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‘Skip phenomenon’ could explain fluctuating positivity for S. aureus bacteremia
NEW ORLEANS – A proportion of patients treated appropriately with antibiotics for Staphylococcus aureus bacteremia can generate a negative blood culture followed by a positive one, a new clinical entity researchers are calling the “skip phenomenon.”
“This pattern is really in cases where people have known Staph. aureus bacteremia; it seems to clear; they’re on appropriate antibiotic therapy; and despite that, we see that the blood cultures come back positive again several days later,” explained Justin A. Fiala, MD, of Mayo Clinic in Rochester, Minn.
In a video interview, Dr. Fiala outlined the findings of the first study to identify and characterize this phenomenon.
Certain patients with S. aureus bacteremia could be at higher risk for skip phenomenon, for example. The nested case-control study identified these higher-risk patients, a population that might warrant more clinical testing.
Dr. Fiala also discussed associations with patient outcomes, as well as the overall prevalence of skip phenomenon in his research, which included more than 900 patients with S. aureus bacteremia treated at Mayo Clinic.
Dr. Fiala had no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW ORLEANS – A proportion of patients treated appropriately with antibiotics for Staphylococcus aureus bacteremia can generate a negative blood culture followed by a positive one, a new clinical entity researchers are calling the “skip phenomenon.”
“This pattern is really in cases where people have known Staph. aureus bacteremia; it seems to clear; they’re on appropriate antibiotic therapy; and despite that, we see that the blood cultures come back positive again several days later,” explained Justin A. Fiala, MD, of Mayo Clinic in Rochester, Minn.
In a video interview, Dr. Fiala outlined the findings of the first study to identify and characterize this phenomenon.
Certain patients with S. aureus bacteremia could be at higher risk for skip phenomenon, for example. The nested case-control study identified these higher-risk patients, a population that might warrant more clinical testing.
Dr. Fiala also discussed associations with patient outcomes, as well as the overall prevalence of skip phenomenon in his research, which included more than 900 patients with S. aureus bacteremia treated at Mayo Clinic.
Dr. Fiala had no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW ORLEANS – A proportion of patients treated appropriately with antibiotics for Staphylococcus aureus bacteremia can generate a negative blood culture followed by a positive one, a new clinical entity researchers are calling the “skip phenomenon.”
“This pattern is really in cases where people have known Staph. aureus bacteremia; it seems to clear; they’re on appropriate antibiotic therapy; and despite that, we see that the blood cultures come back positive again several days later,” explained Justin A. Fiala, MD, of Mayo Clinic in Rochester, Minn.
In a video interview, Dr. Fiala outlined the findings of the first study to identify and characterize this phenomenon.
Certain patients with S. aureus bacteremia could be at higher risk for skip phenomenon, for example. The nested case-control study identified these higher-risk patients, a population that might warrant more clinical testing.
Dr. Fiala also discussed associations with patient outcomes, as well as the overall prevalence of skip phenomenon in his research, which included more than 900 patients with S. aureus bacteremia treated at Mayo Clinic.
Dr. Fiala had no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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.
Inpatient telemedicine could bridge infectious disease specialist gap
NEW ORLEANS – Telemedicine inpatient consultations are a relatively new component in health care, but they could help address the problem of infectious disease physician shortages, particularly in rural communities, according to Lewis McCurdy, MD.
Dr. McCurdy of Carolinas HealthCare System in Charlotte, N.C., shared his experience providing virtual consultations for inpatients at a rural community hospital, noting that the approach was well received by patients, and that uptake by providers doubled during the first year.
Further, the virtual consultations appeared to have important clinical benefits, because very few patients had to be transferred to higher-level acuity facilities. The consultations seemed to help providers with challenging situations that they might not have felt comfortable managing otherwise, such as bloodstream infections, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
In a video interview, Dr. McCurdy discussed the development of the process for using telemedicine for inpatient consultations, outcomes after about 18 months at one facility, and challenges of providing telemedicine services.
The approach could be very helpful for smaller communities without an infectious disease provider, Dr. McCurdy said.
“This allows us to sort of expand our expertise into those communities on a more efficiently scaled basis,” he explained. “So, it does provide one solution to trying to meet the demand in the community for ID expertise.”
Dr. McCurdy reported having no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW ORLEANS – Telemedicine inpatient consultations are a relatively new component in health care, but they could help address the problem of infectious disease physician shortages, particularly in rural communities, according to Lewis McCurdy, MD.
Dr. McCurdy of Carolinas HealthCare System in Charlotte, N.C., shared his experience providing virtual consultations for inpatients at a rural community hospital, noting that the approach was well received by patients, and that uptake by providers doubled during the first year.
Further, the virtual consultations appeared to have important clinical benefits, because very few patients had to be transferred to higher-level acuity facilities. The consultations seemed to help providers with challenging situations that they might not have felt comfortable managing otherwise, such as bloodstream infections, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
In a video interview, Dr. McCurdy discussed the development of the process for using telemedicine for inpatient consultations, outcomes after about 18 months at one facility, and challenges of providing telemedicine services.
The approach could be very helpful for smaller communities without an infectious disease provider, Dr. McCurdy said.
“This allows us to sort of expand our expertise into those communities on a more efficiently scaled basis,” he explained. “So, it does provide one solution to trying to meet the demand in the community for ID expertise.”
Dr. McCurdy reported having no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NEW ORLEANS – Telemedicine inpatient consultations are a relatively new component in health care, but they could help address the problem of infectious disease physician shortages, particularly in rural communities, according to Lewis McCurdy, MD.
Dr. McCurdy of Carolinas HealthCare System in Charlotte, N.C., shared his experience providing virtual consultations for inpatients at a rural community hospital, noting that the approach was well received by patients, and that uptake by providers doubled during the first year.
Further, the virtual consultations appeared to have important clinical benefits, because very few patients had to be transferred to higher-level acuity facilities. The consultations seemed to help providers with challenging situations that they might not have felt comfortable managing otherwise, such as bloodstream infections, he said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
In a video interview, Dr. McCurdy discussed the development of the process for using telemedicine for inpatient consultations, outcomes after about 18 months at one facility, and challenges of providing telemedicine services.
The approach could be very helpful for smaller communities without an infectious disease provider, Dr. McCurdy said.
“This allows us to sort of expand our expertise into those communities on a more efficiently scaled basis,” he explained. “So, it does provide one solution to trying to meet the demand in the community for ID expertise.”
