, Auris robotics, Veracyte, and Veran Medical, as well as consulting fees from Olympus and Auris robotics.
SOURCE: Silvestri GA et al. CHEST. 2020 Jan 21. doi: 10.1016/j.chest.2019.12.024.
FROM CHEST
Colorectal cancer cases spike after start of routine screening
Incidence of colorectal cancer spiked among adults in the United States between the ages of 49 and 50 years, the age when many have routine screening colonoscopies, based on data from a cross-sectional study of 165,160 patients.
“We would expect to see some degree of CRC incidence increase from 49 to 50 years of age owing to screening uptake and diagnosis of preexisting CRCs that may have been clinically undetected,” wrote Wesal H. Abualkhair, MD, of Tulane University, New Orleans, and colleagues.
In a study published in JAMA Network Open, the researchers reviewed data from the Surveillance, Epidemiology, and End Results (SEER) registries from 2000 to 2015 on colorectal cancer incidence in 1-year intervals for adults aged 30-60 years, focusing on the year between ages 49 and 50.
Overall, the incidence of colorectal cancer increased by 46.1% from 49 to 50 years of age, and 93% of these cases were invasive.
The increase in cancer rates occurred across geographical regions, sex, and race, and likely reflects the impact of screening rather than advancing age, the researchers said.
They also found a significant increase in 5-year relative survival (6.9% absolute increase, 10% relative increase) for the transition between 49 and 50 years of age; no other age transitions showed a significant change.
The findings were limited by several factors, including the lack of specific outcomes data and inability to determine the number of years that the cancers existed before diagnosis, the researchers said. However, the results were strengthened by the large study population and detailed yearly assessment.
“Our analysis of the transition from 49 to 50 years provides new, registry-based data regarding risk among individuals younger than 50 years, which can add to preexisting modeling studies to help inform decision-making on the age at which to initiate screening,” the researchers said.
The study did not receive outside funding. Lead author Dr. Abualkhair had no financial conflicts to disclose.
SOURCE: Abualkhair WH et al. JAMA Network Open. 2020 Jan 31. doi: 10.1001/jamanetworkopen.2019.20407.
Incidence of colorectal cancer spiked among adults in the United States between the ages of 49 and 50 years, the age when many have routine screening colonoscopies, based on data from a cross-sectional study of 165,160 patients.
“We would expect to see some degree of CRC incidence increase from 49 to 50 years of age owing to screening uptake and diagnosis of preexisting CRCs that may have been clinically undetected,” wrote Wesal H. Abualkhair, MD, of Tulane University, New Orleans, and colleagues.
In a study published in JAMA Network Open, the researchers reviewed data from the Surveillance, Epidemiology, and End Results (SEER) registries from 2000 to 2015 on colorectal cancer incidence in 1-year intervals for adults aged 30-60 years, focusing on the year between ages 49 and 50.
Overall, the incidence of colorectal cancer increased by 46.1% from 49 to 50 years of age, and 93% of these cases were invasive.
The increase in cancer rates occurred across geographical regions, sex, and race, and likely reflects the impact of screening rather than advancing age, the researchers said.
They also found a significant increase in 5-year relative survival (6.9% absolute increase, 10% relative increase) for the transition between 49 and 50 years of age; no other age transitions showed a significant change.
The findings were limited by several factors, including the lack of specific outcomes data and inability to determine the number of years that the cancers existed before diagnosis, the researchers said. However, the results were strengthened by the large study population and detailed yearly assessment.
“Our analysis of the transition from 49 to 50 years provides new, registry-based data regarding risk among individuals younger than 50 years, which can add to preexisting modeling studies to help inform decision-making on the age at which to initiate screening,” the researchers said.
The study did not receive outside funding. Lead author Dr. Abualkhair had no financial conflicts to disclose.
SOURCE: Abualkhair WH et al. JAMA Network Open. 2020 Jan 31. doi: 10.1001/jamanetworkopen.2019.20407.
Incidence of colorectal cancer spiked among adults in the United States between the ages of 49 and 50 years, the age when many have routine screening colonoscopies, based on data from a cross-sectional study of 165,160 patients.
“We would expect to see some degree of CRC incidence increase from 49 to 50 years of age owing to screening uptake and diagnosis of preexisting CRCs that may have been clinically undetected,” wrote Wesal H. Abualkhair, MD, of Tulane University, New Orleans, and colleagues.
In a study published in JAMA Network Open, the researchers reviewed data from the Surveillance, Epidemiology, and End Results (SEER) registries from 2000 to 2015 on colorectal cancer incidence in 1-year intervals for adults aged 30-60 years, focusing on the year between ages 49 and 50.
Overall, the incidence of colorectal cancer increased by 46.1% from 49 to 50 years of age, and 93% of these cases were invasive.
The increase in cancer rates occurred across geographical regions, sex, and race, and likely reflects the impact of screening rather than advancing age, the researchers said.
They also found a significant increase in 5-year relative survival (6.9% absolute increase, 10% relative increase) for the transition between 49 and 50 years of age; no other age transitions showed a significant change.
The findings were limited by several factors, including the lack of specific outcomes data and inability to determine the number of years that the cancers existed before diagnosis, the researchers said. However, the results were strengthened by the large study population and detailed yearly assessment.
“Our analysis of the transition from 49 to 50 years provides new, registry-based data regarding risk among individuals younger than 50 years, which can add to preexisting modeling studies to help inform decision-making on the age at which to initiate screening,” the researchers said.
The study did not receive outside funding. Lead author Dr. Abualkhair had no financial conflicts to disclose.
SOURCE: Abualkhair WH et al. JAMA Network Open. 2020 Jan 31. doi: 10.1001/jamanetworkopen.2019.20407.
FROM JAMA NETWORK OPEN
Initial ultrasound assessment of appendicitis curbs costs
Assessing appendicitis in children with initial ultrasound followed by computed tomography in the absence of appendix visualization and presence of secondary signs was the most cost-effective approach, according to data from a modeling study of 10 strategies.
Ultrasound is safer and less expensive than computed tomography and avoids radiation exposure; however, cost-effectiveness models of various approaches to imaging have not been well studied, wrote Rebecca Jennings, MD, of Seattle Children’s Hospital, Washington, and colleagues.
In a study published in Pediatrics, the researchers simulated a hypothetical patient population using a Markov cohort model and compared 10 different strategies including CT only, MRI only, and ultrasound followed by CT or MRI after ultrasounds that are negative or fail to visualize the appendix.
Overall, the most cost-effective strategy for moderate-risk patients was the use of ultrasound followed by CT or MRI if the ultrasound failed to visualize the appendix and secondary signs of inflammation were present in the right lower quadrant. The cost of this strategy was $4,815, with effectiveness of 0.99694 quality-adjusted life-years. “The most cost-effective strategy is highly dependent on a patient’s risk stratification,” the researchers noted. Based on their model, imaging was not cost effective for patients with a prevalence less than 16% or greater than 95%. However, those with appendicitis risk between 16% and 95% and no secondary signs of inflammation can forgo further imaging, even without visualization of the appendix for maximum cost-effectiveness, the researchers said.
The study was limited by several factors, including the inability to account for all potential costs related to imaging and outcomes, lack of accounting for the use of sedation when assessing costs, and inability to separate imaging costs from total hospital costs, the researchers noted. However, the results suggest that tailored imaging approaches based on patient risk are the most cost-effective strategies to assess appendicitis, they said.
“The diagnosis and exclusion of appendicitis continues to be one of the primary concerns of providers who care for children with abdominal pain,” wrote Rebecca M. Rentea, MD, and Charles L. Snyder, MD, of Children’s Mercy Hospital Kansas City, Mo., in an accompanying editorial (Pediatrics. 2020 Feb;145:e20193349).
“The best diagnostic and imaging approach to appendicitis has been a topic of interest for some time, and improvements such as appendicitis scoring systems, decreased use of ionized radiation, and adoption of clinical algorithms have been incremental but steady,” they said. Despite the potential of missed appendicitis, the use of an algorithm based on an initial ultrasound and previous possibility of appendicitis described in the study was the most cost effective, they said. In addition, “the ability to visualize the appendix did not alter the most cost-effective approach in those with a moderate risk of appendicitis (most patients),” they concluded.
The study was supported by the University of Washington and Seattle Children’s Hospital Quality Improvement Scholars Program. The researchers had no financial conflicts to disclose.
Dr. Rentea and Dr. Snyder had no financial conflicts to disclose.
SOURCE: Jennings R et al. Pediatrics. 2020. doi: 10.1542/peds.2019-1352.
Assessing appendicitis in children with initial ultrasound followed by computed tomography in the absence of appendix visualization and presence of secondary signs was the most cost-effective approach, according to data from a modeling study of 10 strategies.
Ultrasound is safer and less expensive than computed tomography and avoids radiation exposure; however, cost-effectiveness models of various approaches to imaging have not been well studied, wrote Rebecca Jennings, MD, of Seattle Children’s Hospital, Washington, and colleagues.
In a study published in Pediatrics, the researchers simulated a hypothetical patient population using a Markov cohort model and compared 10 different strategies including CT only, MRI only, and ultrasound followed by CT or MRI after ultrasounds that are negative or fail to visualize the appendix.
Overall, the most cost-effective strategy for moderate-risk patients was the use of ultrasound followed by CT or MRI if the ultrasound failed to visualize the appendix and secondary signs of inflammation were present in the right lower quadrant. The cost of this strategy was $4,815, with effectiveness of 0.99694 quality-adjusted life-years. “The most cost-effective strategy is highly dependent on a patient’s risk stratification,” the researchers noted. Based on their model, imaging was not cost effective for patients with a prevalence less than 16% or greater than 95%. However, those with appendicitis risk between 16% and 95% and no secondary signs of inflammation can forgo further imaging, even without visualization of the appendix for maximum cost-effectiveness, the researchers said.
