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CUTIS Celebrates 55 Years
When the first issue of Cutis was published in February 1965:
- Alopecia was featured on the cover
- Eugene F. Traub, MD, was Chief Editor, and John T. McCarthy, MD, was Assistant Chief Editor
- The cost of a year's subscription was $10
- The editorial objective was to bring readers "in simple and concise form the latest in diagnosis, prognosis and treatment" with articles "dealing with common dermatoses or those rarer diseases of great interest"
- From the Consultant's Corner answered the question: Is diet actually important in the treatment of acne vulgaris?
To our loyal readers, contributors, and Editorial Board members, thank you for continuing to turn to Cutis for the latest in diagnosis, prognosis, and treatment.
To our new readers, we hope you find our articles in simple and concise form relevant to your practice.
To our resident readers, you are entering one of the most rewarding specialties in medicine—dermatology.
Access past issues of Cutis online.
When the first issue of Cutis was published in February 1965:
- Alopecia was featured on the cover
- Eugene F. Traub, MD, was Chief Editor, and John T. McCarthy, MD, was Assistant Chief Editor
- The cost of a year's subscription was $10
- The editorial objective was to bring readers "in simple and concise form the latest in diagnosis, prognosis and treatment" with articles "dealing with common dermatoses or those rarer diseases of great interest"
- From the Consultant's Corner answered the question: Is diet actually important in the treatment of acne vulgaris?
To our loyal readers, contributors, and Editorial Board members, thank you for continuing to turn to Cutis for the latest in diagnosis, prognosis, and treatment.
To our new readers, we hope you find our articles in simple and concise form relevant to your practice.
To our resident readers, you are entering one of the most rewarding specialties in medicine—dermatology.
Access past issues of Cutis online.
When the first issue of Cutis was published in February 1965:
- Alopecia was featured on the cover
- Eugene F. Traub, MD, was Chief Editor, and John T. McCarthy, MD, was Assistant Chief Editor
- The cost of a year's subscription was $10
- The editorial objective was to bring readers "in simple and concise form the latest in diagnosis, prognosis and treatment" with articles "dealing with common dermatoses or those rarer diseases of great interest"
- From the Consultant's Corner answered the question: Is diet actually important in the treatment of acne vulgaris?
To our loyal readers, contributors, and Editorial Board members, thank you for continuing to turn to Cutis for the latest in diagnosis, prognosis, and treatment.
To our new readers, we hope you find our articles in simple and concise form relevant to your practice.
To our resident readers, you are entering one of the most rewarding specialties in medicine—dermatology.
Access past issues of Cutis online.
2019-nCoV: Structure, characteristics of key potential therapy target determined
Researchers have identified the structure of a protein that could turn out to be a potential vaccine target for the 2019-nCoV.
As is typical of other coronaviruses, 2019-nCoV makes use of a densely glycosylated spike protein to gain entry into host cells. The spike protein is a trimeric class I fusion protein that exists in a metastable prefusion conformation that undergoes a dramatic structural rearrangement to fuse the viral membrane with the host-cell membrane, according to Daniel Wrapp of the University of Texas at Austin and colleagues.
The researchers performed a study to synthesize and determine the 3-D structure of the spike protein because it is a logical target for vaccine development and for the development of targeted therapeutics for COVID-19, the disease caused by the virus.
“As soon as we knew this was a coronavirus, we felt we had to jump at it,” senior author Jason S. McLellan, PhD, associate professor of molecular science, said in a press release from the University, “because we could be one of the first ones to get this structure. We knew exactly what mutations to put into this because we’ve already shown these mutations work for a bunch of other coronaviruses.”
Because recent reports by other researchers demonstrated that 2019-nCoV and SARS-CoV spike proteins share the same functional host-cell receptor–angiotensin-converting enzyme 2 (ACE2), Dr. McLellan and his colleagues examined the relation between the two viruses. They found biophysical and structural evidence that the 2019-nCoV spike protein binds ACE2 with higher affinity than the closely related SARS-CoV spike protein. “The high affinity of 2019-nCoV S for human ACE2 may contribute to the apparent ease with which 2019-nCoV can spread from human-to-human; however, additional studies are needed to investigate this possibility,” the researchers wrote.
Focusing their attention on the receptor-binding domain (RBD) of the 2019-nCoV spike protein, they tested several published SARS-CoV RBD-specific monoclonal antibodies against it and found that these antibodies showed no appreciable binding to 2019-nCoV spike protein, which suggests limited antibody cross-reactivity. For this reason, they suggested that future antibody isolation and therapeutic design efforts will benefit from specifically using 2019-nCoV spike proteins as probes.
“This information will support precision vaccine design and discovery of anti-viral therapeutics, accelerating medical countermeasure development,” they concluded.
The research was supported in part by an National Institutes of Health/National Institute of Allergy and Infectious Diseases grant and by intramural funding from the National Institute of Allergy and Infectious Diseases. Four authors are inventors on US patent application No. 62/412,703 (Prefusion Coronavirus Spike Proteins and Their Use) and all are inventors on US patent application No. 62/972,886 (2019-nCoV Vaccine).
SOURCE: Wrapp D et al. Science. 2020 Feb 19. doi: 10.1126/science.abb2507.
Researchers have identified the structure of a protein that could turn out to be a potential vaccine target for the 2019-nCoV.
As is typical of other coronaviruses, 2019-nCoV makes use of a densely glycosylated spike protein to gain entry into host cells. The spike protein is a trimeric class I fusion protein that exists in a metastable prefusion conformation that undergoes a dramatic structural rearrangement to fuse the viral membrane with the host-cell membrane, according to Daniel Wrapp of the University of Texas at Austin and colleagues.
The researchers performed a study to synthesize and determine the 3-D structure of the spike protein because it is a logical target for vaccine development and for the development of targeted therapeutics for COVID-19, the disease caused by the virus.
“As soon as we knew this was a coronavirus, we felt we had to jump at it,” senior author Jason S. McLellan, PhD, associate professor of molecular science, said in a press release from the University, “because we could be one of the first ones to get this structure. We knew exactly what mutations to put into this because we’ve already shown these mutations work for a bunch of other coronaviruses.”
Because recent reports by other researchers demonstrated that 2019-nCoV and SARS-CoV spike proteins share the same functional host-cell receptor–angiotensin-converting enzyme 2 (ACE2), Dr. McLellan and his colleagues examined the relation between the two viruses. They found biophysical and structural evidence that the 2019-nCoV spike protein binds ACE2 with higher affinity than the closely related SARS-CoV spike protein. “The high affinity of 2019-nCoV S for human ACE2 may contribute to the apparent ease with which 2019-nCoV can spread from human-to-human; however, additional studies are needed to investigate this possibility,” the researchers wrote.
Focusing their attention on the receptor-binding domain (RBD) of the 2019-nCoV spike protein, they tested several published SARS-CoV RBD-specific monoclonal antibodies against it and found that these antibodies showed no appreciable binding to 2019-nCoV spike protein, which suggests limited antibody cross-reactivity. For this reason, they suggested that future antibody isolation and therapeutic design efforts will benefit from specifically using 2019-nCoV spike proteins as probes.
“This information will support precision vaccine design and discovery of anti-viral therapeutics, accelerating medical countermeasure development,” they concluded.
The research was supported in part by an National Institutes of Health/National Institute of Allergy and Infectious Diseases grant and by intramural funding from the National Institute of Allergy and Infectious Diseases. Four authors are inventors on US patent application No. 62/412,703 (Prefusion Coronavirus Spike Proteins and Their Use) and all are inventors on US patent application No. 62/972,886 (2019-nCoV Vaccine).
SOURCE: Wrapp D et al. Science. 2020 Feb 19. doi: 10.1126/science.abb2507.
Researchers have identified the structure of a protein that could turn out to be a potential vaccine target for the 2019-nCoV.
As is typical of other coronaviruses, 2019-nCoV makes use of a densely glycosylated spike protein to gain entry into host cells. The spike protein is a trimeric class I fusion protein that exists in a metastable prefusion conformation that undergoes a dramatic structural rearrangement to fuse the viral membrane with the host-cell membrane, according to Daniel Wrapp of the University of Texas at Austin and colleagues.
The researchers performed a study to synthesize and determine the 3-D structure of the spike protein because it is a logical target for vaccine development and for the development of targeted therapeutics for COVID-19, the disease caused by the virus.
“As soon as we knew this was a coronavirus, we felt we had to jump at it,” senior author Jason S. McLellan, PhD, associate professor of molecular science, said in a press release from the University, “because we could be one of the first ones to get this structure. We knew exactly what mutations to put into this because we’ve already shown these mutations work for a bunch of other coronaviruses.”
Because recent reports by other researchers demonstrated that 2019-nCoV and SARS-CoV spike proteins share the same functional host-cell receptor–angiotensin-converting enzyme 2 (ACE2), Dr. McLellan and his colleagues examined the relation between the two viruses. They found biophysical and structural evidence that the 2019-nCoV spike protein binds ACE2 with higher affinity than the closely related SARS-CoV spike protein. “The high affinity of 2019-nCoV S for human ACE2 may contribute to the apparent ease with which 2019-nCoV can spread from human-to-human; however, additional studies are needed to investigate this possibility,” the researchers wrote.
Focusing their attention on the receptor-binding domain (RBD) of the 2019-nCoV spike protein, they tested several published SARS-CoV RBD-specific monoclonal antibodies against it and found that these antibodies showed no appreciable binding to 2019-nCoV spike protein, which suggests limited antibody cross-reactivity. For this reason, they suggested that future antibody isolation and therapeutic design efforts will benefit from specifically using 2019-nCoV spike proteins as probes.
“This information will support precision vaccine design and discovery of anti-viral therapeutics, accelerating medical countermeasure development,” they concluded.
The research was supported in part by an National Institutes of Health/National Institute of Allergy and Infectious Diseases grant and by intramural funding from the National Institute of Allergy and Infectious Diseases. Four authors are inventors on US patent application No. 62/412,703 (Prefusion Coronavirus Spike Proteins and Their Use) and all are inventors on US patent application No. 62/972,886 (2019-nCoV Vaccine).
SOURCE: Wrapp D et al. Science. 2020 Feb 19. doi: 10.1126/science.abb2507.
FROM SCIENCE
Multiomics blood test outperforms others for CRC
SAN FRANCISCO – A blood-based test that integrates data from multiple molecular “omes,” such as the genome and proteome, performs well at spotting early-stage colorectal cancer (CRC), the AI-EMERGE study suggests.
Moreover, the test netted better sensitivity than a fecal immunochemical test (FIT), a circulating tumor DNA (ctDNA) test, and a carcinoembryonic antigen (CEA) test.
Findings were reported in a poster session at the 2020 GI Cancers Symposium, which is cosponsored by the American Gastroenterological Association, American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology.
“Today, about a third of age-appropriate adults are not up to date with [CRC] screening,” lead study investigator Girish Putcha, MD, PhD, chief medical officer of Freenome in San Francisco, noted at the symposium. “A noninvasive blood-based screening test having high sensitivity and specificity for [CRC] generally, but especially for early-stage disease, could help improve adherence and ultimately reduce mortality.”
Dr. Putcha and colleagues evaluated a blood-based multiomics test in 32 patients with CRC of all stages and 539 colonoscopy-confirmed negative control subjects.
The test uses a multiomics platform to pick up both tumor-derived signal and non–tumor-derived signal from the body’s immune response and other sources. The test uses machine learning, and entails whole-genome sequencing, bisulfite sequencing (for assessment of DNA methylation), and protein quantification methods.
At 94% specificity, the test had a 94% sensitivity for spotting stage I and II CRC, 91% sensitivity for stage III and IV CRC, and 91% sensitivity for CRC of any stage. By location, sensitivity was 92% for distal tumors and 88% for proximal tumors.
The multiomics test outperformed a ctDNA test, a CEA test, and a FIT. At a specificity of 96% for both tests, the multiomics test yielded a higher sensitivity than a commercially available FIT stool test (OC-Auto FIT, Polymedco) for stage I and II disease (100% vs. 70%), stage III and IV disease (100% vs. 50%), and any-stage disease (100% vs. 67%).
When set at 100% specificity, the multiomics test outperformed a commercially available plasma ctDNA test (Avenio, Roche) set at 75% specificity. The multiomics test yielded a higher sensitivity for stage I and II disease (94% vs. 38%), stage III and IV disease (91% vs. 55%), and any-stage disease (90% vs. 47%).
At a specificity of 94% for both tests, the multiomics test yielded a higher sensitivity than plasma CEA level for stage I and II disease (94% vs. 18%), stage III and IV disease (91% vs. 45%), and any-stage disease (91% vs. 31%).
“Although there were many exciting aspects to this study, the test’s ability to detect cancers without loss of sensitivity for early-stage cancers was striking to me,” said Michael J. Hall, MD, of Fox Chase Cancer Center in Philadelphia, who was not involved in the study. “The loss of sensitivity in early tumors has been a limitation of other tests – FOBT [fecal occult blood test], FIT – so if this is replicable, this is exciting.”
Although the study was small for a CRC screening assessment, “the preliminary results presented in the poster were certainly compelling enough to support more research,” Dr. Hall said.
Dr. Putcha said that the test will be validated in a prospective, multicenter trial of roughly 10,000 participants at average risk, expected to open later this year. Further research will also help assess the test’s performance among patients with inflammatory bowel disease, for whom false-positive results with some screening tests have been problematic.
The study was sponsored by Freenome. Dr. Putcha is employed by Freenome and has a relationship with Palmetto GBA. Dr. Hall disclosed relationships with Ambry Genetics, AstraZeneca, Caris Life Sciences, Foundation Medicine, Invitae, and Myriad Genetics, and he shares a patent with institutional colleagues for a novel method to investigate hereditary CRC genes.
SOURCE: Putcha G et al. 2020 GI Cancers Symposium, Abstract 66.
Visit the AGA GI Patient Center for education to share with your patients about currently available CRC screenings at https://www.gastro.org/
SAN FRANCISCO – A blood-based test that integrates data from multiple molecular “omes,” such as the genome and proteome, performs well at spotting early-stage colorectal cancer (CRC), the AI-EMERGE study suggests.
Moreover, the test netted better sensitivity than a fecal immunochemical test (FIT), a circulating tumor DNA (ctDNA) test, and a carcinoembryonic antigen (CEA) test.
Findings were reported in a poster session at the 2020 GI Cancers Symposium, which is cosponsored by the American Gastroenterological Association, American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology.
“Today, about a third of age-appropriate adults are not up to date with [CRC] screening,” lead study investigator Girish Putcha, MD, PhD, chief medical officer of Freenome in San Francisco, noted at the symposium. “A noninvasive blood-based screening test having high sensitivity and specificity for [CRC] generally, but especially for early-stage disease, could help improve adherence and ultimately reduce mortality.”
Dr. Putcha and colleagues evaluated a blood-based multiomics test in 32 patients with CRC of all stages and 539 colonoscopy-confirmed negative control subjects.
The test uses a multiomics platform to pick up both tumor-derived signal and non–tumor-derived signal from the body’s immune response and other sources. The test uses machine learning, and entails whole-genome sequencing, bisulfite sequencing (for assessment of DNA methylation), and protein quantification methods.