Dr. McCurdy reported having no disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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.
Absorb’s problems will revise coronary scaffold standards
One-year outcome results of the first bioresorbable coronary scaffold on the U.S. and world markets, Absorb, failed to show longer-term problems with the device that only became apparent with 3-year follow-up.
The failure of Absorb to show benefits after 3 years in the ABSORB II trial will probably not dampen enthusiasm for the concept of a bioresorbable coronary scaffold (BRS). The idea of treating coronary stenoses with a stent that disappears after a few years once it has done its job is a powerfully attractive idea, and reports from several early-stage clinical tests of new BRSs during TCT 2016 showed that many next-generation versions of these devices are in very active development.
The surprising ABSORB II results showed more than just a failure of the Absorb BRS to produce 3 years after placement the improved coronary artery vasomotion and reduced late lumen loss that were the two primary efficacy endpoints of the trial.
The results also showed troubling signs of harm from the BRS, including significantly worse late lumen loss, compared with a contemporary drug-eluting metallic stent. In addition, there was a shocking 1%/year rate of late stent thrombosis during both the second and third years following Absorb placement in coronary arteries, the period when the Absorb BRS was in the process of disappearing, and which did not occur in the study’s control patients who received a conventional, metallic drug-eluting stent.
Patrick W. Serruys, MD, lead investigator of ABSORB II, attributed these adverse outcomes to the “highly thrombogenic” proteoglycan material that formed as the Absorb BRS resorbed, and a “structural discontinuity” of the BRS as it resorbed in some patients, resulting in parts of the scaffold remnant sticking out from the coronary artery wall toward the center of the vessel.
These late flaws in the bioresorption process will now need closer scrutiny during future studies of next-generation BRSs, and will surely mean longer follow-up of pivotal trials and a shift from the 1-year follow-up data used by the Food and Drug Administration when it approved the Absorb BRS last July.
“The challenge for the field [of BRS development] is the late results, as we saw in ABSORB II,” commented David J. Cohen, MD, an interventional cardiologist at Saint Luke’s Health System in Kansas City, Mo. The ABSORB II results “will lead to reexamination of the trial design and endpoints for the next generation of BRSs,” Dr. Cohen predicted at the meeting, sponsored by the Cardiovascular Research Foundation.
“It’s not clear that BRS reduces the duration for DAPT,” Dr. Cohen noted, at least for the Absorb device, which is not full resorbed until it’s been in patients for about 3 years.
A striking property of the next-generation BRSs reported at the meeting was their use of thinner struts and faster resorption times. “These iterations hold immense promise for improving late outcomes,” commented Dean J. Kereiakes, MD, an interventional cardiologist at the Christ Hospital in Cincinnati who helped lead the large U.S. clinical trial of the Absorb BRS, ABSORB III.
[email protected]
On Twitter @mitchelzoler
One-year outcome results of the first bioresorbable coronary scaffold on the U.S. and world markets, Absorb, failed to show longer-term problems with the device that only became apparent with 3-year follow-up.
The failure of Absorb to show benefits after 3 years in the ABSORB II trial will probably not dampen enthusiasm for the concept of a bioresorbable coronary scaffold (BRS). The idea of treating coronary stenoses with a stent that disappears after a few years once it has done its job is a powerfully attractive idea, and reports from several early-stage clinical tests of new BRSs during TCT 2016 showed that many next-generation versions of these devices are in very active development.
The surprising ABSORB II results showed more than just a failure of the Absorb BRS to produce 3 years after placement the improved coronary artery vasomotion and reduced late lumen loss that were the two primary efficacy endpoints of the trial.
The results also showed troubling signs of harm from the BRS, including significantly worse late lumen loss, compared with a contemporary drug-eluting metallic stent. In addition, there was a shocking 1%/year rate of late stent thrombosis during both the second and third years following Absorb placement in coronary arteries, the period when the Absorb BRS was in the process of disappearing, and which did not occur in the study’s control patients who received a conventional, metallic drug-eluting stent.
Patrick W. Serruys, MD, lead investigator of ABSORB II, attributed these adverse outcomes to the “highly thrombogenic” proteoglycan material that formed as the Absorb BRS resorbed, and a “structural discontinuity” of the BRS as it resorbed in some patients, resulting in parts of the scaffold remnant sticking out from the coronary artery wall toward the center of the vessel.
These late flaws in the bioresorption process will now need closer scrutiny during future studies of next-generation BRSs, and will surely mean longer follow-up of pivotal trials and a shift from the 1-year follow-up data used by the Food and Drug Administration when it approved the Absorb BRS last July.
“The challenge for the field [of BRS development] is the late results, as we saw in ABSORB II,” commented David J. Cohen, MD, an interventional cardiologist at Saint Luke’s Health System in Kansas City, Mo. The ABSORB II results “will lead to reexamination of the trial design and endpoints for the next generation of BRSs,” Dr. Cohen predicted at the meeting, sponsored by the Cardiovascular Research Foundation.
“It’s not clear that BRS reduces the duration for DAPT,” Dr. Cohen noted, at least for the Absorb device, which is not full resorbed until it’s been in patients for about 3 years.
A striking property of the next-generation BRSs reported at the meeting was their use of thinner struts and faster resorption times. “These iterations hold immense promise for improving late outcomes,” commented Dean J. Kereiakes, MD, an interventional cardiologist at the Christ Hospital in Cincinnati who helped lead the large U.S. clinical trial of the Absorb BRS, ABSORB III.
[email protected]
On Twitter @mitchelzoler
One-year outcome results of the first bioresorbable coronary scaffold on the U.S. and world markets, Absorb, failed to show longer-term problems with the device that only became apparent with 3-year follow-up.
The failure of Absorb to show benefits after 3 years in the ABSORB II trial will probably not dampen enthusiasm for the concept of a bioresorbable coronary scaffold (BRS). The idea of treating coronary stenoses with a stent that disappears after a few years once it has done its job is a powerfully attractive idea, and reports from several early-stage clinical tests of new BRSs during TCT 2016 showed that many next-generation versions of these devices are in very active development.
The surprising ABSORB II results showed more than just a failure of the Absorb BRS to produce 3 years after placement the improved coronary artery vasomotion and reduced late lumen loss that were the two primary efficacy endpoints of the trial.
