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AJCC Releases Cancer Staging Manual, Eighth Edition
The American Joint Committee on Cancer (AJCC) has released the eighth edition of TNM Cancer Staging Manual, which reflects current understanding of cancer biology concepts and emphasizes a more individualized approach to cancer classification and treatment. This edition presents evidence-based revisions for staging cancer for a number of organ sites and includes the rationales and rules for staging; the definitions of tumor, lymph node involvement, and metastasis; stage groupings; and histologic grade.
Cancer staging provides patients and physicians with the standards for determining the best treatment approach for their disease and their prognosis. Mahul B. Amin, MD, FCAP, Editor-in-Chief of the Eighth Edition, noted that 430 experts from 184 institutions in 22 countries on six continents collaborated to produce this resource. Dr. Amin is professor and chairman emeritus, department of pathology and laboratory medicine, Cedars-Sinai Medical Center, Los Angeles, CA, and incoming chairman and endowed professor of the department of pathology and laboratory medicine at the University of Tennessee Health Sciences Center, Memphis.
Since the Seventh Edition of the manual was published in 2009, researchers and medical practitioners have learned that genomic alterations drive cancer and may vary considerably among tumors that, in the past, were thought to be in the same category, Dr. Amin said.
The American College of Surgeons Commission on Cancer will require accredited hospitals to use the Eighth Edition for all cancer cases diagnosed on or after January 1, 2017. The manual, developed in cooperation with the TNM Committee of the Union for International Cancer Control (UICC), is available for purchase online at http://www.springer.com/us/book/9783319406176.
Find additional information on licensing the content for electronic products at www.cancerstaging.org
The American Joint Committee on Cancer (AJCC) has released the eighth edition of TNM Cancer Staging Manual, which reflects current understanding of cancer biology concepts and emphasizes a more individualized approach to cancer classification and treatment. This edition presents evidence-based revisions for staging cancer for a number of organ sites and includes the rationales and rules for staging; the definitions of tumor, lymph node involvement, and metastasis; stage groupings; and histologic grade.
Cancer staging provides patients and physicians with the standards for determining the best treatment approach for their disease and their prognosis. Mahul B. Amin, MD, FCAP, Editor-in-Chief of the Eighth Edition, noted that 430 experts from 184 institutions in 22 countries on six continents collaborated to produce this resource. Dr. Amin is professor and chairman emeritus, department of pathology and laboratory medicine, Cedars-Sinai Medical Center, Los Angeles, CA, and incoming chairman and endowed professor of the department of pathology and laboratory medicine at the University of Tennessee Health Sciences Center, Memphis.
Since the Seventh Edition of the manual was published in 2009, researchers and medical practitioners have learned that genomic alterations drive cancer and may vary considerably among tumors that, in the past, were thought to be in the same category, Dr. Amin said.
The American College of Surgeons Commission on Cancer will require accredited hospitals to use the Eighth Edition for all cancer cases diagnosed on or after January 1, 2017. The manual, developed in cooperation with the TNM Committee of the Union for International Cancer Control (UICC), is available for purchase online at http://www.springer.com/us/book/9783319406176.
Find additional information on licensing the content for electronic products at www.cancerstaging.org
The American Joint Committee on Cancer (AJCC) has released the eighth edition of TNM Cancer Staging Manual, which reflects current understanding of cancer biology concepts and emphasizes a more individualized approach to cancer classification and treatment. This edition presents evidence-based revisions for staging cancer for a number of organ sites and includes the rationales and rules for staging; the definitions of tumor, lymph node involvement, and metastasis; stage groupings; and histologic grade.
Cancer staging provides patients and physicians with the standards for determining the best treatment approach for their disease and their prognosis. Mahul B. Amin, MD, FCAP, Editor-in-Chief of the Eighth Edition, noted that 430 experts from 184 institutions in 22 countries on six continents collaborated to produce this resource. Dr. Amin is professor and chairman emeritus, department of pathology and laboratory medicine, Cedars-Sinai Medical Center, Los Angeles, CA, and incoming chairman and endowed professor of the department of pathology and laboratory medicine at the University of Tennessee Health Sciences Center, Memphis.
Since the Seventh Edition of the manual was published in 2009, researchers and medical practitioners have learned that genomic alterations drive cancer and may vary considerably among tumors that, in the past, were thought to be in the same category, Dr. Amin said.
The American College of Surgeons Commission on Cancer will require accredited hospitals to use the Eighth Edition for all cancer cases diagnosed on or after January 1, 2017. The manual, developed in cooperation with the TNM Committee of the Union for International Cancer Control (UICC), is available for purchase online at http://www.springer.com/us/book/9783319406176.
Find additional information on licensing the content for electronic products at www.cancerstaging.org
20 Cancer Care facilities receive biannual CoC Outstanding Achievement Award
The Commission on Cancer (CoC) of the American College of Surgeons (ACS) has granted its mid-year 2016 Outstanding Achievement Award (OAA) to a select group of 20 accredited cancer programs throughout the U.S.
Award criteria were based on qualitative and quantitative surveys conducted January 1 through June 30, 2016. The biannual award was established in 2004 to recognize cancer programs that strive for excellence in demonstrating compliance with the CoC standards and are committed to ensuring high-quality cancer care.
A CoC-accredited cancer program is eligible to earn the OAA after completing the accreditation survey and receiving a Performance Report that indicates an accreditation award of “Three-Year with Commendation.” Specifically, the program must receive commendation ratings for the seven commendation level standards and no deficiencies for the remaining 27 standards.
View the list of this year’s first group of OAA recipients on the ACS website at https://www.facs.org/quality-programs/cancer/coc/info/outstanding/2016-part-1.
The Commission on Cancer (CoC) of the American College of Surgeons (ACS) has granted its mid-year 2016 Outstanding Achievement Award (OAA) to a select group of 20 accredited cancer programs throughout the U.S.
Award criteria were based on qualitative and quantitative surveys conducted January 1 through June 30, 2016. The biannual award was established in 2004 to recognize cancer programs that strive for excellence in demonstrating compliance with the CoC standards and are committed to ensuring high-quality cancer care.
A CoC-accredited cancer program is eligible to earn the OAA after completing the accreditation survey and receiving a Performance Report that indicates an accreditation award of “Three-Year with Commendation.” Specifically, the program must receive commendation ratings for the seven commendation level standards and no deficiencies for the remaining 27 standards.
View the list of this year’s first group of OAA recipients on the ACS website at https://www.facs.org/quality-programs/cancer/coc/info/outstanding/2016-part-1.
The Commission on Cancer (CoC) of the American College of Surgeons (ACS) has granted its mid-year 2016 Outstanding Achievement Award (OAA) to a select group of 20 accredited cancer programs throughout the U.S.
Award criteria were based on qualitative and quantitative surveys conducted January 1 through June 30, 2016. The biannual award was established in 2004 to recognize cancer programs that strive for excellence in demonstrating compliance with the CoC standards and are committed to ensuring high-quality cancer care.
A CoC-accredited cancer program is eligible to earn the OAA after completing the accreditation survey and receiving a Performance Report that indicates an accreditation award of “Three-Year with Commendation.” Specifically, the program must receive commendation ratings for the seven commendation level standards and no deficiencies for the remaining 27 standards.
View the list of this year’s first group of OAA recipients on the ACS website at https://www.facs.org/quality-programs/cancer/coc/info/outstanding/2016-part-1.
Travel barriers can impede patient choice for pancreatectomy
AT THE ACS CLINICAL CONGRESS
WASHINGTON – Patients who have the resources to travel to higher-volume hospitals for pancreatectomy have better outcomes than do those who opt to have the surgery in local, small-volume hospitals.
A 10-year review of travel patterns associated with pancreatectomy in California found those who didn’t travel were often elderly, black or Hispanic, and were either self-pay or had public insurance.
“It’s probably because these patients don’t have the resources [finances and transportation] to travel far to the best hospitals for their surgery and have to rely on the closest hospitals for better or for worse – and it seems more like the latter,” he said in an interview at the annual clinical congress of the American College of Surgeons. “So what you see is there is an aspatial barrier to access [limited insurance], as well as spatial barriers to access.”
He and his mentor, David C. Chang, PhD, examined about 13,000 pancreatectomy records included in the California Office of Statewide Health Planning and Development database from 2005 to 2014. The research was conducted at Harvard University and the Massachusetts General Hospital, Boston.
The majority of these patients (11,000) bypassed at least one hospital that offered pancreatectomy to reach their ultimate choice. After bypassing a median of seven facilities, they ended up traveling about 16 miles from home to reach their chosen hospital. Patients who stuck to the closest hospital traveled only about 3 miles.
Generally, bypassers tended to end up in higher-volume hospitals with better outcomes. About half had their pancreatectomy at a hospital that performed more than 20 per year; 40% were at a facility that performed in excess of 40 pancreatectomies annually. Almost 50% of the bypassers also had their surgery at a teaching hospital. The median length of stay at these facilities was 10 days, and they had a median pancreatectomy mortality rate of 3%.
In contrast, patients who didn’t travel ended up at lower-volume hospitals; 60% had their pancreatectomy at a hospital that performed fewer than 10 per year and 22% at a hospital that performed 10-20 per year. Only 18% were treated at an academic center. These hospitals had a significantly longer pancreatectomy length of stay (12 days) and significantly higher pancreatectomy mortality rate (6%).
Older patients were less likely to travel. The age difference came into play beginning at age 50 and grew stronger as patients aged.
Insurance status was highly associated with hospital destination. Privately insured patients were the most likely to travel to better hospitals, followed by those on Medicare. Patients on Medicaid and those who identified as self-pay were significantly less likely to travel. Minorities traveled far less as well; blacks were the least likely to travel from their home base.
