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Official Newspaper of the American College of Surgeons
Trachelectomy rate for early-stage cervical cancer rises to 17% in younger women
based on a recent analysis of the National Cancer Database.
Of 15,150 patients analyzed, the vast majority (97.1%) underwent hysterectomy, but trachelectomy performance increased from 1.5% (95% confidence interval, 0.8%-2.2%; P less than .001) in 2004 to 3.8% (95% CI, 2.7%-4.8%; P less than .001) by 2014. The increase was mostly seen among women younger than 30 years old. In that group, trachelectomy increased from 4.6% (95% CI, 1.0%-8.2%; P less than .001) in 2004 to 17% (95% CI, 10.2%-23.7%; P less than .001) in 2014. Rates among women aged 30-49 years were relatively stable over the same period.
“A possible explanation for this rise in trachelectomy is the trend in delayed childbearing in women in the United States,” wrote Rosa R. Cui, MD, a resident at Columbia University, New York, and her coauthors.
In the analysis, mortality risk and 5-year survival rates were similar between the two procedures. Overall cohort 5-year survival was nearly identical with hysterectomy and trachelectomy at 92.4% and 92.3%, respectively. For stages IA2, IB1, and IB not specified, tumor stage was not associated with differences in 5-year survival for the two procedures. As few patients with stage IB2 tumors received trachelectomy, that data was excluded from the analysis.
Though increasing tumor size made trachelectomy less likely, 30% of patients in the study who underwent trachelectomy had a tumor greater than 2 cm in diameter, and 4% had a tumor greater than 4 cm in diameter. The researchers noted studies published in the past few years suggest abdominal radical trachelectomy may be a safe option for larger tumors, compared with vaginal trachelectomy. In the current analysis, they did not find a statistically significant decrease in survival for trachelectomy patients with tumors greater than 2 cm in diameter, but the sample size was small.
“The trachelectomy procedure has evolved significantly since it was initially described and now encompasses several approaches,” and can be performed more or less conservatively depending on the diagnosis “without compromising outcomes,” wrote Dr. Cui and her coauthors.
The researchers noted that the National Cancer Database does not have data on fertility outcomes, a possible focus of future studies of trachelectomy.
Two coauthors disclosed grants and a fellowship from the National Cancer Institute, and others disclosed consulting for several pharmaceutical companies including Pfizer, Teva, and Eisai.
SOURCE: Cui RR et al. Obstet Gynecol. 2018 Jun;131(6):1085-94.
based on a recent analysis of the National Cancer Database.
Of 15,150 patients analyzed, the vast majority (97.1%) underwent hysterectomy, but trachelectomy performance increased from 1.5% (95% confidence interval, 0.8%-2.2%; P less than .001) in 2004 to 3.8% (95% CI, 2.7%-4.8%; P less than .001) by 2014. The increase was mostly seen among women younger than 30 years old. In that group, trachelectomy increased from 4.6% (95% CI, 1.0%-8.2%; P less than .001) in 2004 to 17% (95% CI, 10.2%-23.7%; P less than .001) in 2014. Rates among women aged 30-49 years were relatively stable over the same period.
“A possible explanation for this rise in trachelectomy is the trend in delayed childbearing in women in the United States,” wrote Rosa R. Cui, MD, a resident at Columbia University, New York, and her coauthors.
In the analysis, mortality risk and 5-year survival rates were similar between the two procedures. Overall cohort 5-year survival was nearly identical with hysterectomy and trachelectomy at 92.4% and 92.3%, respectively. For stages IA2, IB1, and IB not specified, tumor stage was not associated with differences in 5-year survival for the two procedures. As few patients with stage IB2 tumors received trachelectomy, that data was excluded from the analysis.
Though increasing tumor size made trachelectomy less likely, 30% of patients in the study who underwent trachelectomy had a tumor greater than 2 cm in diameter, and 4% had a tumor greater than 4 cm in diameter. The researchers noted studies published in the past few years suggest abdominal radical trachelectomy may be a safe option for larger tumors, compared with vaginal trachelectomy. In the current analysis, they did not find a statistically significant decrease in survival for trachelectomy patients with tumors greater than 2 cm in diameter, but the sample size was small.
“The trachelectomy procedure has evolved significantly since it was initially described and now encompasses several approaches,” and can be performed more or less conservatively depending on the diagnosis “without compromising outcomes,” wrote Dr. Cui and her coauthors.
The researchers noted that the National Cancer Database does not have data on fertility outcomes, a possible focus of future studies of trachelectomy.
Two coauthors disclosed grants and a fellowship from the National Cancer Institute, and others disclosed consulting for several pharmaceutical companies including Pfizer, Teva, and Eisai.
SOURCE: Cui RR et al. Obstet Gynecol. 2018 Jun;131(6):1085-94.
based on a recent analysis of the National Cancer Database.
Of 15,150 patients analyzed, the vast majority (97.1%) underwent hysterectomy, but trachelectomy performance increased from 1.5% (95% confidence interval, 0.8%-2.2%; P less than .001) in 2004 to 3.8% (95% CI, 2.7%-4.8%; P less than .001) by 2014. The increase was mostly seen among women younger than 30 years old. In that group, trachelectomy increased from 4.6% (95% CI, 1.0%-8.2%; P less than .001) in 2004 to 17% (95% CI, 10.2%-23.7%; P less than .001) in 2014. Rates among women aged 30-49 years were relatively stable over the same period.
“A possible explanation for this rise in trachelectomy is the trend in delayed childbearing in women in the United States,” wrote Rosa R. Cui, MD, a resident at Columbia University, New York, and her coauthors.
In the analysis, mortality risk and 5-year survival rates were similar between the two procedures. Overall cohort 5-year survival was nearly identical with hysterectomy and trachelectomy at 92.4% and 92.3%, respectively. For stages IA2, IB1, and IB not specified, tumor stage was not associated with differences in 5-year survival for the two procedures. As few patients with stage IB2 tumors received trachelectomy, that data was excluded from the analysis.
Though increasing tumor size made trachelectomy less likely, 30% of patients in the study who underwent trachelectomy had a tumor greater than 2 cm in diameter, and 4% had a tumor greater than 4 cm in diameter. The researchers noted studies published in the past few years suggest abdominal radical trachelectomy may be a safe option for larger tumors, compared with vaginal trachelectomy. In the current analysis, they did not find a statistically significant decrease in survival for trachelectomy patients with tumors greater than 2 cm in diameter, but the sample size was small.
“The trachelectomy procedure has evolved significantly since it was initially described and now encompasses several approaches,” and can be performed more or less conservatively depending on the diagnosis “without compromising outcomes,” wrote Dr. Cui and her coauthors.
The researchers noted that the National Cancer Database does not have data on fertility outcomes, a possible focus of future studies of trachelectomy.
Two coauthors disclosed grants and a fellowship from the National Cancer Institute, and others disclosed consulting for several pharmaceutical companies including Pfizer, Teva, and Eisai.
SOURCE: Cui RR et al. Obstet Gynecol. 2018 Jun;131(6):1085-94.
FROM OBSTETRICS & GYNECOLOGY
Prostate cancer risk before age 55 higher for black men
according to a new study that drew subjects aged 40-54 years from three public and two private hospitals in the Chicago area.
Black race, rather than socioeconomic or clinical factors, appeared to be the strongest nonmodifiable predictor of prostate cancer risk in that age group, the researchers concluded, based on multivariate analyses that examined the association between prostate cancer risk and clinical setting, race, genetically determined West African ancestry, and clinical and socioeconomic risk factors.
The results suggest that screening practices should be altered, said study investigator Oluwarotimi S. Nettey, MD, of Northwestern University, Chicago. “You might want to think about screening black men who are younger than 55.”
“In the prebiopsy space, most studies have looked at race, age, PSA [level], and prostate volume, and they’ve said that the reason we see that black men have disparate prostate cancer risk on diagnosis is probably because of access to care issues, so that’s been the confounder. We tried to control for this by looking at socioeconomic status through income, marriage, and education, as well as hospital setting,” said Dr. Nettey, who presented the study at a poster session at the annual meeting of the American Urological Association.
Previous studies have examined populations and then conducted a secondary analysis on outcomes in black men. The current study has greater power and is more convincing because outcomes in black men was the primary outcome of the study, according to Robert L. Waterhouse Jr., MD, who is the public policy liaison for the R. Frank Jones Urological Society of the National Medical Association. Dr. Waterhouse, a urologist in Charlotte, N.C., attended the poster session and was not involved in the research.
“This study helps to provide some evidence that black heritage is indeed a significant risk factor in men who develop prostate cancer at an earlier age, and efforts at identifying prostate cancer at an earlier age [should consider] black race as a high-risk group,” said Dr. Waterhouse.
For patients of all ages, biopsies were positive in 63.1% of black men, compared with 41.5% of nonblack men (P less than .001). Cancers were also more advanced in black men: 47.5% were Gleason 3+4 in black men, compared with 40% in nonblack men (P less than .001), and 14.4% were Gleason 4+4 in black men, compared with 9.6% in nonblack men (P = .02).
After researchers controlled for other risk factors, black race was associated with heightened risk of prostate cancer diagnosis (OR, 5.66; P = .02), as was family history (OR, 4.98; P = .01).
There was no association between West African ancestry and prostate cancer risk either as a continuous variable or in quartiles.
Limitations of the study include the fact that race was self-reported and that this was a referred population.
The study received funding from the National Institutes of Health and the U.S. Department of Veterans Affairs. Dr. Nettey reported having no financial disclosures.
SOURCE: Nettey OS et al. AUA Annual Meeting. Abstract MP 21-17.
according to a new study that drew subjects aged 40-54 years from three public and two private hospitals in the Chicago area.
Black race, rather than socioeconomic or clinical factors, appeared to be the strongest nonmodifiable predictor of prostate cancer risk in that age group, the researchers concluded, based on multivariate analyses that examined the association between prostate cancer risk and clinical setting, race, genetically determined West African ancestry, and clinical and socioeconomic risk factors.
The results suggest that screening practices should be altered, said study investigator Oluwarotimi S. Nettey, MD, of Northwestern University, Chicago. “You might want to think about screening black men who are younger than 55.”
“In the prebiopsy space, most studies have looked at race, age, PSA [level], and prostate volume, and they’ve said that the reason we see that black men have disparate prostate cancer risk on diagnosis is probably because of access to care issues, so that’s been the confounder. We tried to control for this by looking at socioeconomic status through income, marriage, and education, as well as hospital setting,” said Dr. Nettey, who presented the study at a poster session at the annual meeting of the American Urological Association.
Previous studies have examined populations and then conducted a secondary analysis on outcomes in black men. The current study has greater power and is more convincing because outcomes in black men was the primary outcome of the study, according to Robert L. Waterhouse Jr., MD, who is the public policy liaison for the R. Frank Jones Urological Society of the National Medical Association. Dr. Waterhouse, a urologist in Charlotte, N.C., attended the poster session and was not involved in the research.
“This study helps to provide some evidence that black heritage is indeed a significant risk factor in men who develop prostate cancer at an earlier age, and efforts at identifying prostate cancer at an earlier age [should consider] black race as a high-risk group,” said Dr. Waterhouse.
For patients of all ages, biopsies were positive in 63.1% of black men, compared with 41.5% of nonblack men (P less than .001). Cancers were also more advanced in black men: 47.5% were Gleason 3+4 in black men, compared with 40% in nonblack men (P less than .001), and 14.4% were Gleason 4+4 in black men, compared with 9.6% in nonblack men (P = .02).
After researchers controlled for other risk factors, black race was associated with heightened risk of prostate cancer diagnosis (OR, 5.66; P = .02), as was family history (OR, 4.98; P = .01).
There was no association between West African ancestry and prostate cancer risk either as a continuous variable or in quartiles.