The study was limited by several factors, including the inability to account for all potential costs related to imaging and outcomes, lack of accounting for the use of sedation when assessing costs, and inability to separate imaging costs from total hospital costs, the researchers noted. However, the results suggest that tailored imaging approaches based on patient risk are the most cost-effective strategies to assess appendicitis, they said.
“The diagnosis and exclusion of appendicitis continues to be one of the primary concerns of providers who care for children with abdominal pain,” wrote Rebecca M. Rentea, MD, and Charles L. Snyder, MD, of Children’s Mercy Hospital Kansas City, Mo., in an accompanying editorial (Pediatrics. 2020 Feb;145:e20193349).
“The best diagnostic and imaging approach to appendicitis has been a topic of interest for some time, and improvements such as appendicitis scoring systems, decreased use of ionized radiation, and adoption of clinical algorithms have been incremental but steady,” they said. Despite the potential of missed appendicitis, the use of an algorithm based on an initial ultrasound and previous possibility of appendicitis described in the study was the most cost effective, they said. In addition, “the ability to visualize the appendix did not alter the most cost-effective approach in those with a moderate risk of appendicitis (most patients),” they concluded.
The study was supported by the University of Washington and Seattle Children’s Hospital Quality Improvement Scholars Program. The researchers had no financial conflicts to disclose.
Dr. Rentea and Dr. Snyder had no financial conflicts to disclose.
SOURCE: Jennings R et al. Pediatrics. 2020. doi: 10.1542/peds.2019-1352.
Assessing appendicitis in children with initial ultrasound followed by computed tomography in the absence of appendix visualization and presence of secondary signs was the most cost-effective approach, according to data from a modeling study of 10 strategies.
Ultrasound is safer and less expensive than computed tomography and avoids radiation exposure; however, cost-effectiveness models of various approaches to imaging have not been well studied, wrote Rebecca Jennings, MD, of Seattle Children’s Hospital, Washington, and colleagues.
In a study published in Pediatrics, the researchers simulated a hypothetical patient population using a Markov cohort model and compared 10 different strategies including CT only, MRI only, and ultrasound followed by CT or MRI after ultrasounds that are negative or fail to visualize the appendix.
Overall, the most cost-effective strategy for moderate-risk patients was the use of ultrasound followed by CT or MRI if the ultrasound failed to visualize the appendix and secondary signs of inflammation were present in the right lower quadrant. The cost of this strategy was $4,815, with effectiveness of 0.99694 quality-adjusted life-years. “The most cost-effective strategy is highly dependent on a patient’s risk stratification,” the researchers noted. Based on their model, imaging was not cost effective for patients with a prevalence less than 16% or greater than 95%. However, those with appendicitis risk between 16% and 95% and no secondary signs of inflammation can forgo further imaging, even without visualization of the appendix for maximum cost-effectiveness, the researchers said.
The study was limited by several factors, including the inability to account for all potential costs related to imaging and outcomes, lack of accounting for the use of sedation when assessing costs, and inability to separate imaging costs from total hospital costs, the researchers noted. However, the results suggest that tailored imaging approaches based on patient risk are the most cost-effective strategies to assess appendicitis, they said.
“The diagnosis and exclusion of appendicitis continues to be one of the primary concerns of providers who care for children with abdominal pain,” wrote Rebecca M. Rentea, MD, and Charles L. Snyder, MD, of Children’s Mercy Hospital Kansas City, Mo., in an accompanying editorial (Pediatrics. 2020 Feb;145:e20193349).
“The best diagnostic and imaging approach to appendicitis has been a topic of interest for some time, and improvements such as appendicitis scoring systems, decreased use of ionized radiation, and adoption of clinical algorithms have been incremental but steady,” they said. Despite the potential of missed appendicitis, the use of an algorithm based on an initial ultrasound and previous possibility of appendicitis described in the study was the most cost effective, they said. In addition, “the ability to visualize the appendix did not alter the most cost-effective approach in those with a moderate risk of appendicitis (most patients),” they concluded.
The study was supported by the University of Washington and Seattle Children’s Hospital Quality Improvement Scholars Program. The researchers had no financial conflicts to disclose.
Dr. Rentea and Dr. Snyder had no financial conflicts to disclose.
SOURCE: Jennings R et al. Pediatrics. 2020. doi: 10.1542/peds.2019-1352.
FROM PEDIATRICS
Most epidermolysis bullosa patients turn to topical antimicrobials
Most patients with epidermolysis bullosa who use topical products choose antimicrobials, according to data from a survey of 202 children and adults.
Management of epidermolysis bullosa (EB) involves a combination of skin protection and infection management, but patient home care practices have not been well studied, wrote Leila Shayegan of Columbia University, New York, and colleagues.
In a study published in Pediatric Dermatology, the researchers surveyed 202 patients who were enrolled in the Epidermolysis Bullosa Clinical Characterization and Outcomes Database during 2017. The patients ranged in age from 1 month to 62 years with an average age of 11 years; 52% were female. The patients represented a range of EB subtypes, including 130 patients with dystrophic EB, 51 patients with EB simplex, 21 with junctional EB, and 3 patients each with Kindler syndrome and unspecified subtypes.
Overall, most of the patients reported cleaning their skin either every day (37%) or every other day (32%). Of the 188 patients who reported using topical products on their wounds, 131 (70%) said they used at least one antimicrobial product, while 125 patients (66%) reported using at least one emollient; 32 (17%) used emollients only, and 21(11%) reported no use of topical products.
The most popular topical antibiotics were mupirocin (31%) and bacitracin (31%). In addition, 14% of respondents used silver-containing products, and 16% used medical-grade honey. Roughly half (51%) of patients who reported use of at least one antimicrobial product used two or more different antimicrobial products.
A total of 38% of patients used only water for cleansing. Of the 131 patients who reported using additives in their cleansing water, 57% added salt, 54% added bleach, 27% added vinegar, and 26% reported “other” additive use, which could include Epsom salt, baking soda, oatmeal, or essential oils, the researchers said. The concentrations of these additives ranged from barely effective 0.002% sodium hypochlorite and 0.002% acetic acid solutions to potentially cytotoxic solutions of 0.09% sodium hypochlorite and 0.156% acetic acid.
“Although the survey was not designed to correlate skin care practices with wound culture results and resistance patterns, widespread use of topical antimicrobials described among EB patients highlights the need for increased emphasis on antibiotic stewardship,” the researchers noted. They added that health care providers should educate patients and families not only about mindful use of antibiotics, but also appropriate concentrations of cleansing additives.
“Optimizing EB patient home skin care routines, along with future longitudinal studies on the impact of EB skin care interventions on microbial resistance patterns, wound healing and [squamous cell carcinoma] risk are necessary to improve outcomes for patients with EB,” they emphasized.
The Epidermolysis Bullosa Clinical Characterization and Outcomes Database used in the study is funded by the Epidermolysis Bullosa Research Partnership and the Epidermolysis Bullosa Medical Research Foundation. Ms. Shayegan had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies including Abeona Therapeutics, Castle Creek Pharmaceuticals, Fibrocell Science, ProQR, and Scioderm.
SOURCE: Shayegan L et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14102.
Most patients with epidermolysis bullosa who use topical products choose antimicrobials, according to data from a survey of 202 children and adults.
Management of epidermolysis bullosa (EB) involves a combination of skin protection and infection management, but patient home care practices have not been well studied, wrote Leila Shayegan of Columbia University, New York, and colleagues.
In a study published in Pediatric Dermatology, the researchers surveyed 202 patients who were enrolled in the Epidermolysis Bullosa Clinical Characterization and Outcomes Database during 2017. The patients ranged in age from 1 month to 62 years with an average age of 11 years; 52% were female. The patients represented a range of EB subtypes, including 130 patients with dystrophic EB, 51 patients with EB simplex, 21 with junctional EB, and 3 patients each with Kindler syndrome and unspecified subtypes.
Overall, most of the patients reported cleaning their skin either every day (37%) or every other day (32%). Of the 188 patients who reported using topical products on their wounds, 131 (70%) said they used at least one antimicrobial product, while 125 patients (66%) reported using at least one emollient; 32 (17%) used emollients only, and 21(11%) reported no use of topical products.
The most popular topical antibiotics were mupirocin (31%) and bacitracin (31%). In addition, 14% of respondents used silver-containing products, and 16% used medical-grade honey. Roughly half (51%) of patients who reported use of at least one antimicrobial product used two or more different antimicrobial products.
A total of 38% of patients used only water for cleansing. Of the 131 patients who reported using additives in their cleansing water, 57% added salt, 54% added bleach, 27% added vinegar, and 26% reported “other” additive use, which could include Epsom salt, baking soda, oatmeal, or essential oils, the researchers said. The concentrations of these additives ranged from barely effective 0.002% sodium hypochlorite and 0.002% acetic acid solutions to potentially cytotoxic solutions of 0.09% sodium hypochlorite and 0.156% acetic acid.
“Although the survey was not designed to correlate skin care practices with wound culture results and resistance patterns, widespread use of topical antimicrobials described among EB patients highlights the need for increased emphasis on antibiotic stewardship,” the researchers noted. They added that health care providers should educate patients and families not only about mindful use of antibiotics, but also appropriate concentrations of cleansing additives.
“Optimizing EB patient home skin care routines, along with future longitudinal studies on the impact of EB skin care interventions on microbial resistance patterns, wound healing and [squamous cell carcinoma] risk are necessary to improve outcomes for patients with EB,” they emphasized.
The Epidermolysis Bullosa Clinical Characterization and Outcomes Database used in the study is funded by the Epidermolysis Bullosa Research Partnership and the Epidermolysis Bullosa Medical Research Foundation. Ms. Shayegan had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies including Abeona Therapeutics, Castle Creek Pharmaceuticals, Fibrocell Science, ProQR, and Scioderm.
