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Even mild MS relapses may signal faster disability accumulation
Nondisabling relapses that occur early in the course of relapsing-remitting multiple sclerosis (RRMS) signal faster accumulation of disability relative to no early relapses, new research suggests. However, in the large registry study, this association was not found in patients treated with high-efficacy, disease-modifying therapies (DMTs) early on.
The results suggest that ,” said lead author Cyrus Daruwalla, MD, department of clinical neurosciences at the University of Cambridge, and Addenbrooke’s Hospital, Cambridge, England.
Dr. Daruwalla presented the findings at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Questioning EMA restrictions
“We designed this project because regulators, including EMA [European Medicines Agency], restrict the use of certain DMTs to only those with disabling relapses. In particular, natalizumab [Tysabri] and fingolimod [Gilenya] can only be used as the first-line therapy for people with rapidly evolving, severe MS – which includes having two disabling relapses in a year,” Dr. Daruwalla noted.
“In clinic, when we see somebody who has a nondisabling relapse, we’re left with the question of what is the prognostic significance of that relapse, and how should it influence treatment decisions,” he added.
Using prospectively collected data from the MSBase international registry, the researchers examined data on individuals with RRMS and complete early relapse severity information.
They compared patients with exclusively nondisabling relapses in the 2 years after definitive RRMS diagnosis with peers with no relapses within this time frame.
To mitigate the confounding effect of DMT use, the investigators performed analyses in participants untreated during follow-up, and then in those who received only older or “platform” therapies (interferon-beta, glatiramer acetate, dimethyl fumarate, or teriflunomide) during follow-up.
In the untreated cohort, 285 patients had nondisabling relapses and 4,717 had no relapses during the 2 years after diagnosis. Those with early nondisabling relapses had a significantly increased risk for disability accumulation (adjusted hazard ratio [aHR], 1.29; 95% confidence interval [CI], 1.00-1.68).
In the treated cohort, 1,074 patients had nondisabling early relapses and 7,262 did not.
In this cohort, those treated with “platform” DMTs who had nondisabling relapses showed a significantly increased risk for disability accumulation compared with treated peers who had no relapses (aHR, 1.33; 95% CI, 1.15-1.54).
Notably, said Dr. Daruwalla, in patients treated at any point during follow-up with high-efficacy DMTs, including monoclonal antibodies, sphingosphine-1 phosphate modulators, and hematopoietic stem cell transplantation, there was no difference in disability accumulation between patients who did and did not experience nondisabling relapses (aHR, 0.90; 95% CI, 0.71-1.13).
The data clearly show that early nondisabling relapses are associated with a higher risk of disability accumulation than no early relapses in people with relapsing remitting MS,” Dr. Daruwalla said.
However, he noted, treatment with high-efficacy DMTs offers protection against disability accumulations.
“Therefore, contrary to EMA guidance, nondisabling relapses should be considered in decisions to initiate or escalate treatment, including with high-efficacy therapies,” he added.
Valuable, confirmatory data
Patricia Coyle, MD, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University, called the study “valuable.”
“It confirms prior data that having relapses is bad in MS even if they are mild, and provides additional modest data in support of high-efficacy versus moderate-efficacy DMT,” said Dr. Coyle, who was not involved with the research.
“Although certainly not definitive, it adds to data supporting high-efficacy as preferred treatment [and] addresses a completely arbitrary governmental limitation to DMT use in Europe,” she added.
The study had no commercial funding. Dr. Daruwalla has reported no relevant financial relationships. Dr. Coyle reports having received consulting fees from Accordant, Biogen, Bristol-Myers Squibb, Celgene, Genentech/Roche, GlaxoSmithKline, Horizon, Janssen, Novartis, Sanofi Genzyme, and Viela Bio; and grant funding from Actelion, Alkermes, Bristol-Myers Squibb, CorEvitas, Genentech/Roche, Sanofi Genzyme, MedDay, and Novartis.
A version of this article first appeared on Medscape.com.
Nondisabling relapses that occur early in the course of relapsing-remitting multiple sclerosis (RRMS) signal faster accumulation of disability relative to no early relapses, new research suggests. However, in the large registry study, this association was not found in patients treated with high-efficacy, disease-modifying therapies (DMTs) early on.
The results suggest that ,” said lead author Cyrus Daruwalla, MD, department of clinical neurosciences at the University of Cambridge, and Addenbrooke’s Hospital, Cambridge, England.
Dr. Daruwalla presented the findings at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Questioning EMA restrictions
“We designed this project because regulators, including EMA [European Medicines Agency], restrict the use of certain DMTs to only those with disabling relapses. In particular, natalizumab [Tysabri] and fingolimod [Gilenya] can only be used as the first-line therapy for people with rapidly evolving, severe MS – which includes having two disabling relapses in a year,” Dr. Daruwalla noted.
“In clinic, when we see somebody who has a nondisabling relapse, we’re left with the question of what is the prognostic significance of that relapse, and how should it influence treatment decisions,” he added.
Using prospectively collected data from the MSBase international registry, the researchers examined data on individuals with RRMS and complete early relapse severity information.
They compared patients with exclusively nondisabling relapses in the 2 years after definitive RRMS diagnosis with peers with no relapses within this time frame.
To mitigate the confounding effect of DMT use, the investigators performed analyses in participants untreated during follow-up, and then in those who received only older or “platform” therapies (interferon-beta, glatiramer acetate, dimethyl fumarate, or teriflunomide) during follow-up.
In the untreated cohort, 285 patients had nondisabling relapses and 4,717 had no relapses during the 2 years after diagnosis. Those with early nondisabling relapses had a significantly increased risk for disability accumulation (adjusted hazard ratio [aHR], 1.29; 95% confidence interval [CI], 1.00-1.68).
In the treated cohort, 1,074 patients had nondisabling early relapses and 7,262 did not.
In this cohort, those treated with “platform” DMTs who had nondisabling relapses showed a significantly increased risk for disability accumulation compared with treated peers who had no relapses (aHR, 1.33; 95% CI, 1.15-1.54).
Notably, said Dr. Daruwalla, in patients treated at any point during follow-up with high-efficacy DMTs, including monoclonal antibodies, sphingosphine-1 phosphate modulators, and hematopoietic stem cell transplantation, there was no difference in disability accumulation between patients who did and did not experience nondisabling relapses (aHR, 0.90; 95% CI, 0.71-1.13).
The data clearly show that early nondisabling relapses are associated with a higher risk of disability accumulation than no early relapses in people with relapsing remitting MS,” Dr. Daruwalla said.
However, he noted, treatment with high-efficacy DMTs offers protection against disability accumulations.
“Therefore, contrary to EMA guidance, nondisabling relapses should be considered in decisions to initiate or escalate treatment, including with high-efficacy therapies,” he added.
Valuable, confirmatory data
Patricia Coyle, MD, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University, called the study “valuable.”
“It confirms prior data that having relapses is bad in MS even if they are mild, and provides additional modest data in support of high-efficacy versus moderate-efficacy DMT,” said Dr. Coyle, who was not involved with the research.
“Although certainly not definitive, it adds to data supporting high-efficacy as preferred treatment [and] addresses a completely arbitrary governmental limitation to DMT use in Europe,” she added.
The study had no commercial funding. Dr. Daruwalla has reported no relevant financial relationships. Dr. Coyle reports having received consulting fees from Accordant, Biogen, Bristol-Myers Squibb, Celgene, Genentech/Roche, GlaxoSmithKline, Horizon, Janssen, Novartis, Sanofi Genzyme, and Viela Bio; and grant funding from Actelion, Alkermes, Bristol-Myers Squibb, CorEvitas, Genentech/Roche, Sanofi Genzyme, MedDay, and Novartis.
A version of this article first appeared on Medscape.com.
Nondisabling relapses that occur early in the course of relapsing-remitting multiple sclerosis (RRMS) signal faster accumulation of disability relative to no early relapses, new research suggests. However, in the large registry study, this association was not found in patients treated with high-efficacy, disease-modifying therapies (DMTs) early on.
The results suggest that ,” said lead author Cyrus Daruwalla, MD, department of clinical neurosciences at the University of Cambridge, and Addenbrooke’s Hospital, Cambridge, England.
Dr. Daruwalla presented the findings at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Questioning EMA restrictions
“We designed this project because regulators, including EMA [European Medicines Agency], restrict the use of certain DMTs to only those with disabling relapses. In particular, natalizumab [Tysabri] and fingolimod [Gilenya] can only be used as the first-line therapy for people with rapidly evolving, severe MS – which includes having two disabling relapses in a year,” Dr. Daruwalla noted.
“In clinic, when we see somebody who has a nondisabling relapse, we’re left with the question of what is the prognostic significance of that relapse, and how should it influence treatment decisions,” he added.
Using prospectively collected data from the MSBase international registry, the researchers examined data on individuals with RRMS and complete early relapse severity information.
They compared patients with exclusively nondisabling relapses in the 2 years after definitive RRMS diagnosis with peers with no relapses within this time frame.
To mitigate the confounding effect of DMT use, the investigators performed analyses in participants untreated during follow-up, and then in those who received only older or “platform” therapies (interferon-beta, glatiramer acetate, dimethyl fumarate, or teriflunomide) during follow-up.
In the untreated cohort, 285 patients had nondisabling relapses and 4,717 had no relapses during the 2 years after diagnosis. Those with early nondisabling relapses had a significantly increased risk for disability accumulation (adjusted hazard ratio [aHR], 1.29; 95% confidence interval [CI], 1.00-1.68).
In the treated cohort, 1,074 patients had nondisabling early relapses and 7,262 did not.
In this cohort, those treated with “platform” DMTs who had nondisabling relapses showed a significantly increased risk for disability accumulation compared with treated peers who had no relapses (aHR, 1.33; 95% CI, 1.15-1.54).
Notably, said Dr. Daruwalla, in patients treated at any point during follow-up with high-efficacy DMTs, including monoclonal antibodies, sphingosphine-1 phosphate modulators, and hematopoietic stem cell transplantation, there was no difference in disability accumulation between patients who did and did not experience nondisabling relapses (aHR, 0.90; 95% CI, 0.71-1.13).
The data clearly show that early nondisabling relapses are associated with a higher risk of disability accumulation than no early relapses in people with relapsing remitting MS,” Dr. Daruwalla said.
However, he noted, treatment with high-efficacy DMTs offers protection against disability accumulations.
“Therefore, contrary to EMA guidance, nondisabling relapses should be considered in decisions to initiate or escalate treatment, including with high-efficacy therapies,” he added.
Valuable, confirmatory data
Patricia Coyle, MD, professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University, called the study “valuable.”
“It confirms prior data that having relapses is bad in MS even if they are mild, and provides additional modest data in support of high-efficacy versus moderate-efficacy DMT,” said Dr. Coyle, who was not involved with the research.
“Although certainly not definitive, it adds to data supporting high-efficacy as preferred treatment [and] addresses a completely arbitrary governmental limitation to DMT use in Europe,” she added.
The study had no commercial funding. Dr. Daruwalla has reported no relevant financial relationships. Dr. Coyle reports having received consulting fees from Accordant, Biogen, Bristol-Myers Squibb, Celgene, Genentech/Roche, GlaxoSmithKline, Horizon, Janssen, Novartis, Sanofi Genzyme, and Viela Bio; and grant funding from Actelion, Alkermes, Bristol-Myers Squibb, CorEvitas, Genentech/Roche, Sanofi Genzyme, MedDay, and Novartis.
A version of this article first appeared on Medscape.com.
FROM ECTRIMS 2022
Longer withdrawal time reduces miss rates in screening colonoscopy
according to a randomized controlled trial conducted in China.