At 94% specificity, the test had a 94% sensitivity for spotting stage I and II CRC, 91% sensitivity for stage III and IV CRC, and 91% sensitivity for CRC of any stage. By location, sensitivity was 92% for distal tumors and 88% for proximal tumors.
The multiomics test outperformed a ctDNA test, a CEA test, and a FIT. At a specificity of 96% for both tests, the multiomics test yielded a higher sensitivity than a commercially available FIT stool test (OC-Auto FIT, Polymedco) for stage I and II disease (100% vs. 70%), stage III and IV disease (100% vs. 50%), and any-stage disease (100% vs. 67%).
When set at 100% specificity, the multiomics test outperformed a commercially available plasma ctDNA test (Avenio, Roche) set at 75% specificity. The multiomics test yielded a higher sensitivity for stage I and II disease (94% vs. 38%), stage III and IV disease (91% vs. 55%), and any-stage disease (90% vs. 47%).
At a specificity of 94% for both tests, the multiomics test yielded a higher sensitivity than plasma CEA level for stage I and II disease (94% vs. 18%), stage III and IV disease (91% vs. 45%), and any-stage disease (91% vs. 31%).
“Although there were many exciting aspects to this study, the test’s ability to detect cancers without loss of sensitivity for early-stage cancers was striking to me,” said Michael J. Hall, MD, of Fox Chase Cancer Center in Philadelphia, who was not involved in the study. “The loss of sensitivity in early tumors has been a limitation of other tests – FOBT [fecal occult blood test], FIT – so if this is replicable, this is exciting.”
Although the study was small for a CRC screening assessment, “the preliminary results presented in the poster were certainly compelling enough to support more research,” Dr. Hall said.
Dr. Putcha said that the test will be validated in a prospective, multicenter trial of roughly 10,000 participants at average risk, expected to open later this year. Further research will also help assess the test’s performance among patients with inflammatory bowel disease, for whom false-positive results with some screening tests have been problematic.
The study was sponsored by Freenome. Dr. Putcha is employed by Freenome and has a relationship with Palmetto GBA. Dr. Hall disclosed relationships with Ambry Genetics, AstraZeneca, Caris Life Sciences, Foundation Medicine, Invitae, and Myriad Genetics, and he shares a patent with institutional colleagues for a novel method to investigate hereditary CRC genes.
SOURCE: Putcha G et al. 2020 GI Cancers Symposium, Abstract 66.
Visit the AGA GI Patient Center for education to share with your patients about currently available CRC screenings at https://www.gastro.org/
SAN FRANCISCO – A blood-based test that integrates data from multiple molecular “omes,” such as the genome and proteome, performs well at spotting early-stage colorectal cancer (CRC), the AI-EMERGE study suggests.
Moreover, the test netted better sensitivity than a fecal immunochemical test (FIT), a circulating tumor DNA (ctDNA) test, and a carcinoembryonic antigen (CEA) test.
Findings were reported in a poster session at the 2020 GI Cancers Symposium, which is cosponsored by the American Gastroenterological Association, American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology.
“Today, about a third of age-appropriate adults are not up to date with [CRC] screening,” lead study investigator Girish Putcha, MD, PhD, chief medical officer of Freenome in San Francisco, noted at the symposium. “A noninvasive blood-based screening test having high sensitivity and specificity for [CRC] generally, but especially for early-stage disease, could help improve adherence and ultimately reduce mortality.”
Dr. Putcha and colleagues evaluated a blood-based multiomics test in 32 patients with CRC of all stages and 539 colonoscopy-confirmed negative control subjects.
The test uses a multiomics platform to pick up both tumor-derived signal and non–tumor-derived signal from the body’s immune response and other sources. The test uses machine learning, and entails whole-genome sequencing, bisulfite sequencing (for assessment of DNA methylation), and protein quantification methods.
At 94% specificity, the test had a 94% sensitivity for spotting stage I and II CRC, 91% sensitivity for stage III and IV CRC, and 91% sensitivity for CRC of any stage. By location, sensitivity was 92% for distal tumors and 88% for proximal tumors.
The multiomics test outperformed a ctDNA test, a CEA test, and a FIT. At a specificity of 96% for both tests, the multiomics test yielded a higher sensitivity than a commercially available FIT stool test (OC-Auto FIT, Polymedco) for stage I and II disease (100% vs. 70%), stage III and IV disease (100% vs. 50%), and any-stage disease (100% vs. 67%).
When set at 100% specificity, the multiomics test outperformed a commercially available plasma ctDNA test (Avenio, Roche) set at 75% specificity. The multiomics test yielded a higher sensitivity for stage I and II disease (94% vs. 38%), stage III and IV disease (91% vs. 55%), and any-stage disease (90% vs. 47%).
At a specificity of 94% for both tests, the multiomics test yielded a higher sensitivity than plasma CEA level for stage I and II disease (94% vs. 18%), stage III and IV disease (91% vs. 45%), and any-stage disease (91% vs. 31%).
“Although there were many exciting aspects to this study, the test’s ability to detect cancers without loss of sensitivity for early-stage cancers was striking to me,” said Michael J. Hall, MD, of Fox Chase Cancer Center in Philadelphia, who was not involved in the study. “The loss of sensitivity in early tumors has been a limitation of other tests – FOBT [fecal occult blood test], FIT – so if this is replicable, this is exciting.”
Although the study was small for a CRC screening assessment, “the preliminary results presented in the poster were certainly compelling enough to support more research,” Dr. Hall said.
Dr. Putcha said that the test will be validated in a prospective, multicenter trial of roughly 10,000 participants at average risk, expected to open later this year. Further research will also help assess the test’s performance among patients with inflammatory bowel disease, for whom false-positive results with some screening tests have been problematic.
The study was sponsored by Freenome. Dr. Putcha is employed by Freenome and has a relationship with Palmetto GBA. Dr. Hall disclosed relationships with Ambry Genetics, AstraZeneca, Caris Life Sciences, Foundation Medicine, Invitae, and Myriad Genetics, and he shares a patent with institutional colleagues for a novel method to investigate hereditary CRC genes.
SOURCE: Putcha G et al. 2020 GI Cancers Symposium, Abstract 66.
Visit the AGA GI Patient Center for education to share with your patients about currently available CRC screenings at https://www.gastro.org/
Banning indoor tanning devices could save lives and money
according to a study published in JAMA Dermatology.
The study also suggests a ban would result in a collective cost savings of $5.7 billion and productivity gains of $41.3 billion.
Compared with a ban on indoor tanning for minors, the benefits of a full ban on devices were 3.7-fold higher in the United States/Canada and 2.6-fold higher in Europe, according to study author Louisa G. Gordon, PhD, of the QIMR Berghofer Medical Research Institute in Brisbane, Australia, and colleagues.
The researchers noted that indoor tanning is regulated in more than 20 countries. Australia has instituted a ban on commercial indoor tanning devices, and Brazil has banned both commercial and private tanning devices.
In the United States, 19 states have banned the use of indoor tanning beds for minors, and 44 states as well as the District of Columbia have some regulation of tanning facilities for minors, according to the National Conference of State Legislatures.
With this study, Dr. Gordon and colleagues sought to explore what effect an outright ban on indoor tanning devices, a prohibition for minors only, or continuing current levels of indoor tanning would have on the health and economy of the United States, Canada, and Europe.
The researchers created a Markov cohort model of 110,932,523 individuals in the United States/Canada and 141,970,492 individuals in Europe, all aged 12-35 years.
The team used data from epidemiologic studies, cost reports, and official cancer registries to estimate the prevalence of indoor tanning, risk of developing melanoma, and mortality rates from skin cancer and other causes. The researchers also estimated health care costs of melanoma treatment in each region as well as the societal cost of dying prematurely from melanoma, adjusted to 2018 dollars.
Results
The model suggested a ban on indoor tanning in the United States and Canada would result in 244,347 fewer melanomas (–8.7%), 89,193 fewer deaths from melanoma (–6.9%), and 7.3 million fewer keratinocyte carcinomas (–7.8%) than continuing at the current levels of use. The ban would also save 428,781 life-years, have a cost savings of $3.5 billion, and confer productivity gains of $27.5 billion, the researchers said.
When applying the ban in Europe, the model estimated 203,736 fewer melanomas (–4.9%), 98,288 fewer deaths from melanoma (–4.4%), and 2.4 million fewer keratinocyte carcinomas (–4.4%). The researchers also noted that Europe would see a gain of 459,669 life-years, a cost savings of $2.1 billion, and a productivity gain of $13.7 billion.
Dr. Gordon and colleagues acknowledged that their model had some limitations, such as in estimating the prevalence of certain skin cancers across Europe, which can range from 10% to 56% depending on the country. In addition, the model did not account for the money spent in implementing a ban, which could include costs associated with regulation, compliance, and buy-back schemes for tanning devices.
Implications
In an interview, Dr. Gordon said the researchers conducted this study to stress the health benefits and cost savings of regulating indoor tanning devices in North America and Europe. She noted that she had previously published a report in 2009 that helped Australia make the decision to ban such devices there, but she said the tanning industry was in its infancy during that time, which factored into the decision to ban indoor tanning (Health Policy. 2009 Mar;89[3]:303-11).
Any ban by a regulatory agency “should include everyone,” Dr. Gordon said, because “banning minors is a halfway attempt to prevent skin cancers.” The danger isn’t just present in children. “People in their 20s and 30s are still very image conscious,” she said. “The pressure is enormous.”
Anyone interested in tanning should use tanning creams or sprays instead of using indoor tanning devices, Dr. Gordon said. “Consumers can control their UV exposure,” she noted. “Prevention is incredibly important, and skin cancer is one of a few cancers we can almost entirely prevent via protecting our skin. The same can’t be said for other horrible cancers.”
Adam Friedman, MD, a professor at George Washington University, Washington, who was not involved in this study, said it should come as no surprise to dermatologists that preventing artificial UVA heavy exposure reduces the incidence of skin cancer, but the “more compelling component of this study is cost.”
“The lay public is extremely health care cost conscientious,” he said. “This is a commonly debated topic for emerging politicians at every level; not to mention, no one enjoys bleeding money. Dermatologists can use the angle of, ‘save skin now, save money later,’ to target the financial burden of accelerated skin aging and skin cancer as a mechanism for persuading patients not to ‘shake and bake.’ ”
While the Food and Drug Administration has proposed restricting the use of indoor tanning devices for minors nationwide, it has not issued a final rule on the matter, and the prospect of an outright ban in the United States for the general population is less feasible, noted Dr. Friedman.
“I think it would be difficult to expand this [proposed] ban given the financial impact on numerous businesses,” he said. “It would likely take more evidence and support beyond the medical community to make this happen, but here’s hoping,”
This study was funded by the World Health Organization UV Radiation Programme and Cancer Council Victoria. One author disclosed personal fees from Cancer Council Victoria, and one disclosed grants from TrygFonden. The other authors and Dr. Friedman reported no relevant conflicts of interest.
SOURCE: Gordon L et al. JAMA Dermatol. 2020 Feb 19. doi: 10.1001/jamadermatol.2020.0001.
according to a study published in JAMA Dermatology.
The study also suggests a ban would result in a collective cost savings of $5.7 billion and productivity gains of $41.3 billion.
Compared with a ban on indoor tanning for minors, the benefits of a full ban on devices were 3.7-fold higher in the United States/Canada and 2.6-fold higher in Europe, according to study author Louisa G. Gordon, PhD, of the QIMR Berghofer Medical Research Institute in Brisbane, Australia, and colleagues.
The researchers noted that indoor tanning is regulated in more than 20 countries. Australia has instituted a ban on commercial indoor tanning devices, and Brazil has banned both commercial and private tanning devices.
In the United States, 19 states have banned the use of indoor tanning beds for minors, and 44 states as well as the District of Columbia have some regulation of tanning facilities for minors, according to the National Conference of State Legislatures.
With this study, Dr. Gordon and colleagues sought to explore what effect an outright ban on indoor tanning devices, a prohibition for minors only, or continuing current levels of indoor tanning would have on the health and economy of the United States, Canada, and Europe.
The researchers created a Markov cohort model of 110,932,523 individuals in the United States/Canada and 141,970,492 individuals in Europe, all aged 12-35 years.
The team used data from epidemiologic studies, cost reports, and official cancer registries to estimate the prevalence of indoor tanning, risk of developing melanoma, and mortality rates from skin cancer and other causes. The researchers also estimated health care costs of melanoma treatment in each region as well as the societal cost of dying prematurely from melanoma, adjusted to 2018 dollars.
Results
The model suggested a ban on indoor tanning in the United States and Canada would result in 244,347 fewer melanomas (–8.7%), 89,193 fewer deaths from melanoma (–6.9%), and 7.3 million fewer keratinocyte carcinomas (–7.8%) than continuing at the current levels of use. The ban would also save 428,781 life-years, have a cost savings of $3.5 billion, and confer productivity gains of $27.5 billion, the researchers said.
When applying the ban in Europe, the model estimated 203,736 fewer melanomas (–4.9%), 98,288 fewer deaths from melanoma (–4.4%), and 2.4 million fewer keratinocyte carcinomas (–4.4%). The researchers also noted that Europe would see a gain of 459,669 life-years, a cost savings of $2.1 billion, and a productivity gain of $13.7 billion.
Dr. Gordon and colleagues acknowledged that their model had some limitations, such as in estimating the prevalence of certain skin cancers across Europe, which can range from 10% to 56% depending on the country. In addition, the model did not account for the money spent in implementing a ban, which could include costs associated with regulation, compliance, and buy-back schemes for tanning devices.
Implications
In an interview, Dr. Gordon said the researchers conducted this study to stress the health benefits and cost savings of regulating indoor tanning devices in North America and Europe. She noted that she had previously published a report in 2009 that helped Australia make the decision to ban such devices there, but she said the tanning industry was in its infancy during that time, which factored into the decision to ban indoor tanning (Health Policy. 2009 Mar;89[3]:303-11).
Any ban by a regulatory agency “should include everyone,” Dr. Gordon said, because “banning minors is a halfway attempt to prevent skin cancers.” The danger isn’t just present in children. “People in their 20s and 30s are still very image conscious,” she said. “The pressure is enormous.”
Anyone interested in tanning should use tanning creams or sprays instead of using indoor tanning devices, Dr. Gordon said. “Consumers can control their UV exposure,” she noted. “Prevention is incredibly important, and skin cancer is one of a few cancers we can almost entirely prevent via protecting our skin. The same can’t be said for other horrible cancers.”
Adam Friedman, MD, a professor at George Washington University, Washington, who was not involved in this study, said it should come as no surprise to dermatologists that preventing artificial UVA heavy exposure reduces the incidence of skin cancer, but the “more compelling component of this study is cost.”
“The lay public is extremely health care cost conscientious,” he said. “This is a commonly debated topic for emerging politicians at every level; not to mention, no one enjoys bleeding money. Dermatologists can use the angle of, ‘save skin now, save money later,’ to target the financial burden of accelerated skin aging and skin cancer as a mechanism for persuading patients not to ‘shake and bake.’ ”
While the Food and Drug Administration has proposed restricting the use of indoor tanning devices for minors nationwide, it has not issued a final rule on the matter, and the prospect of an outright ban in the United States for the general population is less feasible, noted Dr. Friedman.