The results also showed troubling signs of harm from the BRS, including significantly worse late lumen loss, compared with a contemporary drug-eluting metallic stent. In addition, there was a shocking 1%/year rate of late stent thrombosis during both the second and third years following Absorb placement in coronary arteries, the period when the Absorb BRS was in the process of disappearing, and which did not occur in the study’s control patients who received a conventional, metallic drug-eluting stent.
Patrick W. Serruys, MD, lead investigator of ABSORB II, attributed these adverse outcomes to the “highly thrombogenic” proteoglycan material that formed as the Absorb BRS resorbed, and a “structural discontinuity” of the BRS as it resorbed in some patients, resulting in parts of the scaffold remnant sticking out from the coronary artery wall toward the center of the vessel.
These late flaws in the bioresorption process will now need closer scrutiny during future studies of next-generation BRSs, and will surely mean longer follow-up of pivotal trials and a shift from the 1-year follow-up data used by the Food and Drug Administration when it approved the Absorb BRS last July.
“The challenge for the field [of BRS development] is the late results, as we saw in ABSORB II,” commented David J. Cohen, MD, an interventional cardiologist at Saint Luke’s Health System in Kansas City, Mo. The ABSORB II results “will lead to reexamination of the trial design and endpoints for the next generation of BRSs,” Dr. Cohen predicted at the meeting, sponsored by the Cardiovascular Research Foundation.
“It’s not clear that BRS reduces the duration for DAPT,” Dr. Cohen noted, at least for the Absorb device, which is not full resorbed until it’s been in patients for about 3 years.
A striking property of the next-generation BRSs reported at the meeting was their use of thinner struts and faster resorption times. “These iterations hold immense promise for improving late outcomes,” commented Dean J. Kereiakes, MD, an interventional cardiologist at the Christ Hospital in Cincinnati who helped lead the large U.S. clinical trial of the Absorb BRS, ABSORB III.
[email protected]
On Twitter @mitchelzoler
Phase II data suggest IV zanamivir safe for severe flu in kids
NEW ORLEANS – The investigational intravenous formulation of the neuraminidase inhibitor zanamivir appears to be a safe influenza treatment for hospitalized children and adolescents at high risk of complications who can’t tolerate enteral therapy, according to findings from an open-label, multicenter, phase II study.
In 71 such patients with laboratory-confirmed flu, who presented within 7 days of illness onset and who received intravenous zanamivir (IVZ) for 5-10 days, 72% experienced adverse events (AEs), 21% experienced serious adverse events, and 5 deaths occurred, but none were considered by the investigators to be attributable to IVZ, Jeffrey Blumer, MD, reported at IDWeek, an annual scientific meeting on infectious diseases.
Rather, the adverse events were “fairly diverse. ... the kinds of things normally seen in critically ill pediatric populations,” he said.
The patients, who had a mean age of 7 years, were treated with IVZ doses selected to provide exposures comparable to 600 mg in adults – a dosage shown in prior studies to be safe and well-tolerated in adults. Patients aged 6 months to under age 6 years received twice-daily doses of 14 mg/kg, and those aged 6 years to less than 18 years received twice-daily doses of 12 mg/kg, not to exceed 600 mg. Doses were adjusted for renal function.
Patients were enrolled from five countries, and most (69%) had received prior treatment with oseltamivir. More than half (56%) had chronic medical conditions.
The median time from symptom onset to IVZ treatment was 4 days, Dr. Blumer of the University of Toledo (Ohio) said 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.
Infiltrate on chest x-ray was seen in 59% of patients, mechanical ventilation was required in 34% of patients, and extracorporeal membrane oxygenation was required in 6% of patients. Treatment in the intensive care unit was required in 65% of patients, and cumulative mortality was 4% at 14 days, and 7% at 28 days.
“Overall, the [IVZ] exposure and then the elimination profiles were consistent across the entire age cohort – unusual for most drugs, but it seemed to hold true, which makes zanamivir a lot easier for us to work with in pediatrics,” Dr. Blumer said.
While the numbers are small, exposure and response delineation didn’t seem to be impacted by mechanical ventilation, by extracorporeal membrane oxygenation, or by continuous renal replacement therapy, which is a good sign, he noted.
“So we generally had good, consistent experience here. ... Overall, 64 of the 71 patients survived, got better, left the ICU, and left the hospital,” Dr. Blumer said.
Of note, a treatment-emergent resistance substitution, E119G, was detected in a day 5 H1N1 isolate from an immunocompetent patient who improved clinically while on IVZ, he said, adding that no phenotype data were available as the sample could not be cultured.
The findings are important, because while zanamivir is currently labeled for patients older than 7 years, and the intravenous formulation currently in development has been shown to be safe for adults, there is a critical unmet need for an effective parenteral treatment for severe flu in children at high risk of complications who cannot tolerate enteral therapy.
“We need a drug that is available for the critically ill. We need a drug available for kids who are unable to take oral therapy, and for treatment of oseltamivir-resistant strains,” he said, adding that the current findings suggest that IVZ – with dose selection based on age, weight, and renal function – is a suitable treatment option for such patients.
“In conclusion, what we saw in this open-label trial was that the dose selection that we utilized gave us the kind of exposure we’d expect, and it seems it was an appropriate way to approach pediatric patients,” he said. “There wasn’t any safety signal attributable to the drug, and the overall pattern was more that of serious influenza, rather than of drug exposure.”
Dr. Blumer reported receiving research support from GlaxoSmithKline, which sponsored the study.
NEW ORLEANS – The investigational intravenous formulation of the neuraminidase inhibitor zanamivir appears to be a safe influenza treatment for hospitalized children and adolescents at high risk of complications who can’t tolerate enteral therapy, according to findings from an open-label, multicenter, phase II study.
In 71 such patients with laboratory-confirmed flu, who presented within 7 days of illness onset and who received intravenous zanamivir (IVZ) for 5-10 days, 72% experienced adverse events (AEs), 21% experienced serious adverse events, and 5 deaths occurred, but none were considered by the investigators to be attributable to IVZ, Jeffrey Blumer, MD, reported at IDWeek, an annual scientific meeting on infectious diseases.
Rather, the adverse events were “fairly diverse. ... the kinds of things normally seen in critically ill pediatric populations,” he said.
The patients, who had a mean age of 7 years, were treated with IVZ doses selected to provide exposures comparable to 600 mg in adults – a dosage shown in prior studies to be safe and well-tolerated in adults. Patients aged 6 months to under age 6 years received twice-daily doses of 14 mg/kg, and those aged 6 years to less than 18 years received twice-daily doses of 12 mg/kg, not to exceed 600 mg. Doses were adjusted for renal function.