Limitations of the study include the fact that race was self-reported and that this was a referred population.
The study received funding from the National Institutes of Health and the U.S. Department of Veterans Affairs. Dr. Nettey reported having no financial disclosures.
SOURCE: Nettey OS et al. AUA Annual Meeting. Abstract MP 21-17.
according to a new study that drew subjects aged 40-54 years from three public and two private hospitals in the Chicago area.
Black race, rather than socioeconomic or clinical factors, appeared to be the strongest nonmodifiable predictor of prostate cancer risk in that age group, the researchers concluded, based on multivariate analyses that examined the association between prostate cancer risk and clinical setting, race, genetically determined West African ancestry, and clinical and socioeconomic risk factors.
The results suggest that screening practices should be altered, said study investigator Oluwarotimi S. Nettey, MD, of Northwestern University, Chicago. “You might want to think about screening black men who are younger than 55.”
“In the prebiopsy space, most studies have looked at race, age, PSA [level], and prostate volume, and they’ve said that the reason we see that black men have disparate prostate cancer risk on diagnosis is probably because of access to care issues, so that’s been the confounder. We tried to control for this by looking at socioeconomic status through income, marriage, and education, as well as hospital setting,” said Dr. Nettey, who presented the study at a poster session at the annual meeting of the American Urological Association.
Previous studies have examined populations and then conducted a secondary analysis on outcomes in black men. The current study has greater power and is more convincing because outcomes in black men was the primary outcome of the study, according to Robert L. Waterhouse Jr., MD, who is the public policy liaison for the R. Frank Jones Urological Society of the National Medical Association. Dr. Waterhouse, a urologist in Charlotte, N.C., attended the poster session and was not involved in the research.
“This study helps to provide some evidence that black heritage is indeed a significant risk factor in men who develop prostate cancer at an earlier age, and efforts at identifying prostate cancer at an earlier age [should consider] black race as a high-risk group,” said Dr. Waterhouse.
For patients of all ages, biopsies were positive in 63.1% of black men, compared with 41.5% of nonblack men (P less than .001). Cancers were also more advanced in black men: 47.5% were Gleason 3+4 in black men, compared with 40% in nonblack men (P less than .001), and 14.4% were Gleason 4+4 in black men, compared with 9.6% in nonblack men (P = .02).
After researchers controlled for other risk factors, black race was associated with heightened risk of prostate cancer diagnosis (OR, 5.66; P = .02), as was family history (OR, 4.98; P = .01).
There was no association between West African ancestry and prostate cancer risk either as a continuous variable or in quartiles.
Limitations of the study include the fact that race was self-reported and that this was a referred population.
The study received funding from the National Institutes of Health and the U.S. Department of Veterans Affairs. Dr. Nettey reported having no financial disclosures.
SOURCE: Nettey OS et al. AUA Annual Meeting. Abstract MP 21-17.
REPORTING FROM THE AUA ANNUAL MEETING
Key clinical point: Black race appears to be a key risk factor for prostate cancer in younger men.
Major finding: Black men younger than age 55 years undergoing prostate biopsies were 5.6 times more likely than other men to have a positive biopsy result.
Study details: Retrospective analysis of 564 men.
Disclosures: The study received funding from the National Institutes of Health and the U.S. Department of Veterans Affairs. Dr. Nettey reported having no financial disclosures.
Source: Nettey OS et al. AUA Annual Meeting. Abstract MP 21-17.
Looking for lower Medicare drug costs? Ask your pharmacist for the cash price
As part of President Donald Trump’s blueprint to bring down prescription costs, Medicare officials have warned insurers that “gag orders” keeping pharmacists from alerting seniors that they could save money by paying cash – rather than using their insurance – are “unacceptable and contrary” to the government’s effort to promote price transparency.
But the agency stopped short of requiring insurers to lift such restrictions on pharmacists.
That doesn’t mean people with Medicare drug coverage are destined to overpay for prescriptions. But first, they must ask the pharmacist about that option, said Julie Carter, federal policy associate at the Medicare Rights Center, a patient advocacy group.
“If they bring it up, then we can inform them of those prices,” said Nick Newman, PharmD, a pharmacist and the manager at Essentra Pharmacy in rural Marengo, Ohio. “It’s a moral dilemma for the pharmacist, knowing what would be best for the patient, but not being able to help them and hoping they will ask you about the comparison.”
A simple question could unlock some savings for millions of beneficiaries.
But details may be hard to find: Medicare’s website and annual handbook don’t mention it.
“If you don’t know that there are a bunch of different prices that could be available at any given pharmacy, you don’t know what you don’t know,” said Leigh Purvis, the AARP Public Policy Institute’s director of health services research.
Researchers analyzing 9.5 million Part D prescription claims reported in a letter in the Journal of the American Medical Association in March that a patient’s copayment was higher than the cash price for nearly one in four drugs purchased in 2013. For 12 of the 20 most commonly prescribed drugs, patients overpaid by more than 33%.
Although the study found that the average overpayment for a single prescription was relatively small, Dr. Newman said he had seen consumers pay as much as $30 more than the cash price.
And many beneficiaries may not know that, if they pay a lower cash price for a covered drug at a pharmacy that participates in their insurance plan and then submit the proper documentation, insurers must count it toward their out-of-pocket expenses. The total of those expenses can trigger the drug coverage gap, commonly called the doughnut hole. (This year, the gap begins after the plan and beneficiary spend $3,750 and ends once the beneficiary has spent a total of $5,000.)
Daniel Nam, executive director of federal programs at America’s Health Insurance Plans, a trade group, agreed that “patients should have access to the lowest price possible at the pharmacy.” But he said Medicare’s warning, contained in a letter in May 2018, takes aim at an increasingly rare occurrence. Gag order clauses are “not something they are incorporating into their contracts,” he said.
UnitedHealthcare, whose popular prescription drug plans dominate the market, does not include them in any of its Medicare, Medicaid, or commercial insurance contracts, said Matt Burns, a company spokesman.
Pharmacy benefit managers also said gag orders are not typical. “If it is happening, it is very much an outlier,” said Mark Merritt, president and CEO of the Pharmaceutical Care Management Association.
However, some pharmacists disagree. Kala Shankle, policy and regulatory affairs director for the National Community Pharmacists Association, which represents 22,000 independent pharmacies, said insurers have punished pharmacists who violate gag orders by dropping them from the plan’s network.
In Ohio, one of several states that have banned gag orders in insurance contracts, including some Medicare drug plans, officials responded to complaints about the problem.
“The Department has received inquiries related to entities withholding cost-saving information from consumers, which sometimes results in an insured [patient] paying more for pharmacy benefits than the actual cost of such pharmacy benefits,” the department said in April.
Illinois and Ohio state legislators are considering bills to make such restrictions illegal, and similar legislation has been introduced in the U.S. Senate.
“If we didn’t have these gag clauses, there would not be a need for the legislation and policy changes movement that’s going on in the country,” said Garth Reynolds, executive director of the Illinois Pharmacists Association.
KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
As part of President Donald Trump’s blueprint to bring down prescription costs, Medicare officials have warned insurers that “gag orders” keeping pharmacists from alerting seniors that they could save money by paying cash – rather than using their insurance – are “unacceptable and contrary” to the government’s effort to promote price transparency.
But the agency stopped short of requiring insurers to lift such restrictions on pharmacists.
That doesn’t mean people with Medicare drug coverage are destined to overpay for prescriptions. But first, they must ask the pharmacist about that option, said Julie Carter, federal policy associate at the Medicare Rights Center, a patient advocacy group.
“If they bring it up, then we can inform them of those prices,” said Nick Newman, PharmD, a pharmacist and the manager at Essentra Pharmacy in rural Marengo, Ohio. “It’s a moral dilemma for the pharmacist, knowing what would be best for the patient, but not being able to help them and hoping they will ask you about the comparison.”
A simple question could unlock some savings for millions of beneficiaries.
But details may be hard to find: Medicare’s website and annual handbook don’t mention it.
“If you don’t know that there are a bunch of different prices that could be available at any given pharmacy, you don’t know what you don’t know,” said Leigh Purvis, the AARP Public Policy Institute’s director of health services research.
Researchers analyzing 9.5 million Part D prescription claims reported in a letter in the Journal of the American Medical Association in March that a patient’s copayment was higher than the cash price for nearly one in four drugs purchased in 2013. For 12 of the 20 most commonly prescribed drugs, patients overpaid by more than 33%.
Although the study found that the average overpayment for a single prescription was relatively small, Dr. Newman said he had seen consumers pay as much as $30 more than the cash price.
And many beneficiaries may not know that, if they pay a lower cash price for a covered drug at a pharmacy that participates in their insurance plan and then submit the proper documentation, insurers must count it toward their out-of-pocket expenses. The total of those expenses can trigger the drug coverage gap, commonly called the doughnut hole. (This year, the gap begins after the plan and beneficiary spend $3,750 and ends once the beneficiary has spent a total of $5,000.)
Daniel Nam, executive director of federal programs at America’s Health Insurance Plans, a trade group, agreed that “patients should have access to the lowest price possible at the pharmacy.” But he said Medicare’s warning, contained in a letter in May 2018, takes aim at an increasingly rare occurrence. Gag order clauses are “not something they are incorporating into their contracts,” he said.
UnitedHealthcare, whose popular prescription drug plans dominate the market, does not include them in any of its Medicare, Medicaid, or commercial insurance contracts, said Matt Burns, a company spokesman.
Pharmacy benefit managers also said gag orders are not typical. “If it is happening, it is very much an outlier,” said Mark Merritt, president and CEO of the Pharmaceutical Care Management Association.
However, some pharmacists disagree. Kala Shankle, policy and regulatory affairs director for the National Community Pharmacists Association, which represents 22,000 independent pharmacies, said insurers have punished pharmacists who violate gag orders by dropping them from the plan’s network.
In Ohio, one of several states that have banned gag orders in insurance contracts, including some Medicare drug plans, officials responded to complaints about the problem.
“The Department has received inquiries related to entities withholding cost-saving information from consumers, which sometimes results in an insured [patient] paying more for pharmacy benefits than the actual cost of such pharmacy benefits,” the department said in April.
Illinois and Ohio state legislators are considering bills to make such restrictions illegal, and similar legislation has been introduced in the U.S. Senate.
“If we didn’t have these gag clauses, there would not be a need for the legislation and policy changes movement that’s going on in the country,” said Garth Reynolds, executive director of the Illinois Pharmacists Association.
KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
As part of President Donald Trump’s blueprint to bring down prescription costs, Medicare officials have warned insurers that “gag orders” keeping pharmacists from alerting seniors that they could save money by paying cash – rather than using their insurance – are “unacceptable and contrary” to the government’s effort to promote price transparency.
But the agency stopped short of requiring insurers to lift such restrictions on pharmacists.
That doesn’t mean people with Medicare drug coverage are destined to overpay for prescriptions. But first, they must ask the pharmacist about that option, said Julie Carter, federal policy associate at the Medicare Rights Center, a patient advocacy group.
“If they bring it up, then we can inform them of those prices,” said Nick Newman, PharmD, a pharmacist and the manager at Essentra Pharmacy in rural Marengo, Ohio. “It’s a moral dilemma for the pharmacist, knowing what would be best for the patient, but not being able to help them and hoping they will ask you about the comparison.”
A simple question could unlock some savings for millions of beneficiaries.
But details may be hard to find: Medicare’s website and annual handbook don’t mention it.
“If you don’t know that there are a bunch of different prices that could be available at any given pharmacy, you don’t know what you don’t know,” said Leigh Purvis, the AARP Public Policy Institute’s director of health services research.
