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CT opens extended window for stroke thrombolysis
MONTREAL – An extended time window for thrombolytic treatment of acute ischemic stroke patients using tissue plasminogen activator out to 9 hours from stroke onset was safe and effective using CT perfusion imaging and automated imaging processing software to select suitable patients in the EXTEND trial. This result matches the groundbreaking finding reported earlier in 2018 that used MRI to select patients for extended thrombolysis.
“To reproduce our results you need to set up CT perfusion” as well as the RAPID software for automated image processing to identify patients with a small infarct core and a large area of salvageable brain, said Henry Ma, MD, a stroke neurologist at Monash University, Melbourne, as he reported results from the trial at the World Stroke Congress. “EXTEND is the first positive thrombolysis trial in an extended time window using automated penumbral imaging.”
The new finding, from a trial with 225 randomized stroke patients, was especially notable because, by showing the validity of CT imaging for patient selection, it makes applying the extended time window for thrombolytic therapy more feasible for U.S. and Canadian stroke centers where CT imaging is much more common than MRI. A report from European investigators published in August 2018 from the WAKE-UP trial showed that thrombolysis with tissue plasminogen activator (tPA) was safe and effective when administered to patients who woke up with an acute ischemic stroke that had occurred more than 4.5 hours before treatment, but this study exclusively used MRI for patient selection (N Engl J Med. 2018 Aug 16;379[7]:611-22).
“In North America, our systems are more equipped for using CT,” commented Ashfaq Shuaib, MD, a professor of medicine and neurologist at the University of Alberta, Edmonton. Based on the WAKE-UP results, “MR would be preferred, but what we’ve been doing [since the WAKE-UP report] is if we see a CT scan that’s good we go ahead” with thrombolysis.
“Biologically, it doesn’t matter whether you use MR or CT; they both index the same underlying pathology. We’ve been hesitant to go beyond the MR finding from WAKE-UP, where there were data, but the findings from EXTEND were right in line with the WAKE-UP results, and that’s all we need to be reassured” that CT perfusion imaging also works for patient selection, commented Jeffrey L. Saver, MD, professor of medicine and director of the Comprehensive Stroke Center at the University of California, Los Angeles.
CT perfusion imaging and automated image processing “worked to select stroke patients” for an extended time window for treatment with mechanical thrombectomy in the DAWN (N Engl J Med. 2018 Jan 4;378[1]:11-21) and DEFUSE 3 (N Engl J Med. 2018 Feb 22;378[8]:308-18) trials, a history that makes the new finding of successfully using CT imaging to select patients who qualify for extended use of thrombolysis “a convincing result,” Dr. Saver said in an interview. The new EXTEND findings “will have a major impact” on using an extended time window for thrombolysis in U.S. practice, he predicted.
The EXTEND trial (Int J Stroke. 2012 Jan 1;7[1]:74-80) ran at 22 sites in Australia, 11 sites in Taiwan, and 1 center in New Zealand. Recruitment of patients into the study stopped early, after enrolling 225 patients, in June 2018, when results from WAKE-UP came out.
The EXTEND investigators enrolled patients who were either 4.5-9 hours out from the onset of their stroke or patients with a wake-up stroke with an uncertain onset. Participating centers could use either CT perfusion or MRI to identify candidates for treatment, and all used the RAPID software for image processing to identify patients with a perfusion lesion of at least 10 mL and an ischemic core volume no greater than 70 mL. Dr. Ma did not report what percentage of patients underwent imaging with each of these methods, but hinted that clinicians had used CT for a majority of the cases. The study randomized patients to receive either 0.9 mg/kg tPA or placebo, and by the trial protocol none of the enrolled patients received treatment with mechanical thrombectomy.
The trial’s primary endpoint was the percentage of patients with a modified Rankin Scale score of 0 or 1 at 90 days after their stroke, which was achieved by 44% more patients in the tPA group relative to the placebo arm after adjustment for age and baseline stroke severity, a statistically significant difference. The results were also positive for several secondary endpoints, such as recanalization 24 hours after treatment, which occurred in 67% of patients treated with tPA and 37% of the control patients, a statistically significant 68% relative improvement with thrombolysis.
Mortality at 90 days was similar in the two arms – 9% among the placebo patients and 12% among those who received tPA. The rate of symptomatic intracranial hemorrhage 36 hours after treatment was significantly higher among patients treated with tPA at 6%, compared with 1% in the placebo group, but the magnitude of this adverse effect was consistent with rates of intracranial hemorrhages previously reported in other studies of thrombolytic treatment for acute ischemic stroke, Dr. Ma said. The small number of increased intracranial hemorrhages “was not associated with increased mortality, and did not negate the positive result of an improved rate of excellent functional outcomes.”
These findings will likely spur further adoption of imaging processing software of the type used in EXTEND by U.S. stroke centers, Dr. Saver predicted.
“More and more centers have been getting this [software], and now they have two reasons to have it: to identify patients for an extended window for mechanical thrombectomy and to identify patients for an extended window for thrombolysis. It is a compelling case to have the imaging software as widely disseminated as possible. Centers that want to do the best for patients should have this imaging-processing software,” Dr. Saver said.
Dr. Ma and Dr. Shuaib reported no disclosures. Dr. Saver has received research funding and personal fees from Medtronic-Abbott and Neuravia.
SOURCE: Ma H et al. Int J. Stroke. 2018 Oct;13(2S):235, Abstract 1014.
Ever since results from the WAKE-UP trial came out earlier in 2018, we at the University of Cincinnati have been imaging acute ischemic stroke patients who presented outside the standard 4.5-hour time limit for thrombolysis with MRI to see if they qualify for an extended window for thrombolysis. But this has been a cumbersome and redundant process because our default imaging method is CT, so we have been imaging potential candidates for an extended thrombolytic window twice, first with CT and then later with MRI.
The EXTEND findings also provide a further reason for U.S. stroke centers to purchase and use some type of imaging processing software if they don’t already have it, either the RAPID software that was used in EXTEND or one of the several similar software packages that are now available. Several primary stroke centers in my area still do not currently use this software, although its use has been quickly spreading and it will now be increasingly hard for these centers to hold off acquiring it. Fortunately the increased competition among software vendors who sell this type of software has meant that the price has been dropping.
Pooja Khatri, MD , is a professor of neurology and director of acute stroke at the University of Cincinnati. She has been a consultant to Biogen, Greenwich, and PTC Therapeutics. She made these comments in an interview.
Ever since results from the WAKE-UP trial came out earlier in 2018, we at the University of Cincinnati have been imaging acute ischemic stroke patients who presented outside the standard 4.5-hour time limit for thrombolysis with MRI to see if they qualify for an extended window for thrombolysis. But this has been a cumbersome and redundant process because our default imaging method is CT, so we have been imaging potential candidates for an extended thrombolytic window twice, first with CT and then later with MRI.
The EXTEND findings also provide a further reason for U.S. stroke centers to purchase and use some type of imaging processing software if they don’t already have it, either the RAPID software that was used in EXTEND or one of the several similar software packages that are now available. Several primary stroke centers in my area still do not currently use this software, although its use has been quickly spreading and it will now be increasingly hard for these centers to hold off acquiring it. Fortunately the increased competition among software vendors who sell this type of software has meant that the price has been dropping.
Pooja Khatri, MD , is a professor of neurology and director of acute stroke at the University of Cincinnati. She has been a consultant to Biogen, Greenwich, and PTC Therapeutics. She made these comments in an interview.
Ever since results from the WAKE-UP trial came out earlier in 2018, we at the University of Cincinnati have been imaging acute ischemic stroke patients who presented outside the standard 4.5-hour time limit for thrombolysis with MRI to see if they qualify for an extended window for thrombolysis. But this has been a cumbersome and redundant process because our default imaging method is CT, so we have been imaging potential candidates for an extended thrombolytic window twice, first with CT and then later with MRI.
The EXTEND findings also provide a further reason for U.S. stroke centers to purchase and use some type of imaging processing software if they don’t already have it, either the RAPID software that was used in EXTEND or one of the several similar software packages that are now available. Several primary stroke centers in my area still do not currently use this software, although its use has been quickly spreading and it will now be increasingly hard for these centers to hold off acquiring it. Fortunately the increased competition among software vendors who sell this type of software has meant that the price has been dropping.
Pooja Khatri, MD , is a professor of neurology and director of acute stroke at the University of Cincinnati. She has been a consultant to Biogen, Greenwich, and PTC Therapeutics. She made these comments in an interview.
MONTREAL – An extended time window for thrombolytic treatment of acute ischemic stroke patients using tissue plasminogen activator out to 9 hours from stroke onset was safe and effective using CT perfusion imaging and automated imaging processing software to select suitable patients in the EXTEND trial. This result matches the groundbreaking finding reported earlier in 2018 that used MRI to select patients for extended thrombolysis.
“To reproduce our results you need to set up CT perfusion” as well as the RAPID software for automated image processing to identify patients with a small infarct core and a large area of salvageable brain, said Henry Ma, MD, a stroke neurologist at Monash University, Melbourne, as he reported results from the trial at the World Stroke Congress. “EXTEND is the first positive thrombolysis trial in an extended time window using automated penumbral imaging.”
The new finding, from a trial with 225 randomized stroke patients, was especially notable because, by showing the validity of CT imaging for patient selection, it makes applying the extended time window for thrombolytic therapy more feasible for U.S. and Canadian stroke centers where CT imaging is much more common than MRI. A report from European investigators published in August 2018 from the WAKE-UP trial showed that thrombolysis with tissue plasminogen activator (tPA) was safe and effective when administered to patients who woke up with an acute ischemic stroke that had occurred more than 4.5 hours before treatment, but this study exclusively used MRI for patient selection (N Engl J Med. 2018 Aug 16;379[7]:611-22).
“In North America, our systems are more equipped for using CT,” commented Ashfaq Shuaib, MD, a professor of medicine and neurologist at the University of Alberta, Edmonton. Based on the WAKE-UP results, “MR would be preferred, but what we’ve been doing [since the WAKE-UP report] is if we see a CT scan that’s good we go ahead” with thrombolysis.
“Biologically, it doesn’t matter whether you use MR or CT; they both index the same underlying pathology. We’ve been hesitant to go beyond the MR finding from WAKE-UP, where there were data, but the findings from EXTEND were right in line with the WAKE-UP results, and that’s all we need to be reassured” that CT perfusion imaging also works for patient selection, commented Jeffrey L. Saver, MD, professor of medicine and director of the Comprehensive Stroke Center at the University of California, Los Angeles.
CT perfusion imaging and automated image processing “worked to select stroke patients” for an extended time window for treatment with mechanical thrombectomy in the DAWN (N Engl J Med. 2018 Jan 4;378[1]:11-21) and DEFUSE 3 (N Engl J Med. 2018 Feb 22;378[8]:308-18) trials, a history that makes the new finding of successfully using CT imaging to select patients who qualify for extended use of thrombolysis “a convincing result,” Dr. Saver said in an interview. The new EXTEND findings “will have a major impact” on using an extended time window for thrombolysis in U.S. practice, he predicted.
The EXTEND trial (Int J Stroke. 2012 Jan 1;7[1]:74-80) ran at 22 sites in Australia, 11 sites in Taiwan, and 1 center in New Zealand. Recruitment of patients into the study stopped early, after enrolling 225 patients, in June 2018, when results from WAKE-UP came out.
The EXTEND investigators enrolled patients who were either 4.5-9 hours out from the onset of their stroke or patients with a wake-up stroke with an uncertain onset. Participating centers could use either CT perfusion or MRI to identify candidates for treatment, and all used the RAPID software for image processing to identify patients with a perfusion lesion of at least 10 mL and an ischemic core volume no greater than 70 mL. Dr. Ma did not report what percentage of patients underwent imaging with each of these methods, but hinted that clinicians had used CT for a majority of the cases. The study randomized patients to receive either 0.9 mg/kg tPA or placebo, and by the trial protocol none of the enrolled patients received treatment with mechanical thrombectomy.
The trial’s primary endpoint was the percentage of patients with a modified Rankin Scale score of 0 or 1 at 90 days after their stroke, which was achieved by 44% more patients in the tPA group relative to the placebo arm after adjustment for age and baseline stroke severity, a statistically significant difference. The results were also positive for several secondary endpoints, such as recanalization 24 hours after treatment, which occurred in 67% of patients treated with tPA and 37% of the control patients, a statistically significant 68% relative improvement with thrombolysis.
Mortality at 90 days was similar in the two arms – 9% among the placebo patients and 12% among those who received tPA. The rate of symptomatic intracranial hemorrhage 36 hours after treatment was significantly higher among patients treated with tPA at 6%, compared with 1% in the placebo group, but the magnitude of this adverse effect was consistent with rates of intracranial hemorrhages previously reported in other studies of thrombolytic treatment for acute ischemic stroke, Dr. Ma said. The small number of increased intracranial hemorrhages “was not associated with increased mortality, and did not negate the positive result of an improved rate of excellent functional outcomes.”
These findings will likely spur further adoption of imaging processing software of the type used in EXTEND by U.S. stroke centers, Dr. Saver predicted.
“More and more centers have been getting this [software], and now they have two reasons to have it: to identify patients for an extended window for mechanical thrombectomy and to identify patients for an extended window for thrombolysis. It is a compelling case to have the imaging software as widely disseminated as possible. Centers that want to do the best for patients should have this imaging-processing software,” Dr. Saver said.
Dr. Ma and Dr. Shuaib reported no disclosures. Dr. Saver has received research funding and personal fees from Medtronic-Abbott and Neuravia.
SOURCE: Ma H et al. Int J. Stroke. 2018 Oct;13(2S):235, Abstract 1014.
MONTREAL – An extended time window for thrombolytic treatment of acute ischemic stroke patients using tissue plasminogen activator out to 9 hours from stroke onset was safe and effective using CT perfusion imaging and automated imaging processing software to select suitable patients in the EXTEND trial. This result matches the groundbreaking finding reported earlier in 2018 that used MRI to select patients for extended thrombolysis.
“To reproduce our results you need to set up CT perfusion” as well as the RAPID software for automated image processing to identify patients with a small infarct core and a large area of salvageable brain, said Henry Ma, MD, a stroke neurologist at Monash University, Melbourne, as he reported results from the trial at the World Stroke Congress. “EXTEND is the first positive thrombolysis trial in an extended time window using automated penumbral imaging.”
The new finding, from a trial with 225 randomized stroke patients, was especially notable because, by showing the validity of CT imaging for patient selection, it makes applying the extended time window for thrombolytic therapy more feasible for U.S. and Canadian stroke centers where CT imaging is much more common than MRI. A report from European investigators published in August 2018 from the WAKE-UP trial showed that thrombolysis with tissue plasminogen activator (tPA) was safe and effective when administered to patients who woke up with an acute ischemic stroke that had occurred more than 4.5 hours before treatment, but this study exclusively used MRI for patient selection (N Engl J Med. 2018 Aug 16;379[7]:611-22).