“Individual colonoscopists may acquire significant benefits in the ADR, AMR, AAMR, and high-risk adenoma miss rate from a 3-minute WT prolongation without compromising detection efficiency,” Zhao-Shen Li, MD, PhD, director, department of gastroenterology, Changhai Hospital and Second Military Medical University, Shanghai, said in an interview.
Based on evidence to date, the 9-minute WT “deserves to be considered as a new quality indicator to further optimize colonoscopy quality,” Dr. Li added.
The study is published online in the American Journal of Gastroenterology.
“This study certainly supports the notion that lengthening the examination time during colonoscopy results in more adenomas being detected,” Ziad F. Gellad, MD, who wasn’t involved in the study, told this news organization.
“When linking that with other studies showing a positive correlation between adenoma detection rate and interval cancers, we can conjecture that these longer exams will result in improved cancer detection. This makes intuitive sense,” said Dr. Gellad, associate professor of medicine, Duke University Medical Center, Durham, N.C.
In an earlier study, Dr. Li and colleagues found that prolonging the WT from a mean of 6 minutes to 9 minutes significantly improved the ADR (27.1% vs. 36.6%, P = .001).
Their latest study involved 733 asymptomatic adults aged 40-75 years undergoing screening colonoscopy by 15 gastroenterologists at 11 tertiary hospitals in China.
Participants were randomly allocated to segmental tandem screening colonoscopy with 9-minute withdrawal first (9MF) followed by 6-minute withdrawal (6MF) or vice versa.
In an intention-to-treat analysis, compared with 6MF, 9MF significantly reduced the lesion-level AMR (14.5% vs. 36.6%, P < .001), which was the primary outcome, and the participant-level AMR (10.9% vs. 25.9%; P < .001).
The 9MF also significantly reduced the AAMR (5.3% vs. 46.9%, P = .002), multiple AMR (20.7% vs. 56.5%; P = .01), and high-risk AMR (14.6% vs. 39.5%; P = .01) – without compromising detection efficiency.
The longer withdrawal time was also associated with a lower false-negative rate for adenomas (5.2% vs. 11.7%; P = .002) and high-risk adenomas (2.2% vs. 5%; P < .05), as well as a lower rate of shortening the surveillance schedule (P < .001).
A 9-minute mean WT also led to an improved ADR (42.3% vs. 33.5%, P = .02). The ADR improvement was associated with diminutive (P = .01), flat (P = .01), and tubular adenomas (P = .02).
Notably, colonoscopists with high ADRs (≥ 25%) in routine practice also showed a tendency of ADR improvement through a 3-minute prolongation (41% vs. 34.8%; P for interaction = .62), the investigators wrote.
Dr. Gellad said in an interview the study “reinforces the importance of careful inspection of the colonic mucosa during colonoscopy withdrawal. This should take as long as it takes to do it right, and that will vary by patient and by endoscopist.”
“Measurement of withdrawal time is helpful for quality improvement purposes when physician detection rates or miss rates are below goal,” Dr. Gellad added, “but timing the withdrawal should not be a goal in and of itself,”
The study was supported by the National Science and Technology Plan Project of the Ministry of Science and Technology of China. The authors reported no relevant financial relationships. Dr. Gellad is a consultant for Merck and Novo Nordisk and a cofounder of Higgs Boson.
A version of this article first appeared on Medscape.com.
according to a randomized controlled trial conducted in China.
“Individual colonoscopists may acquire significant benefits in the ADR, AMR, AAMR, and high-risk adenoma miss rate from a 3-minute WT prolongation without compromising detection efficiency,” Zhao-Shen Li, MD, PhD, director, department of gastroenterology, Changhai Hospital and Second Military Medical University, Shanghai, said in an interview.
Based on evidence to date, the 9-minute WT “deserves to be considered as a new quality indicator to further optimize colonoscopy quality,” Dr. Li added.
The study is published online in the American Journal of Gastroenterology.
“This study certainly supports the notion that lengthening the examination time during colonoscopy results in more adenomas being detected,” Ziad F. Gellad, MD, who wasn’t involved in the study, told this news organization.
“When linking that with other studies showing a positive correlation between adenoma detection rate and interval cancers, we can conjecture that these longer exams will result in improved cancer detection. This makes intuitive sense,” said Dr. Gellad, associate professor of medicine, Duke University Medical Center, Durham, N.C.
In an earlier study, Dr. Li and colleagues found that prolonging the WT from a mean of 6 minutes to 9 minutes significantly improved the ADR (27.1% vs. 36.6%, P = .001).
Their latest study involved 733 asymptomatic adults aged 40-75 years undergoing screening colonoscopy by 15 gastroenterologists at 11 tertiary hospitals in China.
Participants were randomly allocated to segmental tandem screening colonoscopy with 9-minute withdrawal first (9MF) followed by 6-minute withdrawal (6MF) or vice versa.
In an intention-to-treat analysis, compared with 6MF, 9MF significantly reduced the lesion-level AMR (14.5% vs. 36.6%, P < .001), which was the primary outcome, and the participant-level AMR (10.9% vs. 25.9%; P < .001).
The 9MF also significantly reduced the AAMR (5.3% vs. 46.9%, P = .002), multiple AMR (20.7% vs. 56.5%; P = .01), and high-risk AMR (14.6% vs. 39.5%; P = .01) – without compromising detection efficiency.
The longer withdrawal time was also associated with a lower false-negative rate for adenomas (5.2% vs. 11.7%; P = .002) and high-risk adenomas (2.2% vs. 5%; P < .05), as well as a lower rate of shortening the surveillance schedule (P < .001).
A 9-minute mean WT also led to an improved ADR (42.3% vs. 33.5%, P = .02). The ADR improvement was associated with diminutive (P = .01), flat (P = .01), and tubular adenomas (P = .02).
Notably, colonoscopists with high ADRs (≥ 25%) in routine practice also showed a tendency of ADR improvement through a 3-minute prolongation (41% vs. 34.8%; P for interaction = .62), the investigators wrote.
Dr. Gellad said in an interview the study “reinforces the importance of careful inspection of the colonic mucosa during colonoscopy withdrawal. This should take as long as it takes to do it right, and that will vary by patient and by endoscopist.”
“Measurement of withdrawal time is helpful for quality improvement purposes when physician detection rates or miss rates are below goal,” Dr. Gellad added, “but timing the withdrawal should not be a goal in and of itself,”
The study was supported by the National Science and Technology Plan Project of the Ministry of Science and Technology of China. The authors reported no relevant financial relationships. Dr. Gellad is a consultant for Merck and Novo Nordisk and a cofounder of Higgs Boson.
A version of this article first appeared on Medscape.com.
according to a randomized controlled trial conducted in China.
“Individual colonoscopists may acquire significant benefits in the ADR, AMR, AAMR, and high-risk adenoma miss rate from a 3-minute WT prolongation without compromising detection efficiency,” Zhao-Shen Li, MD, PhD, director, department of gastroenterology, Changhai Hospital and Second Military Medical University, Shanghai, said in an interview.
Based on evidence to date, the 9-minute WT “deserves to be considered as a new quality indicator to further optimize colonoscopy quality,” Dr. Li added.
The study is published online in the American Journal of Gastroenterology.
“This study certainly supports the notion that lengthening the examination time during colonoscopy results in more adenomas being detected,” Ziad F. Gellad, MD, who wasn’t involved in the study, told this news organization.
“When linking that with other studies showing a positive correlation between adenoma detection rate and interval cancers, we can conjecture that these longer exams will result in improved cancer detection. This makes intuitive sense,” said Dr. Gellad, associate professor of medicine, Duke University Medical Center, Durham, N.C.
In an earlier study, Dr. Li and colleagues found that prolonging the WT from a mean of 6 minutes to 9 minutes significantly improved the ADR (27.1% vs. 36.6%, P = .001).
Their latest study involved 733 asymptomatic adults aged 40-75 years undergoing screening colonoscopy by 15 gastroenterologists at 11 tertiary hospitals in China.
Participants were randomly allocated to segmental tandem screening colonoscopy with 9-minute withdrawal first (9MF) followed by 6-minute withdrawal (6MF) or vice versa.
In an intention-to-treat analysis, compared with 6MF, 9MF significantly reduced the lesion-level AMR (14.5% vs. 36.6%, P < .001), which was the primary outcome, and the participant-level AMR (10.9% vs. 25.9%; P < .001).
The 9MF also significantly reduced the AAMR (5.3% vs. 46.9%, P = .002), multiple AMR (20.7% vs. 56.5%; P = .01), and high-risk AMR (14.6% vs. 39.5%; P = .01) – without compromising detection efficiency.
The longer withdrawal time was also associated with a lower false-negative rate for adenomas (5.2% vs. 11.7%; P = .002) and high-risk adenomas (2.2% vs. 5%; P < .05), as well as a lower rate of shortening the surveillance schedule (P < .001).
A 9-minute mean WT also led to an improved ADR (42.3% vs. 33.5%, P = .02). The ADR improvement was associated with diminutive (P = .01), flat (P = .01), and tubular adenomas (P = .02).
Notably, colonoscopists with high ADRs (≥ 25%) in routine practice also showed a tendency of ADR improvement through a 3-minute prolongation (41% vs. 34.8%; P for interaction = .62), the investigators wrote.
Dr. Gellad said in an interview the study “reinforces the importance of careful inspection of the colonic mucosa during colonoscopy withdrawal. This should take as long as it takes to do it right, and that will vary by patient and by endoscopist.”
“Measurement of withdrawal time is helpful for quality improvement purposes when physician detection rates or miss rates are below goal,” Dr. Gellad added, “but timing the withdrawal should not be a goal in and of itself,”
The study was supported by the National Science and Technology Plan Project of the Ministry of Science and Technology of China. The authors reported no relevant financial relationships. Dr. Gellad is a consultant for Merck and Novo Nordisk and a cofounder of Higgs Boson.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY
Downward trend in Medicare payments for GI services
“When Medicare reimbursements decrease, health outcomes, health care access, and patient satisfaction may be affected, particularly in light of high inflation and increased costs due to staffing shortages, increased staffing salaries, and additional equipment necessary for COVID-19 safety,” researchers wrote in The American Journal of Gastroenterology.
Samir A. Shah, MD, of Brown University, Providence, R.I., and colleagues evaluated trends from 2007 to 2022 in Medicare reimbursement for the top 10 common GI procedures.
These procedures, which included colonoscopies, endoscopies, and gastrostomy tube placement, were identified through a joint list published by the American College of Gastroenterology, the American Society of Gastrointestinal Endoscopy, and the American Gastroenterological Association.
From 2007 to 2022, unadjusted and adjusted reimbursement for GI procedures declined by 7% and 33%, respectively, on average.
The adjusted change in physician reimbursement ranged from a decrease of roughly 29% for esophagus endoscopy to 38% for colonoscopy and biopsy, the study team found.
They found that the decline in reimbursement of GI procedures was significantly larger after 2015 (P < .001).
From 2007 to 2014, the mean decrease in physician reimbursement for GI services was 6.7%, and the annual growth rate in reimbursement was –1.0%.
In comparison, from 2015 to 2022, the mean decrease in physician reimbursement was 28.2%, and the mean annual growth rate in reimbursement was –4.7%.
To examine trends in reimbursement for office and inpatient visits from 2007 to 2022, the researchers identified the top five current procedural terminology (CPT) codes from outpatient office and inpatient consult visits provided to Medicare Part B beneficiaries by gastroenterologists.
In contrast to the reimbursement trends for GI procedures, the unadjusted physician reimbursement for inpatient and outpatient visits showed an average increase of 32%.
However, after adjustment for inflation, physician reimbursement for patient visits showed an average decline of 4.9%.
Overall, reimbursement for outpatient visits increased by 4.3%, while reimbursement for inpatient visits decreased by 18.8%.