Patients were enrolled from five countries, and most (69%) had received prior treatment with oseltamivir. More than half (56%) had chronic medical conditions.
The median time from symptom onset to IVZ treatment was 4 days, Dr. Blumer of the University of Toledo (Ohio) said 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.
Infiltrate on chest x-ray was seen in 59% of patients, mechanical ventilation was required in 34% of patients, and extracorporeal membrane oxygenation was required in 6% of patients. Treatment in the intensive care unit was required in 65% of patients, and cumulative mortality was 4% at 14 days, and 7% at 28 days.
“Overall, the [IVZ] exposure and then the elimination profiles were consistent across the entire age cohort – unusual for most drugs, but it seemed to hold true, which makes zanamivir a lot easier for us to work with in pediatrics,” Dr. Blumer said.
While the numbers are small, exposure and response delineation didn’t seem to be impacted by mechanical ventilation, by extracorporeal membrane oxygenation, or by continuous renal replacement therapy, which is a good sign, he noted.
“So we generally had good, consistent experience here. ... Overall, 64 of the 71 patients survived, got better, left the ICU, and left the hospital,” Dr. Blumer said.
Of note, a treatment-emergent resistance substitution, E119G, was detected in a day 5 H1N1 isolate from an immunocompetent patient who improved clinically while on IVZ, he said, adding that no phenotype data were available as the sample could not be cultured.
The findings are important, because while zanamivir is currently labeled for patients older than 7 years, and the intravenous formulation currently in development has been shown to be safe for adults, there is a critical unmet need for an effective parenteral treatment for severe flu in children at high risk of complications who cannot tolerate enteral therapy.
“We need a drug that is available for the critically ill. We need a drug available for kids who are unable to take oral therapy, and for treatment of oseltamivir-resistant strains,” he said, adding that the current findings suggest that IVZ – with dose selection based on age, weight, and renal function – is a suitable treatment option for such patients.
“In conclusion, what we saw in this open-label trial was that the dose selection that we utilized gave us the kind of exposure we’d expect, and it seems it was an appropriate way to approach pediatric patients,” he said. “There wasn’t any safety signal attributable to the drug, and the overall pattern was more that of serious influenza, rather than of drug exposure.”
Dr. Blumer reported receiving research support from GlaxoSmithKline, which sponsored the study.
NEW ORLEANS – The investigational intravenous formulation of the neuraminidase inhibitor zanamivir appears to be a safe influenza treatment for hospitalized children and adolescents at high risk of complications who can’t tolerate enteral therapy, according to findings from an open-label, multicenter, phase II study.
In 71 such patients with laboratory-confirmed flu, who presented within 7 days of illness onset and who received intravenous zanamivir (IVZ) for 5-10 days, 72% experienced adverse events (AEs), 21% experienced serious adverse events, and 5 deaths occurred, but none were considered by the investigators to be attributable to IVZ, Jeffrey Blumer, MD, reported at IDWeek, an annual scientific meeting on infectious diseases.
Rather, the adverse events were “fairly diverse. ... the kinds of things normally seen in critically ill pediatric populations,” he said.
The patients, who had a mean age of 7 years, were treated with IVZ doses selected to provide exposures comparable to 600 mg in adults – a dosage shown in prior studies to be safe and well-tolerated in adults. Patients aged 6 months to under age 6 years received twice-daily doses of 14 mg/kg, and those aged 6 years to less than 18 years received twice-daily doses of 12 mg/kg, not to exceed 600 mg. Doses were adjusted for renal function.
Patients were enrolled from five countries, and most (69%) had received prior treatment with oseltamivir. More than half (56%) had chronic medical conditions.
The median time from symptom onset to IVZ treatment was 4 days, Dr. Blumer of the University of Toledo (Ohio) said 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.
Infiltrate on chest x-ray was seen in 59% of patients, mechanical ventilation was required in 34% of patients, and extracorporeal membrane oxygenation was required in 6% of patients. Treatment in the intensive care unit was required in 65% of patients, and cumulative mortality was 4% at 14 days, and 7% at 28 days.
“Overall, the [IVZ] exposure and then the elimination profiles were consistent across the entire age cohort – unusual for most drugs, but it seemed to hold true, which makes zanamivir a lot easier for us to work with in pediatrics,” Dr. Blumer said.
While the numbers are small, exposure and response delineation didn’t seem to be impacted by mechanical ventilation, by extracorporeal membrane oxygenation, or by continuous renal replacement therapy, which is a good sign, he noted.
“So we generally had good, consistent experience here. ... Overall, 64 of the 71 patients survived, got better, left the ICU, and left the hospital,” Dr. Blumer said.
Of note, a treatment-emergent resistance substitution, E119G, was detected in a day 5 H1N1 isolate from an immunocompetent patient who improved clinically while on IVZ, he said, adding that no phenotype data were available as the sample could not be cultured.
The findings are important, because while zanamivir is currently labeled for patients older than 7 years, and the intravenous formulation currently in development has been shown to be safe for adults, there is a critical unmet need for an effective parenteral treatment for severe flu in children at high risk of complications who cannot tolerate enteral therapy.
“We need a drug that is available for the critically ill. We need a drug available for kids who are unable to take oral therapy, and for treatment of oseltamivir-resistant strains,” he said, adding that the current findings suggest that IVZ – with dose selection based on age, weight, and renal function – is a suitable treatment option for such patients.
“In conclusion, what we saw in this open-label trial was that the dose selection that we utilized gave us the kind of exposure we’d expect, and it seems it was an appropriate way to approach pediatric patients,” he said. “There wasn’t any safety signal attributable to the drug, and the overall pattern was more that of serious influenza, rather than of drug exposure.”
Dr. Blumer reported receiving research support from GlaxoSmithKline, which sponsored the study.
AT ID WEEK 2016
Key clinical point:
Major finding: A total of 72% of patients experienced adverse events and 21% experienced serious adverse events, but none were considered by the investigators to be attributable to intravenous zanamivir.
Data source: An open-label, multicenter, phase II study of 71 children with laboratory-confirmed influenza.
Disclosures: Dr. Blumer reported receiving research support from GlaxoSmithKline, which sponsored the study.
VIDEO: PCI outcomes lag in women, minorities
WASHINGTON – The relatively low number of women and minority-group patients enrolled into cardiovascular disease clinical trials may skew the results, based on a comparison of outcomes following coronary stenting in an analysis of more than 4,000 patients.