SOURCE: Shayegan L et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14102.
Most patients with epidermolysis bullosa who use topical products choose antimicrobials, according to data from a survey of 202 children and adults.
Management of epidermolysis bullosa (EB) involves a combination of skin protection and infection management, but patient home care practices have not been well studied, wrote Leila Shayegan of Columbia University, New York, and colleagues.
In a study published in Pediatric Dermatology, the researchers surveyed 202 patients who were enrolled in the Epidermolysis Bullosa Clinical Characterization and Outcomes Database during 2017. The patients ranged in age from 1 month to 62 years with an average age of 11 years; 52% were female. The patients represented a range of EB subtypes, including 130 patients with dystrophic EB, 51 patients with EB simplex, 21 with junctional EB, and 3 patients each with Kindler syndrome and unspecified subtypes.
Overall, most of the patients reported cleaning their skin either every day (37%) or every other day (32%). Of the 188 patients who reported using topical products on their wounds, 131 (70%) said they used at least one antimicrobial product, while 125 patients (66%) reported using at least one emollient; 32 (17%) used emollients only, and 21(11%) reported no use of topical products.
The most popular topical antibiotics were mupirocin (31%) and bacitracin (31%). In addition, 14% of respondents used silver-containing products, and 16% used medical-grade honey. Roughly half (51%) of patients who reported use of at least one antimicrobial product used two or more different antimicrobial products.
A total of 38% of patients used only water for cleansing. Of the 131 patients who reported using additives in their cleansing water, 57% added salt, 54% added bleach, 27% added vinegar, and 26% reported “other” additive use, which could include Epsom salt, baking soda, oatmeal, or essential oils, the researchers said. The concentrations of these additives ranged from barely effective 0.002% sodium hypochlorite and 0.002% acetic acid solutions to potentially cytotoxic solutions of 0.09% sodium hypochlorite and 0.156% acetic acid.
“Although the survey was not designed to correlate skin care practices with wound culture results and resistance patterns, widespread use of topical antimicrobials described among EB patients highlights the need for increased emphasis on antibiotic stewardship,” the researchers noted. They added that health care providers should educate patients and families not only about mindful use of antibiotics, but also appropriate concentrations of cleansing additives.
“Optimizing EB patient home skin care routines, along with future longitudinal studies on the impact of EB skin care interventions on microbial resistance patterns, wound healing and [squamous cell carcinoma] risk are necessary to improve outcomes for patients with EB,” they emphasized.
The Epidermolysis Bullosa Clinical Characterization and Outcomes Database used in the study is funded by the Epidermolysis Bullosa Research Partnership and the Epidermolysis Bullosa Medical Research Foundation. Ms. Shayegan had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies including Abeona Therapeutics, Castle Creek Pharmaceuticals, Fibrocell Science, ProQR, and Scioderm.
SOURCE: Shayegan L et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14102.
FROM PEDIATRIC DERMATOLOGY
Zoledronate promotes postdenosumab bone retention
Women with osteoporosis who received a single infusion of zoledronate after discontinuing denosumab (Prolia) maintained bone mineral density at both the lumbar spine and the total hip, based on data from 120 individuals.
Although denosumab is often prescribed for postmenopausal osteoporosis, its effects disappear when treatment ends, wrote Judith Everts-Graber, MD, of OsteoRheuma Bern (Switzerland), and colleagues. In addition, recent reports of increased fractures in osteoporotic women after denosumab discontinuation highlight the need for subsequent therapy, but no protocol has been established.
In a study published in the Journal of Bone and Mineral Research, the investigators reviewed data from women aged older than 48 years with postmenopausal osteoporosis who were treated with denosumab between Aug. 1, 2010, and March 31, 2019. The women received four or more injections of 60 mg denosumab administered at 6-month intervals, followed by a single infusion of 5 mg zoledronate 6 months after the final denosumab injection. Patients were evaluated using dual-energy x-ray absorptiometry and vertebral fracture assessment every 2 years after starting denosumab; the average duration of treatment was 3 years.
At an average of 2.5 years after discontinuing denosumab, women who received zoledronate retained 66% of bone mineral density (BMD) gains at the lumbar spine, 49% at the total hip, and 57% at the femoral neck. In addition, three patients developed symptomatic single vertebral fractures and four patients developed peripheral fractures between 1 and 3 years after their last denosumab injections, but none of these patients sustained multiple fractures.
All bone loss occurred within 18 months of denosumab discontinuation, and no significant differences appeared between patients with gains in BMD greater than or less than 9%.
The study findings were limited by several factors, including the retrospective design and the lack of a control group, the researchers noted. However, they collected data from 11 of 28 patients who did not follow the treatment recommendations and did not receive zoledronate after discontinuing denosumab. “As expected, BMD of the lumbar spine and total hip decreased to baseline,” they wrote. In addition, 2 of the 11 patients experienced multiple vertebral fractures.
A single 5-mg infusion of zoledronate “may be a promising step in identifying sequential long-term treatment strategies for osteoporosis,” the researchers concluded. “Nevertheless, each patient requires an individualized surveillance and treatment plan after denosumab discontinuation, including BMD assessment, evaluation of bone turnover markers and consideration of individual clinical risk factors, in particular prevalent fragility fractures.”
The study was funded by OsteoRheuma Bern. The researchers reported having no financial conflicts.
SOURCE: Everts-Graber J et al. J Bone Miner Res. 2020 Jan 28. doi: 10.1002/jbmr.3962.
Women with osteoporosis who received a single infusion of zoledronate after discontinuing denosumab (Prolia) maintained bone mineral density at both the lumbar spine and the total hip, based on data from 120 individuals.
Although denosumab is often prescribed for postmenopausal osteoporosis, its effects disappear when treatment ends, wrote Judith Everts-Graber, MD, of OsteoRheuma Bern (Switzerland), and colleagues. In addition, recent reports of increased fractures in osteoporotic women after denosumab discontinuation highlight the need for subsequent therapy, but no protocol has been established.
In a study published in the Journal of Bone and Mineral Research, the investigators reviewed data from women aged older than 48 years with postmenopausal osteoporosis who were treated with denosumab between Aug. 1, 2010, and March 31, 2019. The women received four or more injections of 60 mg denosumab administered at 6-month intervals, followed by a single infusion of 5 mg zoledronate 6 months after the final denosumab injection. Patients were evaluated using dual-energy x-ray absorptiometry and vertebral fracture assessment every 2 years after starting denosumab; the average duration of treatment was 3 years.
At an average of 2.5 years after discontinuing denosumab, women who received zoledronate retained 66% of bone mineral density (BMD) gains at the lumbar spine, 49% at the total hip, and 57% at the femoral neck. In addition, three patients developed symptomatic single vertebral fractures and four patients developed peripheral fractures between 1 and 3 years after their last denosumab injections, but none of these patients sustained multiple fractures.
All bone loss occurred within 18 months of denosumab discontinuation, and no significant differences appeared between patients with gains in BMD greater than or less than 9%.
The study findings were limited by several factors, including the retrospective design and the lack of a control group, the researchers noted. However, they collected data from 11 of 28 patients who did not follow the treatment recommendations and did not receive zoledronate after discontinuing denosumab. “As expected, BMD of the lumbar spine and total hip decreased to baseline,” they wrote. In addition, 2 of the 11 patients experienced multiple vertebral fractures.
A single 5-mg infusion of zoledronate “may be a promising step in identifying sequential long-term treatment strategies for osteoporosis,” the researchers concluded. “Nevertheless, each patient requires an individualized surveillance and treatment plan after denosumab discontinuation, including BMD assessment, evaluation of bone turnover markers and consideration of individual clinical risk factors, in particular prevalent fragility fractures.”
The study was funded by OsteoRheuma Bern. The researchers reported having no financial conflicts.
SOURCE: Everts-Graber J et al. J Bone Miner Res. 2020 Jan 28. doi: 10.1002/jbmr.3962.
Women with osteoporosis who received a single infusion of zoledronate after discontinuing denosumab (Prolia) maintained bone mineral density at both the lumbar spine and the total hip, based on data from 120 individuals.
Although denosumab is often prescribed for postmenopausal osteoporosis, its effects disappear when treatment ends, wrote Judith Everts-Graber, MD, of OsteoRheuma Bern (Switzerland), and colleagues. In addition, recent reports of increased fractures in osteoporotic women after denosumab discontinuation highlight the need for subsequent therapy, but no protocol has been established.
In a study published in the Journal of Bone and Mineral Research, the investigators reviewed data from women aged older than 48 years with postmenopausal osteoporosis who were treated with denosumab between Aug. 1, 2010, and March 31, 2019. The women received four or more injections of 60 mg denosumab administered at 6-month intervals, followed by a single infusion of 5 mg zoledronate 6 months after the final denosumab injection. Patients were evaluated using dual-energy x-ray absorptiometry and vertebral fracture assessment every 2 years after starting denosumab; the average duration of treatment was 3 years.
At an average of 2.5 years after discontinuing denosumab, women who received zoledronate retained 66% of bone mineral density (BMD) gains at the lumbar spine, 49% at the total hip, and 57% at the femoral neck. In addition, three patients developed symptomatic single vertebral fractures and four patients developed peripheral fractures between 1 and 3 years after their last denosumab injections, but none of these patients sustained multiple fractures.
All bone loss occurred within 18 months of denosumab discontinuation, and no significant differences appeared between patients with gains in BMD greater than or less than 9%.
The study findings were limited by several factors, including the retrospective design and the lack of a control group, the researchers noted. However, they collected data from 11 of 28 patients who did not follow the treatment recommendations and did not receive zoledronate after discontinuing denosumab. “As expected, BMD of the lumbar spine and total hip decreased to baseline,” they wrote. In addition, 2 of the 11 patients experienced multiple vertebral fractures.