“I think it would be difficult to expand this [proposed] ban given the financial impact on numerous businesses,” he said. “It would likely take more evidence and support beyond the medical community to make this happen, but here’s hoping,”
This study was funded by the World Health Organization UV Radiation Programme and Cancer Council Victoria. One author disclosed personal fees from Cancer Council Victoria, and one disclosed grants from TrygFonden. The other authors and Dr. Friedman reported no relevant conflicts of interest.
SOURCE: Gordon L et al. JAMA Dermatol. 2020 Feb 19. doi: 10.1001/jamadermatol.2020.0001.
according to a study published in JAMA Dermatology.
The study also suggests a ban would result in a collective cost savings of $5.7 billion and productivity gains of $41.3 billion.
Compared with a ban on indoor tanning for minors, the benefits of a full ban on devices were 3.7-fold higher in the United States/Canada and 2.6-fold higher in Europe, according to study author Louisa G. Gordon, PhD, of the QIMR Berghofer Medical Research Institute in Brisbane, Australia, and colleagues.
The researchers noted that indoor tanning is regulated in more than 20 countries. Australia has instituted a ban on commercial indoor tanning devices, and Brazil has banned both commercial and private tanning devices.
In the United States, 19 states have banned the use of indoor tanning beds for minors, and 44 states as well as the District of Columbia have some regulation of tanning facilities for minors, according to the National Conference of State Legislatures.
With this study, Dr. Gordon and colleagues sought to explore what effect an outright ban on indoor tanning devices, a prohibition for minors only, or continuing current levels of indoor tanning would have on the health and economy of the United States, Canada, and Europe.
The researchers created a Markov cohort model of 110,932,523 individuals in the United States/Canada and 141,970,492 individuals in Europe, all aged 12-35 years.
The team used data from epidemiologic studies, cost reports, and official cancer registries to estimate the prevalence of indoor tanning, risk of developing melanoma, and mortality rates from skin cancer and other causes. The researchers also estimated health care costs of melanoma treatment in each region as well as the societal cost of dying prematurely from melanoma, adjusted to 2018 dollars.
Results
The model suggested a ban on indoor tanning in the United States and Canada would result in 244,347 fewer melanomas (–8.7%), 89,193 fewer deaths from melanoma (–6.9%), and 7.3 million fewer keratinocyte carcinomas (–7.8%) than continuing at the current levels of use. The ban would also save 428,781 life-years, have a cost savings of $3.5 billion, and confer productivity gains of $27.5 billion, the researchers said.
When applying the ban in Europe, the model estimated 203,736 fewer melanomas (–4.9%), 98,288 fewer deaths from melanoma (–4.4%), and 2.4 million fewer keratinocyte carcinomas (–4.4%). The researchers also noted that Europe would see a gain of 459,669 life-years, a cost savings of $2.1 billion, and a productivity gain of $13.7 billion.
Dr. Gordon and colleagues acknowledged that their model had some limitations, such as in estimating the prevalence of certain skin cancers across Europe, which can range from 10% to 56% depending on the country. In addition, the model did not account for the money spent in implementing a ban, which could include costs associated with regulation, compliance, and buy-back schemes for tanning devices.
Implications
In an interview, Dr. Gordon said the researchers conducted this study to stress the health benefits and cost savings of regulating indoor tanning devices in North America and Europe. She noted that she had previously published a report in 2009 that helped Australia make the decision to ban such devices there, but she said the tanning industry was in its infancy during that time, which factored into the decision to ban indoor tanning (Health Policy. 2009 Mar;89[3]:303-11).
Any ban by a regulatory agency “should include everyone,” Dr. Gordon said, because “banning minors is a halfway attempt to prevent skin cancers.” The danger isn’t just present in children. “People in their 20s and 30s are still very image conscious,” she said. “The pressure is enormous.”
Anyone interested in tanning should use tanning creams or sprays instead of using indoor tanning devices, Dr. Gordon said. “Consumers can control their UV exposure,” she noted. “Prevention is incredibly important, and skin cancer is one of a few cancers we can almost entirely prevent via protecting our skin. The same can’t be said for other horrible cancers.”
Adam Friedman, MD, a professor at George Washington University, Washington, who was not involved in this study, said it should come as no surprise to dermatologists that preventing artificial UVA heavy exposure reduces the incidence of skin cancer, but the “more compelling component of this study is cost.”
“The lay public is extremely health care cost conscientious,” he said. “This is a commonly debated topic for emerging politicians at every level; not to mention, no one enjoys bleeding money. Dermatologists can use the angle of, ‘save skin now, save money later,’ to target the financial burden of accelerated skin aging and skin cancer as a mechanism for persuading patients not to ‘shake and bake.’ ”
While the Food and Drug Administration has proposed restricting the use of indoor tanning devices for minors nationwide, it has not issued a final rule on the matter, and the prospect of an outright ban in the United States for the general population is less feasible, noted Dr. Friedman.
“I think it would be difficult to expand this [proposed] ban given the financial impact on numerous businesses,” he said. “It would likely take more evidence and support beyond the medical community to make this happen, but here’s hoping,”
This study was funded by the World Health Organization UV Radiation Programme and Cancer Council Victoria. One author disclosed personal fees from Cancer Council Victoria, and one disclosed grants from TrygFonden. The other authors and Dr. Friedman reported no relevant conflicts of interest.
SOURCE: Gordon L et al. JAMA Dermatol. 2020 Feb 19. doi: 10.1001/jamadermatol.2020.0001.
FROM JAMA DERMATOLOGY
Shingles vaccine linked to lower stroke risk
LOS ANGELES – Prevention of shingles with the Zoster Vaccine Live may reduce the risk of subsequent stroke among older adults as well, the first study to examine this association suggests. Shingles vaccination was linked to a 20% decrease in stroke risk in people younger than 80 years of age in the large Medicare cohort study. Older participants showed a 10% reduced risk, according to data released in advance of formal presentation at this week’s International Stroke Conference, sponsored by the American Heart Association.
Reductions were seen for both ischemic and hemorrhagic events.
“Our findings might encourage people age 50 or older to get vaccinated against shingles and to prevent shingles-associated stroke risk,” Quanhe Yang, PhD, lead study author and senior scientist at the Centers for Disease Control and Prevention, said in an interview.
Dr. Yang and colleagues evaluated the only shingles vaccine available at the time of the study, Zoster Vaccine Live (Zostavax). However, the CDC now calls an adjuvanted, nonlive recombinant vaccine (Shingrix) the preferred shingles vaccine for healthy adults aged 50 years and older. Shingrix was approved in 2017. Zostavax, approved in 2006, can still be used in healthy adults aged 60 years and older, the agency states.
A reduction in inflammation from Zoster Vaccine Live may be the mechanism by which stroke risk is reduced, Dr. Yang said. The newer vaccine, which the CDC notes is more than 90% effective, might provide even greater protection against stroke, although more research is needed, he added.
Interestingly, prior research suggested that, once a person develops shingles, it may be too late. Dr. Yang and colleagues showed vaccination or antiviral treatment after a shingles episode was not effective at reducing stroke risk in research presented at the 2019 International Stroke Conference.
Shingles can present as a painful reactivation of chickenpox, also known as the varicella-zoster virus. Shingles is also common; Dr. Yang estimated one in three people who had chickenpox will develop the condition at some point in their lifetime. In addition, researchers have linked shingles to an elevated risk of stroke.
To assess the vaccine’s protective effect on stroke, Dr. Yang and colleagues reviewed health records for 1.38 million Medicare recipients. All participants were aged 66 years or older, had no history of stroke at baseline, and received the Zoster Vaccine Live during 2008-2016. The investigators compared the stroke rate in this vaccinated group with the rate in a matched control group of the same number of Medicare fee-for-service beneficiaries who did not receive the vaccination. They adjusted their analysis for age, sex, race, medications, and comorbidities.
The overall decrease of 16% in stroke risk associated with vaccination included a 12% drop in hemorrhagic stroke and 18% decrease in ischemic stroke over a median follow-up of 3.9 years follow-up (interquartile range, 2.7-5.4).
The adjusted hazard ratios comparing the vaccinated with control groups were 0.84 (95% confidence interval, 0.83-0.85) for all stroke; 0.82 (95% CI, 0.81-0.83) for acute ischemic stroke; and 0.88 (95% CI, 0.84-0.91) for hemorrhagic stroke.
The vaccinated group experienced 42,267 stroke events during that time. This rate included 33,510 acute ischemic strokes and 4,318 hemorrhagic strokes. At the same time, 48,139 strokes occurred in the control group. The breakdown included 39,334 ischemic and 4,713 hemorrhagic events.
“Approximately 1 million people in the United States get shingles each year, yet there is a vaccine to help prevent it,” Dr. Yang stated in a news release. “Our study results may encourage people ages 50 and older to follow the recommendation and get vaccinated against shingles. You are reducing the risk of shingles, and at the same time, you may be reducing your risk of stroke.”
“Further studies are needed to confirm our findings of association between Zostavax vaccine and risk of stroke,” Dr. Yang said.
Because the CDC Advisory Committee on Immunization Practices recommended Shingrix vaccine only for healthy adults 50 years and older in 2017, there were insufficient data in Medicare to study the association between that vaccine and risk of stroke at the time of the current study.
“However, two doses of Shingrix are more than 90% effective at preventing shingles and postherpetic neuralgia, and higher than that of Zostavax,” Dr. Yang said.
‘Very intriguing’ research
“This is a very interesting study,” Ralph L. Sacco, MD, past president of the American Heart Association, said in a video commentary released in advance of the conference. It was a very large sample, he noted, and those older than age 60 years who had the vaccine were protected with a lower risk for both ischemic and hemorrhagic stroke.
“So it is very intriguing,” added Dr. Sacco, chairman of the department of neurology at the University of Miami. “We know things like shingles can increase inflammation and increase the risk of stroke,” Dr. Sacco said, “but this is the first time in a very large Medicare database that it was shown that those who had the vaccine had a lower risk of stroke.”
The CDC funded this study. Dr. Yang and Dr. Sacco have disclosed no relevant financial relationships.
SOURCE: Yang Q et al. ISC 2020, Abstract TP493.
This article first appeared on Medscape.com.
LOS ANGELES – Prevention of shingles with the Zoster Vaccine Live may reduce the risk of subsequent stroke among older adults as well, the first study to examine this association suggests. Shingles vaccination was linked to a 20% decrease in stroke risk in people younger than 80 years of age in the large Medicare cohort study. Older participants showed a 10% reduced risk, according to data released in advance of formal presentation at this week’s International Stroke Conference, sponsored by the American Heart Association.
Reductions were seen for both ischemic and hemorrhagic events.
“Our findings might encourage people age 50 or older to get vaccinated against shingles and to prevent shingles-associated stroke risk,” Quanhe Yang, PhD, lead study author and senior scientist at the Centers for Disease Control and Prevention, said in an interview.
Dr. Yang and colleagues evaluated the only shingles vaccine available at the time of the study, Zoster Vaccine Live (Zostavax). However, the CDC now calls an adjuvanted, nonlive recombinant vaccine (Shingrix) the preferred shingles vaccine for healthy adults aged 50 years and older. Shingrix was approved in 2017. Zostavax, approved in 2006, can still be used in healthy adults aged 60 years and older, the agency states.
A reduction in inflammation from Zoster Vaccine Live may be the mechanism by which stroke risk is reduced, Dr. Yang said. The newer vaccine, which the CDC notes is more than 90% effective, might provide even greater protection against stroke, although more research is needed, he added.
Interestingly, prior research suggested that, once a person develops shingles, it may be too late. Dr. Yang and colleagues showed vaccination or antiviral treatment after a shingles episode was not effective at reducing stroke risk in research presented at the 2019 International Stroke Conference.
Shingles can present as a painful reactivation of chickenpox, also known as the varicella-zoster virus. Shingles is also common; Dr. Yang estimated one in three people who had chickenpox will develop the condition at some point in their lifetime. In addition, researchers have linked shingles to an elevated risk of stroke.
To assess the vaccine’s protective effect on stroke, Dr. Yang and colleagues reviewed health records for 1.38 million Medicare recipients. All participants were aged 66 years or older, had no history of stroke at baseline, and received the Zoster Vaccine Live during 2008-2016. The investigators compared the stroke rate in this vaccinated group with the rate in a matched control group of the same number of Medicare fee-for-service beneficiaries who did not receive the vaccination. They adjusted their analysis for age, sex, race, medications, and comorbidities.
The overall decrease of 16% in stroke risk associated with vaccination included a 12% drop in hemorrhagic stroke and 18% decrease in ischemic stroke over a median follow-up of 3.9 years follow-up (interquartile range, 2.7-5.4).
The adjusted hazard ratios comparing the vaccinated with control groups were 0.84 (95% confidence interval, 0.83-0.85) for all stroke; 0.82 (95% CI, 0.81-0.83) for acute ischemic stroke; and 0.88 (95% CI, 0.84-0.91) for hemorrhagic stroke.
The vaccinated group experienced 42,267 stroke events during that time. This rate included 33,510 acute ischemic strokes and 4,318 hemorrhagic strokes. At the same time, 48,139 strokes occurred in the control group. The breakdown included 39,334 ischemic and 4,713 hemorrhagic events.
“Approximately 1 million people in the United States get shingles each year, yet there is a vaccine to help prevent it,” Dr. Yang stated in a news release. “Our study results may encourage people ages 50 and older to follow the recommendation and get vaccinated against shingles. You are reducing the risk of shingles, and at the same time, you may be reducing your risk of stroke.”
“Further studies are needed to confirm our findings of association between Zostavax vaccine and risk of stroke,” Dr. Yang said.
Because the CDC Advisory Committee on Immunization Practices recommended Shingrix vaccine only for healthy adults 50 years and older in 2017, there were insufficient data in Medicare to study the association between that vaccine and risk of stroke at the time of the current study.
“However, two doses of Shingrix are more than 90% effective at preventing shingles and postherpetic neuralgia, and higher than that of Zostavax,” Dr. Yang said.
‘Very intriguing’ research
“This is a very interesting study,” Ralph L. Sacco, MD, past president of the American Heart Association, said in a video commentary released in advance of the conference. It was a very large sample, he noted, and those older than age 60 years who had the vaccine were protected with a lower risk for both ischemic and hemorrhagic stroke.
“So it is very intriguing,” added Dr. Sacco, chairman of the department of neurology at the University of Miami. “We know things like shingles can increase inflammation and increase the risk of stroke,” Dr. Sacco said, “but this is the first time in a very large Medicare database that it was shown that those who had the vaccine had a lower risk of stroke.”
The CDC funded this study. Dr. Yang and Dr. Sacco have disclosed no relevant financial relationships.
SOURCE: Yang Q et al. ISC 2020, Abstract TP493.
This article first appeared on Medscape.com.
LOS ANGELES – Prevention of shingles with the Zoster Vaccine Live may reduce the risk of subsequent stroke among older adults as well, the first study to examine this association suggests. Shingles vaccination was linked to a 20% decrease in stroke risk in people younger than 80 years of age in the large Medicare cohort study. Older participants showed a 10% reduced risk, according to data released in advance of formal presentation at this week’s International Stroke Conference, sponsored by the American Heart Association.
Reductions were seen for both ischemic and hemorrhagic events.
“Our findings might encourage people age 50 or older to get vaccinated against shingles and to prevent shingles-associated stroke risk,” Quanhe Yang, PhD, lead study author and senior scientist at the Centers for Disease Control and Prevention, said in an interview.