“In North America, our systems are more equipped for using CT,” commented Ashfaq Shuaib, MD, a professor of medicine and neurologist at the University of Alberta, Edmonton. Based on the WAKE-UP results, “MR would be preferred, but what we’ve been doing [since the WAKE-UP report] is if we see a CT scan that’s good we go ahead” with thrombolysis.
“Biologically, it doesn’t matter whether you use MR or CT; they both index the same underlying pathology. We’ve been hesitant to go beyond the MR finding from WAKE-UP, where there were data, but the findings from EXTEND were right in line with the WAKE-UP results, and that’s all we need to be reassured” that CT perfusion imaging also works for patient selection, commented Jeffrey L. Saver, MD, professor of medicine and director of the Comprehensive Stroke Center at the University of California, Los Angeles.
CT perfusion imaging and automated image processing “worked to select stroke patients” for an extended time window for treatment with mechanical thrombectomy in the DAWN (N Engl J Med. 2018 Jan 4;378[1]:11-21) and DEFUSE 3 (N Engl J Med. 2018 Feb 22;378[8]:308-18) trials, a history that makes the new finding of successfully using CT imaging to select patients who qualify for extended use of thrombolysis “a convincing result,” Dr. Saver said in an interview. The new EXTEND findings “will have a major impact” on using an extended time window for thrombolysis in U.S. practice, he predicted.
The EXTEND trial (Int J Stroke. 2012 Jan 1;7[1]:74-80) ran at 22 sites in Australia, 11 sites in Taiwan, and 1 center in New Zealand. Recruitment of patients into the study stopped early, after enrolling 225 patients, in June 2018, when results from WAKE-UP came out.
The EXTEND investigators enrolled patients who were either 4.5-9 hours out from the onset of their stroke or patients with a wake-up stroke with an uncertain onset. Participating centers could use either CT perfusion or MRI to identify candidates for treatment, and all used the RAPID software for image processing to identify patients with a perfusion lesion of at least 10 mL and an ischemic core volume no greater than 70 mL. Dr. Ma did not report what percentage of patients underwent imaging with each of these methods, but hinted that clinicians had used CT for a majority of the cases. The study randomized patients to receive either 0.9 mg/kg tPA or placebo, and by the trial protocol none of the enrolled patients received treatment with mechanical thrombectomy.
The trial’s primary endpoint was the percentage of patients with a modified Rankin Scale score of 0 or 1 at 90 days after their stroke, which was achieved by 44% more patients in the tPA group relative to the placebo arm after adjustment for age and baseline stroke severity, a statistically significant difference. The results were also positive for several secondary endpoints, such as recanalization 24 hours after treatment, which occurred in 67% of patients treated with tPA and 37% of the control patients, a statistically significant 68% relative improvement with thrombolysis.
Mortality at 90 days was similar in the two arms – 9% among the placebo patients and 12% among those who received tPA. The rate of symptomatic intracranial hemorrhage 36 hours after treatment was significantly higher among patients treated with tPA at 6%, compared with 1% in the placebo group, but the magnitude of this adverse effect was consistent with rates of intracranial hemorrhages previously reported in other studies of thrombolytic treatment for acute ischemic stroke, Dr. Ma said. The small number of increased intracranial hemorrhages “was not associated with increased mortality, and did not negate the positive result of an improved rate of excellent functional outcomes.”
These findings will likely spur further adoption of imaging processing software of the type used in EXTEND by U.S. stroke centers, Dr. Saver predicted.
“More and more centers have been getting this [software], and now they have two reasons to have it: to identify patients for an extended window for mechanical thrombectomy and to identify patients for an extended window for thrombolysis. It is a compelling case to have the imaging software as widely disseminated as possible. Centers that want to do the best for patients should have this imaging-processing software,” Dr. Saver said.
Dr. Ma and Dr. Shuaib reported no disclosures. Dr. Saver has received research funding and personal fees from Medtronic-Abbott and Neuravia.
SOURCE: Ma H et al. Int J. Stroke. 2018 Oct;13(2S):235, Abstract 1014.
REPORTING FROM THE WORLD STROKE CONGRESS
Key clinical point:
Major finding: Patients who received thrombolysis 4.5-9 hours after stroke onset had a 44% increased rate of good outcomes, compared with controls.
Study details: EXTEND, a multicenter, controlled trial with 225 patients.
Disclosures: Dr. Ma and Dr. Shuaib had no disclosures. Dr. Saver has received research funding and personal fees from Medtronic-Abbott and Neuravia.
Source: Ma H et al. Int J. Stroke. 2018 Oct;13(2S):235, Abstract 1014.
Fever, intestinal symptoms may delay diagnosis of Kawasaki disease in children
Symptoms of gastrointestinal involvement such as abdominal pain and vomiting may delay diagnosis of Kawasaki disease in pediatric patients.
“The clinical onset of Kawasaki disease with gastrointestinal involvement often leads to diagnostic and therapeutic delays – a risk factor for the development of coronary complications,” Claudia Colomba, MD, from the department of sciences for health promotion and mother and child care at the University of Palermo (Italy), and her colleagues wrote in the Journal of Pediatrics.
After caring for a boy aged 14 years at their center who presented with these symptoms, Dr. Colomba and her colleagues performed a search of the PubMed and Scopus databases and identified 33 articles with 48 total cases of Kawasaki disease with intestinal involvement between 1979 and 2017.
There were 40 cases of fever (82%), 34 cases of abdominal pain (69%), and 24 cases of vomiting (49%) at disease onset, with diarrhea occurring in 14 cases (29%) and jaundice in 1 case (2%), the researchers noted. Cardiac involvement occurred in 21 cases (43%). With regard to imaging, 38 cases of pseudo-obstruction (77%) were identified by plain radiograph, ultrasonography, and CT. Over half of the cases required surgery; of these 25 cases (51%), 8 cases involved a resection of the restricted loop and included a temporary colostomy (16%), 5 cases were exploratory laparotomy (10%), and there was 1 case with enterolysis (2%).
A total of 45 patients received medical treatment, with 12 patients (25%) receiving intravenous immunoglobulin and 18 (37%) receiving intravenous immunoglobulin plus aspirin. One patient had cyanosis and hand and foot gangrene. There were three patients who died, with massive liver necrosis identified during the autopsy of one patient. Of the other two who died, one did so 2 days after exploratory laparotomy and the other died because of Pseudomonas septic shock.
The researchers reported a good outcome in 28 patients (57%), which included 3 cases where there was no treatment.
“The diagnosis of Kawasaki disease should be considered in all children with fever, abdominal pain, and radiologic signs of pseudo-obstruction, even in the absence of typical symptoms and signs,” Dr. Colomba and her colleagues wrote. “A more comprehensive analysis including all clinical forms of Kawasaki disease would be useful to correlate intestinal involvement with worse outcomes for cardiac complications, as well as to clues to more rapid diagnosis and avoidance of unnecessary invasive procedures.”
The authors reported no relevant conflicts of interest.
SOURCE: Colomba C et al. J Pediatr. 2018 Jul 17. doi: 10.1016/j.jpeds.2018.06.034.
Adding abdominal pain–first presentation to Kawasaki disease is not unprecedented considering lymph node–first presentation was first introduced as a concept in the Journal of Pediatrics in 2013, Sarah S. Long, MD, wrote in a related editorial.
“It should not be too surprising that intestinal vasculitis could be significant in some cases,” Dr. Long said. “Might it not suggest an intestinal portal of microbe or super antigen entry, as might cervical lymphadenitis a respiratory tract portal of entry?”
Dr. Long noted diagnostic and reporting bias was most likely the cause of the 43% rate of coronary artery aneurysms reported in the study by Colomba et al, but said that “it behooves us all to consider Kawasaki disease in the differential when a child has high fever and abdominal pain.”
Dr. Long is a professor of pediatrics at Drexel University, Philadelphia. She made her comments regarding the article by Colomba et al. in the Journal of Pediatrics (2018 Jul 17. doi: 10.1016/j.jpeds.2018.09.018 ). Dr. Long is on the editorial board of the journal, served as the chief editor on and receives royalties from “Principles and Practice of Pediatric Infectious Diseases,” and serves as the associate editor of the Red Book Report of the American Academy of Pediatrics Committee on Infectious Diseases.
Adding abdominal pain–first presentation to Kawasaki disease is not unprecedented considering lymph node–first presentation was first introduced as a concept in the Journal of Pediatrics in 2013, Sarah S. Long, MD, wrote in a related editorial.
“It should not be too surprising that intestinal vasculitis could be significant in some cases,” Dr. Long said. “Might it not suggest an intestinal portal of microbe or super antigen entry, as might cervical lymphadenitis a respiratory tract portal of entry?”
Dr. Long noted diagnostic and reporting bias was most likely the cause of the 43% rate of coronary artery aneurysms reported in the study by Colomba et al, but said that “it behooves us all to consider Kawasaki disease in the differential when a child has high fever and abdominal pain.”
Dr. Long is a professor of pediatrics at Drexel University, Philadelphia. She made her comments regarding the article by Colomba et al. in the Journal of Pediatrics (2018 Jul 17. doi: 10.1016/j.jpeds.2018.09.018 ). Dr. Long is on the editorial board of the journal, served as the chief editor on and receives royalties from “Principles and Practice of Pediatric Infectious Diseases,” and serves as the associate editor of the Red Book Report of the American Academy of Pediatrics Committee on Infectious Diseases.
Adding abdominal pain–first presentation to Kawasaki disease is not unprecedented considering lymph node–first presentation was first introduced as a concept in the Journal of Pediatrics in 2013, Sarah S. Long, MD, wrote in a related editorial.
“It should not be too surprising that intestinal vasculitis could be significant in some cases,” Dr. Long said. “Might it not suggest an intestinal portal of microbe or super antigen entry, as might cervical lymphadenitis a respiratory tract portal of entry?”
Dr. Long noted diagnostic and reporting bias was most likely the cause of the 43% rate of coronary artery aneurysms reported in the study by Colomba et al, but said that “it behooves us all to consider Kawasaki disease in the differential when a child has high fever and abdominal pain.”
Dr. Long is a professor of pediatrics at Drexel University, Philadelphia. She made her comments regarding the article by Colomba et al. in the Journal of Pediatrics (2018 Jul 17. doi: 10.1016/j.jpeds.2018.09.018 ). Dr. Long is on the editorial board of the journal, served as the chief editor on and receives royalties from “Principles and Practice of Pediatric Infectious Diseases,” and serves as the associate editor of the Red Book Report of the American Academy of Pediatrics Committee on Infectious Diseases.
Symptoms of gastrointestinal involvement such as abdominal pain and vomiting may delay diagnosis of Kawasaki disease in pediatric patients.
“The clinical onset of Kawasaki disease with gastrointestinal involvement often leads to diagnostic and therapeutic delays – a risk factor for the development of coronary complications,” Claudia Colomba, MD, from the department of sciences for health promotion and mother and child care at the University of Palermo (Italy), and her colleagues wrote in the Journal of Pediatrics.
After caring for a boy aged 14 years at their center who presented with these symptoms, Dr. Colomba and her colleagues performed a search of the PubMed and Scopus databases and identified 33 articles with 48 total cases of Kawasaki disease with intestinal involvement between 1979 and 2017.
There were 40 cases of fever (82%), 34 cases of abdominal pain (69%), and 24 cases of vomiting (49%) at disease onset, with diarrhea occurring in 14 cases (29%) and jaundice in 1 case (2%), the researchers noted. Cardiac involvement occurred in 21 cases (43%). With regard to imaging, 38 cases of pseudo-obstruction (77%) were identified by plain radiograph, ultrasonography, and CT. Over half of the cases required surgery; of these 25 cases (51%), 8 cases involved a resection of the restricted loop and included a temporary colostomy (16%), 5 cases were exploratory laparotomy (10%), and there was 1 case with enterolysis (2%).
A total of 45 patients received medical treatment, with 12 patients (25%) receiving intravenous immunoglobulin and 18 (37%) receiving intravenous immunoglobulin plus aspirin. One patient had cyanosis and hand and foot gangrene. There were three patients who died, with massive liver necrosis identified during the autopsy of one patient. Of the other two who died, one did so 2 days after exploratory laparotomy and the other died because of Pseudomonas septic shock.
The researchers reported a good outcome in 28 patients (57%), which included 3 cases where there was no treatment.
“The diagnosis of Kawasaki disease should be considered in all children with fever, abdominal pain, and radiologic signs of pseudo-obstruction, even in the absence of typical symptoms and signs,” Dr. Colomba and her colleagues wrote. “A more comprehensive analysis including all clinical forms of Kawasaki disease would be useful to correlate intestinal involvement with worse outcomes for cardiac complications, as well as to clues to more rapid diagnosis and avoidance of unnecessary invasive procedures.”
The authors reported no relevant conflicts of interest.
SOURCE: Colomba C et al. J Pediatr. 2018 Jul 17. doi: 10.1016/j.jpeds.2018.06.034.
Symptoms of gastrointestinal involvement such as abdominal pain and vomiting may delay diagnosis of Kawasaki disease in pediatric patients.
“The clinical onset of Kawasaki disease with gastrointestinal involvement often leads to diagnostic and therapeutic delays – a risk factor for the development of coronary complications,” Claudia Colomba, MD, from the department of sciences for health promotion and mother and child care at the University of Palermo (Italy), and her colleagues wrote in the Journal of Pediatrics.
After caring for a boy aged 14 years at their center who presented with these symptoms, Dr. Colomba and her colleagues performed a search of the PubMed and Scopus databases and identified 33 articles with 48 total cases of Kawasaki disease with intestinal involvement between 1979 and 2017.
There were 40 cases of fever (82%), 34 cases of abdominal pain (69%), and 24 cases of vomiting (49%) at disease onset, with diarrhea occurring in 14 cases (29%) and jaundice in 1 case (2%), the researchers noted. Cardiac involvement occurred in 21 cases (43%). With regard to imaging, 38 cases of pseudo-obstruction (77%) were identified by plain radiograph, ultrasonography, and CT. Over half of the cases required surgery; of these 25 cases (51%), 8 cases involved a resection of the restricted loop and included a temporary colostomy (16%), 5 cases were exploratory laparotomy (10%), and there was 1 case with enterolysis (2%).
A total of 45 patients received medical treatment, with 12 patients (25%) receiving intravenous immunoglobulin and 18 (37%) receiving intravenous immunoglobulin plus aspirin. One patient had cyanosis and hand and foot gangrene. There were three patients who died, with massive liver necrosis identified during the autopsy of one patient. Of the other two who died, one did so 2 days after exploratory laparotomy and the other died because of Pseudomonas septic shock.
