LIVERPOOL, ENGLAND – Serum levels of the cardiac biomarker troponin might prove useful for assessing the risk of death from cardiovascular causes in patients with inflammatory arthritis, according to study findings presented at the British Society for Rheumatology annual conference.

“In this analysis we have shown that baseline troponin levels predict cardiovascular death in inflammatory arthritis, and this association is independent of the traditional risk factors, inflammation, and disease characteristics at baseline,” said study author Sarah Skeoch, MBChB, who works at the Arthritis Research UK Centre for Epidemiology in the division of musculoskeletal and dermatological sciences at the University of Manchester (England).

Sara Freeman/MDedge News

The median follow up was 11.2 years, totaling 11,237 person-years, and during that time 158 deaths occurred, of which 27 were due to ischemic events. The median time from inclusion in NOAR to death was 7.4 years.

When levels of hs-TnI were separated into tertiles, a 12.5-fold increased risk was observed when comparing patients in the highest (more than 7.7 pg/mL) to lowest tertiles (less than 5.2 pg/mL).

“The magnitude of risk between the highest and the lowest tertile was much greater than observed in the general population,” Dr. Skeoch said, and although not directly comparable, she said the hazard ratios were 12.5 and 1.67, “which again suggests that troponin may be an effective tool or addition to the risk prediction models in inflammatory arthritis.”

Unlike some biomarkers, assays to assess troponin are already available in the clinic, Dr. Skeoch commented, “so if further work by us and other groups do suggest a role for troponin, this could be translated fairly rapidly into clinical practice.”

Further research needs to look at why troponin is raised and what is its relationship to other risk factors. “There is a strong association with traditional risk factors such as lipids, so it would stand to reason that managing those risk factors, as well as lifestyle factors, would have a positive impact,” Dr. Skeoch suggested.

The NOAR register is funded by Arthritis Research UK and the U.K. National Institute for Health Research. Dr. Skeoch and her coauthors had no relevant financial conflicts of interest.

SOURCE: Skeoch S et al. BSR 2018. Rheumatology. 2018;57[Suppl. 3]:key075.192.

LIVERPOOL, ENGLAND – Serum levels of the cardiac biomarker troponin might prove useful for assessing the risk of death from cardiovascular causes in patients with inflammatory arthritis, according to study findings presented at the British Society for Rheumatology annual conference.

“In this analysis we have shown that baseline troponin levels predict cardiovascular death in inflammatory arthritis, and this association is independent of the traditional risk factors, inflammation, and disease characteristics at baseline,” said study author Sarah Skeoch, MBChB, who works at the Arthritis Research UK Centre for Epidemiology in the division of musculoskeletal and dermatological sciences at the University of Manchester (England).

Sara Freeman/MDedge News

The median follow up was 11.2 years, totaling 11,237 person-years, and during that time 158 deaths occurred, of which 27 were due to ischemic events. The median time from inclusion in NOAR to death was 7.4 years.

When levels of hs-TnI were separated into tertiles, a 12.5-fold increased risk was observed when comparing patients in the highest (more than 7.7 pg/mL) to lowest tertiles (less than 5.2 pg/mL).

“The magnitude of risk between the highest and the lowest tertile was much greater than observed in the general population,” Dr. Skeoch said, and although not directly comparable, she said the hazard ratios were 12.5 and 1.67, “which again suggests that troponin may be an effective tool or addition to the risk prediction models in inflammatory arthritis.”

Unlike some biomarkers, assays to assess troponin are already available in the clinic, Dr. Skeoch commented, “so if further work by us and other groups do suggest a role for troponin, this could be translated fairly rapidly into clinical practice.”

Further research needs to look at why troponin is raised and what is its relationship to other risk factors. “There is a strong association with traditional risk factors such as lipids, so it would stand to reason that managing those risk factors, as well as lifestyle factors, would have a positive impact,” Dr. Skeoch suggested.

The NOAR register is funded by Arthritis Research UK and the U.K. National Institute for Health Research. Dr. Skeoch and her coauthors had no relevant financial conflicts of interest.

SOURCE: Skeoch S et al. BSR 2018. Rheumatology. 2018;57[Suppl. 3]:key075.192.

LIVERPOOL, ENGLAND – Serum levels of the cardiac biomarker troponin might prove useful for assessing the risk of death from cardiovascular causes in patients with inflammatory arthritis, according to study findings presented at the British Society for Rheumatology annual conference.

“In this analysis we have shown that baseline troponin levels predict cardiovascular death in inflammatory arthritis, and this association is independent of the traditional risk factors, inflammation, and disease characteristics at baseline,” said study author Sarah Skeoch, MBChB, who works at the Arthritis Research UK Centre for Epidemiology in the division of musculoskeletal and dermatological sciences at the University of Manchester (England).

Sara Freeman/MDedge News

The median follow up was 11.2 years, totaling 11,237 person-years, and during that time 158 deaths occurred, of which 27 were due to ischemic events. The median time from inclusion in NOAR to death was 7.4 years.

When levels of hs-TnI were separated into tertiles, a 12.5-fold increased risk was observed when comparing patients in the highest (more than 7.7 pg/mL) to lowest tertiles (less than 5.2 pg/mL).

“The magnitude of risk between the highest and the lowest tertile was much greater than observed in the general population,” Dr. Skeoch said, and although not directly comparable, she said the hazard ratios were 12.5 and 1.67, “which again suggests that troponin may be an effective tool or addition to the risk prediction models in inflammatory arthritis.”

Unlike some biomarkers, assays to assess troponin are already available in the clinic, Dr. Skeoch commented, “so if further work by us and other groups do suggest a role for troponin, this could be translated fairly rapidly into clinical practice.”

Further research needs to look at why troponin is raised and what is its relationship to other risk factors. “There is a strong association with traditional risk factors such as lipids, so it would stand to reason that managing those risk factors, as well as lifestyle factors, would have a positive impact,” Dr. Skeoch suggested.

The NOAR register is funded by Arthritis Research UK and the U.K. National Institute for Health Research. Dr. Skeoch and her coauthors had no relevant financial conflicts of interest.

SOURCE: Skeoch S et al. BSR 2018. Rheumatology. 2018;57[Suppl. 3]:key075.192.

Treatment with tralokinumab, a fully human monoclonal antibody that binds to and neutralizes interleukin-13 (IL-13), was associated with improvements in disease symptoms in patients with moderate to severe atopic dermatitis (AD), in a recent phase 2b study published in the Journal of Allergy and Clinical Immunology.

The randomized, double-blind, placebo-controlled, dose-ranging study assigned 204 patients to receive placebo or 45 mg, 150 mg, or 300 mg of tralokinumab administered subcutaneously every second week for 12 weeks. The groups had similar demographics and disease characteristics. The patients were aged 15-75 years and had Eczema Area and Severity Index (EASI) scores of 12 or more and an Investigator Global Assessment (IGA) score of 3 or higher. The coprimary endpoints were change in EASI from baseline to week 12 and the percentage of patients with either 0 (clear) or 1 (almost clear) on the IGA scale.

The higher dosages of tralokinumab showed the greatest adjusted mean differences in EASI scores: reductions of 4.36 for the 150-mg group (P = .03) and 4.94 for the 300-mg group (P = .01), compared with placebo. The changes in the 300-mg group were apparent as early as 4 weeks into treatment and were maintained beyond the 12-week mark. The greatest differences, compared with placebo, in IGA were seen in the 300-mg group as well.

Furthermore, patients who had high levels of biomarkers associated with IL-13 showed greater improvements than those seen in the intention-to-treat population at large. By week 12, patient-reported pruritus was also improved, and there were improvements in Dermatology Quality of Life Index (which did not persist past 12 weeks).

Most treatment-emergent adverse events were considered only mild or moderate, and the few more serious events were deemed unrelated to the study drug. The most common adverse events were upper respiratory infections and headaches.