Dr. Yang and colleagues evaluated the only shingles vaccine available at the time of the study, Zoster Vaccine Live (Zostavax). However, the CDC now calls an adjuvanted, nonlive recombinant vaccine (Shingrix) the preferred shingles vaccine for healthy adults aged 50 years and older. Shingrix was approved in 2017. Zostavax, approved in 2006, can still be used in healthy adults aged 60 years and older, the agency states.
A reduction in inflammation from Zoster Vaccine Live may be the mechanism by which stroke risk is reduced, Dr. Yang said. The newer vaccine, which the CDC notes is more than 90% effective, might provide even greater protection against stroke, although more research is needed, he added.
Interestingly, prior research suggested that, once a person develops shingles, it may be too late. Dr. Yang and colleagues showed vaccination or antiviral treatment after a shingles episode was not effective at reducing stroke risk in research presented at the 2019 International Stroke Conference.
Shingles can present as a painful reactivation of chickenpox, also known as the varicella-zoster virus. Shingles is also common; Dr. Yang estimated one in three people who had chickenpox will develop the condition at some point in their lifetime. In addition, researchers have linked shingles to an elevated risk of stroke.
To assess the vaccine’s protective effect on stroke, Dr. Yang and colleagues reviewed health records for 1.38 million Medicare recipients. All participants were aged 66 years or older, had no history of stroke at baseline, and received the Zoster Vaccine Live during 2008-2016. The investigators compared the stroke rate in this vaccinated group with the rate in a matched control group of the same number of Medicare fee-for-service beneficiaries who did not receive the vaccination. They adjusted their analysis for age, sex, race, medications, and comorbidities.
The overall decrease of 16% in stroke risk associated with vaccination included a 12% drop in hemorrhagic stroke and 18% decrease in ischemic stroke over a median follow-up of 3.9 years follow-up (interquartile range, 2.7-5.4).
The adjusted hazard ratios comparing the vaccinated with control groups were 0.84 (95% confidence interval, 0.83-0.85) for all stroke; 0.82 (95% CI, 0.81-0.83) for acute ischemic stroke; and 0.88 (95% CI, 0.84-0.91) for hemorrhagic stroke.
The vaccinated group experienced 42,267 stroke events during that time. This rate included 33,510 acute ischemic strokes and 4,318 hemorrhagic strokes. At the same time, 48,139 strokes occurred in the control group. The breakdown included 39,334 ischemic and 4,713 hemorrhagic events.
“Approximately 1 million people in the United States get shingles each year, yet there is a vaccine to help prevent it,” Dr. Yang stated in a news release. “Our study results may encourage people ages 50 and older to follow the recommendation and get vaccinated against shingles. You are reducing the risk of shingles, and at the same time, you may be reducing your risk of stroke.”
“Further studies are needed to confirm our findings of association between Zostavax vaccine and risk of stroke,” Dr. Yang said.
Because the CDC Advisory Committee on Immunization Practices recommended Shingrix vaccine only for healthy adults 50 years and older in 2017, there were insufficient data in Medicare to study the association between that vaccine and risk of stroke at the time of the current study.
“However, two doses of Shingrix are more than 90% effective at preventing shingles and postherpetic neuralgia, and higher than that of Zostavax,” Dr. Yang said.
‘Very intriguing’ research
“This is a very interesting study,” Ralph L. Sacco, MD, past president of the American Heart Association, said in a video commentary released in advance of the conference. It was a very large sample, he noted, and those older than age 60 years who had the vaccine were protected with a lower risk for both ischemic and hemorrhagic stroke.
“So it is very intriguing,” added Dr. Sacco, chairman of the department of neurology at the University of Miami. “We know things like shingles can increase inflammation and increase the risk of stroke,” Dr. Sacco said, “but this is the first time in a very large Medicare database that it was shown that those who had the vaccine had a lower risk of stroke.”
The CDC funded this study. Dr. Yang and Dr. Sacco have disclosed no relevant financial relationships.
SOURCE: Yang Q et al. ISC 2020, Abstract TP493.
This article first appeared on Medscape.com.
REPORTING FROM ISC 2020
Stroke risk tied to diabetic retinopathy may not be modifiable
LOS ANGELES – Evidence continues to mount that diabetic retinopathy predicts elevated risk for stroke.
In a new study with nearly 3,000 people, those with diabetic retinopathy were 60% more likely than others with diabetes to develop an incident stroke over time. Investigators also found that addressing glucose, lipids, and blood pressure levels did not mitigate this risk in this secondary analysis of the ACCORD Eye Study.
“We are not surprised with the finding that diabetic retinopathy increases the risk of stroke — as diabetic retinopathy is common microvascular disease that is an established risk factor for cardiovascular disease,” lead author Ka-Ho Wong, BS, MBA, said in an interview.
However, “we were surprised that none of the trial interventions mitigated this risk, in particular the intensive blood pressure reduction, because hypertension is the most important cause of microvascular disease,” he said. Mr. Wong is clinical research coordinator and lab manager of the de Havenon Lab at the University of Utah Health Hospitals and Clinics in Salt Lake City.
The study findings were released Feb. 12, 2020, in advance of formal presentation at the International Stroke Conference sponsored by the American Heart Association.
Common predictor of vascular disease
Diabetic retinopathy is the most common complication of diabetes mellitus, affecting up to 50% of people living with type 1 and type 2 diabetes. In addition, previous research suggests that macrovascular diabetes complications, including stroke, could share a common or synergistic pathway.
This small vessel damage in the eye also has been linked to an increased risk of adverse cardiac events, including heart failure, as previously reported by Medscape Medical News.
To find out more, Mr. Wong and colleagues analyzed 2,828 participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study. They compared the stroke risk between 874 people with diabetic retinopathy and another 1,954 diabetics without this complication. The average age was 62 years and 62% were men.
Diabetic neuropathy at baseline was diagnosed using the Early Treatment Diabetic Retinopathy Study Severity Scale using seven-field stereoscopic fundus photographs.
A total of 117 participants experienced a stroke during a mean follow-up of 5.4 years.
The investigators found that diabetic retinopathy was more common among patients who had a stroke (41%) versus 31% of those without a stroke (P = .016). The link between diabetic retinopathy and stroke remained in an analysis adjusted for multiple factors, including baseline age, gender, race, total cholesterol, A1c, smoking, and more. Risk remained elevated, with a hazard ratio of 1.60 (95% confidence interval, 1.10-2.32; P = .015).
Regarding the potential for modifying this risk, the association was unaffected among participants randomly assigned to the ACCORD glucose intervention (P = .305), lipid intervention (P = .546), or blood pressure intervention (P = .422).
The study was a secondary analysis, so information on stroke type and location were unavailable.
The big picture
“Diabetic retinopathy is associated with an increased risk of stroke, which suggests that the microvascular pathology inherent to diabetic retinopathy has larger cardiovascular implications,” the researchers noted.
Despite these findings, the researchers suggest that patients with diabetic retinopathy receive aggressive medical management to try to reduce their stroke risk.
“It’s important for everyone with diabetes to maintain good blood glucose control, and those with established diabetic retinopathy should pay particular attention to meeting all the stroke prevention guidelines that are established by the American Stroke Association,” said Mr. Wong.
“Patients with established diabetic retinopathy should pay particular attention to meeting all stroke prevention guidelines established by the [American Heart Association],” he added.
Mr. Wong and colleagues would like to expand on these findings. Pending grant application and funding support, they propose conducting a prospective, observational trial in stroke patients with baseline diabetic retinopathy. One aim would be to identify the most common mechanisms leading to stroke in this population, “which would have important implications for prevention efforts,” he said.
Consistent Findings
“The results of the study showing that having diabetic retinopathy is also associated with an increase in stroke really isn’t surprising. There have been other studies, population-based studies, done in the past, that have found a similar relationship,” Larry B. Goldstein, MD, said in a video commentary on the findings.
“The results are actually quite consistent with several other studies that have evaluated the same relationship,” added Dr. Goldstein, who is chair of the department of neurology and codirector of the Kentucky Neuroscience Institute, University of Kentucky HealthCare, Lexington.
Mr. Wong and Dr. Goldstein have disclosed no relevant financial relationships. The NIH’s National Institute of Neurological Disorders and Stroke funded the study.
This article first appeared on Medscape.com.
LOS ANGELES – Evidence continues to mount that diabetic retinopathy predicts elevated risk for stroke.
In a new study with nearly 3,000 people, those with diabetic retinopathy were 60% more likely than others with diabetes to develop an incident stroke over time. Investigators also found that addressing glucose, lipids, and blood pressure levels did not mitigate this risk in this secondary analysis of the ACCORD Eye Study.
“We are not surprised with the finding that diabetic retinopathy increases the risk of stroke — as diabetic retinopathy is common microvascular disease that is an established risk factor for cardiovascular disease,” lead author Ka-Ho Wong, BS, MBA, said in an interview.
However, “we were surprised that none of the trial interventions mitigated this risk, in particular the intensive blood pressure reduction, because hypertension is the most important cause of microvascular disease,” he said. Mr. Wong is clinical research coordinator and lab manager of the de Havenon Lab at the University of Utah Health Hospitals and Clinics in Salt Lake City.
The study findings were released Feb. 12, 2020, in advance of formal presentation at the International Stroke Conference sponsored by the American Heart Association.
Common predictor of vascular disease
Diabetic retinopathy is the most common complication of diabetes mellitus, affecting up to 50% of people living with type 1 and type 2 diabetes. In addition, previous research suggests that macrovascular diabetes complications, including stroke, could share a common or synergistic pathway.
This small vessel damage in the eye also has been linked to an increased risk of adverse cardiac events, including heart failure, as previously reported by Medscape Medical News.
To find out more, Mr. Wong and colleagues analyzed 2,828 participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study. They compared the stroke risk between 874 people with diabetic retinopathy and another 1,954 diabetics without this complication. The average age was 62 years and 62% were men.
Diabetic neuropathy at baseline was diagnosed using the Early Treatment Diabetic Retinopathy Study Severity Scale using seven-field stereoscopic fundus photographs.
A total of 117 participants experienced a stroke during a mean follow-up of 5.4 years.
The investigators found that diabetic retinopathy was more common among patients who had a stroke (41%) versus 31% of those without a stroke (P = .016). The link between diabetic retinopathy and stroke remained in an analysis adjusted for multiple factors, including baseline age, gender, race, total cholesterol, A1c, smoking, and more. Risk remained elevated, with a hazard ratio of 1.60 (95% confidence interval, 1.10-2.32; P = .015).
Regarding the potential for modifying this risk, the association was unaffected among participants randomly assigned to the ACCORD glucose intervention (P = .305), lipid intervention (P = .546), or blood pressure intervention (P = .422).
The study was a secondary analysis, so information on stroke type and location were unavailable.
The big picture
“Diabetic retinopathy is associated with an increased risk of stroke, which suggests that the microvascular pathology inherent to diabetic retinopathy has larger cardiovascular implications,” the researchers noted.
Despite these findings, the researchers suggest that patients with diabetic retinopathy receive aggressive medical management to try to reduce their stroke risk.
“It’s important for everyone with diabetes to maintain good blood glucose control, and those with established diabetic retinopathy should pay particular attention to meeting all the stroke prevention guidelines that are established by the American Stroke Association,” said Mr. Wong.
“Patients with established diabetic retinopathy should pay particular attention to meeting all stroke prevention guidelines established by the [American Heart Association],” he added.
Mr. Wong and colleagues would like to expand on these findings. Pending grant application and funding support, they propose conducting a prospective, observational trial in stroke patients with baseline diabetic retinopathy. One aim would be to identify the most common mechanisms leading to stroke in this population, “which would have important implications for prevention efforts,” he said.
Consistent Findings
“The results of the study showing that having diabetic retinopathy is also associated with an increase in stroke really isn’t surprising. There have been other studies, population-based studies, done in the past, that have found a similar relationship,” Larry B. Goldstein, MD, said in a video commentary on the findings.
“The results are actually quite consistent with several other studies that have evaluated the same relationship,” added Dr. Goldstein, who is chair of the department of neurology and codirector of the Kentucky Neuroscience Institute, University of Kentucky HealthCare, Lexington.
Mr. Wong and Dr. Goldstein have disclosed no relevant financial relationships. The NIH’s National Institute of Neurological Disorders and Stroke funded the study.
This article first appeared on Medscape.com.
LOS ANGELES – Evidence continues to mount that diabetic retinopathy predicts elevated risk for stroke.
In a new study with nearly 3,000 people, those with diabetic retinopathy were 60% more likely than others with diabetes to develop an incident stroke over time. Investigators also found that addressing glucose, lipids, and blood pressure levels did not mitigate this risk in this secondary analysis of the ACCORD Eye Study.
“We are not surprised with the finding that diabetic retinopathy increases the risk of stroke — as diabetic retinopathy is common microvascular disease that is an established risk factor for cardiovascular disease,” lead author Ka-Ho Wong, BS, MBA, said in an interview.
However, “we were surprised that none of the trial interventions mitigated this risk, in particular the intensive blood pressure reduction, because hypertension is the most important cause of microvascular disease,” he said. Mr. Wong is clinical research coordinator and lab manager of the de Havenon Lab at the University of Utah Health Hospitals and Clinics in Salt Lake City.
The study findings were released Feb. 12, 2020, in advance of formal presentation at the International Stroke Conference sponsored by the American Heart Association.
Common predictor of vascular disease
Diabetic retinopathy is the most common complication of diabetes mellitus, affecting up to 50% of people living with type 1 and type 2 diabetes. In addition, previous research suggests that macrovascular diabetes complications, including stroke, could share a common or synergistic pathway.
This small vessel damage in the eye also has been linked to an increased risk of adverse cardiac events, including heart failure, as previously reported by Medscape Medical News.
To find out more, Mr. Wong and colleagues analyzed 2,828 participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study. They compared the stroke risk between 874 people with diabetic retinopathy and another 1,954 diabetics without this complication. The average age was 62 years and 62% were men.
Diabetic neuropathy at baseline was diagnosed using the Early Treatment Diabetic Retinopathy Study Severity Scale using seven-field stereoscopic fundus photographs.
A total of 117 participants experienced a stroke during a mean follow-up of 5.4 years.
The investigators found that diabetic retinopathy was more common among patients who had a stroke (41%) versus 31% of those without a stroke (P = .016). The link between diabetic retinopathy and stroke remained in an analysis adjusted for multiple factors, including baseline age, gender, race, total cholesterol, A1c, smoking, and more. Risk remained elevated, with a hazard ratio of 1.60 (95% confidence interval, 1.10-2.32; P = .015).
Regarding the potential for modifying this risk, the association was unaffected among participants randomly assigned to the ACCORD glucose intervention (P = .305), lipid intervention (P = .546), or blood pressure intervention (P = .422).
The study was a secondary analysis, so information on stroke type and location were unavailable.
The big picture
“Diabetic retinopathy is associated with an increased risk of stroke, which suggests that the microvascular pathology inherent to diabetic retinopathy has larger cardiovascular implications,” the researchers noted.
Despite these findings, the researchers suggest that patients with diabetic retinopathy receive aggressive medical management to try to reduce their stroke risk.
“It’s important for everyone with diabetes to maintain good blood glucose control, and those with established diabetic retinopathy should pay particular attention to meeting all the stroke prevention guidelines that are established by the American Stroke Association,” said Mr. Wong.