Dr. Shah and colleagues said their findings are important, given that Medicare patients make up a substantial and growing proportion of patients with GI problems and because fewer than 1% of gastroenterologists have opted out of Medicare.
They noted that the trends in GI reimbursement they observed mirror trends in other specialties, which have also noted a decrease in adjusted reimbursement for care.
The study had no financial support. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“When Medicare reimbursements decrease, health outcomes, health care access, and patient satisfaction may be affected, particularly in light of high inflation and increased costs due to staffing shortages, increased staffing salaries, and additional equipment necessary for COVID-19 safety,” researchers wrote in The American Journal of Gastroenterology.
Samir A. Shah, MD, of Brown University, Providence, R.I., and colleagues evaluated trends from 2007 to 2022 in Medicare reimbursement for the top 10 common GI procedures.
These procedures, which included colonoscopies, endoscopies, and gastrostomy tube placement, were identified through a joint list published by the American College of Gastroenterology, the American Society of Gastrointestinal Endoscopy, and the American Gastroenterological Association.
From 2007 to 2022, unadjusted and adjusted reimbursement for GI procedures declined by 7% and 33%, respectively, on average.
The adjusted change in physician reimbursement ranged from a decrease of roughly 29% for esophagus endoscopy to 38% for colonoscopy and biopsy, the study team found.
They found that the decline in reimbursement of GI procedures was significantly larger after 2015 (P < .001).
From 2007 to 2014, the mean decrease in physician reimbursement for GI services was 6.7%, and the annual growth rate in reimbursement was –1.0%.
In comparison, from 2015 to 2022, the mean decrease in physician reimbursement was 28.2%, and the mean annual growth rate in reimbursement was –4.7%.
To examine trends in reimbursement for office and inpatient visits from 2007 to 2022, the researchers identified the top five current procedural terminology (CPT) codes from outpatient office and inpatient consult visits provided to Medicare Part B beneficiaries by gastroenterologists.
In contrast to the reimbursement trends for GI procedures, the unadjusted physician reimbursement for inpatient and outpatient visits showed an average increase of 32%.
However, after adjustment for inflation, physician reimbursement for patient visits showed an average decline of 4.9%.
Overall, reimbursement for outpatient visits increased by 4.3%, while reimbursement for inpatient visits decreased by 18.8%.
Dr. Shah and colleagues said their findings are important, given that Medicare patients make up a substantial and growing proportion of patients with GI problems and because fewer than 1% of gastroenterologists have opted out of Medicare.
They noted that the trends in GI reimbursement they observed mirror trends in other specialties, which have also noted a decrease in adjusted reimbursement for care.
The study had no financial support. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“When Medicare reimbursements decrease, health outcomes, health care access, and patient satisfaction may be affected, particularly in light of high inflation and increased costs due to staffing shortages, increased staffing salaries, and additional equipment necessary for COVID-19 safety,” researchers wrote in The American Journal of Gastroenterology.
Samir A. Shah, MD, of Brown University, Providence, R.I., and colleagues evaluated trends from 2007 to 2022 in Medicare reimbursement for the top 10 common GI procedures.
These procedures, which included colonoscopies, endoscopies, and gastrostomy tube placement, were identified through a joint list published by the American College of Gastroenterology, the American Society of Gastrointestinal Endoscopy, and the American Gastroenterological Association.
From 2007 to 2022, unadjusted and adjusted reimbursement for GI procedures declined by 7% and 33%, respectively, on average.
The adjusted change in physician reimbursement ranged from a decrease of roughly 29% for esophagus endoscopy to 38% for colonoscopy and biopsy, the study team found.
They found that the decline in reimbursement of GI procedures was significantly larger after 2015 (P < .001).
From 2007 to 2014, the mean decrease in physician reimbursement for GI services was 6.7%, and the annual growth rate in reimbursement was –1.0%.
In comparison, from 2015 to 2022, the mean decrease in physician reimbursement was 28.2%, and the mean annual growth rate in reimbursement was –4.7%.
To examine trends in reimbursement for office and inpatient visits from 2007 to 2022, the researchers identified the top five current procedural terminology (CPT) codes from outpatient office and inpatient consult visits provided to Medicare Part B beneficiaries by gastroenterologists.
In contrast to the reimbursement trends for GI procedures, the unadjusted physician reimbursement for inpatient and outpatient visits showed an average increase of 32%.
However, after adjustment for inflation, physician reimbursement for patient visits showed an average decline of 4.9%.
Overall, reimbursement for outpatient visits increased by 4.3%, while reimbursement for inpatient visits decreased by 18.8%.
Dr. Shah and colleagues said their findings are important, given that Medicare patients make up a substantial and growing proportion of patients with GI problems and because fewer than 1% of gastroenterologists have opted out of Medicare.
They noted that the trends in GI reimbursement they observed mirror trends in other specialties, which have also noted a decrease in adjusted reimbursement for care.
The study had no financial support. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY
FDA puts REMS requirements on hold to ensure continuity of care
In a Nov. 2 notice on its website, the FDA said it is aware that health care professionals and patients continue to experience ongoing difficulties with the clozapine REMS program, including issues with patient access to clozapine following discharge from inpatient care.
A chief concern is that inpatient pharmacies are only allowed to dispense a 7-days’ supply of clozapine to the patient upon discharge.
To address this issue, the FDA said it will now (temporarily) not object if inpatient pharmacies dispense a days’ supply of clozapine that aligns with the patient’s monitoring frequency.
For example, a 7-days’ supply for weekly monitoring, a 14-days’ supply for twice-monthly monitoring, and a 30-days’ supply for monthly monitoring upon discharge from an inpatient facility.
Clozapine is a second-generation (atypical) antipsychotic used to treat schizophrenia that is not well controlled with standard antipsychotics.
While clozapine can be highly effective in some patients, it also carries serious risks, including a decrease in neutrophil count, which can lead to severe neutropenia, serious infections, and death.
As a result, those taking the drug must undergo regular absolute neutrophil count monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.
The FDA says it will continue to exercise earlier enforcement discretion regarding the clozapine REMS program announced back in November 2021. This includes allowing pharmacists to dispense clozapine without a REMS dispense authorization and allowing wholesalers to ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS.
“We understand that difficulties with the clozapine REMS program have caused frustration and have led to problems with patient access to clozapine. FDA takes these concerns seriously. Continuity of care, patient access to clozapine, and patient safety are our highest priorities,” the FDA says.
The agency is working closely with the clozapine REMS program administrators to address these challenges and avoid interruptions in patient care.
The FDA encourages pharmacists and prescribers to continue working with the clozapine REMS to complete certification and prescribers to enroll patients in the program.
A version of this article first appeared on Medscape.com.
In a Nov. 2 notice on its website, the FDA said it is aware that health care professionals and patients continue to experience ongoing difficulties with the clozapine REMS program, including issues with patient access to clozapine following discharge from inpatient care.
A chief concern is that inpatient pharmacies are only allowed to dispense a 7-days’ supply of clozapine to the patient upon discharge.
To address this issue, the FDA said it will now (temporarily) not object if inpatient pharmacies dispense a days’ supply of clozapine that aligns with the patient’s monitoring frequency.
For example, a 7-days’ supply for weekly monitoring, a 14-days’ supply for twice-monthly monitoring, and a 30-days’ supply for monthly monitoring upon discharge from an inpatient facility.
Clozapine is a second-generation (atypical) antipsychotic used to treat schizophrenia that is not well controlled with standard antipsychotics.
While clozapine can be highly effective in some patients, it also carries serious risks, including a decrease in neutrophil count, which can lead to severe neutropenia, serious infections, and death.
As a result, those taking the drug must undergo regular absolute neutrophil count monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.
The FDA says it will continue to exercise earlier enforcement discretion regarding the clozapine REMS program announced back in November 2021. This includes allowing pharmacists to dispense clozapine without a REMS dispense authorization and allowing wholesalers to ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS.
“We understand that difficulties with the clozapine REMS program have caused frustration and have led to problems with patient access to clozapine. FDA takes these concerns seriously. Continuity of care, patient access to clozapine, and patient safety are our highest priorities,” the FDA says.
The agency is working closely with the clozapine REMS program administrators to address these challenges and avoid interruptions in patient care.
The FDA encourages pharmacists and prescribers to continue working with the clozapine REMS to complete certification and prescribers to enroll patients in the program.
A version of this article first appeared on Medscape.com.
In a Nov. 2 notice on its website, the FDA said it is aware that health care professionals and patients continue to experience ongoing difficulties with the clozapine REMS program, including issues with patient access to clozapine following discharge from inpatient care.
A chief concern is that inpatient pharmacies are only allowed to dispense a 7-days’ supply of clozapine to the patient upon discharge.
To address this issue, the FDA said it will now (temporarily) not object if inpatient pharmacies dispense a days’ supply of clozapine that aligns with the patient’s monitoring frequency.
For example, a 7-days’ supply for weekly monitoring, a 14-days’ supply for twice-monthly monitoring, and a 30-days’ supply for monthly monitoring upon discharge from an inpatient facility.
Clozapine is a second-generation (atypical) antipsychotic used to treat schizophrenia that is not well controlled with standard antipsychotics.
While clozapine can be highly effective in some patients, it also carries serious risks, including a decrease in neutrophil count, which can lead to severe neutropenia, serious infections, and death.
As a result, those taking the drug must undergo regular absolute neutrophil count monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.
The FDA says it will continue to exercise earlier enforcement discretion regarding the clozapine REMS program announced back in November 2021. This includes allowing pharmacists to dispense clozapine without a REMS dispense authorization and allowing wholesalers to ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS.
“We understand that difficulties with the clozapine REMS program have caused frustration and have led to problems with patient access to clozapine. FDA takes these concerns seriously. Continuity of care, patient access to clozapine, and patient safety are our highest priorities,” the FDA says.
The agency is working closely with the clozapine REMS program administrators to address these challenges and avoid interruptions in patient care.
The FDA encourages pharmacists and prescribers to continue working with the clozapine REMS to complete certification and prescribers to enroll patients in the program.
A version of this article first appeared on Medscape.com.
‘Lucid dying’: EEG backs near-death experience during CPR
“These recalled experiences and brain wave changes may be the first signs of the so-called ‘near-death’ experience, and we have captured them for the first time in a large study,” lead investigator Sam Parnia, MD, PhD, with NYU Langone Health, said in a news release.
Identifying measurable electrical signs of lucid and heightened brain activity during CPR, coupled with stories of recalled near-death experiences, suggests that the human sense of self and consciousness, much like other biological body functions, may not stop completely around the time of death, Dr. Parnia added.
He presented the findings Nov. 6 at a resuscitation science symposium at the American Heart Association scientific sessions.
The AWARE II study
“For years, some people in cardiac arrest have reported being lucid, often with a heightened sense of consciousness, while seemingly unconscious and on the brink of death,” Dr. Parnia noted in an interview.
“Yet, no one’s ever be able to prove it and a lot of people have dismissed these experiences, thinking it’s all just a trick on the brain,” Dr. Parnia said.
In a first-of-its-kind study, Dr. Parnia and colleagues examined consciousness and its underlying electrocortical biomarkers during CPR for in-hospital cardiac arrest (IHCA).
They incorporated independent audiovisual testing of awareness with continuous real-time EEG and cerebral oxygenation (rSO2) monitoring into CPR.
Only 53 of the 567 IHCA patients survived (9.3%). Among the 28 (52.8%) IHCA survivors who completed interviews, 11 (39.3%) reported unique, lucid experiences during resuscitation.
These experiences included a perception of separation from one’s body, observing events without pain or distress, and an awareness and meaningful evaluation of life, including of their actions, intentions, and thoughts toward others.