Researchers analyzing 9.5 million Part D prescription claims reported in a letter in the Journal of the American Medical Association in March that a patient’s copayment was higher than the cash price for nearly one in four drugs purchased in 2013. For 12 of the 20 most commonly prescribed drugs, patients overpaid by more than 33%.
Although the study found that the average overpayment for a single prescription was relatively small, Dr. Newman said he had seen consumers pay as much as $30 more than the cash price.
And many beneficiaries may not know that, if they pay a lower cash price for a covered drug at a pharmacy that participates in their insurance plan and then submit the proper documentation, insurers must count it toward their out-of-pocket expenses. The total of those expenses can trigger the drug coverage gap, commonly called the doughnut hole. (This year, the gap begins after the plan and beneficiary spend $3,750 and ends once the beneficiary has spent a total of $5,000.)
Daniel Nam, executive director of federal programs at America’s Health Insurance Plans, a trade group, agreed that “patients should have access to the lowest price possible at the pharmacy.” But he said Medicare’s warning, contained in a letter in May 2018, takes aim at an increasingly rare occurrence. Gag order clauses are “not something they are incorporating into their contracts,” he said.
UnitedHealthcare, whose popular prescription drug plans dominate the market, does not include them in any of its Medicare, Medicaid, or commercial insurance contracts, said Matt Burns, a company spokesman.
Pharmacy benefit managers also said gag orders are not typical. “If it is happening, it is very much an outlier,” said Mark Merritt, president and CEO of the Pharmaceutical Care Management Association.
However, some pharmacists disagree. Kala Shankle, policy and regulatory affairs director for the National Community Pharmacists Association, which represents 22,000 independent pharmacies, said insurers have punished pharmacists who violate gag orders by dropping them from the plan’s network.
In Ohio, one of several states that have banned gag orders in insurance contracts, including some Medicare drug plans, officials responded to complaints about the problem.
“The Department has received inquiries related to entities withholding cost-saving information from consumers, which sometimes results in an insured [patient] paying more for pharmacy benefits than the actual cost of such pharmacy benefits,” the department said in April.
Illinois and Ohio state legislators are considering bills to make such restrictions illegal, and similar legislation has been introduced in the U.S. Senate.
“If we didn’t have these gag clauses, there would not be a need for the legislation and policy changes movement that’s going on in the country,” said Garth Reynolds, executive director of the Illinois Pharmacists Association.
KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Percutaneous procedure gives alternative to anticoagulation for portal vein thrombosis
WASHINGTON – Catheter-directed clot lysis and thrombectomy with creation of a bypass shunt is a reasonable alternative to prolonged anticoagulation for treating patients with portal vein thrombosis (PVT) based on the accumulated reported experience since 1993 using this percutaneous treatment.
” Nelson Valentin, MD, said at the annual Digestive Disease Week.® “TIPS should be considered a viable treatment option for patients with PVT,” said Dr. Valentin, a gastroenterology fellow at Mount Sinai Beth Israel hospital in New York.
“There is sufficient evidence from these reports to at least consider TIPS as an adjunct to anticoagulation or perhaps as primary therapy,” especially for patients with PVT who have a contraindication for anticoagulation, Dr. Valentin said in an interview. Standard anticoagulation for PVT would today involve acute treatment with a low-molecular-weight heparin followed by oral anticoagulation for a total treatment time of at least 6 months and continued for a year or longer in some patients. A recently published review of reported experience using anticoagulation to treat PVT found a complete recanalization rate of 41% and a complete or partial rate of 66%, which suggests that TIPS is at least as effective, although Dr. Valentin cautioned that no reported study has directly compared the two alternative approaches. A study designed to make this direct comparison is warranted by the reported results using TIPS, Dr. Valentin said. And the experience with TIPS positions it as an option for patients who do not respond to anticoagulation or would prefer an alternative to prolonged anticoagulation.
One factor currently limiting use of TIPS, which is usually performed by an interventional radiologist, is that the procedure is technically demanding, with a limited number of operators with the expertise to perform it. If TIPS became more widely accepted as an option for treating PVT, then the pool of interventionalists experienced with performing the procedure would grow, Dr. Valentin noted.
[email protected]
On Twitter @mitchelzoler
SOURCE: Valentin N et al. Digestive Disease Week, Presentation 361.
WASHINGTON – Catheter-directed clot lysis and thrombectomy with creation of a bypass shunt is a reasonable alternative to prolonged anticoagulation for treating patients with portal vein thrombosis (PVT) based on the accumulated reported experience since 1993 using this percutaneous treatment.
” Nelson Valentin, MD, said at the annual Digestive Disease Week.® “TIPS should be considered a viable treatment option for patients with PVT,” said Dr. Valentin, a gastroenterology fellow at Mount Sinai Beth Israel hospital in New York.
“There is sufficient evidence from these reports to at least consider TIPS as an adjunct to anticoagulation or perhaps as primary therapy,” especially for patients with PVT who have a contraindication for anticoagulation, Dr. Valentin said in an interview. Standard anticoagulation for PVT would today involve acute treatment with a low-molecular-weight heparin followed by oral anticoagulation for a total treatment time of at least 6 months and continued for a year or longer in some patients. A recently published review of reported experience using anticoagulation to treat PVT found a complete recanalization rate of 41% and a complete or partial rate of 66%, which suggests that TIPS is at least as effective, although Dr. Valentin cautioned that no reported study has directly compared the two alternative approaches. A study designed to make this direct comparison is warranted by the reported results using TIPS, Dr. Valentin said. And the experience with TIPS positions it as an option for patients who do not respond to anticoagulation or would prefer an alternative to prolonged anticoagulation.
One factor currently limiting use of TIPS, which is usually performed by an interventional radiologist, is that the procedure is technically demanding, with a limited number of operators with the expertise to perform it. If TIPS became more widely accepted as an option for treating PVT, then the pool of interventionalists experienced with performing the procedure would grow, Dr. Valentin noted.
[email protected]
On Twitter @mitchelzoler
SOURCE: Valentin N et al. Digestive Disease Week, Presentation 361.
WASHINGTON – Catheter-directed clot lysis and thrombectomy with creation of a bypass shunt is a reasonable alternative to prolonged anticoagulation for treating patients with portal vein thrombosis (PVT) based on the accumulated reported experience since 1993 using this percutaneous treatment.
” Nelson Valentin, MD, said at the annual Digestive Disease Week.® “TIPS should be considered a viable treatment option for patients with PVT,” said Dr. Valentin, a gastroenterology fellow at Mount Sinai Beth Israel hospital in New York.
“There is sufficient evidence from these reports to at least consider TIPS as an adjunct to anticoagulation or perhaps as primary therapy,” especially for patients with PVT who have a contraindication for anticoagulation, Dr. Valentin said in an interview. Standard anticoagulation for PVT would today involve acute treatment with a low-molecular-weight heparin followed by oral anticoagulation for a total treatment time of at least 6 months and continued for a year or longer in some patients. A recently published review of reported experience using anticoagulation to treat PVT found a complete recanalization rate of 41% and a complete or partial rate of 66%, which suggests that TIPS is at least as effective, although Dr. Valentin cautioned that no reported study has directly compared the two alternative approaches. A study designed to make this direct comparison is warranted by the reported results using TIPS, Dr. Valentin said. And the experience with TIPS positions it as an option for patients who do not respond to anticoagulation or would prefer an alternative to prolonged anticoagulation.
One factor currently limiting use of TIPS, which is usually performed by an interventional radiologist, is that the procedure is technically demanding, with a limited number of operators with the expertise to perform it. If TIPS became more widely accepted as an option for treating PVT, then the pool of interventionalists experienced with performing the procedure would grow, Dr. Valentin noted.
[email protected]
On Twitter @mitchelzoler
SOURCE: Valentin N et al. Digestive Disease Week, Presentation 361.
REPORTING FROM DDW 2018
Key clinical point: Reported worldwide experience with TIPS in 439 patients shows it works and is relatively safe.
Major finding: TIPS was technically successful in 87% of reported patients and achieved complete portal recanalization in 74% of patients.
Study details: Systematic review of 18 published case series from 1993 to 2016 with 439 total patients.
Disclosures: Dr. Valentin had no disclosures.
Source: Valentin N et al. Digestive Disease Week, Presentation 361.
Study eyes liver transplantation after Region 5 UNOS downstaging
Liver transplantation led to “excellent outcomes” when performed after downstaging hepatocellular carcinoma using the UNOS (United Network for Organ Sharing) Region 5 protocol, investigators reported.
Downstaging succeeded for 58% of patients, and an estimated 87% of transplantation recipients were alive and recurrence free at 5 years, said Neil Mehta, MD, of the University of California, San Francisco, and his associates. The findings support expanding priority access to liver transplantation to include patients whose hepatocellular carcinoma (HCC) has been successfully downstaged, they said. “In the meantime, UNOS has recently approved the Region 5 downstaging protocol for receiving automatic HCC-MELD exception listing,” they wrote. The report was published in the June issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.11.037).
This is the first multicenter study of HCC downstaging according to a uniform protocol, the researchers noted. In multivariable analyses, downstaging was significantly more likely to fail in the setting of moderate to severe (Child Pugh B or C) hepatic impairment (hazard ratio, 3.3; 95% confidence interval, 3.0 to 3.6; P less than .001) or baseline alpha-fetoprotein level above 1,000 ng/mL (HR, 1.6; 95% CI, 1.4 to 1.9; P less than .001).
The incidence of HCC in the United States is expected to keep rising for at least another decade because of epidemic levels of fatty liver disease and chronic hepatitis C, the investigators noted. Downstaging HCC with local-regional therapy is a common bridge to transplantation, and successful treatment tends to reflect favorable tumor biology, which bodes well for transplantation. However, no multicenter study had evaluated these associations. Therefore, the investigators retrospectively studied 187 patients with HCC from three centers in California who underwent downstaging according to the UNOS Region 5 protocol between 2002 and 2012.
A total of 156 patients (83%) were successfully downstaged to within Milan criteria after a median of 2.7 months (interquartile range, 1.4 to 4.9 months), said the researchers. Among patients who were successfully downstaged but did not undergo transplantation, 37 patients had tumor progression or died from liver-related causes after a median of 6 months, while 10 patients remained on the transplant list. Among the 109 patients who underwent transplantation after a median of 13 months (interquartile range 6 to 19 months), median follow-up time was 4.3 years and estimated 5-year survival was 80%, and estimated recurrence-free survival was 87%.
Fully 68% of successfully downstaged patients required only one local-regional treatment, the researchers said. The Region 5 protocol considers patients eligible for downstaging if they have a single HCC lesion measuring up to 8 cm or multiple lesions whose combined diameters do not exceed 8 cm, and no evidence of extrahepatic disease or vascular invasion on multiphase computed tomography or magnetic resonance imaging.
The protocol considers downstaging successful if it results in one lesion measuring up to 5 cm or no more than three lesions of up to 3 cm each. Thus, patients who start out with four or five lesions must have complete necrosis of at least one to two tumors. Successfully downstaged patients must remain free of acute hepatic decompensation for at least 3 consecutive months before undergoing transplantation, according to the protocol.
“Slight refinements in the inclusion criteria for downstaging seem warranted [given] that all Child’s B/C patients with pretreatment alpha-fetoprotein greater than 1000 ng/mL suffered poor outcomes when downstaging was attempted,” the investigators noted. They reported that the 1-year risk of failed downstaging was 70% among patients with both Child’s B/C cirrhosis and alpha-fetoprotein level at or above 1000 ng/mL, 32% among patients with one risk factor, and 14% among patients with no risk factors (P less than .001).
The National Institutes of Health provided partial funding. The investigators reported having no conflicts of interest.
SOURCE: Mehta N, et al. Clin Gastroenterol Hepatol. 2017 Nov 23. doi: 10.1016/j.cgh.2017.11.037.