A single 5-mg infusion of zoledronate “may be a promising step in identifying sequential long-term treatment strategies for osteoporosis,” the researchers concluded. “Nevertheless, each patient requires an individualized surveillance and treatment plan after denosumab discontinuation, including BMD assessment, evaluation of bone turnover markers and consideration of individual clinical risk factors, in particular prevalent fragility fractures.”
The study was funded by OsteoRheuma Bern. The researchers reported having no financial conflicts.
SOURCE: Everts-Graber J et al. J Bone Miner Res. 2020 Jan 28. doi: 10.1002/jbmr.3962.
FROM THE JOURNAL OF BONE AND MINERAL RESEARCH
Lasers expunge mucosal tattoos
, researchers reported.
Mucocutaneous tattoos are relatively rare, and lasers have been used for their removal, but cases and results have not been well documented, wrote Hao Feng, MD, then of the Laser & Skin Surgery Center of New York, and the department of dermatology, New York University, and coauthors.
In a report published in Lasers in Surgery and Medicine, the clinicians noted significant improvement with no scarring or dyspigmentation at 1 month after the last treatment session in two patients, with mucosal tattoos that had not been previously treated.
In one case, a healthy 19-year-old woman with Fitzpatrick skin type II presented for removal of a 6‐month‐old, black tattoo on the mucosal surface of her lower lip. She received six treatment sessions at months 0, 1, 3, 5, 7, and 12 with a QS 694‐nm ruby laser at settings of 6-mm spot size, 20-nanosecond pulse duration, and 3.0-3.5 J/cm2.
In a second case, a 30‐year‐old man with Fitzpatrick skin type IV presented for removal of a 10‐year‐old black tattoo on his left buccal mucosa. He received one treatment with 755-nm alexandrite picosecond lasers at settings of 2.5-mm spot size, 500-picosecond pulse duration, and 3.36 J/cm2.
Both patients experienced local mild discomfort, erythema, and edema after treatment.
“Older tattoos respond better and quicker on the skin to laser treatments, and it is likely the reason why the buccal mucosa tattoo (10 years) resolved with a single treatment whereas the lower lip tattoo (6 months) required six treatments,” the authors noted.
Mucosal tattoos, they added, “tend to respond better, faster, and with less unwanted side effects than tattoos on the skin. This may relate to the fact that mucosal skin is thinner, non-keratinized, well‐vascularized, and contains less melanin content.”
As to which laser is the best choice for removing mucosal tattoos, the authors noted that it is unclear, but while they said they have been using picosecond lasers for tattoo removals, QS lasers “remain excellent treatment modalities,” they wrote.
“Given the excellent clinical response combined with lack of scarring and dyspigmentation in our highly satisfied patients, it is the authors’ opinion that laser treatment should be considered as the first‐line treatment in removing unwanted cosmetic mucosal tattoos. This can be accomplished with various wavelengths in the picosecond and nanosecond domains,” they concluded.
Dr. Feng, who is now director of laser surgery and cosmetic dermatology at the University of Connecticut Health Center, Farmington, disclosed serving as a consultant and medical monitor for Cytrellis Biosystems. Another author disclosed serving on the advisory boards for Cytrellis, Syneron Candela, and Cynosure; owning stocks or having stock options with Cytrellis; and investing in Syneron Candela, Cynosure, and Cytrellis. The remaining two authors had no disclosures.
SOURCE: Feng H et al. Lasers Surg Med. 2019 Dec 30. doi: 10.1002/lsm.23207.
, researchers reported.
Mucocutaneous tattoos are relatively rare, and lasers have been used for their removal, but cases and results have not been well documented, wrote Hao Feng, MD, then of the Laser & Skin Surgery Center of New York, and the department of dermatology, New York University, and coauthors.
In a report published in Lasers in Surgery and Medicine, the clinicians noted significant improvement with no scarring or dyspigmentation at 1 month after the last treatment session in two patients, with mucosal tattoos that had not been previously treated.
In one case, a healthy 19-year-old woman with Fitzpatrick skin type II presented for removal of a 6‐month‐old, black tattoo on the mucosal surface of her lower lip. She received six treatment sessions at months 0, 1, 3, 5, 7, and 12 with a QS 694‐nm ruby laser at settings of 6-mm spot size, 20-nanosecond pulse duration, and 3.0-3.5 J/cm2.
In a second case, a 30‐year‐old man with Fitzpatrick skin type IV presented for removal of a 10‐year‐old black tattoo on his left buccal mucosa. He received one treatment with 755-nm alexandrite picosecond lasers at settings of 2.5-mm spot size, 500-picosecond pulse duration, and 3.36 J/cm2.
Both patients experienced local mild discomfort, erythema, and edema after treatment.
“Older tattoos respond better and quicker on the skin to laser treatments, and it is likely the reason why the buccal mucosa tattoo (10 years) resolved with a single treatment whereas the lower lip tattoo (6 months) required six treatments,” the authors noted.
Mucosal tattoos, they added, “tend to respond better, faster, and with less unwanted side effects than tattoos on the skin. This may relate to the fact that mucosal skin is thinner, non-keratinized, well‐vascularized, and contains less melanin content.”
As to which laser is the best choice for removing mucosal tattoos, the authors noted that it is unclear, but while they said they have been using picosecond lasers for tattoo removals, QS lasers “remain excellent treatment modalities,” they wrote.
“Given the excellent clinical response combined with lack of scarring and dyspigmentation in our highly satisfied patients, it is the authors’ opinion that laser treatment should be considered as the first‐line treatment in removing unwanted cosmetic mucosal tattoos. This can be accomplished with various wavelengths in the picosecond and nanosecond domains,” they concluded.
Dr. Feng, who is now director of laser surgery and cosmetic dermatology at the University of Connecticut Health Center, Farmington, disclosed serving as a consultant and medical monitor for Cytrellis Biosystems. Another author disclosed serving on the advisory boards for Cytrellis, Syneron Candela, and Cynosure; owning stocks or having stock options with Cytrellis; and investing in Syneron Candela, Cynosure, and Cytrellis. The remaining two authors had no disclosures.
SOURCE: Feng H et al. Lasers Surg Med. 2019 Dec 30. doi: 10.1002/lsm.23207.
, researchers reported.
Mucocutaneous tattoos are relatively rare, and lasers have been used for their removal, but cases and results have not been well documented, wrote Hao Feng, MD, then of the Laser & Skin Surgery Center of New York, and the department of dermatology, New York University, and coauthors.
In a report published in Lasers in Surgery and Medicine, the clinicians noted significant improvement with no scarring or dyspigmentation at 1 month after the last treatment session in two patients, with mucosal tattoos that had not been previously treated.
In one case, a healthy 19-year-old woman with Fitzpatrick skin type II presented for removal of a 6‐month‐old, black tattoo on the mucosal surface of her lower lip. She received six treatment sessions at months 0, 1, 3, 5, 7, and 12 with a QS 694‐nm ruby laser at settings of 6-mm spot size, 20-nanosecond pulse duration, and 3.0-3.5 J/cm2.
In a second case, a 30‐year‐old man with Fitzpatrick skin type IV presented for removal of a 10‐year‐old black tattoo on his left buccal mucosa. He received one treatment with 755-nm alexandrite picosecond lasers at settings of 2.5-mm spot size, 500-picosecond pulse duration, and 3.36 J/cm2.
Both patients experienced local mild discomfort, erythema, and edema after treatment.
“Older tattoos respond better and quicker on the skin to laser treatments, and it is likely the reason why the buccal mucosa tattoo (10 years) resolved with a single treatment whereas the lower lip tattoo (6 months) required six treatments,” the authors noted.
Mucosal tattoos, they added, “tend to respond better, faster, and with less unwanted side effects than tattoos on the skin. This may relate to the fact that mucosal skin is thinner, non-keratinized, well‐vascularized, and contains less melanin content.”
As to which laser is the best choice for removing mucosal tattoos, the authors noted that it is unclear, but while they said they have been using picosecond lasers for tattoo removals, QS lasers “remain excellent treatment modalities,” they wrote.
“Given the excellent clinical response combined with lack of scarring and dyspigmentation in our highly satisfied patients, it is the authors’ opinion that laser treatment should be considered as the first‐line treatment in removing unwanted cosmetic mucosal tattoos. This can be accomplished with various wavelengths in the picosecond and nanosecond domains,” they concluded.
Dr. Feng, who is now director of laser surgery and cosmetic dermatology at the University of Connecticut Health Center, Farmington, disclosed serving as a consultant and medical monitor for Cytrellis Biosystems. Another author disclosed serving on the advisory boards for Cytrellis, Syneron Candela, and Cynosure; owning stocks or having stock options with Cytrellis; and investing in Syneron Candela, Cynosure, and Cytrellis. The remaining two authors had no disclosures.
SOURCE: Feng H et al. Lasers Surg Med. 2019 Dec 30. doi: 10.1002/lsm.23207.
FROM LASERS IN SURGERY AND MEDICINE
FFR use nearly halved 1-year mortality risk in ischemic heart disease
Use of fractional flow reserve significantly improved 1-year mortality rates in adults with stable ischemic heart disease, according to a review of 17,989 patients.
Although fractional flow reserve (FFR) has demonstrated value in guiding coronary revascularization, its impact on outcomes in patients with stable ischemic heart disease has not been well studied in a large population, wrote Rushi V. Parikh, MD, of the University of California, Los Angeles, and colleagues.
In a study published in the Journal of the American College of Cardiology, the researchers analyzed data from the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program for adults who underwent coronary angiography between January 2009 and September 2017. The study included patients with angiographically intermediate disease, defined as 40%-69% diameter stenosis on visual inspection.