“These lucid experiences of death are not hallucinations or delusions. They cannot be considered a trick of a disordered or dying brain, but rather a unique human experience that emerges on the brink of death,” Dr. Parnia said.
And what’s “fascinating,” he added, is that despite marked cerebral ischemia (mean regional oxygen saturation [rSO2] 43%), near-normal/physiologic EEG activity (gamma, delta, theta, alpha, and beta rhythms) consistent with consciousness and a possible resumption of a network-level of cognitive and neuronal activity emerged for as long as 35-60 minutes into CPR.
Some of these brain waves normally occur when people are conscious and performing higher mental functions, including thinking, memory retrieval, and conscious perception, he said.
‘Seismic shift’ in understanding of death
This is the first time such biomarkers of consciousness have been identified during cardiac arrest and CPR, Dr. Parnia said.
He said further study is needed to more precisely define biomarkers of what is considered to be clinical consciousness and the recalled experience of death, and to monitor the long-term psychological effects of resuscitation after cardiac arrest.
“Our understanding of death has gone through a seismic shift in the last few years,” he said.
“The biological discoveries around death and the postmortem period are completely different to the social conventions that we have about death. That is, we perceive of death as being the end, but actually what we’re finding is that brain cells don’t die immediately. They die very slowly over many hours of time,” Dr. Parnia noted.
Reached for comment, Ajmal Zemmar, MD, PhD, of University of Louisville (Ky.), noted that several studies, including this one, “challenge the traditional way that we think of death – that when the heart stops beating that’s when we die.”
The observation that during cardiac arrest and CPR, the brain waves are still normal for up to an hour is “fairly remarkable,” Dr. Zemmar told this news organization.
“However, whether there is conscious perception or not is very hard to answer,” he cautioned.
“This type of research tries to bridge the objective EEG recordings with the subjective description you get from the patient, but it’s hard to know when conscious perception stops,” he said.
Funding and support for the study were provided by NYU Langone Health, The John Templeton Foundation, and the UK Resuscitation Council, and National Institutes for Health Research. Dr. Parnia and Dr. Zemmar reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“These recalled experiences and brain wave changes may be the first signs of the so-called ‘near-death’ experience, and we have captured them for the first time in a large study,” lead investigator Sam Parnia, MD, PhD, with NYU Langone Health, said in a news release.
Identifying measurable electrical signs of lucid and heightened brain activity during CPR, coupled with stories of recalled near-death experiences, suggests that the human sense of self and consciousness, much like other biological body functions, may not stop completely around the time of death, Dr. Parnia added.
He presented the findings Nov. 6 at a resuscitation science symposium at the American Heart Association scientific sessions.
The AWARE II study
“For years, some people in cardiac arrest have reported being lucid, often with a heightened sense of consciousness, while seemingly unconscious and on the brink of death,” Dr. Parnia noted in an interview.
“Yet, no one’s ever be able to prove it and a lot of people have dismissed these experiences, thinking it’s all just a trick on the brain,” Dr. Parnia said.
In a first-of-its-kind study, Dr. Parnia and colleagues examined consciousness and its underlying electrocortical biomarkers during CPR for in-hospital cardiac arrest (IHCA).
They incorporated independent audiovisual testing of awareness with continuous real-time EEG and cerebral oxygenation (rSO2) monitoring into CPR.
Only 53 of the 567 IHCA patients survived (9.3%). Among the 28 (52.8%) IHCA survivors who completed interviews, 11 (39.3%) reported unique, lucid experiences during resuscitation.
These experiences included a perception of separation from one’s body, observing events without pain or distress, and an awareness and meaningful evaluation of life, including of their actions, intentions, and thoughts toward others.
“These lucid experiences of death are not hallucinations or delusions. They cannot be considered a trick of a disordered or dying brain, but rather a unique human experience that emerges on the brink of death,” Dr. Parnia said.
And what’s “fascinating,” he added, is that despite marked cerebral ischemia (mean regional oxygen saturation [rSO2] 43%), near-normal/physiologic EEG activity (gamma, delta, theta, alpha, and beta rhythms) consistent with consciousness and a possible resumption of a network-level of cognitive and neuronal activity emerged for as long as 35-60 minutes into CPR.
Some of these brain waves normally occur when people are conscious and performing higher mental functions, including thinking, memory retrieval, and conscious perception, he said.
‘Seismic shift’ in understanding of death
This is the first time such biomarkers of consciousness have been identified during cardiac arrest and CPR, Dr. Parnia said.
He said further study is needed to more precisely define biomarkers of what is considered to be clinical consciousness and the recalled experience of death, and to monitor the long-term psychological effects of resuscitation after cardiac arrest.
“Our understanding of death has gone through a seismic shift in the last few years,” he said.
“The biological discoveries around death and the postmortem period are completely different to the social conventions that we have about death. That is, we perceive of death as being the end, but actually what we’re finding is that brain cells don’t die immediately. They die very slowly over many hours of time,” Dr. Parnia noted.
Reached for comment, Ajmal Zemmar, MD, PhD, of University of Louisville (Ky.), noted that several studies, including this one, “challenge the traditional way that we think of death – that when the heart stops beating that’s when we die.”
The observation that during cardiac arrest and CPR, the brain waves are still normal for up to an hour is “fairly remarkable,” Dr. Zemmar told this news organization.
“However, whether there is conscious perception or not is very hard to answer,” he cautioned.
“This type of research tries to bridge the objective EEG recordings with the subjective description you get from the patient, but it’s hard to know when conscious perception stops,” he said.
Funding and support for the study were provided by NYU Langone Health, The John Templeton Foundation, and the UK Resuscitation Council, and National Institutes for Health Research. Dr. Parnia and Dr. Zemmar reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“These recalled experiences and brain wave changes may be the first signs of the so-called ‘near-death’ experience, and we have captured them for the first time in a large study,” lead investigator Sam Parnia, MD, PhD, with NYU Langone Health, said in a news release.
Identifying measurable electrical signs of lucid and heightened brain activity during CPR, coupled with stories of recalled near-death experiences, suggests that the human sense of self and consciousness, much like other biological body functions, may not stop completely around the time of death, Dr. Parnia added.
He presented the findings Nov. 6 at a resuscitation science symposium at the American Heart Association scientific sessions.
The AWARE II study
“For years, some people in cardiac arrest have reported being lucid, often with a heightened sense of consciousness, while seemingly unconscious and on the brink of death,” Dr. Parnia noted in an interview.
“Yet, no one’s ever be able to prove it and a lot of people have dismissed these experiences, thinking it’s all just a trick on the brain,” Dr. Parnia said.
In a first-of-its-kind study, Dr. Parnia and colleagues examined consciousness and its underlying electrocortical biomarkers during CPR for in-hospital cardiac arrest (IHCA).
They incorporated independent audiovisual testing of awareness with continuous real-time EEG and cerebral oxygenation (rSO2) monitoring into CPR.
Only 53 of the 567 IHCA patients survived (9.3%). Among the 28 (52.8%) IHCA survivors who completed interviews, 11 (39.3%) reported unique, lucid experiences during resuscitation.
These experiences included a perception of separation from one’s body, observing events without pain or distress, and an awareness and meaningful evaluation of life, including of their actions, intentions, and thoughts toward others.
“These lucid experiences of death are not hallucinations or delusions. They cannot be considered a trick of a disordered or dying brain, but rather a unique human experience that emerges on the brink of death,” Dr. Parnia said.
And what’s “fascinating,” he added, is that despite marked cerebral ischemia (mean regional oxygen saturation [rSO2] 43%), near-normal/physiologic EEG activity (gamma, delta, theta, alpha, and beta rhythms) consistent with consciousness and a possible resumption of a network-level of cognitive and neuronal activity emerged for as long as 35-60 minutes into CPR.
Some of these brain waves normally occur when people are conscious and performing higher mental functions, including thinking, memory retrieval, and conscious perception, he said.
‘Seismic shift’ in understanding of death
This is the first time such biomarkers of consciousness have been identified during cardiac arrest and CPR, Dr. Parnia said.
He said further study is needed to more precisely define biomarkers of what is considered to be clinical consciousness and the recalled experience of death, and to monitor the long-term psychological effects of resuscitation after cardiac arrest.
“Our understanding of death has gone through a seismic shift in the last few years,” he said.
“The biological discoveries around death and the postmortem period are completely different to the social conventions that we have about death. That is, we perceive of death as being the end, but actually what we’re finding is that brain cells don’t die immediately. They die very slowly over many hours of time,” Dr. Parnia noted.
Reached for comment, Ajmal Zemmar, MD, PhD, of University of Louisville (Ky.), noted that several studies, including this one, “challenge the traditional way that we think of death – that when the heart stops beating that’s when we die.”
The observation that during cardiac arrest and CPR, the brain waves are still normal for up to an hour is “fairly remarkable,” Dr. Zemmar told this news organization.
“However, whether there is conscious perception or not is very hard to answer,” he cautioned.
“This type of research tries to bridge the objective EEG recordings with the subjective description you get from the patient, but it’s hard to know when conscious perception stops,” he said.
Funding and support for the study were provided by NYU Langone Health, The John Templeton Foundation, and the UK Resuscitation Council, and National Institutes for Health Research. Dr. Parnia and Dr. Zemmar reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AHA 2022
A cost-effective de-escalation strategy in advanced melanoma
Response-adapted , an economic analysis found.
“The rising costs of cancer therapies are becoming untenable for both patients and payers, and there is both clinical and economic benefit to finding less expensive treatment alternatives,” Wolfgang Kunz, MD, University Hospital, Ludwig Maximilian University of Munich, told this news organization.
This economic analysis “highlights that leveraging modern diagnostic capabilities can do just that: Pairing drug regimens with CT-image analysis to optimize dosages can reduce health care costs and improve clinical outcomes,” Dr. Kunz said.
The study was published online in JAMA Dermatology.
While the use of immunotherapies over the past decade has improved the prognosis for patients with advanced melanoma, these drugs come with a hefty price tag.
One potential way to help reduce costs: de-escalate therapy. The ADAPT-IT trial demonstrated similar progression-free and overall survival among patients who received response-adapted ipilimumab discontinuation and those who received standard of care.
In the current analysis, Dr. Kunz and colleagues wanted to understand whether this response-adapted approach was also cost effective.
The team applied economic modeling to data from the ADAPT-IT trial as well as CheckMate 067, in which patients received standard of care four doses of combination ipilimumab-nivolumab followed by nivolumab monotherapy. In the ADAPT-IT trial, patients also initially received the immunotherapy combination but had CT scans to determine their response after two doses; if they responded, patients discontinued ipilimumab and continued with nivolumab monotherapy.
Overall, ADAPT-IT showed that responders could forgo the additional two doses of ipilimumab plus nivolumab while maintaining similar progression-free survival and overall survival seen at 18 months in the CheckMate 067 trial.
The current economic analysis, based on 41 patients from ADAPT-IT and 314 from CheckMate 067, showed a potential reduction in health care costs of $19,891 per patient with the response-adapted approach.
Response-adapted treatment was the cost-effective option in 94% of simulated scenarios.
When extrapolated to 2019 incidence rates of distant melanoma cases, yearly national savings could reach about $58 million.
“In the relatively small space of immunotherapies in advanced melanoma, we hope this analysis motivates clinicians to consider response-adapted treatment,” Dr. Kunz told this news organization.
“On the larger scale, this analysis serves as a stepping stone to more response-guided treatment protocols,” Dr. Kunz added. “With drug costs rising and imaging capabilities growing, more frequent image-guided adjustments are a perfect fit into the personalized care model.”
When applying the cost savings noted in this analysis across all treated patients, “the economic impact may be profound,” said Joseph Skitzki, MD, surgical oncologist, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., who wasn’t involved in the study. The “financial toxicity of cancer care is increasingly recognized as a potential barrier to optimal outcomes and any measures to mitigate cost may be impactful.”