“Participants entering the study had not achieved an adequate response to stable topical glucocorticoids during the 2-week run-in period and, therefore, represent a population with moderate to severe AD and major unmet treatment needs,” the investigators wrote. “The clinically meaningful benefits observed by combining tralokinumab treatment with topical glucocorticoids suggests that tralokinumab could demonstrate improvements in participants whose symptoms cannot be effectively controlled by topical glucocorticoids alone.”

The study was funded by MedImmune, a member of the AstraZeneca Group. Five authors were or are employees of the company; the three remaining authors had disclosures related to numerous pharmaceutical companies, including two with disclosures that included MedImmune.

[email protected]

SOURCE: Wollenberg A et al. J Allergy Clin Immunol. 2018 Jun 12. doi: 10.1016/j.jaci.2018.05.029.

Treatment with tralokinumab, a fully human monoclonal antibody that binds to and neutralizes interleukin-13 (IL-13), was associated with improvements in disease symptoms in patients with moderate to severe atopic dermatitis (AD), in a recent phase 2b study published in the Journal of Allergy and Clinical Immunology.

The randomized, double-blind, placebo-controlled, dose-ranging study assigned 204 patients to receive placebo or 45 mg, 150 mg, or 300 mg of tralokinumab administered subcutaneously every second week for 12 weeks. The groups had similar demographics and disease characteristics. The patients were aged 15-75 years and had Eczema Area and Severity Index (EASI) scores of 12 or more and an Investigator Global Assessment (IGA) score of 3 or higher. The coprimary endpoints were change in EASI from baseline to week 12 and the percentage of patients with either 0 (clear) or 1 (almost clear) on the IGA scale.

The higher dosages of tralokinumab showed the greatest adjusted mean differences in EASI scores: reductions of 4.36 for the 150-mg group (P = .03) and 4.94 for the 300-mg group (P = .01), compared with placebo. The changes in the 300-mg group were apparent as early as 4 weeks into treatment and were maintained beyond the 12-week mark. The greatest differences, compared with placebo, in IGA were seen in the 300-mg group as well.

Furthermore, patients who had high levels of biomarkers associated with IL-13 showed greater improvements than those seen in the intention-to-treat population at large. By week 12, patient-reported pruritus was also improved, and there were improvements in Dermatology Quality of Life Index (which did not persist past 12 weeks).

Most treatment-emergent adverse events were considered only mild or moderate, and the few more serious events were deemed unrelated to the study drug. The most common adverse events were upper respiratory infections and headaches.

“Participants entering the study had not achieved an adequate response to stable topical glucocorticoids during the 2-week run-in period and, therefore, represent a population with moderate to severe AD and major unmet treatment needs,” the investigators wrote. “The clinically meaningful benefits observed by combining tralokinumab treatment with topical glucocorticoids suggests that tralokinumab could demonstrate improvements in participants whose symptoms cannot be effectively controlled by topical glucocorticoids alone.”

The study was funded by MedImmune, a member of the AstraZeneca Group. Five authors were or are employees of the company; the three remaining authors had disclosures related to numerous pharmaceutical companies, including two with disclosures that included MedImmune.

[email protected]

SOURCE: Wollenberg A et al. J Allergy Clin Immunol. 2018 Jun 12. doi: 10.1016/j.jaci.2018.05.029.

Treatment with tralokinumab, a fully human monoclonal antibody that binds to and neutralizes interleukin-13 (IL-13), was associated with improvements in disease symptoms in patients with moderate to severe atopic dermatitis (AD), in a recent phase 2b study published in the Journal of Allergy and Clinical Immunology.

The randomized, double-blind, placebo-controlled, dose-ranging study assigned 204 patients to receive placebo or 45 mg, 150 mg, or 300 mg of tralokinumab administered subcutaneously every second week for 12 weeks. The groups had similar demographics and disease characteristics. The patients were aged 15-75 years and had Eczema Area and Severity Index (EASI) scores of 12 or more and an Investigator Global Assessment (IGA) score of 3 or higher. The coprimary endpoints were change in EASI from baseline to week 12 and the percentage of patients with either 0 (clear) or 1 (almost clear) on the IGA scale.

The higher dosages of tralokinumab showed the greatest adjusted mean differences in EASI scores: reductions of 4.36 for the 150-mg group (P = .03) and 4.94 for the 300-mg group (P = .01), compared with placebo. The changes in the 300-mg group were apparent as early as 4 weeks into treatment and were maintained beyond the 12-week mark. The greatest differences, compared with placebo, in IGA were seen in the 300-mg group as well.

Furthermore, patients who had high levels of biomarkers associated with IL-13 showed greater improvements than those seen in the intention-to-treat population at large. By week 12, patient-reported pruritus was also improved, and there were improvements in Dermatology Quality of Life Index (which did not persist past 12 weeks).

Most treatment-emergent adverse events were considered only mild or moderate, and the few more serious events were deemed unrelated to the study drug. The most common adverse events were upper respiratory infections and headaches.

“Participants entering the study had not achieved an adequate response to stable topical glucocorticoids during the 2-week run-in period and, therefore, represent a population with moderate to severe AD and major unmet treatment needs,” the investigators wrote. “The clinically meaningful benefits observed by combining tralokinumab treatment with topical glucocorticoids suggests that tralokinumab could demonstrate improvements in participants whose symptoms cannot be effectively controlled by topical glucocorticoids alone.”

The study was funded by MedImmune, a member of the AstraZeneca Group. Five authors were or are employees of the company; the three remaining authors had disclosures related to numerous pharmaceutical companies, including two with disclosures that included MedImmune.

[email protected]

SOURCE: Wollenberg A et al. J Allergy Clin Immunol. 2018 Jun 12. doi: 10.1016/j.jaci.2018.05.029.

Small employers will more easily be able to band together to buy health insurance under rules issued June 19 by the Trump administration, but the change could raise premiums for plans sold through the Affordable Care Act’s (ACA’s) online marketplaces, analysts say.

The move loosens restrictions on so-called association health plans, allowing more businesses, including sole proprietors, to join forces to buy health coverage in bulk for their workers.

By effectively shifting small-business coverage into the large-group market, it exempts such plans from ACA requirements for 10 “essential” health benefits, such as mental health care and prescription drug coverage, prompting warnings of “junk insurance” from consumer advocates.

Supporters say the new Labor Department rules, which the government estimated could create health plans covering as many as 11 million people, will lead to more affordable choices for some employers.

When it comes to health insurance, “the regulatory burden on small businesses should certainly not be more than that on large companies,” Labor Secretary Alexander Acosta told reporters June 19.

Existing rules limit association plans to groups of employers in the same industry in the same region.

The new regulations eliminate the geographical restriction for similar employers, allowing, for example, family-owned auto-repair shops in multiple states to offer one big health plan, said Christopher Condeluci, a health benefits lawyer and former Senate Finance Committee aide.

The rules, to be implemented in stages into next year, also allow companies in different industries in the same region to form a group to offer coverage – even if the only reason is to provide health insurance.

Like other coverage under the ACA, association insurance plans will still be required to cover preexisting illnesses.

Analysts warn that, because these changes will likely siphon away employers with relatively healthy consumers from ACA coverage into less-expensive trade-association plans, the result could be higher costs in the online marketplaces.

“If you have a group that is healthier than average, you might get a better rate from one of these plans, and your broker is going to come and say, ‘Hey, I can get you a better deal,’ ” said Dan Mendelson, president of Avalere Health, a consulting firm.

That would mean that, on balance, consumers insured through ACA small-group and individual plans could be older, sicker, and more expensive, adding to years of erosion of the ACA marketplaces engineered by Republicans hostile to the law.

Loosening rules for association plans would lead to 3.2 million people leaving the ACA plans by 2022 and raising premiums for those remaining in individual markets by 3.5%, Avalere calculated this year.