During 12 months following coronary-disease treatment with percutaneous coronary intervention (PCI), women of diverse racial and ethnic backgrounds had a statistically significant 60% relative increase in death and myocardial infarctions, compared with white men, after adjustment for known baseline variables, Wayne B. Batchelor, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Minority patients, a mix of women and men, had a 90% relative rise in death and MIs, and a 60% higher rate of MIs after adjustment, both statistically significant differences.
Dr. Batchelor and his associates have not yet analyzed what factors are behind these worse outcomes in women and minority patients. But he suspects social and economic factors may provide at least some explanation, including income, education, language fluency, exercise habits, and access to health care.
“I think the trends we saw are real; the question is what accounts for the differences,” said Dr. Batchelor, an interventional cardiologist in Tallahassee, Fla. Regardless of the causes, he believes that the outcome differences have important immediate messages.
“We need to ensure better representation of women and minorities in clinical trials,” he said in an interview. “We don’t collect enough data from women and minorities. Historically, they have been underrepresented in trials.”
Another lesson is the importance of putting women and minority patients with cardiovascular disease on guideline-directed treatment, including dual antiplatelet therapy, lipid-lowering drugs, and antihypertensive drugs. The results show potential opportunity to further improve outcomes in women and minority patients, Dr. Batchelor said at the meeting, sponsored by the Cardiovascular Research Foundation.
The PLATINUM Diversity trial enrolled 1,501 women and men from minority groups with coronary disease who required PCI at one of 52 U.S. sites. For his analysis, Dr. Batchelor combined the 12-month outcomes of these patients with 12-month data from 2,687 unselected patients enrolled in the PROMUS Element Plus post-marketing approval study, a group of mostly white men.
The PLATINUM Diversity trial was sponsored by Boston Scientific. Dr. Batchelor has received research support from and has been a speaker for and consultant to Boston Scientific. He also has been a speaker for and consultant to Abbott Vascular and Medtronic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected] On Twitter @mitchelzoler
WASHINGTON – The relatively low number of women and minority-group patients enrolled into cardiovascular disease clinical trials may skew the results, based on a comparison of outcomes following coronary stenting in an analysis of more than 4,000 patients.
During 12 months following coronary-disease treatment with percutaneous coronary intervention (PCI), women of diverse racial and ethnic backgrounds had a statistically significant 60% relative increase in death and myocardial infarctions, compared with white men, after adjustment for known baseline variables, Wayne B. Batchelor, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Minority patients, a mix of women and men, had a 90% relative rise in death and MIs, and a 60% higher rate of MIs after adjustment, both statistically significant differences.
Dr. Batchelor and his associates have not yet analyzed what factors are behind these worse outcomes in women and minority patients. But he suspects social and economic factors may provide at least some explanation, including income, education, language fluency, exercise habits, and access to health care.
“I think the trends we saw are real; the question is what accounts for the differences,” said Dr. Batchelor, an interventional cardiologist in Tallahassee, Fla. Regardless of the causes, he believes that the outcome differences have important immediate messages.
“We need to ensure better representation of women and minorities in clinical trials,” he said in an interview. “We don’t collect enough data from women and minorities. Historically, they have been underrepresented in trials.”
Another lesson is the importance of putting women and minority patients with cardiovascular disease on guideline-directed treatment, including dual antiplatelet therapy, lipid-lowering drugs, and antihypertensive drugs. The results show potential opportunity to further improve outcomes in women and minority patients, Dr. Batchelor said at the meeting, sponsored by the Cardiovascular Research Foundation.
The PLATINUM Diversity trial enrolled 1,501 women and men from minority groups with coronary disease who required PCI at one of 52 U.S. sites. For his analysis, Dr. Batchelor combined the 12-month outcomes of these patients with 12-month data from 2,687 unselected patients enrolled in the PROMUS Element Plus post-marketing approval study, a group of mostly white men.
The PLATINUM Diversity trial was sponsored by Boston Scientific. Dr. Batchelor has received research support from and has been a speaker for and consultant to Boston Scientific. He also has been a speaker for and consultant to Abbott Vascular and Medtronic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected] On Twitter @mitchelzoler
WASHINGTON – The relatively low number of women and minority-group patients enrolled into cardiovascular disease clinical trials may skew the results, based on a comparison of outcomes following coronary stenting in an analysis of more than 4,000 patients.
During 12 months following coronary-disease treatment with percutaneous coronary intervention (PCI), women of diverse racial and ethnic backgrounds had a statistically significant 60% relative increase in death and myocardial infarctions, compared with white men, after adjustment for known baseline variables, Wayne B. Batchelor, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Minority patients, a mix of women and men, had a 90% relative rise in death and MIs, and a 60% higher rate of MIs after adjustment, both statistically significant differences.
Dr. Batchelor and his associates have not yet analyzed what factors are behind these worse outcomes in women and minority patients. But he suspects social and economic factors may provide at least some explanation, including income, education, language fluency, exercise habits, and access to health care.
“I think the trends we saw are real; the question is what accounts for the differences,” said Dr. Batchelor, an interventional cardiologist in Tallahassee, Fla. Regardless of the causes, he believes that the outcome differences have important immediate messages.
“We need to ensure better representation of women and minorities in clinical trials,” he said in an interview. “We don’t collect enough data from women and minorities. Historically, they have been underrepresented in trials.”
Another lesson is the importance of putting women and minority patients with cardiovascular disease on guideline-directed treatment, including dual antiplatelet therapy, lipid-lowering drugs, and antihypertensive drugs. The results show potential opportunity to further improve outcomes in women and minority patients, Dr. Batchelor said at the meeting, sponsored by the Cardiovascular Research Foundation.
The PLATINUM Diversity trial enrolled 1,501 women and men from minority groups with coronary disease who required PCI at one of 52 U.S. sites. For his analysis, Dr. Batchelor combined the 12-month outcomes of these patients with 12-month data from 2,687 unselected patients enrolled in the PROMUS Element Plus post-marketing approval study, a group of mostly white men.
The PLATINUM Diversity trial was sponsored by Boston Scientific. Dr. Batchelor has received research support from and has been a speaker for and consultant to Boston Scientific. He also has been a speaker for and consultant to Abbott Vascular and Medtronic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected] On Twitter @mitchelzoler
Key clinical point:
Major finding: One year after percutaneous coronary intervention, death or myocardial infarction was 60% higher in women and 90% higher in minorities, compared with white men.