However, Dr. Skitzki said several caveats need to be considered.
One is that the data included from ADAPT-IT only included 41 patients, compared with 314 patients from CheckMate 067.
“It is possible that a larger real-world study utilizing the ADAPT-IT protocol may not be as favorable in terms of outcomes and could lessen the economic impact of de-escalation, although any form of de-escalation is likely to have a cost benefit,” Dr. Skitzki said in an interview.
A real-world response–adapted de-escalation clinical trial, with an emphasis on costs and a benchmark of similar progression-free and overall survival, should be conducted before the de-escalated option becomes “practice changing,” Dr. Skitzki said.
Jeffrey Weber, MD, PhD, deputy director, Perlmutter Cancer Center, NYU Langone Health, New York, also urged caution in interpreting the results.
“I would not base treatment decisions on a small sampling of 41 patients in the absence of a randomized comparison,” Dr. Weber told this news organization. “Without a proper comparison, I would not advocate using only two doses of ipilimumab-nivolumab to make decisions on treatment.”
Dr. Skitzki added that, while “studies like this one are desperately needed to lessen the economic impact of new and emerging combination immunotherapies,” there is likely also a “disincentive for pharmaceutical companies to conduct this type of research.”
This research had no specific funding. Dr. Kunz and Dr. Skitzki reported no relevant conflicts of interest. Dr. Weber disclosed relationships with Merck, Genentech, AstraZeneca, Pfizer, Regeneron, and GSK, among others, and holds equity in Cytomx, Biond, NexImmune, and Immunomax.
A version of this article first appeared on Medscape.com.
Response-adapted , an economic analysis found.
“The rising costs of cancer therapies are becoming untenable for both patients and payers, and there is both clinical and economic benefit to finding less expensive treatment alternatives,” Wolfgang Kunz, MD, University Hospital, Ludwig Maximilian University of Munich, told this news organization.
This economic analysis “highlights that leveraging modern diagnostic capabilities can do just that: Pairing drug regimens with CT-image analysis to optimize dosages can reduce health care costs and improve clinical outcomes,” Dr. Kunz said.
The study was published online in JAMA Dermatology.
While the use of immunotherapies over the past decade has improved the prognosis for patients with advanced melanoma, these drugs come with a hefty price tag.
One potential way to help reduce costs: de-escalate therapy. The ADAPT-IT trial demonstrated similar progression-free and overall survival among patients who received response-adapted ipilimumab discontinuation and those who received standard of care.
In the current analysis, Dr. Kunz and colleagues wanted to understand whether this response-adapted approach was also cost effective.
The team applied economic modeling to data from the ADAPT-IT trial as well as CheckMate 067, in which patients received standard of care four doses of combination ipilimumab-nivolumab followed by nivolumab monotherapy. In the ADAPT-IT trial, patients also initially received the immunotherapy combination but had CT scans to determine their response after two doses; if they responded, patients discontinued ipilimumab and continued with nivolumab monotherapy.
Overall, ADAPT-IT showed that responders could forgo the additional two doses of ipilimumab plus nivolumab while maintaining similar progression-free survival and overall survival seen at 18 months in the CheckMate 067 trial.
The current economic analysis, based on 41 patients from ADAPT-IT and 314 from CheckMate 067, showed a potential reduction in health care costs of $19,891 per patient with the response-adapted approach.
Response-adapted treatment was the cost-effective option in 94% of simulated scenarios.
When extrapolated to 2019 incidence rates of distant melanoma cases, yearly national savings could reach about $58 million.
“In the relatively small space of immunotherapies in advanced melanoma, we hope this analysis motivates clinicians to consider response-adapted treatment,” Dr. Kunz told this news organization.
“On the larger scale, this analysis serves as a stepping stone to more response-guided treatment protocols,” Dr. Kunz added. “With drug costs rising and imaging capabilities growing, more frequent image-guided adjustments are a perfect fit into the personalized care model.”
When applying the cost savings noted in this analysis across all treated patients, “the economic impact may be profound,” said Joseph Skitzki, MD, surgical oncologist, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., who wasn’t involved in the study. The “financial toxicity of cancer care is increasingly recognized as a potential barrier to optimal outcomes and any measures to mitigate cost may be impactful.”
However, Dr. Skitzki said several caveats need to be considered.
One is that the data included from ADAPT-IT only included 41 patients, compared with 314 patients from CheckMate 067.
“It is possible that a larger real-world study utilizing the ADAPT-IT protocol may not be as favorable in terms of outcomes and could lessen the economic impact of de-escalation, although any form of de-escalation is likely to have a cost benefit,” Dr. Skitzki said in an interview.
A real-world response–adapted de-escalation clinical trial, with an emphasis on costs and a benchmark of similar progression-free and overall survival, should be conducted before the de-escalated option becomes “practice changing,” Dr. Skitzki said.
Jeffrey Weber, MD, PhD, deputy director, Perlmutter Cancer Center, NYU Langone Health, New York, also urged caution in interpreting the results.
“I would not base treatment decisions on a small sampling of 41 patients in the absence of a randomized comparison,” Dr. Weber told this news organization. “Without a proper comparison, I would not advocate using only two doses of ipilimumab-nivolumab to make decisions on treatment.”
Dr. Skitzki added that, while “studies like this one are desperately needed to lessen the economic impact of new and emerging combination immunotherapies,” there is likely also a “disincentive for pharmaceutical companies to conduct this type of research.”
This research had no specific funding. Dr. Kunz and Dr. Skitzki reported no relevant conflicts of interest. Dr. Weber disclosed relationships with Merck, Genentech, AstraZeneca, Pfizer, Regeneron, and GSK, among others, and holds equity in Cytomx, Biond, NexImmune, and Immunomax.
A version of this article first appeared on Medscape.com.
Response-adapted , an economic analysis found.
“The rising costs of cancer therapies are becoming untenable for both patients and payers, and there is both clinical and economic benefit to finding less expensive treatment alternatives,” Wolfgang Kunz, MD, University Hospital, Ludwig Maximilian University of Munich, told this news organization.
This economic analysis “highlights that leveraging modern diagnostic capabilities can do just that: Pairing drug regimens with CT-image analysis to optimize dosages can reduce health care costs and improve clinical outcomes,” Dr. Kunz said.
The study was published online in JAMA Dermatology.
While the use of immunotherapies over the past decade has improved the prognosis for patients with advanced melanoma, these drugs come with a hefty price tag.
One potential way to help reduce costs: de-escalate therapy. The ADAPT-IT trial demonstrated similar progression-free and overall survival among patients who received response-adapted ipilimumab discontinuation and those who received standard of care.
In the current analysis, Dr. Kunz and colleagues wanted to understand whether this response-adapted approach was also cost effective.
The team applied economic modeling to data from the ADAPT-IT trial as well as CheckMate 067, in which patients received standard of care four doses of combination ipilimumab-nivolumab followed by nivolumab monotherapy. In the ADAPT-IT trial, patients also initially received the immunotherapy combination but had CT scans to determine their response after two doses; if they responded, patients discontinued ipilimumab and continued with nivolumab monotherapy.
Overall, ADAPT-IT showed that responders could forgo the additional two doses of ipilimumab plus nivolumab while maintaining similar progression-free survival and overall survival seen at 18 months in the CheckMate 067 trial.
The current economic analysis, based on 41 patients from ADAPT-IT and 314 from CheckMate 067, showed a potential reduction in health care costs of $19,891 per patient with the response-adapted approach.
Response-adapted treatment was the cost-effective option in 94% of simulated scenarios.
When extrapolated to 2019 incidence rates of distant melanoma cases, yearly national savings could reach about $58 million.
“In the relatively small space of immunotherapies in advanced melanoma, we hope this analysis motivates clinicians to consider response-adapted treatment,” Dr. Kunz told this news organization.
“On the larger scale, this analysis serves as a stepping stone to more response-guided treatment protocols,” Dr. Kunz added. “With drug costs rising and imaging capabilities growing, more frequent image-guided adjustments are a perfect fit into the personalized care model.”
When applying the cost savings noted in this analysis across all treated patients, “the economic impact may be profound,” said Joseph Skitzki, MD, surgical oncologist, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., who wasn’t involved in the study. The “financial toxicity of cancer care is increasingly recognized as a potential barrier to optimal outcomes and any measures to mitigate cost may be impactful.”
However, Dr. Skitzki said several caveats need to be considered.
One is that the data included from ADAPT-IT only included 41 patients, compared with 314 patients from CheckMate 067.
“It is possible that a larger real-world study utilizing the ADAPT-IT protocol may not be as favorable in terms of outcomes and could lessen the economic impact of de-escalation, although any form of de-escalation is likely to have a cost benefit,” Dr. Skitzki said in an interview.
A real-world response–adapted de-escalation clinical trial, with an emphasis on costs and a benchmark of similar progression-free and overall survival, should be conducted before the de-escalated option becomes “practice changing,” Dr. Skitzki said.
Jeffrey Weber, MD, PhD, deputy director, Perlmutter Cancer Center, NYU Langone Health, New York, also urged caution in interpreting the results.
“I would not base treatment decisions on a small sampling of 41 patients in the absence of a randomized comparison,” Dr. Weber told this news organization. “Without a proper comparison, I would not advocate using only two doses of ipilimumab-nivolumab to make decisions on treatment.”
Dr. Skitzki added that, while “studies like this one are desperately needed to lessen the economic impact of new and emerging combination immunotherapies,” there is likely also a “disincentive for pharmaceutical companies to conduct this type of research.”
This research had no specific funding. Dr. Kunz and Dr. Skitzki reported no relevant conflicts of interest. Dr. Weber disclosed relationships with Merck, Genentech, AstraZeneca, Pfizer, Regeneron, and GSK, among others, and holds equity in Cytomx, Biond, NexImmune, and Immunomax.
A version of this article first appeared on Medscape.com.
FDA expands tenofovir alafenamide (Vemlidy) use to adolescents with chronic HBV
the drug’s manufacturer has announced.
The approval in the pediatric patient population was supported by 24-week data from a phase 2 clinical trial comparing treatment with tenofovir alafenamide (25 mg once daily) with placebo in 70 treatment-naive and treatment-experienced patients aged 12-18 years weighing at least 35 kg.
The study met its primary endpoint of percentage of patients with HBV DNA levels less than 20 IU/mL at 24 weeks of therapy, Gilead Sciences said in a press release.
Overall, 10 of 47 (21%) patients treated with tenofovir alafenamide achieved HBV DNA less than 20 IU/mL at 24 weeks, compared with 0 of 23 (0%) treated with placebo.
The rates of serum ALT normalization were higher with tenofovir alafenamide than with placebo (44% vs 0%).
The mean percent changes in bone mineral density (BMD) from baseline to 24 weeks were numerically similar for tenofovir alafenamide– and placebo-treated patients (2.4% and 1.9% for lumbar spine, and 1.5% and 1.9% for whole body, respectively).
The mean changes from baseline BMD z scores were –0.03 and –0.09 for lumbar spine, and –0.05 and –0.01 for whole body, for tenofovir alafenamide and placebo groups, respectively.
The FDA initially approved the nucleoside analog reverse transcriptase inhibitor in 2016 for adults with chronic HBV.
The drug was approved in Europe in 2017 for chronic HBV infection in adults and adolescents aged 12 years and older weighing at least 35 kg.
Tenofovir alafenamide carries a boxed warning citing risks for lactic acidosis/severe hepatomegaly with steatosis and posttreatment severe acute exacerbation of HBV.
A version of this article first appeared on Medscape.com.
the drug’s manufacturer has announced.