In this time of value-based surgical outcomes, the study has some interesting implications, Dr. Fong said. Many health care systems are undertaking a volume pledge, which aims to funnel patients who need high-risk procedures to centers that perform a large number of them annually. But there is a flip side to that coin, which could, in essence, make things even tougher on patients who find travel challenging.
“The Volume Pledge aims to stop hospitals that are low volume in certain procedures from continuing to do them, on the basis that high-volume hospitals often do better in terms of outcomes. But there are very much unintended consequences of the pledge, such as hampering access to surgery. Because inevitably, you’ll increase distance needed to travel for each patient to get care if low-volume hospitals stopped offering their services.”
In his study, Dr. Fong found that some California counties had only one hospital that offered pancreatectomy, and that was a low-volume facility. If that hospital was forced to stop offering the procedure, patients with less resources could face even more obstacles to getting the treatment they need.
“Eliminating [low-volume hospital procedures] will have dire consequences. Our study showed that the elderly, racial/ethnic minorities, uninsured and those on Medicaid generally don’t travel for care, and this pledge may compound on that and widen disparity or even worse, some may not even get care as a result.”
Dr. Fong had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
AT THE ACS CLINICAL CONGRESS
WASHINGTON – Patients who have the resources to travel to higher-volume hospitals for pancreatectomy have better outcomes than do those who opt to have the surgery in local, small-volume hospitals.
A 10-year review of travel patterns associated with pancreatectomy in California found those who didn’t travel were often elderly, black or Hispanic, and were either self-pay or had public insurance.
“It’s probably because these patients don’t have the resources [finances and transportation] to travel far to the best hospitals for their surgery and have to rely on the closest hospitals for better or for worse – and it seems more like the latter,” he said in an interview at the annual clinical congress of the American College of Surgeons. “So what you see is there is an aspatial barrier to access [limited insurance], as well as spatial barriers to access.”
He and his mentor, David C. Chang, PhD, examined about 13,000 pancreatectomy records included in the California Office of Statewide Health Planning and Development database from 2005 to 2014. The research was conducted at Harvard University and the Massachusetts General Hospital, Boston.
The majority of these patients (11,000) bypassed at least one hospital that offered pancreatectomy to reach their ultimate choice. After bypassing a median of seven facilities, they ended up traveling about 16 miles from home to reach their chosen hospital. Patients who stuck to the closest hospital traveled only about 3 miles.
Generally, bypassers tended to end up in higher-volume hospitals with better outcomes. About half had their pancreatectomy at a hospital that performed more than 20 per year; 40% were at a facility that performed in excess of 40 pancreatectomies annually. Almost 50% of the bypassers also had their surgery at a teaching hospital. The median length of stay at these facilities was 10 days, and they had a median pancreatectomy mortality rate of 3%.
In contrast, patients who didn’t travel ended up at lower-volume hospitals; 60% had their pancreatectomy at a hospital that performed fewer than 10 per year and 22% at a hospital that performed 10-20 per year. Only 18% were treated at an academic center. These hospitals had a significantly longer pancreatectomy length of stay (12 days) and significantly higher pancreatectomy mortality rate (6%).
Older patients were less likely to travel. The age difference came into play beginning at age 50 and grew stronger as patients aged.
Insurance status was highly associated with hospital destination. Privately insured patients were the most likely to travel to better hospitals, followed by those on Medicare. Patients on Medicaid and those who identified as self-pay were significantly less likely to travel. Minorities traveled far less as well; blacks were the least likely to travel from their home base.
In this time of value-based surgical outcomes, the study has some interesting implications, Dr. Fong said. Many health care systems are undertaking a volume pledge, which aims to funnel patients who need high-risk procedures to centers that perform a large number of them annually. But there is a flip side to that coin, which could, in essence, make things even tougher on patients who find travel challenging.
“The Volume Pledge aims to stop hospitals that are low volume in certain procedures from continuing to do them, on the basis that high-volume hospitals often do better in terms of outcomes. But there are very much unintended consequences of the pledge, such as hampering access to surgery. Because inevitably, you’ll increase distance needed to travel for each patient to get care if low-volume hospitals stopped offering their services.”
In his study, Dr. Fong found that some California counties had only one hospital that offered pancreatectomy, and that was a low-volume facility. If that hospital was forced to stop offering the procedure, patients with less resources could face even more obstacles to getting the treatment they need.
“Eliminating [low-volume hospital procedures] will have dire consequences. Our study showed that the elderly, racial/ethnic minorities, uninsured and those on Medicaid generally don’t travel for care, and this pledge may compound on that and widen disparity or even worse, some may not even get care as a result.”
Dr. Fong had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
AT THE ACS CLINICAL CONGRESS
WASHINGTON – Patients who have the resources to travel to higher-volume hospitals for pancreatectomy have better outcomes than do those who opt to have the surgery in local, small-volume hospitals.
A 10-year review of travel patterns associated with pancreatectomy in California found those who didn’t travel were often elderly, black or Hispanic, and were either self-pay or had public insurance.
“It’s probably because these patients don’t have the resources [finances and transportation] to travel far to the best hospitals for their surgery and have to rely on the closest hospitals for better or for worse – and it seems more like the latter,” he said in an interview at the annual clinical congress of the American College of Surgeons. “So what you see is there is an aspatial barrier to access [limited insurance], as well as spatial barriers to access.”
He and his mentor, David C. Chang, PhD, examined about 13,000 pancreatectomy records included in the California Office of Statewide Health Planning and Development database from 2005 to 2014. The research was conducted at Harvard University and the Massachusetts General Hospital, Boston.
The majority of these patients (11,000) bypassed at least one hospital that offered pancreatectomy to reach their ultimate choice. After bypassing a median of seven facilities, they ended up traveling about 16 miles from home to reach their chosen hospital. Patients who stuck to the closest hospital traveled only about 3 miles.
Generally, bypassers tended to end up in higher-volume hospitals with better outcomes. About half had their pancreatectomy at a hospital that performed more than 20 per year; 40% were at a facility that performed in excess of 40 pancreatectomies annually. Almost 50% of the bypassers also had their surgery at a teaching hospital. The median length of stay at these facilities was 10 days, and they had a median pancreatectomy mortality rate of 3%.
In contrast, patients who didn’t travel ended up at lower-volume hospitals; 60% had their pancreatectomy at a hospital that performed fewer than 10 per year and 22% at a hospital that performed 10-20 per year. Only 18% were treated at an academic center. These hospitals had a significantly longer pancreatectomy length of stay (12 days) and significantly higher pancreatectomy mortality rate (6%).
Older patients were less likely to travel. The age difference came into play beginning at age 50 and grew stronger as patients aged.
Insurance status was highly associated with hospital destination. Privately insured patients were the most likely to travel to better hospitals, followed by those on Medicare. Patients on Medicaid and those who identified as self-pay were significantly less likely to travel. Minorities traveled far less as well; blacks were the least likely to travel from their home base.
In this time of value-based surgical outcomes, the study has some interesting implications, Dr. Fong said. Many health care systems are undertaking a volume pledge, which aims to funnel patients who need high-risk procedures to centers that perform a large number of them annually. But there is a flip side to that coin, which could, in essence, make things even tougher on patients who find travel challenging.
“The Volume Pledge aims to stop hospitals that are low volume in certain procedures from continuing to do them, on the basis that high-volume hospitals often do better in terms of outcomes. But there are very much unintended consequences of the pledge, such as hampering access to surgery. Because inevitably, you’ll increase distance needed to travel for each patient to get care if low-volume hospitals stopped offering their services.”
In his study, Dr. Fong found that some California counties had only one hospital that offered pancreatectomy, and that was a low-volume facility. If that hospital was forced to stop offering the procedure, patients with less resources could face even more obstacles to getting the treatment they need.
“Eliminating [low-volume hospital procedures] will have dire consequences. Our study showed that the elderly, racial/ethnic minorities, uninsured and those on Medicaid generally don’t travel for care, and this pledge may compound on that and widen disparity or even worse, some may not even get care as a result.”
Dr. Fong had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
Key clinical point:
Major finding: About 60% of patients who didn’t travel had surgery at a low-volume hospital with a higher mortality rate and longer length of stay.
Data source: The 10-year California database review comprised 13,000 patients.
Disclosures: Dr. Fong had no financial disclosures.
Readmissions after bariatric surgery more common among black patients
WASHINGTON – Readmissions after bariatric surgery are significantly higher among black patients than among whites.
The reasons aren’t entirely clear, but since long-term morbidity and mortality are equivalent, they are probably more related to socioeconomics than clinical factors, Matthew Whealon, MD, said at the annual clinical congress of the American College of Surgeons.
“I think they are multifactorial,” said Dr. Whealon of the University of California, Irvine. “Some of it may be related to comorbidities, but other factors could be socioeconomic status, insurance status, access to primary care and follow-up care, even home support systems and patient expectations after surgery. I think it’s incumbent upon us to try and identify some of these risk factors and address them before surgery to reduce this disparity in readmissions.”
Black patients undergoing Roux-en-Y bypass were significantly younger (43 vs. 45 years), and more often women (86% vs. 78%). They also had significantly higher body mass index than did white patients (48 vs. 46 kg/m2). More black individuals had a BMI of 50 kg/m2 or higher.
There were no significant differences in the severity of comorbidities. About 70% of each group had severe comorbidities as classified by the American Anesthesiologists Society risk assessment profile.