“Patients with established diabetic retinopathy should pay particular attention to meeting all stroke prevention guidelines established by the [American Heart Association],” he added.
Mr. Wong and colleagues would like to expand on these findings. Pending grant application and funding support, they propose conducting a prospective, observational trial in stroke patients with baseline diabetic retinopathy. One aim would be to identify the most common mechanisms leading to stroke in this population, “which would have important implications for prevention efforts,” he said.
Consistent Findings
“The results of the study showing that having diabetic retinopathy is also associated with an increase in stroke really isn’t surprising. There have been other studies, population-based studies, done in the past, that have found a similar relationship,” Larry B. Goldstein, MD, said in a video commentary on the findings.
“The results are actually quite consistent with several other studies that have evaluated the same relationship,” added Dr. Goldstein, who is chair of the department of neurology and codirector of the Kentucky Neuroscience Institute, University of Kentucky HealthCare, Lexington.
Mr. Wong and Dr. Goldstein have disclosed no relevant financial relationships. The NIH’s National Institute of Neurological Disorders and Stroke funded the study.
This article first appeared on Medscape.com.
REPORTING FROM ISC 2020
Data back botulinum toxin for facial flushing, androgenetic alopecia
LAHAINA, HAWAII – The list of Mark Rubin, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
There are data to support these uses, and there are data associating botulinum toxin treatment with improvement in depression, which suggest the effect may not be necessarily be related to improvement in appearance, said Dr. Rubin, who is in private practice in Beverly Hills, Calif., and is associate professor of dermatology at the University of California, San Diego.
Facial flushing: Very few people use botulinum toxin for facial flushing, but Dr. Rubin, who is among those who do not, described the data as “impressive.” Several trials, he noted, have found that very small doses can significantly reduce the amount of facial erythema, including an average 45% reduction after 60 days in one trial of 24 women (Acta Med Iran. 2016 Jul;54[7]:454-7).
In another study of 25 patients with facial erythema related to rosacea who were treated with 14-45 units intradermally to the nasal tip, bridge, and alae, there were statistically significant improvements in erythema 1, 2, and 3 months after treatment among the 15 with complete data (Dermatol Surg. 2015 Jan;41 Suppl 1:S9-16).
“If you’re using very small doses and they’re intradermal, there really is minimal risk you’re going to have a problem by inadvertently affecting musculature” in these patients, Dr. Rubin commented.
In another study of 9 patients with rosacea, treatment with incobotulinumtoxinA was associated with a significant reduction in erythema, papules, pustules, and telangiectasias, up to 15 weeks, compared with saline. The treatment patients also experienced less burning and stinging that did those who received saline (J Drugs Dermatol. 2017 Jun 1;16[6]:549-54.)
Menopausal hot flashes: Dr. Rubin described one study of 60 patients with severe hot flashes that compared saline with botulinum toxin, injected in 40 sites (2 units per site), including the neck, hairline, scalp, and chest. At 60 days’ follow-up, those treated with botulinum toxin had a significant reduction in sweating and in the number and severity of hot flashes; these women also had improved mood in terms of depression and irritability (Dermatol Surg. 2011 Nov;37[11]:1579-83).
Androgenetic alopecia: In a 60-week study of 50 men with androgenetic alopecia (Hamilton ratings of II-IV), 150 units of botulinum toxin A was injected into the scalp muscles (temporalis, frontalis, periauricular, and occipital), and repeated 6 months later (Plast Reconstr Surg. 2010 Nov;126[5]:246e-8e). Among the 40 patients who completed the trial, 75% had a response, and from baseline to 48 weeks, there was an 18% increase in mean hair counts in a 2 cm area, and a“profound” 39% reduction in hair loss (as measured by hair counts on the pillow in the morning), Dr. Rubin noted.
“Presumably, this is because if you’re relaxing the scalp muscles you’re getting increased blood flow into the scalp,” including increased oxygenation, which decreases the conversion of testosterone to dihydrotestosterone and increases the conversion of testosterone to estradiol, he said.
In another study, 8 of 10 patients with androgenic alopecia has “good to excellent” results 24 weeks after botulinum toxin injections with 5 units per site at 30 sites. Referring to the increasing popularity of platelet-rich plasma (PRP) injections for male pattern alopecia, Dr. Rubin said that in his opinion “PRP certainly doesn’t do any better” than botulinum toxin for male pattern alopecia and is a much more involved injection, “so this is definitely something worth considering if you have more people coming into your practice thinking about injections for male pattern alopecia.”
Pore size and sebum production: A 2019 review of published studies of botulinum toxin A looking at the effect on sebum and pore size, Dr. Rubin said, found that most studies “suggest it does actually reduce pore size and sebum production” (J Cosmet Dermatol. 2019 Apr;18[2]:451-7).
This can be considered an option for those patients concerned about pore size, who are not satisfied with results of retinoid or laser treatment, he commented. This approach may not have an effect in all patients, so he advised first treating a small trial area, and photographing patients to record their level of improvement. “It’s rarely profound, but it’s additive, it’s one more thing you can do.”
Depression: These data include a study of 30 patients with major depression, half who received one onabotulinumtoxinA injection in the glabellar area as adjunctive treatment of depression. After 6 weeks, those who were treated had an average of 47% reduction in depression scores on the Hamilton Depression Rating Scale, compared with an average 9% reduction among those on placebo (J Psychiatr Res. 2012 May;46[5]:574-81). Two recent studies have had similar results, according to Dr. Rubin.
Results of another study, he said, raise the question of whether patients are less depressed because they are pleased with the cosmetic effects or if there is another explanation (J Am Acad Dermatol. 2016 Jan;74[1]:171-3.e1). The study, which included 59 patients with depression treated in the glabellar areas with botulinum toxin injections, found no association between severity of the furrows and degree of depression or between the degree of furrow correction and degree of relief from depression after treatment. “So the patients who had the most improvement were not necessarily the ones who were the least depressed afterwards,” he said.
These data imply that something else may be occurring that is not necessarily muscle related, he said.
Dr. Rubin said he had no relevant disclosures. SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – The list of Mark Rubin, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
There are data to support these uses, and there are data associating botulinum toxin treatment with improvement in depression, which suggest the effect may not be necessarily be related to improvement in appearance, said Dr. Rubin, who is in private practice in Beverly Hills, Calif., and is associate professor of dermatology at the University of California, San Diego.
Facial flushing: Very few people use botulinum toxin for facial flushing, but Dr. Rubin, who is among those who do not, described the data as “impressive.” Several trials, he noted, have found that very small doses can significantly reduce the amount of facial erythema, including an average 45% reduction after 60 days in one trial of 24 women (Acta Med Iran. 2016 Jul;54[7]:454-7).
In another study of 25 patients with facial erythema related to rosacea who were treated with 14-45 units intradermally to the nasal tip, bridge, and alae, there were statistically significant improvements in erythema 1, 2, and 3 months after treatment among the 15 with complete data (Dermatol Surg. 2015 Jan;41 Suppl 1:S9-16).
“If you’re using very small doses and they’re intradermal, there really is minimal risk you’re going to have a problem by inadvertently affecting musculature” in these patients, Dr. Rubin commented.
In another study of 9 patients with rosacea, treatment with incobotulinumtoxinA was associated with a significant reduction in erythema, papules, pustules, and telangiectasias, up to 15 weeks, compared with saline. The treatment patients also experienced less burning and stinging that did those who received saline (J Drugs Dermatol. 2017 Jun 1;16[6]:549-54.)
Menopausal hot flashes: Dr. Rubin described one study of 60 patients with severe hot flashes that compared saline with botulinum toxin, injected in 40 sites (2 units per site), including the neck, hairline, scalp, and chest. At 60 days’ follow-up, those treated with botulinum toxin had a significant reduction in sweating and in the number and severity of hot flashes; these women also had improved mood in terms of depression and irritability (Dermatol Surg. 2011 Nov;37[11]:1579-83).
Androgenetic alopecia: In a 60-week study of 50 men with androgenetic alopecia (Hamilton ratings of II-IV), 150 units of botulinum toxin A was injected into the scalp muscles (temporalis, frontalis, periauricular, and occipital), and repeated 6 months later (Plast Reconstr Surg. 2010 Nov;126[5]:246e-8e). Among the 40 patients who completed the trial, 75% had a response, and from baseline to 48 weeks, there was an 18% increase in mean hair counts in a 2 cm area, and a“profound” 39% reduction in hair loss (as measured by hair counts on the pillow in the morning), Dr. Rubin noted.
“Presumably, this is because if you’re relaxing the scalp muscles you’re getting increased blood flow into the scalp,” including increased oxygenation, which decreases the conversion of testosterone to dihydrotestosterone and increases the conversion of testosterone to estradiol, he said.
In another study, 8 of 10 patients with androgenic alopecia has “good to excellent” results 24 weeks after botulinum toxin injections with 5 units per site at 30 sites. Referring to the increasing popularity of platelet-rich plasma (PRP) injections for male pattern alopecia, Dr. Rubin said that in his opinion “PRP certainly doesn’t do any better” than botulinum toxin for male pattern alopecia and is a much more involved injection, “so this is definitely something worth considering if you have more people coming into your practice thinking about injections for male pattern alopecia.”
Pore size and sebum production: A 2019 review of published studies of botulinum toxin A looking at the effect on sebum and pore size, Dr. Rubin said, found that most studies “suggest it does actually reduce pore size and sebum production” (J Cosmet Dermatol. 2019 Apr;18[2]:451-7).
This can be considered an option for those patients concerned about pore size, who are not satisfied with results of retinoid or laser treatment, he commented. This approach may not have an effect in all patients, so he advised first treating a small trial area, and photographing patients to record their level of improvement. “It’s rarely profound, but it’s additive, it’s one more thing you can do.”
Depression: These data include a study of 30 patients with major depression, half who received one onabotulinumtoxinA injection in the glabellar area as adjunctive treatment of depression. After 6 weeks, those who were treated had an average of 47% reduction in depression scores on the Hamilton Depression Rating Scale, compared with an average 9% reduction among those on placebo (J Psychiatr Res. 2012 May;46[5]:574-81). Two recent studies have had similar results, according to Dr. Rubin.
Results of another study, he said, raise the question of whether patients are less depressed because they are pleased with the cosmetic effects or if there is another explanation (J Am Acad Dermatol. 2016 Jan;74[1]:171-3.e1). The study, which included 59 patients with depression treated in the glabellar areas with botulinum toxin injections, found no association between severity of the furrows and degree of depression or between the degree of furrow correction and degree of relief from depression after treatment. “So the patients who had the most improvement were not necessarily the ones who were the least depressed afterwards,” he said.
These data imply that something else may be occurring that is not necessarily muscle related, he said.
Dr. Rubin said he had no relevant disclosures. SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
LAHAINA, HAWAII – The list of Mark Rubin, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
There are data to support these uses, and there are data associating botulinum toxin treatment with improvement in depression, which suggest the effect may not be necessarily be related to improvement in appearance, said Dr. Rubin, who is in private practice in Beverly Hills, Calif., and is associate professor of dermatology at the University of California, San Diego.
Facial flushing: Very few people use botulinum toxin for facial flushing, but Dr. Rubin, who is among those who do not, described the data as “impressive.” Several trials, he noted, have found that very small doses can significantly reduce the amount of facial erythema, including an average 45% reduction after 60 days in one trial of 24 women (Acta Med Iran. 2016 Jul;54[7]:454-7).
In another study of 25 patients with facial erythema related to rosacea who were treated with 14-45 units intradermally to the nasal tip, bridge, and alae, there were statistically significant improvements in erythema 1, 2, and 3 months after treatment among the 15 with complete data (Dermatol Surg. 2015 Jan;41 Suppl 1:S9-16).
“If you’re using very small doses and they’re intradermal, there really is minimal risk you’re going to have a problem by inadvertently affecting musculature” in these patients, Dr. Rubin commented.
In another study of 9 patients with rosacea, treatment with incobotulinumtoxinA was associated with a significant reduction in erythema, papules, pustules, and telangiectasias, up to 15 weeks, compared with saline. The treatment patients also experienced less burning and stinging that did those who received saline (J Drugs Dermatol. 2017 Jun 1;16[6]:549-54.)
Menopausal hot flashes: Dr. Rubin described one study of 60 patients with severe hot flashes that compared saline with botulinum toxin, injected in 40 sites (2 units per site), including the neck, hairline, scalp, and chest. At 60 days’ follow-up, those treated with botulinum toxin had a significant reduction in sweating and in the number and severity of hot flashes; these women also had improved mood in terms of depression and irritability (Dermatol Surg. 2011 Nov;37[11]:1579-83).
Androgenetic alopecia: In a 60-week study of 50 men with androgenetic alopecia (Hamilton ratings of II-IV), 150 units of botulinum toxin A was injected into the scalp muscles (temporalis, frontalis, periauricular, and occipital), and repeated 6 months later (Plast Reconstr Surg. 2010 Nov;126[5]:246e-8e). Among the 40 patients who completed the trial, 75% had a response, and from baseline to 48 weeks, there was an 18% increase in mean hair counts in a 2 cm area, and a“profound” 39% reduction in hair loss (as measured by hair counts on the pillow in the morning), Dr. Rubin noted.
“Presumably, this is because if you’re relaxing the scalp muscles you’re getting increased blood flow into the scalp,” including increased oxygenation, which decreases the conversion of testosterone to dihydrotestosterone and increases the conversion of testosterone to estradiol, he said.
In another study, 8 of 10 patients with androgenic alopecia has “good to excellent” results 24 weeks after botulinum toxin injections with 5 units per site at 30 sites. Referring to the increasing popularity of platelet-rich plasma (PRP) injections for male pattern alopecia, Dr. Rubin said that in his opinion “PRP certainly doesn’t do any better” than botulinum toxin for male pattern alopecia and is a much more involved injection, “so this is definitely something worth considering if you have more people coming into your practice thinking about injections for male pattern alopecia.”
Pore size and sebum production: A 2019 review of published studies of botulinum toxin A looking at the effect on sebum and pore size, Dr. Rubin said, found that most studies “suggest it does actually reduce pore size and sebum production” (J Cosmet Dermatol. 2019 Apr;18[2]:451-7).
This can be considered an option for those patients concerned about pore size, who are not satisfied with results of retinoid or laser treatment, he commented. This approach may not have an effect in all patients, so he advised first treating a small trial area, and photographing patients to record their level of improvement. “It’s rarely profound, but it’s additive, it’s one more thing you can do.”
Depression: These data include a study of 30 patients with major depression, half who received one onabotulinumtoxinA injection in the glabellar area as adjunctive treatment of depression. After 6 weeks, those who were treated had an average of 47% reduction in depression scores on the Hamilton Depression Rating Scale, compared with an average 9% reduction among those on placebo (J Psychiatr Res. 2012 May;46[5]:574-81). Two recent studies have had similar results, according to Dr. Rubin.
Results of another study, he said, raise the question of whether patients are less depressed because they are pleased with the cosmetic effects or if there is another explanation (J Am Acad Dermatol. 2016 Jan;74[1]:171-3.e1). The study, which included 59 patients with depression treated in the glabellar areas with botulinum toxin injections, found no association between severity of the furrows and degree of depression or between the degree of furrow correction and degree of relief from depression after treatment. “So the patients who had the most improvement were not necessarily the ones who were the least depressed afterwards,” he said.