The approval in the pediatric patient population was supported by 24-week data from a phase 2 clinical trial comparing treatment with tenofovir alafenamide (25 mg once daily) with placebo in 70 treatment-naive and treatment-experienced patients aged 12-18 years weighing at least 35 kg.
The study met its primary endpoint of percentage of patients with HBV DNA levels less than 20 IU/mL at 24 weeks of therapy, Gilead Sciences said in a press release.
Overall, 10 of 47 (21%) patients treated with tenofovir alafenamide achieved HBV DNA less than 20 IU/mL at 24 weeks, compared with 0 of 23 (0%) treated with placebo.
The rates of serum ALT normalization were higher with tenofovir alafenamide than with placebo (44% vs 0%).
The mean percent changes in bone mineral density (BMD) from baseline to 24 weeks were numerically similar for tenofovir alafenamide– and placebo-treated patients (2.4% and 1.9% for lumbar spine, and 1.5% and 1.9% for whole body, respectively).
The mean changes from baseline BMD z scores were –0.03 and –0.09 for lumbar spine, and –0.05 and –0.01 for whole body, for tenofovir alafenamide and placebo groups, respectively.
The FDA initially approved the nucleoside analog reverse transcriptase inhibitor in 2016 for adults with chronic HBV.
The drug was approved in Europe in 2017 for chronic HBV infection in adults and adolescents aged 12 years and older weighing at least 35 kg.
Tenofovir alafenamide carries a boxed warning citing risks for lactic acidosis/severe hepatomegaly with steatosis and posttreatment severe acute exacerbation of HBV.
A version of this article first appeared on Medscape.com.
the drug’s manufacturer has announced.
The approval in the pediatric patient population was supported by 24-week data from a phase 2 clinical trial comparing treatment with tenofovir alafenamide (25 mg once daily) with placebo in 70 treatment-naive and treatment-experienced patients aged 12-18 years weighing at least 35 kg.
The study met its primary endpoint of percentage of patients with HBV DNA levels less than 20 IU/mL at 24 weeks of therapy, Gilead Sciences said in a press release.
Overall, 10 of 47 (21%) patients treated with tenofovir alafenamide achieved HBV DNA less than 20 IU/mL at 24 weeks, compared with 0 of 23 (0%) treated with placebo.
The rates of serum ALT normalization were higher with tenofovir alafenamide than with placebo (44% vs 0%).
The mean percent changes in bone mineral density (BMD) from baseline to 24 weeks were numerically similar for tenofovir alafenamide– and placebo-treated patients (2.4% and 1.9% for lumbar spine, and 1.5% and 1.9% for whole body, respectively).
The mean changes from baseline BMD z scores were –0.03 and –0.09 for lumbar spine, and –0.05 and –0.01 for whole body, for tenofovir alafenamide and placebo groups, respectively.
The FDA initially approved the nucleoside analog reverse transcriptase inhibitor in 2016 for adults with chronic HBV.
The drug was approved in Europe in 2017 for chronic HBV infection in adults and adolescents aged 12 years and older weighing at least 35 kg.
Tenofovir alafenamide carries a boxed warning citing risks for lactic acidosis/severe hepatomegaly with steatosis and posttreatment severe acute exacerbation of HBV.
A version of this article first appeared on Medscape.com.
ACC/AHA issues updated guidance on aortic disease
focusing on surgical intervention considerations, consistent imaging practices, genetic and familial screenings, and the importance of multidisciplinary care.
“There has been a host of new evidence-based research available for clinicians in the past decade when it comes to aortic disease. It was time to reevaluate and update the previous, existing guidelines,” Eric M. Isselbacher, MD, MSc, chair of the writing committee, said in a statement.
“We hope this new guideline can inform clinical practices with up-to-date and synthesized recommendations, targeted toward a full multidisciplinary aortic team working to provide the best possible care for this vulnerable patient population,” added Dr. Isselbacher, codirector of the Thoracic Aortic Center at Massachusetts General Hospital, Boston.
The 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease was simultaneously published online in the Journal of the American College of Cardiology and Circulation.
The new guideline replaces the 2010 ACCF/AHA Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease and the 2015 Surgery for Aortic Dilation in Patients With Bicuspid Aortic Valves: A Statement of Clarification From the ACC/AHA Task Force on Clinical Practice Guidelines.
The new guideline is intended to be used with the 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.
It brings together guidelines for both the thoracic and abdominal aorta and is targeted to cardiovascular clinicians involved in the care of people with aortic disease, including general cardiovascular care clinicians and emergency medicine clinicians, the writing group says.
Among the key recommendations in the new guideline are the following:
- Screen first-degree relatives of individuals diagnosed with aneurysms of the aortic root or ascending thoracic aorta, or those with aortic dissection to identify individuals most at risk for aortic disease. Screening would include genetic testing and imaging.
- Be consistent in the way CT or MRI are obtained and reported; in the measurement of aortic size and features; and in how often images are used for monitoring before and after repair surgery or other intervention. Ideally, all surveillance imaging for an individual should be done using the same modality and in the same lab, the guideline notes.
- For individuals who require aortic intervention, know that outcomes are optimized when surgery is performed by an experienced surgeon working in a multidisciplinary aortic team. The new guideline recommends “a specialized hospital team with expertise in the evaluation and management of aortic disease, in which care is delivered in a comprehensive, multidisciplinary manner.”
- At centers with multidisciplinary aortic teams and experienced surgeons, the threshold for surgical intervention for sporadic aortic root and ascending aortic aneurysms has been lowered from 5.5 cm to 5.0 cm in select individuals, and even lower in specific scenarios among patients with heritable thoracic aortic aneurysms.
- In patients who are significantly smaller or taller than average, surgical thresholds may incorporate indexing of the aortic root or ascending aortic diameter to either patient body surface area or height, or aortic cross-sectional area to patient height.
- Rapid aortic growth is a risk factor for rupture and the definition for rapid aneurysm growth rate has been updated. Surgery is now recommended for patients with aneurysms of aortic root and ascending thoracic aorta with a confirmed growth rate of ≥ 0.3 cm per year across 2 consecutive years or ≥ 0.5 cm in 1 year.
- In patients undergoing aortic root replacement surgery, valve-sparing aortic root replacement is reasonable if the valve is suitable for repair and when performed by experienced surgeons in a multidisciplinary aortic team.
- Patients with acute type A aortic dissection, if clinically stable, should be considered for transfer to a high-volume aortic center to improve survival. The operative repair of type A aortic dissection should entail at least an open distal anastomosis rather than just a simple supracoronary interposition graft.
- For management of uncomplicated type B aortic dissection, there is an increasing role for . Clinical trials of repair of thoracoabdominal aortic aneurysms with endografts are reporting results that suggest endovascular repair is an option for patients with suitable anatomy.
- Shared decision-making between the patient and multidisciplinary aortic team is highly encouraged, especially when the patient is on the borderline of thresholds for repair or eligible for different types of surgical repair.
- Shared decision-making should also be used with individuals who are pregnant or may become pregnant to consider the risks of pregnancy in individuals with aortic disease.
The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American College of Radiology, the Society of Cardiovascular Anesthesiologists, the Society for Cardiovascular Angiography and Interventions, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.
It has been endorsed by the Society of Interventional Radiology and the Society for Vascular Surgery.
A version of this article first appeared on Medscape.com.
focusing on surgical intervention considerations, consistent imaging practices, genetic and familial screenings, and the importance of multidisciplinary care.
“There has been a host of new evidence-based research available for clinicians in the past decade when it comes to aortic disease. It was time to reevaluate and update the previous, existing guidelines,” Eric M. Isselbacher, MD, MSc, chair of the writing committee, said in a statement.
“We hope this new guideline can inform clinical practices with up-to-date and synthesized recommendations, targeted toward a full multidisciplinary aortic team working to provide the best possible care for this vulnerable patient population,” added Dr. Isselbacher, codirector of the Thoracic Aortic Center at Massachusetts General Hospital, Boston.
The 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease was simultaneously published online in the Journal of the American College of Cardiology and Circulation.
The new guideline replaces the 2010 ACCF/AHA Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease and the 2015 Surgery for Aortic Dilation in Patients With Bicuspid Aortic Valves: A Statement of Clarification From the ACC/AHA Task Force on Clinical Practice Guidelines.
The new guideline is intended to be used with the 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.
It brings together guidelines for both the thoracic and abdominal aorta and is targeted to cardiovascular clinicians involved in the care of people with aortic disease, including general cardiovascular care clinicians and emergency medicine clinicians, the writing group says.
Among the key recommendations in the new guideline are the following:
- Screen first-degree relatives of individuals diagnosed with aneurysms of the aortic root or ascending thoracic aorta, or those with aortic dissection to identify individuals most at risk for aortic disease. Screening would include genetic testing and imaging.
- Be consistent in the way CT or MRI are obtained and reported; in the measurement of aortic size and features; and in how often images are used for monitoring before and after repair surgery or other intervention. Ideally, all surveillance imaging for an individual should be done using the same modality and in the same lab, the guideline notes.
- For individuals who require aortic intervention, know that outcomes are optimized when surgery is performed by an experienced surgeon working in a multidisciplinary aortic team. The new guideline recommends “a specialized hospital team with expertise in the evaluation and management of aortic disease, in which care is delivered in a comprehensive, multidisciplinary manner.”
- At centers with multidisciplinary aortic teams and experienced surgeons, the threshold for surgical intervention for sporadic aortic root and ascending aortic aneurysms has been lowered from 5.5 cm to 5.0 cm in select individuals, and even lower in specific scenarios among patients with heritable thoracic aortic aneurysms.
- In patients who are significantly smaller or taller than average, surgical thresholds may incorporate indexing of the aortic root or ascending aortic diameter to either patient body surface area or height, or aortic cross-sectional area to patient height.
- Rapid aortic growth is a risk factor for rupture and the definition for rapid aneurysm growth rate has been updated. Surgery is now recommended for patients with aneurysms of aortic root and ascending thoracic aorta with a confirmed growth rate of ≥ 0.3 cm per year across 2 consecutive years or ≥ 0.5 cm in 1 year.
- In patients undergoing aortic root replacement surgery, valve-sparing aortic root replacement is reasonable if the valve is suitable for repair and when performed by experienced surgeons in a multidisciplinary aortic team.
- Patients with acute type A aortic dissection, if clinically stable, should be considered for transfer to a high-volume aortic center to improve survival. The operative repair of type A aortic dissection should entail at least an open distal anastomosis rather than just a simple supracoronary interposition graft.
- For management of uncomplicated type B aortic dissection, there is an increasing role for . Clinical trials of repair of thoracoabdominal aortic aneurysms with endografts are reporting results that suggest endovascular repair is an option for patients with suitable anatomy.
- Shared decision-making between the patient and multidisciplinary aortic team is highly encouraged, especially when the patient is on the borderline of thresholds for repair or eligible for different types of surgical repair.
- Shared decision-making should also be used with individuals who are pregnant or may become pregnant to consider the risks of pregnancy in individuals with aortic disease.
The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American College of Radiology, the Society of Cardiovascular Anesthesiologists, the Society for Cardiovascular Angiography and Interventions, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.
It has been endorsed by the Society of Interventional Radiology and the Society for Vascular Surgery.
A version of this article first appeared on Medscape.com.
focusing on surgical intervention considerations, consistent imaging practices, genetic and familial screenings, and the importance of multidisciplinary care.
“There has been a host of new evidence-based research available for clinicians in the past decade when it comes to aortic disease. It was time to reevaluate and update the previous, existing guidelines,” Eric M. Isselbacher, MD, MSc, chair of the writing committee, said in a statement.