Liver transplantation of selected patients with hepatocellular carcinoma (HCC) is an accepted indication and associated with excellent outcomes. Until recently, criteria for liver transplantation were based on the Milan criteria that only took size and number of tumors under consideration. In this multicenter study, patients who were outside of Milan criteria were successfully downstaged to within Milan criteria with locoregional therapy and subsequently transplanted with excellent outcomes. Salient features included the following. 1) Six months waiting after the first treatment and 3 months after downstaging was required to ensure that the tumor stage remained within Milan criteria. 2) Any specific type of locoregional therapy was allowed. 3) Downstaging was possible in a majority of patients after a single treatment. 4) Patients with alpha-fetoprotein greater than 1000 ng/mL (approximately 10%) as well as presence of substantial decompensated liver disease (approximately 40%) did not have favorable outcomes. 4) On multivariable analysis, tumor biology was a stronger predictor of poor outcomes than was stage of liver disease.
Sumeet K. Asrani, MD, MSc, is associate professor in medicine and hepatologist at Baylor University Medical Center, and medical director of the Center for Advanced Liver Disease, Dallas. He has no conflicts of interest.
Liver transplantation of selected patients with hepatocellular carcinoma (HCC) is an accepted indication and associated with excellent outcomes. Until recently, criteria for liver transplantation were based on the Milan criteria that only took size and number of tumors under consideration. In this multicenter study, patients who were outside of Milan criteria were successfully downstaged to within Milan criteria with locoregional therapy and subsequently transplanted with excellent outcomes. Salient features included the following. 1) Six months waiting after the first treatment and 3 months after downstaging was required to ensure that the tumor stage remained within Milan criteria. 2) Any specific type of locoregional therapy was allowed. 3) Downstaging was possible in a majority of patients after a single treatment. 4) Patients with alpha-fetoprotein greater than 1000 ng/mL (approximately 10%) as well as presence of substantial decompensated liver disease (approximately 40%) did not have favorable outcomes. 4) On multivariable analysis, tumor biology was a stronger predictor of poor outcomes than was stage of liver disease.
Sumeet K. Asrani, MD, MSc, is associate professor in medicine and hepatologist at Baylor University Medical Center, and medical director of the Center for Advanced Liver Disease, Dallas. He has no conflicts of interest.
Liver transplantation of selected patients with hepatocellular carcinoma (HCC) is an accepted indication and associated with excellent outcomes. Until recently, criteria for liver transplantation were based on the Milan criteria that only took size and number of tumors under consideration. In this multicenter study, patients who were outside of Milan criteria were successfully downstaged to within Milan criteria with locoregional therapy and subsequently transplanted with excellent outcomes. Salient features included the following. 1) Six months waiting after the first treatment and 3 months after downstaging was required to ensure that the tumor stage remained within Milan criteria. 2) Any specific type of locoregional therapy was allowed. 3) Downstaging was possible in a majority of patients after a single treatment. 4) Patients with alpha-fetoprotein greater than 1000 ng/mL (approximately 10%) as well as presence of substantial decompensated liver disease (approximately 40%) did not have favorable outcomes. 4) On multivariable analysis, tumor biology was a stronger predictor of poor outcomes than was stage of liver disease.
Sumeet K. Asrani, MD, MSc, is associate professor in medicine and hepatologist at Baylor University Medical Center, and medical director of the Center for Advanced Liver Disease, Dallas. He has no conflicts of interest.
Liver transplantation led to “excellent outcomes” when performed after downstaging hepatocellular carcinoma using the UNOS (United Network for Organ Sharing) Region 5 protocol, investigators reported.
Downstaging succeeded for 58% of patients, and an estimated 87% of transplantation recipients were alive and recurrence free at 5 years, said Neil Mehta, MD, of the University of California, San Francisco, and his associates. The findings support expanding priority access to liver transplantation to include patients whose hepatocellular carcinoma (HCC) has been successfully downstaged, they said. “In the meantime, UNOS has recently approved the Region 5 downstaging protocol for receiving automatic HCC-MELD exception listing,” they wrote. The report was published in the June issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.11.037).
This is the first multicenter study of HCC downstaging according to a uniform protocol, the researchers noted. In multivariable analyses, downstaging was significantly more likely to fail in the setting of moderate to severe (Child Pugh B or C) hepatic impairment (hazard ratio, 3.3; 95% confidence interval, 3.0 to 3.6; P less than .001) or baseline alpha-fetoprotein level above 1,000 ng/mL (HR, 1.6; 95% CI, 1.4 to 1.9; P less than .001).
The incidence of HCC in the United States is expected to keep rising for at least another decade because of epidemic levels of fatty liver disease and chronic hepatitis C, the investigators noted. Downstaging HCC with local-regional therapy is a common bridge to transplantation, and successful treatment tends to reflect favorable tumor biology, which bodes well for transplantation. However, no multicenter study had evaluated these associations. Therefore, the investigators retrospectively studied 187 patients with HCC from three centers in California who underwent downstaging according to the UNOS Region 5 protocol between 2002 and 2012.
A total of 156 patients (83%) were successfully downstaged to within Milan criteria after a median of 2.7 months (interquartile range, 1.4 to 4.9 months), said the researchers. Among patients who were successfully downstaged but did not undergo transplantation, 37 patients had tumor progression or died from liver-related causes after a median of 6 months, while 10 patients remained on the transplant list. Among the 109 patients who underwent transplantation after a median of 13 months (interquartile range 6 to 19 months), median follow-up time was 4.3 years and estimated 5-year survival was 80%, and estimated recurrence-free survival was 87%.
Fully 68% of successfully downstaged patients required only one local-regional treatment, the researchers said. The Region 5 protocol considers patients eligible for downstaging if they have a single HCC lesion measuring up to 8 cm or multiple lesions whose combined diameters do not exceed 8 cm, and no evidence of extrahepatic disease or vascular invasion on multiphase computed tomography or magnetic resonance imaging.
The protocol considers downstaging successful if it results in one lesion measuring up to 5 cm or no more than three lesions of up to 3 cm each. Thus, patients who start out with four or five lesions must have complete necrosis of at least one to two tumors. Successfully downstaged patients must remain free of acute hepatic decompensation for at least 3 consecutive months before undergoing transplantation, according to the protocol.
“Slight refinements in the inclusion criteria for downstaging seem warranted [given] that all Child’s B/C patients with pretreatment alpha-fetoprotein greater than 1000 ng/mL suffered poor outcomes when downstaging was attempted,” the investigators noted. They reported that the 1-year risk of failed downstaging was 70% among patients with both Child’s B/C cirrhosis and alpha-fetoprotein level at or above 1000 ng/mL, 32% among patients with one risk factor, and 14% among patients with no risk factors (P less than .001).
The National Institutes of Health provided partial funding. The investigators reported having no conflicts of interest.
SOURCE: Mehta N, et al. Clin Gastroenterol Hepatol. 2017 Nov 23. doi: 10.1016/j.cgh.2017.11.037.
Liver transplantation led to “excellent outcomes” when performed after downstaging hepatocellular carcinoma using the UNOS (United Network for Organ Sharing) Region 5 protocol, investigators reported.
Downstaging succeeded for 58% of patients, and an estimated 87% of transplantation recipients were alive and recurrence free at 5 years, said Neil Mehta, MD, of the University of California, San Francisco, and his associates. The findings support expanding priority access to liver transplantation to include patients whose hepatocellular carcinoma (HCC) has been successfully downstaged, they said. “In the meantime, UNOS has recently approved the Region 5 downstaging protocol for receiving automatic HCC-MELD exception listing,” they wrote. The report was published in the June issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.11.037).
This is the first multicenter study of HCC downstaging according to a uniform protocol, the researchers noted. In multivariable analyses, downstaging was significantly more likely to fail in the setting of moderate to severe (Child Pugh B or C) hepatic impairment (hazard ratio, 3.3; 95% confidence interval, 3.0 to 3.6; P less than .001) or baseline alpha-fetoprotein level above 1,000 ng/mL (HR, 1.6; 95% CI, 1.4 to 1.9; P less than .001).
The incidence of HCC in the United States is expected to keep rising for at least another decade because of epidemic levels of fatty liver disease and chronic hepatitis C, the investigators noted. Downstaging HCC with local-regional therapy is a common bridge to transplantation, and successful treatment tends to reflect favorable tumor biology, which bodes well for transplantation. However, no multicenter study had evaluated these associations. Therefore, the investigators retrospectively studied 187 patients with HCC from three centers in California who underwent downstaging according to the UNOS Region 5 protocol between 2002 and 2012.
A total of 156 patients (83%) were successfully downstaged to within Milan criteria after a median of 2.7 months (interquartile range, 1.4 to 4.9 months), said the researchers. Among patients who were successfully downstaged but did not undergo transplantation, 37 patients had tumor progression or died from liver-related causes after a median of 6 months, while 10 patients remained on the transplant list. Among the 109 patients who underwent transplantation after a median of 13 months (interquartile range 6 to 19 months), median follow-up time was 4.3 years and estimated 5-year survival was 80%, and estimated recurrence-free survival was 87%.
Fully 68% of successfully downstaged patients required only one local-regional treatment, the researchers said. The Region 5 protocol considers patients eligible for downstaging if they have a single HCC lesion measuring up to 8 cm or multiple lesions whose combined diameters do not exceed 8 cm, and no evidence of extrahepatic disease or vascular invasion on multiphase computed tomography or magnetic resonance imaging.
The protocol considers downstaging successful if it results in one lesion measuring up to 5 cm or no more than three lesions of up to 3 cm each. Thus, patients who start out with four or five lesions must have complete necrosis of at least one to two tumors. Successfully downstaged patients must remain free of acute hepatic decompensation for at least 3 consecutive months before undergoing transplantation, according to the protocol.
“Slight refinements in the inclusion criteria for downstaging seem warranted [given] that all Child’s B/C patients with pretreatment alpha-fetoprotein greater than 1000 ng/mL suffered poor outcomes when downstaging was attempted,” the investigators noted. They reported that the 1-year risk of failed downstaging was 70% among patients with both Child’s B/C cirrhosis and alpha-fetoprotein level at or above 1000 ng/mL, 32% among patients with one risk factor, and 14% among patients with no risk factors (P less than .001).
The National Institutes of Health provided partial funding. The investigators reported having no conflicts of interest.
SOURCE: Mehta N, et al. Clin Gastroenterol Hepatol. 2017 Nov 23. doi: 10.1016/j.cgh.2017.11.037.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: Liver transplantation led to excellent outcomes when performed after downstaging hepatocellular carcinoma according to the UNOS (United Network for Organ Sharing) Region 5 protocol.
Major finding: Downstaging succeeded in 58% of patients. Estimated 5-year posttransplantation recurrence-free survival was 87%.
Study details: Retrospective multicenter study of 187 patients with hepatocellular carcinoma.
Disclosures: The National Institutes of Health provided partial funding. The investigators reported having no conflicts of interest.
Source: Mehta N et al. Clin Gastroenterol Hepatol. 2017 Nov 23. doi: 10.1016/j.cgh.2017.11.037.
Severity of sepsis-associated coagulopathy predicts hospital mortality
Patients with appear to be at heightened risk of death, according to results of a large retrospective cohort study.
The risk of death in the study increased with the severity of the sepsis-associated coagulopathy, which was defined using international normalized ratio (INR) and platelet counts.
Those findings suggest that the severity of coagulation abnormalities might be used to quantify mortality risk, according to investigator Patrick G. Lyons, MD, of the division of pulmonary and critical care medicine, Washington University, St. Louis, and his coinvestigators.
“Future trials of sepsis therapies targeting the coagulation cascade should take into account the presence or absence of sepsis-associated coagulopathy, as well as the severity of sepsis-associated coagulopathy, when formulating potential trial designs,” the investigators wrote in the journal Critical Care Medicine.