The researchers reported a good outcome in 28 patients (57%), which included 3 cases where there was no treatment.
“The diagnosis of Kawasaki disease should be considered in all children with fever, abdominal pain, and radiologic signs of pseudo-obstruction, even in the absence of typical symptoms and signs,” Dr. Colomba and her colleagues wrote. “A more comprehensive analysis including all clinical forms of Kawasaki disease would be useful to correlate intestinal involvement with worse outcomes for cardiac complications, as well as to clues to more rapid diagnosis and avoidance of unnecessary invasive procedures.”
The authors reported no relevant conflicts of interest.
SOURCE: Colomba C et al. J Pediatr. 2018 Jul 17. doi: 10.1016/j.jpeds.2018.06.034.
FROM THE JOURNAL OF PEDIATRICS
Key clinical point: Abdominal pain, fever, and radiologically identified pseudo-obstruction may delay diagnosis of Kawasaki disease in children and should be considered for these patients.
Major finding: Fever, abdominal pain, and vomiting were the most common symptoms that appeared prior to traditional Kawasaki disease symptoms.
Study details: A systematic review of 48 cases of Kawasaki disease patients with intestinal involvement.
Disclosures: The authors reported no relevant conflicts of interest.
Source: Colomba C et al. J Pediatr. 2018 Jul 17. doi: 10.1016/j.jpeds.2018.06.034.
Bleeding score could help identify hemophilia
Bleeding scores may be helpful in identifying hemophilia patients, regardless of whether or not clotting factor levels are known, results of a recent investigation suggest.
Both hemophilia A and B patients had significantly higher bleeding scores as assessed by the ISTH-BAT (International Society on Thrombosis and Hemostasis–Bleeding Assessment Tool), compared with control subjects, according to results of the study.
Moreover, hemophilia patients classified as severe had significantly higher ISTH-BAT scores compared with those classified as mild, reported by Munira Borhany, MD, of the National Institute of Blood Disease and Bone Marrow Transplantation, Karachi, Pakistan, and her colleagues.
“The ISTH-BAT can be easily used in the clinics by physicians and can help to identify those patients who should be further investigated,” Dr. Borhany and her coauthors reported in the journal Transfusion and Apheresis Science.
The ISTH-BAT, established to standardize the reporting of bleeding symptoms, scores symptoms from 0, which indicates absent or trivial, to 4, meaning a symptom that requires medical intervention. Total scores considered abnormal are 4 or greater in men, 6 and greater in women, and 3 and greater in children, according to previously published reports.
In the present cross-sectional study, Dr. Borhany and her colleagues evaluated bleeding scores for 115 adult and pediatric patients – 78 with hemophilia A and 37 with hemophilia B – who were treated in Pakistan between 2014 and 2016.
Bleeding scores were a mean of 13.5 and 13.2 for hemophilia A and B patients, respectively, and 0.8 for 100 healthy male controls also included in the study. Scores were significantly higher in hemophilia patients versus controls (P less than .001), but not different between hemophilia A and B patients, the investigators reported.
Further results suggested a correlation between factor levels and clinical presentation of bleeding symptoms, according to the investigators. Statistically significant differences in bleeding scores also were seen between patients with severe and mild disease, and between severe and moderate disease, but not between the mild and moderate groups, they added.
Most studies of bleeding questionnaires to date have been in patients with von Willebrand disease or platelet disorders, with very little data on hemophilia.
“Apart from one recent study using ISTH-BAT in hemophilia carriers as part of assessing quality of life, we are unaware of other studies examining this assessment tool in hemophilia,” the researchers wrote.
This study cohort was unique, according to the investigators, because it included a substantial number of adults who were new patients with bleeding symptoms who had no previous diagnosis of hemophilia. “This allowed assessing whether investigators may tend to apply a higher score when knowing very low factor levels in hemophilia patients,” they said.
In fact, there was no major difference in bleeding scores for those newly diagnosed patients versus already diagnosed patients.
Results of an ongoing study will determine whether the ISTH BAT bleeding score can predict risk of bleeding in hemophilia patients, according to Dr. Borhany and her coauthors.
They reported having no conflicts of interest.
SOURCE: Borhany M et al. Transfus Apher Sci. 2018 Aug;57(4):556-60.
Bleeding scores may be helpful in identifying hemophilia patients, regardless of whether or not clotting factor levels are known, results of a recent investigation suggest.
Both hemophilia A and B patients had significantly higher bleeding scores as assessed by the ISTH-BAT (International Society on Thrombosis and Hemostasis–Bleeding Assessment Tool), compared with control subjects, according to results of the study.
Moreover, hemophilia patients classified as severe had significantly higher ISTH-BAT scores compared with those classified as mild, reported by Munira Borhany, MD, of the National Institute of Blood Disease and Bone Marrow Transplantation, Karachi, Pakistan, and her colleagues.
“The ISTH-BAT can be easily used in the clinics by physicians and can help to identify those patients who should be further investigated,” Dr. Borhany and her coauthors reported in the journal Transfusion and Apheresis Science.
The ISTH-BAT, established to standardize the reporting of bleeding symptoms, scores symptoms from 0, which indicates absent or trivial, to 4, meaning a symptom that requires medical intervention. Total scores considered abnormal are 4 or greater in men, 6 and greater in women, and 3 and greater in children, according to previously published reports.
In the present cross-sectional study, Dr. Borhany and her colleagues evaluated bleeding scores for 115 adult and pediatric patients – 78 with hemophilia A and 37 with hemophilia B – who were treated in Pakistan between 2014 and 2016.
Bleeding scores were a mean of 13.5 and 13.2 for hemophilia A and B patients, respectively, and 0.8 for 100 healthy male controls also included in the study. Scores were significantly higher in hemophilia patients versus controls (P less than .001), but not different between hemophilia A and B patients, the investigators reported.
Further results suggested a correlation between factor levels and clinical presentation of bleeding symptoms, according to the investigators. Statistically significant differences in bleeding scores also were seen between patients with severe and mild disease, and between severe and moderate disease, but not between the mild and moderate groups, they added.
Most studies of bleeding questionnaires to date have been in patients with von Willebrand disease or platelet disorders, with very little data on hemophilia.
“Apart from one recent study using ISTH-BAT in hemophilia carriers as part of assessing quality of life, we are unaware of other studies examining this assessment tool in hemophilia,” the researchers wrote.
This study cohort was unique, according to the investigators, because it included a substantial number of adults who were new patients with bleeding symptoms who had no previous diagnosis of hemophilia. “This allowed assessing whether investigators may tend to apply a higher score when knowing very low factor levels in hemophilia patients,” they said.
In fact, there was no major difference in bleeding scores for those newly diagnosed patients versus already diagnosed patients.
Results of an ongoing study will determine whether the ISTH BAT bleeding score can predict risk of bleeding in hemophilia patients, according to Dr. Borhany and her coauthors.
They reported having no conflicts of interest.
SOURCE: Borhany M et al. Transfus Apher Sci. 2018 Aug;57(4):556-60.
Bleeding scores may be helpful in identifying hemophilia patients, regardless of whether or not clotting factor levels are known, results of a recent investigation suggest.
Both hemophilia A and B patients had significantly higher bleeding scores as assessed by the ISTH-BAT (International Society on Thrombosis and Hemostasis–Bleeding Assessment Tool), compared with control subjects, according to results of the study.
Moreover, hemophilia patients classified as severe had significantly higher ISTH-BAT scores compared with those classified as mild, reported by Munira Borhany, MD, of the National Institute of Blood Disease and Bone Marrow Transplantation, Karachi, Pakistan, and her colleagues.
“The ISTH-BAT can be easily used in the clinics by physicians and can help to identify those patients who should be further investigated,” Dr. Borhany and her coauthors reported in the journal Transfusion and Apheresis Science.
The ISTH-BAT, established to standardize the reporting of bleeding symptoms, scores symptoms from 0, which indicates absent or trivial, to 4, meaning a symptom that requires medical intervention. Total scores considered abnormal are 4 or greater in men, 6 and greater in women, and 3 and greater in children, according to previously published reports.
In the present cross-sectional study, Dr. Borhany and her colleagues evaluated bleeding scores for 115 adult and pediatric patients – 78 with hemophilia A and 37 with hemophilia B – who were treated in Pakistan between 2014 and 2016.
Bleeding scores were a mean of 13.5 and 13.2 for hemophilia A and B patients, respectively, and 0.8 for 100 healthy male controls also included in the study. Scores were significantly higher in hemophilia patients versus controls (P less than .001), but not different between hemophilia A and B patients, the investigators reported.
Further results suggested a correlation between factor levels and clinical presentation of bleeding symptoms, according to the investigators. Statistically significant differences in bleeding scores also were seen between patients with severe and mild disease, and between severe and moderate disease, but not between the mild and moderate groups, they added.
Most studies of bleeding questionnaires to date have been in patients with von Willebrand disease or platelet disorders, with very little data on hemophilia.
“Apart from one recent study using ISTH-BAT in hemophilia carriers as part of assessing quality of life, we are unaware of other studies examining this assessment tool in hemophilia,” the researchers wrote.
This study cohort was unique, according to the investigators, because it included a substantial number of adults who were new patients with bleeding symptoms who had no previous diagnosis of hemophilia. “This allowed assessing whether investigators may tend to apply a higher score when knowing very low factor levels in hemophilia patients,” they said.
In fact, there was no major difference in bleeding scores for those newly diagnosed patients versus already diagnosed patients.
Results of an ongoing study will determine whether the ISTH BAT bleeding score can predict risk of bleeding in hemophilia patients, according to Dr. Borhany and her coauthors.
They reported having no conflicts of interest.
SOURCE: Borhany M et al. Transfus Apher Sci. 2018 Aug;57(4):556-60.
FROM TRANSFUSION AND APHERESIS SCIENCE
Key clinical point:
Major finding: Bleeding scores were a mean of 13.5 and 13.2 for hemophilia A and B patients, respectively, and 0.8 for healthy male controls (P less than .001).
Study details: A cross-sectional study included 115 adult and pediatric patients with hemophilia A or B treated in Pakistan between 2014 and 2016.
Disclosures: The authors reported having no conflicts of interest.
Source: Borhany M et al. Transfus Apher Sci. 2018 Aug;57(4):556-60.
Palliative care update highlights role of nonspecialists
The new edition of providing care for critically ill patients, not just those clinicians actively specialized in palliative care.
The Clinical Practice Guidelines for Quality Palliative Care, 4th Edition, emphasizes the importance of palliative care provided by “clinicians in primary care and specialty care practices, such as oncologists,” the guideline authors stated.
The latest revision of the guideline aims to establish a foundation for “gold-standard” palliative care for people living with serious illness, regardless of diagnosis, prognosis, setting, or age, according to the National Coalition for Hospice and Palliative Care, which published the clinical practice guidelines.
The update was developed by the National Consensus Project for Quality Palliative Care (NCP), which includes 16 national organizations with palliative care and hospice expertise, and is endorsed by more than 80 national organizations, including the American Society of Hematology and the Oncology Nurses Society.
One key reason for the update, according to the NCP, was to acknowledge that today’s health care system may not be meeting patients’ palliative care needs.
Specifically, the guidelines call on all clinicians who are not palliative specialists to integrate palliative care principles into their routine assessment of seriously ill patients with conditions such as heart failure, lung disease, and cancer.
This approach differs from the way palliative care is traditionally practiced, often by fellowship-trained physicians, trained nurses, and other specialists who provide that support.
The guidelines are organized into sections covering palliative care structure and processes, care for the patient nearing the end of life, and specific aspects of palliative care, including physical, psychological, and psychiatric; social; cultural, ethical, and legal; and spiritual, religious, and existential aspects.
“The expectation is that all clinicians caring for seriously ill patients will integrate palliative care competencies, such as safe and effective pain and symptom management and expert communication skills in their practice, and palliative care specialists will provide expertise for those with the most complex needs,” the guideline authors wrote.
Implications for treatment of oncology patients
These new guidelines represent a “blueprint for what it looks like to provide high-quality, comprehensive palliative care to people with serious illness,” said Thomas W. LeBlanc, MD, who is a medical oncologist, palliative care physician, and patient experience researcher at Duke University, Durham, N.C.
“Part of this report to is about trying to raise the game of everybody in medicine and provide a higher basic level of primary palliative care to all people with serious illness, but then also to figure out who has higher levels of needs where the specialists should be applied, since they are a scarce resource,” said Dr. LeBlanc.
An issue with that traditional model is a shortage of specialized clinicians to meet palliative care needs, said Dr. LeBlanc, whose clinical practice and research focuses on palliative care needs of patients with hematologic malignancies.
“Palliative care has matured as a field such that we are now actually facing workforce shortage issues and really fundamental questions about who needs us the most, and how we increase our reach to improve the lives of more patients and families facing serious illness,” he said in an interview.
That’s a major driver behind the emphasis in these latest guidelines on providing palliative care in the community, coordinating care, and dealing with care transitions, he added.
“I hope that this document will help to demonstrate the value and the need for palliative care specialists, and for improvements in primary care in the care of patients with hematologic diseases in general,” he said. “To me, this adds increasing legitimacy to this whole field.”
Palliative care in surgical care
These guidelines are particularly useful to surgeons in part because of their focus on what’s known as primary palliative care, said to Geoffrey P. Dunn, MD, former chair of the American College of Surgeons Committee on Surgical Palliative Care. Palliative care, the new guidelines suggest, can be implemented by nonspecialists.
Primary palliative care includes diverse skills such as breaking adverse news to patients, managing uncomplicated pain, and being able to recognize signs and symptoms of imminent demise. “These are the minimum deliverables for all people dealing with seriously ill patients,” Dr. Dunn said in an interview. “It’s palliative care that any practicing physician should be able to handle.”
Dr. Dunn concurred with Dr. LaBlanc about the workforce shortage in the palliative field. The traditional model has created a shortage of specialized clinicians to meet palliative care needs. Across the board, “staffing for palliative teams is very inconsistent,” said Dr. Dunn. “It’s a classic unfunded mandate.”
While these guidelines are a step forward in recognizing the importance of palliative care outside of the palliative care specialty, there is no reference to surgery anywhere in the text of the 141-page prepublication draft provided by the NCP, Dr. Dunn noted in the interview.
“There’s still a danger of parallel universes, where surgery is developing its own understanding of this in parallel with the more general national palliative care movement,” he said. Despite that, there is a growing connection between surgery and the broader palliative care community. That linkage is especially important given the number of seriously ill patients with high symptom burden that are seen in surgery.
“I think where surgeons are beginning to find [palliative principles] very helpful is dealing with these protracted serial discussions with families in difficult circumstances, such as how long is the life support going to be prolonged in someone with a devastating head injury, or multiple system organ failure in the elderly,” Dr. Dunn added.