“We hope this new guideline can inform clinical practices with up-to-date and synthesized recommendations, targeted toward a full multidisciplinary aortic team working to provide the best possible care for this vulnerable patient population,” added Dr. Isselbacher, codirector of the Thoracic Aortic Center at Massachusetts General Hospital, Boston.
The 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease was simultaneously published online in the Journal of the American College of Cardiology and Circulation.
The new guideline replaces the 2010 ACCF/AHA Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease and the 2015 Surgery for Aortic Dilation in Patients With Bicuspid Aortic Valves: A Statement of Clarification From the ACC/AHA Task Force on Clinical Practice Guidelines.
The new guideline is intended to be used with the 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.
It brings together guidelines for both the thoracic and abdominal aorta and is targeted to cardiovascular clinicians involved in the care of people with aortic disease, including general cardiovascular care clinicians and emergency medicine clinicians, the writing group says.
Among the key recommendations in the new guideline are the following:
- Screen first-degree relatives of individuals diagnosed with aneurysms of the aortic root or ascending thoracic aorta, or those with aortic dissection to identify individuals most at risk for aortic disease. Screening would include genetic testing and imaging.
- Be consistent in the way CT or MRI are obtained and reported; in the measurement of aortic size and features; and in how often images are used for monitoring before and after repair surgery or other intervention. Ideally, all surveillance imaging for an individual should be done using the same modality and in the same lab, the guideline notes.
- For individuals who require aortic intervention, know that outcomes are optimized when surgery is performed by an experienced surgeon working in a multidisciplinary aortic team. The new guideline recommends “a specialized hospital team with expertise in the evaluation and management of aortic disease, in which care is delivered in a comprehensive, multidisciplinary manner.”
- At centers with multidisciplinary aortic teams and experienced surgeons, the threshold for surgical intervention for sporadic aortic root and ascending aortic aneurysms has been lowered from 5.5 cm to 5.0 cm in select individuals, and even lower in specific scenarios among patients with heritable thoracic aortic aneurysms.
- In patients who are significantly smaller or taller than average, surgical thresholds may incorporate indexing of the aortic root or ascending aortic diameter to either patient body surface area or height, or aortic cross-sectional area to patient height.
- Rapid aortic growth is a risk factor for rupture and the definition for rapid aneurysm growth rate has been updated. Surgery is now recommended for patients with aneurysms of aortic root and ascending thoracic aorta with a confirmed growth rate of ≥ 0.3 cm per year across 2 consecutive years or ≥ 0.5 cm in 1 year.
- In patients undergoing aortic root replacement surgery, valve-sparing aortic root replacement is reasonable if the valve is suitable for repair and when performed by experienced surgeons in a multidisciplinary aortic team.
- Patients with acute type A aortic dissection, if clinically stable, should be considered for transfer to a high-volume aortic center to improve survival. The operative repair of type A aortic dissection should entail at least an open distal anastomosis rather than just a simple supracoronary interposition graft.
- For management of uncomplicated type B aortic dissection, there is an increasing role for . Clinical trials of repair of thoracoabdominal aortic aneurysms with endografts are reporting results that suggest endovascular repair is an option for patients with suitable anatomy.
- Shared decision-making between the patient and multidisciplinary aortic team is highly encouraged, especially when the patient is on the borderline of thresholds for repair or eligible for different types of surgical repair.
- Shared decision-making should also be used with individuals who are pregnant or may become pregnant to consider the risks of pregnancy in individuals with aortic disease.
The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American College of Radiology, the Society of Cardiovascular Anesthesiologists, the Society for Cardiovascular Angiography and Interventions, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.
It has been endorsed by the Society of Interventional Radiology and the Society for Vascular Surgery.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION
Stroke risk rises with years of drinking in young adults
“The rate of stroke among young adults has been increasing over the last few decades, and stroke in young adults causes death and serious disability,” study coauthor Eue-Keun Choi, MD, PhD, of Seoul National University, Republic of Korea, said in a statement.
“If we could prevent stroke in young adults by reducing alcohol consumption, that could potentially have a substantial impact on the health of individuals and the overall burden of stroke on society,” Dr. Choi added.
The study was published online in Neurology.
Compounding effects
Using data from a Korean national health database, the researchers identified roughly 1.5 million adults aged 20-39 years (mean age 29.5 years, 72% male) who had four consecutive annual health examinations during which they were asked about their alcohol use.
During a median follow-up of roughly 6 years, 3,153 individuals suffered a stroke.
After multivariate adjustment accounting for other factors that could affect the risk for stroke, such as hypertension, smoking, and body mass index, the risk of stroke increased steadily with the number of years of moderate to heavy drinking, defined as 105 grams or more of alcohol per week.
Compared with light drinkers or teetotalers, stroke risk increased 19% with 2 years of moderate to heavy drinking and 22% and 23%, respectively, for 3 and 4 years of moderate or heaving drinking.
The positive dose-response relationship was chiefly driven by increased risk of hemorrhagic stroke; with 2, 3 and 4 years of moderate to heavy drinking, hemorrhagic stroke risk increased 30%, 42% and 36%, respectively, relative to light/no drinking.
“Since more than 90% of the burden of stroke overall can be attributed to potentially modifiable risk factors, including alcohol consumption, and since stroke in young adults severely impacts both the individual and society by limiting their activities during their most productive years, reducing alcohol consumption should be emphasized in young adults with heavy drinking habits as part of any strategy to prevent stroke,” Dr. Choi said.
A limitation of the study is that only Korean people were included, so the results may not apply to people of other races and ethnicities, they noted. In addition, people filled out questionnaires about their alcohol consumption, which may introduce recall bias.
Consistent evidence
“For decades, the evidence was suggestive that a moderate amount of alcohol daily is actually beneficial – one to two drinks in men and one drink in women – at reducing major vascular outcomes,” Pierre Fayad, MD, professor, department of neurological sciences, and director of the Nebraska Stroke Center, University of Nebraska Medical Center, Omaha, said in commenting on the research.
Yet, over the past few years, some research has found no evidence of benefit with moderate alcohol intake. There is, however, “consistent evidence” that shows a detrimental effect of excessive alcohol, particularly binge drinking, especially in young adults, Dr. Fayad said.
This study, he said, “adds to the known detrimental effects of excessive alcohol intake, in increasing the risk of stroke, particularly in young adults.
“The bottom line: Young adults who usually have a low risk of stroke increase their risk significantly by heavy alcohol drinking, and Koreans are equally at risk as other populations,” Dr. Fayad said.
The study was supported by the Korea Medical Device Development Fund and the Korea National Research Foundation. Dr. Choi and Dr. Fayad report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“The rate of stroke among young adults has been increasing over the last few decades, and stroke in young adults causes death and serious disability,” study coauthor Eue-Keun Choi, MD, PhD, of Seoul National University, Republic of Korea, said in a statement.
“If we could prevent stroke in young adults by reducing alcohol consumption, that could potentially have a substantial impact on the health of individuals and the overall burden of stroke on society,” Dr. Choi added.
The study was published online in Neurology.
Compounding effects
Using data from a Korean national health database, the researchers identified roughly 1.5 million adults aged 20-39 years (mean age 29.5 years, 72% male) who had four consecutive annual health examinations during which they were asked about their alcohol use.
During a median follow-up of roughly 6 years, 3,153 individuals suffered a stroke.
After multivariate adjustment accounting for other factors that could affect the risk for stroke, such as hypertension, smoking, and body mass index, the risk of stroke increased steadily with the number of years of moderate to heavy drinking, defined as 105 grams or more of alcohol per week.
Compared with light drinkers or teetotalers, stroke risk increased 19% with 2 years of moderate to heavy drinking and 22% and 23%, respectively, for 3 and 4 years of moderate or heaving drinking.
The positive dose-response relationship was chiefly driven by increased risk of hemorrhagic stroke; with 2, 3 and 4 years of moderate to heavy drinking, hemorrhagic stroke risk increased 30%, 42% and 36%, respectively, relative to light/no drinking.
“Since more than 90% of the burden of stroke overall can be attributed to potentially modifiable risk factors, including alcohol consumption, and since stroke in young adults severely impacts both the individual and society by limiting their activities during their most productive years, reducing alcohol consumption should be emphasized in young adults with heavy drinking habits as part of any strategy to prevent stroke,” Dr. Choi said.
A limitation of the study is that only Korean people were included, so the results may not apply to people of other races and ethnicities, they noted. In addition, people filled out questionnaires about their alcohol consumption, which may introduce recall bias.
Consistent evidence
“For decades, the evidence was suggestive that a moderate amount of alcohol daily is actually beneficial – one to two drinks in men and one drink in women – at reducing major vascular outcomes,” Pierre Fayad, MD, professor, department of neurological sciences, and director of the Nebraska Stroke Center, University of Nebraska Medical Center, Omaha, said in commenting on the research.
Yet, over the past few years, some research has found no evidence of benefit with moderate alcohol intake. There is, however, “consistent evidence” that shows a detrimental effect of excessive alcohol, particularly binge drinking, especially in young adults, Dr. Fayad said.
This study, he said, “adds to the known detrimental effects of excessive alcohol intake, in increasing the risk of stroke, particularly in young adults.
“The bottom line: Young adults who usually have a low risk of stroke increase their risk significantly by heavy alcohol drinking, and Koreans are equally at risk as other populations,” Dr. Fayad said.
The study was supported by the Korea Medical Device Development Fund and the Korea National Research Foundation. Dr. Choi and Dr. Fayad report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“The rate of stroke among young adults has been increasing over the last few decades, and stroke in young adults causes death and serious disability,” study coauthor Eue-Keun Choi, MD, PhD, of Seoul National University, Republic of Korea, said in a statement.
“If we could prevent stroke in young adults by reducing alcohol consumption, that could potentially have a substantial impact on the health of individuals and the overall burden of stroke on society,” Dr. Choi added.
The study was published online in Neurology.
Compounding effects
Using data from a Korean national health database, the researchers identified roughly 1.5 million adults aged 20-39 years (mean age 29.5 years, 72% male) who had four consecutive annual health examinations during which they were asked about their alcohol use.
During a median follow-up of roughly 6 years, 3,153 individuals suffered a stroke.
After multivariate adjustment accounting for other factors that could affect the risk for stroke, such as hypertension, smoking, and body mass index, the risk of stroke increased steadily with the number of years of moderate to heavy drinking, defined as 105 grams or more of alcohol per week.
Compared with light drinkers or teetotalers, stroke risk increased 19% with 2 years of moderate to heavy drinking and 22% and 23%, respectively, for 3 and 4 years of moderate or heaving drinking.
The positive dose-response relationship was chiefly driven by increased risk of hemorrhagic stroke; with 2, 3 and 4 years of moderate to heavy drinking, hemorrhagic stroke risk increased 30%, 42% and 36%, respectively, relative to light/no drinking.
“Since more than 90% of the burden of stroke overall can be attributed to potentially modifiable risk factors, including alcohol consumption, and since stroke in young adults severely impacts both the individual and society by limiting their activities during their most productive years, reducing alcohol consumption should be emphasized in young adults with heavy drinking habits as part of any strategy to prevent stroke,” Dr. Choi said.
A limitation of the study is that only Korean people were included, so the results may not apply to people of other races and ethnicities, they noted. In addition, people filled out questionnaires about their alcohol consumption, which may introduce recall bias.
Consistent evidence
“For decades, the evidence was suggestive that a moderate amount of alcohol daily is actually beneficial – one to two drinks in men and one drink in women – at reducing major vascular outcomes,” Pierre Fayad, MD, professor, department of neurological sciences, and director of the Nebraska Stroke Center, University of Nebraska Medical Center, Omaha, said in commenting on the research.
Yet, over the past few years, some research has found no evidence of benefit with moderate alcohol intake. There is, however, “consistent evidence” that shows a detrimental effect of excessive alcohol, particularly binge drinking, especially in young adults, Dr. Fayad said.