Data source: PLATINUM Diversity, a multicenter, single-arm study with 1,501 patients, and the PROMUS Element Plus U.S. postmarketing approval study with 2,683 patients.
Disclosures: The PLATINUM Diversity trial was sponsored by Boston Scientific. Dr. Batchelor has received research support from and has been a speaker for and consultant to Boston Scientific. He also has been a speaker for and consultant to Abbott Vascular and Medtronic.
NCCN: Deliver vincristine by mini IV drip bag
Always dilute chemotherapy agent vincristine and administer it by mini IV-drip bag, instead of syringe, urges the National Comprehensive Cancer Network in a new campaign.
The goal of “Just Bag It” is to prevent a rare but uniformly fatal medical error – administering vincristine to the spinal fluid. When syringes are side by side – one with vincristine for IV push, another with a chemotherapeutic agent meant for push into the spinal fluid – it is just too easy to make a mistake. When administered intrathecally, vincristine causes ascending paralysis, neurological defects, and eventually death.
Despite all the warning labels and checks, “this still happens,” Marc Stewart, MD, cochair of the National Comprehensive Cancer Network (NCCN) Best Practices Committee, as well as medical director of the Seattle Cancer Care Alliance and professor of medicine at the University of Washington, said at a press conference. 
Mini IV-drip bag administration will make it “virtually impossible. No physician would hook the bag up to a needle in someone’s spine” and even if they did, there wouldn’t be enough pressure in the bag to push vincristine in, he said.
The group has encouraged drip-bag delivery of vincristine for years, but only about half of hospitals have adopted the policy. The mistake happens so rarely – about 125 cases since the 1960s – “that the motivation for change is just not there.” Until somebody like NCCN calls it out in a high-profile campaign, “it’s not high on the radar screen,” Dr. Stewart said. It should be a relatively easy fix because bagging vincristine is not more costly. In general, the cost difference versus syringe “is going to be pennies,” he said.
“We challenge all medical centers, hospitals, and oncology practices around the nation and the world to implement this medication safety policy so this error never occurs again,” NCCN Chief Executive Officer Robert Carlson, MD, said in a press release. A medical oncologist, he witnessed the death of a 21-year-old patient after an intrathecal vincristine injection in 2005.
“Some health care providers may associate the use of an IV bag with a heightened risk of extravasation, but research shows that the risk of extravasation is extremely low (less than 0.05%) regardless of how vincristine is administered,” the press release noted.
Vincristine is widely used in treating patients with leukemia or lymphoma.
The safety of intravenous administration of vincristine has been a long-standing concern for anyone who participates in the management of patients with hematologic malignancies. As we all know, accidental intrathecal administration of vincristine is uniformly fatal.
At many centers, including ours, policies related to intravenous infusion of vesicants via a peripheral line have made the implementation of the safety recommendations difficult. It is not surprising that only 50% of hospitals surveyed by NCCN have fully implemented the mini-bag recommendation given the concern for extravasation. However, the newest ONS guidelines for vesicant administration allow for short-term infusions via a peripheral line. For our center, this support has been instrumental in allowing us to move to a practice with the recommended mini-bags. The NCCN “Just Bag It” campaign will likely help to move institutions such as ours to be in compliance with this important safety initiative.
Donna Capozzi, PharmD, is associate director of ambulatory services in the department of pharmacy at the Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine in Philadelphia. She is on the editorial advisory board of Hematology News, a publication of this news company.
The safety of intravenous administration of vincristine has been a long-standing concern for anyone who participates in the management of patients with hematologic malignancies. As we all know, accidental intrathecal administration of vincristine is uniformly fatal.
At many centers, including ours, policies related to intravenous infusion of vesicants via a peripheral line have made the implementation of the safety recommendations difficult. It is not surprising that only 50% of hospitals surveyed by NCCN have fully implemented the mini-bag recommendation given the concern for extravasation. However, the newest ONS guidelines for vesicant administration allow for short-term infusions via a peripheral line. For our center, this support has been instrumental in allowing us to move to a practice with the recommended mini-bags. The NCCN “Just Bag It” campaign will likely help to move institutions such as ours to be in compliance with this important safety initiative.
Donna Capozzi, PharmD, is associate director of ambulatory services in the department of pharmacy at the Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine in Philadelphia. She is on the editorial advisory board of Hematology News, a publication of this news company.
The safety of intravenous administration of vincristine has been a long-standing concern for anyone who participates in the management of patients with hematologic malignancies. As we all know, accidental intrathecal administration of vincristine is uniformly fatal.
At many centers, including ours, policies related to intravenous infusion of vesicants via a peripheral line have made the implementation of the safety recommendations difficult. It is not surprising that only 50% of hospitals surveyed by NCCN have fully implemented the mini-bag recommendation given the concern for extravasation. However, the newest ONS guidelines for vesicant administration allow for short-term infusions via a peripheral line. For our center, this support has been instrumental in allowing us to move to a practice with the recommended mini-bags. The NCCN “Just Bag It” campaign will likely help to move institutions such as ours to be in compliance with this important safety initiative.
Donna Capozzi, PharmD, is associate director of ambulatory services in the department of pharmacy at the Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine in Philadelphia. She is on the editorial advisory board of Hematology News, a publication of this news company.
Always dilute chemotherapy agent vincristine and administer it by mini IV-drip bag, instead of syringe, urges the National Comprehensive Cancer Network in a new campaign.
The goal of “Just Bag It” is to prevent a rare but uniformly fatal medical error – administering vincristine to the spinal fluid. When syringes are side by side – one with vincristine for IV push, another with a chemotherapeutic agent meant for push into the spinal fluid – it is just too easy to make a mistake. When administered intrathecally, vincristine causes ascending paralysis, neurological defects, and eventually death.
Despite all the warning labels and checks, “this still happens,” Marc Stewart, MD, cochair of the National Comprehensive Cancer Network (NCCN) Best Practices Committee, as well as medical director of the Seattle Cancer Care Alliance and professor of medicine at the University of Washington, said at a press conference.
Mini IV-drip bag administration will make it “virtually impossible. No physician would hook the bag up to a needle in someone’s spine” and even if they did, there wouldn’t be enough pressure in the bag to push vincristine in, he said.