The new edition of providing care for critically ill patients, not just those clinicians actively specialized in palliative care.
The Clinical Practice Guidelines for Quality Palliative Care, 4th Edition, emphasizes the importance of palliative care provided by “clinicians in primary care and specialty care practices, such as oncologists,” the guideline authors stated.
The latest revision of the guideline aims to establish a foundation for “gold-standard” palliative care for people living with serious illness, regardless of diagnosis, prognosis, setting, or age, according to the National Coalition for Hospice and Palliative Care, which published the clinical practice guidelines.
The update was developed by the National Consensus Project for Quality Palliative Care (NCP), which includes 16 national organizations with palliative care and hospice expertise, and is endorsed by more than 80 national organizations, including the American Society of Hematology and the Oncology Nurses Society.
One key reason for the update, according to the NCP, was to acknowledge that today’s health care system may not be meeting patients’ palliative care needs.
Specifically, the guidelines call on all clinicians who are not palliative specialists to integrate palliative care principles into their routine assessment of seriously ill patients with conditions such as heart failure, lung disease, and cancer.
This approach differs from the way palliative care is traditionally practiced, often by fellowship-trained physicians, trained nurses, and other specialists who provide that support.
The guidelines are organized into sections covering palliative care structure and processes, care for the patient nearing the end of life, and specific aspects of palliative care, including physical, psychological, and psychiatric; social; cultural, ethical, and legal; and spiritual, religious, and existential aspects.
“The expectation is that all clinicians caring for seriously ill patients will integrate palliative care competencies, such as safe and effective pain and symptom management and expert communication skills in their practice, and palliative care specialists will provide expertise for those with the most complex needs,” the guideline authors wrote.
Implications for treatment of oncology patients
These new guidelines represent a “blueprint for what it looks like to provide high-quality, comprehensive palliative care to people with serious illness,” said Thomas W. LeBlanc, MD, who is a medical oncologist, palliative care physician, and patient experience researcher at Duke University, Durham, N.C.
“Part of this report to is about trying to raise the game of everybody in medicine and provide a higher basic level of primary palliative care to all people with serious illness, but then also to figure out who has higher levels of needs where the specialists should be applied, since they are a scarce resource,” said Dr. LeBlanc.
An issue with that traditional model is a shortage of specialized clinicians to meet palliative care needs, said Dr. LeBlanc, whose clinical practice and research focuses on palliative care needs of patients with hematologic malignancies.
“Palliative care has matured as a field such that we are now actually facing workforce shortage issues and really fundamental questions about who needs us the most, and how we increase our reach to improve the lives of more patients and families facing serious illness,” he said in an interview.
That’s a major driver behind the emphasis in these latest guidelines on providing palliative care in the community, coordinating care, and dealing with care transitions, he added.
“I hope that this document will help to demonstrate the value and the need for palliative care specialists, and for improvements in primary care in the care of patients with hematologic diseases in general,” he said. “To me, this adds increasing legitimacy to this whole field.”
Palliative care in surgical care
These guidelines are particularly useful to surgeons in part because of their focus on what’s known as primary palliative care, said to Geoffrey P. Dunn, MD, former chair of the American College of Surgeons Committee on Surgical Palliative Care. Palliative care, the new guidelines suggest, can be implemented by nonspecialists.
Primary palliative care includes diverse skills such as breaking adverse news to patients, managing uncomplicated pain, and being able to recognize signs and symptoms of imminent demise. “These are the minimum deliverables for all people dealing with seriously ill patients,” Dr. Dunn said in an interview. “It’s palliative care that any practicing physician should be able to handle.”
Dr. Dunn concurred with Dr. LaBlanc about the workforce shortage in the palliative field. The traditional model has created a shortage of specialized clinicians to meet palliative care needs. Across the board, “staffing for palliative teams is very inconsistent,” said Dr. Dunn. “It’s a classic unfunded mandate.”
While these guidelines are a step forward in recognizing the importance of palliative care outside of the palliative care specialty, there is no reference to surgery anywhere in the text of the 141-page prepublication draft provided by the NCP, Dr. Dunn noted in the interview.
“There’s still a danger of parallel universes, where surgery is developing its own understanding of this in parallel with the more general national palliative care movement,” he said. Despite that, there is a growing connection between surgery and the broader palliative care community. That linkage is especially important given the number of seriously ill patients with high symptom burden that are seen in surgery.
“I think where surgeons are beginning to find [palliative principles] very helpful is dealing with these protracted serial discussions with families in difficult circumstances, such as how long is the life support going to be prolonged in someone with a devastating head injury, or multiple system organ failure in the elderly,” Dr. Dunn added.
The new edition of providing care for critically ill patients, not just those clinicians actively specialized in palliative care.
The Clinical Practice Guidelines for Quality Palliative Care, 4th Edition, emphasizes the importance of palliative care provided by “clinicians in primary care and specialty care practices, such as oncologists,” the guideline authors stated.
The latest revision of the guideline aims to establish a foundation for “gold-standard” palliative care for people living with serious illness, regardless of diagnosis, prognosis, setting, or age, according to the National Coalition for Hospice and Palliative Care, which published the clinical practice guidelines.
The update was developed by the National Consensus Project for Quality Palliative Care (NCP), which includes 16 national organizations with palliative care and hospice expertise, and is endorsed by more than 80 national organizations, including the American Society of Hematology and the Oncology Nurses Society.
One key reason for the update, according to the NCP, was to acknowledge that today’s health care system may not be meeting patients’ palliative care needs.
Specifically, the guidelines call on all clinicians who are not palliative specialists to integrate palliative care principles into their routine assessment of seriously ill patients with conditions such as heart failure, lung disease, and cancer.
This approach differs from the way palliative care is traditionally practiced, often by fellowship-trained physicians, trained nurses, and other specialists who provide that support.
The guidelines are organized into sections covering palliative care structure and processes, care for the patient nearing the end of life, and specific aspects of palliative care, including physical, psychological, and psychiatric; social; cultural, ethical, and legal; and spiritual, religious, and existential aspects.
“The expectation is that all clinicians caring for seriously ill patients will integrate palliative care competencies, such as safe and effective pain and symptom management and expert communication skills in their practice, and palliative care specialists will provide expertise for those with the most complex needs,” the guideline authors wrote.
Implications for treatment of oncology patients
These new guidelines represent a “blueprint for what it looks like to provide high-quality, comprehensive palliative care to people with serious illness,” said Thomas W. LeBlanc, MD, who is a medical oncologist, palliative care physician, and patient experience researcher at Duke University, Durham, N.C.
“Part of this report to is about trying to raise the game of everybody in medicine and provide a higher basic level of primary palliative care to all people with serious illness, but then also to figure out who has higher levels of needs where the specialists should be applied, since they are a scarce resource,” said Dr. LeBlanc.
An issue with that traditional model is a shortage of specialized clinicians to meet palliative care needs, said Dr. LeBlanc, whose clinical practice and research focuses on palliative care needs of patients with hematologic malignancies.
“Palliative care has matured as a field such that we are now actually facing workforce shortage issues and really fundamental questions about who needs us the most, and how we increase our reach to improve the lives of more patients and families facing serious illness,” he said in an interview.
That’s a major driver behind the emphasis in these latest guidelines on providing palliative care in the community, coordinating care, and dealing with care transitions, he added.
“I hope that this document will help to demonstrate the value and the need for palliative care specialists, and for improvements in primary care in the care of patients with hematologic diseases in general,” he said. “To me, this adds increasing legitimacy to this whole field.”
Palliative care in surgical care
These guidelines are particularly useful to surgeons in part because of their focus on what’s known as primary palliative care, said to Geoffrey P. Dunn, MD, former chair of the American College of Surgeons Committee on Surgical Palliative Care. Palliative care, the new guidelines suggest, can be implemented by nonspecialists.
Primary palliative care includes diverse skills such as breaking adverse news to patients, managing uncomplicated pain, and being able to recognize signs and symptoms of imminent demise. “These are the minimum deliverables for all people dealing with seriously ill patients,” Dr. Dunn said in an interview. “It’s palliative care that any practicing physician should be able to handle.”
Dr. Dunn concurred with Dr. LaBlanc about the workforce shortage in the palliative field. The traditional model has created a shortage of specialized clinicians to meet palliative care needs. Across the board, “staffing for palliative teams is very inconsistent,” said Dr. Dunn. “It’s a classic unfunded mandate.”
While these guidelines are a step forward in recognizing the importance of palliative care outside of the palliative care specialty, there is no reference to surgery anywhere in the text of the 141-page prepublication draft provided by the NCP, Dr. Dunn noted in the interview.
“There’s still a danger of parallel universes, where surgery is developing its own understanding of this in parallel with the more general national palliative care movement,” he said. Despite that, there is a growing connection between surgery and the broader palliative care community. That linkage is especially important given the number of seriously ill patients with high symptom burden that are seen in surgery.
“I think where surgeons are beginning to find [palliative principles] very helpful is dealing with these protracted serial discussions with families in difficult circumstances, such as how long is the life support going to be prolonged in someone with a devastating head injury, or multiple system organ failure in the elderly,” Dr. Dunn added.
Rapid bacterial testing of platelets saves money, reduces waste
BOSTON – Rapid bacterial testing of platelets in a hospital blood bank can result in both significant cost savings and reduced wastage of blood products, investigators said.
Rapid bacterial testing of 6- or 7-day-old apheresis platelets resulted in projected annual cost savings of nearly $89,000 per year and cut the rate of platelet wastage from expiration by more than half, reported Adam L. Booth, MD, chief resident in the department of pathology at the University of Texas, Galveston, and his colleagues.
“When a person takes all this time to come in and donate, they do it under the impression that they’re going to help somebody, or several people, and you hate to see those platelets wasted. You want them to be used,” he said in an interview at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
Platelets typically have a shelf life of just 5 days because longer storage increases the risk for bacterial growth and the potential for transfusion-transmitted infections, Dr. Booth and his colleagues noted in a poster presentation.
A recently published Food and Drug Administration draft guidance for blood banks and transfusion services proposed changing regulations regarding bacterial control of blood products to allow for extended dating if the platelets are collected in an FDA-approved 7-day storage container with labeling that requires testing every product with a bacterial detection device, or if the platelets are individually tested for bacterial detection using an approved device.
To see what effect the regulations, if implemented as expected, might have on acquisition costs and wastage of apheresis platelets, the investigators reviewed their center’s platelet acquisition costs and wastage from expiration 12 months before and 6 months after implementation of a rapid bacterial testing protocol, with 6-month results projected out to 1 year for comparison purposes.
They looked at data on bacterial testing of 6-day and 7-day-old apheresis platelets, and excluded data on platelet units that were due to expire on day 5 because they were not stored in FDA-approved containers.
Prior to testing, 332 units at a mean per-unit cost of $516.96 were wasted, for an annual cost of more than $171,000. After the start of testing, however, the annualized rate of waste dropped to 117 units, for an annualized cost of more than $60,000. The difference – minus the cost of rapid bacterial testing – resulted in an annual savings for the institution of nearly $89,000.
Prior to rapid testing, the annual wastage rate was 24%; after testing, it dropped to an annualized 10% rate, the investigators reported.
The number of units transfused and the associated costs of transfusions were similar between the time periods studied.
“Our findings suggest that rapid bacterial testing can simultaneously enhance the safety of apheresis platelet transfusions and contribute to significant cost savings,” Dr. Booth and his colleagues wrote.
The study was internally funded. The authors reported having no conflicts of interest.
SOURCE: Booth AL et al. AABB18, Abstract INV4.
BOSTON – Rapid bacterial testing of platelets in a hospital blood bank can result in both significant cost savings and reduced wastage of blood products, investigators said.
Rapid bacterial testing of 6- or 7-day-old apheresis platelets resulted in projected annual cost savings of nearly $89,000 per year and cut the rate of platelet wastage from expiration by more than half, reported Adam L. Booth, MD, chief resident in the department of pathology at the University of Texas, Galveston, and his colleagues.
“When a person takes all this time to come in and donate, they do it under the impression that they’re going to help somebody, or several people, and you hate to see those platelets wasted. You want them to be used,” he said in an interview at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
Platelets typically have a shelf life of just 5 days because longer storage increases the risk for bacterial growth and the potential for transfusion-transmitted infections, Dr. Booth and his colleagues noted in a poster presentation.
A recently published Food and Drug Administration draft guidance for blood banks and transfusion services proposed changing regulations regarding bacterial control of blood products to allow for extended dating if the platelets are collected in an FDA-approved 7-day storage container with labeling that requires testing every product with a bacterial detection device, or if the platelets are individually tested for bacterial detection using an approved device.
To see what effect the regulations, if implemented as expected, might have on acquisition costs and wastage of apheresis platelets, the investigators reviewed their center’s platelet acquisition costs and wastage from expiration 12 months before and 6 months after implementation of a rapid bacterial testing protocol, with 6-month results projected out to 1 year for comparison purposes.
They looked at data on bacterial testing of 6-day and 7-day-old apheresis platelets, and excluded data on platelet units that were due to expire on day 5 because they were not stored in FDA-approved containers.
Prior to testing, 332 units at a mean per-unit cost of $516.96 were wasted, for an annual cost of more than $171,000. After the start of testing, however, the annualized rate of waste dropped to 117 units, for an annualized cost of more than $60,000. The difference – minus the cost of rapid bacterial testing – resulted in an annual savings for the institution of nearly $89,000.
Prior to rapid testing, the annual wastage rate was 24%; after testing, it dropped to an annualized 10% rate, the investigators reported.
The number of units transfused and the associated costs of transfusions were similar between the time periods studied.
“Our findings suggest that rapid bacterial testing can simultaneously enhance the safety of apheresis platelet transfusions and contribute to significant cost savings,” Dr. Booth and his colleagues wrote.
The study was internally funded. The authors reported having no conflicts of interest.
SOURCE: Booth AL et al. AABB18, Abstract INV4.
BOSTON – Rapid bacterial testing of platelets in a hospital blood bank can result in both significant cost savings and reduced wastage of blood products, investigators said.
Rapid bacterial testing of 6- or 7-day-old apheresis platelets resulted in projected annual cost savings of nearly $89,000 per year and cut the rate of platelet wastage from expiration by more than half, reported Adam L. Booth, MD, chief resident in the department of pathology at the University of Texas, Galveston, and his colleagues.
“When a person takes all this time to come in and donate, they do it under the impression that they’re going to help somebody, or several people, and you hate to see those platelets wasted. You want them to be used,” he said in an interview at AABB 2018, the annual meeting of the group formerly known as the American Association of Blood Banks.
Platelets typically have a shelf life of just 5 days because longer storage increases the risk for bacterial growth and the potential for transfusion-transmitted infections, Dr. Booth and his colleagues noted in a poster presentation.