America’s Health Insurance Plans, the largest medical insurance trade group, issued a statement saying the regulation “may lead to higher premiums” in ACA insurance and “could result in fewer insured Americans.”

Unlike ACA plans, association coverage does not have to include benefits across the broad “essential” categories, including hospitalization and emergency care.

The National Association of Insurance Commissioners previously warned that such plans “threaten the stability of the small group market” and “provide inadequate benefits and insufficient protection to consumers.”

The American Academy of Actuaries has expressed similar concerns.

Business groups praised the change, proposed in draft form earlier this year.

“We’ve been advocating for association health plans for almost 20 years, and we’re pleased to see the department moving aggressively forward,” said David French, senior vice president of government relations for the National Retail Federation.

Association plans have been around for decades, although enrollment has been more limited since the ACA’s passage. While some of the plans have worked well for their members, others have a checkered history.

In April, for example, Massachusetts regulators settled with Kansas-based Unified Life Insurance Company, which agreed to pay $2.8 million to resolve allegations that it engaged in deceptive practices, such as claiming it covered services that it did not.

The coverage “was sold across state lines and was issued through a third-party association,” according to a release from the Massachusetts attorney general’s office.

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Small employers will more easily be able to band together to buy health insurance under rules issued June 19 by the Trump administration, but the change could raise premiums for plans sold through the Affordable Care Act’s (ACA’s) online marketplaces, analysts say.

The move loosens restrictions on so-called association health plans, allowing more businesses, including sole proprietors, to join forces to buy health coverage in bulk for their workers.

By effectively shifting small-business coverage into the large-group market, it exempts such plans from ACA requirements for 10 “essential” health benefits, such as mental health care and prescription drug coverage, prompting warnings of “junk insurance” from consumer advocates.

Supporters say the new Labor Department rules, which the government estimated could create health plans covering as many as 11 million people, will lead to more affordable choices for some employers.

When it comes to health insurance, “the regulatory burden on small businesses should certainly not be more than that on large companies,” Labor Secretary Alexander Acosta told reporters June 19.

Existing rules limit association plans to groups of employers in the same industry in the same region.

The new regulations eliminate the geographical restriction for similar employers, allowing, for example, family-owned auto-repair shops in multiple states to offer one big health plan, said Christopher Condeluci, a health benefits lawyer and former Senate Finance Committee aide.

The rules, to be implemented in stages into next year, also allow companies in different industries in the same region to form a group to offer coverage – even if the only reason is to provide health insurance.

Like other coverage under the ACA, association insurance plans will still be required to cover preexisting illnesses.

Analysts warn that, because these changes will likely siphon away employers with relatively healthy consumers from ACA coverage into less-expensive trade-association plans, the result could be higher costs in the online marketplaces.

“If you have a group that is healthier than average, you might get a better rate from one of these plans, and your broker is going to come and say, ‘Hey, I can get you a better deal,’ ” said Dan Mendelson, president of Avalere Health, a consulting firm.

That would mean that, on balance, consumers insured through ACA small-group and individual plans could be older, sicker, and more expensive, adding to years of erosion of the ACA marketplaces engineered by Republicans hostile to the law.

Loosening rules for association plans would lead to 3.2 million people leaving the ACA plans by 2022 and raising premiums for those remaining in individual markets by 3.5%, Avalere calculated this year.

America’s Health Insurance Plans, the largest medical insurance trade group, issued a statement saying the regulation “may lead to higher premiums” in ACA insurance and “could result in fewer insured Americans.”

Unlike ACA plans, association coverage does not have to include benefits across the broad “essential” categories, including hospitalization and emergency care.

The National Association of Insurance Commissioners previously warned that such plans “threaten the stability of the small group market” and “provide inadequate benefits and insufficient protection to consumers.”

The American Academy of Actuaries has expressed similar concerns.

Business groups praised the change, proposed in draft form earlier this year.

“We’ve been advocating for association health plans for almost 20 years, and we’re pleased to see the department moving aggressively forward,” said David French, senior vice president of government relations for the National Retail Federation.

Association plans have been around for decades, although enrollment has been more limited since the ACA’s passage. While some of the plans have worked well for their members, others have a checkered history.

In April, for example, Massachusetts regulators settled with Kansas-based Unified Life Insurance Company, which agreed to pay $2.8 million to resolve allegations that it engaged in deceptive practices, such as claiming it covered services that it did not.

The coverage “was sold across state lines and was issued through a third-party association,” according to a release from the Massachusetts attorney general’s office.

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Small employers will more easily be able to band together to buy health insurance under rules issued June 19 by the Trump administration, but the change could raise premiums for plans sold through the Affordable Care Act’s (ACA’s) online marketplaces, analysts say.

The move loosens restrictions on so-called association health plans, allowing more businesses, including sole proprietors, to join forces to buy health coverage in bulk for their workers.

By effectively shifting small-business coverage into the large-group market, it exempts such plans from ACA requirements for 10 “essential” health benefits, such as mental health care and prescription drug coverage, prompting warnings of “junk insurance” from consumer advocates.

Supporters say the new Labor Department rules, which the government estimated could create health plans covering as many as 11 million people, will lead to more affordable choices for some employers.

When it comes to health insurance, “the regulatory burden on small businesses should certainly not be more than that on large companies,” Labor Secretary Alexander Acosta told reporters June 19.

Existing rules limit association plans to groups of employers in the same industry in the same region.

The new regulations eliminate the geographical restriction for similar employers, allowing, for example, family-owned auto-repair shops in multiple states to offer one big health plan, said Christopher Condeluci, a health benefits lawyer and former Senate Finance Committee aide.

The rules, to be implemented in stages into next year, also allow companies in different industries in the same region to form a group to offer coverage – even if the only reason is to provide health insurance.

Like other coverage under the ACA, association insurance plans will still be required to cover preexisting illnesses.

Analysts warn that, because these changes will likely siphon away employers with relatively healthy consumers from ACA coverage into less-expensive trade-association plans, the result could be higher costs in the online marketplaces.

“If you have a group that is healthier than average, you might get a better rate from one of these plans, and your broker is going to come and say, ‘Hey, I can get you a better deal,’ ” said Dan Mendelson, president of Avalere Health, a consulting firm.

That would mean that, on balance, consumers insured through ACA small-group and individual plans could be older, sicker, and more expensive, adding to years of erosion of the ACA marketplaces engineered by Republicans hostile to the law.

Loosening rules for association plans would lead to 3.2 million people leaving the ACA plans by 2022 and raising premiums for those remaining in individual markets by 3.5%, Avalere calculated this year.

America’s Health Insurance Plans, the largest medical insurance trade group, issued a statement saying the regulation “may lead to higher premiums” in ACA insurance and “could result in fewer insured Americans.”

Unlike ACA plans, association coverage does not have to include benefits across the broad “essential” categories, including hospitalization and emergency care.

The National Association of Insurance Commissioners previously warned that such plans “threaten the stability of the small group market” and “provide inadequate benefits and insufficient protection to consumers.”

The American Academy of Actuaries has expressed similar concerns.

Business groups praised the change, proposed in draft form earlier this year.

“We’ve been advocating for association health plans for almost 20 years, and we’re pleased to see the department moving aggressively forward,” said David French, senior vice president of government relations for the National Retail Federation.

Association plans have been around for decades, although enrollment has been more limited since the ACA’s passage. While some of the plans have worked well for their members, others have a checkered history.

In April, for example, Massachusetts regulators settled with Kansas-based Unified Life Insurance Company, which agreed to pay $2.8 million to resolve allegations that it engaged in deceptive practices, such as claiming it covered services that it did not.

The coverage “was sold across state lines and was issued through a third-party association,” according to a release from the Massachusetts attorney general’s office.

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Among the reasons health care providers give for adolescent human papillomavirus (HPV) vaccination, U.S. parents ranked cancer prevention as the best, according to an analysis of a national survey.