The rate of FFR use increased from 14.8% to 18.5% during the study period for all patients with intermediate lesions, and from 44% to 75% for those who had percutaneous coronary intervention, the researchers wrote.
Overall, based on hazard models, 1-year mortality was significantly lower in patients who underwent FFR, compared with those who had angiography only (2.8% vs. 5.9%; P less than 0.001). In addition, FFR use in revascularization was associated with a 43% reduced 1-year mortality risk, compared with angiography only.
The findings were limited by several factors, including the observational nature of the study, inability to distinguish between cardiovascular and noncardiovascular mortality, lack of data on the technical performance of the FFR, and a relatively short follow-up period, the researchers noted.
However, the results were strengthened by the large sample size, and support the use of FFR-guided revascularization in patients with angiographically intermediate stenosis, they wrote.
“Future registry-based studies accounting for all physiologic modalities are warranted to accurately quantify the landscape of coronary physiology-guided revascularization,” they added.
The study was supported in part by the Rocky Mountain Regional VA Medical Center in Aurora, Colo. Lead author Dr. Parikh had no financial conflicts to disclose.
SOURCE: Parikh RV et al. J Am Coll Cardiol. 2020 Feb 4;75:409-19.
Although the study suggests that the use of fractional flow reserve (FFR) has increased, it remains underused despite evidence and recommendations, wrote Julien Adjedj, MD, and Benoit Guillon, MD, in an accompanying editorial (J Am Coll Cardiol. 2020 Feb 4;75:420-1).
“Of course, time, cost, and need for hyperemia are often perceived as stumbling blocks. Yet, the real question is whether the cardiology community – not only interventional cardiologists – has truly adopted FFR (i.e., using it routinely and treating according to the results),” they wrote.
The editorialists noted that, in this study, typical predictors of FFR included younger age, multivessel or left main disease, previous history of percutaneous coronary intervention, no heart failure, and higher left ventricular ejection fraction.
“However, neither the absence of documented ischemia nor the presence of symptoms influenced the use of FFR. Significant site-level variation in FFR was observed,” they wrote. “This important finding suggests that the main reason for FFR underutilization in the contemporary era is operator belief regarding the utility of coronary physiology, and that revised reimbursement policies and additional education/training may not have a meaningful impact on FFR adoption.”
The editorialists emphasized that, although FFR use has increased, the findings of a significant decrease in mortality support additional use of FFR “and good reasons to do so.”
Dr. Adjedj is affiliated with the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, and had no financial conflicts to disclose. Dr. Guillon is affiliated with the University Hospital Jean Minjoz in Besançon, France, and disclosed a grant from Sanofi and participation in a conference for Abbott.
Although the study suggests that the use of fractional flow reserve (FFR) has increased, it remains underused despite evidence and recommendations, wrote Julien Adjedj, MD, and Benoit Guillon, MD, in an accompanying editorial (J Am Coll Cardiol. 2020 Feb 4;75:420-1).
“Of course, time, cost, and need for hyperemia are often perceived as stumbling blocks. Yet, the real question is whether the cardiology community – not only interventional cardiologists – has truly adopted FFR (i.e., using it routinely and treating according to the results),” they wrote.
The editorialists noted that, in this study, typical predictors of FFR included younger age, multivessel or left main disease, previous history of percutaneous coronary intervention, no heart failure, and higher left ventricular ejection fraction.
“However, neither the absence of documented ischemia nor the presence of symptoms influenced the use of FFR. Significant site-level variation in FFR was observed,” they wrote. “This important finding suggests that the main reason for FFR underutilization in the contemporary era is operator belief regarding the utility of coronary physiology, and that revised reimbursement policies and additional education/training may not have a meaningful impact on FFR adoption.”
The editorialists emphasized that, although FFR use has increased, the findings of a significant decrease in mortality support additional use of FFR “and good reasons to do so.”
Dr. Adjedj is affiliated with the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, and had no financial conflicts to disclose. Dr. Guillon is affiliated with the University Hospital Jean Minjoz in Besançon, France, and disclosed a grant from Sanofi and participation in a conference for Abbott.
Although the study suggests that the use of fractional flow reserve (FFR) has increased, it remains underused despite evidence and recommendations, wrote Julien Adjedj, MD, and Benoit Guillon, MD, in an accompanying editorial (J Am Coll Cardiol. 2020 Feb 4;75:420-1).
“Of course, time, cost, and need for hyperemia are often perceived as stumbling blocks. Yet, the real question is whether the cardiology community – not only interventional cardiologists – has truly adopted FFR (i.e., using it routinely and treating according to the results),” they wrote.
The editorialists noted that, in this study, typical predictors of FFR included younger age, multivessel or left main disease, previous history of percutaneous coronary intervention, no heart failure, and higher left ventricular ejection fraction.
“However, neither the absence of documented ischemia nor the presence of symptoms influenced the use of FFR. Significant site-level variation in FFR was observed,” they wrote. “This important finding suggests that the main reason for FFR underutilization in the contemporary era is operator belief regarding the utility of coronary physiology, and that revised reimbursement policies and additional education/training may not have a meaningful impact on FFR adoption.”
The editorialists emphasized that, although FFR use has increased, the findings of a significant decrease in mortality support additional use of FFR “and good reasons to do so.”
Dr. Adjedj is affiliated with the Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, and had no financial conflicts to disclose. Dr. Guillon is affiliated with the University Hospital Jean Minjoz in Besançon, France, and disclosed a grant from Sanofi and participation in a conference for Abbott.
Use of fractional flow reserve significantly improved 1-year mortality rates in adults with stable ischemic heart disease, according to a review of 17,989 patients.
Although fractional flow reserve (FFR) has demonstrated value in guiding coronary revascularization, its impact on outcomes in patients with stable ischemic heart disease has not been well studied in a large population, wrote Rushi V. Parikh, MD, of the University of California, Los Angeles, and colleagues.
In a study published in the Journal of the American College of Cardiology, the researchers analyzed data from the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program for adults who underwent coronary angiography between January 2009 and September 2017. The study included patients with angiographically intermediate disease, defined as 40%-69% diameter stenosis on visual inspection.
The rate of FFR use increased from 14.8% to 18.5% during the study period for all patients with intermediate lesions, and from 44% to 75% for those who had percutaneous coronary intervention, the researchers wrote.
Overall, based on hazard models, 1-year mortality was significantly lower in patients who underwent FFR, compared with those who had angiography only (2.8% vs. 5.9%; P less than 0.001). In addition, FFR use in revascularization was associated with a 43% reduced 1-year mortality risk, compared with angiography only.
The findings were limited by several factors, including the observational nature of the study, inability to distinguish between cardiovascular and noncardiovascular mortality, lack of data on the technical performance of the FFR, and a relatively short follow-up period, the researchers noted.
However, the results were strengthened by the large sample size, and support the use of FFR-guided revascularization in patients with angiographically intermediate stenosis, they wrote.
“Future registry-based studies accounting for all physiologic modalities are warranted to accurately quantify the landscape of coronary physiology-guided revascularization,” they added.
The study was supported in part by the Rocky Mountain Regional VA Medical Center in Aurora, Colo. Lead author Dr. Parikh had no financial conflicts to disclose.
SOURCE: Parikh RV et al. J Am Coll Cardiol. 2020 Feb 4;75:409-19.
Use of fractional flow reserve significantly improved 1-year mortality rates in adults with stable ischemic heart disease, according to a review of 17,989 patients.
Although fractional flow reserve (FFR) has demonstrated value in guiding coronary revascularization, its impact on outcomes in patients with stable ischemic heart disease has not been well studied in a large population, wrote Rushi V. Parikh, MD, of the University of California, Los Angeles, and colleagues.
In a study published in the Journal of the American College of Cardiology, the researchers analyzed data from the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program for adults who underwent coronary angiography between January 2009 and September 2017. The study included patients with angiographically intermediate disease, defined as 40%-69% diameter stenosis on visual inspection.
The rate of FFR use increased from 14.8% to 18.5% during the study period for all patients with intermediate lesions, and from 44% to 75% for those who had percutaneous coronary intervention, the researchers wrote.
Overall, based on hazard models, 1-year mortality was significantly lower in patients who underwent FFR, compared with those who had angiography only (2.8% vs. 5.9%; P less than 0.001). In addition, FFR use in revascularization was associated with a 43% reduced 1-year mortality risk, compared with angiography only.
The findings were limited by several factors, including the observational nature of the study, inability to distinguish between cardiovascular and noncardiovascular mortality, lack of data on the technical performance of the FFR, and a relatively short follow-up period, the researchers noted.
However, the results were strengthened by the large sample size, and support the use of FFR-guided revascularization in patients with angiographically intermediate stenosis, they wrote.
“Future registry-based studies accounting for all physiologic modalities are warranted to accurately quantify the landscape of coronary physiology-guided revascularization,” they added.
The study was supported in part by the Rocky Mountain Regional VA Medical Center in Aurora, Colo. Lead author Dr. Parikh had no financial conflicts to disclose.
SOURCE: Parikh RV et al. J Am Coll Cardiol. 2020 Feb 4;75:409-19.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point: Use of fractional flow reserve to assist in revascularization significantly reduced the 1-year mortality risk in patients with stable ischemic heart disease.
Major finding:
Study details: The data come from a review of 17,989 patients who underwent coronary angiography during 2009-2017.
Disclosures: The study was supported in part by the Rocky Mountain Regional Veterans Affairs Medical Center in Aurora, Colo. Lead author Dr. Parikh had no financial conflicts to disclose.
Source: Parikh RV et al. J Am Coll Cardiol. 2020 Feb 4;75:409-19.
Core behaviors enhance communication about neonatal death
Clinicians can improve communications with parents during neonatal end-of-life situations by adopting key behaviors such as sitting down to talk to parents and using the infant’s name, according to data from a simulation study.