A recently published Food and Drug Administration draft guidance for blood banks and transfusion services proposed changing regulations regarding bacterial control of blood products to allow for extended dating if the platelets are collected in an FDA-approved 7-day storage container with labeling that requires testing every product with a bacterial detection device, or if the platelets are individually tested for bacterial detection using an approved device.
To see what effect the regulations, if implemented as expected, might have on acquisition costs and wastage of apheresis platelets, the investigators reviewed their center’s platelet acquisition costs and wastage from expiration 12 months before and 6 months after implementation of a rapid bacterial testing protocol, with 6-month results projected out to 1 year for comparison purposes.
They looked at data on bacterial testing of 6-day and 7-day-old apheresis platelets, and excluded data on platelet units that were due to expire on day 5 because they were not stored in FDA-approved containers.
Prior to testing, 332 units at a mean per-unit cost of $516.96 were wasted, for an annual cost of more than $171,000. After the start of testing, however, the annualized rate of waste dropped to 117 units, for an annualized cost of more than $60,000. The difference – minus the cost of rapid bacterial testing – resulted in an annual savings for the institution of nearly $89,000.
Prior to rapid testing, the annual wastage rate was 24%; after testing, it dropped to an annualized 10% rate, the investigators reported.
The number of units transfused and the associated costs of transfusions were similar between the time periods studied.
“Our findings suggest that rapid bacterial testing can simultaneously enhance the safety of apheresis platelet transfusions and contribute to significant cost savings,” Dr. Booth and his colleagues wrote.
The study was internally funded. The authors reported having no conflicts of interest.
SOURCE: Booth AL et al. AABB18, Abstract INV4.
REPORTING FROM AABB18
Key clinical point:
Major finding: Annualized cost savings with rapid bacterial testing were nearly $89,000; platelet wastage decreased from 24% to 10%.
Study details: A retrospective analysis of costs and product wastage before and after implementation of rapid bacterial testing.
Disclosures: The study was internally funded. The authors reported having no conflicts of interest.
Source: Booth AL et al. AABB18, Abstract INV4.
Is respiratory compromise the new “sepsis”?
Hospitalists can play a key role in prevention
Clinicians and even the general public are aware of the dangers of sepsis, the life-threatening illness caused by a body’s response to an infection. Irrespective of one’s perception of pharmaceutical marketing materials or the evidence-based medicine used, awareness about sepsis has led to earlier diagnosis and interventions that have likely saved countless patients’ lives.
Moreover, hospitalists have played a key role in sepsis prevention. In their research, “Improving Survival from Sepsis in Noncritical Units: Role of Hospitalists and Sepsis Team in Early Detection and Initial Treatment of Septic Patients,” Adriana Ducci, MD, and her colleagues showed that a hospitalist-managed sepsis protocol improved sepsis case notifications and patient outcomes.
Although sepsis and respiratory compromise are clearly very different conditions, I believe that greater awareness about respiratory compromise will lead to earlier diagnosis and interventions, which will theoretically improve patient outcomes. Moreover, as with the sepsis awareness campaign, hospitalists can play a key role in recognizing respiratory compromise and in the implementation of appropriate interventions.
As defined by the Respiratory Compromise Institute, “respiratory compromise” is defined as a state in which there is a high likelihood of decompensation into respiratory failure and/or death, but, in which specific interventions – be it therapeutic and/or monitoring – might prevent or mitigate this decompensation.
A significant segment of patients who may be at risk for respiratory compromise are those receiving opioids. The cost of opioid-related adverse events, in terms of both human life and hospital expenses, remains at the forefront of the public eye. It has been estimated that yearly costs in the United States associated with opioid-related postoperative respiratory failure were estimated at $2 billion.
Thomas W. Frederickson MD, FACP, SFHM, MBA, the lead author of the Society of Hospital Medicine guide for Reducing Adverse Drug Events Related to Opioids (RADEO), emphasized in a podcast with the Physician-Patient Alliance for Health & Safety the need to identify patient conditions that pose a greater risk of respiratory compromise.
In particular, Dr. Frederickson pointed out the need to screen for obstructive sleep apnea (OSA): “Patients with obstructive sleep apnea are dependent upon their arousal mechanism in order to avoid respiratory depression and eventual respiratory failure. When these patients receive opioid medication, it decreases this ability for arousal. That puts them at risk for a sudden spiral that includes respiratory insufficiency and respiratory arrest. This can happen very quickly and part of the risk is that the traditional monitoring for sedation that we use in the hospital – that is on a periodic basis and depends upon nursing interventions and questioning – really becomes much less effective in this patient population that can have a respiratory arrest, because of failure to arouse, very quickly. So, a monitoring regimen that takes place every 60 minutes is likely to be ineffective.”
Patient conditions such as OSA should be considered, along with other comorbidities. As the RADEO Guide states: “Before starting opioid therapy, either in surgical or non-surgical settings, it is important to identify any real or potential risks of respiratory depression or other opioid-related adverse effects. Patient comorbidities such as OSA, neurologic disorders, organ impairment, substance abuse history, and other medication use are important aspects to consider.”
Although we have clearly recognized a significant increase in respiratory complications associated with opioid administration, there are other areas, which are non–opioid related, that can create respiratory compromise. We view many patients with stable or underlying respiratory conditions, whether it be COPD, sleep apnea, or preexisting pathophysiology, where either due to sedative agents, or an acute illness – like pneumonia – they can go from a stable condition to respiratory compromise and become at risk for respiratory failure.
A classic example of that in my world of anesthesia has been the well-recognized area of non–operating room anesthesia – in particular, in endoscopy suites where numerous endoscopy procedures are performed under the administration of propofol or other anxiolytic-like drugs. There has been a well-recognized incidence of sentinel events related to oxygenation and ventilation, including death.
Many clinicians see sedation as a benign introduction of relatively limited-effect drugs, which isn’t always true. So, therefore, it is essential that clinicians understand three things:
1. The drugs we employ as sedative agents can have variable effects on individuals depending on their tolerance and their underlying medical condition.
2. The dosages and particular combination of drugs employed may cause an adverse event – for example, the combination of opioids and benzodiazepines.
3. There are factors that can distract from the clinical assessment of routine vital signs, such as respiratory rate, heart rate, and blood pressure. For example, when pulse oximetry is administered with oxygen therapy, there can often be a delay in the recognition of hypoventilation. Consequently, that’s why more and more clinicians are beginning to utilize capnography, or CO2 monitoring, in the expired gas to earlier detect depressed respiratory rate and/or apnea, as well as signs of hypoventilation or inadequate ventilation.
There clearly are obstacles to continuous patient monitoring, such as the associated cost, familiarity with the utilization, the benefit, as well as the limitations of specific monitors in different clinical situations, which mandates an educational process to employ these. However, currently, patient monitoring provides the best early indicator of a patient’s deterioration and the possibility of respiratory compromise.
In my field, we have become very comfortable with capnography and patient monitoring, because for decades it’s been a standard of care for monitoring in the operating room. The role for utilization of capnography for patients who are receiving an opioid or sedative agent outside of the operating room needs to be further assessed. However, technology is not a silver bullet and should be used as an adjunct to clinical judgment in at-risk populations.
Simple recognition and greater awareness of respiratory compromise, just as with sepsis awareness campaigns, will mean more patients are diagnosed earlier, more appropriate interventions are made, and hopefully more adverse events and patient deaths are averted.
Dr. Vender is the emeritus Harris Family Foundation chairman of the department of anesthesiology at NorthShore University Health System in Evanston, Ill. He is clinical professor at the University of Chicago Pritzker School of Medicine and chairman, Clinical Advisory Committee, Respiratory Compromise Institute. Dr. Vender has consulted with Medtronic.
Hospitalists can play a key role in prevention
Hospitalists can play a key role in prevention
Clinicians and even the general public are aware of the dangers of sepsis, the life-threatening illness caused by a body’s response to an infection. Irrespective of one’s perception of pharmaceutical marketing materials or the evidence-based medicine used, awareness about sepsis has led to earlier diagnosis and interventions that have likely saved countless patients’ lives.
Moreover, hospitalists have played a key role in sepsis prevention. In their research, “Improving Survival from Sepsis in Noncritical Units: Role of Hospitalists and Sepsis Team in Early Detection and Initial Treatment of Septic Patients,” Adriana Ducci, MD, and her colleagues showed that a hospitalist-managed sepsis protocol improved sepsis case notifications and patient outcomes.
Although sepsis and respiratory compromise are clearly very different conditions, I believe that greater awareness about respiratory compromise will lead to earlier diagnosis and interventions, which will theoretically improve patient outcomes. Moreover, as with the sepsis awareness campaign, hospitalists can play a key role in recognizing respiratory compromise and in the implementation of appropriate interventions.
As defined by the Respiratory Compromise Institute, “respiratory compromise” is defined as a state in which there is a high likelihood of decompensation into respiratory failure and/or death, but, in which specific interventions – be it therapeutic and/or monitoring – might prevent or mitigate this decompensation.
A significant segment of patients who may be at risk for respiratory compromise are those receiving opioids. The cost of opioid-related adverse events, in terms of both human life and hospital expenses, remains at the forefront of the public eye. It has been estimated that yearly costs in the United States associated with opioid-related postoperative respiratory failure were estimated at $2 billion.
Thomas W. Frederickson MD, FACP, SFHM, MBA, the lead author of the Society of Hospital Medicine guide for Reducing Adverse Drug Events Related to Opioids (RADEO), emphasized in a podcast with the Physician-Patient Alliance for Health & Safety the need to identify patient conditions that pose a greater risk of respiratory compromise.
In particular, Dr. Frederickson pointed out the need to screen for obstructive sleep apnea (OSA): “Patients with obstructive sleep apnea are dependent upon their arousal mechanism in order to avoid respiratory depression and eventual respiratory failure. When these patients receive opioid medication, it decreases this ability for arousal. That puts them at risk for a sudden spiral that includes respiratory insufficiency and respiratory arrest. This can happen very quickly and part of the risk is that the traditional monitoring for sedation that we use in the hospital – that is on a periodic basis and depends upon nursing interventions and questioning – really becomes much less effective in this patient population that can have a respiratory arrest, because of failure to arouse, very quickly. So, a monitoring regimen that takes place every 60 minutes is likely to be ineffective.”
Patient conditions such as OSA should be considered, along with other comorbidities. As the RADEO Guide states: “Before starting opioid therapy, either in surgical or non-surgical settings, it is important to identify any real or potential risks of respiratory depression or other opioid-related adverse effects. Patient comorbidities such as OSA, neurologic disorders, organ impairment, substance abuse history, and other medication use are important aspects to consider.”
Although we have clearly recognized a significant increase in respiratory complications associated with opioid administration, there are other areas, which are non–opioid related, that can create respiratory compromise. We view many patients with stable or underlying respiratory conditions, whether it be COPD, sleep apnea, or preexisting pathophysiology, where either due to sedative agents, or an acute illness – like pneumonia – they can go from a stable condition to respiratory compromise and become at risk for respiratory failure.
A classic example of that in my world of anesthesia has been the well-recognized area of non–operating room anesthesia – in particular, in endoscopy suites where numerous endoscopy procedures are performed under the administration of propofol or other anxiolytic-like drugs. There has been a well-recognized incidence of sentinel events related to oxygenation and ventilation, including death.
Many clinicians see sedation as a benign introduction of relatively limited-effect drugs, which isn’t always true. So, therefore, it is essential that clinicians understand three things:
1. The drugs we employ as sedative agents can have variable effects on individuals depending on their tolerance and their underlying medical condition.
2. The dosages and particular combination of drugs employed may cause an adverse event – for example, the combination of opioids and benzodiazepines.
3. There are factors that can distract from the clinical assessment of routine vital signs, such as respiratory rate, heart rate, and blood pressure. For example, when pulse oximetry is administered with oxygen therapy, there can often be a delay in the recognition of hypoventilation. Consequently, that’s why more and more clinicians are beginning to utilize capnography, or CO2 monitoring, in the expired gas to earlier detect depressed respiratory rate and/or apnea, as well as signs of hypoventilation or inadequate ventilation.
There clearly are obstacles to continuous patient monitoring, such as the associated cost, familiarity with the utilization, the benefit, as well as the limitations of specific monitors in different clinical situations, which mandates an educational process to employ these. However, currently, patient monitoring provides the best early indicator of a patient’s deterioration and the possibility of respiratory compromise.
In my field, we have become very comfortable with capnography and patient monitoring, because for decades it’s been a standard of care for monitoring in the operating room. The role for utilization of capnography for patients who are receiving an opioid or sedative agent outside of the operating room needs to be further assessed. However, technology is not a silver bullet and should be used as an adjunct to clinical judgment in at-risk populations.
Simple recognition and greater awareness of respiratory compromise, just as with sepsis awareness campaigns, will mean more patients are diagnosed earlier, more appropriate interventions are made, and hopefully more adverse events and patient deaths are averted.
Dr. Vender is the emeritus Harris Family Foundation chairman of the department of anesthesiology at NorthShore University Health System in Evanston, Ill. He is clinical professor at the University of Chicago Pritzker School of Medicine and chairman, Clinical Advisory Committee, Respiratory Compromise Institute. Dr. Vender has consulted with Medtronic.
Clinicians and even the general public are aware of the dangers of sepsis, the life-threatening illness caused by a body’s response to an infection. Irrespective of one’s perception of pharmaceutical marketing materials or the evidence-based medicine used, awareness about sepsis has led to earlier diagnosis and interventions that have likely saved countless patients’ lives.
Moreover, hospitalists have played a key role in sepsis prevention. In their research, “Improving Survival from Sepsis in Noncritical Units: Role of Hospitalists and Sepsis Team in Early Detection and Initial Treatment of Septic Patients,” Adriana Ducci, MD, and her colleagues showed that a hospitalist-managed sepsis protocol improved sepsis case notifications and patient outcomes.
Although sepsis and respiratory compromise are clearly very different conditions, I believe that greater awareness about respiratory compromise will lead to earlier diagnosis and interventions, which will theoretically improve patient outcomes. Moreover, as with the sepsis awareness campaign, hospitalists can play a key role in recognizing respiratory compromise and in the implementation of appropriate interventions.
As defined by the Respiratory Compromise Institute, “respiratory compromise” is defined as a state in which there is a high likelihood of decompensation into respiratory failure and/or death, but, in which specific interventions – be it therapeutic and/or monitoring – might prevent or mitigate this decompensation.
A significant segment of patients who may be at risk for respiratory compromise are those receiving opioids. The cost of opioid-related adverse events, in terms of both human life and hospital expenses, remains at the forefront of the public eye. It has been estimated that yearly costs in the United States associated with opioid-related postoperative respiratory failure were estimated at $2 billion.