Preventing a common infection also ranked highly as a reason for giving the vaccine, as did appeals to the vaccine’s lasting benefits and safety, the analysis showed.

Choreograph/Thinkstock

SOURCE: Gilkey MB et al. Cancer Epidemiol Biomarkers Prev. 2018 Jul;27(7):762-7.

Among the reasons health care providers give for adolescent human papillomavirus (HPV) vaccination, U.S. parents ranked cancer prevention as the best, according to an analysis of a national survey.

Preventing a common infection also ranked highly as a reason for giving the vaccine, as did appeals to the vaccine’s lasting benefits and safety, the analysis showed.

Choreograph/Thinkstock

SOURCE: Gilkey MB et al. Cancer Epidemiol Biomarkers Prev. 2018 Jul;27(7):762-7.

Among the reasons health care providers give for adolescent human papillomavirus (HPV) vaccination, U.S. parents ranked cancer prevention as the best, according to an analysis of a national survey.

Preventing a common infection also ranked highly as a reason for giving the vaccine, as did appeals to the vaccine’s lasting benefits and safety, the analysis showed.

Choreograph/Thinkstock

SOURCE: Gilkey MB et al. Cancer Epidemiol Biomarkers Prev. 2018 Jul;27(7):762-7.

CHICAGO – High levels of blood and tissue tumor mutational burden appear to have value as biomarkers for checkpoint inhibition response in patients with non–small cell lung cancer, according to interim findings from the ongoing B-F1RST study and a retrospective analysis of data from several prior studies.

The retrospective analysis also demonstrated the value of tissue tumor mutational burden (tTMB) as a biomarker for checkpoint inhibition benefit in patients with metastatic urothelial carcinoma and melanoma.

Progression-free survival (PFS) at a minimum of 6 months in 58 evaluable NSCLC patients from the single-arm phase 2b B-F1RST study of first-line atezolizumab monotherapy was 9.5 vs. 2.8 months in those with a high (16 or greater mutations/coding sequence) vs. low (less than 16 mutations/coding sequence) blood tumor mutational burden (bTMB) score (hazard ratio, 0.49), Vamsidhar Velcheti, MD, reported during an oral abstract session at the annual meeting of the American Society of Clinical Oncology.

Progression-free survival hazard ratios improved as bTMB scores increased, explained Dr. Velcheti, associate director of the Center for Immuno-Oncology Research at Taussig Cancer Institute, Cleveland Clinic.

“At the prespecified cutoff of 16, the hazard ratio is 0.51 and this suggests strong correlation of bTMB with clinical benefit,” he said.

The objective response rate in these biomarker evaluable patients was 12.1% and the disease control rate was 25.9%; in the high vs. low bTMB patients the overall response rate was 36.4% vs. 6.4%, he noted, adding that the responses in the high bTMB patients were deeper and more durable, and the safety profile of atezolizumab (Tecentriq) in the trial thus far is consistent with the known adverse event profile for the agent.

Further, prior studies, including the randomized phase 3 OAK and phase 2 POPLAR studies of second-line atezolizumab monotherapy, showed that high bTMB was associated with a PFS benefit.

In the current study, bTMB was evaluated prospectively for the first time as a predictive marker for first-line atezolizumab in stage IIIb-IVb locally advanced or metastatic NSCLC using a next-generation sequencing-based panel. Patients were treated with atezolizumab at a dose of 1,200 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or loss of clinical benefit.

The findings show preliminary utility of bTMB as a predictive biomarker for PFS and ORR, and further support bTMB selection of patients in the ongoing phase 3 B-FAST study, which is currently enrolling, Dr. Velcheti said, noting that the findings are encouraging, as 30% of patients with NSCLC have inadequate tumor tissue for molecular testing at diagnosis.

B-F1RST is also ongoing, but has completed enrollment at 153 patients. Primary analysis results will be presented later this year, he said.

Similarly, tTMB was associated with checkpoint inhibitor efficacy across tumor types and lines of therapy in the retrospective analysis of data from seven atezolizumab monotherapy trials.

The overall response rate (ORR) in 987 patients from those studies was 16%, but the response rates were 30% vs. 14% in 125 patients with high tTMB scores vs. 812 patients with low tTMB scores, David R. Gandara, MD, reported during the oral abstract session.

Median duration of response (DOR) was 16.6 months overall but was 29 vs. 14 months in those with high vs. low tTMB scores, respectively, added Dr. Gandara, a professor and director of the thoracic oncology program at the University of California, Davis.

This association was not seen in control cohorts of the three randomized studies included in the analysis (OAK, POPLAR, and IMvigor211), he noted, explaining that the pooled overall response rate in controls was 14.9%, and the response rate in those with high vs. low tTMB scores was 14.4% and 15.1%, respectively.

Further, an exploratory analysis of the three randomized studies showed that PFS increased with increasing levels of tumor mutational burden (TMB). The hazard ratio for PFS at TMB greater than or equal to 16 was 0.71, and the association occurred only in patients receiving atezolizumab.

“As has been previously reported from other studies, [high TMB] identifies a patient population which is distinct from [programmed death-ligand 1] immunohistochemistry and yet complementary,” he said, noting that both high tTMB and high PD-L1 have been shown to predict response independently, and in the current study it is the “small proportion of patients with both [high] TMB and PD-L1 ... that have the best response rate.”

The findings, which highlight “the association of high TMB and enrichment of ORR, DOR, and PFS benefit with atezolizumab monotherapy across indications and lines of therapy,” and demonstrate that high TMB may serve as a surrogate for neoantigen load (NAL – a component of TMB that has been linked with immune response) and complement PD-L1 expression in enriching for clinical benefit from immunotherapy, he concluded, noting that harmonization efforts are underway to standardize TMB platforms and computational algorithms.

Dr. Velcheti has reported financial relationships with Amgen, AstraZeneca/MedImmune, Bristol-Myers Squibb, and many others. He has received research funding to his institution from Alkermes, Altor BioScience, Atreca, Bristol-Myers Squibb, and others. Dr. Gandara reported financial relationships with ARIAD, AstraZeneca, Boehringer Ingelheim, Celgene, and many others. He has received research funding to his institution from AstraZeneca/MedImmune, Bristol-Myers Squibb, Clovis Oncology, Genentech, and others.

SOURCES: Velcheti V et al. ASCO 2018 Abstract 12001; Legrand FA et al. ASCO 2018 Abstract 12000.

CHICAGO – High levels of blood and tissue tumor mutational burden appear to have value as biomarkers for checkpoint inhibition response in patients with non–small cell lung cancer, according to interim findings from the ongoing B-F1RST study and a retrospective analysis of data from several prior studies.

The retrospective analysis also demonstrated the value of tissue tumor mutational burden (tTMB) as a biomarker for checkpoint inhibition benefit in patients with metastatic urothelial carcinoma and melanoma.

Progression-free survival (PFS) at a minimum of 6 months in 58 evaluable NSCLC patients from the single-arm phase 2b B-F1RST study of first-line atezolizumab monotherapy was 9.5 vs. 2.8 months in those with a high (16 or greater mutations/coding sequence) vs. low (less than 16 mutations/coding sequence) blood tumor mutational burden (bTMB) score (hazard ratio, 0.49), Vamsidhar Velcheti, MD, reported during an oral abstract session at the annual meeting of the American Society of Clinical Oncology.

Progression-free survival hazard ratios improved as bTMB scores increased, explained Dr. Velcheti, associate director of the Center for Immuno-Oncology Research at Taussig Cancer Institute, Cleveland Clinic.

“At the prespecified cutoff of 16, the hazard ratio is 0.51 and this suggests strong correlation of bTMB with clinical benefit,” he said.

The objective response rate in these biomarker evaluable patients was 12.1% and the disease control rate was 25.9%; in the high vs. low bTMB patients the overall response rate was 36.4% vs. 6.4%, he noted, adding that the responses in the high bTMB patients were deeper and more durable, and the safety profile of atezolizumab (Tecentriq) in the trial thus far is consistent with the known adverse event profile for the agent.