“Empirical evidence regarding communication with parents during and after a child’s critical instability or death is scarce,” wrote Marie-Hélène Lizotte, MD, of Centre Hospitalier Universitaire Sainte-Justine, Montréal, and colleagues. Noting that realistic simulation has been shown to help clinicians improve their communication skills, the investigators recruited clinicians to participate in a simulated unsuccessful neonatal resuscitation to identify behaviors associated with optimal parent communication.
Behaviors associated with high scores for clinicians deemed “good communicators” included introducing themselves to parents, using the infant’s name (if known), sitting down to speak to parents, not leaving the infant alone on the bed after death, and allowing time for silence, the researchers reported in Pediatrics.
The investigators presented the video simulations to evaluators, including clinicians and bereaved parents. In the simulation, a term infant was born after an emergency cesarean delivery for fetal distress and died after an unsuccessful attempt at resuscitation. A manikin infant was programmed to remain pulseless, and two actors played the roles of the parents in the video.
Evaluators scored the videos for overall performance and for communication with the parent actors during and after the resuscitation.
Overall, parent evaluators and parent actors agreed with clinicians on what actions exemplified optimal communication in about 81% of evaluations. Discrepancies were mainly related to the language participants used related to death, as some parent evaluators said they had trouble understanding certain sentences or found them insensitive, such as “her heart never came back” and “allowing natural death.”
A total of 31 participants were recruited for the simulation, including 15 pediatric residents, 5 neonatal fellows, 3 neonatologists, 3 neonatal nurse practitioners, and 5 transport and resuscitation team providers. Videos of the simulations were examined by 21 evaluators, including bereaved parents, the parent actors, a neonatologist, a maternal-fetal medicine specialist, a psychologist, and a respiratory therapist. There were 651 evaluations.
The study findings were limited by several factors including the use of a single center, use of videos for evaluations, and the use of a single infant-resuscitation scenario, the researchers noted. The results were strengthened, however, by the large number of evaluations, and they support the core behaviors as “a skeleton on which to build additional skills with practice and training” with attention to cultural differences in their application, such as recognizing that infants are not named until after birth in some cultures, they said.
The existing literature on strategies for providing empathy and support to parents facing the death of a child is limited, but this simulation study provides a design model to help address this issue, Chris Feudtner, MD, of the Children’s Hospital of Philadelphia wrote in an accompanying editorial. “Overall, this study, in terms of design and methodologic rigor, is a great advance toward answering our key question: how to best support parents in such circumstances,” he said.
Dr. Feudtner said that he would divide the clinician behaviors into two groups. The first, “Calm kind politeness,” includes acknowledging the parents, introducing themselves, using the infant’s name, and remaining calm. The second set of behaviors, which he called “Skillful situational leadership,” includes preparing parents for the resuscitation activities and providing verbal milestones that prepared them for the fatal outcome.
“Picking up on a metaphor offered by the authors of the study, training and repetitive drills on these specific behaviors cannot be emphasized enough because they are not only the skeleton of excellent communication; they are likely also the muscles, the heart, and even the soul,” he concluded.
The study was supported by a grant from the Fonds de Recherche en Santé du Québec and the Medical Education Grant from Centre Hospitalier Universitaire Sainte-Justine. The researchers and Dr. Feudtner reported no financial conflicts.
SOURCE: Lizotte M-H et al. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-1925; Feudtner C. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-3116.
Clinicians can improve communications with parents during neonatal end-of-life situations by adopting key behaviors such as sitting down to talk to parents and using the infant’s name, according to data from a simulation study.
“Empirical evidence regarding communication with parents during and after a child’s critical instability or death is scarce,” wrote Marie-Hélène Lizotte, MD, of Centre Hospitalier Universitaire Sainte-Justine, Montréal, and colleagues. Noting that realistic simulation has been shown to help clinicians improve their communication skills, the investigators recruited clinicians to participate in a simulated unsuccessful neonatal resuscitation to identify behaviors associated with optimal parent communication.
Behaviors associated with high scores for clinicians deemed “good communicators” included introducing themselves to parents, using the infant’s name (if known), sitting down to speak to parents, not leaving the infant alone on the bed after death, and allowing time for silence, the researchers reported in Pediatrics.
The investigators presented the video simulations to evaluators, including clinicians and bereaved parents. In the simulation, a term infant was born after an emergency cesarean delivery for fetal distress and died after an unsuccessful attempt at resuscitation. A manikin infant was programmed to remain pulseless, and two actors played the roles of the parents in the video.
Evaluators scored the videos for overall performance and for communication with the parent actors during and after the resuscitation.
Overall, parent evaluators and parent actors agreed with clinicians on what actions exemplified optimal communication in about 81% of evaluations. Discrepancies were mainly related to the language participants used related to death, as some parent evaluators said they had trouble understanding certain sentences or found them insensitive, such as “her heart never came back” and “allowing natural death.”
A total of 31 participants were recruited for the simulation, including 15 pediatric residents, 5 neonatal fellows, 3 neonatologists, 3 neonatal nurse practitioners, and 5 transport and resuscitation team providers. Videos of the simulations were examined by 21 evaluators, including bereaved parents, the parent actors, a neonatologist, a maternal-fetal medicine specialist, a psychologist, and a respiratory therapist. There were 651 evaluations.
The study findings were limited by several factors including the use of a single center, use of videos for evaluations, and the use of a single infant-resuscitation scenario, the researchers noted. The results were strengthened, however, by the large number of evaluations, and they support the core behaviors as “a skeleton on which to build additional skills with practice and training” with attention to cultural differences in their application, such as recognizing that infants are not named until after birth in some cultures, they said.
The existing literature on strategies for providing empathy and support to parents facing the death of a child is limited, but this simulation study provides a design model to help address this issue, Chris Feudtner, MD, of the Children’s Hospital of Philadelphia wrote in an accompanying editorial. “Overall, this study, in terms of design and methodologic rigor, is a great advance toward answering our key question: how to best support parents in such circumstances,” he said.
Dr. Feudtner said that he would divide the clinician behaviors into two groups. The first, “Calm kind politeness,” includes acknowledging the parents, introducing themselves, using the infant’s name, and remaining calm. The second set of behaviors, which he called “Skillful situational leadership,” includes preparing parents for the resuscitation activities and providing verbal milestones that prepared them for the fatal outcome.
“Picking up on a metaphor offered by the authors of the study, training and repetitive drills on these specific behaviors cannot be emphasized enough because they are not only the skeleton of excellent communication; they are likely also the muscles, the heart, and even the soul,” he concluded.
The study was supported by a grant from the Fonds de Recherche en Santé du Québec and the Medical Education Grant from Centre Hospitalier Universitaire Sainte-Justine. The researchers and Dr. Feudtner reported no financial conflicts.
SOURCE: Lizotte M-H et al. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-1925; Feudtner C. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-3116.
Clinicians can improve communications with parents during neonatal end-of-life situations by adopting key behaviors such as sitting down to talk to parents and using the infant’s name, according to data from a simulation study.
“Empirical evidence regarding communication with parents during and after a child’s critical instability or death is scarce,” wrote Marie-Hélène Lizotte, MD, of Centre Hospitalier Universitaire Sainte-Justine, Montréal, and colleagues. Noting that realistic simulation has been shown to help clinicians improve their communication skills, the investigators recruited clinicians to participate in a simulated unsuccessful neonatal resuscitation to identify behaviors associated with optimal parent communication.
Behaviors associated with high scores for clinicians deemed “good communicators” included introducing themselves to parents, using the infant’s name (if known), sitting down to speak to parents, not leaving the infant alone on the bed after death, and allowing time for silence, the researchers reported in Pediatrics.
The investigators presented the video simulations to evaluators, including clinicians and bereaved parents. In the simulation, a term infant was born after an emergency cesarean delivery for fetal distress and died after an unsuccessful attempt at resuscitation. A manikin infant was programmed to remain pulseless, and two actors played the roles of the parents in the video.
Evaluators scored the videos for overall performance and for communication with the parent actors during and after the resuscitation.
Overall, parent evaluators and parent actors agreed with clinicians on what actions exemplified optimal communication in about 81% of evaluations. Discrepancies were mainly related to the language participants used related to death, as some parent evaluators said they had trouble understanding certain sentences or found them insensitive, such as “her heart never came back” and “allowing natural death.”
A total of 31 participants were recruited for the simulation, including 15 pediatric residents, 5 neonatal fellows, 3 neonatologists, 3 neonatal nurse practitioners, and 5 transport and resuscitation team providers. Videos of the simulations were examined by 21 evaluators, including bereaved parents, the parent actors, a neonatologist, a maternal-fetal medicine specialist, a psychologist, and a respiratory therapist. There were 651 evaluations.
The study findings were limited by several factors including the use of a single center, use of videos for evaluations, and the use of a single infant-resuscitation scenario, the researchers noted. The results were strengthened, however, by the large number of evaluations, and they support the core behaviors as “a skeleton on which to build additional skills with practice and training” with attention to cultural differences in their application, such as recognizing that infants are not named until after birth in some cultures, they said.
The existing literature on strategies for providing empathy and support to parents facing the death of a child is limited, but this simulation study provides a design model to help address this issue, Chris Feudtner, MD, of the Children’s Hospital of Philadelphia wrote in an accompanying editorial. “Overall, this study, in terms of design and methodologic rigor, is a great advance toward answering our key question: how to best support parents in such circumstances,” he said.
Dr. Feudtner said that he would divide the clinician behaviors into two groups. The first, “Calm kind politeness,” includes acknowledging the parents, introducing themselves, using the infant’s name, and remaining calm. The second set of behaviors, which he called “Skillful situational leadership,” includes preparing parents for the resuscitation activities and providing verbal milestones that prepared them for the fatal outcome.