However, those comorbidities were different. Among black patients, steroid use, heart failure, hypertension, and end-stage renal disease were significantly more common. Among white patients, chronic obstructive pulmonary disease and bleeding disorders were more common.
There were no differences in 30-day mortality (less than 1% of each group); serious morbidity (3%) or any morbidity (5%); length of stay (2.4 days); or reoperation (2.6%).
However, readmissions were significantly more likely among black patients (8% vs. 5.6%). This translated to a 29% increased risk of readmission (OR 1.29).
Compared to whites, blacks who had a laparoscopic vertical sleeve gastrectomy were also significantly younger (42 vs. 45 years); more often women (87% vs. 76%); and heavier (BMI 47 vs. 45 kg/m2). Again, they were more likely to have a BMI of more than 50 kg/m2 (28% vs. 21%).
Significantly more were in the ASA class 3 of severe comorbidities (70% vs.66%). There were also differences in the comorbidities, with blacks more likely to have heart failure, hypertension, and end-stage renal disease, and whites more likely to have diabetes, smoking, dyspnea, and chronic obstructive pulmonary disease.
Among these patients, 30-day mortality was not different (less than 1%). Serious morbidity was also similar (about 2%), as was any morbidity (about 3%). The reoperation rate was the same (1.2%).
Length of stay was longer among black patients but this was not clinically significant, Dr. Whealon said: It still hovered right around 2 days.
But readmissions were significantly more common among blacks (5% vs. 3%). This difference translated to a 35% increased risk of readmission (odds ratio 1.35).
The nature of the NSQIP data makes it impossible to tease out any other factors that might have contributed to this finding. However, Dr. Whealon said, the equivalent findings on morbidity and mortality are very encouraging and represent a big improvement.
“We have done very well in driving down morbidity and mortality among these patients. Mortality rates are one tenth of what we were seeing a decade ago.”
This change hasn’t been well documented yet because many of the large studies showing racial and ethnic mortality disparities include data drawn from open bariatric surgery, which has been almost completely abandoned in favor of the much safer laparoscopic approaches.
Dr. Whealon had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
WASHINGTON – Readmissions after bariatric surgery are significantly higher among black patients than among whites.
The reasons aren’t entirely clear, but since long-term morbidity and mortality are equivalent, they are probably more related to socioeconomics than clinical factors, Matthew Whealon, MD, said at the annual clinical congress of the American College of Surgeons.
“I think they are multifactorial,” said Dr. Whealon of the University of California, Irvine. “Some of it may be related to comorbidities, but other factors could be socioeconomic status, insurance status, access to primary care and follow-up care, even home support systems and patient expectations after surgery. I think it’s incumbent upon us to try and identify some of these risk factors and address them before surgery to reduce this disparity in readmissions.”
Black patients undergoing Roux-en-Y bypass were significantly younger (43 vs. 45 years), and more often women (86% vs. 78%). They also had significantly higher body mass index than did white patients (48 vs. 46 kg/m2). More black individuals had a BMI of 50 kg/m2 or higher.
There were no significant differences in the severity of comorbidities. About 70% of each group had severe comorbidities as classified by the American Anesthesiologists Society risk assessment profile.
However, those comorbidities were different. Among black patients, steroid use, heart failure, hypertension, and end-stage renal disease were significantly more common. Among white patients, chronic obstructive pulmonary disease and bleeding disorders were more common.
There were no differences in 30-day mortality (less than 1% of each group); serious morbidity (3%) or any morbidity (5%); length of stay (2.4 days); or reoperation (2.6%).
However, readmissions were significantly more likely among black patients (8% vs. 5.6%). This translated to a 29% increased risk of readmission (OR 1.29).
Compared to whites, blacks who had a laparoscopic vertical sleeve gastrectomy were also significantly younger (42 vs. 45 years); more often women (87% vs. 76%); and heavier (BMI 47 vs. 45 kg/m2). Again, they were more likely to have a BMI of more than 50 kg/m2 (28% vs. 21%).
Significantly more were in the ASA class 3 of severe comorbidities (70% vs.66%). There were also differences in the comorbidities, with blacks more likely to have heart failure, hypertension, and end-stage renal disease, and whites more likely to have diabetes, smoking, dyspnea, and chronic obstructive pulmonary disease.
Among these patients, 30-day mortality was not different (less than 1%). Serious morbidity was also similar (about 2%), as was any morbidity (about 3%). The reoperation rate was the same (1.2%).
Length of stay was longer among black patients but this was not clinically significant, Dr. Whealon said: It still hovered right around 2 days.
But readmissions were significantly more common among blacks (5% vs. 3%). This difference translated to a 35% increased risk of readmission (odds ratio 1.35).
The nature of the NSQIP data makes it impossible to tease out any other factors that might have contributed to this finding. However, Dr. Whealon said, the equivalent findings on morbidity and mortality are very encouraging and represent a big improvement.
“We have done very well in driving down morbidity and mortality among these patients. Mortality rates are one tenth of what we were seeing a decade ago.”
This change hasn’t been well documented yet because many of the large studies showing racial and ethnic mortality disparities include data drawn from open bariatric surgery, which has been almost completely abandoned in favor of the much safer laparoscopic approaches.
Dr. Whealon had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
WASHINGTON – Readmissions after bariatric surgery are significantly higher among black patients than among whites.
The reasons aren’t entirely clear, but since long-term morbidity and mortality are equivalent, they are probably more related to socioeconomics than clinical factors, Matthew Whealon, MD, said at the annual clinical congress of the American College of Surgeons.
“I think they are multifactorial,” said Dr. Whealon of the University of California, Irvine. “Some of it may be related to comorbidities, but other factors could be socioeconomic status, insurance status, access to primary care and follow-up care, even home support systems and patient expectations after surgery. I think it’s incumbent upon us to try and identify some of these risk factors and address them before surgery to reduce this disparity in readmissions.”
Black patients undergoing Roux-en-Y bypass were significantly younger (43 vs. 45 years), and more often women (86% vs. 78%). They also had significantly higher body mass index than did white patients (48 vs. 46 kg/m2). More black individuals had a BMI of 50 kg/m2 or higher.
There were no significant differences in the severity of comorbidities. About 70% of each group had severe comorbidities as classified by the American Anesthesiologists Society risk assessment profile.
However, those comorbidities were different. Among black patients, steroid use, heart failure, hypertension, and end-stage renal disease were significantly more common. Among white patients, chronic obstructive pulmonary disease and bleeding disorders were more common.
There were no differences in 30-day mortality (less than 1% of each group); serious morbidity (3%) or any morbidity (5%); length of stay (2.4 days); or reoperation (2.6%).
However, readmissions were significantly more likely among black patients (8% vs. 5.6%). This translated to a 29% increased risk of readmission (OR 1.29).
Compared to whites, blacks who had a laparoscopic vertical sleeve gastrectomy were also significantly younger (42 vs. 45 years); more often women (87% vs. 76%); and heavier (BMI 47 vs. 45 kg/m2). Again, they were more likely to have a BMI of more than 50 kg/m2 (28% vs. 21%).
Significantly more were in the ASA class 3 of severe comorbidities (70% vs.66%). There were also differences in the comorbidities, with blacks more likely to have heart failure, hypertension, and end-stage renal disease, and whites more likely to have diabetes, smoking, dyspnea, and chronic obstructive pulmonary disease.
Among these patients, 30-day mortality was not different (less than 1%). Serious morbidity was also similar (about 2%), as was any morbidity (about 3%). The reoperation rate was the same (1.2%).
Length of stay was longer among black patients but this was not clinically significant, Dr. Whealon said: It still hovered right around 2 days.
But readmissions were significantly more common among blacks (5% vs. 3%). This difference translated to a 35% increased risk of readmission (odds ratio 1.35).
The nature of the NSQIP data makes it impossible to tease out any other factors that might have contributed to this finding. However, Dr. Whealon said, the equivalent findings on morbidity and mortality are very encouraging and represent a big improvement.
“We have done very well in driving down morbidity and mortality among these patients. Mortality rates are one tenth of what we were seeing a decade ago.”
This change hasn’t been well documented yet because many of the large studies showing racial and ethnic mortality disparities include data drawn from open bariatric surgery, which has been almost completely abandoned in favor of the much safer laparoscopic approaches.
Dr. Whealon had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: Black patients were 29% more likely to be readmitted after Roux-en-Y and 35% more likely to be readmitted after sleeve gastrectomy.
Data source: The NSQIP database review comprised about 62,000 surgeries.
Disclosures: Dr. Whealon had no financial disclosures.
Robotic surgery instruments ‘virtually impossible’ to clean completely
Instruments used for robotic surgery are “virtually impossible” to clean completely, according to a report published in Infection Control & Hospital Epidemiology.
“A new standard for the cleaning of complex surgical instruments needs to be established, especially for those used in robotic surgery,” wrote Yuhei Saito of the surgical center at the University of Tokyo Hospital and associates.
They assessed the residual contamination of both robotic and regular surgical instruments at their medical center because “hospital staff in central sterile supply departments are troubled by the reprocessing of robotic instruments because they cannot be disassembled for cleaning like other endoscopic instruments. Their complex structure impairs brushing the inner surface of narrow lumens, resulting in failure to [completely] remove contaminants,” the researchers wrote.
In the first phase of the study, the researchers examined 41 instruments immediately after they were used in robotic surgery (7 radical prostatectomies and 2 anterior resections of the rectum) and 27 regular instruments immediately after they were used for open surgery (gastrectomy and colectomy). The robotic instruments were contaminated with 72.3 × 103 mcg of protein each, compared with 5.5 × 103 mcg of protein on the regular instruments, the investigators reported (Infect Control Hosp Epidemiol. 2016 Oct 31. doi: 10.1017/ice.2016.249).