Thomas W. Frederickson MD, FACP, SFHM, MBA, the lead author of the Society of Hospital Medicine guide for Reducing Adverse Drug Events Related to Opioids (RADEO), emphasized in a podcast with the Physician-Patient Alliance for Health & Safety the need to identify patient conditions that pose a greater risk of respiratory compromise.
In particular, Dr. Frederickson pointed out the need to screen for obstructive sleep apnea (OSA): “Patients with obstructive sleep apnea are dependent upon their arousal mechanism in order to avoid respiratory depression and eventual respiratory failure. When these patients receive opioid medication, it decreases this ability for arousal. That puts them at risk for a sudden spiral that includes respiratory insufficiency and respiratory arrest. This can happen very quickly and part of the risk is that the traditional monitoring for sedation that we use in the hospital – that is on a periodic basis and depends upon nursing interventions and questioning – really becomes much less effective in this patient population that can have a respiratory arrest, because of failure to arouse, very quickly. So, a monitoring regimen that takes place every 60 minutes is likely to be ineffective.”
Patient conditions such as OSA should be considered, along with other comorbidities. As the RADEO Guide states: “Before starting opioid therapy, either in surgical or non-surgical settings, it is important to identify any real or potential risks of respiratory depression or other opioid-related adverse effects. Patient comorbidities such as OSA, neurologic disorders, organ impairment, substance abuse history, and other medication use are important aspects to consider.”
Although we have clearly recognized a significant increase in respiratory complications associated with opioid administration, there are other areas, which are non–opioid related, that can create respiratory compromise. We view many patients with stable or underlying respiratory conditions, whether it be COPD, sleep apnea, or preexisting pathophysiology, where either due to sedative agents, or an acute illness – like pneumonia – they can go from a stable condition to respiratory compromise and become at risk for respiratory failure.
A classic example of that in my world of anesthesia has been the well-recognized area of non–operating room anesthesia – in particular, in endoscopy suites where numerous endoscopy procedures are performed under the administration of propofol or other anxiolytic-like drugs. There has been a well-recognized incidence of sentinel events related to oxygenation and ventilation, including death.
Many clinicians see sedation as a benign introduction of relatively limited-effect drugs, which isn’t always true. So, therefore, it is essential that clinicians understand three things:
1. The drugs we employ as sedative agents can have variable effects on individuals depending on their tolerance and their underlying medical condition.
2. The dosages and particular combination of drugs employed may cause an adverse event – for example, the combination of opioids and benzodiazepines.
3. There are factors that can distract from the clinical assessment of routine vital signs, such as respiratory rate, heart rate, and blood pressure. For example, when pulse oximetry is administered with oxygen therapy, there can often be a delay in the recognition of hypoventilation. Consequently, that’s why more and more clinicians are beginning to utilize capnography, or CO2 monitoring, in the expired gas to earlier detect depressed respiratory rate and/or apnea, as well as signs of hypoventilation or inadequate ventilation.
There clearly are obstacles to continuous patient monitoring, such as the associated cost, familiarity with the utilization, the benefit, as well as the limitations of specific monitors in different clinical situations, which mandates an educational process to employ these. However, currently, patient monitoring provides the best early indicator of a patient’s deterioration and the possibility of respiratory compromise.
In my field, we have become very comfortable with capnography and patient monitoring, because for decades it’s been a standard of care for monitoring in the operating room. The role for utilization of capnography for patients who are receiving an opioid or sedative agent outside of the operating room needs to be further assessed. However, technology is not a silver bullet and should be used as an adjunct to clinical judgment in at-risk populations.
Simple recognition and greater awareness of respiratory compromise, just as with sepsis awareness campaigns, will mean more patients are diagnosed earlier, more appropriate interventions are made, and hopefully more adverse events and patient deaths are averted.
Dr. Vender is the emeritus Harris Family Foundation chairman of the department of anesthesiology at NorthShore University Health System in Evanston, Ill. He is clinical professor at the University of Chicago Pritzker School of Medicine and chairman, Clinical Advisory Committee, Respiratory Compromise Institute. Dr. Vender has consulted with Medtronic.
Three-drug combo proves effective against multidrug-resistant UTIs
SAN FRANCISCO – A combination of ceftriaxone, a beta-lactamase inhibitor, and disodium ethylenediaminetetraacetic acid (EDTA) is superior to meropenem in the treatment of complicated urinary tract infections caused by extended-spectrum beta-lactamase (ESBL) gram-negative bacteria, according to a new study.
The post-hoc analysis also found that the three-drug combination – known as CSE – is noninferior to meropenem in multidrug-resistant (MDR) and ceftriaxone-nonsusceptible (C-NS) pathogens.
CSE is aimed at the growing problem of antibiotic resistance, particularly the mechanisms used by bacteria to counter beta-lactamase inhibitors. EDTA chelates zinc and calcium, and many of the resistance mechanisms rely on one or the other of these ions to function. In in vitro models, the combination of sulbactam and EDTA restores activity of ceftriaxone against various beta-lactamases.
Mohd Amin Mir, MD, head of clinical research at the Venus Medicine Research Center, Panchkula, India, and presenter of the study, said that, in the case of efflux pumps, “when there is EDTA present, it chelates the calcium, and that means there is no energy for the efflux pump to throw out the drug.”
The penems, which include meropenem, are a class of synthetic antibiotics with an unsaturated beta-lactam ring. Like other antibiotics, they are under assault from antibiotic resistance, especially beta-lactamase enzymes. “Penems are very precious drugs. The objective of developing [EDTA combinations] is to save the penems,” Dr. Mir said at an annual scientific meeting on infectious diseases.
The PLEA trial randomized 143 patients with complicated urinary tract infections or acute pyelonephritis to CSE (1 g ceftriaxone/500 mg sulbactam/37 mg EDTA) every 12 hours or 1 g meropenem (MR) as a 30-minute intravenous infusion over 30 minutes. Patients received treatment for 5-14 days.
The original study demonstrated that CSE is noninferior to meropenem at a 10% noninferiority margin. The researchers conducted a post-hoc analysis of patients who presented with complicated UTIs or acute pyelonephritis cases that were C-NS, ESBL-positive, or multidrug-resistant (MDR) pathogens. The researchers defined MDR as resistance to three or more categories of antimicrobial agents.
Of patients who received CSE, 97.3% had pathogens that were nonsusceptible to ceftriaxone, as did 98.6% of those who received MR; 85.1% of CSE and 81.2% of MR patients had an ESBL-producing pathogen; and 74.3% of infections in the CSE group were MDR, as were 65.2% of the MR group.
In all three resistant phenotypes, CSE at least trended to more favorable outcomes. In the MDR group, 96.4% of CSE patients achieved a clinical cure, compared with 88.9% in the MR group, and 94.5% achieved microbial eradication, compared with 86.75% in the MR group.
In the ESBL subgroup, 100% of patients in the CSE group achieved a clinical cure, compared with 89.3%, while 98.4% had complete eradication in the CSE group, compared with 87.5%. In the C-NS subgroup, 95.8% in the CSE group achieved a clinical cure, compared with 91.2%, and 94.4% achieved eradication, compared with 89.7% in the MR group.
In the ESBL subgroup, the lower bound of the 95% confidence interval of the between-group difference was greater than 0, indicating superiority of CSE over MR for both clinical cure and eradication. In the MDR and C-NS subgroups, CSE achieved noninferiority at a –10% margin.
CSE is currently commercially available in India, and the manufacturer is now seeking approval in Europe and the United States.
SOURCE: Mir MA et al. IDWeek 2018, Abstract 1959.
SAN FRANCISCO – A combination of ceftriaxone, a beta-lactamase inhibitor, and disodium ethylenediaminetetraacetic acid (EDTA) is superior to meropenem in the treatment of complicated urinary tract infections caused by extended-spectrum beta-lactamase (ESBL) gram-negative bacteria, according to a new study.
The post-hoc analysis also found that the three-drug combination – known as CSE – is noninferior to meropenem in multidrug-resistant (MDR) and ceftriaxone-nonsusceptible (C-NS) pathogens.
CSE is aimed at the growing problem of antibiotic resistance, particularly the mechanisms used by bacteria to counter beta-lactamase inhibitors. EDTA chelates zinc and calcium, and many of the resistance mechanisms rely on one or the other of these ions to function. In in vitro models, the combination of sulbactam and EDTA restores activity of ceftriaxone against various beta-lactamases.
Mohd Amin Mir, MD, head of clinical research at the Venus Medicine Research Center, Panchkula, India, and presenter of the study, said that, in the case of efflux pumps, “when there is EDTA present, it chelates the calcium, and that means there is no energy for the efflux pump to throw out the drug.”
The penems, which include meropenem, are a class of synthetic antibiotics with an unsaturated beta-lactam ring. Like other antibiotics, they are under assault from antibiotic resistance, especially beta-lactamase enzymes. “Penems are very precious drugs. The objective of developing [EDTA combinations] is to save the penems,” Dr. Mir said at an annual scientific meeting on infectious diseases.
The PLEA trial randomized 143 patients with complicated urinary tract infections or acute pyelonephritis to CSE (1 g ceftriaxone/500 mg sulbactam/37 mg EDTA) every 12 hours or 1 g meropenem (MR) as a 30-minute intravenous infusion over 30 minutes. Patients received treatment for 5-14 days.
The original study demonstrated that CSE is noninferior to meropenem at a 10% noninferiority margin. The researchers conducted a post-hoc analysis of patients who presented with complicated UTIs or acute pyelonephritis cases that were C-NS, ESBL-positive, or multidrug-resistant (MDR) pathogens. The researchers defined MDR as resistance to three or more categories of antimicrobial agents.
Of patients who received CSE, 97.3% had pathogens that were nonsusceptible to ceftriaxone, as did 98.6% of those who received MR; 85.1% of CSE and 81.2% of MR patients had an ESBL-producing pathogen; and 74.3% of infections in the CSE group were MDR, as were 65.2% of the MR group.
In all three resistant phenotypes, CSE at least trended to more favorable outcomes. In the MDR group, 96.4% of CSE patients achieved a clinical cure, compared with 88.9% in the MR group, and 94.5% achieved microbial eradication, compared with 86.75% in the MR group.
In the ESBL subgroup, 100% of patients in the CSE group achieved a clinical cure, compared with 89.3%, while 98.4% had complete eradication in the CSE group, compared with 87.5%. In the C-NS subgroup, 95.8% in the CSE group achieved a clinical cure, compared with 91.2%, and 94.4% achieved eradication, compared with 89.7% in the MR group.
In the ESBL subgroup, the lower bound of the 95% confidence interval of the between-group difference was greater than 0, indicating superiority of CSE over MR for both clinical cure and eradication. In the MDR and C-NS subgroups, CSE achieved noninferiority at a –10% margin.
CSE is currently commercially available in India, and the manufacturer is now seeking approval in Europe and the United States.
SOURCE: Mir MA et al. IDWeek 2018, Abstract 1959.
SAN FRANCISCO – A combination of ceftriaxone, a beta-lactamase inhibitor, and disodium ethylenediaminetetraacetic acid (EDTA) is superior to meropenem in the treatment of complicated urinary tract infections caused by extended-spectrum beta-lactamase (ESBL) gram-negative bacteria, according to a new study.
The post-hoc analysis also found that the three-drug combination – known as CSE – is noninferior to meropenem in multidrug-resistant (MDR) and ceftriaxone-nonsusceptible (C-NS) pathogens.
CSE is aimed at the growing problem of antibiotic resistance, particularly the mechanisms used by bacteria to counter beta-lactamase inhibitors. EDTA chelates zinc and calcium, and many of the resistance mechanisms rely on one or the other of these ions to function. In in vitro models, the combination of sulbactam and EDTA restores activity of ceftriaxone against various beta-lactamases.
Mohd Amin Mir, MD, head of clinical research at the Venus Medicine Research Center, Panchkula, India, and presenter of the study, said that, in the case of efflux pumps, “when there is EDTA present, it chelates the calcium, and that means there is no energy for the efflux pump to throw out the drug.”
The penems, which include meropenem, are a class of synthetic antibiotics with an unsaturated beta-lactam ring. Like other antibiotics, they are under assault from antibiotic resistance, especially beta-lactamase enzymes. “Penems are very precious drugs. The objective of developing [EDTA combinations] is to save the penems,” Dr. Mir said at an annual scientific meeting on infectious diseases.
The PLEA trial randomized 143 patients with complicated urinary tract infections or acute pyelonephritis to CSE (1 g ceftriaxone/500 mg sulbactam/37 mg EDTA) every 12 hours or 1 g meropenem (MR) as a 30-minute intravenous infusion over 30 minutes. Patients received treatment for 5-14 days.
The original study demonstrated that CSE is noninferior to meropenem at a 10% noninferiority margin. The researchers conducted a post-hoc analysis of patients who presented with complicated UTIs or acute pyelonephritis cases that were C-NS, ESBL-positive, or multidrug-resistant (MDR) pathogens. The researchers defined MDR as resistance to three or more categories of antimicrobial agents.
Of patients who received CSE, 97.3% had pathogens that were nonsusceptible to ceftriaxone, as did 98.6% of those who received MR; 85.1% of CSE and 81.2% of MR patients had an ESBL-producing pathogen; and 74.3% of infections in the CSE group were MDR, as were 65.2% of the MR group.
In all three resistant phenotypes, CSE at least trended to more favorable outcomes. In the MDR group, 96.4% of CSE patients achieved a clinical cure, compared with 88.9% in the MR group, and 94.5% achieved microbial eradication, compared with 86.75% in the MR group.
In the ESBL subgroup, 100% of patients in the CSE group achieved a clinical cure, compared with 89.3%, while 98.4% had complete eradication in the CSE group, compared with 87.5%. In the C-NS subgroup, 95.8% in the CSE group achieved a clinical cure, compared with 91.2%, and 94.4% achieved eradication, compared with 89.7% in the MR group.
In the ESBL subgroup, the lower bound of the 95% confidence interval of the between-group difference was greater than 0, indicating superiority of CSE over MR for both clinical cure and eradication. In the MDR and C-NS subgroups, CSE achieved noninferiority at a –10% margin.
CSE is currently commercially available in India, and the manufacturer is now seeking approval in Europe and the United States.
SOURCE: Mir MA et al. IDWeek 2018, Abstract 1959.
REPORTING FROM IDWEEK 2018
Key clinical point:
Major finding: The combination was noninferior in the context of different resistant subtypes.
Study details: Posthoc analysis of a randomized, controlled trial (n = 143).
Disclosures: The study was funded by Venus Medicine Research Center, which employs Dr. Mir.
Source: Mir MA et al. IDWeek 2018, Abstract 1959.