“Picking up on a metaphor offered by the authors of the study, training and repetitive drills on these specific behaviors cannot be emphasized enough because they are not only the skeleton of excellent communication; they are likely also the muscles, the heart, and even the soul,” he concluded.
The study was supported by a grant from the Fonds de Recherche en Santé du Québec and the Medical Education Grant from Centre Hospitalier Universitaire Sainte-Justine. The researchers and Dr. Feudtner reported no financial conflicts.
SOURCE: Lizotte M-H et al. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-1925; Feudtner C. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-3116.
FROM PEDIATRICS
Key clinical point: Clinicians who took steps such as sitting down and using the infant’s name were seen by parents as good communicators.
Major finding: Evaluators of a simulation agreed 81% of the time on defining optimal communication.
Study details: The data come from a simulation study of 31 participants and 21 evaluators and a total of 651 evaluations.
Disclosures: The study was supported in part by the Fonds de Recherche en Santé du Québec and the Medical Education Grant from Centre Hospitalier Universitaire Sainte-Justine. The researchers and editorialist said they had no financial conflicts.
Source: Lizotte M-H et al. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-1925; Feudtner C. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-3116.
EVALI update warns of chemicals in vaping products
A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).
Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.
“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.
In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.
Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.
The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.
The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.
Nicotine-only vaping products
In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.
A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.
In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).
Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.
The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.
In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.
The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.
SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.
A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).
Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.
“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.
In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.
Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.
The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.
The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.
Nicotine-only vaping products
In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.
A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.
In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).
Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.
The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.
In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.
The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.
SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.
A report issued by the Centers for Disease Control and Prevention confirms that 82% of patients presenting with e-cigarette– or vaping product use–associated lung injury (EVALI) used products containing tetrahydrocannabinol (THC).
Another report published in the CDC’s Morbidity and Mortality Weekly Report assessed cases in which the patients reported using only nicotine-containing vaping products.
“As of Jan. 14, 2020, a total of 2,668 hospitalized EVALI cases had been reported to CDC,” based on data from the National Syndromic Surveillance Program (NSSP), wrote Vikram P. Krishnasamy, MD, of the National Center for Injury Prevention and Control at the CDC, Atlanta, and colleagues. Cases have occurred in all 50 states, the District of Columbia, the U.S. Virgin Islands, and Puerto Rico. The age of the patients ranged from 13 to 85 years, with an average age of 24 years; 66% were male, and 73% were non-Hispanic white.
In addition, 57% of the patients reported using any nicotine-containing product, and 14% of these reported use of nicotine products exclusively.
Previous studies have shown that vitamin E acetate is associated with the EVALI outbreak, which peaked during the week of Sept. 15, 2019, with 215 reported hospital admissions, Dr. Krishnasamy and associates noted. “However, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases,” they said.
The study findings were limited by several factors, including incomplete data on product use, increased reporting of vaping product use at emergency department visits after increased public awareness of risk, and inconsistency in the health care facilities contributing data via the NSSP, the researchers wrote.
The decline in EVALI cases since September 2019 may be related to factors including the rapid public health response to increase awareness of the risks of vaping, and the possible removal of vitamin E acetate as a diluent in THC-containing products, but clinicians and public health professionals should remain on alert for new EVALI cases and continue to discourage the use of THC-containing e-cigarette or vaping products, Dr. Krishnasamy and associates concluded.
Nicotine-only vaping products
In a second report published in MMWR, Isaac Ghinai, MBBS, of the Illinois Department of Public Health and CDC researchers examined characteristics of EVALI patients in Illinois who reported using only nicotine-containing vaping products.
A total of 9 of 121 (7%) EVALI patients surveyed in Illinois reported no indication of THC use. These patients were more likely than those who reported any use of THC-containing products to be female (78% vs. 25%) and aged 45 years and older (33% vs. 2%); P less than .01 in both cases.
In addition, EVALI patients with no indication of THC-containing product use were less likely than THC product users to present with constitutional symptoms (56% vs. 96%) or initial leukocytosis (38% vs. 91%), or to have previously visited an outpatient provider or ED before being hospitalized (25% vs. 80%).
Other presenting characteristics including initial vital signs and lab results, as well as the frequency of severe outcomes such as death or respiratory failure, were not significantly different between users and nonusers of THC-containing vaping products.
The study findings were limited by factors including the use of self-reports, the small sample size, and lack of initial and follow-up interviews for all EVALI patients, the researchers noted. However, the results support the CDC’s recommendation that “persons should not use THC-containing e-cigarette, or vaping, products, particularly those obtained from informal sources such as friends, family members, or from in-person or online dealers,” and should not add vitamin E acetate or other substances to these products, they said.
In addition, users of nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not return to cigarettes, but should explore other options to help them quit, Dr. Ghinai, and associates said.
The studies were supported by the CDC. The researchers in both studies had no financial conflicts to disclose.
SOURCES: Krishnasamy VP et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e2; Ghinai I et al. MMWR Morb Mortal Wkly Rep. 17 Jan 2020. doi: 10.15585/mmwr.mm6903e1.
FROM MMWR
FDA supports sunscreen safety studies
Six active in a randomized trial including four product types. The results were published in JAMA.
The testing was done as part of a proposed rule on sunscreen, published in February 2019, which requested additional information on sunscreen ingredients. Murali K. Matta, PhD, of the Food and Drug Administration and coauthors wrote that these plasma concentrations “surpassed the FDA threshold for potentially waiving additional safety studies for sunscreens.” But, they added, the findings “do not indicate that individuals should refrain from the use of sunscreen.”
This was a follow-up study to a smaller study of 24 health volunteers published last year that determined that the sunscreen active ingredients tested were absorbed systemically (JAMA. 2019;321[21]:2082-91). “This follow-up study expanded the sample size, tested additional sunscreen active ingredients and formulations, and confirmed the finding that sunscreen active ingredients are systemically absorbed,” the authors wrote.
To gather information on the absorption of active ingredients in sunscreens, the investigators randomized 48 adults to one of four sunscreen products (lotion, aerosol spray, nonaerosol spray, or pump spray) with one of six active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate). Not all products contained each of the ingredients.
The participants applied the products in amounts of 2 mg/cm2 to 75% of body surface area at baseline, no use on day 1 and four times a day at 2-hour intervals on days 2 through 4. The researchers collected blood samples over 21 days and measured the maximum plasma concentrations. The average age of the participants was 37 years, and half were women. The study was conducted in a clinical pharmacology unit.
The geometric mean maximum plasma concentrations for the primary endpoint of avobenzone in lotion, aerosol spray, nonaerosol spray, and pump spray were 7.1 ng/mL, 3.5 ng/mL, 3.5 ng/mL, and 3.3 ng/mL, respectively.
For oxybenzone, the concentrations were 258.1 ng/mL and 180.1 ng/mL, respectively, for lotion and aerosol spray. The concentrations for octocrylene were 7.8 ng/mL, 6.6 ng/mL, and 6.6 ng/mL, respectively, for lotion, aerosol spray, and nonaerosol spray.
For homosalate, the geometric mean plasma concentrations were 23.1 ng/mL for aerosol spray, 17.9 for nonaerosol spray, and 13.9 for pump spray. For octisalate, the concentrations were 5.1 ng/mL, 5.8 ng/mL, and 4.6 ng/mL, respectively, for aerosol spray, nonaerosol spray, and pump spray. For octinoxate, the concentrations were 7.9 ng/mL for nonaerosol spray and 5.2 ng/mL for pump spray.
“The systemic exposures, as measured by geometric mean maximum plasma concentrations, of all the tested active ingredients were higher than 0.5 ng/mL after a single application,” the researchers noted.
Overall, the most common event was rash, which was reported in 14 participants.
The study findings were limited by several factors including the use of an indoor clinical setting, rather than outdoor exposure; the inability to assess absorption differences by formulation and Fitzpatrick skin type; and the variation in amounts of ingredients among products, the researchers noted. However, the results can be used to design additional studies needed to research the effects of systemic exposure to sunscreen ingredients, they said.
In an accompanying editorial (JAMA. 2020;323:223-4), Adewole S. Adamson, MD, of the University of Texas at Austin, and Kanade Shinkai, MD, of the University of California, San Francisco, wrote that “the study did not address key questions about sunscreen safety,” including the length of time it takes “for plasma concentrations of sunscreen ingredients to fall below the FDA threshold for safety testing.” Dr. Shinkai is also editor in chief of JAMA Dermatology.
“In making an informed decision, clinicians must determine whether the magnitude of the benefit exceeds the risk of potential harm for a specific individual,” they said. “Importantly, this balance may be different, depending on characteristics of the sunscreen user (e.g., for individuals with darker skin types and for children) and may depend on the frequency and duration of application (e.g., daily vs. intermittent use; starting in infancy or later in life),” they noted.
“In the absence of clear data demonstrating harm, the use of chemical sunscreen may still be considered appropriate; the use of mineral-based sunscreen is a well-established safe alternative,” although the potential harms remain uncertain until the sunscreen industry conducts the safety studies recommended by the FDA, Dr. Adamson and Dr. Shinkai concluded.
In a statement released by the FDA on Jan 21, the day the study was published, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said that, considering the “recognized public health benefits” of using sunscreen, the FDA “urges Americans to use sunscreens in conjunction with other sun protective measures (such as protective clothing).”
Commenting on the study, she said, “results from our study released today show there is evidence that some sunscreen active ingredients may be absorbed. However, the fact that an ingredient is absorbed through the skin and into the body does not mean that the ingredient is unsafe, nor does the FDA seeking further information indicate such. Rather, this finding calls for further industry testing to determine the safety and effect of systemic exposure of sunscreen ingredients, especially with chronic use.”