In the second phase of the study, the researchers examined another 24 robotic instruments and 40 regular instruments after they were used in surgery and then cleaned according to the manufacturers’ instructions three successive times. For the robotic instruments, this involved manually brushing the outer surface while moving the instrument “wrists” through their full range of motion, followed by 15 minutes of ultrasonication with enzymatic detergent, flushing the lumen with a water gun through flush ports, and rinsing the entire instrument. For regular instruments, cleaning involved washer-disinfectors and included 5 minutes of ultrasonication, 10 minutes of spraying with an alkaline detergent, and 10 minutes of disinfection via heating.
The level of contamination declined with each successive cleaning but still remained comparatively high for the robotic instruments. The amount of protein contaminants released in the three cleanings was 650, 550, and 530 mcg per robotic instrument, compared with 16, 17, and 17 mcg per ordinary instrument.
The efficacy of cleaning was 97.6% for robotic instruments and 99.1% for regular instruments, the researchers reported.
This study was not designed to assess whether residual contamination is associated with adverse events such as infection in subsequent patients, and there are few data available on this topic.
“We have to recognize that there might be a considerable volume of insufficient cleaning or occult surgical site infections,” the investigators wrote.
New instrument washers equipped with a specific cleaning function for narrow lumens are becoming available, they noted, and “further study should be conducted using these washers with improved cleaning efficacy.”
The study was supported by the Japan Society for the Promotion of Science. The investigators reported having no relevant financial disclosures.
Instruments used for robotic surgery are “virtually impossible” to clean completely, according to a report published in Infection Control & Hospital Epidemiology.
“A new standard for the cleaning of complex surgical instruments needs to be established, especially for those used in robotic surgery,” wrote Yuhei Saito of the surgical center at the University of Tokyo Hospital and associates.
They assessed the residual contamination of both robotic and regular surgical instruments at their medical center because “hospital staff in central sterile supply departments are troubled by the reprocessing of robotic instruments because they cannot be disassembled for cleaning like other endoscopic instruments. Their complex structure impairs brushing the inner surface of narrow lumens, resulting in failure to [completely] remove contaminants,” the researchers wrote.
In the first phase of the study, the researchers examined 41 instruments immediately after they were used in robotic surgery (7 radical prostatectomies and 2 anterior resections of the rectum) and 27 regular instruments immediately after they were used for open surgery (gastrectomy and colectomy). The robotic instruments were contaminated with 72.3 × 103 mcg of protein each, compared with 5.5 × 103 mcg of protein on the regular instruments, the investigators reported (Infect Control Hosp Epidemiol. 2016 Oct 31. doi: 10.1017/ice.2016.249).
In the second phase of the study, the researchers examined another 24 robotic instruments and 40 regular instruments after they were used in surgery and then cleaned according to the manufacturers’ instructions three successive times. For the robotic instruments, this involved manually brushing the outer surface while moving the instrument “wrists” through their full range of motion, followed by 15 minutes of ultrasonication with enzymatic detergent, flushing the lumen with a water gun through flush ports, and rinsing the entire instrument. For regular instruments, cleaning involved washer-disinfectors and included 5 minutes of ultrasonication, 10 minutes of spraying with an alkaline detergent, and 10 minutes of disinfection via heating.
The level of contamination declined with each successive cleaning but still remained comparatively high for the robotic instruments. The amount of protein contaminants released in the three cleanings was 650, 550, and 530 mcg per robotic instrument, compared with 16, 17, and 17 mcg per ordinary instrument.
The efficacy of cleaning was 97.6% for robotic instruments and 99.1% for regular instruments, the researchers reported.
This study was not designed to assess whether residual contamination is associated with adverse events such as infection in subsequent patients, and there are few data available on this topic.
“We have to recognize that there might be a considerable volume of insufficient cleaning or occult surgical site infections,” the investigators wrote.
New instrument washers equipped with a specific cleaning function for narrow lumens are becoming available, they noted, and “further study should be conducted using these washers with improved cleaning efficacy.”
The study was supported by the Japan Society for the Promotion of Science. The investigators reported having no relevant financial disclosures.
Instruments used for robotic surgery are “virtually impossible” to clean completely, according to a report published in Infection Control & Hospital Epidemiology.
“A new standard for the cleaning of complex surgical instruments needs to be established, especially for those used in robotic surgery,” wrote Yuhei Saito of the surgical center at the University of Tokyo Hospital and associates.
They assessed the residual contamination of both robotic and regular surgical instruments at their medical center because “hospital staff in central sterile supply departments are troubled by the reprocessing of robotic instruments because they cannot be disassembled for cleaning like other endoscopic instruments. Their complex structure impairs brushing the inner surface of narrow lumens, resulting in failure to [completely] remove contaminants,” the researchers wrote.
In the first phase of the study, the researchers examined 41 instruments immediately after they were used in robotic surgery (7 radical prostatectomies and 2 anterior resections of the rectum) and 27 regular instruments immediately after they were used for open surgery (gastrectomy and colectomy). The robotic instruments were contaminated with 72.3 × 103 mcg of protein each, compared with 5.5 × 103 mcg of protein on the regular instruments, the investigators reported (Infect Control Hosp Epidemiol. 2016 Oct 31. doi: 10.1017/ice.2016.249).
In the second phase of the study, the researchers examined another 24 robotic instruments and 40 regular instruments after they were used in surgery and then cleaned according to the manufacturers’ instructions three successive times. For the robotic instruments, this involved manually brushing the outer surface while moving the instrument “wrists” through their full range of motion, followed by 15 minutes of ultrasonication with enzymatic detergent, flushing the lumen with a water gun through flush ports, and rinsing the entire instrument. For regular instruments, cleaning involved washer-disinfectors and included 5 minutes of ultrasonication, 10 minutes of spraying with an alkaline detergent, and 10 minutes of disinfection via heating.
The level of contamination declined with each successive cleaning but still remained comparatively high for the robotic instruments. The amount of protein contaminants released in the three cleanings was 650, 550, and 530 mcg per robotic instrument, compared with 16, 17, and 17 mcg per ordinary instrument.
The efficacy of cleaning was 97.6% for robotic instruments and 99.1% for regular instruments, the researchers reported.
This study was not designed to assess whether residual contamination is associated with adverse events such as infection in subsequent patients, and there are few data available on this topic.
“We have to recognize that there might be a considerable volume of insufficient cleaning or occult surgical site infections,” the investigators wrote.
New instrument washers equipped with a specific cleaning function for narrow lumens are becoming available, they noted, and “further study should be conducted using these washers with improved cleaning efficacy.”
The study was supported by the Japan Society for the Promotion of Science. The investigators reported having no relevant financial disclosures.
FROM INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY
Key clinical point:
Major finding: Immediately after surgery, robotic instruments were contaminated with 72.3 × 103 mcg of protein each, compared with 5.5 × 103 mcg of protein on regular instruments.
Data source: A single-center analysis of protein contamination before and after three successive cleanings on 65 instruments used for robotic surgery and 67 regular instruments used for open surgery.
Disclosures: This study was supported by the Japan Society for the Promotion of Science. The investigators reported having no relevant financial disclosures.
Long-term opioid use uncommon among trauma patients
WASHINGTON – Patients with traumatic injuries don’t appear to be at undue risk of sustained opioid use, a large database review has demonstrated.
More than half of the 13,000 patients in the study were discharged on opioids, but they were able to discontinue them fairly rapidly, Muhammad Chaudhary, MD, said at the annual clinical congress of the American College of Surgeons. Within 3 months, less than one-third were still using the drugs, and 1 year later, only 1% were still taking an opioid pain medication.
Dr. Chaudhary examined opioid use among 13,624 patients included in the Tricare military insurance database. The patients were treated for traumatic injuries they received during 2007-2013. Most of the patients were men (82%), and the largest age group was 18- to 24-year-olds (39%). Military rank was used as a proxy for socioeconomic status in this study: 15% of the cohort had an officer rank, while the rest were junior or senior enlisted personnel.
The group was very healthy, with a median Charlson Comorbidity Index score of 0. They were somewhat seriously injured, however. The median Injury Severity Score was 13, and the range was 9-17. Anxiety and depression were uncommon (9% and 7%, respectively).
More than half the patients (54%) were discharged on an opioid medication. That percentage dropped very rapidly. By 90 days after discharge, just 9% of patients were still taking the drugs. By 1 year, only 1% were using opioids.
Dr. Chaudhary conducted a multivariate analysis that controlled for a number of factors, including age, gender, marital status, rank, mental health status, injury severity, comorbidities, and treatment environment. Two factors – black race and younger age (18-24 years) – significantly increased the likelihood of early opioid discontinuation (8% and 11%, respectively). There were no significant interactions with anxiety or depression.
Junior enlisted personnel – the proxy group for lower socioeconomic status – and those with a prolonged length of stay were significantly less likely to get off the medications, Dr. Chaudhary said.
“While we strongly believe that these factors should not be used to determine who can get opioids, it might make sense to enhance perioperative surveillance and engage pain management services early on in patients with risk factors, to reduce the risk of sustained opioid use,” he concluded.
Dr. Chaudhary had no financial disclosures.
[email protected]
On Twitter @alz_gal
WASHINGTON – Patients with traumatic injuries don’t appear to be at undue risk of sustained opioid use, a large database review has demonstrated.
More than half of the 13,000 patients in the study were discharged on opioids, but they were able to discontinue them fairly rapidly, Muhammad Chaudhary, MD, said at the annual clinical congress of the American College of Surgeons. Within 3 months, less than one-third were still using the drugs, and 1 year later, only 1% were still taking an opioid pain medication.