Statins cut all-cause mortality in spinal cord injury
ATLANTA – Statin use among a cohort of veterans with traumatic spinal cord injury reduced all-cause mortality, results from a novel observational study showed.
“This is the first clinical study to show that administration of statins irrespective of the lipid levels reduces all-cause mortality, not just cardiovascular mortality,” lead study author Meheroz H. Rabadi, MD, said in an interview in advance of the annual meeting of the American Neurological Association. “This clinical study confirms the impression of several prior studies in animal models with spinal cord injury, which have shown the anti-inflammatory and neuro-protective effects of statins.”
To determine whether statin use in a cohort of patients with traumatic spinal cord injuries (SCI) reduced overall and cause-specific mortality, Dr. Rabadi and his colleagues retrospectively reviewed the medical charts and death records of 163 individuals with SCI who were treated at the Oklahoma City Veterans Administration Medical Center Spinal Cord Injury & Disease, Multiple Sclerosis, and ALS Program, an outpatient clinic, from 2000 to 2014. They collected data on statin use, duration of statin use, and intensity of statin therapy, as well as cause-specific mortality.
Of the 163 subjects studied, 75 (46%) had taken statins for an average of 5.7 years, and had greater cardiovascular risk burdens than those who had not taken statins. The mortality rate for patients on statins, however, was 33.8-49.9 per 1,000 person-years, compared with 47.4-66.8 deaths per 1,000 person-years among those who had not taken statins. Kaplan-Meier survival curves showed a significant difference between the two groups (P less than .0052). Within the statin group, neither duration nor average intensity of statin therapy affected mortality.
“We were surprised to note statins reduced pneumonia-related mortality in patients with SCI,” Dr. Rabadi said. “Since our publication there have been several publications, including a meta-analysis of statins reducing community-acquired pneumonia-related mortality and reducing the need for mechanical ventilation or ICU admission (see CHEST 2015;148:523-32, Clin Med (Lond) 2017;17(5):403-7, and Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2018;40(1):30-40). Another surprise was neither the intensity, duration, or types of statin affected the result.”
He acknowledged certain limitations of the analysis, including its retrospective design, its relatively small sample size, and the fact that most of the subjects were non-Hispanic white men. “Routine prescription of statins in any dose in patients with SCI – even if the lipid profile is normal – is more beneficial than detrimental over the long haul,” concluded Dr. Rabadi, who also directs the Oklahoma VAMC Stroke Program. “Nearly all our patients with SCI continue to be on varying doses of statins.”
Dr. Rabadi reported having no financial disclosures.
[email protected]
SOURCE: Ann Neurol. 2018;84[S22]:S127. Abstract S302.
ATLANTA – Statin use among a cohort of veterans with traumatic spinal cord injury reduced all-cause mortality, results from a novel observational study showed.
“This is the first clinical study to show that administration of statins irrespective of the lipid levels reduces all-cause mortality, not just cardiovascular mortality,” lead study author Meheroz H. Rabadi, MD, said in an interview in advance of the annual meeting of the American Neurological Association. “This clinical study confirms the impression of several prior studies in animal models with spinal cord injury, which have shown the anti-inflammatory and neuro-protective effects of statins.”
To determine whether statin use in a cohort of patients with traumatic spinal cord injuries (SCI) reduced overall and cause-specific mortality, Dr. Rabadi and his colleagues retrospectively reviewed the medical charts and death records of 163 individuals with SCI who were treated at the Oklahoma City Veterans Administration Medical Center Spinal Cord Injury & Disease, Multiple Sclerosis, and ALS Program, an outpatient clinic, from 2000 to 2014. They collected data on statin use, duration of statin use, and intensity of statin therapy, as well as cause-specific mortality.
Of the 163 subjects studied, 75 (46%) had taken statins for an average of 5.7 years, and had greater cardiovascular risk burdens than those who had not taken statins. The mortality rate for patients on statins, however, was 33.8-49.9 per 1,000 person-years, compared with 47.4-66.8 deaths per 1,000 person-years among those who had not taken statins. Kaplan-Meier survival curves showed a significant difference between the two groups (P less than .0052). Within the statin group, neither duration nor average intensity of statin therapy affected mortality.
“We were surprised to note statins reduced pneumonia-related mortality in patients with SCI,” Dr. Rabadi said. “Since our publication there have been several publications, including a meta-analysis of statins reducing community-acquired pneumonia-related mortality and reducing the need for mechanical ventilation or ICU admission (see CHEST 2015;148:523-32, Clin Med (Lond) 2017;17(5):403-7, and Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2018;40(1):30-40). Another surprise was neither the intensity, duration, or types of statin affected the result.”
He acknowledged certain limitations of the analysis, including its retrospective design, its relatively small sample size, and the fact that most of the subjects were non-Hispanic white men. “Routine prescription of statins in any dose in patients with SCI – even if the lipid profile is normal – is more beneficial than detrimental over the long haul,” concluded Dr. Rabadi, who also directs the Oklahoma VAMC Stroke Program. “Nearly all our patients with SCI continue to be on varying doses of statins.”
Dr. Rabadi reported having no financial disclosures.
[email protected]
SOURCE: Ann Neurol. 2018;84[S22]:S127. Abstract S302.
ATLANTA – Statin use among a cohort of veterans with traumatic spinal cord injury reduced all-cause mortality, results from a novel observational study showed.
“This is the first clinical study to show that administration of statins irrespective of the lipid levels reduces all-cause mortality, not just cardiovascular mortality,” lead study author Meheroz H. Rabadi, MD, said in an interview in advance of the annual meeting of the American Neurological Association. “This clinical study confirms the impression of several prior studies in animal models with spinal cord injury, which have shown the anti-inflammatory and neuro-protective effects of statins.”
To determine whether statin use in a cohort of patients with traumatic spinal cord injuries (SCI) reduced overall and cause-specific mortality, Dr. Rabadi and his colleagues retrospectively reviewed the medical charts and death records of 163 individuals with SCI who were treated at the Oklahoma City Veterans Administration Medical Center Spinal Cord Injury & Disease, Multiple Sclerosis, and ALS Program, an outpatient clinic, from 2000 to 2014. They collected data on statin use, duration of statin use, and intensity of statin therapy, as well as cause-specific mortality.
Of the 163 subjects studied, 75 (46%) had taken statins for an average of 5.7 years, and had greater cardiovascular risk burdens than those who had not taken statins. The mortality rate for patients on statins, however, was 33.8-49.9 per 1,000 person-years, compared with 47.4-66.8 deaths per 1,000 person-years among those who had not taken statins. Kaplan-Meier survival curves showed a significant difference between the two groups (P less than .0052). Within the statin group, neither duration nor average intensity of statin therapy affected mortality.
“We were surprised to note statins reduced pneumonia-related mortality in patients with SCI,” Dr. Rabadi said. “Since our publication there have been several publications, including a meta-analysis of statins reducing community-acquired pneumonia-related mortality and reducing the need for mechanical ventilation or ICU admission (see CHEST 2015;148:523-32, Clin Med (Lond) 2017;17(5):403-7, and Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2018;40(1):30-40). Another surprise was neither the intensity, duration, or types of statin affected the result.”
He acknowledged certain limitations of the analysis, including its retrospective design, its relatively small sample size, and the fact that most of the subjects were non-Hispanic white men. “Routine prescription of statins in any dose in patients with SCI – even if the lipid profile is normal – is more beneficial than detrimental over the long haul,” concluded Dr. Rabadi, who also directs the Oklahoma VAMC Stroke Program. “Nearly all our patients with SCI continue to be on varying doses of statins.”
Dr. Rabadi reported having no financial disclosures.
[email protected]
SOURCE: Ann Neurol. 2018;84[S22]:S127. Abstract S302.
AT ANA 2018
Key clinical point:
Major finding: The mortality rate for patients on statins was 33.8-49.9 per 1,000 person-years, compared with 47.4-66.8 deaths per 1,000 person-years among those who had not taken statins (P less than .0052).
Study details: A retrospective review of 163 individuals with traumatic spinal cord injuries.
Disclosures: Dr. Rabadi reported having no financial disclosures.
Source: Ann Neurol. 2018;84[S22]:S127. Abstract S302.
Septic shock: Innovative treatment options in the wings
BOSTON– treatment that require more investigation, but nevertheless appear promising, Rishi Rattan, MD, said at the annual clinical congress of the American College of Surgeons.
Trials evaluating vitamin C in this setting have demonstrated a large mortality impact with an absence of side effects, according to Dr. Rattan, a trauma and critical care surgeon with the Ryder Trauma Center at the University of Miami.
“It’s something that I have decided to start early adopting, and many of my colleagues at University of Miami do as well,” Dr. Rattan said in a panel session on updates in septic shock. “We’re anecdotally so far at least seeing good results and are going to be excited to see what these ongoing trials show.”
As an antioxidant, vitamin C has anti-inflammatory properties that may possibly attenuate the overly exuberant inflammatory response seen in septic shock, Dr. Rattan said in his presentation.
The limited clinical data for vitamin C in refractory shock include three studies, of which two are randomized controlled trials, comprising a total of 146 patients, he added.
“I will admit an N of 146 is hardly practice-changing for most people,” Dr. Rattan said. “There’s still a significant and sustained large mortality effect for the use of vitamin C, with nearly no adverse effects.”
Pooled analysis of all three studies revealed a marked reduction in mortality with the use of vitamin C (odds ratio, 0.17, 95% confidence interval 0.07–0.40; P less than .001), according to a meta-analysis recently just published in Critical Care that Dr. Rattan referenced in his presentation (Critical Care 2018;22:258, DOI:10.1186/s13054-018-2191-x).
When taken in recommended dosages, vitamin C given with corticosteroids and thiamine is without known side effects, researcher Paul E. Marik wrote earlier this year in an editorial in Pharmacology & Therapeutics (2018;189[9]:63-70, DOI:10.1016/j.pharmthera.2018.04.007) noted Dr. Rattan, who said he uses the intravenous vitamin C, thiamine, and hydrocortisone protocol previously reported by Dr. Marik and colleagues.
There are 13 ongoing trials, including some prospective blinded, randomized trials, looking at the role of vitamin C in refractory shock, he added.
Angiotensin-II is another intervention that may be promising in refractory septic shock, Dr. Rattan told attendees, pointing to the 2017 publication of the ATHOS-3 trial in the New England Journal of Medicine (2017; 377:419-430,DOI: 10.1056/NEJMoa1704154) showing that treatment increased blood pressure in patients with vasodilatory shock not responding to conventional vasopressors at high doses.
Likewise, methylene blue has shown promise in septic shock, at least in some limited clinical investigations and anecdotally in patients not improving despite standard interventions. “I’ve been able to have a couple patients walk out of the hospital with the use of methylene blue,” Dr. Rattan said. “Again, the plural of ‘anecdote’ is not ‘data,’ but it’s something to consider for the early adopters.”
Dr. Rattan had no disclosures related to his presentation.
BOSTON– treatment that require more investigation, but nevertheless appear promising, Rishi Rattan, MD, said at the annual clinical congress of the American College of Surgeons.
Trials evaluating vitamin C in this setting have demonstrated a large mortality impact with an absence of side effects, according to Dr. Rattan, a trauma and critical care surgeon with the Ryder Trauma Center at the University of Miami.
“It’s something that I have decided to start early adopting, and many of my colleagues at University of Miami do as well,” Dr. Rattan said in a panel session on updates in septic shock. “We’re anecdotally so far at least seeing good results and are going to be excited to see what these ongoing trials show.”
As an antioxidant, vitamin C has anti-inflammatory properties that may possibly attenuate the overly exuberant inflammatory response seen in septic shock, Dr. Rattan said in his presentation.
The limited clinical data for vitamin C in refractory shock include three studies, of which two are randomized controlled trials, comprising a total of 146 patients, he added.
“I will admit an N of 146 is hardly practice-changing for most people,” Dr. Rattan said. “There’s still a significant and sustained large mortality effect for the use of vitamin C, with nearly no adverse effects.”
Pooled analysis of all three studies revealed a marked reduction in mortality with the use of vitamin C (odds ratio, 0.17, 95% confidence interval 0.07–0.40; P less than .001), according to a meta-analysis recently just published in Critical Care that Dr. Rattan referenced in his presentation (Critical Care 2018;22:258, DOI:10.1186/s13054-018-2191-x).
When taken in recommended dosages, vitamin C given with corticosteroids and thiamine is without known side effects, researcher Paul E. Marik wrote earlier this year in an editorial in Pharmacology & Therapeutics (2018;189[9]:63-70, DOI:10.1016/j.pharmthera.2018.04.007) noted Dr. Rattan, who said he uses the intravenous vitamin C, thiamine, and hydrocortisone protocol previously reported by Dr. Marik and colleagues.
There are 13 ongoing trials, including some prospective blinded, randomized trials, looking at the role of vitamin C in refractory shock, he added.
Angiotensin-II is another intervention that may be promising in refractory septic shock, Dr. Rattan told attendees, pointing to the 2017 publication of the ATHOS-3 trial in the New England Journal of Medicine (2017; 377:419-430,DOI: 10.1056/NEJMoa1704154) showing that treatment increased blood pressure in patients with vasodilatory shock not responding to conventional vasopressors at high doses.
Likewise, methylene blue has shown promise in septic shock, at least in some limited clinical investigations and anecdotally in patients not improving despite standard interventions. “I’ve been able to have a couple patients walk out of the hospital with the use of methylene blue,” Dr. Rattan said. “Again, the plural of ‘anecdote’ is not ‘data,’ but it’s something to consider for the early adopters.”
Dr. Rattan had no disclosures related to his presentation.
BOSTON– treatment that require more investigation, but nevertheless appear promising, Rishi Rattan, MD, said at the annual clinical congress of the American College of Surgeons.
Trials evaluating vitamin C in this setting have demonstrated a large mortality impact with an absence of side effects, according to Dr. Rattan, a trauma and critical care surgeon with the Ryder Trauma Center at the University of Miami.
“It’s something that I have decided to start early adopting, and many of my colleagues at University of Miami do as well,” Dr. Rattan said in a panel session on updates in septic shock. “We’re anecdotally so far at least seeing good results and are going to be excited to see what these ongoing trials show.”
As an antioxidant, vitamin C has anti-inflammatory properties that may possibly attenuate the overly exuberant inflammatory response seen in septic shock, Dr. Rattan said in his presentation.
The limited clinical data for vitamin C in refractory shock include three studies, of which two are randomized controlled trials, comprising a total of 146 patients, he added.
“I will admit an N of 146 is hardly practice-changing for most people,” Dr. Rattan said. “There’s still a significant and sustained large mortality effect for the use of vitamin C, with nearly no adverse effects.”
Pooled analysis of all three studies revealed a marked reduction in mortality with the use of vitamin C (odds ratio, 0.17, 95% confidence interval 0.07–0.40; P less than .001), according to a meta-analysis recently just published in Critical Care that Dr. Rattan referenced in his presentation (Critical Care 2018;22:258, DOI:10.1186/s13054-018-2191-x).