The group has encouraged drip-bag delivery of vincristine for years, but only about half of hospitals have adopted the policy. The mistake happens so rarely – about 125 cases since the 1960s – “that the motivation for change is just not there.” Until somebody like NCCN calls it out in a high-profile campaign, “it’s not high on the radar screen,” Dr. Stewart said. It should be a relatively easy fix because bagging vincristine is not more costly. In general, the cost difference versus syringe “is going to be pennies,” he said.
“We challenge all medical centers, hospitals, and oncology practices around the nation and the world to implement this medication safety policy so this error never occurs again,” NCCN Chief Executive Officer Robert Carlson, MD, said in a press release. A medical oncologist, he witnessed the death of a 21-year-old patient after an intrathecal vincristine injection in 2005.
“Some health care providers may associate the use of an IV bag with a heightened risk of extravasation, but research shows that the risk of extravasation is extremely low (less than 0.05%) regardless of how vincristine is administered,” the press release noted.
Vincristine is widely used in treating patients with leukemia or lymphoma.
Always dilute chemotherapy agent vincristine and administer it by mini IV-drip bag, instead of syringe, urges the National Comprehensive Cancer Network in a new campaign.
The goal of “Just Bag It” is to prevent a rare but uniformly fatal medical error – administering vincristine to the spinal fluid. When syringes are side by side – one with vincristine for IV push, another with a chemotherapeutic agent meant for push into the spinal fluid – it is just too easy to make a mistake. When administered intrathecally, vincristine causes ascending paralysis, neurological defects, and eventually death.
Despite all the warning labels and checks, “this still happens,” Marc Stewart, MD, cochair of the National Comprehensive Cancer Network (NCCN) Best Practices Committee, as well as medical director of the Seattle Cancer Care Alliance and professor of medicine at the University of Washington, said at a press conference.
Mini IV-drip bag administration will make it “virtually impossible. No physician would hook the bag up to a needle in someone’s spine” and even if they did, there wouldn’t be enough pressure in the bag to push vincristine in, he said.
The group has encouraged drip-bag delivery of vincristine for years, but only about half of hospitals have adopted the policy. The mistake happens so rarely – about 125 cases since the 1960s – “that the motivation for change is just not there.” Until somebody like NCCN calls it out in a high-profile campaign, “it’s not high on the radar screen,” Dr. Stewart said. It should be a relatively easy fix because bagging vincristine is not more costly. In general, the cost difference versus syringe “is going to be pennies,” he said.
“We challenge all medical centers, hospitals, and oncology practices around the nation and the world to implement this medication safety policy so this error never occurs again,” NCCN Chief Executive Officer Robert Carlson, MD, said in a press release. A medical oncologist, he witnessed the death of a 21-year-old patient after an intrathecal vincristine injection in 2005.
“Some health care providers may associate the use of an IV bag with a heightened risk of extravasation, but research shows that the risk of extravasation is extremely low (less than 0.05%) regardless of how vincristine is administered,” the press release noted.
Vincristine is widely used in treating patients with leukemia or lymphoma.
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.
Combine qSOFA and SIRS for best sepsis score
LOS ANGELES – Instead of replacing the Systemic Inflammatory Response Syndrome (SIRS) score with the new quick Sequential Organ Failure Assessment (qSOFA) score to identify severe sepsis patients, it might be best to use both, according to two studies presented at the American College of Chest Physicians annual meeting.
The gold standard 3rd International Consensus Definitions for Sepsis and Septic Shock Task Force recently introduced qSOFA to replace SIRS, in part because SIRS is too sensitive. With criteria that include a temperature above 38° C; a heart rate above 90 bpm, and a respiratory rate above 20 breaths per minute, it’s possible to score positive on SIRS by walking up a flight of stairs, audience members at the study presentations noted.
The first study at the meeting session – a prospective cohort of 152 patients scored by both systems within 8 hours of ICU admission at the New York–Presbyterian Hospital – found that qSOFA was slightly better at predicting in-hospital mortality and ICU-free days, but no better than SIRS at predicting ventilator- or organ failure–free days.
However, of the 36% of patients (55) who met only one of the three qSOFA criteria - a respiratory rate of 22 breaths per minute, altered mental status, or a systolic blood pressure of 100 mg Hg or less - 6% (3) died in the hospital. Of those patients, two-thirds (2) were SIRS positive, meaning that they met two or more SIRS criteria.
“Having a borderline qSOFA of 1 point, which is considered negative, with the addition of having SIRS criteria, should raise concerns that patients need further evaluation. SIRS criteria should not be [entirely] discarded” in favor of qSOFA, said lead investigator Eli Finkelsztein, MD, of the New York–Presbyterian Hospital in New York City
The second study – a review of 6,811 severe sepsis/septic shock patients scored by both systems within 3 hours of emergency department admission at the University of Kansas Hospital emergency department in Kansas City – found that the two scores performed largely the same when it came to predicting ICU admission and 30-day mortality, but that people who met two or more criteria in both systems were of special concern.
Twenty-five percent of patients (1,713) scored 2 or more on both SIRS and qSOFA. These patients were more likely to be admitted to the ICU and be readmitted to the hospital after a month, compared with those patients who were positive in only one scoring system or negative in both. Additional factors associated with these patients were that they had the longest ICU and hospital lengths of stay. Two hundred (12%) of these patients scoring 2 or more on both SIRS and qSOFA died within 30 days.
“SIRS criteria continue to be more sensitive at identifying severe sepsis, but they are equally as accurate [as qSOFA criteria] at predicting adverse patient outcomes,” said lead investigator and Kansas University medical student Amanda Deis.
SIRS and qSOFA take only a few seconds to assess at the bedside. Using both builds “a clinical picture,” she said.
There was no industry funding for the work, and the investigators had no relevant financial disclosures.
Everybody got fed up with SIRS because it’s overly sensitive, but now we’ve swung in the other direction. It’s absolutely true that qSOFA is more specific, but one of the presenters had a 6% rate of qSOFA missing sick patients.
We want to be somewhere in the middle in terms of not missing too many of these cases. I thought 6% was reasonable, but others may not.
Zaza Cohen, MD, is the director of critical care at Mountainside Hospital in Montclair, N.J. He moderated - but was not involved with - the two studies.
Everybody got fed up with SIRS because it’s overly sensitive, but now we’ve swung in the other direction. It’s absolutely true that qSOFA is more specific, but one of the presenters had a 6% rate of qSOFA missing sick patients.
We want to be somewhere in the middle in terms of not missing too many of these cases. I thought 6% was reasonable, but others may not.
