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Weight can block psychiatric facility admission
SAN FRANCISCO – Not too long ago, a 42-year-old homeless man could not leave the Los Angeles County Hospital because he was too heavy.
He had been admitted on a 72-hour involuntary psychiatric hold because he was suicidal; he had a history of severe depression and had made several attempts in the past. He had few social connections and had come in covered in lice after sleeping outdoors for months. He was mobile, but barely so, with the help of a walker.
He was cleaned up and medically stabilized at the hospital, but when it came time to transfer him to a psychiatric facility, no one would take him because he was morbidly obese, with a body mass index (BMI) of 53 mg/m2.
“We noticed this had happened with other patients. It wasn’t just this one case, so we” decided to take a closer look, said Katherine Camfield, MD, a psychiatric resident at Los Angeles County Hospital.
She and her colleagues called 43 inpatient psychiatric facilities in L.A. County. It turned out that 41, more than 60% of the total and including both public and private facilities, had weight restrictions. Staff members at the remaining two facilities were unsure.
For 2 hospitals, it was a BMI above 50; for 17, a weight above 350 pounds; and for 6, a weight above 300 pounds. Three had a limit of just 250 pounds. Others decided on a case-by-case basis. About 10% of the people put on psychiatric holds at the L.A. County Hospital weigh 250 pounds or more and therefore would not meet the weight limits at many facilities.
Some hospitals cited concerns about staff injuries from moving – or trying to calm – a large patient. Others said they did not have lifts and other specialized equipment or that their beds could not handle the weight. Others did not really give a reason.
County hospitals “are not a very therapeutic milieu; staff and nursing aren’t necessarily trained for unstable psychiatric patients,” Dr. Camfield said at the American Psychiatric Association annual meeting.
“Honestly, having a mental illness alone increases your risk of obesity, and then we give a lot of medications that increase the risk” even more. “It’s a vicious cycle,” and one that raises the issue of discrimination, although “whether these routine denials to access psychiatric hospitalization violate antidiscrimination laws is unclear,” she said.
She and her colleagues plan to take a deeper dive into the issue, to find out how widespread the problem is, and the reasons behind it. They are also interested in cost; “a county facility has limited resources; are they being misallocated because these patients are stuck in the hospital?” Dr. Camfield wondered.
The homeless man never made to a psychiatric facility. He was put on antidepressants and stayed in the county hospital for 20 days, until he was no longer suicidal. He then was transferred to skilled nursing facility.
There was no external funding, and Dr. Camfield had no disclosures.
SAN FRANCISCO – Not too long ago, a 42-year-old homeless man could not leave the Los Angeles County Hospital because he was too heavy.
He had been admitted on a 72-hour involuntary psychiatric hold because he was suicidal; he had a history of severe depression and had made several attempts in the past. He had few social connections and had come in covered in lice after sleeping outdoors for months. He was mobile, but barely so, with the help of a walker.
He was cleaned up and medically stabilized at the hospital, but when it came time to transfer him to a psychiatric facility, no one would take him because he was morbidly obese, with a body mass index (BMI) of 53 mg/m2.
“We noticed this had happened with other patients. It wasn’t just this one case, so we” decided to take a closer look, said Katherine Camfield, MD, a psychiatric resident at Los Angeles County Hospital.
She and her colleagues called 43 inpatient psychiatric facilities in L.A. County. It turned out that 41, more than 60% of the total and including both public and private facilities, had weight restrictions. Staff members at the remaining two facilities were unsure.
For 2 hospitals, it was a BMI above 50; for 17, a weight above 350 pounds; and for 6, a weight above 300 pounds. Three had a limit of just 250 pounds. Others decided on a case-by-case basis. About 10% of the people put on psychiatric holds at the L.A. County Hospital weigh 250 pounds or more and therefore would not meet the weight limits at many facilities.
Some hospitals cited concerns about staff injuries from moving – or trying to calm – a large patient. Others said they did not have lifts and other specialized equipment or that their beds could not handle the weight. Others did not really give a reason.
County hospitals “are not a very therapeutic milieu; staff and nursing aren’t necessarily trained for unstable psychiatric patients,” Dr. Camfield said at the American Psychiatric Association annual meeting.
“Honestly, having a mental illness alone increases your risk of obesity, and then we give a lot of medications that increase the risk” even more. “It’s a vicious cycle,” and one that raises the issue of discrimination, although “whether these routine denials to access psychiatric hospitalization violate antidiscrimination laws is unclear,” she said.
She and her colleagues plan to take a deeper dive into the issue, to find out how widespread the problem is, and the reasons behind it. They are also interested in cost; “a county facility has limited resources; are they being misallocated because these patients are stuck in the hospital?” Dr. Camfield wondered.