Dr. Chaudhary examined opioid use among 13,624 patients included in the Tricare military insurance database. The patients were treated for traumatic injuries they received during 2007-2013. Most of the patients were men (82%), and the largest age group was 18- to 24-year-olds (39%). Military rank was used as a proxy for socioeconomic status in this study: 15% of the cohort had an officer rank, while the rest were junior or senior enlisted personnel.
The group was very healthy, with a median Charlson Comorbidity Index score of 0. They were somewhat seriously injured, however. The median Injury Severity Score was 13, and the range was 9-17. Anxiety and depression were uncommon (9% and 7%, respectively).
More than half the patients (54%) were discharged on an opioid medication. That percentage dropped very rapidly. By 90 days after discharge, just 9% of patients were still taking the drugs. By 1 year, only 1% were using opioids.
Dr. Chaudhary conducted a multivariate analysis that controlled for a number of factors, including age, gender, marital status, rank, mental health status, injury severity, comorbidities, and treatment environment. Two factors – black race and younger age (18-24 years) – significantly increased the likelihood of early opioid discontinuation (8% and 11%, respectively). There were no significant interactions with anxiety or depression.
Junior enlisted personnel – the proxy group for lower socioeconomic status – and those with a prolonged length of stay were significantly less likely to get off the medications, Dr. Chaudhary said.
“While we strongly believe that these factors should not be used to determine who can get opioids, it might make sense to enhance perioperative surveillance and engage pain management services early on in patients with risk factors, to reduce the risk of sustained opioid use,” he concluded.
Dr. Chaudhary had no financial disclosures.
[email protected]
On Twitter @alz_gal
WASHINGTON – Patients with traumatic injuries don’t appear to be at undue risk of sustained opioid use, a large database review has demonstrated.
More than half of the 13,000 patients in the study were discharged on opioids, but they were able to discontinue them fairly rapidly, Muhammad Chaudhary, MD, said at the annual clinical congress of the American College of Surgeons. Within 3 months, less than one-third were still using the drugs, and 1 year later, only 1% were still taking an opioid pain medication.
Dr. Chaudhary examined opioid use among 13,624 patients included in the Tricare military insurance database. The patients were treated for traumatic injuries they received during 2007-2013. Most of the patients were men (82%), and the largest age group was 18- to 24-year-olds (39%). Military rank was used as a proxy for socioeconomic status in this study: 15% of the cohort had an officer rank, while the rest were junior or senior enlisted personnel.
The group was very healthy, with a median Charlson Comorbidity Index score of 0. They were somewhat seriously injured, however. The median Injury Severity Score was 13, and the range was 9-17. Anxiety and depression were uncommon (9% and 7%, respectively).
More than half the patients (54%) were discharged on an opioid medication. That percentage dropped very rapidly. By 90 days after discharge, just 9% of patients were still taking the drugs. By 1 year, only 1% were using opioids.
Dr. Chaudhary conducted a multivariate analysis that controlled for a number of factors, including age, gender, marital status, rank, mental health status, injury severity, comorbidities, and treatment environment. Two factors – black race and younger age (18-24 years) – significantly increased the likelihood of early opioid discontinuation (8% and 11%, respectively). There were no significant interactions with anxiety or depression.
Junior enlisted personnel – the proxy group for lower socioeconomic status – and those with a prolonged length of stay were significantly less likely to get off the medications, Dr. Chaudhary said.
“While we strongly believe that these factors should not be used to determine who can get opioids, it might make sense to enhance perioperative surveillance and engage pain management services early on in patients with risk factors, to reduce the risk of sustained opioid use,” he concluded.
Dr. Chaudhary had no financial disclosures.
[email protected]
On Twitter @alz_gal
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: A year after discharge, only 1% of the patients were still using a prescription opioid pain medication.
Data source: A database review including 13,642 patients.
Disclosures: Dr. Chaudhary had no financial disclosures.
Hypotension ‘dose’ drives mortality in traumatic brain injury
NEW ORLEANS – The severity and duration of hypotension in traumatic brain injury patients during EMS transport to an emergency department has a tight and essentially linear relationship to their mortality rate during subsequent weeks of recovery, according to an analysis of more than 7,500 brain-injured patients.
For each doubling of the combined severity and duration of hypotension during the prehospital period, when systolic blood pressure was less than 90 mm Hg, patient mortality rose by 19%, Daniel W. Spaite, MD, reported at the American Heart Association scientific sessions.
However, the results do not address whether aggressive treatment of hypotension by EMS technicians in a patient with traumatic brain injury (TBI) leads to reduced mortality. That question is being assessed as part of the primary endpoint of the Excellence in Prehospital Injury Care-Traumatic Brain Injury (EPIC-TBI) study, which should have an answer by the end of 2017, said Dr. Spaite, professor of emergency medicine at the University of Arizona in Tuscon.
The innovation introduced by Dr. Spaite and his associates in their analysis of the EPIC-TBI data was to drill down into each patient’s hypotensive event, made possible by the 16,711 patients enrolled in EPIC-TBI.
The calculation they performed was limited to patients with EMS records of at least two blood pressure measurements during prehospital transport. These data allowed them to use both the extent to which systolic blood pressure dropped below 90 mm Hg and the amount of time pressure was below this threshold to better define the total hypotension exposure each patient received.
This meant that a TBI patient with a systolic pressure of 80 mm Hg for 10 minutes had twice the hypotension exposure of both a patient with a pressure of 85 mm Hg for 10 minutes, and a patient with a pressure of 80 mm Hg for 5 minutes.
Their analysis also adjusted the relationship of this total hypotensive dose and subsequent mortality based on several baseline demographic and clinical variables, including age, sex, injury severity, trauma type, and head-region severity score. After adjustment, the researchers found a “strikingly linear relationship” between hypotension dose and mortality, Dr. Spaite said, although a clear dose-response relationship was also evident in the unadjusted data.
EPIC-TBI enrolled TBI patients age 10 years or older during 2007-2014 through participation by dozens of EMS providers throughout Arizona. For the current analysis, the researchers identified 7,521 patients from the total group who had at least two blood pressure measurements taken during their prehospital EMS care and also met other inclusion criteria.
The best way to manage hypotension in TBI patients during the prehospital period remains unclear. Simply raising blood pressure with fluid infusion may not necessarily help, because it could exacerbate a patient’s bleeding, Dr. Spaite noted during an interview.
The primary goal of EPIC-TBI is to assess the impact of the third edition of the traumatic brain injury guidelines released in 2007 by the Brain Trauma Foundation. (The fourth edition of these guidelines came out in August 2016.) The new finding by Dr. Spaite and his associates will allow the full EPIC-TBI analysis to correlate patient outcomes with the impact that acute, prehospital treatment had on the hypotension dose received by each patient, he noted.
“What’s remarkable is that the single, prehospital parameter of hypotension for just a few minutes during transport can have such a strong impact on survival, given all the other factors that can influence outcomes” in TBI patients once they reach a hospital and during the period they remain hospitalized, Dr. Spaite said.
[email protected] On Twitter @mitchelzoler
NEW ORLEANS – The severity and duration of hypotension in traumatic brain injury patients during EMS transport to an emergency department has a tight and essentially linear relationship to their mortality rate during subsequent weeks of recovery, according to an analysis of more than 7,500 brain-injured patients.
For each doubling of the combined severity and duration of hypotension during the prehospital period, when systolic blood pressure was less than 90 mm Hg, patient mortality rose by 19%, Daniel W. Spaite, MD, reported at the American Heart Association scientific sessions.
However, the results do not address whether aggressive treatment of hypotension by EMS technicians in a patient with traumatic brain injury (TBI) leads to reduced mortality. That question is being assessed as part of the primary endpoint of the Excellence in Prehospital Injury Care-Traumatic Brain Injury (EPIC-TBI) study, which should have an answer by the end of 2017, said Dr. Spaite, professor of emergency medicine at the University of Arizona in Tuscon.
The innovation introduced by Dr. Spaite and his associates in their analysis of the EPIC-TBI data was to drill down into each patient’s hypotensive event, made possible by the 16,711 patients enrolled in EPIC-TBI.
The calculation they performed was limited to patients with EMS records of at least two blood pressure measurements during prehospital transport. These data allowed them to use both the extent to which systolic blood pressure dropped below 90 mm Hg and the amount of time pressure was below this threshold to better define the total hypotension exposure each patient received.
This meant that a TBI patient with a systolic pressure of 80 mm Hg for 10 minutes had twice the hypotension exposure of both a patient with a pressure of 85 mm Hg for 10 minutes, and a patient with a pressure of 80 mm Hg for 5 minutes.
Their analysis also adjusted the relationship of this total hypotensive dose and subsequent mortality based on several baseline demographic and clinical variables, including age, sex, injury severity, trauma type, and head-region severity score. After adjustment, the researchers found a “strikingly linear relationship” between hypotension dose and mortality, Dr. Spaite said, although a clear dose-response relationship was also evident in the unadjusted data.
EPIC-TBI enrolled TBI patients age 10 years or older during 2007-2014 through participation by dozens of EMS providers throughout Arizona. For the current analysis, the researchers identified 7,521 patients from the total group who had at least two blood pressure measurements taken during their prehospital EMS care and also met other inclusion criteria.
The best way to manage hypotension in TBI patients during the prehospital period remains unclear. Simply raising blood pressure with fluid infusion may not necessarily help, because it could exacerbate a patient’s bleeding, Dr. Spaite noted during an interview.