Their retrospective cohort study included 6,148 consecutive patients with sepsis or septic shock hospitalized at a 1,300-bed urban academic medical center between 2010 and 2015. Of that group, 26% had sepsis-associated coagulopathy, defined as having both an INR of 1.2 or higher and a platelet count less than 150,000/mcL. Sepsis-associated coagulopathy was classified as mild for 4%, moderate for 16%, and severe for 6% of the cohort.
Hospital mortality was 25.4% for patients with no sepsis-associated coagulopathy, the research team found, increasing progressively from 27.0% for mild, 40.7% for moderate, and 56.1% for patients in the most severe category of sepsis-associated coagulopathy (P less than .001).
Hospital and ICU days also increased progressively according to the severity of coagulopathy, they reported.
Both presence and severity of sepsis-associated coagulopathy remained independently associated with hospital mortality even after adjustments were made for patient characteristics, hospitalization variables, and interactions between sepsis-associated coagulopathy and cancer, investigators said. Odds ratios ranged from 1.33 to 2.14 for presence of sepsis-associated coagulopathy, and from 1.18 to 1.51 for severity, they reported in the journal.
These data have potential implications for managing patients with sepsis, according to Dr. Lyons and coinvestigators. In particular, severity of sepsis-associated coagulopathy might be used as “another relatively simple way” to compare sepsis patient populations, similar to other markers of severity such as the Sequential Organ Failure Assessment score.
“This could have important implications for comparing the outcomes of patients with sepsis from different hospitals, especially with increasing requirements for public reporting of such data through systems such as the Severe Sepsis/Septic Shock Early Management Bundle-1 and New York State’s Rory’s Regulations,” the investigators wrote.
Reported disclosures for the study included institutional funding from Asahi Kasei Pharma America by one coauthor, and support from Barnes-Jewish Hospital Foundation by another. No other potential conflicts of interest were reported.
SOURCE: Lyons PG et al. Crit Care Med. 2018 May;46(5):736-42.
This study outlines a simplified classification scheme for coagulopathy with implications that are potentially “profound,” according to authors of an editorial accompanying the journal article.
“Despite the frequency with which hemostatic derangements occur in sepsis, there has not been a widely accepted system for stratification of coagulopathies,” said editorialists Garrett W. Britton, DO, Cody Babcock, PharmD, and Christopher J. Colombo, MD. “Of the most cited criteria, all have varying concordance, and one does not seem to have an advantage over another.”
In the present study, patients with sepsis-associated coagulopathy were stratified into mild, moderate, and severe categories based on international normalized ratio (INR) levels and platelet counts.
While the study has limitations including a sicker patient cohort and arbitrarily chosen severity thresholds, the investigators did find progressively increasing mortality rates that correlated with severity and were independent of confounding variables.
“Overall, this stratification system will prove useful in identifying target populations in future interventional studies,” the editorial authors wrote.
Since sepsis-related mortality remains high, the ultimate goal of research should be identifying varying phenotypes of the disease and targeting them with specific therapies, they added.
“Lyons et al. have aided the first steps in that process with their straightforward classification scheme for sepsis-associated coagulopathy,” they wrote. “Intelligently designed therapeutic trials ‘evaluating’ the response of these phenotypes to new (or old) pharmacotherapy should be the ultimate goal.”
Garrett W. Britton, DO, is with the department of medicine, critical care section, Walter Reed National Military Medical Center, Bethesda, Md. Cody Babcock, PharmD, and Christopher J. Colombo, MD, are with the department of medicine, critical care section, Dwight David Eisenhower Army Medical Center, Fort Gordon, Ga. These comments are derived from their editorial in Critical Care Medicine . The authors had no disclosures beyond reporting government work.
This study outlines a simplified classification scheme for coagulopathy with implications that are potentially “profound,” according to authors of an editorial accompanying the journal article.
“Despite the frequency with which hemostatic derangements occur in sepsis, there has not been a widely accepted system for stratification of coagulopathies,” said editorialists Garrett W. Britton, DO, Cody Babcock, PharmD, and Christopher J. Colombo, MD. “Of the most cited criteria, all have varying concordance, and one does not seem to have an advantage over another.”
In the present study, patients with sepsis-associated coagulopathy were stratified into mild, moderate, and severe categories based on international normalized ratio (INR) levels and platelet counts.
While the study has limitations including a sicker patient cohort and arbitrarily chosen severity thresholds, the investigators did find progressively increasing mortality rates that correlated with severity and were independent of confounding variables.
“Overall, this stratification system will prove useful in identifying target populations in future interventional studies,” the editorial authors wrote.
Since sepsis-related mortality remains high, the ultimate goal of research should be identifying varying phenotypes of the disease and targeting them with specific therapies, they added.
“Lyons et al. have aided the first steps in that process with their straightforward classification scheme for sepsis-associated coagulopathy,” they wrote. “Intelligently designed therapeutic trials ‘evaluating’ the response of these phenotypes to new (or old) pharmacotherapy should be the ultimate goal.”
Garrett W. Britton, DO, is with the department of medicine, critical care section, Walter Reed National Military Medical Center, Bethesda, Md. Cody Babcock, PharmD, and Christopher J. Colombo, MD, are with the department of medicine, critical care section, Dwight David Eisenhower Army Medical Center, Fort Gordon, Ga. These comments are derived from their editorial in Critical Care Medicine . The authors had no disclosures beyond reporting government work.
This study outlines a simplified classification scheme for coagulopathy with implications that are potentially “profound,” according to authors of an editorial accompanying the journal article.
“Despite the frequency with which hemostatic derangements occur in sepsis, there has not been a widely accepted system for stratification of coagulopathies,” said editorialists Garrett W. Britton, DO, Cody Babcock, PharmD, and Christopher J. Colombo, MD. “Of the most cited criteria, all have varying concordance, and one does not seem to have an advantage over another.”
In the present study, patients with sepsis-associated coagulopathy were stratified into mild, moderate, and severe categories based on international normalized ratio (INR) levels and platelet counts.
While the study has limitations including a sicker patient cohort and arbitrarily chosen severity thresholds, the investigators did find progressively increasing mortality rates that correlated with severity and were independent of confounding variables.
“Overall, this stratification system will prove useful in identifying target populations in future interventional studies,” the editorial authors wrote.
Since sepsis-related mortality remains high, the ultimate goal of research should be identifying varying phenotypes of the disease and targeting them with specific therapies, they added.
“Lyons et al. have aided the first steps in that process with their straightforward classification scheme for sepsis-associated coagulopathy,” they wrote. “Intelligently designed therapeutic trials ‘evaluating’ the response of these phenotypes to new (or old) pharmacotherapy should be the ultimate goal.”
Garrett W. Britton, DO, is with the department of medicine, critical care section, Walter Reed National Military Medical Center, Bethesda, Md. Cody Babcock, PharmD, and Christopher J. Colombo, MD, are with the department of medicine, critical care section, Dwight David Eisenhower Army Medical Center, Fort Gordon, Ga. These comments are derived from their editorial in Critical Care Medicine . The authors had no disclosures beyond reporting government work.
Patients with appear to be at heightened risk of death, according to results of a large retrospective cohort study.
The risk of death in the study increased with the severity of the sepsis-associated coagulopathy, which was defined using international normalized ratio (INR) and platelet counts.
Those findings suggest that the severity of coagulation abnormalities might be used to quantify mortality risk, according to investigator Patrick G. Lyons, MD, of the division of pulmonary and critical care medicine, Washington University, St. Louis, and his coinvestigators.
“Future trials of sepsis therapies targeting the coagulation cascade should take into account the presence or absence of sepsis-associated coagulopathy, as well as the severity of sepsis-associated coagulopathy, when formulating potential trial designs,” the investigators wrote in the journal Critical Care Medicine.
Their retrospective cohort study included 6,148 consecutive patients with sepsis or septic shock hospitalized at a 1,300-bed urban academic medical center between 2010 and 2015. Of that group, 26% had sepsis-associated coagulopathy, defined as having both an INR of 1.2 or higher and a platelet count less than 150,000/mcL. Sepsis-associated coagulopathy was classified as mild for 4%, moderate for 16%, and severe for 6% of the cohort.
Hospital mortality was 25.4% for patients with no sepsis-associated coagulopathy, the research team found, increasing progressively from 27.0% for mild, 40.7% for moderate, and 56.1% for patients in the most severe category of sepsis-associated coagulopathy (P less than .001).
Hospital and ICU days also increased progressively according to the severity of coagulopathy, they reported.
Both presence and severity of sepsis-associated coagulopathy remained independently associated with hospital mortality even after adjustments were made for patient characteristics, hospitalization variables, and interactions between sepsis-associated coagulopathy and cancer, investigators said. Odds ratios ranged from 1.33 to 2.14 for presence of sepsis-associated coagulopathy, and from 1.18 to 1.51 for severity, they reported in the journal.
These data have potential implications for managing patients with sepsis, according to Dr. Lyons and coinvestigators. In particular, severity of sepsis-associated coagulopathy might be used as “another relatively simple way” to compare sepsis patient populations, similar to other markers of severity such as the Sequential Organ Failure Assessment score.
“This could have important implications for comparing the outcomes of patients with sepsis from different hospitals, especially with increasing requirements for public reporting of such data through systems such as the Severe Sepsis/Septic Shock Early Management Bundle-1 and New York State’s Rory’s Regulations,” the investigators wrote.
Reported disclosures for the study included institutional funding from Asahi Kasei Pharma America by one coauthor, and support from Barnes-Jewish Hospital Foundation by another. No other potential conflicts of interest were reported.
SOURCE: Lyons PG et al. Crit Care Med. 2018 May;46(5):736-42.
Patients with appear to be at heightened risk of death, according to results of a large retrospective cohort study.
The risk of death in the study increased with the severity of the sepsis-associated coagulopathy, which was defined using international normalized ratio (INR) and platelet counts.
Those findings suggest that the severity of coagulation abnormalities might be used to quantify mortality risk, according to investigator Patrick G. Lyons, MD, of the division of pulmonary and critical care medicine, Washington University, St. Louis, and his coinvestigators.
“Future trials of sepsis therapies targeting the coagulation cascade should take into account the presence or absence of sepsis-associated coagulopathy, as well as the severity of sepsis-associated coagulopathy, when formulating potential trial designs,” the investigators wrote in the journal Critical Care Medicine.
Their retrospective cohort study included 6,148 consecutive patients with sepsis or septic shock hospitalized at a 1,300-bed urban academic medical center between 2010 and 2015. Of that group, 26% had sepsis-associated coagulopathy, defined as having both an INR of 1.2 or higher and a platelet count less than 150,000/mcL. Sepsis-associated coagulopathy was classified as mild for 4%, moderate for 16%, and severe for 6% of the cohort.
Hospital mortality was 25.4% for patients with no sepsis-associated coagulopathy, the research team found, increasing progressively from 27.0% for mild, 40.7% for moderate, and 56.1% for patients in the most severe category of sepsis-associated coagulopathy (P less than .001).
Hospital and ICU days also increased progressively according to the severity of coagulopathy, they reported.
Both presence and severity of sepsis-associated coagulopathy remained independently associated with hospital mortality even after adjustments were made for patient characteristics, hospitalization variables, and interactions between sepsis-associated coagulopathy and cancer, investigators said. Odds ratios ranged from 1.33 to 2.14 for presence of sepsis-associated coagulopathy, and from 1.18 to 1.51 for severity, they reported in the journal.
These data have potential implications for managing patients with sepsis, according to Dr. Lyons and coinvestigators. In particular, severity of sepsis-associated coagulopathy might be used as “another relatively simple way” to compare sepsis patient populations, similar to other markers of severity such as the Sequential Organ Failure Assessment score.