Further, prior studies, including the randomized phase 3 OAK and phase 2 POPLAR studies of second-line atezolizumab monotherapy, showed that high bTMB was associated with a PFS benefit.

In the current study, bTMB was evaluated prospectively for the first time as a predictive marker for first-line atezolizumab in stage IIIb-IVb locally advanced or metastatic NSCLC using a next-generation sequencing-based panel. Patients were treated with atezolizumab at a dose of 1,200 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or loss of clinical benefit.

The findings show preliminary utility of bTMB as a predictive biomarker for PFS and ORR, and further support bTMB selection of patients in the ongoing phase 3 B-FAST study, which is currently enrolling, Dr. Velcheti said, noting that the findings are encouraging, as 30% of patients with NSCLC have inadequate tumor tissue for molecular testing at diagnosis.

B-F1RST is also ongoing, but has completed enrollment at 153 patients. Primary analysis results will be presented later this year, he said.

Similarly, tTMB was associated with checkpoint inhibitor efficacy across tumor types and lines of therapy in the retrospective analysis of data from seven atezolizumab monotherapy trials.

The overall response rate (ORR) in 987 patients from those studies was 16%, but the response rates were 30% vs. 14% in 125 patients with high tTMB scores vs. 812 patients with low tTMB scores, David R. Gandara, MD, reported during the oral abstract session.

Median duration of response (DOR) was 16.6 months overall but was 29 vs. 14 months in those with high vs. low tTMB scores, respectively, added Dr. Gandara, a professor and director of the thoracic oncology program at the University of California, Davis.

This association was not seen in control cohorts of the three randomized studies included in the analysis (OAK, POPLAR, and IMvigor211), he noted, explaining that the pooled overall response rate in controls was 14.9%, and the response rate in those with high vs. low tTMB scores was 14.4% and 15.1%, respectively.

Further, an exploratory analysis of the three randomized studies showed that PFS increased with increasing levels of tumor mutational burden (TMB). The hazard ratio for PFS at TMB greater than or equal to 16 was 0.71, and the association occurred only in patients receiving atezolizumab.

“As has been previously reported from other studies, [high TMB] identifies a patient population which is distinct from [programmed death-ligand 1] immunohistochemistry and yet complementary,” he said, noting that both high tTMB and high PD-L1 have been shown to predict response independently, and in the current study it is the “small proportion of patients with both [high] TMB and PD-L1 ... that have the best response rate.”

The findings, which highlight “the association of high TMB and enrichment of ORR, DOR, and PFS benefit with atezolizumab monotherapy across indications and lines of therapy,” and demonstrate that high TMB may serve as a surrogate for neoantigen load (NAL – a component of TMB that has been linked with immune response) and complement PD-L1 expression in enriching for clinical benefit from immunotherapy, he concluded, noting that harmonization efforts are underway to standardize TMB platforms and computational algorithms.

Dr. Velcheti has reported financial relationships with Amgen, AstraZeneca/MedImmune, Bristol-Myers Squibb, and many others. He has received research funding to his institution from Alkermes, Altor BioScience, Atreca, Bristol-Myers Squibb, and others. Dr. Gandara reported financial relationships with ARIAD, AstraZeneca, Boehringer Ingelheim, Celgene, and many others. He has received research funding to his institution from AstraZeneca/MedImmune, Bristol-Myers Squibb, Clovis Oncology, Genentech, and others.

SOURCES: Velcheti V et al. ASCO 2018 Abstract 12001; Legrand FA et al. ASCO 2018 Abstract 12000.

CHICAGO – High levels of blood and tissue tumor mutational burden appear to have value as biomarkers for checkpoint inhibition response in patients with non–small cell lung cancer, according to interim findings from the ongoing B-F1RST study and a retrospective analysis of data from several prior studies.

The retrospective analysis also demonstrated the value of tissue tumor mutational burden (tTMB) as a biomarker for checkpoint inhibition benefit in patients with metastatic urothelial carcinoma and melanoma.

Progression-free survival (PFS) at a minimum of 6 months in 58 evaluable NSCLC patients from the single-arm phase 2b B-F1RST study of first-line atezolizumab monotherapy was 9.5 vs. 2.8 months in those with a high (16 or greater mutations/coding sequence) vs. low (less than 16 mutations/coding sequence) blood tumor mutational burden (bTMB) score (hazard ratio, 0.49), Vamsidhar Velcheti, MD, reported during an oral abstract session at the annual meeting of the American Society of Clinical Oncology.

Progression-free survival hazard ratios improved as bTMB scores increased, explained Dr. Velcheti, associate director of the Center for Immuno-Oncology Research at Taussig Cancer Institute, Cleveland Clinic.

“At the prespecified cutoff of 16, the hazard ratio is 0.51 and this suggests strong correlation of bTMB with clinical benefit,” he said.

The objective response rate in these biomarker evaluable patients was 12.1% and the disease control rate was 25.9%; in the high vs. low bTMB patients the overall response rate was 36.4% vs. 6.4%, he noted, adding that the responses in the high bTMB patients were deeper and more durable, and the safety profile of atezolizumab (Tecentriq) in the trial thus far is consistent with the known adverse event profile for the agent.

Further, prior studies, including the randomized phase 3 OAK and phase 2 POPLAR studies of second-line atezolizumab monotherapy, showed that high bTMB was associated with a PFS benefit.

In the current study, bTMB was evaluated prospectively for the first time as a predictive marker for first-line atezolizumab in stage IIIb-IVb locally advanced or metastatic NSCLC using a next-generation sequencing-based panel. Patients were treated with atezolizumab at a dose of 1,200 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or loss of clinical benefit.

The findings show preliminary utility of bTMB as a predictive biomarker for PFS and ORR, and further support bTMB selection of patients in the ongoing phase 3 B-FAST study, which is currently enrolling, Dr. Velcheti said, noting that the findings are encouraging, as 30% of patients with NSCLC have inadequate tumor tissue for molecular testing at diagnosis.

B-F1RST is also ongoing, but has completed enrollment at 153 patients. Primary analysis results will be presented later this year, he said.

Similarly, tTMB was associated with checkpoint inhibitor efficacy across tumor types and lines of therapy in the retrospective analysis of data from seven atezolizumab monotherapy trials.

The overall response rate (ORR) in 987 patients from those studies was 16%, but the response rates were 30% vs. 14% in 125 patients with high tTMB scores vs. 812 patients with low tTMB scores, David R. Gandara, MD, reported during the oral abstract session.

Median duration of response (DOR) was 16.6 months overall but was 29 vs. 14 months in those with high vs. low tTMB scores, respectively, added Dr. Gandara, a professor and director of the thoracic oncology program at the University of California, Davis.

This association was not seen in control cohorts of the three randomized studies included in the analysis (OAK, POPLAR, and IMvigor211), he noted, explaining that the pooled overall response rate in controls was 14.9%, and the response rate in those with high vs. low tTMB scores was 14.4% and 15.1%, respectively.

Further, an exploratory analysis of the three randomized studies showed that PFS increased with increasing levels of tumor mutational burden (TMB). The hazard ratio for PFS at TMB greater than or equal to 16 was 0.71, and the association occurred only in patients receiving atezolizumab.

“As has been previously reported from other studies, [high TMB] identifies a patient population which is distinct from [programmed death-ligand 1] immunohistochemistry and yet complementary,” he said, noting that both high tTMB and high PD-L1 have been shown to predict response independently, and in the current study it is the “small proportion of patients with both [high] TMB and PD-L1 ... that have the best response rate.”

The findings, which highlight “the association of high TMB and enrichment of ORR, DOR, and PFS benefit with atezolizumab monotherapy across indications and lines of therapy,” and demonstrate that high TMB may serve as a surrogate for neoantigen load (NAL – a component of TMB that has been linked with immune response) and complement PD-L1 expression in enriching for clinical benefit from immunotherapy, he concluded, noting that harmonization efforts are underway to standardize TMB platforms and computational algorithms.