The primary goal of EPIC-TBI is to assess the impact of the third edition of the traumatic brain injury guidelines released in 2007 by the Brain Trauma Foundation. (The fourth edition of these guidelines came out in August 2016.) The new finding by Dr. Spaite and his associates will allow the full EPIC-TBI analysis to correlate patient outcomes with the impact that acute, prehospital treatment had on the hypotension dose received by each patient, he noted.
“What’s remarkable is that the single, prehospital parameter of hypotension for just a few minutes during transport can have such a strong impact on survival, given all the other factors that can influence outcomes” in TBI patients once they reach a hospital and during the period they remain hospitalized, Dr. Spaite said.
[email protected] On Twitter @mitchelzoler
NEW ORLEANS – The severity and duration of hypotension in traumatic brain injury patients during EMS transport to an emergency department has a tight and essentially linear relationship to their mortality rate during subsequent weeks of recovery, according to an analysis of more than 7,500 brain-injured patients.
For each doubling of the combined severity and duration of hypotension during the prehospital period, when systolic blood pressure was less than 90 mm Hg, patient mortality rose by 19%, Daniel W. Spaite, MD, reported at the American Heart Association scientific sessions.
However, the results do not address whether aggressive treatment of hypotension by EMS technicians in a patient with traumatic brain injury (TBI) leads to reduced mortality. That question is being assessed as part of the primary endpoint of the Excellence in Prehospital Injury Care-Traumatic Brain Injury (EPIC-TBI) study, which should have an answer by the end of 2017, said Dr. Spaite, professor of emergency medicine at the University of Arizona in Tuscon.
The innovation introduced by Dr. Spaite and his associates in their analysis of the EPIC-TBI data was to drill down into each patient’s hypotensive event, made possible by the 16,711 patients enrolled in EPIC-TBI.
The calculation they performed was limited to patients with EMS records of at least two blood pressure measurements during prehospital transport. These data allowed them to use both the extent to which systolic blood pressure dropped below 90 mm Hg and the amount of time pressure was below this threshold to better define the total hypotension exposure each patient received.
This meant that a TBI patient with a systolic pressure of 80 mm Hg for 10 minutes had twice the hypotension exposure of both a patient with a pressure of 85 mm Hg for 10 minutes, and a patient with a pressure of 80 mm Hg for 5 minutes.
Their analysis also adjusted the relationship of this total hypotensive dose and subsequent mortality based on several baseline demographic and clinical variables, including age, sex, injury severity, trauma type, and head-region severity score. After adjustment, the researchers found a “strikingly linear relationship” between hypotension dose and mortality, Dr. Spaite said, although a clear dose-response relationship was also evident in the unadjusted data.
EPIC-TBI enrolled TBI patients age 10 years or older during 2007-2014 through participation by dozens of EMS providers throughout Arizona. For the current analysis, the researchers identified 7,521 patients from the total group who had at least two blood pressure measurements taken during their prehospital EMS care and also met other inclusion criteria.
The best way to manage hypotension in TBI patients during the prehospital period remains unclear. Simply raising blood pressure with fluid infusion may not necessarily help, because it could exacerbate a patient’s bleeding, Dr. Spaite noted during an interview.
The primary goal of EPIC-TBI is to assess the impact of the third edition of the traumatic brain injury guidelines released in 2007 by the Brain Trauma Foundation. (The fourth edition of these guidelines came out in August 2016.) The new finding by Dr. Spaite and his associates will allow the full EPIC-TBI analysis to correlate patient outcomes with the impact that acute, prehospital treatment had on the hypotension dose received by each patient, he noted.
“What’s remarkable is that the single, prehospital parameter of hypotension for just a few minutes during transport can have such a strong impact on survival, given all the other factors that can influence outcomes” in TBI patients once they reach a hospital and during the period they remain hospitalized, Dr. Spaite said.
[email protected] On Twitter @mitchelzoler
Key clinical point:
Major finding: For each doubling of the dose of prehospital hypotension (a function of severity and duration), mortality rose by 19%.
Data source: EPIC-TBI, a multicenter study with 16,711 patients, including 7,521 who met inclusion criteria for the current analysis.
Disclosures: Dr. Spaite had no disclosures.
Infectious disease physicians: Antibiotic shortages are the new norm
NEW ORLEANS – Antibiotic shortages reported by the Emerging Infections Network (EIN) in 2011 persist in 2016, according to a web-based follow-up survey of infectious disease physicians.
Of 701 network members who responded to the EIN survey in early 2016, 70% reported needing to modify their antimicrobial choice because of a shortage in the past 2 years. They did so by using broader-spectrum agents (75% of respondents), more costly agents (58%), less effective second-line agents (45%), and more toxic agents (37%), Adi Gundlapalli, MD, PhD, reported at an annual scientific meeting on infectious diseases.
In addition, 73% of respondents reported that the shortages affected patient care or outcomes, reported Dr. Gundlapalli of the University of Utah, Salt Lake City.
The percentage of respondents reporting adverse patient outcomes related to shortages increased from 2011 to 2016 (51% vs.73%), he noted at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The top 10 antimicrobials they reported as being in short supply were piperacillin-tazobactam, ampicillin-sulbactam, meropenem, cefotaxime, cefepime, trimethoprim-sulfamethoxazole (TMP-SMX), doxycycline, imipenem, acyclovir, and amikacin. TMP-SMX and acyclovir were in short supply at both time points.
The most common ways respondents reported learning about drug shortages were from hospital notification (76%), from a colleague (56%), from a pharmacy that contacted them regarding a prescription for the agent (53%), or from the Food and Drug Administration website or another website on shortages (23%). The most common ways of learning about a shortage changed – from notification after trying to prescribe a drug in 2011, to proactive hospital/system (local) notification in 2016; 71% of respondents said that communications in 2016 were sufficient.
Most respondents (83%) reported that guidelines for dealing with shortages had been developed by an antimicrobial stewardship program (ASP) at their institution.
“This, I think, is one of the highlight results,” said Dr. Gundlapalli, who is also a staff physician at the VA Salt Lake City Health System. “In 2011, we had no specific question or comments received about [ASPs], and here in 2016, 83% of respondents’ institutions had developed guidelines related to drug shortages.”
Respondents also had the opportunity to submit free-text responses, and among the themes that emerged was concern regarding toxicity and adverse outcomes associated with increased use of aminoglycosides because of the shortage of piperacillin-tazobactam. Another – described as a blessing in disguise – was the shortage of meropenem, which led one ASP to “institute restrictions on its use, which have continued,” he said.
“Another theme was ‘simpler agents seem more likely to be in shortage,’ ” Dr. Gundlapalli said, noting ampicillin-sulbactam in 2016 and Pen-G as examples.
“And then, of course, the other theme across the board ... was our new asset,” he said, explaining that some respondents commented on the value of ASP pharmacists and programs to help with drug shortage issues.
The overall theme of this follow-up survey, in the context of prior surveys in 2001 and 2011, is that antibiotic shortages are the “new normal – a way of life,” Dr. Gundlapalli said.
“The concerns do persist, and we feel there is further work to be done here,” he said. He specifically noted that there is a need to inform and educate fellows and colleagues in hospitals, increase awareness generally, improve communication strategies, and conduct detailed studies on adverse effects and outcomes.
“And now, since ASPs are very pervasive ... maybe it’s time to formalize and delineate the role of ASPs in antimicrobial shortages,” he said.
The problem of antibiotic shortages “harkens back to the day when penicillin was recycled in the urine [of soldiers in World War II] to save this very scarce resource ... but that’s a very extreme measure to take,” noted Donald Graham, MD, of the Springfield (Ill.) Clinic, one of the study’s coauthors. “It seems like it’s time for the other federal arm – namely, the Food and Drug Administration – to do something about this.”
Dr. Graham said he believes the problem is in part because of economics, and in part because of “the higher standards that the FDA imposes upon these manufacturing concerns.” These drugs often are low-profit items, and it isn’t always in the financial best interest of a pharmaceutical company to upgrade their facilities.
“But they really have to recognize the importance of having availability of these simple agents,” he said, pleading with any FDA representatives in the audience to “maybe think about some of these very high standards.”
Dr. Gundlapalli reported having no disclosures. Dr. Graham disclosed relationships with Astellas and Theravance Biopharma.
NEW ORLEANS – Antibiotic shortages reported by the Emerging Infections Network (EIN) in 2011 persist in 2016, according to a web-based follow-up survey of infectious disease physicians.
Of 701 network members who responded to the EIN survey in early 2016, 70% reported needing to modify their antimicrobial choice because of a shortage in the past 2 years. They did so by using broader-spectrum agents (75% of respondents), more costly agents (58%), less effective second-line agents (45%), and more toxic agents (37%), Adi Gundlapalli, MD, PhD, reported at an annual scientific meeting on infectious diseases.
In addition, 73% of respondents reported that the shortages affected patient care or outcomes, reported Dr. Gundlapalli of the University of Utah, Salt Lake City.
The percentage of respondents reporting adverse patient outcomes related to shortages increased from 2011 to 2016 (51% vs.73%), he noted at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The top 10 antimicrobials they reported as being in short supply were piperacillin-tazobactam, ampicillin-sulbactam, meropenem, cefotaxime, cefepime, trimethoprim-sulfamethoxazole (TMP-SMX), doxycycline, imipenem, acyclovir, and amikacin. TMP-SMX and acyclovir were in short supply at both time points.
The most common ways respondents reported learning about drug shortages were from hospital notification (76%), from a colleague (56%), from a pharmacy that contacted them regarding a prescription for the agent (53%), or from the Food and Drug Administration website or another website on shortages (23%). The most common ways of learning about a shortage changed – from notification after trying to prescribe a drug in 2011, to proactive hospital/system (local) notification in 2016; 71% of respondents said that communications in 2016 were sufficient.