These data imply that something else may be occurring that is not necessarily muscle related, he said.
Dr. Rubin said he had no relevant disclosures. SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
Carotid endarterectomy surpasses stenting in elderly, asymptomatic patients
LOS ANGELES – Carotid artery stenting in older, asymptomatic patients with severe carotid artery stenosis is, in general, as bad an idea as it has already proven to be in symptomatic patients, with a multifold increase in adverse short- and mid-term outcomes, compared with similar older, asymptomatic patients who underwent endarterectomy, according to a combined-study analysis with more than 2,500 patients.
The risk for poor outcomes in patients with severe but asymptomatic carotid artery disease who underwent carotid artery stenting (CAS), compared with patients who instead underwent carotid endarterectomy (CEA) “abruptly increased around age 75,” in an analysis that combined data from the two major, published, randomized trials that compared these two interventions in this patient population, Jenifer H. Voeks, PhD said at the International Stroke Conference sponsored by the American Heart Association.
These results “largely mirror” the findings from a similar combined analysis of data from four major, randomized trials that compared CEA and CAS in patients with symptomatic carotid disease, she noted (Lancet. 2016 Mar 26;387[10025]:1305-11). The new findings in an expanded population of asymptomatic patients derived from two separate studies showed that, in patients aged 70 years or less, “CAS appears to be a reasonable alternative to CEA, but above age 70, and certainly above age 75, age-related risk factors such as cerebrovascular anatomy and underlying cerebral pathology should be carefully considered before selecting patients for CAS,” said Dr. Voeks, a neurology researcher at the Medical University of South Carolina, Charleston. Many experts also believe that, for asymptomatic patients, intensive medical management may have returned as an alternative to either of these invasive approaches for treating severe carotid stenosis and has achieved a level of equipoise that led to the launch of CREST 2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial). CREST 2 is comparing CEA and CAS with medical management, and is scheduled to report results in 2021.
The data for this analysis in asymptomatic patients came from the first CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial; N Engl J Med. 2010 Jul 1;363[1]:11-23), which included 1,181 asymptomatic patients (nearly half the total enrollment, with symptomatic patients making up the balance) and had no age ceiling, as well as all 1,453 patients from the ACT 1 trial, which enrolled exclusively asymptomatic patients and limited enrollment to patients aged 79 years or less (N Engl J Med. 2016 Mar 17;374[11]: 1011-20). Because the maximum age of patients in ACT 1 was 79 years, for this analysis Dr. Voeks and associates only included the 1,091 asymptomatic CREST patients who also were within the same age ceiling. The resulting cohort of 2,544 included 1,637 patients who underwent CAS and 907 who underwent CEA (because of a 3:1 randomization ratio in ACT 1), creating the largest data set to compare CAS and CEA by age in asymptomatic patients, Dr. Voeks noted. When subdivided by age, 30% of the cohort was younger that 65 years, 54% were 65-74, and 16% were 75-79.
The primary outcome the researchers used for their analysis was the combined incidence of periprocedural stroke, MI, or death, plus the incidence of ipsilateral stroke during 4 years of follow-up post procedure. Among patients who underwent CAS, this outcome occurred in roughly 9% of patients aged 75-79 years and in about 3% of those younger than 65 years, a hazard ratio of 2.9 that was statistically significant. In contrast, the incidence of the primary outcome among patients aged 65-74 years was just 30% higher, compared with patients aged less than 65 years, a difference that was not statistically significant.
Patients who underwent CEA showed no similar relationship between age and outcome. The incidence of the primary outcome among the CEA patients was roughly the same, about 3.5%, regardless of their age.
A second analysis that considered age as a continuous variable showed a sharply spiked increase in the risk for CAS patients, compared with CEA patients once they reached about age 73-75 years. Until about age 72, the rate of the primary outcome was nearly the same regardless of whether patients underwent CAS or CEA, but the risk for adverse outcomes rose “steeply” starting at about age 75 so that by age 79 the rate of the primary outcome approached 300% higher among the CAS patients compared with CEA patients, Dr. Voeks said.
She cautioned that the analysis included just 115 total primary-outcome events, which makes the incidence rate estimates somewhat imprecise, and that the data reflect outcomes in patients who were treated more than a decade ago, but these data remain the only reported results from large randomized trials that compared CAS and CEA in asymptomatic patients.
Dr. Voeks reported no disclosures.
SOURCE: Voeks JH al. Stroke. 2020 Feb 12;51[suppl 1], Abstract 70.
The role for carotid intervention in asymptomatic patients with severe carotid stenosis, usually defined as a stenosis that obstructs at least 70% of the carotid lumen, is controversial right now because intensive medical management has not been compared with invasive treatments, such as carotid endarterectomy and carotid stenting, for well over a decade. New drugs and new regimens have become treatment options for patients with advanced atherosclerotic carotid artery disease, and this has returned us to a state of equipoise for medical versus interventional management. That’s the premise behind CREST 2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial), which is comparing medical treatment against endarterectomy and against carotid stenting in a randomized study. The results may be available in 2021.
The new findings are very important for helping patients and their families make informed decisions. CAS is often perceived as the safer option for older patients because it is less traumatic and invasive than CEA. The data that Dr. Voeks reported show once again that this intuitive impression about CAS in the elderly is belied by the evidence. But the findings also require cautious interpretation because they came from a post hoc, subgroup analysis.
Mai N. Nguyen-Huynh, MD , is a vascular neurologist with Kaiser Permanente Northern California in Oakland. She had no relevant disclosures. She made these comments in an interview.
The role for carotid intervention in asymptomatic patients with severe carotid stenosis, usually defined as a stenosis that obstructs at least 70% of the carotid lumen, is controversial right now because intensive medical management has not been compared with invasive treatments, such as carotid endarterectomy and carotid stenting, for well over a decade. New drugs and new regimens have become treatment options for patients with advanced atherosclerotic carotid artery disease, and this has returned us to a state of equipoise for medical versus interventional management. That’s the premise behind CREST 2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial), which is comparing medical treatment against endarterectomy and against carotid stenting in a randomized study. The results may be available in 2021.
The new findings are very important for helping patients and their families make informed decisions. CAS is often perceived as the safer option for older patients because it is less traumatic and invasive than CEA. The data that Dr. Voeks reported show once again that this intuitive impression about CAS in the elderly is belied by the evidence. But the findings also require cautious interpretation because they came from a post hoc, subgroup analysis.
Mai N. Nguyen-Huynh, MD , is a vascular neurologist with Kaiser Permanente Northern California in Oakland. She had no relevant disclosures. She made these comments in an interview.
The role for carotid intervention in asymptomatic patients with severe carotid stenosis, usually defined as a stenosis that obstructs at least 70% of the carotid lumen, is controversial right now because intensive medical management has not been compared with invasive treatments, such as carotid endarterectomy and carotid stenting, for well over a decade. New drugs and new regimens have become treatment options for patients with advanced atherosclerotic carotid artery disease, and this has returned us to a state of equipoise for medical versus interventional management. That’s the premise behind CREST 2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial), which is comparing medical treatment against endarterectomy and against carotid stenting in a randomized study. The results may be available in 2021.
The new findings are very important for helping patients and their families make informed decisions. CAS is often perceived as the safer option for older patients because it is less traumatic and invasive than CEA. The data that Dr. Voeks reported show once again that this intuitive impression about CAS in the elderly is belied by the evidence. But the findings also require cautious interpretation because they came from a post hoc, subgroup analysis.
Mai N. Nguyen-Huynh, MD , is a vascular neurologist with Kaiser Permanente Northern California in Oakland. She had no relevant disclosures. She made these comments in an interview.
LOS ANGELES – Carotid artery stenting in older, asymptomatic patients with severe carotid artery stenosis is, in general, as bad an idea as it has already proven to be in symptomatic patients, with a multifold increase in adverse short- and mid-term outcomes, compared with similar older, asymptomatic patients who underwent endarterectomy, according to a combined-study analysis with more than 2,500 patients.
The risk for poor outcomes in patients with severe but asymptomatic carotid artery disease who underwent carotid artery stenting (CAS), compared with patients who instead underwent carotid endarterectomy (CEA) “abruptly increased around age 75,” in an analysis that combined data from the two major, published, randomized trials that compared these two interventions in this patient population, Jenifer H. Voeks, PhD said at the International Stroke Conference sponsored by the American Heart Association.
These results “largely mirror” the findings from a similar combined analysis of data from four major, randomized trials that compared CEA and CAS in patients with symptomatic carotid disease, she noted (Lancet. 2016 Mar 26;387[10025]:1305-11). The new findings in an expanded population of asymptomatic patients derived from two separate studies showed that, in patients aged 70 years or less, “CAS appears to be a reasonable alternative to CEA, but above age 70, and certainly above age 75, age-related risk factors such as cerebrovascular anatomy and underlying cerebral pathology should be carefully considered before selecting patients for CAS,” said Dr. Voeks, a neurology researcher at the Medical University of South Carolina, Charleston. Many experts also believe that, for asymptomatic patients, intensive medical management may have returned as an alternative to either of these invasive approaches for treating severe carotid stenosis and has achieved a level of equipoise that led to the launch of CREST 2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial). CREST 2 is comparing CEA and CAS with medical management, and is scheduled to report results in 2021.
The data for this analysis in asymptomatic patients came from the first CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial; N Engl J Med. 2010 Jul 1;363[1]:11-23), which included 1,181 asymptomatic patients (nearly half the total enrollment, with symptomatic patients making up the balance) and had no age ceiling, as well as all 1,453 patients from the ACT 1 trial, which enrolled exclusively asymptomatic patients and limited enrollment to patients aged 79 years or less (N Engl J Med. 2016 Mar 17;374[11]: 1011-20). Because the maximum age of patients in ACT 1 was 79 years, for this analysis Dr. Voeks and associates only included the 1,091 asymptomatic CREST patients who also were within the same age ceiling. The resulting cohort of 2,544 included 1,637 patients who underwent CAS and 907 who underwent CEA (because of a 3:1 randomization ratio in ACT 1), creating the largest data set to compare CAS and CEA by age in asymptomatic patients, Dr. Voeks noted. When subdivided by age, 30% of the cohort was younger that 65 years, 54% were 65-74, and 16% were 75-79.
The primary outcome the researchers used for their analysis was the combined incidence of periprocedural stroke, MI, or death, plus the incidence of ipsilateral stroke during 4 years of follow-up post procedure. Among patients who underwent CAS, this outcome occurred in roughly 9% of patients aged 75-79 years and in about 3% of those younger than 65 years, a hazard ratio of 2.9 that was statistically significant. In contrast, the incidence of the primary outcome among patients aged 65-74 years was just 30% higher, compared with patients aged less than 65 years, a difference that was not statistically significant.
Patients who underwent CEA showed no similar relationship between age and outcome. The incidence of the primary outcome among the CEA patients was roughly the same, about 3.5%, regardless of their age.
A second analysis that considered age as a continuous variable showed a sharply spiked increase in the risk for CAS patients, compared with CEA patients once they reached about age 73-75 years. Until about age 72, the rate of the primary outcome was nearly the same regardless of whether patients underwent CAS or CEA, but the risk for adverse outcomes rose “steeply” starting at about age 75 so that by age 79 the rate of the primary outcome approached 300% higher among the CAS patients compared with CEA patients, Dr. Voeks said.
She cautioned that the analysis included just 115 total primary-outcome events, which makes the incidence rate estimates somewhat imprecise, and that the data reflect outcomes in patients who were treated more than a decade ago, but these data remain the only reported results from large randomized trials that compared CAS and CEA in asymptomatic patients.
Dr. Voeks reported no disclosures.
SOURCE: Voeks JH al. Stroke. 2020 Feb 12;51[suppl 1], Abstract 70.
LOS ANGELES – Carotid artery stenting in older, asymptomatic patients with severe carotid artery stenosis is, in general, as bad an idea as it has already proven to be in symptomatic patients, with a multifold increase in adverse short- and mid-term outcomes, compared with similar older, asymptomatic patients who underwent endarterectomy, according to a combined-study analysis with more than 2,500 patients.
The risk for poor outcomes in patients with severe but asymptomatic carotid artery disease who underwent carotid artery stenting (CAS), compared with patients who instead underwent carotid endarterectomy (CEA) “abruptly increased around age 75,” in an analysis that combined data from the two major, published, randomized trials that compared these two interventions in this patient population, Jenifer H. Voeks, PhD said at the International Stroke Conference sponsored by the American Heart Association.
These results “largely mirror” the findings from a similar combined analysis of data from four major, randomized trials that compared CEA and CAS in patients with symptomatic carotid disease, she noted (Lancet. 2016 Mar 26;387[10025]:1305-11). The new findings in an expanded population of asymptomatic patients derived from two separate studies showed that, in patients aged 70 years or less, “CAS appears to be a reasonable alternative to CEA, but above age 70, and certainly above age 75, age-related risk factors such as cerebrovascular anatomy and underlying cerebral pathology should be carefully considered before selecting patients for CAS,” said Dr. Voeks, a neurology researcher at the Medical University of South Carolina, Charleston. Many experts also believe that, for asymptomatic patients, intensive medical management may have returned as an alternative to either of these invasive approaches for treating severe carotid stenosis and has achieved a level of equipoise that led to the launch of CREST 2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial). CREST 2 is comparing CEA and CAS with medical management, and is scheduled to report results in 2021.
The data for this analysis in asymptomatic patients came from the first CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial; N Engl J Med. 2010 Jul 1;363[1]:11-23), which included 1,181 asymptomatic patients (nearly half the total enrollment, with symptomatic patients making up the balance) and had no age ceiling, as well as all 1,453 patients from the ACT 1 trial, which enrolled exclusively asymptomatic patients and limited enrollment to patients aged 79 years or less (N Engl J Med. 2016 Mar 17;374[11]: 1011-20). Because the maximum age of patients in ACT 1 was 79 years, for this analysis Dr. Voeks and associates only included the 1,091 asymptomatic CREST patients who also were within the same age ceiling. The resulting cohort of 2,544 included 1,637 patients who underwent CAS and 907 who underwent CEA (because of a 3:1 randomization ratio in ACT 1), creating the largest data set to compare CAS and CEA by age in asymptomatic patients, Dr. Voeks noted. When subdivided by age, 30% of the cohort was younger that 65 years, 54% were 65-74, and 16% were 75-79.
The primary outcome the researchers used for their analysis was the combined incidence of periprocedural stroke, MI, or death, plus the incidence of ipsilateral stroke during 4 years of follow-up post procedure. Among patients who underwent CAS, this outcome occurred in roughly 9% of patients aged 75-79 years and in about 3% of those younger than 65 years, a hazard ratio of 2.9 that was statistically significant. In contrast, the incidence of the primary outcome among patients aged 65-74 years was just 30% higher, compared with patients aged less than 65 years, a difference that was not statistically significant.
Patients who underwent CEA showed no similar relationship between age and outcome. The incidence of the primary outcome among the CEA patients was roughly the same, about 3.5%, regardless of their age.
A second analysis that considered age as a continuous variable showed a sharply spiked increase in the risk for CAS patients, compared with CEA patients once they reached about age 73-75 years. Until about age 72, the rate of the primary outcome was nearly the same regardless of whether patients underwent CAS or CEA, but the risk for adverse outcomes rose “steeply” starting at about age 75 so that by age 79 the rate of the primary outcome approached 300% higher among the CAS patients compared with CEA patients, Dr. Voeks said.