“This could have important implications for comparing the outcomes of patients with sepsis from different hospitals, especially with increasing requirements for public reporting of such data through systems such as the Severe Sepsis/Septic Shock Early Management Bundle-1 and New York State’s Rory’s Regulations,” the investigators wrote.
Reported disclosures for the study included institutional funding from Asahi Kasei Pharma America by one coauthor, and support from Barnes-Jewish Hospital Foundation by another. No other potential conflicts of interest were reported.
SOURCE: Lyons PG et al. Crit Care Med. 2018 May;46(5):736-42.
FROM CRITICAL CARE MEDICINE
Key clinical point: Risk of hospital mortality increased incrementally with the severity of sepsis-related coagulopathy.
Major finding: Hospital mortality was 25.4% for patients with no sepsis-associated coagulopathy, increasing progressively up to 56.1% for patients in the most severe category.
Study details: A retrospective cohort study including 6,148 consecutive patients hospitalized at a 1,300-bed urban academic medical center between 2010 and 2015.
Disclosures: One author reported institutional funding from Asahi Kasei Pharma America and another noted support from Barnes-Jewish Hospital Foundation. No other potential conflicts of interest were reported.
Source: Lyons PG et al. Crit Care Med. 2018 May;46(5):73642.
Liver transplantation is on the rise for patients with severe alcoholic hepatitis
More transplant centers are offering liver transplantation as a viable therapeutic option for patients with severe alcoholic hepatitis who do not respond to steroid treatment.
“Alcoholic hepatitis is a disease caused by drinking alcohol. Excessive alcohol consumption causes fat to build up in your liver cells, as well as inflammation and scarring of the liver,” stated Saroja Bangaru, MD, chief resident at the University of Texas, Dallas. “Severe alcoholic hepatitis has an extremely high mortality and steroids are really the mainstay of therapy. Some alcoholic hepatitis patients do not respond to steroids and a significant percentage of them will die within 3 months. For these patients, liver transplantation is a therapeutic option.”
Dr. Bangaru and her colleagues conducted a survey that gathered data from 45 transplant centers in the United States and found that an increasing number have changed this practice and now offer liver transplantation to patients with severe alcoholic hepatitis.
The survey revealed that 51.1% of the 45 clinics offered liver transplantation to patients who had not yet been sober for 6 months, and 47.8% of transplant centers reported performing at least one liver transplant for severe alcoholic hepatitis. Just over a third (34.8%) of these centers had conducted three to five liver transplants, while only 8.9% of clinics performed at least six transplants. It is of note that most clinics have transplanted livers in fewer than five patients with severe alcoholic hepatitis, Dr. Bangaru said at the annual Digestive Disease Week®.
Patients experienced positive outcomes from these transplants, with almost 75% of surveyed clinics reporting 1-year survival rates of more than 90%, and 15% reporting 1-year survival rates of 80%-90%.
A factor that may have contributed to such positive outcomes was good patient selection based on liver transplant criteria for severe alcoholic hepatitis. More than 85% of center directors believed that liver transplant candidates should have a strong social support system, absence of severe psychiatric disorders, and a completed psychosocial evaluation, among other criteria.
Dr. Bangaru pointed out that the change in treating patients who have not abstained from alcohol is a break from traditional medical practice. “Historically, transplant centers would not consider a liver transplantation as an option unless a patient had abstained from drinking alcohol for 6 months. This rule was due to a concern that the patient would return to drinking after transplant as well as a perceived high risk that patients who continued drinking would miss medical appointments, fail to take their immunosuppressants and medications, and that this would lead to eventual graft failure.”
Another compounding issue was that patients were not counseled on their alcohol consumption habits, leading to further issues with transplantation. “Not infrequently, patients receive a diagnosis of severe alcoholic hepatitis during their initial visit and no one had previously told them to stop drinking. Since their presentation was preceded by active alcohol consumption, they would essentially be rendered ineligible for a transplant at that time,” she said.
Despite the history surrounding liver transplants in patients with severe alcoholic hepatitis, Dr. Bangaru hopes the shift in practice will improve the lives of more patients. “Because this practice of transplantation is being increasingly accepted and demonstrating positive outcomes, the hope is that more patients will be evaluated for transplantation and that transplant centers will improve their posttransplant support to ensure patients have great success after transplantation.”
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
More transplant centers are offering liver transplantation as a viable therapeutic option for patients with severe alcoholic hepatitis who do not respond to steroid treatment.
“Alcoholic hepatitis is a disease caused by drinking alcohol. Excessive alcohol consumption causes fat to build up in your liver cells, as well as inflammation and scarring of the liver,” stated Saroja Bangaru, MD, chief resident at the University of Texas, Dallas. “Severe alcoholic hepatitis has an extremely high mortality and steroids are really the mainstay of therapy. Some alcoholic hepatitis patients do not respond to steroids and a significant percentage of them will die within 3 months. For these patients, liver transplantation is a therapeutic option.”
Dr. Bangaru and her colleagues conducted a survey that gathered data from 45 transplant centers in the United States and found that an increasing number have changed this practice and now offer liver transplantation to patients with severe alcoholic hepatitis.
The survey revealed that 51.1% of the 45 clinics offered liver transplantation to patients who had not yet been sober for 6 months, and 47.8% of transplant centers reported performing at least one liver transplant for severe alcoholic hepatitis. Just over a third (34.8%) of these centers had conducted three to five liver transplants, while only 8.9% of clinics performed at least six transplants. It is of note that most clinics have transplanted livers in fewer than five patients with severe alcoholic hepatitis, Dr. Bangaru said at the annual Digestive Disease Week®.
Patients experienced positive outcomes from these transplants, with almost 75% of surveyed clinics reporting 1-year survival rates of more than 90%, and 15% reporting 1-year survival rates of 80%-90%.
A factor that may have contributed to such positive outcomes was good patient selection based on liver transplant criteria for severe alcoholic hepatitis. More than 85% of center directors believed that liver transplant candidates should have a strong social support system, absence of severe psychiatric disorders, and a completed psychosocial evaluation, among other criteria.
Dr. Bangaru pointed out that the change in treating patients who have not abstained from alcohol is a break from traditional medical practice. “Historically, transplant centers would not consider a liver transplantation as an option unless a patient had abstained from drinking alcohol for 6 months. This rule was due to a concern that the patient would return to drinking after transplant as well as a perceived high risk that patients who continued drinking would miss medical appointments, fail to take their immunosuppressants and medications, and that this would lead to eventual graft failure.”
Another compounding issue was that patients were not counseled on their alcohol consumption habits, leading to further issues with transplantation. “Not infrequently, patients receive a diagnosis of severe alcoholic hepatitis during their initial visit and no one had previously told them to stop drinking. Since their presentation was preceded by active alcohol consumption, they would essentially be rendered ineligible for a transplant at that time,” she said.
Despite the history surrounding liver transplants in patients with severe alcoholic hepatitis, Dr. Bangaru hopes the shift in practice will improve the lives of more patients. “Because this practice of transplantation is being increasingly accepted and demonstrating positive outcomes, the hope is that more patients will be evaluated for transplantation and that transplant centers will improve their posttransplant support to ensure patients have great success after transplantation.”
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
More transplant centers are offering liver transplantation as a viable therapeutic option for patients with severe alcoholic hepatitis who do not respond to steroid treatment.
“Alcoholic hepatitis is a disease caused by drinking alcohol. Excessive alcohol consumption causes fat to build up in your liver cells, as well as inflammation and scarring of the liver,” stated Saroja Bangaru, MD, chief resident at the University of Texas, Dallas. “Severe alcoholic hepatitis has an extremely high mortality and steroids are really the mainstay of therapy. Some alcoholic hepatitis patients do not respond to steroids and a significant percentage of them will die within 3 months. For these patients, liver transplantation is a therapeutic option.”
Dr. Bangaru and her colleagues conducted a survey that gathered data from 45 transplant centers in the United States and found that an increasing number have changed this practice and now offer liver transplantation to patients with severe alcoholic hepatitis.
The survey revealed that 51.1% of the 45 clinics offered liver transplantation to patients who had not yet been sober for 6 months, and 47.8% of transplant centers reported performing at least one liver transplant for severe alcoholic hepatitis. Just over a third (34.8%) of these centers had conducted three to five liver transplants, while only 8.9% of clinics performed at least six transplants. It is of note that most clinics have transplanted livers in fewer than five patients with severe alcoholic hepatitis, Dr. Bangaru said at the annual Digestive Disease Week®.
Patients experienced positive outcomes from these transplants, with almost 75% of surveyed clinics reporting 1-year survival rates of more than 90%, and 15% reporting 1-year survival rates of 80%-90%.
A factor that may have contributed to such positive outcomes was good patient selection based on liver transplant criteria for severe alcoholic hepatitis. More than 85% of center directors believed that liver transplant candidates should have a strong social support system, absence of severe psychiatric disorders, and a completed psychosocial evaluation, among other criteria.
Dr. Bangaru pointed out that the change in treating patients who have not abstained from alcohol is a break from traditional medical practice. “Historically, transplant centers would not consider a liver transplantation as an option unless a patient had abstained from drinking alcohol for 6 months. This rule was due to a concern that the patient would return to drinking after transplant as well as a perceived high risk that patients who continued drinking would miss medical appointments, fail to take their immunosuppressants and medications, and that this would lead to eventual graft failure.”
Another compounding issue was that patients were not counseled on their alcohol consumption habits, leading to further issues with transplantation. “Not infrequently, patients receive a diagnosis of severe alcoholic hepatitis during their initial visit and no one had previously told them to stop drinking. Since their presentation was preceded by active alcohol consumption, they would essentially be rendered ineligible for a transplant at that time,” she said.
Despite the history surrounding liver transplants in patients with severe alcoholic hepatitis, Dr. Bangaru hopes the shift in practice will improve the lives of more patients. “Because this practice of transplantation is being increasingly accepted and demonstrating positive outcomes, the hope is that more patients will be evaluated for transplantation and that transplant centers will improve their posttransplant support to ensure patients have great success after transplantation.”
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
REPORTING FROM DDW
Simple bedside tool effectively detected sepsis in the ED
SAN DIEGO – The product of compared with the quick Sequential Organ Failure Assessment prompt, a small, single-center study showed.
“We know a lot about the pathophysiology of sepsis, but we don’t have great ways of identifying septic patients at an early stage,” lead study author David Lynch, MD, said in an interview at an international conference of the American Thoracic Society.
He noted that screening tools such as the quick Sequential Organ Failure Assessment and Systemic Inflammatory Response Syndrome criteria have a sensitivity of about 70% in detecting sepsis. “Over the last 10-15 years we’ve been able to find ways of improving outcomes in patients whom we confirm are septic with early antibiotics and fluids,” said Dr. Lynch, a second-year resident in the division of pulmonary and critical care medicine within the department of medicine at the University of North Carolina at Chapel Hill. “We know that in sepsis, systemic vascular resistance is decreased and cardiac output is increased. We tried to come up with a way of estimating cardiac output at the bedside by multiplying heart rate with pulse pressure, with the pulse pressure being the surrogate for stroke volume, which you can measure easily.”
In a cross-sectional, observational study, Dr. Lynch, senior author Thomas Bice, MD, and their associates reviewed the records of 116 patients who were admitted directly to the University of North Carolina’s medical ICU (MICU) from the UNC ED between Jan. 5, 2016, and June 30, 2017. The primary outcome of interest was culture-positive sepsis, and the primary exposure was the product of pulse pressure and heart rate. Patients were determined to be positive for sepsis if an infection was suspected (such as if blood cultures were drawn and antibiotics were started), the admitting physician suspected sepsis, and cultures were subsequently positive.