Most respondents (83%) reported that guidelines for dealing with shortages had been developed by an antimicrobial stewardship program (ASP) at their institution.
“This, I think, is one of the highlight results,” said Dr. Gundlapalli, who is also a staff physician at the VA Salt Lake City Health System. “In 2011, we had no specific question or comments received about [ASPs], and here in 2016, 83% of respondents’ institutions had developed guidelines related to drug shortages.”
Respondents also had the opportunity to submit free-text responses, and among the themes that emerged was concern regarding toxicity and adverse outcomes associated with increased use of aminoglycosides because of the shortage of piperacillin-tazobactam. Another – described as a blessing in disguise – was the shortage of meropenem, which led one ASP to “institute restrictions on its use, which have continued,” he said.
“Another theme was ‘simpler agents seem more likely to be in shortage,’ ” Dr. Gundlapalli said, noting ampicillin-sulbactam in 2016 and Pen-G as examples.
“And then, of course, the other theme across the board ... was our new asset,” he said, explaining that some respondents commented on the value of ASP pharmacists and programs to help with drug shortage issues.
The overall theme of this follow-up survey, in the context of prior surveys in 2001 and 2011, is that antibiotic shortages are the “new normal – a way of life,” Dr. Gundlapalli said.
“The concerns do persist, and we feel there is further work to be done here,” he said. He specifically noted that there is a need to inform and educate fellows and colleagues in hospitals, increase awareness generally, improve communication strategies, and conduct detailed studies on adverse effects and outcomes.
“And now, since ASPs are very pervasive ... maybe it’s time to formalize and delineate the role of ASPs in antimicrobial shortages,” he said.
The problem of antibiotic shortages “harkens back to the day when penicillin was recycled in the urine [of soldiers in World War II] to save this very scarce resource ... but that’s a very extreme measure to take,” noted Donald Graham, MD, of the Springfield (Ill.) Clinic, one of the study’s coauthors. “It seems like it’s time for the other federal arm – namely, the Food and Drug Administration – to do something about this.”
Dr. Graham said he believes the problem is in part because of economics, and in part because of “the higher standards that the FDA imposes upon these manufacturing concerns.” These drugs often are low-profit items, and it isn’t always in the financial best interest of a pharmaceutical company to upgrade their facilities.
“But they really have to recognize the importance of having availability of these simple agents,” he said, pleading with any FDA representatives in the audience to “maybe think about some of these very high standards.”
Dr. Gundlapalli reported having no disclosures. Dr. Graham disclosed relationships with Astellas and Theravance Biopharma.
NEW ORLEANS – Antibiotic shortages reported by the Emerging Infections Network (EIN) in 2011 persist in 2016, according to a web-based follow-up survey of infectious disease physicians.
Of 701 network members who responded to the EIN survey in early 2016, 70% reported needing to modify their antimicrobial choice because of a shortage in the past 2 years. They did so by using broader-spectrum agents (75% of respondents), more costly agents (58%), less effective second-line agents (45%), and more toxic agents (37%), Adi Gundlapalli, MD, PhD, reported at an annual scientific meeting on infectious diseases.
In addition, 73% of respondents reported that the shortages affected patient care or outcomes, reported Dr. Gundlapalli of the University of Utah, Salt Lake City.
The percentage of respondents reporting adverse patient outcomes related to shortages increased from 2011 to 2016 (51% vs.73%), he noted at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The top 10 antimicrobials they reported as being in short supply were piperacillin-tazobactam, ampicillin-sulbactam, meropenem, cefotaxime, cefepime, trimethoprim-sulfamethoxazole (TMP-SMX), doxycycline, imipenem, acyclovir, and amikacin. TMP-SMX and acyclovir were in short supply at both time points.
The most common ways respondents reported learning about drug shortages were from hospital notification (76%), from a colleague (56%), from a pharmacy that contacted them regarding a prescription for the agent (53%), or from the Food and Drug Administration website or another website on shortages (23%). The most common ways of learning about a shortage changed – from notification after trying to prescribe a drug in 2011, to proactive hospital/system (local) notification in 2016; 71% of respondents said that communications in 2016 were sufficient.
Most respondents (83%) reported that guidelines for dealing with shortages had been developed by an antimicrobial stewardship program (ASP) at their institution.
“This, I think, is one of the highlight results,” said Dr. Gundlapalli, who is also a staff physician at the VA Salt Lake City Health System. “In 2011, we had no specific question or comments received about [ASPs], and here in 2016, 83% of respondents’ institutions had developed guidelines related to drug shortages.”
Respondents also had the opportunity to submit free-text responses, and among the themes that emerged was concern regarding toxicity and adverse outcomes associated with increased use of aminoglycosides because of the shortage of piperacillin-tazobactam. Another – described as a blessing in disguise – was the shortage of meropenem, which led one ASP to “institute restrictions on its use, which have continued,” he said.
“Another theme was ‘simpler agents seem more likely to be in shortage,’ ” Dr. Gundlapalli said, noting ampicillin-sulbactam in 2016 and Pen-G as examples.
“And then, of course, the other theme across the board ... was our new asset,” he said, explaining that some respondents commented on the value of ASP pharmacists and programs to help with drug shortage issues.
The overall theme of this follow-up survey, in the context of prior surveys in 2001 and 2011, is that antibiotic shortages are the “new normal – a way of life,” Dr. Gundlapalli said.
“The concerns do persist, and we feel there is further work to be done here,” he said. He specifically noted that there is a need to inform and educate fellows and colleagues in hospitals, increase awareness generally, improve communication strategies, and conduct detailed studies on adverse effects and outcomes.
“And now, since ASPs are very pervasive ... maybe it’s time to formalize and delineate the role of ASPs in antimicrobial shortages,” he said.
The problem of antibiotic shortages “harkens back to the day when penicillin was recycled in the urine [of soldiers in World War II] to save this very scarce resource ... but that’s a very extreme measure to take,” noted Donald Graham, MD, of the Springfield (Ill.) Clinic, one of the study’s coauthors. “It seems like it’s time for the other federal arm – namely, the Food and Drug Administration – to do something about this.”
Dr. Graham said he believes the problem is in part because of economics, and in part because of “the higher standards that the FDA imposes upon these manufacturing concerns.” These drugs often are low-profit items, and it isn’t always in the financial best interest of a pharmaceutical company to upgrade their facilities.
“But they really have to recognize the importance of having availability of these simple agents,” he said, pleading with any FDA representatives in the audience to “maybe think about some of these very high standards.”
Dr. Gundlapalli reported having no disclosures. Dr. Graham disclosed relationships with Astellas and Theravance Biopharma.
AT IDWEEK 2016
Key clinical point:
Major finding: 70% of respondents reported needing to modify their antimicrobial choice because of a shortage in the past 2 years, and 73% said shortages affected patient care or outcomes.
Data source: A follow-up survey of 701 physicians.
Disclosures: Dr. Gundlapalli reported having no disclosures. Dr. Graham disclosed relationships with Astellas and Theravance Biopharma.
Fragmented readmission after liver transplant linked to adverse outcomes
CORONADO, CALIF. – Postdischarge surgical care fragmentation significantly increases the risk of both 30-day mortality and subsequent readmission in the first year following orthotopic liver transplantation, results from a study of national data showed.
“In an era of regionalization and centers of excellence, the likelihood for postdischarge fragmentation, defined as readmission to any hospital other than the hospital at which the surgery was performed, is an increasing reality,” Anai N. Kothari, MD, said at the annual meeting of the Western Surgical Association. “In many different surgical subspecialties – major vascular operations, bariatric surgery, oncologic resections – it’s known to be a risk factor for adverse events and poor quality. Postdischarge fragmentation is common, [and related to] as often as one in four readmissions. It increases the risk for short- and long-term morbidity and mortality, decreases survival, and increases cost.”
Dr. Kothari reported results from 2,996 patients with 7,485 readmission encounters at 299 hospitals. Of the 7,485 readmissions, 6,249 (83.5%) were nonfragmented, and 1,236 (16.5%) were fragmented. The mean age of patients was 55 years. There were no significant differences in baseline characteristics between patients with nonfragmented and fragmented admissions in terms of patient age, sex, preoperative and postoperative length of stay, Charlson comorbidity index, and comorbidities, with the exception of renal failure, which was more common among patients in the fragmented admission group.
Compared with the patients in the nonfragmented admission group, those in the fragmented admission group had a greater number of average readmissions per patient (3.3 vs. 2.5, respectively; P less than .0001) and a greater number of average days to readmission (168 vs. 105; P less than .0001). Reasons for readmission differed among the two groups. Patients readmitted to the index transplant center were more likely to have a biliary, hematologic, or neurologic complication, while those in the fragmented admissions group were more likely to be readmitted for things like electrolyte disturbances, respiratory issues, gastrointestinal issues, or hematologic-related issues. There was no difference in overall cost of care between the two groups (an average of $11,621.68 vs. $11.585.39, respectively).
After the investigators adjusted for age, sex, reason for readmission, cost of the index liver transplant, readmission length of stay, number of previous readmissions, and time from transplant, postdischarge fragmentation increased the odds of both 30-day mortality (OR, 1.75) and 30-day readmission (OR, 2.14). “It looks like just having a fragmented readmission is an independent predictor for an adverse event,” Dr. Kothari said.