Dr. Velcheti has reported financial relationships with Amgen, AstraZeneca/MedImmune, Bristol-Myers Squibb, and many others. He has received research funding to his institution from Alkermes, Altor BioScience, Atreca, Bristol-Myers Squibb, and others. Dr. Gandara reported financial relationships with ARIAD, AstraZeneca, Boehringer Ingelheim, Celgene, and many others. He has received research funding to his institution from AstraZeneca/MedImmune, Bristol-Myers Squibb, Clovis Oncology, Genentech, and others.

SOURCES: Velcheti V et al. ASCO 2018 Abstract 12001; Legrand FA et al. ASCO 2018 Abstract 12000.

More than half (56%) of adult patients with hemophilia are adherent to a prescribed prophylaxis regimen, but compliance appears less likely among patients who are having difficulty coping with pain or have a high conviction of disease.

Ana Torres-Ortuño, PhD, of the University of Murcia (Spain) and her colleagues performed a multicenter, cross-sectional descriptive study of 23 adult patients with severe hemophilia A or hemophilia B using various validated questionnaires that measured quality of life, disease perception, coping strategies, and treatment adherence.

Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

[email protected]

SOURCE: Torres-Ortuño A et al. Vox Sang. 2018 May 24. doi: 10.1111/vox.12669.

More than half (56%) of adult patients with hemophilia are adherent to a prescribed prophylaxis regimen, but compliance appears less likely among patients who are having difficulty coping with pain or have a high conviction of disease.

Ana Torres-Ortuño, PhD, of the University of Murcia (Spain) and her colleagues performed a multicenter, cross-sectional descriptive study of 23 adult patients with severe hemophilia A or hemophilia B using various validated questionnaires that measured quality of life, disease perception, coping strategies, and treatment adherence.

Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

[email protected]

SOURCE: Torres-Ortuño A et al. Vox Sang. 2018 May 24. doi: 10.1111/vox.12669.

More than half (56%) of adult patients with hemophilia are adherent to a prescribed prophylaxis regimen, but compliance appears less likely among patients who are having difficulty coping with pain or have a high conviction of disease.

Ana Torres-Ortuño, PhD, of the University of Murcia (Spain) and her colleagues performed a multicenter, cross-sectional descriptive study of 23 adult patients with severe hemophilia A or hemophilia B using various validated questionnaires that measured quality of life, disease perception, coping strategies, and treatment adherence.

Crystal/Wikimedia Commons/Creative Commons Attribution 2.0

[email protected]

SOURCE: Torres-Ortuño A et al. Vox Sang. 2018 May 24. doi: 10.1111/vox.12669.

Postoperative delirium has a high prevalence among vascular surgery patients, increasing morbidity, mortality and length of stay (LOS),according to Rima G. Styra, MD, and her colleagues at the University of Toronto (Canada).

In Friday’s Scientific Session 5, Dr. Styra will present their prospective study, which found that there were preop risk factors for delirium that can be determined by a surgical team in order to identify high risk patients; their study also looked at the impacts of delirium on hospital costs.

She and her colleagues preoperatively assessed 173 elective vascular surgery patients for cognitive function using the Montreal Cognitive Assessment Scale (MoCA) and the Confusion Assessment Method (CAM) for postoperative delirium, which was verified by chart and clinical review.

Friday, June 22

3:30–5 p.m.

HCC, Ballroom A/B

SS26: The Impact of Pre-Operative Cognitive Impairment and Type of Vascular Surgery on Postoperative Delirium and Cost Implications

Postoperative delirium has a high prevalence among vascular surgery patients, increasing morbidity, mortality and length of stay (LOS),according to Rima G. Styra, MD, and her colleagues at the University of Toronto (Canada).

In Friday’s Scientific Session 5, Dr. Styra will present their prospective study, which found that there were preop risk factors for delirium that can be determined by a surgical team in order to identify high risk patients; their study also looked at the impacts of delirium on hospital costs.

She and her colleagues preoperatively assessed 173 elective vascular surgery patients for cognitive function using the Montreal Cognitive Assessment Scale (MoCA) and the Confusion Assessment Method (CAM) for postoperative delirium, which was verified by chart and clinical review.

Friday, June 22

3:30–5 p.m.

HCC, Ballroom A/B

SS26: The Impact of Pre-Operative Cognitive Impairment and Type of Vascular Surgery on Postoperative Delirium and Cost Implications

Postoperative delirium has a high prevalence among vascular surgery patients, increasing morbidity, mortality and length of stay (LOS),according to Rima G. Styra, MD, and her colleagues at the University of Toronto (Canada).

In Friday’s Scientific Session 5, Dr. Styra will present their prospective study, which found that there were preop risk factors for delirium that can be determined by a surgical team in order to identify high risk patients; their study also looked at the impacts of delirium on hospital costs.

She and her colleagues preoperatively assessed 173 elective vascular surgery patients for cognitive function using the Montreal Cognitive Assessment Scale (MoCA) and the Confusion Assessment Method (CAM) for postoperative delirium, which was verified by chart and clinical review.

Friday, June 22

3:30–5 p.m.

HCC, Ballroom A/B

SS26: The Impact of Pre-Operative Cognitive Impairment and Type of Vascular Surgery on Postoperative Delirium and Cost Implications

The Safety and Efficacy Study for Reverse Flow Used during Carotid Artery Stenting Procedure (ROADSTER) multicenter trial reported the lowest stroke rate in high-risk patients compared with any prospective trial of TFCAS, according to Mahmoud B. Malas, MD, of the Johns Hopkins Hospital and his colleagues. However, clinical trials have selection criteria that exclude many patients, and are highly selective of operators performing the procedures, which limit generalizability. Dr. Malas will present a study in Scientific Session S4 that he and his colleagues did to compare in-hospital outcomes after TCAR and TFCAS as reported in VQI.

They analyzed data from the initial 646 patients enrolled in the SVS VQI TCAR Surveillance Project (TSP) and compared it with that of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. They used multivariable logistic regression and 1:1 coarsened exact matching (CEM) to analyze neurologic adverse events [stroke and transient ischemic attacks (TIAs)] and in-hospital mortality. Patients in the two procedures were matched on age, race, coronary artery disease, congestive heart failure, prior CABG/PCI, chronic kidney disease, diabetes, ASA class, symptomatic status, restenosis, anatomical and medical risk, emergency status, and preoperative medication use.

Compared with more than 10,000 patients undergoing TFCAS, the 638 undergoing TCAR were significantly older and had more cardiac comorbidities. In contrast, patients in the TFCAS group were more likely to be symptomatic and to have a restenotic lesion. There was no significant change in the odds of stroke/death in TFCAS over the study period.

The rates of in-hospital TIA/stroke as well as TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs.1.9% and 3.8% vs.2.2%, respectively; both P = .04). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients; however, the difference was significant only in the TFCAS (5.3% vs. 2.7%, P less than .001). On multivariable analysis, TFCAS was associated with twice the odds of in-hospital neurologic events and TIA/stroke/death compared with TCAR, independent of symptomatic status. CEM showed similar results.

“Our results show that patients undergoing TCAR had significantly higher medical comorbidities, but half the risk of in-hospital TIA/stroke/death compared to patients undergoing TFCAS. This initial evaluation of VQI TSP demonstrates the ability to rapidly monitor new devices/procedures in real world practice. While preliminary, this is the first study to confirm the benefit of TCAR compared to TFCAS in real-world practice,” Dr. Malas concluded. 

Friday, June 22

3:30 - 5 p.m.