When taken in recommended dosages, vitamin C given with corticosteroids and thiamine is without known side effects, researcher Paul E. Marik wrote earlier this year in an editorial in Pharmacology & Therapeutics (2018;189[9]:63-70, DOI:10.1016/j.pharmthera.2018.04.007) noted Dr. Rattan, who said he uses the intravenous vitamin C, thiamine, and hydrocortisone protocol previously reported by Dr. Marik and colleagues.
There are 13 ongoing trials, including some prospective blinded, randomized trials, looking at the role of vitamin C in refractory shock, he added.
Angiotensin-II is another intervention that may be promising in refractory septic shock, Dr. Rattan told attendees, pointing to the 2017 publication of the ATHOS-3 trial in the New England Journal of Medicine (2017; 377:419-430,DOI: 10.1056/NEJMoa1704154) showing that treatment increased blood pressure in patients with vasodilatory shock not responding to conventional vasopressors at high doses.
Likewise, methylene blue has shown promise in septic shock, at least in some limited clinical investigations and anecdotally in patients not improving despite standard interventions. “I’ve been able to have a couple patients walk out of the hospital with the use of methylene blue,” Dr. Rattan said. “Again, the plural of ‘anecdote’ is not ‘data,’ but it’s something to consider for the early adopters.”
Dr. Rattan had no disclosures related to his presentation.
AT THE ACS CLINICAL CONGRESS
Endoscopy-related infections found higher than expected, prophylaxis overused
ATLANTA – The risk of infection from flexible endoscopes is far greater than generally believed, despite the excessive use of prophylactic antimicrobials in patients undergoing endoscopy, recent studies show.
Many gastroenterologists and guidelines from professional organizations use a reference point of “less than one per million” regarding the risk of infection from scopes, but a Johns Hopkins University study of more than 2.3 million patients in 6 states showed that the infection risk with colonoscopy is about 1 per 1,000, the risk for upper gastrointestinal endoscopy is about 3 per 1,000, and the risk with cystoscopy is about 4 per 1,000, Cori Ofstead said at the International Conference on Emerging Infectious Diseases.
“For bronchoscopy [the infection risk] was 15.6 in 1,000, which is 1.6% – not anywhere in the 1 in a million range,” said Ms. Ofstead, president and chief executive officer of Ofstead & Associates, a St. Paul, Minn. health care research firm.
It also turns out that prophylactic antibiotics are frequently given to patients undergoing routine endoscopy procedures, she said, noting that four major associations – two gastroenterology associations and two urology associations in the United States and Europe – recommend that prophylactic antimicrobials be given with routine endoscopies for certain patients undergoing certain types of procedures.
One U.S. organization is recommending prophylactic antimicrobials for every patient undergoing ureteroscopy, she added.
A Cleveland Clinic study looking at the impact of those American Urological Association guidelines for prophylactic antimicrobials showed that in a subset of patients with negative urine cultures before ureteroscopy, 100% received the prophylaxis, and 68% were also given other antimicrobials to take home.
“So the question, of course, is how well does this work...,” Ms. Ofstead said. “They found 3%-4% infection, with the rates exactly the same – no statistically significant differences – between patients who got prophylaxis just in the hospital or who went home with prophylactic meds, and they concluded that there was no benefit to the extra take-home antimicrobials.”
Others studies in multiple countries show either no impact or only minor impact of this prophylaxis on infection rates, and yet all show infection rates after endoscopy that are not one in a million, but in “the percentage point range,” she said.
“As we move toward more of these minimally invasive procedures, we need to be aware that we’re using extremely complex instruments that are very difficult to clean and disinfect or sterilize,” she said, adding that “in the field we’re seeing that improper reprocessing is actually business as usual.”
Infections have been seen with all kinds of scopes, Ms. Ofstead noted.
“The potential for this becoming a bit of a monster is enhanced by the widespread use of prophylactic antimicrobials during endoscopy, and I’m also troubled by the quick reaction of giving people antimicrobials when they have a positive culture from a scope rather than making sure the scope is clean,” she said, explaining that while most scopes have microbes and patients could be getting infections, they also may be reacting to soil and endotoxins in the scope rather than microbes.
“In any case, to reduce risks there are a number of things people can do,” she said. When using reusable scopes, proper cleaning is essential. “I think we should be moving toward scopes that can be disassembled so we can see inside and get those channels clean,” adding that efforts should also be made to move toward single-use scopes.
“Particularly in these outbreak situations where we’re using bronchoscopy on multiple patients, there’s just no excuse for reusing bronchoscopes and not sterilizing them between uses and making darn sure that they’re not full of whatever our outbreak pathogen is,” Ms. Ofstead said. “And lastly, I’m hoping that some folks here can talk some sense into people at the professional associations who are recommending prophylactic antimicrobial use, because if we don’t get some stewardship going, we’re going to be in big trouble.”
The guidelines create a conundrum for doctors who are torn between that stewardship and a failure to follow the recommendations.
“Their professional organization is telling them to give prophylactic antimicrobials. If they don’t do it and a patients gets an infection, that’s a malpractice issue. So we’ve got to go through those associations and get them to stop recommending prophylactic antimicrobials when there is no evidence of their effectiveness,” she said.
Ms. Ofstead has been a consultant for 3M Company, Ambu, Auris, Boston Scientific, Cogentix, Convergascent, Healthmark, Invendo Medical, Nanosonics, and Advanced Sterilization Products, and has received grant/research support from 3M Company, Advanced Sterilization Products, Ambu, Boston Scientific, Cogentix, Healthmark, Invendo Medical, Medivators, and Steris.
SOURCE: Ofstead C., ICEID 2018 Presentation.
ATLANTA – The risk of infection from flexible endoscopes is far greater than generally believed, despite the excessive use of prophylactic antimicrobials in patients undergoing endoscopy, recent studies show.
Many gastroenterologists and guidelines from professional organizations use a reference point of “less than one per million” regarding the risk of infection from scopes, but a Johns Hopkins University study of more than 2.3 million patients in 6 states showed that the infection risk with colonoscopy is about 1 per 1,000, the risk for upper gastrointestinal endoscopy is about 3 per 1,000, and the risk with cystoscopy is about 4 per 1,000, Cori Ofstead said at the International Conference on Emerging Infectious Diseases.
“For bronchoscopy [the infection risk] was 15.6 in 1,000, which is 1.6% – not anywhere in the 1 in a million range,” said Ms. Ofstead, president and chief executive officer of Ofstead & Associates, a St. Paul, Minn. health care research firm.
It also turns out that prophylactic antibiotics are frequently given to patients undergoing routine endoscopy procedures, she said, noting that four major associations – two gastroenterology associations and two urology associations in the United States and Europe – recommend that prophylactic antimicrobials be given with routine endoscopies for certain patients undergoing certain types of procedures.
One U.S. organization is recommending prophylactic antimicrobials for every patient undergoing ureteroscopy, she added.
A Cleveland Clinic study looking at the impact of those American Urological Association guidelines for prophylactic antimicrobials showed that in a subset of patients with negative urine cultures before ureteroscopy, 100% received the prophylaxis, and 68% were also given other antimicrobials to take home.
“So the question, of course, is how well does this work...,” Ms. Ofstead said. “They found 3%-4% infection, with the rates exactly the same – no statistically significant differences – between patients who got prophylaxis just in the hospital or who went home with prophylactic meds, and they concluded that there was no benefit to the extra take-home antimicrobials.”
Others studies in multiple countries show either no impact or only minor impact of this prophylaxis on infection rates, and yet all show infection rates after endoscopy that are not one in a million, but in “the percentage point range,” she said.
“As we move toward more of these minimally invasive procedures, we need to be aware that we’re using extremely complex instruments that are very difficult to clean and disinfect or sterilize,” she said, adding that “in the field we’re seeing that improper reprocessing is actually business as usual.”
Infections have been seen with all kinds of scopes, Ms. Ofstead noted.
“The potential for this becoming a bit of a monster is enhanced by the widespread use of prophylactic antimicrobials during endoscopy, and I’m also troubled by the quick reaction of giving people antimicrobials when they have a positive culture from a scope rather than making sure the scope is clean,” she said, explaining that while most scopes have microbes and patients could be getting infections, they also may be reacting to soil and endotoxins in the scope rather than microbes.
“In any case, to reduce risks there are a number of things people can do,” she said. When using reusable scopes, proper cleaning is essential. “I think we should be moving toward scopes that can be disassembled so we can see inside and get those channels clean,” adding that efforts should also be made to move toward single-use scopes.
“Particularly in these outbreak situations where we’re using bronchoscopy on multiple patients, there’s just no excuse for reusing bronchoscopes and not sterilizing them between uses and making darn sure that they’re not full of whatever our outbreak pathogen is,” Ms. Ofstead said. “And lastly, I’m hoping that some folks here can talk some sense into people at the professional associations who are recommending prophylactic antimicrobial use, because if we don’t get some stewardship going, we’re going to be in big trouble.”
The guidelines create a conundrum for doctors who are torn between that stewardship and a failure to follow the recommendations.
“Their professional organization is telling them to give prophylactic antimicrobials. If they don’t do it and a patients gets an infection, that’s a malpractice issue. So we’ve got to go through those associations and get them to stop recommending prophylactic antimicrobials when there is no evidence of their effectiveness,” she said.
Ms. Ofstead has been a consultant for 3M Company, Ambu, Auris, Boston Scientific, Cogentix, Convergascent, Healthmark, Invendo Medical, Nanosonics, and Advanced Sterilization Products, and has received grant/research support from 3M Company, Advanced Sterilization Products, Ambu, Boston Scientific, Cogentix, Healthmark, Invendo Medical, Medivators, and Steris.
SOURCE: Ofstead C., ICEID 2018 Presentation.
ATLANTA – The risk of infection from flexible endoscopes is far greater than generally believed, despite the excessive use of prophylactic antimicrobials in patients undergoing endoscopy, recent studies show.
Many gastroenterologists and guidelines from professional organizations use a reference point of “less than one per million” regarding the risk of infection from scopes, but a Johns Hopkins University study of more than 2.3 million patients in 6 states showed that the infection risk with colonoscopy is about 1 per 1,000, the risk for upper gastrointestinal endoscopy is about 3 per 1,000, and the risk with cystoscopy is about 4 per 1,000, Cori Ofstead said at the International Conference on Emerging Infectious Diseases.
“For bronchoscopy [the infection risk] was 15.6 in 1,000, which is 1.6% – not anywhere in the 1 in a million range,” said Ms. Ofstead, president and chief executive officer of Ofstead & Associates, a St. Paul, Minn. health care research firm.
It also turns out that prophylactic antibiotics are frequently given to patients undergoing routine endoscopy procedures, she said, noting that four major associations – two gastroenterology associations and two urology associations in the United States and Europe – recommend that prophylactic antimicrobials be given with routine endoscopies for certain patients undergoing certain types of procedures.
One U.S. organization is recommending prophylactic antimicrobials for every patient undergoing ureteroscopy, she added.
A Cleveland Clinic study looking at the impact of those American Urological Association guidelines for prophylactic antimicrobials showed that in a subset of patients with negative urine cultures before ureteroscopy, 100% received the prophylaxis, and 68% were also given other antimicrobials to take home.
“So the question, of course, is how well does this work...,” Ms. Ofstead said. “They found 3%-4% infection, with the rates exactly the same – no statistically significant differences – between patients who got prophylaxis just in the hospital or who went home with prophylactic meds, and they concluded that there was no benefit to the extra take-home antimicrobials.”
Others studies in multiple countries show either no impact or only minor impact of this prophylaxis on infection rates, and yet all show infection rates after endoscopy that are not one in a million, but in “the percentage point range,” she said.
“As we move toward more of these minimally invasive procedures, we need to be aware that we’re using extremely complex instruments that are very difficult to clean and disinfect or sterilize,” she said, adding that “in the field we’re seeing that improper reprocessing is actually business as usual.”
Infections have been seen with all kinds of scopes, Ms. Ofstead noted.
“The potential for this becoming a bit of a monster is enhanced by the widespread use of prophylactic antimicrobials during endoscopy, and I’m also troubled by the quick reaction of giving people antimicrobials when they have a positive culture from a scope rather than making sure the scope is clean,” she said, explaining that while most scopes have microbes and patients could be getting infections, they also may be reacting to soil and endotoxins in the scope rather than microbes.
“In any case, to reduce risks there are a number of things people can do,” she said. When using reusable scopes, proper cleaning is essential. “I think we should be moving toward scopes that can be disassembled so we can see inside and get those channels clean,” adding that efforts should also be made to move toward single-use scopes.
“Particularly in these outbreak situations where we’re using bronchoscopy on multiple patients, there’s just no excuse for reusing bronchoscopes and not sterilizing them between uses and making darn sure that they’re not full of whatever our outbreak pathogen is,” Ms. Ofstead said. “And lastly, I’m hoping that some folks here can talk some sense into people at the professional associations who are recommending prophylactic antimicrobial use, because if we don’t get some stewardship going, we’re going to be in big trouble.”
The guidelines create a conundrum for doctors who are torn between that stewardship and a failure to follow the recommendations.
“Their professional organization is telling them to give prophylactic antimicrobials. If they don’t do it and a patients gets an infection, that’s a malpractice issue. So we’ve got to go through those associations and get them to stop recommending prophylactic antimicrobials when there is no evidence of their effectiveness,” she said.
Ms. Ofstead has been a consultant for 3M Company, Ambu, Auris, Boston Scientific, Cogentix, Convergascent, Healthmark, Invendo Medical, Nanosonics, and Advanced Sterilization Products, and has received grant/research support from 3M Company, Advanced Sterilization Products, Ambu, Boston Scientific, Cogentix, Healthmark, Invendo Medical, Medivators, and Steris.
SOURCE: Ofstead C., ICEID 2018 Presentation.
REPORTING FROM ICEID 2018
Key clinical point:
Major finding: Infection risk is about 1 per 1,000 with colonoscopy; 3 per 1,000 with upper gastrointestinal endoscopy; and 4 per 1,000 with cystoscopy.
Study details: Endoscopic procedures performed at ASCs in 2014 all-payer claims data from 6 U.S. states.
Disclosures: Ms. Ofstead has been a consultant for 3M Company, Ambu, Auris, Boston Scientific, Cogentix, Convergascent, Healthmark, Invendo Medical, Nanosonics, and Advanced Sterilization Products, and has received grant/research support from 3M Company, Advanced Sterilization Products, Ambu, Boston Scientific, Cogentix, Healthmark, Invendo Medical, Medivators, and Steris.
Source: Ofstead C et al. ICEID 2018 Presentation.