Zaza Cohen, MD, is the director of critical care at Mountainside Hospital in Montclair, N.J. He moderated - but was not involved with - the two studies.
Everybody got fed up with SIRS because it’s overly sensitive, but now we’ve swung in the other direction. It’s absolutely true that qSOFA is more specific, but one of the presenters had a 6% rate of qSOFA missing sick patients.
We want to be somewhere in the middle in terms of not missing too many of these cases. I thought 6% was reasonable, but others may not.
Zaza Cohen, MD, is the director of critical care at Mountainside Hospital in Montclair, N.J. He moderated - but was not involved with - the two studies.
LOS ANGELES – Instead of replacing the Systemic Inflammatory Response Syndrome (SIRS) score with the new quick Sequential Organ Failure Assessment (qSOFA) score to identify severe sepsis patients, it might be best to use both, according to two studies presented at the American College of Chest Physicians annual meeting.
The gold standard 3rd International Consensus Definitions for Sepsis and Septic Shock Task Force recently introduced qSOFA to replace SIRS, in part because SIRS is too sensitive. With criteria that include a temperature above 38° C; a heart rate above 90 bpm, and a respiratory rate above 20 breaths per minute, it’s possible to score positive on SIRS by walking up a flight of stairs, audience members at the study presentations noted.
The first study at the meeting session – a prospective cohort of 152 patients scored by both systems within 8 hours of ICU admission at the New York–Presbyterian Hospital – found that qSOFA was slightly better at predicting in-hospital mortality and ICU-free days, but no better than SIRS at predicting ventilator- or organ failure–free days.
However, of the 36% of patients (55) who met only one of the three qSOFA criteria - a respiratory rate of 22 breaths per minute, altered mental status, or a systolic blood pressure of 100 mg Hg or less - 6% (3) died in the hospital. Of those patients, two-thirds (2) were SIRS positive, meaning that they met two or more SIRS criteria.
“Having a borderline qSOFA of 1 point, which is considered negative, with the addition of having SIRS criteria, should raise concerns that patients need further evaluation. SIRS criteria should not be [entirely] discarded” in favor of qSOFA, said lead investigator Eli Finkelsztein, MD, of the New York–Presbyterian Hospital in New York City
The second study – a review of 6,811 severe sepsis/septic shock patients scored by both systems within 3 hours of emergency department admission at the University of Kansas Hospital emergency department in Kansas City – found that the two scores performed largely the same when it came to predicting ICU admission and 30-day mortality, but that people who met two or more criteria in both systems were of special concern.
Twenty-five percent of patients (1,713) scored 2 or more on both SIRS and qSOFA. These patients were more likely to be admitted to the ICU and be readmitted to the hospital after a month, compared with those patients who were positive in only one scoring system or negative in both. Additional factors associated with these patients were that they had the longest ICU and hospital lengths of stay. Two hundred (12%) of these patients scoring 2 or more on both SIRS and qSOFA died within 30 days.
“SIRS criteria continue to be more sensitive at identifying severe sepsis, but they are equally as accurate [as qSOFA criteria] at predicting adverse patient outcomes,” said lead investigator and Kansas University medical student Amanda Deis.
SIRS and qSOFA take only a few seconds to assess at the bedside. Using both builds “a clinical picture,” she said.
There was no industry funding for the work, and the investigators had no relevant financial disclosures.
LOS ANGELES – Instead of replacing the Systemic Inflammatory Response Syndrome (SIRS) score with the new quick Sequential Organ Failure Assessment (qSOFA) score to identify severe sepsis patients, it might be best to use both, according to two studies presented at the American College of Chest Physicians annual meeting.
The gold standard 3rd International Consensus Definitions for Sepsis and Septic Shock Task Force recently introduced qSOFA to replace SIRS, in part because SIRS is too sensitive. With criteria that include a temperature above 38° C; a heart rate above 90 bpm, and a respiratory rate above 20 breaths per minute, it’s possible to score positive on SIRS by walking up a flight of stairs, audience members at the study presentations noted.
The first study at the meeting session – a prospective cohort of 152 patients scored by both systems within 8 hours of ICU admission at the New York–Presbyterian Hospital – found that qSOFA was slightly better at predicting in-hospital mortality and ICU-free days, but no better than SIRS at predicting ventilator- or organ failure–free days.
However, of the 36% of patients (55) who met only one of the three qSOFA criteria - a respiratory rate of 22 breaths per minute, altered mental status, or a systolic blood pressure of 100 mg Hg or less - 6% (3) died in the hospital. Of those patients, two-thirds (2) were SIRS positive, meaning that they met two or more SIRS criteria.
“Having a borderline qSOFA of 1 point, which is considered negative, with the addition of having SIRS criteria, should raise concerns that patients need further evaluation. SIRS criteria should not be [entirely] discarded” in favor of qSOFA, said lead investigator Eli Finkelsztein, MD, of the New York–Presbyterian Hospital in New York City
The second study – a review of 6,811 severe sepsis/septic shock patients scored by both systems within 3 hours of emergency department admission at the University of Kansas Hospital emergency department in Kansas City – found that the two scores performed largely the same when it came to predicting ICU admission and 30-day mortality, but that people who met two or more criteria in both systems were of special concern.
Twenty-five percent of patients (1,713) scored 2 or more on both SIRS and qSOFA. These patients were more likely to be admitted to the ICU and be readmitted to the hospital after a month, compared with those patients who were positive in only one scoring system or negative in both. Additional factors associated with these patients were that they had the longest ICU and hospital lengths of stay. Two hundred (12%) of these patients scoring 2 or more on both SIRS and qSOFA died within 30 days.
“SIRS criteria continue to be more sensitive at identifying severe sepsis, but they are equally as accurate [as qSOFA criteria] at predicting adverse patient outcomes,” said lead investigator and Kansas University medical student Amanda Deis.
SIRS and qSOFA take only a few seconds to assess at the bedside. Using both builds “a clinical picture,” she said.
There was no industry funding for the work, and the investigators had no relevant financial disclosures.
AT CHEST 2016
Key clinical point:
Major finding: Of the 36% of patients who met only one of the three qSOFA criteria, 6% died in the hospital. Of those patients, two-thirds were SIRS positive, meaning that they met two or more SIRS criteria.
Data source: Two studies of almost 7,000 septic patients.
Disclosures: There was no industry funding for the work, and the investigators had no relevant financial disclosures.