HCC, Ballroom A/B

SS24: Transcarotid Artery Revascularization (TCAR) vs. Transfemoral Carotid Artery Stenting (TFCAS) in the SVS Vascular Quality Initiative

The Safety and Efficacy Study for Reverse Flow Used during Carotid Artery Stenting Procedure (ROADSTER) multicenter trial reported the lowest stroke rate in high-risk patients compared with any prospective trial of TFCAS, according to Mahmoud B. Malas, MD, of the Johns Hopkins Hospital and his colleagues. However, clinical trials have selection criteria that exclude many patients, and are highly selective of operators performing the procedures, which limit generalizability. Dr. Malas will present a study in Scientific Session S4 that he and his colleagues did to compare in-hospital outcomes after TCAR and TFCAS as reported in VQI.

They analyzed data from the initial 646 patients enrolled in the SVS VQI TCAR Surveillance Project (TSP) and compared it with that of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. They used multivariable logistic regression and 1:1 coarsened exact matching (CEM) to analyze neurologic adverse events [stroke and transient ischemic attacks (TIAs)] and in-hospital mortality. Patients in the two procedures were matched on age, race, coronary artery disease, congestive heart failure, prior CABG/PCI, chronic kidney disease, diabetes, ASA class, symptomatic status, restenosis, anatomical and medical risk, emergency status, and preoperative medication use.

Compared with more than 10,000 patients undergoing TFCAS, the 638 undergoing TCAR were significantly older and had more cardiac comorbidities. In contrast, patients in the TFCAS group were more likely to be symptomatic and to have a restenotic lesion. There was no significant change in the odds of stroke/death in TFCAS over the study period.

The rates of in-hospital TIA/stroke as well as TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs.1.9% and 3.8% vs.2.2%, respectively; both P = .04). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients; however, the difference was significant only in the TFCAS (5.3% vs. 2.7%, P less than .001). On multivariable analysis, TFCAS was associated with twice the odds of in-hospital neurologic events and TIA/stroke/death compared with TCAR, independent of symptomatic status. CEM showed similar results.

“Our results show that patients undergoing TCAR had significantly higher medical comorbidities, but half the risk of in-hospital TIA/stroke/death compared to patients undergoing TFCAS. This initial evaluation of VQI TSP demonstrates the ability to rapidly monitor new devices/procedures in real world practice. While preliminary, this is the first study to confirm the benefit of TCAR compared to TFCAS in real-world practice,” Dr. Malas concluded. 

Friday, June 22

3:30 - 5 p.m.

HCC, Ballroom A/B

SS24: Transcarotid Artery Revascularization (TCAR) vs. Transfemoral Carotid Artery Stenting (TFCAS) in the SVS Vascular Quality Initiative

The Safety and Efficacy Study for Reverse Flow Used during Carotid Artery Stenting Procedure (ROADSTER) multicenter trial reported the lowest stroke rate in high-risk patients compared with any prospective trial of TFCAS, according to Mahmoud B. Malas, MD, of the Johns Hopkins Hospital and his colleagues. However, clinical trials have selection criteria that exclude many patients, and are highly selective of operators performing the procedures, which limit generalizability. Dr. Malas will present a study in Scientific Session S4 that he and his colleagues did to compare in-hospital outcomes after TCAR and TFCAS as reported in VQI.

They analyzed data from the initial 646 patients enrolled in the SVS VQI TCAR Surveillance Project (TSP) and compared it with that of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. They used multivariable logistic regression and 1:1 coarsened exact matching (CEM) to analyze neurologic adverse events [stroke and transient ischemic attacks (TIAs)] and in-hospital mortality. Patients in the two procedures were matched on age, race, coronary artery disease, congestive heart failure, prior CABG/PCI, chronic kidney disease, diabetes, ASA class, symptomatic status, restenosis, anatomical and medical risk, emergency status, and preoperative medication use.

Compared with more than 10,000 patients undergoing TFCAS, the 638 undergoing TCAR were significantly older and had more cardiac comorbidities. In contrast, patients in the TFCAS group were more likely to be symptomatic and to have a restenotic lesion. There was no significant change in the odds of stroke/death in TFCAS over the study period.

The rates of in-hospital TIA/stroke as well as TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs.1.9% and 3.8% vs.2.2%, respectively; both P = .04). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients; however, the difference was significant only in the TFCAS (5.3% vs. 2.7%, P less than .001). On multivariable analysis, TFCAS was associated with twice the odds of in-hospital neurologic events and TIA/stroke/death compared with TCAR, independent of symptomatic status. CEM showed similar results.

“Our results show that patients undergoing TCAR had significantly higher medical comorbidities, but half the risk of in-hospital TIA/stroke/death compared to patients undergoing TFCAS. This initial evaluation of VQI TSP demonstrates the ability to rapidly monitor new devices/procedures in real world practice. While preliminary, this is the first study to confirm the benefit of TCAR compared to TFCAS in real-world practice,” Dr. Malas concluded. 

Friday, June 22

3:30 - 5 p.m.

HCC, Ballroom A/B

SS24: Transcarotid Artery Revascularization (TCAR) vs. Transfemoral Carotid Artery Stenting (TFCAS) in the SVS Vascular Quality Initiative

Two nearly ubiquitous herpes viruses are abundant in the brains of people with Alzheimer’s disease and appear to integrate themselves into the patient’s own genome, where the viruses play havoc with genes involved in Alzheimer’s pathogenesis, among other things, a new study reports.

The genomic analysis of hundreds of Alzheimer’s disease (AD) brain samples found human herpesvirus 6a and 7 (HHV-6a, HHV-7) in the entorhinal cortex and the hippocampus, the initial sites of beta-amyloid overexpression in the disease, first authors Benjamin Readhead, MBBS, Jean-Vianney Haure-Mirande, PhD, and colleagues reported June 21 in Neuron.

[email protected]

SOURCE: Readhead B et al. Neuron. 2018 June 21. doi: 10.1016/j.neuron.2018.05.023.

Two nearly ubiquitous herpes viruses are abundant in the brains of people with Alzheimer’s disease and appear to integrate themselves into the patient’s own genome, where the viruses play havoc with genes involved in Alzheimer’s pathogenesis, among other things, a new study reports.

The genomic analysis of hundreds of Alzheimer’s disease (AD) brain samples found human herpesvirus 6a and 7 (HHV-6a, HHV-7) in the entorhinal cortex and the hippocampus, the initial sites of beta-amyloid overexpression in the disease, first authors Benjamin Readhead, MBBS, Jean-Vianney Haure-Mirande, PhD, and colleagues reported June 21 in Neuron.

[email protected]

SOURCE: Readhead B et al. Neuron. 2018 June 21. doi: 10.1016/j.neuron.2018.05.023.

Two nearly ubiquitous herpes viruses are abundant in the brains of people with Alzheimer’s disease and appear to integrate themselves into the patient’s own genome, where the viruses play havoc with genes involved in Alzheimer’s pathogenesis, among other things, a new study reports.

The genomic analysis of hundreds of Alzheimer’s disease (AD) brain samples found human herpesvirus 6a and 7 (HHV-6a, HHV-7) in the entorhinal cortex and the hippocampus, the initial sites of beta-amyloid overexpression in the disease, first authors Benjamin Readhead, MBBS, Jean-Vianney Haure-Mirande, PhD, and colleagues reported June 21 in Neuron.

[email protected]

SOURCE: Readhead B et al. Neuron. 2018 June 21. doi: 10.1016/j.neuron.2018.05.023.

About six months ago, an 8-year-old girl developed an asymptomatic rash near her ear. Her mother suspects it is psoriasis, which runs heavily in the family—but their primary care provider favors a fungal diagnosis. He prescribes a succession of topical and oral antifungal medications (including nystatin and terbinafine), which yield no discernable improvement. At this point, referral to dermatology is made.  

The child’s mother denies any history of recent infections (eg, strep throat) on her daughter’s behalf. Furthermore, there are no reports of pain associated with the rash or elsewhere.