Significant predictors of adverse events following a fragmented readmission included an increased number of previous readmissions (OR, 1.07) and readmission within 90 days of orthotopic liver transplant (OR, 2.19). “These two factors may be important for guiding providers to say, ‘If you have these things, this patient should likely come back to their index transplant center,’” Dr. Kothari said.
He reported having no relevant financial disclosures.
CORONADO, CALIF. – Postdischarge surgical care fragmentation significantly increases the risk of both 30-day mortality and subsequent readmission in the first year following orthotopic liver transplantation, results from a study of national data showed.
“In an era of regionalization and centers of excellence, the likelihood for postdischarge fragmentation, defined as readmission to any hospital other than the hospital at which the surgery was performed, is an increasing reality,” Anai N. Kothari, MD, said at the annual meeting of the Western Surgical Association. “In many different surgical subspecialties – major vascular operations, bariatric surgery, oncologic resections – it’s known to be a risk factor for adverse events and poor quality. Postdischarge fragmentation is common, [and related to] as often as one in four readmissions. It increases the risk for short- and long-term morbidity and mortality, decreases survival, and increases cost.”
Dr. Kothari reported results from 2,996 patients with 7,485 readmission encounters at 299 hospitals. Of the 7,485 readmissions, 6,249 (83.5%) were nonfragmented, and 1,236 (16.5%) were fragmented. The mean age of patients was 55 years. There were no significant differences in baseline characteristics between patients with nonfragmented and fragmented admissions in terms of patient age, sex, preoperative and postoperative length of stay, Charlson comorbidity index, and comorbidities, with the exception of renal failure, which was more common among patients in the fragmented admission group.
Compared with the patients in the nonfragmented admission group, those in the fragmented admission group had a greater number of average readmissions per patient (3.3 vs. 2.5, respectively; P less than .0001) and a greater number of average days to readmission (168 vs. 105; P less than .0001). Reasons for readmission differed among the two groups. Patients readmitted to the index transplant center were more likely to have a biliary, hematologic, or neurologic complication, while those in the fragmented admissions group were more likely to be readmitted for things like electrolyte disturbances, respiratory issues, gastrointestinal issues, or hematologic-related issues. There was no difference in overall cost of care between the two groups (an average of $11,621.68 vs. $11.585.39, respectively).
After the investigators adjusted for age, sex, reason for readmission, cost of the index liver transplant, readmission length of stay, number of previous readmissions, and time from transplant, postdischarge fragmentation increased the odds of both 30-day mortality (OR, 1.75) and 30-day readmission (OR, 2.14). “It looks like just having a fragmented readmission is an independent predictor for an adverse event,” Dr. Kothari said.
Significant predictors of adverse events following a fragmented readmission included an increased number of previous readmissions (OR, 1.07) and readmission within 90 days of orthotopic liver transplant (OR, 2.19). “These two factors may be important for guiding providers to say, ‘If you have these things, this patient should likely come back to their index transplant center,’” Dr. Kothari said.
He reported having no relevant financial disclosures.
CORONADO, CALIF. – Postdischarge surgical care fragmentation significantly increases the risk of both 30-day mortality and subsequent readmission in the first year following orthotopic liver transplantation, results from a study of national data showed.
“In an era of regionalization and centers of excellence, the likelihood for postdischarge fragmentation, defined as readmission to any hospital other than the hospital at which the surgery was performed, is an increasing reality,” Anai N. Kothari, MD, said at the annual meeting of the Western Surgical Association. “In many different surgical subspecialties – major vascular operations, bariatric surgery, oncologic resections – it’s known to be a risk factor for adverse events and poor quality. Postdischarge fragmentation is common, [and related to] as often as one in four readmissions. It increases the risk for short- and long-term morbidity and mortality, decreases survival, and increases cost.”
Dr. Kothari reported results from 2,996 patients with 7,485 readmission encounters at 299 hospitals. Of the 7,485 readmissions, 6,249 (83.5%) were nonfragmented, and 1,236 (16.5%) were fragmented. The mean age of patients was 55 years. There were no significant differences in baseline characteristics between patients with nonfragmented and fragmented admissions in terms of patient age, sex, preoperative and postoperative length of stay, Charlson comorbidity index, and comorbidities, with the exception of renal failure, which was more common among patients in the fragmented admission group.
Compared with the patients in the nonfragmented admission group, those in the fragmented admission group had a greater number of average readmissions per patient (3.3 vs. 2.5, respectively; P less than .0001) and a greater number of average days to readmission (168 vs. 105; P less than .0001). Reasons for readmission differed among the two groups. Patients readmitted to the index transplant center were more likely to have a biliary, hematologic, or neurologic complication, while those in the fragmented admissions group were more likely to be readmitted for things like electrolyte disturbances, respiratory issues, gastrointestinal issues, or hematologic-related issues. There was no difference in overall cost of care between the two groups (an average of $11,621.68 vs. $11.585.39, respectively).
After the investigators adjusted for age, sex, reason for readmission, cost of the index liver transplant, readmission length of stay, number of previous readmissions, and time from transplant, postdischarge fragmentation increased the odds of both 30-day mortality (OR, 1.75) and 30-day readmission (OR, 2.14). “It looks like just having a fragmented readmission is an independent predictor for an adverse event,” Dr. Kothari said.
Significant predictors of adverse events following a fragmented readmission included an increased number of previous readmissions (OR, 1.07) and readmission within 90 days of orthotopic liver transplant (OR, 2.19). “These two factors may be important for guiding providers to say, ‘If you have these things, this patient should likely come back to their index transplant center,’” Dr. Kothari said.
He reported having no relevant financial disclosures.
AT WSA 2016
Key clinical point:
Major finding: After investigators adjusted for numerous variables, postdischarge fragmentation following orthotopic liver transplantation increased the odds of both 30-day mortality (OR, 1.75) and 30-day readmission (OR, 2.14).
Data source: An analysis of data from the Healthcare Cost and Utilization Project State Inpatient Databases for Florida and California between 2006 and 2011 to identify 2,996 patients who underwent orthotopic liver transplantation.
Disclosures: Dr. Kothari reported having no relevant financial disclosures.
Therapeutic alternative to liver transplantation could be on horizon in NASH
BOSTON – A novel therapeutic approach to nonalcoholic steatohepatitis could one day mean sufferers of this severe form of nonalcoholic fatty liver disease have an alternative to transplantation.
Preclinical findings from a study using mesenchymal stem cells adapted from unsuitable organs for transplant have shown promise in suppressing inflammation in nonalcoholic steatohepatitis (NASH).
By adding an inflammatory cocktail to cell cultures, with or without immunosuppression with cyclosporine, Dr. Gellynck and his colleagues were able to provoke secretion of anti-inflammatory and antifibrotic cytokines. HepaStem was shown to inhibit the T-lymphocyte response to the inflammation and also suppress the dendritic cell generation and function in co-culture experiments. In a NASH disease model culture, the immunosuppression did not solely affect disease progression, but cell-based treatment significantly and dose-dependently decreased collagen levels. A single HepaStem injection “significantly” decreased the nonalcoholic fatty liver disease activity disease score, supporting the proposed mechanism of action, namely reduced inflammation.
Dr. Gellynck and his colleagues believe their findings warrant phase I/II studies in humans with NASH.
All study workers are employed by Promethera Biosciences.
[email protected]
On Twitter @whitneymcknight
BOSTON – A novel therapeutic approach to nonalcoholic steatohepatitis could one day mean sufferers of this severe form of nonalcoholic fatty liver disease have an alternative to transplantation.
Preclinical findings from a study using mesenchymal stem cells adapted from unsuitable organs for transplant have shown promise in suppressing inflammation in nonalcoholic steatohepatitis (NASH).
By adding an inflammatory cocktail to cell cultures, with or without immunosuppression with cyclosporine, Dr. Gellynck and his colleagues were able to provoke secretion of anti-inflammatory and antifibrotic cytokines. HepaStem was shown to inhibit the T-lymphocyte response to the inflammation and also suppress the dendritic cell generation and function in co-culture experiments. In a NASH disease model culture, the immunosuppression did not solely affect disease progression, but cell-based treatment significantly and dose-dependently decreased collagen levels. A single HepaStem injection “significantly” decreased the nonalcoholic fatty liver disease activity disease score, supporting the proposed mechanism of action, namely reduced inflammation.
Dr. Gellynck and his colleagues believe their findings warrant phase I/II studies in humans with NASH.
All study workers are employed by Promethera Biosciences.
[email protected]
On Twitter @whitneymcknight
BOSTON – A novel therapeutic approach to nonalcoholic steatohepatitis could one day mean sufferers of this severe form of nonalcoholic fatty liver disease have an alternative to transplantation.
Preclinical findings from a study using mesenchymal stem cells adapted from unsuitable organs for transplant have shown promise in suppressing inflammation in nonalcoholic steatohepatitis (NASH).
By adding an inflammatory cocktail to cell cultures, with or without immunosuppression with cyclosporine, Dr. Gellynck and his colleagues were able to provoke secretion of anti-inflammatory and antifibrotic cytokines. HepaStem was shown to inhibit the T-lymphocyte response to the inflammation and also suppress the dendritic cell generation and function in co-culture experiments. In a NASH disease model culture, the immunosuppression did not solely affect disease progression, but cell-based treatment significantly and dose-dependently decreased collagen levels. A single HepaStem injection “significantly” decreased the nonalcoholic fatty liver disease activity disease score, supporting the proposed mechanism of action, namely reduced inflammation.
Dr. Gellynck and his colleagues believe their findings warrant phase I/II studies in humans with NASH.
All study workers are employed by Promethera Biosciences.
[email protected]
On Twitter @whitneymcknight
FROM THE LIVER MEETING 2016