The study was supported by the FDA. The researchers and editorial authors had no financial conflicts to disclose.
SOURCES: Matta MK et al. JAMA. 2020;323:256-267.
Six active in a randomized trial including four product types. The results were published in JAMA.
The testing was done as part of a proposed rule on sunscreen, published in February 2019, which requested additional information on sunscreen ingredients. Murali K. Matta, PhD, of the Food and Drug Administration and coauthors wrote that these plasma concentrations “surpassed the FDA threshold for potentially waiving additional safety studies for sunscreens.” But, they added, the findings “do not indicate that individuals should refrain from the use of sunscreen.”
This was a follow-up study to a smaller study of 24 health volunteers published last year that determined that the sunscreen active ingredients tested were absorbed systemically (JAMA. 2019;321[21]:2082-91). “This follow-up study expanded the sample size, tested additional sunscreen active ingredients and formulations, and confirmed the finding that sunscreen active ingredients are systemically absorbed,” the authors wrote.
To gather information on the absorption of active ingredients in sunscreens, the investigators randomized 48 adults to one of four sunscreen products (lotion, aerosol spray, nonaerosol spray, or pump spray) with one of six active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate). Not all products contained each of the ingredients.
The participants applied the products in amounts of 2 mg/cm2 to 75% of body surface area at baseline, no use on day 1 and four times a day at 2-hour intervals on days 2 through 4. The researchers collected blood samples over 21 days and measured the maximum plasma concentrations. The average age of the participants was 37 years, and half were women. The study was conducted in a clinical pharmacology unit.
The geometric mean maximum plasma concentrations for the primary endpoint of avobenzone in lotion, aerosol spray, nonaerosol spray, and pump spray were 7.1 ng/mL, 3.5 ng/mL, 3.5 ng/mL, and 3.3 ng/mL, respectively.
For oxybenzone, the concentrations were 258.1 ng/mL and 180.1 ng/mL, respectively, for lotion and aerosol spray. The concentrations for octocrylene were 7.8 ng/mL, 6.6 ng/mL, and 6.6 ng/mL, respectively, for lotion, aerosol spray, and nonaerosol spray.
For homosalate, the geometric mean plasma concentrations were 23.1 ng/mL for aerosol spray, 17.9 for nonaerosol spray, and 13.9 for pump spray. For octisalate, the concentrations were 5.1 ng/mL, 5.8 ng/mL, and 4.6 ng/mL, respectively, for aerosol spray, nonaerosol spray, and pump spray. For octinoxate, the concentrations were 7.9 ng/mL for nonaerosol spray and 5.2 ng/mL for pump spray.
“The systemic exposures, as measured by geometric mean maximum plasma concentrations, of all the tested active ingredients were higher than 0.5 ng/mL after a single application,” the researchers noted.
Overall, the most common event was rash, which was reported in 14 participants.
The study findings were limited by several factors including the use of an indoor clinical setting, rather than outdoor exposure; the inability to assess absorption differences by formulation and Fitzpatrick skin type; and the variation in amounts of ingredients among products, the researchers noted. However, the results can be used to design additional studies needed to research the effects of systemic exposure to sunscreen ingredients, they said.
In an accompanying editorial (JAMA. 2020;323:223-4), Adewole S. Adamson, MD, of the University of Texas at Austin, and Kanade Shinkai, MD, of the University of California, San Francisco, wrote that “the study did not address key questions about sunscreen safety,” including the length of time it takes “for plasma concentrations of sunscreen ingredients to fall below the FDA threshold for safety testing.” Dr. Shinkai is also editor in chief of JAMA Dermatology.
“In making an informed decision, clinicians must determine whether the magnitude of the benefit exceeds the risk of potential harm for a specific individual,” they said. “Importantly, this balance may be different, depending on characteristics of the sunscreen user (e.g., for individuals with darker skin types and for children) and may depend on the frequency and duration of application (e.g., daily vs. intermittent use; starting in infancy or later in life),” they noted.
“In the absence of clear data demonstrating harm, the use of chemical sunscreen may still be considered appropriate; the use of mineral-based sunscreen is a well-established safe alternative,” although the potential harms remain uncertain until the sunscreen industry conducts the safety studies recommended by the FDA, Dr. Adamson and Dr. Shinkai concluded.
In a statement released by the FDA on Jan 21, the day the study was published, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said that, considering the “recognized public health benefits” of using sunscreen, the FDA “urges Americans to use sunscreens in conjunction with other sun protective measures (such as protective clothing).”
Commenting on the study, she said, “results from our study released today show there is evidence that some sunscreen active ingredients may be absorbed. However, the fact that an ingredient is absorbed through the skin and into the body does not mean that the ingredient is unsafe, nor does the FDA seeking further information indicate such. Rather, this finding calls for further industry testing to determine the safety and effect of systemic exposure of sunscreen ingredients, especially with chronic use.”
The study was supported by the FDA. The researchers and editorial authors had no financial conflicts to disclose.
SOURCES: Matta MK et al. JAMA. 2020;323:256-267.
Six active in a randomized trial including four product types. The results were published in JAMA.
The testing was done as part of a proposed rule on sunscreen, published in February 2019, which requested additional information on sunscreen ingredients. Murali K. Matta, PhD, of the Food and Drug Administration and coauthors wrote that these plasma concentrations “surpassed the FDA threshold for potentially waiving additional safety studies for sunscreens.” But, they added, the findings “do not indicate that individuals should refrain from the use of sunscreen.”
This was a follow-up study to a smaller study of 24 health volunteers published last year that determined that the sunscreen active ingredients tested were absorbed systemically (JAMA. 2019;321[21]:2082-91). “This follow-up study expanded the sample size, tested additional sunscreen active ingredients and formulations, and confirmed the finding that sunscreen active ingredients are systemically absorbed,” the authors wrote.
To gather information on the absorption of active ingredients in sunscreens, the investigators randomized 48 adults to one of four sunscreen products (lotion, aerosol spray, nonaerosol spray, or pump spray) with one of six active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate). Not all products contained each of the ingredients.
The participants applied the products in amounts of 2 mg/cm2 to 75% of body surface area at baseline, no use on day 1 and four times a day at 2-hour intervals on days 2 through 4. The researchers collected blood samples over 21 days and measured the maximum plasma concentrations. The average age of the participants was 37 years, and half were women. The study was conducted in a clinical pharmacology unit.
The geometric mean maximum plasma concentrations for the primary endpoint of avobenzone in lotion, aerosol spray, nonaerosol spray, and pump spray were 7.1 ng/mL, 3.5 ng/mL, 3.5 ng/mL, and 3.3 ng/mL, respectively.
For oxybenzone, the concentrations were 258.1 ng/mL and 180.1 ng/mL, respectively, for lotion and aerosol spray. The concentrations for octocrylene were 7.8 ng/mL, 6.6 ng/mL, and 6.6 ng/mL, respectively, for lotion, aerosol spray, and nonaerosol spray.
For homosalate, the geometric mean plasma concentrations were 23.1 ng/mL for aerosol spray, 17.9 for nonaerosol spray, and 13.9 for pump spray. For octisalate, the concentrations were 5.1 ng/mL, 5.8 ng/mL, and 4.6 ng/mL, respectively, for aerosol spray, nonaerosol spray, and pump spray. For octinoxate, the concentrations were 7.9 ng/mL for nonaerosol spray and 5.2 ng/mL for pump spray.
“The systemic exposures, as measured by geometric mean maximum plasma concentrations, of all the tested active ingredients were higher than 0.5 ng/mL after a single application,” the researchers noted.
Overall, the most common event was rash, which was reported in 14 participants.
The study findings were limited by several factors including the use of an indoor clinical setting, rather than outdoor exposure; the inability to assess absorption differences by formulation and Fitzpatrick skin type; and the variation in amounts of ingredients among products, the researchers noted. However, the results can be used to design additional studies needed to research the effects of systemic exposure to sunscreen ingredients, they said.
In an accompanying editorial (JAMA. 2020;323:223-4), Adewole S. Adamson, MD, of the University of Texas at Austin, and Kanade Shinkai, MD, of the University of California, San Francisco, wrote that “the study did not address key questions about sunscreen safety,” including the length of time it takes “for plasma concentrations of sunscreen ingredients to fall below the FDA threshold for safety testing.” Dr. Shinkai is also editor in chief of JAMA Dermatology.
“In making an informed decision, clinicians must determine whether the magnitude of the benefit exceeds the risk of potential harm for a specific individual,” they said. “Importantly, this balance may be different, depending on characteristics of the sunscreen user (e.g., for individuals with darker skin types and for children) and may depend on the frequency and duration of application (e.g., daily vs. intermittent use; starting in infancy or later in life),” they noted.
“In the absence of clear data demonstrating harm, the use of chemical sunscreen may still be considered appropriate; the use of mineral-based sunscreen is a well-established safe alternative,” although the potential harms remain uncertain until the sunscreen industry conducts the safety studies recommended by the FDA, Dr. Adamson and Dr. Shinkai concluded.
In a statement released by the FDA on Jan 21, the day the study was published, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said that, considering the “recognized public health benefits” of using sunscreen, the FDA “urges Americans to use sunscreens in conjunction with other sun protective measures (such as protective clothing).”
Commenting on the study, she said, “results from our study released today show there is evidence that some sunscreen active ingredients may be absorbed. However, the fact that an ingredient is absorbed through the skin and into the body does not mean that the ingredient is unsafe, nor does the FDA seeking further information indicate such. Rather, this finding calls for further industry testing to determine the safety and effect of systemic exposure of sunscreen ingredients, especially with chronic use.”
The study was supported by the FDA. The researchers and editorial authors had no financial conflicts to disclose.
SOURCES: Matta MK et al. JAMA. 2020;323:256-267.
FROM JAMA