EXAMINATION
The rash, which is confined to the external right ear, is composed of uniformly smooth white scale on a faintly salmon base. The entire lesion measures about 3 cm at its widest point, and the margins are arciform and well-defined.

No such lesions are seen elsewhere, but tiny pits can be seen on one fingernail.

What is the diagnosis?

In psoriasis, keratinocytes matriculate upward from the basal layer to the skin surface at four times the normal rate—so quickly that they have no chance to lose their nuclei (as they normally would). They then pile up, creating plaques of micaceous white scale on a salmon-pink base. Histologically, the smoothly undulating dermoepidermal junction is jammed together, producing fused ridges with clumps of neutrophils on their tips.

While it favors extensor surfaces of extremities, psoriasis can show up anywhere on the body—on the genitals, mouth, and in the nails, where it can cause pits, dystrophy, discoloration, onycholysis, and onychorrhexis.

Unfortunately, this is probably just the beginning of this child’s psoriasis. The good news is that we’re in a golden age of psoriasis treatment, with more drugs than ever to choose from and even more in development. For this patient, we used a keratolytic agent (urea lotion) to thin out the surface scale, in order to allow a class 4 steroid cream to reach the pink inflammatory portion. Within a month, most of this patch had cleared, though we can be fairly sure it and others like it will be back. Education and ongoing follow-up will be needed, in case she is among the 20% to 25% of patients who will develop psoriatic arthropathy, a crippling form of arthritis.

It is certainly possible to develop a fungal infection on or in an ear, but for that to happen, there has to be a source (eg, animal, person, soil). Moreover, the scale would look entirely different, with clearing centers and advancing margins. The likely truth is that this was called “fungal” for lack of any other suspects.

TAKE-HOME LEARNING POINTS

• White scale on a salmon-pink base typifies psoriasis vulgaris, a very common diagnosis that is often mistaken for fungal infection; biopsy can be extremely helpful in establishing or ruling out this diagnosis.
• Psoriasis has a genetic basis, with many gene loci identified to date, but only about 30% of affected patients can attest to a family history.
• In addition to having unsightly, often itchy lesions, psoriasis patients are also at risk for psoriatic arthropathy, a potentially crippling condition.
• The best news is that we have many drugs with which to treat this disease, including a whole family of drugs termed “the biologics,” which directly (and successfully!) address the disease.

About six months ago, an 8-year-old girl developed an asymptomatic rash near her ear. Her mother suspects it is psoriasis, which runs heavily in the family—but their primary care provider favors a fungal diagnosis. He prescribes a succession of topical and oral antifungal medications (including nystatin and terbinafine), which yield no discernable improvement. At this point, referral to dermatology is made.  

The child’s mother denies any history of recent infections (eg, strep throat) on her daughter’s behalf. Furthermore, there are no reports of pain associated with the rash or elsewhere.

EXAMINATION
The rash, which is confined to the external right ear, is composed of uniformly smooth white scale on a faintly salmon base. The entire lesion measures about 3 cm at its widest point, and the margins are arciform and well-defined.

No such lesions are seen elsewhere, but tiny pits can be seen on one fingernail.

What is the diagnosis?

In psoriasis, keratinocytes matriculate upward from the basal layer to the skin surface at four times the normal rate—so quickly that they have no chance to lose their nuclei (as they normally would). They then pile up, creating plaques of micaceous white scale on a salmon-pink base. Histologically, the smoothly undulating dermoepidermal junction is jammed together, producing fused ridges with clumps of neutrophils on their tips.

While it favors extensor surfaces of extremities, psoriasis can show up anywhere on the body—on the genitals, mouth, and in the nails, where it can cause pits, dystrophy, discoloration, onycholysis, and onychorrhexis.

Unfortunately, this is probably just the beginning of this child’s psoriasis. The good news is that we’re in a golden age of psoriasis treatment, with more drugs than ever to choose from and even more in development. For this patient, we used a keratolytic agent (urea lotion) to thin out the surface scale, in order to allow a class 4 steroid cream to reach the pink inflammatory portion. Within a month, most of this patch had cleared, though we can be fairly sure it and others like it will be back. Education and ongoing follow-up will be needed, in case she is among the 20% to 25% of patients who will develop psoriatic arthropathy, a crippling form of arthritis.

It is certainly possible to develop a fungal infection on or in an ear, but for that to happen, there has to be a source (eg, animal, person, soil). Moreover, the scale would look entirely different, with clearing centers and advancing margins. The likely truth is that this was called “fungal” for lack of any other suspects.

TAKE-HOME LEARNING POINTS

• White scale on a salmon-pink base typifies psoriasis vulgaris, a very common diagnosis that is often mistaken for fungal infection; biopsy can be extremely helpful in establishing or ruling out this diagnosis.
• Psoriasis has a genetic basis, with many gene loci identified to date, but only about 30% of affected patients can attest to a family history.
• In addition to having unsightly, often itchy lesions, psoriasis patients are also at risk for psoriatic arthropathy, a potentially crippling condition.
• The best news is that we have many drugs with which to treat this disease, including a whole family of drugs termed “the biologics,” which directly (and successfully!) address the disease.

About six months ago, an 8-year-old girl developed an asymptomatic rash near her ear. Her mother suspects it is psoriasis, which runs heavily in the family—but their primary care provider favors a fungal diagnosis. He prescribes a succession of topical and oral antifungal medications (including nystatin and terbinafine), which yield no discernable improvement. At this point, referral to dermatology is made.  

The child’s mother denies any history of recent infections (eg, strep throat) on her daughter’s behalf. Furthermore, there are no reports of pain associated with the rash or elsewhere.

EXAMINATION
The rash, which is confined to the external right ear, is composed of uniformly smooth white scale on a faintly salmon base. The entire lesion measures about 3 cm at its widest point, and the margins are arciform and well-defined.

No such lesions are seen elsewhere, but tiny pits can be seen on one fingernail.

What is the diagnosis?

In psoriasis, keratinocytes matriculate upward from the basal layer to the skin surface at four times the normal rate—so quickly that they have no chance to lose their nuclei (as they normally would). They then pile up, creating plaques of micaceous white scale on a salmon-pink base. Histologically, the smoothly undulating dermoepidermal junction is jammed together, producing fused ridges with clumps of neutrophils on their tips.

While it favors extensor surfaces of extremities, psoriasis can show up anywhere on the body—on the genitals, mouth, and in the nails, where it can cause pits, dystrophy, discoloration, onycholysis, and onychorrhexis.

Unfortunately, this is probably just the beginning of this child’s psoriasis. The good news is that we’re in a golden age of psoriasis treatment, with more drugs than ever to choose from and even more in development. For this patient, we used a keratolytic agent (urea lotion) to thin out the surface scale, in order to allow a class 4 steroid cream to reach the pink inflammatory portion. Within a month, most of this patch had cleared, though we can be fairly sure it and others like it will be back. Education and ongoing follow-up will be needed, in case she is among the 20% to 25% of patients who will develop psoriatic arthropathy, a crippling form of arthritis.

It is certainly possible to develop a fungal infection on or in an ear, but for that to happen, there has to be a source (eg, animal, person, soil). Moreover, the scale would look entirely different, with clearing centers and advancing margins. The likely truth is that this was called “fungal” for lack of any other suspects.

TAKE-HOME LEARNING POINTS

• White scale on a salmon-pink base typifies psoriasis vulgaris, a very common diagnosis that is often mistaken for fungal infection; biopsy can be extremely helpful in establishing or ruling out this diagnosis.
• Psoriasis has a genetic basis, with many gene loci identified to date, but only about 30% of affected patients can attest to a family history.
• In addition to having unsightly, often itchy lesions, psoriasis patients are also at risk for psoriatic arthropathy, a potentially crippling condition.
• The best news is that we have many drugs with which to treat this disease, including a whole family of drugs termed “the biologics,” which directly (and successfully!) address the disease.