She cautioned that the analysis included just 115 total primary-outcome events, which makes the incidence rate estimates somewhat imprecise, and that the data reflect outcomes in patients who were treated more than a decade ago, but these data remain the only reported results from large randomized trials that compared CAS and CEA in asymptomatic patients.
Dr. Voeks reported no disclosures.
SOURCE: Voeks JH al. Stroke. 2020 Feb 12;51[suppl 1], Abstract 70.
REPORTING FROM ISC 2020
Pulsed field catheter ablation shows huge clinical promise for AFib
NATIONAL HARBOR, MD. – Cardiac electrophysiologists have reported using pulsed field ablation, a new power source for catheter ablation of atrial fibrillation, on fewer than 150 patients worldwide in initial clinical studies, but its performance so far and the promise it carries for substantially improving the safety and efficacy of catheter ablation has convinced many experts that it represents the future for this intervention.
“I’m very excited about PFA [pulsed field ablation]. It may make everything else obsolete,” Andrea Natale, MD, said at the annual International AF Symposium. “We need to see more efficacy data, but just for safety alone there is no reason to use anything else,” commented Dr. Natale, executive medical director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin,Tex.
“The main issue is safety, and if PFA lives up to its promise, then [using it preferentially] is not a difficult decision,” commented Francis E. Marchlinski, MD, professor of medicine and director of electrophysiology at the University of Pennsylvania.
“The only question is whether it has good long-term efficacy” because so far no patients have been followed for longer than about a year after PFA treatment, noted Moussa Mansour, MD, director of the cardiac electrophysiology laboratory at Massachusetts General Hospital in Boston. “If that piece turns out to be true, then I think it will be a winner.”
Vivek Y. Reddy, MD, one of the few investigators to have already collaborated on clinical studies that used PFA to catheter ablate both in patients with paroxysmal and, more recently, persistent atrial fibrillation (AFib), put it this way: “I’m 99% sure” PFA will be the energy of choice in the near future for AFib catheter ablation. The 1% of uncertainty “is only because of what might be unknown, something we’re not expecting,” said Dr. Reddy, professor of medicine and director of the cardiac arrhythmia service at Mount Sinai Medical Center in New York.
He and his associates at a center in Prague and at a second site in Bordeaux, France, reported their collective experience in 2019 regarding use of PFA on 81 patients with symptomatic, paroxysmal AFib who had not responded to at least one antiarrhythmic drug (J Am Coll Cardiol. 2019 Jul;74[3]:315-26). During a session on PFA at the symposium, Pierre Jaïs, MD, a cardiac electrophysiologist and professor of cardiology at the University of Bordeaux, updated this experience to now include 113 patients treated by the end of 2019 at the same two centers plus now an added third site, an experience accumulated by a total of five operators. Fifty-one patients have now been followed for at least a year, with no “unexpected” safety events, said Dr. Jaïs, The most recent 88 patients underwent PFA without general anesthesia. The ablation technique has undergone several refinements during this experience, and with use of the most recent, biphasic protocol that’s so far treated 26 patients, 24 (92%) of the treated patients had no reconnected AFib circuits in their atrial tissue when they underwent remapping 3 months after their procedure.
Magnetic resonance imaging of the left atria of these patients after pulmonary vein isolation with PFA showed a uniquely homogeneous and continuous lesion that functionally isolated each vein from surrounding atrial tissue and denoted a more uniform and complete ablation, Dr. Jaïs noted. “I have never seen [an ablation] as homogeneous.” The Magnetic resonance pictures also showed that the esophagus in each treated patient remained completely undamaged. “Esophageal sparing is systematically observed,” along with phrenic nerve sparing that’s in notable contrast with what’s seen with conventional energy sources, he said. The images also indicated that edema was substantially reduced compared with both radiofrequency and cryoablation, while mechanical function of treated left atria has consistently been “well preserved.”
“For the first time, we can use extra power to ensure durable lesions without compromising safety,” Dr. Jaïs concluded. PFA appears to put AFib ablation “on the verge of a totally new era.”
The less extensive and briefer experience in patients with persistent AFib has been completely consistent. This included 25 patients who had not responded to at least one antiarrhythmic drug treated by either of two operators, one in Prague and the other in Split, Croatia. All 25 patients who underwent pulmonary vein isolation had the procedure successfully completed as assessed with acute mapping of arrhythmia circuits after ablation, and the 24 of these patients who also underwent posterior wall ablation with the PFA device all had a successful acute result according to mapping, Dr. Reddy reported. No patient had an adverse event. PFA treatments were relatively fast, with an average procedure time in this series of 132 minutes. Repeat mapping 3 months after treatment is still pending.
At the heart of PFA’s safety is its “myocardial selectivity” which has so far kept PFA from causing any esophageal or phrenic nerve injuries, two potential complications of conventional AFib catheter ablation with use of either radiofrequency or cryo energy. Dr. Reddy was quick to highlight that there is no absolute selectivity for myocardium. “If you create a big enough field, it will electroporate everything, but the margin [between safety and damage] seems wide enough to take advantage” of focally damaging myocardial tissue in the left atrium to disrupt arrhythmia circuits while sparing adjacent tissue. Irreversible electroporation is the means by which PFA destroys targets cells while leaving other tissue unscathed, and a precisely adjusted PFA signal can focus its lethal effect exclusively on myocardial cells, a feature of PFA that Dr. Reddy called “lucky.”
The pulsed field ablation studies have been sponsored by Farapulse, the company developing this device, which in May 2019 received breakthrough designation for priority review from the Food and Drug Administration.
Dr. Reddy and Dr. Jaïs are both consultants to and shareholders in Farapulse. Dr. Natale has received honoraria from or has been a consultant to Biotronik, Janssen, Medtronic, and St. Jude. Dr. Marchlinski has been a consultant to or has received honoraria from Abbott EP/St. Jude, Biotronik, and Medtronic. Dr. Mansour has been a consultant for Abbott and Medtronic, has an equity interest or stock options in NewPace and EPD Solutions, and has received research grants from Abbott, Boehringer Ingelheim, Pfizer, and Sentre Heart. In addition, all sources have received consulting fees, honoraria, and/or research grants from Biosense Webster and Boston Scientific.
NATIONAL HARBOR, MD. – Cardiac electrophysiologists have reported using pulsed field ablation, a new power source for catheter ablation of atrial fibrillation, on fewer than 150 patients worldwide in initial clinical studies, but its performance so far and the promise it carries for substantially improving the safety and efficacy of catheter ablation has convinced many experts that it represents the future for this intervention.
“I’m very excited about PFA [pulsed field ablation]. It may make everything else obsolete,” Andrea Natale, MD, said at the annual International AF Symposium. “We need to see more efficacy data, but just for safety alone there is no reason to use anything else,” commented Dr. Natale, executive medical director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin,Tex.
“The main issue is safety, and if PFA lives up to its promise, then [using it preferentially] is not a difficult decision,” commented Francis E. Marchlinski, MD, professor of medicine and director of electrophysiology at the University of Pennsylvania.
“The only question is whether it has good long-term efficacy” because so far no patients have been followed for longer than about a year after PFA treatment, noted Moussa Mansour, MD, director of the cardiac electrophysiology laboratory at Massachusetts General Hospital in Boston. “If that piece turns out to be true, then I think it will be a winner.”
Vivek Y. Reddy, MD, one of the few investigators to have already collaborated on clinical studies that used PFA to catheter ablate both in patients with paroxysmal and, more recently, persistent atrial fibrillation (AFib), put it this way: “I’m 99% sure” PFA will be the energy of choice in the near future for AFib catheter ablation. The 1% of uncertainty “is only because of what might be unknown, something we’re not expecting,” said Dr. Reddy, professor of medicine and director of the cardiac arrhythmia service at Mount Sinai Medical Center in New York.
He and his associates at a center in Prague and at a second site in Bordeaux, France, reported their collective experience in 2019 regarding use of PFA on 81 patients with symptomatic, paroxysmal AFib who had not responded to at least one antiarrhythmic drug (J Am Coll Cardiol. 2019 Jul;74[3]:315-26). During a session on PFA at the symposium, Pierre Jaïs, MD, a cardiac electrophysiologist and professor of cardiology at the University of Bordeaux, updated this experience to now include 113 patients treated by the end of 2019 at the same two centers plus now an added third site, an experience accumulated by a total of five operators. Fifty-one patients have now been followed for at least a year, with no “unexpected” safety events, said Dr. Jaïs, The most recent 88 patients underwent PFA without general anesthesia. The ablation technique has undergone several refinements during this experience, and with use of the most recent, biphasic protocol that’s so far treated 26 patients, 24 (92%) of the treated patients had no reconnected AFib circuits in their atrial tissue when they underwent remapping 3 months after their procedure.
Magnetic resonance imaging of the left atria of these patients after pulmonary vein isolation with PFA showed a uniquely homogeneous and continuous lesion that functionally isolated each vein from surrounding atrial tissue and denoted a more uniform and complete ablation, Dr. Jaïs noted. “I have never seen [an ablation] as homogeneous.” The Magnetic resonance pictures also showed that the esophagus in each treated patient remained completely undamaged. “Esophageal sparing is systematically observed,” along with phrenic nerve sparing that’s in notable contrast with what’s seen with conventional energy sources, he said. The images also indicated that edema was substantially reduced compared with both radiofrequency and cryoablation, while mechanical function of treated left atria has consistently been “well preserved.”
“For the first time, we can use extra power to ensure durable lesions without compromising safety,” Dr. Jaïs concluded. PFA appears to put AFib ablation “on the verge of a totally new era.”
The less extensive and briefer experience in patients with persistent AFib has been completely consistent. This included 25 patients who had not responded to at least one antiarrhythmic drug treated by either of two operators, one in Prague and the other in Split, Croatia. All 25 patients who underwent pulmonary vein isolation had the procedure successfully completed as assessed with acute mapping of arrhythmia circuits after ablation, and the 24 of these patients who also underwent posterior wall ablation with the PFA device all had a successful acute result according to mapping, Dr. Reddy reported. No patient had an adverse event. PFA treatments were relatively fast, with an average procedure time in this series of 132 minutes. Repeat mapping 3 months after treatment is still pending.
At the heart of PFA’s safety is its “myocardial selectivity” which has so far kept PFA from causing any esophageal or phrenic nerve injuries, two potential complications of conventional AFib catheter ablation with use of either radiofrequency or cryo energy. Dr. Reddy was quick to highlight that there is no absolute selectivity for myocardium. “If you create a big enough field, it will electroporate everything, but the margin [between safety and damage] seems wide enough to take advantage” of focally damaging myocardial tissue in the left atrium to disrupt arrhythmia circuits while sparing adjacent tissue. Irreversible electroporation is the means by which PFA destroys targets cells while leaving other tissue unscathed, and a precisely adjusted PFA signal can focus its lethal effect exclusively on myocardial cells, a feature of PFA that Dr. Reddy called “lucky.”
The pulsed field ablation studies have been sponsored by Farapulse, the company developing this device, which in May 2019 received breakthrough designation for priority review from the Food and Drug Administration.
Dr. Reddy and Dr. Jaïs are both consultants to and shareholders in Farapulse. Dr. Natale has received honoraria from or has been a consultant to Biotronik, Janssen, Medtronic, and St. Jude. Dr. Marchlinski has been a consultant to or has received honoraria from Abbott EP/St. Jude, Biotronik, and Medtronic. Dr. Mansour has been a consultant for Abbott and Medtronic, has an equity interest or stock options in NewPace and EPD Solutions, and has received research grants from Abbott, Boehringer Ingelheim, Pfizer, and Sentre Heart. In addition, all sources have received consulting fees, honoraria, and/or research grants from Biosense Webster and Boston Scientific.
NATIONAL HARBOR, MD. – Cardiac electrophysiologists have reported using pulsed field ablation, a new power source for catheter ablation of atrial fibrillation, on fewer than 150 patients worldwide in initial clinical studies, but its performance so far and the promise it carries for substantially improving the safety and efficacy of catheter ablation has convinced many experts that it represents the future for this intervention.
“I’m very excited about PFA [pulsed field ablation]. It may make everything else obsolete,” Andrea Natale, MD, said at the annual International AF Symposium. “We need to see more efficacy data, but just for safety alone there is no reason to use anything else,” commented Dr. Natale, executive medical director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin,Tex.
“The main issue is safety, and if PFA lives up to its promise, then [using it preferentially] is not a difficult decision,” commented Francis E. Marchlinski, MD, professor of medicine and director of electrophysiology at the University of Pennsylvania.
“The only question is whether it has good long-term efficacy” because so far no patients have been followed for longer than about a year after PFA treatment, noted Moussa Mansour, MD, director of the cardiac electrophysiology laboratory at Massachusetts General Hospital in Boston. “If that piece turns out to be true, then I think it will be a winner.”
Vivek Y. Reddy, MD, one of the few investigators to have already collaborated on clinical studies that used PFA to catheter ablate both in patients with paroxysmal and, more recently, persistent atrial fibrillation (AFib), put it this way: “I’m 99% sure” PFA will be the energy of choice in the near future for AFib catheter ablation. The 1% of uncertainty “is only because of what might be unknown, something we’re not expecting,” said Dr. Reddy, professor of medicine and director of the cardiac arrhythmia service at Mount Sinai Medical Center in New York.
He and his associates at a center in Prague and at a second site in Bordeaux, France, reported their collective experience in 2019 regarding use of PFA on 81 patients with symptomatic, paroxysmal AFib who had not responded to at least one antiarrhythmic drug (J Am Coll Cardiol. 2019 Jul;74[3]:315-26). During a session on PFA at the symposium, Pierre Jaïs, MD, a cardiac electrophysiologist and professor of cardiology at the University of Bordeaux, updated this experience to now include 113 patients treated by the end of 2019 at the same two centers plus now an added third site, an experience accumulated by a total of five operators. Fifty-one patients have now been followed for at least a year, with no “unexpected” safety events, said Dr. Jaïs, The most recent 88 patients underwent PFA without general anesthesia. The ablation technique has undergone several refinements during this experience, and with use of the most recent, biphasic protocol that’s so far treated 26 patients, 24 (92%) of the treated patients had no reconnected AFib circuits in their atrial tissue when they underwent remapping 3 months after their procedure.
Magnetic resonance imaging of the left atria of these patients after pulmonary vein isolation with PFA showed a uniquely homogeneous and continuous lesion that functionally isolated each vein from surrounding atrial tissue and denoted a more uniform and complete ablation, Dr. Jaïs noted. “I have never seen [an ablation] as homogeneous.” The Magnetic resonance pictures also showed that the esophagus in each treated patient remained completely undamaged. “Esophageal sparing is systematically observed,” along with phrenic nerve sparing that’s in notable contrast with what’s seen with conventional energy sources, he said. The images also indicated that edema was substantially reduced compared with both radiofrequency and cryoablation, while mechanical function of treated left atria has consistently been “well preserved.”
“For the first time, we can use extra power to ensure durable lesions without compromising safety,” Dr. Jaïs concluded. PFA appears to put AFib ablation “on the verge of a totally new era.”