The average age of all patients was 53 years, 51% were female, the mortality rate was 12%, and the median length of stay was 4 days. A total of 25 of the 116 patients (22%) were positive for sepsis. The researchers observed that the pulse pressure multiplied by the heart rate was significantly higher in the culture-positive sepsis group, compared with controls (6,710 vs. 3,741, respectively; P less than .001).
Dr. Lynch and his associates found that, as a continuous variable, pulse pressure multiplied by the heart rate accurately classified 90% of sepsis cases (area under the receiver operator curve, 0.96; P less than .001). When using 5,000 as a cutoff, pulse pressure multiplied by the heart rate had a sensitivity of 100% and a specificity of 89% in detecting culture-positive sepsis. “We were surprised by how high the sensitivity was,” Dr. Lynch said. “The question is, will this translate to a larger cohort? And, would this be transferable to all patients in the ED, as opposed to the sicker patients who are going to the MICU?”
He and his associates plan to confirm the study’s results in a broader population of patients. “We don’t yet understand at what point in time this would be most applicable,” he added. “We looked at the first set of vitals when they came into the ED. We’d like to know if that applies to the second, third and fourth set of vitals, and whether it would be most useful to have an average of those.”
The study was supported in part by a grant from the National Institutes of Health. Dr. Lynch reported having no financial disclosures.
SAN DIEGO – The product of compared with the quick Sequential Organ Failure Assessment prompt, a small, single-center study showed.
“We know a lot about the pathophysiology of sepsis, but we don’t have great ways of identifying septic patients at an early stage,” lead study author David Lynch, MD, said in an interview at an international conference of the American Thoracic Society.
He noted that screening tools such as the quick Sequential Organ Failure Assessment and Systemic Inflammatory Response Syndrome criteria have a sensitivity of about 70% in detecting sepsis. “Over the last 10-15 years we’ve been able to find ways of improving outcomes in patients whom we confirm are septic with early antibiotics and fluids,” said Dr. Lynch, a second-year resident in the division of pulmonary and critical care medicine within the department of medicine at the University of North Carolina at Chapel Hill. “We know that in sepsis, systemic vascular resistance is decreased and cardiac output is increased. We tried to come up with a way of estimating cardiac output at the bedside by multiplying heart rate with pulse pressure, with the pulse pressure being the surrogate for stroke volume, which you can measure easily.”
In a cross-sectional, observational study, Dr. Lynch, senior author Thomas Bice, MD, and their associates reviewed the records of 116 patients who were admitted directly to the University of North Carolina’s medical ICU (MICU) from the UNC ED between Jan. 5, 2016, and June 30, 2017. The primary outcome of interest was culture-positive sepsis, and the primary exposure was the product of pulse pressure and heart rate. Patients were determined to be positive for sepsis if an infection was suspected (such as if blood cultures were drawn and antibiotics were started), the admitting physician suspected sepsis, and cultures were subsequently positive.
The average age of all patients was 53 years, 51% were female, the mortality rate was 12%, and the median length of stay was 4 days. A total of 25 of the 116 patients (22%) were positive for sepsis. The researchers observed that the pulse pressure multiplied by the heart rate was significantly higher in the culture-positive sepsis group, compared with controls (6,710 vs. 3,741, respectively; P less than .001).
Dr. Lynch and his associates found that, as a continuous variable, pulse pressure multiplied by the heart rate accurately classified 90% of sepsis cases (area under the receiver operator curve, 0.96; P less than .001). When using 5,000 as a cutoff, pulse pressure multiplied by the heart rate had a sensitivity of 100% and a specificity of 89% in detecting culture-positive sepsis. “We were surprised by how high the sensitivity was,” Dr. Lynch said. “The question is, will this translate to a larger cohort? And, would this be transferable to all patients in the ED, as opposed to the sicker patients who are going to the MICU?”
He and his associates plan to confirm the study’s results in a broader population of patients. “We don’t yet understand at what point in time this would be most applicable,” he added. “We looked at the first set of vitals when they came into the ED. We’d like to know if that applies to the second, third and fourth set of vitals, and whether it would be most useful to have an average of those.”
The study was supported in part by a grant from the National Institutes of Health. Dr. Lynch reported having no financial disclosures.
SAN DIEGO – The product of compared with the quick Sequential Organ Failure Assessment prompt, a small, single-center study showed.
“We know a lot about the pathophysiology of sepsis, but we don’t have great ways of identifying septic patients at an early stage,” lead study author David Lynch, MD, said in an interview at an international conference of the American Thoracic Society.
He noted that screening tools such as the quick Sequential Organ Failure Assessment and Systemic Inflammatory Response Syndrome criteria have a sensitivity of about 70% in detecting sepsis. “Over the last 10-15 years we’ve been able to find ways of improving outcomes in patients whom we confirm are septic with early antibiotics and fluids,” said Dr. Lynch, a second-year resident in the division of pulmonary and critical care medicine within the department of medicine at the University of North Carolina at Chapel Hill. “We know that in sepsis, systemic vascular resistance is decreased and cardiac output is increased. We tried to come up with a way of estimating cardiac output at the bedside by multiplying heart rate with pulse pressure, with the pulse pressure being the surrogate for stroke volume, which you can measure easily.”
In a cross-sectional, observational study, Dr. Lynch, senior author Thomas Bice, MD, and their associates reviewed the records of 116 patients who were admitted directly to the University of North Carolina’s medical ICU (MICU) from the UNC ED between Jan. 5, 2016, and June 30, 2017. The primary outcome of interest was culture-positive sepsis, and the primary exposure was the product of pulse pressure and heart rate. Patients were determined to be positive for sepsis if an infection was suspected (such as if blood cultures were drawn and antibiotics were started), the admitting physician suspected sepsis, and cultures were subsequently positive.
The average age of all patients was 53 years, 51% were female, the mortality rate was 12%, and the median length of stay was 4 days. A total of 25 of the 116 patients (22%) were positive for sepsis. The researchers observed that the pulse pressure multiplied by the heart rate was significantly higher in the culture-positive sepsis group, compared with controls (6,710 vs. 3,741, respectively; P less than .001).
Dr. Lynch and his associates found that, as a continuous variable, pulse pressure multiplied by the heart rate accurately classified 90% of sepsis cases (area under the receiver operator curve, 0.96; P less than .001). When using 5,000 as a cutoff, pulse pressure multiplied by the heart rate had a sensitivity of 100% and a specificity of 89% in detecting culture-positive sepsis. “We were surprised by how high the sensitivity was,” Dr. Lynch said. “The question is, will this translate to a larger cohort? And, would this be transferable to all patients in the ED, as opposed to the sicker patients who are going to the MICU?”
He and his associates plan to confirm the study’s results in a broader population of patients. “We don’t yet understand at what point in time this would be most applicable,” he added. “We looked at the first set of vitals when they came into the ED. We’d like to know if that applies to the second, third and fourth set of vitals, and whether it would be most useful to have an average of those.”
The study was supported in part by a grant from the National Institutes of Health. Dr. Lynch reported having no financial disclosures.
REPORTING FROM ATS 2018
Key clinical point: A simple calculation of pulse pressure multiplied by heart rate at ED triage could lead to earlier implementation of lifesaving interventions in septic patients.
Major finding: When using 5,000 as a cutoff, pulse pressure multiplied by heart rate had a sensitivity of 100% and a specificity of 89% in detecting culture-positive sepsis.
Study details: A cross-sectional, observational study of 116 medical ICU patients who were admitted directly from an ED.
Disclosures: The study was supported in part by a grant from the National Institutes of Health. Dr. Lynch reported having no financial disclosures.
Delays in lactate measurement ups mortality risk in sepsis patients
For patients with , findings of a retrospective study show.
Those patients had a longer time to administration of IV fluids (IVF) and antibiotics, researchers reported in the journal Chest®.
In previous studies, delayed antibiotics in patients with sepsis has been associated with increased mortality, wrote Xuan Han, MD, department of medicine, University of Chicago, and coauthors. “Systematic early lactate measurements when a patient presents with sepsis may thus be useful in prompting earlier, potentially life-saving interventions,” they noted.
The retrospective study comprised 5,762 adults admitted to the University of Chicago from November 2008 to January 2016. These patients met criteria for severe sepsis, as outlined in the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), a quality measure introduced by the Centers for Medicare & Medicaid Services in 2015. The SEP-1 mandates interventions including lactate draws and antibiotics for patients identified as having severe sepsis via clinical and laboratory evaluation, the authors noted.
They found that 60% of these patients had serum lactate measurements drawn within the time window specified in SEP-1. But timelines varied significantly by setting, at just 32% in patients who first met the criteria on the wards, compared with 55% in the ICU, and 79% in the emergency department.
In-hospital mortality was highest in patients with delayed lactate measurements, at 29%, compared with 27% for those with lactates taken within the specified time window, and 23% for patients without lactate samples (P less than .01), the researchers reported.
For patients with initial lactates greater than 2.0 mmol/L, the increase in odds of death was 2% for each hour of delay, while no such increase was noted in patients with initial lactates lower than that threshold.
The increased odds of death in patients with higher initial lactates was significant (odds ratio, 1.02; 95% confidence interval, 1.0003-1.05; P = .04); however, the association was no longer significant when adjusted for time to IVF and antibiotics (P = .51). Based on that observation, the difference in mortality may be due to earlier interventions among patients treated in the specified time frame.
“Patients with lactates drawn within the SEP-1 window received both IV antibiotics and fluids sooner than their counterparts who had lactates drawn outside of the window,” Dr. Han and coauthors explained.
These findings complement prior studies suggesting the benefit of interventions in patients with lactate levels above 2.0 mmol/L, and, conversely, highlight the fact that many patients who meet the severe sepsis criteria nevertheless have normal lactates.
“Although elements of the SEP-1 bundle are useful in managing sepsis, the measure may also lead to an increase in lactate measurements and subsequently excessive utilization of resources on patients who may not benefit,” the researchers wrote.
They reported disclosures related to Philips Healthcare, Laerdal Medical, and Quant HC, among other entities.
SOURCE: Han X et al. Chest. 2018 May 24. doi: 10.1016/j.chest.2018.03.025.
For patients with , findings of a retrospective study show.
Those patients had a longer time to administration of IV fluids (IVF) and antibiotics, researchers reported in the journal Chest®.
In previous studies, delayed antibiotics in patients with sepsis has been associated with increased mortality, wrote Xuan Han, MD, department of medicine, University of Chicago, and coauthors. “Systematic early lactate measurements when a patient presents with sepsis may thus be useful in prompting earlier, potentially life-saving interventions,” they noted.
The retrospective study comprised 5,762 adults admitted to the University of Chicago from November 2008 to January 2016. These patients met criteria for severe sepsis, as outlined in the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), a quality measure introduced by the Centers for Medicare & Medicaid Services in 2015. The SEP-1 mandates interventions including lactate draws and antibiotics for patients identified as having severe sepsis via clinical and laboratory evaluation, the authors noted.
They found that 60% of these patients had serum lactate measurements drawn within the time window specified in SEP-1. But timelines varied significantly by setting, at just 32% in patients who first met the criteria on the wards, compared with 55% in the ICU, and 79% in the emergency department.
In-hospital mortality was highest in patients with delayed lactate measurements, at 29%, compared with 27% for those with lactates taken within the specified time window, and 23% for patients without lactate samples (P less than .01), the researchers reported.
For patients with initial lactates greater than 2.0 mmol/L, the increase in odds of death was 2% for each hour of delay, while no such increase was noted in patients with initial lactates lower than that threshold.
The increased odds of death in patients with higher initial lactates was significant (odds ratio, 1.02; 95% confidence interval, 1.0003-1.05; P = .04); however, the association was no longer significant when adjusted for time to IVF and antibiotics (P = .51). Based on that observation, the difference in mortality may be due to earlier interventions among patients treated in the specified time frame.