This study, he said, “adds to the known detrimental effects of excessive alcohol intake, in increasing the risk of stroke, particularly in young adults.
“The bottom line: Young adults who usually have a low risk of stroke increase their risk significantly by heavy alcohol drinking, and Koreans are equally at risk as other populations,” Dr. Fayad said.
The study was supported by the Korea Medical Device Development Fund and the Korea National Research Foundation. Dr. Choi and Dr. Fayad report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM NEUROLOGY
New CDC guidance on prescribing opioids for pain
The 2022 Clinical Practice Guideline provides guidance on determining whether to initiate opioids for pain; selecting opioids and determining opioid dosages; deciding duration of initial opioid prescription and conducting follow-up; and assessing risk and addressing potential harms of opioid use.
“Patients with pain should receive compassionate, safe, and effective pain care. We want clinicians and patients to have the information they need to weigh the benefits of different approaches to pain care, with the goal of helping people reduce their pain and improve their quality of life,” Christopher M. Jones, PharmD, DrPH, acting director for the CDC’s National Center for Injury Prevention and Control, said in a news release.
How to taper safely
The last guideline on the topic was released by CDC in 2016. Since then, new evidence has emerged regarding the benefits and risks of prescription opioids for acute and chronic pain, comparisons with nonopioid pain treatments, dosing strategies, opioid dose-dependent effects, risk mitigation strategies, and opioid tapering and discontinuation, the CDC says.
A “critical” addition to the 2022 guideline is advice on tapering opioids, Dr. Jones said during a press briefing.
“Practical tips on how to taper in an individualized patient-centered manner have been added to help clinicians if the decision is made to taper opioids, and the guideline explicitly advises against abrupt discontinuation or rapid dose reductions of opioids,” Dr. Jones said.
“That is based on lessons learned over the last several years as well as new science about how we approach tapering and the real harms that can result when patients are abruptly discontinued or rapidly tapered,” he added.
The updated guideline was published online Nov. 3 in the Morbidity and Mortality Weekly Report.
Key recommendations in the 100-page document include the following:
- In determining whether or not to initiate opioids, nonopioid therapies are at least as effective as opioids for many common types of acute pain. Use of nondrug and nonopioid drug therapies should be maximized as appropriate, and opioid therapy should only be considered for acute pain if it is anticipated that benefits outweigh risks to the patient.
- Before starting opioid therapy, providers should discuss with patients the realistic benefits and known risks of opioid therapy.
- Before starting ongoing opioid therapy for patients with subacute pain lasting 1 to 3 months or chronic pain lasting more than 3 months, providers should work with patients to establish treatment goals for pain and function, and consideration should be given as to how opioid therapy will be discontinued if benefits do not outweigh risks.
- Once opioids are started, the lowest effective dose of immediate-release opioids should be prescribed for no longer than needed for the expected duration of pain severe enough to require opioids.
- Within 1 to 4 weeks of starting opioid therapy for subacute or chronic pain, providers should work with patients to evaluate and carefully weigh benefits and risks of continuing opioid therapy; care should be exercised when increasing, continuing, or reducing opioid dosage.
- Before starting and periodically during ongoing opioid therapy, providers should evaluate risk for opioid-related harms and should work with patients to incorporate relevant strategies to mitigate risk, including offering naloxone and reviewing potential interactions with any other prescribed medications or substance used.
- Abrupt discontinuation of opioids should be avoided, especially for patients receiving high doses.
- For treating patients with opioid use disorder, treatment with evidence-based medications should be provided, or arrangements for such treatment should be made.
Dr. Jones emphasized that the guideline is “voluntary and meant to guide shared decision-making between a clinician and patient. It’s not meant to be implemented as absolute limits of policy or practice by clinicians, health systems, insurance companies, governmental entities.”
He also noted that the “current state of the overdose crisis, which is very much driven by illicit synthetic opioids, is not the aim of this guideline.
“The release of this guideline is really about advancing pain care and improving the lives of patients living with pain,” he said.
“We know that at least 1 in 5 people in the country have chronic pain. It’s one of the most common reasons why people present to their health care provider, and the goal here is to advance pain care, function, and quality of life for that patient population, while also reducing misuse, diversion, and consequences of prescription opioid misuse,” Dr. Jones added.
A version of this article first appeared on Medscape.com.
The 2022 Clinical Practice Guideline provides guidance on determining whether to initiate opioids for pain; selecting opioids and determining opioid dosages; deciding duration of initial opioid prescription and conducting follow-up; and assessing risk and addressing potential harms of opioid use.
“Patients with pain should receive compassionate, safe, and effective pain care. We want clinicians and patients to have the information they need to weigh the benefits of different approaches to pain care, with the goal of helping people reduce their pain and improve their quality of life,” Christopher M. Jones, PharmD, DrPH, acting director for the CDC’s National Center for Injury Prevention and Control, said in a news release.
How to taper safely
The last guideline on the topic was released by CDC in 2016. Since then, new evidence has emerged regarding the benefits and risks of prescription opioids for acute and chronic pain, comparisons with nonopioid pain treatments, dosing strategies, opioid dose-dependent effects, risk mitigation strategies, and opioid tapering and discontinuation, the CDC says.
A “critical” addition to the 2022 guideline is advice on tapering opioids, Dr. Jones said during a press briefing.
“Practical tips on how to taper in an individualized patient-centered manner have been added to help clinicians if the decision is made to taper opioids, and the guideline explicitly advises against abrupt discontinuation or rapid dose reductions of opioids,” Dr. Jones said.
“That is based on lessons learned over the last several years as well as new science about how we approach tapering and the real harms that can result when patients are abruptly discontinued or rapidly tapered,” he added.
The updated guideline was published online Nov. 3 in the Morbidity and Mortality Weekly Report.
Key recommendations in the 100-page document include the following:
- In determining whether or not to initiate opioids, nonopioid therapies are at least as effective as opioids for many common types of acute pain. Use of nondrug and nonopioid drug therapies should be maximized as appropriate, and opioid therapy should only be considered for acute pain if it is anticipated that benefits outweigh risks to the patient.
- Before starting opioid therapy, providers should discuss with patients the realistic benefits and known risks of opioid therapy.
- Before starting ongoing opioid therapy for patients with subacute pain lasting 1 to 3 months or chronic pain lasting more than 3 months, providers should work with patients to establish treatment goals for pain and function, and consideration should be given as to how opioid therapy will be discontinued if benefits do not outweigh risks.
- Once opioids are started, the lowest effective dose of immediate-release opioids should be prescribed for no longer than needed for the expected duration of pain severe enough to require opioids.
- Within 1 to 4 weeks of starting opioid therapy for subacute or chronic pain, providers should work with patients to evaluate and carefully weigh benefits and risks of continuing opioid therapy; care should be exercised when increasing, continuing, or reducing opioid dosage.
- Before starting and periodically during ongoing opioid therapy, providers should evaluate risk for opioid-related harms and should work with patients to incorporate relevant strategies to mitigate risk, including offering naloxone and reviewing potential interactions with any other prescribed medications or substance used.
- Abrupt discontinuation of opioids should be avoided, especially for patients receiving high doses.
- For treating patients with opioid use disorder, treatment with evidence-based medications should be provided, or arrangements for such treatment should be made.
Dr. Jones emphasized that the guideline is “voluntary and meant to guide shared decision-making between a clinician and patient. It’s not meant to be implemented as absolute limits of policy or practice by clinicians, health systems, insurance companies, governmental entities.”
He also noted that the “current state of the overdose crisis, which is very much driven by illicit synthetic opioids, is not the aim of this guideline.
“The release of this guideline is really about advancing pain care and improving the lives of patients living with pain,” he said.
“We know that at least 1 in 5 people in the country have chronic pain. It’s one of the most common reasons why people present to their health care provider, and the goal here is to advance pain care, function, and quality of life for that patient population, while also reducing misuse, diversion, and consequences of prescription opioid misuse,” Dr. Jones added.
A version of this article first appeared on Medscape.com.
The 2022 Clinical Practice Guideline provides guidance on determining whether to initiate opioids for pain; selecting opioids and determining opioid dosages; deciding duration of initial opioid prescription and conducting follow-up; and assessing risk and addressing potential harms of opioid use.
“Patients with pain should receive compassionate, safe, and effective pain care. We want clinicians and patients to have the information they need to weigh the benefits of different approaches to pain care, with the goal of helping people reduce their pain and improve their quality of life,” Christopher M. Jones, PharmD, DrPH, acting director for the CDC’s National Center for Injury Prevention and Control, said in a news release.
How to taper safely
The last guideline on the topic was released by CDC in 2016. Since then, new evidence has emerged regarding the benefits and risks of prescription opioids for acute and chronic pain, comparisons with nonopioid pain treatments, dosing strategies, opioid dose-dependent effects, risk mitigation strategies, and opioid tapering and discontinuation, the CDC says.
A “critical” addition to the 2022 guideline is advice on tapering opioids, Dr. Jones said during a press briefing.
“Practical tips on how to taper in an individualized patient-centered manner have been added to help clinicians if the decision is made to taper opioids, and the guideline explicitly advises against abrupt discontinuation or rapid dose reductions of opioids,” Dr. Jones said.
“That is based on lessons learned over the last several years as well as new science about how we approach tapering and the real harms that can result when patients are abruptly discontinued or rapidly tapered,” he added.
The updated guideline was published online Nov. 3 in the Morbidity and Mortality Weekly Report.
Key recommendations in the 100-page document include the following:
- In determining whether or not to initiate opioids, nonopioid therapies are at least as effective as opioids for many common types of acute pain. Use of nondrug and nonopioid drug therapies should be maximized as appropriate, and opioid therapy should only be considered for acute pain if it is anticipated that benefits outweigh risks to the patient.
- Before starting opioid therapy, providers should discuss with patients the realistic benefits and known risks of opioid therapy.
- Before starting ongoing opioid therapy for patients with subacute pain lasting 1 to 3 months or chronic pain lasting more than 3 months, providers should work with patients to establish treatment goals for pain and function, and consideration should be given as to how opioid therapy will be discontinued if benefits do not outweigh risks.
- Once opioids are started, the lowest effective dose of immediate-release opioids should be prescribed for no longer than needed for the expected duration of pain severe enough to require opioids.
- Within 1 to 4 weeks of starting opioid therapy for subacute or chronic pain, providers should work with patients to evaluate and carefully weigh benefits and risks of continuing opioid therapy; care should be exercised when increasing, continuing, or reducing opioid dosage.
- Before starting and periodically during ongoing opioid therapy, providers should evaluate risk for opioid-related harms and should work with patients to incorporate relevant strategies to mitigate risk, including offering naloxone and reviewing potential interactions with any other prescribed medications or substance used.
- Abrupt discontinuation of opioids should be avoided, especially for patients receiving high doses.
- For treating patients with opioid use disorder, treatment with evidence-based medications should be provided, or arrangements for such treatment should be made.
Dr. Jones emphasized that the guideline is “voluntary and meant to guide shared decision-making between a clinician and patient. It’s not meant to be implemented as absolute limits of policy or practice by clinicians, health systems, insurance companies, governmental entities.”
He also noted that the “current state of the overdose crisis, which is very much driven by illicit synthetic opioids, is not the aim of this guideline.
“The release of this guideline is really about advancing pain care and improving the lives of patients living with pain,” he said.
“We know that at least 1 in 5 people in the country have chronic pain. It’s one of the most common reasons why people present to their health care provider, and the goal here is to advance pain care, function, and quality of life for that patient population, while also reducing misuse, diversion, and consequences of prescription opioid misuse,” Dr. Jones added.
A version of this article first appeared on Medscape.com.