The less extensive and briefer experience in patients with persistent AFib has been completely consistent. This included 25 patients who had not responded to at least one antiarrhythmic drug treated by either of two operators, one in Prague and the other in Split, Croatia. All 25 patients who underwent pulmonary vein isolation had the procedure successfully completed as assessed with acute mapping of arrhythmia circuits after ablation, and the 24 of these patients who also underwent posterior wall ablation with the PFA device all had a successful acute result according to mapping, Dr. Reddy reported. No patient had an adverse event. PFA treatments were relatively fast, with an average procedure time in this series of 132 minutes. Repeat mapping 3 months after treatment is still pending.
At the heart of PFA’s safety is its “myocardial selectivity” which has so far kept PFA from causing any esophageal or phrenic nerve injuries, two potential complications of conventional AFib catheter ablation with use of either radiofrequency or cryo energy. Dr. Reddy was quick to highlight that there is no absolute selectivity for myocardium. “If you create a big enough field, it will electroporate everything, but the margin [between safety and damage] seems wide enough to take advantage” of focally damaging myocardial tissue in the left atrium to disrupt arrhythmia circuits while sparing adjacent tissue. Irreversible electroporation is the means by which PFA destroys targets cells while leaving other tissue unscathed, and a precisely adjusted PFA signal can focus its lethal effect exclusively on myocardial cells, a feature of PFA that Dr. Reddy called “lucky.”
The pulsed field ablation studies have been sponsored by Farapulse, the company developing this device, which in May 2019 received breakthrough designation for priority review from the Food and Drug Administration.
Dr. Reddy and Dr. Jaïs are both consultants to and shareholders in Farapulse. Dr. Natale has received honoraria from or has been a consultant to Biotronik, Janssen, Medtronic, and St. Jude. Dr. Marchlinski has been a consultant to or has received honoraria from Abbott EP/St. Jude, Biotronik, and Medtronic. Dr. Mansour has been a consultant for Abbott and Medtronic, has an equity interest or stock options in NewPace and EPD Solutions, and has received research grants from Abbott, Boehringer Ingelheim, Pfizer, and Sentre Heart. In addition, all sources have received consulting fees, honoraria, and/or research grants from Biosense Webster and Boston Scientific.
EXPERT ANALYSIS FROM THE AF SYMPOSIUM 2020
Study links CRP, FC monitoring, more remission
AUSTIN, TEX. – A program of frequent monitoring in Crohn’s disease and ulcerative colitis that includes fecal calprotectin (FC) and C-reactive protein (CRP) testing may be cost effective to significantly reduce disease recurrence and hospitalization rates, according to a review of published studies presented at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
“Some data show that calprotectin levels rise months before the onset of symptoms, so it’s my practice that every 3-4 months patients should undergo CRP and calprotectin testing, if they’re willing to do so, while they’re on biologic therapy,” Frank I. Scott, MD, MSCE, of the University of Colorado in Aurora, Denver, said in an interview after the presentation.
Regular monitoring of the two levels makes sense as the practice of tight control of IBD symptoms and treating to target has emerged over the past decade, Dr. Scott said. He noted the 2015 Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) guidelines called for using CRP and FC as adjunctive targets only in symptom assessment (Am J Gastroenterol. 2015:110[9]:1324-58). “I argue that we’ve had a growing body of literature that we should be using these tests regularly as well,” he said.
STRIDE calls for endoscopic assessment 6-9 months after therapy change and consideration of cross-sectional imaging if the small bowel is involved, with assessment every 3 months until symptoms improve and then every 6-12 months thereafter.
However, Dr. Scott noted potential drawbacks to these follow-up steps. “They currently focus on clinical symptoms in the short-term follow-up, and we know from looking at our disease activity indices, such as the CDAI [Crohn’s disease activity index] or Harvey-Bradshaw index, that they don’t always perfectly correlate with actual mucosal healing or resolution of inflammation in Crohn’s or [ulcerative colitis],” he said, pointing to a 2014 study that found CDAI had an area under the curve of 0.57, “which is pretty poor correlation” (Gut. 2014;63[1]:88-95).
Whereas a study of 2,499 patients that showed CRP had an area under the curve of 0.72 and FC of 0.89 (Am J Gastroentrol. 2015;110[6]:802-19). “CRP is a really attractive potential noninvasive marker of inflammation,” he said. “It’s relatively inexpensive, it’s widely available, and the cutoff ranges are well defined.”
He noted four potential drawbacks of CRP: the false-positive rate is relatively high; as a marker of systemic inflammation it’s not specific to the GI tract; false negatives have been well described, with up to 15% of patients not registering a response; and levels can depend on disease location. “Those with isolated ileal disease, for instance, may have relatively low CRP elevations when their disease is active,” Dr. Scott said.
Stool-based FC “represents a potentially more attractive option,” Dr. Scott said. Along with an area under the curve superior to CRP, FC has a documented sensitivity and specificity of 88% and 73%, respectively, versus 49% and 92% for CRP. Drawbacks of fecal calprotectin are that it’s specific to the GI tract but not inflammatory bowel disease, it costs more, and insurance coverage is not as universal as it is for CRP, although more carriers are covering the test, he said.
“However, we do know that through clinical trial data that the use of CRP and FC, in addition to clinical symptom monitoring, does appear to improve care,” Dr. Scott said, noting that the CALM trial of tight disease control through the frequent use of biochemical markers of inflammation with anti–tumor necrosis therapy bore this out (Lancet. 2018;390[10114]:2779-89). “This trial was able to demonstrate at 48 weeks that mucosal healing rates were improved in those receiving CRP and FC monitoring, compared to symptom monitoring alone, with higher rates of steroid-free remission at each visit, which persisted over the follow-up time.”
Dr. Scott also cited a post hoc analysis of CALM trial data that validated CRP and FC monitoring to improve steroid-free remission rates and other outcomes (Gut. 2019 Jul 8. doi: 10.1136/gutjnl-2019-318256). That trial reported steroid-free remission rates of 39.3% with clinical management and 59.8% with tight control, a 34% overall difference (P less than .001). “And it was cost effective to incorporate this monitoring at a cost of about $24,300 per quality-adjusted life-year, well below the typically used $50,000 willingness-to-pay threshold when considering new tests,” Dr. Scott said.
Dr. Scott acknowledged that FC testing may pose some inconvenience to patients when collecting their stool samples, but accuracy has improved. “Laboratories are becoming more reliable in terms of what the values are, and the cutoffs are becoming more defined as far as what’s positive and what’s negative, so it’s good way to monitor whether or not patients are at increased risk of a future flare,” he said.
Dr. Scott reported financial relationships with Takeda, Janssen, Merck and PRIME.
SOURCE: Scott FI et al. Crohn’s & Colitis Congress 2020, Session Sp125.
AUSTIN, TEX. – A program of frequent monitoring in Crohn’s disease and ulcerative colitis that includes fecal calprotectin (FC) and C-reactive protein (CRP) testing may be cost effective to significantly reduce disease recurrence and hospitalization rates, according to a review of published studies presented at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
“Some data show that calprotectin levels rise months before the onset of symptoms, so it’s my practice that every 3-4 months patients should undergo CRP and calprotectin testing, if they’re willing to do so, while they’re on biologic therapy,” Frank I. Scott, MD, MSCE, of the University of Colorado in Aurora, Denver, said in an interview after the presentation.
Regular monitoring of the two levels makes sense as the practice of tight control of IBD symptoms and treating to target has emerged over the past decade, Dr. Scott said. He noted the 2015 Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) guidelines called for using CRP and FC as adjunctive targets only in symptom assessment (Am J Gastroenterol. 2015:110[9]:1324-58). “I argue that we’ve had a growing body of literature that we should be using these tests regularly as well,” he said.
STRIDE calls for endoscopic assessment 6-9 months after therapy change and consideration of cross-sectional imaging if the small bowel is involved, with assessment every 3 months until symptoms improve and then every 6-12 months thereafter.
However, Dr. Scott noted potential drawbacks to these follow-up steps. “They currently focus on clinical symptoms in the short-term follow-up, and we know from looking at our disease activity indices, such as the CDAI [Crohn’s disease activity index] or Harvey-Bradshaw index, that they don’t always perfectly correlate with actual mucosal healing or resolution of inflammation in Crohn’s or [ulcerative colitis],” he said, pointing to a 2014 study that found CDAI had an area under the curve of 0.57, “which is pretty poor correlation” (Gut. 2014;63[1]:88-95).
Whereas a study of 2,499 patients that showed CRP had an area under the curve of 0.72 and FC of 0.89 (Am J Gastroentrol. 2015;110[6]:802-19). “CRP is a really attractive potential noninvasive marker of inflammation,” he said. “It’s relatively inexpensive, it’s widely available, and the cutoff ranges are well defined.”
He noted four potential drawbacks of CRP: the false-positive rate is relatively high; as a marker of systemic inflammation it’s not specific to the GI tract; false negatives have been well described, with up to 15% of patients not registering a response; and levels can depend on disease location. “Those with isolated ileal disease, for instance, may have relatively low CRP elevations when their disease is active,” Dr. Scott said.
Stool-based FC “represents a potentially more attractive option,” Dr. Scott said. Along with an area under the curve superior to CRP, FC has a documented sensitivity and specificity of 88% and 73%, respectively, versus 49% and 92% for CRP. Drawbacks of fecal calprotectin are that it’s specific to the GI tract but not inflammatory bowel disease, it costs more, and insurance coverage is not as universal as it is for CRP, although more carriers are covering the test, he said.
“However, we do know that through clinical trial data that the use of CRP and FC, in addition to clinical symptom monitoring, does appear to improve care,” Dr. Scott said, noting that the CALM trial of tight disease control through the frequent use of biochemical markers of inflammation with anti–tumor necrosis therapy bore this out (Lancet. 2018;390[10114]:2779-89). “This trial was able to demonstrate at 48 weeks that mucosal healing rates were improved in those receiving CRP and FC monitoring, compared to symptom monitoring alone, with higher rates of steroid-free remission at each visit, which persisted over the follow-up time.”
Dr. Scott also cited a post hoc analysis of CALM trial data that validated CRP and FC monitoring to improve steroid-free remission rates and other outcomes (Gut. 2019 Jul 8. doi: 10.1136/gutjnl-2019-318256). That trial reported steroid-free remission rates of 39.3% with clinical management and 59.8% with tight control, a 34% overall difference (P less than .001). “And it was cost effective to incorporate this monitoring at a cost of about $24,300 per quality-adjusted life-year, well below the typically used $50,000 willingness-to-pay threshold when considering new tests,” Dr. Scott said.
Dr. Scott acknowledged that FC testing may pose some inconvenience to patients when collecting their stool samples, but accuracy has improved. “Laboratories are becoming more reliable in terms of what the values are, and the cutoffs are becoming more defined as far as what’s positive and what’s negative, so it’s good way to monitor whether or not patients are at increased risk of a future flare,” he said.
Dr. Scott reported financial relationships with Takeda, Janssen, Merck and PRIME.
SOURCE: Scott FI et al. Crohn’s & Colitis Congress 2020, Session Sp125.
AUSTIN, TEX. – A program of frequent monitoring in Crohn’s disease and ulcerative colitis that includes fecal calprotectin (FC) and C-reactive protein (CRP) testing may be cost effective to significantly reduce disease recurrence and hospitalization rates, according to a review of published studies presented at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
“Some data show that calprotectin levels rise months before the onset of symptoms, so it’s my practice that every 3-4 months patients should undergo CRP and calprotectin testing, if they’re willing to do so, while they’re on biologic therapy,” Frank I. Scott, MD, MSCE, of the University of Colorado in Aurora, Denver, said in an interview after the presentation.
Regular monitoring of the two levels makes sense as the practice of tight control of IBD symptoms and treating to target has emerged over the past decade, Dr. Scott said. He noted the 2015 Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) guidelines called for using CRP and FC as adjunctive targets only in symptom assessment (Am J Gastroenterol. 2015:110[9]:1324-58). “I argue that we’ve had a growing body of literature that we should be using these tests regularly as well,” he said.
STRIDE calls for endoscopic assessment 6-9 months after therapy change and consideration of cross-sectional imaging if the small bowel is involved, with assessment every 3 months until symptoms improve and then every 6-12 months thereafter.
However, Dr. Scott noted potential drawbacks to these follow-up steps. “They currently focus on clinical symptoms in the short-term follow-up, and we know from looking at our disease activity indices, such as the CDAI [Crohn’s disease activity index] or Harvey-Bradshaw index, that they don’t always perfectly correlate with actual mucosal healing or resolution of inflammation in Crohn’s or [ulcerative colitis],” he said, pointing to a 2014 study that found CDAI had an area under the curve of 0.57, “which is pretty poor correlation” (Gut. 2014;63[1]:88-95).
Whereas a study of 2,499 patients that showed CRP had an area under the curve of 0.72 and FC of 0.89 (Am J Gastroentrol. 2015;110[6]:802-19). “CRP is a really attractive potential noninvasive marker of inflammation,” he said. “It’s relatively inexpensive, it’s widely available, and the cutoff ranges are well defined.”
He noted four potential drawbacks of CRP: the false-positive rate is relatively high; as a marker of systemic inflammation it’s not specific to the GI tract; false negatives have been well described, with up to 15% of patients not registering a response; and levels can depend on disease location. “Those with isolated ileal disease, for instance, may have relatively low CRP elevations when their disease is active,” Dr. Scott said.
Stool-based FC “represents a potentially more attractive option,” Dr. Scott said. Along with an area under the curve superior to CRP, FC has a documented sensitivity and specificity of 88% and 73%, respectively, versus 49% and 92% for CRP. Drawbacks of fecal calprotectin are that it’s specific to the GI tract but not inflammatory bowel disease, it costs more, and insurance coverage is not as universal as it is for CRP, although more carriers are covering the test, he said.
“However, we do know that through clinical trial data that the use of CRP and FC, in addition to clinical symptom monitoring, does appear to improve care,” Dr. Scott said, noting that the CALM trial of tight disease control through the frequent use of biochemical markers of inflammation with anti–tumor necrosis therapy bore this out (Lancet. 2018;390[10114]:2779-89). “This trial was able to demonstrate at 48 weeks that mucosal healing rates were improved in those receiving CRP and FC monitoring, compared to symptom monitoring alone, with higher rates of steroid-free remission at each visit, which persisted over the follow-up time.”
Dr. Scott also cited a post hoc analysis of CALM trial data that validated CRP and FC monitoring to improve steroid-free remission rates and other outcomes (Gut. 2019 Jul 8. doi: 10.1136/gutjnl-2019-318256). That trial reported steroid-free remission rates of 39.3% with clinical management and 59.8% with tight control, a 34% overall difference (P less than .001). “And it was cost effective to incorporate this monitoring at a cost of about $24,300 per quality-adjusted life-year, well below the typically used $50,000 willingness-to-pay threshold when considering new tests,” Dr. Scott said.
Dr. Scott acknowledged that FC testing may pose some inconvenience to patients when collecting their stool samples, but accuracy has improved. “Laboratories are becoming more reliable in terms of what the values are, and the cutoffs are becoming more defined as far as what’s positive and what’s negative, so it’s good way to monitor whether or not patients are at increased risk of a future flare,” he said.
Dr. Scott reported financial relationships with Takeda, Janssen, Merck and PRIME.
SOURCE: Scott FI et al. Crohn’s & Colitis Congress 2020, Session Sp125.
REPORTING FROM CROHN’S & COLITIS CONGRESS