The homeless man never made to a psychiatric facility. He was put on antidepressants and stayed in the county hospital for 20 days, until he was no longer suicidal. He then was transferred to skilled nursing facility.
There was no external funding, and Dr. Camfield had no disclosures.
SAN FRANCISCO – Not too long ago, a 42-year-old homeless man could not leave the Los Angeles County Hospital because he was too heavy.
He had been admitted on a 72-hour involuntary psychiatric hold because he was suicidal; he had a history of severe depression and had made several attempts in the past. He had few social connections and had come in covered in lice after sleeping outdoors for months. He was mobile, but barely so, with the help of a walker.
He was cleaned up and medically stabilized at the hospital, but when it came time to transfer him to a psychiatric facility, no one would take him because he was morbidly obese, with a body mass index (BMI) of 53 mg/m2.
“We noticed this had happened with other patients. It wasn’t just this one case, so we” decided to take a closer look, said Katherine Camfield, MD, a psychiatric resident at Los Angeles County Hospital.
She and her colleagues called 43 inpatient psychiatric facilities in L.A. County. It turned out that 41, more than 60% of the total and including both public and private facilities, had weight restrictions. Staff members at the remaining two facilities were unsure.
For 2 hospitals, it was a BMI above 50; for 17, a weight above 350 pounds; and for 6, a weight above 300 pounds. Three had a limit of just 250 pounds. Others decided on a case-by-case basis. About 10% of the people put on psychiatric holds at the L.A. County Hospital weigh 250 pounds or more and therefore would not meet the weight limits at many facilities.
Some hospitals cited concerns about staff injuries from moving – or trying to calm – a large patient. Others said they did not have lifts and other specialized equipment or that their beds could not handle the weight. Others did not really give a reason.
County hospitals “are not a very therapeutic milieu; staff and nursing aren’t necessarily trained for unstable psychiatric patients,” Dr. Camfield said at the American Psychiatric Association annual meeting.
“Honestly, having a mental illness alone increases your risk of obesity, and then we give a lot of medications that increase the risk” even more. “It’s a vicious cycle,” and one that raises the issue of discrimination, although “whether these routine denials to access psychiatric hospitalization violate antidiscrimination laws is unclear,” she said.
She and her colleagues plan to take a deeper dive into the issue, to find out how widespread the problem is, and the reasons behind it. They are also interested in cost; “a county facility has limited resources; are they being misallocated because these patients are stuck in the hospital?” Dr. Camfield wondered.
The homeless man never made to a psychiatric facility. He was put on antidepressants and stayed in the county hospital for 20 days, until he was no longer suicidal. He then was transferred to skilled nursing facility.
There was no external funding, and Dr. Camfield had no disclosures.
REPORTING FROM APA 2019
Confronting physician depression and suicide
Please join us Monday, June 3, at 8:00 p.m. ET as we discuss depression in physicians and the resulting tragedies, as well as how to help physicians receive the treatment they need to prevent suicide.
Our special guests include physicians with expertise on the triggers of physician depression and solutions for fighting this epidemic, Sarah Candler, MD, (@sarahgcandler) and Elisabeth Poorman, MD, (@DrPoorman). We hope you will participate in our Twitter chat on June 3 at 8 p.m. ET. #MDedgeChats
Physicians have higher rates of depression and suicide, compared with the general population, according to the American Foundation for Suicide Prevention. Suicide rates for male physicians are 1.41 times higher than in the general population and, for female physicians, 2.27 times greater.
“But these numbers come from only those deaths that are reported publicly,” Dr. Poorman wrote in an article that was published by WBUR, Boston’s NPR News Station. In fact, as Dr. Poorman was writing this story, she learned of five separate deaths that were widely known to be suicides, but never publicly identified as such, she said.
One possible explanation for physicians’ higher likelihood of becoming depressed or dying by suicide, compared with other professionals, is their hesitance to receive mental health treatment, experts have suggested. Psychiatrist Michael F. Myers, MD, found anecdotal evidence of this tendency when he interviewed the loved ones, friends, and colleagues of physicians who took their own lives.
In this chat we will discuss this topic and other possible reasons for the high rate of depression and suicide among physicians.
Topics of conversation
Question 1: What are the causes of physician depression and suicide in training and practice?
Question 2: How can we end stigma against seeking mental health treatment among physicians?
Question 3: How can we prevent depression and suicide among medical students and physicians?
Question 4: Which institutions or programs are exemplars in providing resources to improve mental health?
Question 5: What organizational and political changes are likely to reduce physician suicides?