“Patients with lactates drawn within the SEP-1 window received both IV antibiotics and fluids sooner than their counterparts who had lactates drawn outside of the window,” Dr. Han and coauthors explained.
These findings complement prior studies suggesting the benefit of interventions in patients with lactate levels above 2.0 mmol/L, and, conversely, highlight the fact that many patients who meet the severe sepsis criteria nevertheless have normal lactates.
“Although elements of the SEP-1 bundle are useful in managing sepsis, the measure may also lead to an increase in lactate measurements and subsequently excessive utilization of resources on patients who may not benefit,” the researchers wrote.
They reported disclosures related to Philips Healthcare, Laerdal Medical, and Quant HC, among other entities.
SOURCE: Han X et al. Chest. 2018 May 24. doi: 10.1016/j.chest.2018.03.025.
For patients with , findings of a retrospective study show.
Those patients had a longer time to administration of IV fluids (IVF) and antibiotics, researchers reported in the journal Chest®.
In previous studies, delayed antibiotics in patients with sepsis has been associated with increased mortality, wrote Xuan Han, MD, department of medicine, University of Chicago, and coauthors. “Systematic early lactate measurements when a patient presents with sepsis may thus be useful in prompting earlier, potentially life-saving interventions,” they noted.
The retrospective study comprised 5,762 adults admitted to the University of Chicago from November 2008 to January 2016. These patients met criteria for severe sepsis, as outlined in the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1), a quality measure introduced by the Centers for Medicare & Medicaid Services in 2015. The SEP-1 mandates interventions including lactate draws and antibiotics for patients identified as having severe sepsis via clinical and laboratory evaluation, the authors noted.
They found that 60% of these patients had serum lactate measurements drawn within the time window specified in SEP-1. But timelines varied significantly by setting, at just 32% in patients who first met the criteria on the wards, compared with 55% in the ICU, and 79% in the emergency department.
In-hospital mortality was highest in patients with delayed lactate measurements, at 29%, compared with 27% for those with lactates taken within the specified time window, and 23% for patients without lactate samples (P less than .01), the researchers reported.
For patients with initial lactates greater than 2.0 mmol/L, the increase in odds of death was 2% for each hour of delay, while no such increase was noted in patients with initial lactates lower than that threshold.
The increased odds of death in patients with higher initial lactates was significant (odds ratio, 1.02; 95% confidence interval, 1.0003-1.05; P = .04); however, the association was no longer significant when adjusted for time to IVF and antibiotics (P = .51). Based on that observation, the difference in mortality may be due to earlier interventions among patients treated in the specified time frame.
“Patients with lactates drawn within the SEP-1 window received both IV antibiotics and fluids sooner than their counterparts who had lactates drawn outside of the window,” Dr. Han and coauthors explained.
These findings complement prior studies suggesting the benefit of interventions in patients with lactate levels above 2.0 mmol/L, and, conversely, highlight the fact that many patients who meet the severe sepsis criteria nevertheless have normal lactates.
“Although elements of the SEP-1 bundle are useful in managing sepsis, the measure may also lead to an increase in lactate measurements and subsequently excessive utilization of resources on patients who may not benefit,” the researchers wrote.
They reported disclosures related to Philips Healthcare, Laerdal Medical, and Quant HC, among other entities.
SOURCE: Han X et al. Chest. 2018 May 24. doi: 10.1016/j.chest.2018.03.025.
FROM CHEST
Key clinical point: Sepsis patients who have timely lactate measurements have lower mortality risk.
Major finding: Odds of death increased with each hour of delay (odds ratio, 1.02).
Study details: Retrospective study of 5,762 admissions meeting Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) criteria for severe sepsis.
Disclosures: The study authors reported disclosures related to Philips Healthcare, Laerdal Medical, and Quant HC, among other entities.
Source: Han X et al. Chest. 2018 May 24. doi: 10.1016/j.chest.2018.03.025.
Regular skin exams reduced advanced KCs in posttransplant patients
ORLANDO – Annual skin exams reduced the rate of advanced keratinocyte carcinoma (KC) after solid organ transplant by 34%, according to a review of 10,198 transplant patients in Ontario, Canada.
Transplant patients have a far higher risk of KC than the general public because of immunosuppression: A quarter of patients are affected within 5 years. Transplant guidelines have recommended annual skin exams.
Other studies have reported adherence rates of up to 50%, but the numbers were based largely on patient self-report. Instead, the Ontario study used billing codes and other administrative data to get an idea of how many patients actually followed through.
“I would be surprised if other jurisdictions have significantly better rates of adherence,” said lead investigator An-Wen Chan, MD, of the division of dermatology at the University of Toronto and director of a transplant dermatology clinic at the University Health Network.
Part of the problem is that there’s just not a lot of evidence that annual screenings improve KC outcomes, he noted.
To help plug that evidence gap, Dr. Chan and his team reviewed transplant cases in Ontario going back to the mid-1990s; 62% of the patients had kidney transplants, 24% had liver transplants, and the rest had heart or lung transplants. The patients were all aged over 18 years; 60% were white, 15% Asian, 4% black, and the rest unknown. About two-thirds were men.
Adherence to annual dermatology checkups at least 75% of the time was associated with a marked reduction in the development of advanced KC, defined as lesions greater than 2 cm and requiring reconstruction and lymphadenectomy (adjusted hazard ratio, 0.66; 95% CI, 0.48-0.92).
Increasing age at transplant, white race, male sex, and past history of skin cancer were among the factors that were associated with increased risk. There was a trend toward increased risk with liver, lung, and heart transplants, as opposed to kidney transplants. Results were adjusted for demographic, transplant, and other variables.
In short, “adherence to annual dermatology assessments ... reduced KC-related morbidity and death. The highest risk patients were not necessarily the ones that saw their dermatologist annually,” Dr. Chan said.
Rates of adherence varied across transplant sites. It’s probably less of a problem at the University of Toronto, where Dr. Chan is embedded with the transplant team and where he can educate patients and providers on the importance of annual screening and help ensure that it’s done.
“We have a rigorous skin referral policy in place and really target transplant patients to be seen within a year. Having a dermatologist dedicated to transplant dermatology really helps,” he said. The next step is to define the optimal frequency of posttransplant skin cancer screening and to address barriers to screening.
There was no industry funding for the work, and Dr. Chan had no relevant disclosures.
SOURCE: Chan A et al. IID 2018, Abstract 522.
ORLANDO – Annual skin exams reduced the rate of advanced keratinocyte carcinoma (KC) after solid organ transplant by 34%, according to a review of 10,198 transplant patients in Ontario, Canada.
Transplant patients have a far higher risk of KC than the general public because of immunosuppression: A quarter of patients are affected within 5 years. Transplant guidelines have recommended annual skin exams.
Other studies have reported adherence rates of up to 50%, but the numbers were based largely on patient self-report. Instead, the Ontario study used billing codes and other administrative data to get an idea of how many patients actually followed through.
“I would be surprised if other jurisdictions have significantly better rates of adherence,” said lead investigator An-Wen Chan, MD, of the division of dermatology at the University of Toronto and director of a transplant dermatology clinic at the University Health Network.
Part of the problem is that there’s just not a lot of evidence that annual screenings improve KC outcomes, he noted.
To help plug that evidence gap, Dr. Chan and his team reviewed transplant cases in Ontario going back to the mid-1990s; 62% of the patients had kidney transplants, 24% had liver transplants, and the rest had heart or lung transplants. The patients were all aged over 18 years; 60% were white, 15% Asian, 4% black, and the rest unknown. About two-thirds were men.
Adherence to annual dermatology checkups at least 75% of the time was associated with a marked reduction in the development of advanced KC, defined as lesions greater than 2 cm and requiring reconstruction and lymphadenectomy (adjusted hazard ratio, 0.66; 95% CI, 0.48-0.92).
Increasing age at transplant, white race, male sex, and past history of skin cancer were among the factors that were associated with increased risk. There was a trend toward increased risk with liver, lung, and heart transplants, as opposed to kidney transplants. Results were adjusted for demographic, transplant, and other variables.
In short, “adherence to annual dermatology assessments ... reduced KC-related morbidity and death. The highest risk patients were not necessarily the ones that saw their dermatologist annually,” Dr. Chan said.
Rates of adherence varied across transplant sites. It’s probably less of a problem at the University of Toronto, where Dr. Chan is embedded with the transplant team and where he can educate patients and providers on the importance of annual screening and help ensure that it’s done.
“We have a rigorous skin referral policy in place and really target transplant patients to be seen within a year. Having a dermatologist dedicated to transplant dermatology really helps,” he said. The next step is to define the optimal frequency of posttransplant skin cancer screening and to address barriers to screening.
There was no industry funding for the work, and Dr. Chan had no relevant disclosures.
SOURCE: Chan A et al. IID 2018, Abstract 522.
ORLANDO – Annual skin exams reduced the rate of advanced keratinocyte carcinoma (KC) after solid organ transplant by 34%, according to a review of 10,198 transplant patients in Ontario, Canada.
Transplant patients have a far higher risk of KC than the general public because of immunosuppression: A quarter of patients are affected within 5 years. Transplant guidelines have recommended annual skin exams.
Other studies have reported adherence rates of up to 50%, but the numbers were based largely on patient self-report. Instead, the Ontario study used billing codes and other administrative data to get an idea of how many patients actually followed through.
“I would be surprised if other jurisdictions have significantly better rates of adherence,” said lead investigator An-Wen Chan, MD, of the division of dermatology at the University of Toronto and director of a transplant dermatology clinic at the University Health Network.
Part of the problem is that there’s just not a lot of evidence that annual screenings improve KC outcomes, he noted.
To help plug that evidence gap, Dr. Chan and his team reviewed transplant cases in Ontario going back to the mid-1990s; 62% of the patients had kidney transplants, 24% had liver transplants, and the rest had heart or lung transplants. The patients were all aged over 18 years; 60% were white, 15% Asian, 4% black, and the rest unknown. About two-thirds were men.
Adherence to annual dermatology checkups at least 75% of the time was associated with a marked reduction in the development of advanced KC, defined as lesions greater than 2 cm and requiring reconstruction and lymphadenectomy (adjusted hazard ratio, 0.66; 95% CI, 0.48-0.92).
Increasing age at transplant, white race, male sex, and past history of skin cancer were among the factors that were associated with increased risk. There was a trend toward increased risk with liver, lung, and heart transplants, as opposed to kidney transplants. Results were adjusted for demographic, transplant, and other variables.
In short, “adherence to annual dermatology assessments ... reduced KC-related morbidity and death. The highest risk patients were not necessarily the ones that saw their dermatologist annually,” Dr. Chan said.
Rates of adherence varied across transplant sites. It’s probably less of a problem at the University of Toronto, where Dr. Chan is embedded with the transplant team and where he can educate patients and providers on the importance of annual screening and help ensure that it’s done.
“We have a rigorous skin referral policy in place and really target transplant patients to be seen within a year. Having a dermatologist dedicated to transplant dermatology really helps,” he said. The next step is to define the optimal frequency of posttransplant skin cancer screening and to address barriers to screening.
There was no industry funding for the work, and Dr. Chan had no relevant disclosures.
SOURCE: Chan A et al. IID 2018, Abstract 522.
REPORTING FROM IID 2018
Key clinical point: Transplant patients need help to ensure they get annual dermatology checkups.
Major finding: Just 2.1% of the patients in the review had annual exams, and less than half saw a dermatologist even once during an average of 5-years follow-up.
Study details: A review of 10,198 solid organ transplant cases.
Disclosures: There was no industry funding, and the lead investigator had no disclosures.
Source: Chan A et al. IID 2018, Abstract 522