Resources
1. Getting Back to Medicine as a Community
2. What stops physicians from getting mental health care?
3. Risk considerations for suicidal physicians
4. Two more and counting: Suicide in medical trainees
5. How to talk with a struggling physician colleague
6. Healthcare industry takes on high physician suicide rates, mental health stigma
7. The Curbsiders episode #129 Depression and Suicide: Occupational Hazards of Practicing Medicine
8. Creating Joy in Medicine in St. Paul, MN: A Case Study
About Dr. Poorman
Dr. Poorman (@DrPoorman) is a primary care physician at the University of Washington in Seattle, a freelance journalist covering issues related to medicine, and a frequent speaker on the causes of and solutions to mental illness among providers.
Her writing has been featured in Self, The Guardian. Medpage Today’s KevinMD.com, and other publications. She produces the blog: https://www.drpoorman.org/what-we-do.
About Dr. Candler
Dr. Candler (@sarahgcandler) is a primary care physician in Houston. She is coeditor of the Annals Fresh Look blog, and a member of Internal Medicine News’ Editorial Advisory Board.
She is currently consulting for a tech firm and will later be joining Iora Health to start a Medicare Advantage clinic.
Please join us Monday, June 3, at 8:00 p.m. ET as we discuss depression in physicians and the resulting tragedies, as well as how to help physicians receive the treatment they need to prevent suicide.
Our special guests include physicians with expertise on the triggers of physician depression and solutions for fighting this epidemic, Sarah Candler, MD, (@sarahgcandler) and Elisabeth Poorman, MD, (@DrPoorman). We hope you will participate in our Twitter chat on June 3 at 8 p.m. ET. #MDedgeChats
Physicians have higher rates of depression and suicide, compared with the general population, according to the American Foundation for Suicide Prevention. Suicide rates for male physicians are 1.41 times higher than in the general population and, for female physicians, 2.27 times greater.
“But these numbers come from only those deaths that are reported publicly,” Dr. Poorman wrote in an article that was published by WBUR, Boston’s NPR News Station. In fact, as Dr. Poorman was writing this story, she learned of five separate deaths that were widely known to be suicides, but never publicly identified as such, she said.
One possible explanation for physicians’ higher likelihood of becoming depressed or dying by suicide, compared with other professionals, is their hesitance to receive mental health treatment, experts have suggested. Psychiatrist Michael F. Myers, MD, found anecdotal evidence of this tendency when he interviewed the loved ones, friends, and colleagues of physicians who took their own lives.
In this chat we will discuss this topic and other possible reasons for the high rate of depression and suicide among physicians.
Topics of conversation
Question 1: What are the causes of physician depression and suicide in training and practice?
Question 2: How can we end stigma against seeking mental health treatment among physicians?
Question 3: How can we prevent depression and suicide among medical students and physicians?
Question 4: Which institutions or programs are exemplars in providing resources to improve mental health?
Question 5: What organizational and political changes are likely to reduce physician suicides?
Resources
1. Getting Back to Medicine as a Community
2. What stops physicians from getting mental health care?
3. Risk considerations for suicidal physicians
4. Two more and counting: Suicide in medical trainees
5. How to talk with a struggling physician colleague
6. Healthcare industry takes on high physician suicide rates, mental health stigma
7. The Curbsiders episode #129 Depression and Suicide: Occupational Hazards of Practicing Medicine
8. Creating Joy in Medicine in St. Paul, MN: A Case Study
About Dr. Poorman
Dr. Poorman (@DrPoorman) is a primary care physician at the University of Washington in Seattle, a freelance journalist covering issues related to medicine, and a frequent speaker on the causes of and solutions to mental illness among providers.
Her writing has been featured in Self, The Guardian. Medpage Today’s KevinMD.com, and other publications. She produces the blog: https://www.drpoorman.org/what-we-do.
About Dr. Candler
Dr. Candler (@sarahgcandler) is a primary care physician in Houston. She is coeditor of the Annals Fresh Look blog, and a member of Internal Medicine News’ Editorial Advisory Board.
She is currently consulting for a tech firm and will later be joining Iora Health to start a Medicare Advantage clinic.
Please join us Monday, June 3, at 8:00 p.m. ET as we discuss depression in physicians and the resulting tragedies, as well as how to help physicians receive the treatment they need to prevent suicide.
Our special guests include physicians with expertise on the triggers of physician depression and solutions for fighting this epidemic, Sarah Candler, MD, (@sarahgcandler) and Elisabeth Poorman, MD, (@DrPoorman). We hope you will participate in our Twitter chat on June 3 at 8 p.m. ET. #MDedgeChats
Physicians have higher rates of depression and suicide, compared with the general population, according to the American Foundation for Suicide Prevention. Suicide rates for male physicians are 1.41 times higher than in the general population and, for female physicians, 2.27 times greater.
“But these numbers come from only those deaths that are reported publicly,” Dr. Poorman wrote in an article that was published by WBUR, Boston’s NPR News Station. In fact, as Dr. Poorman was writing this story, she learned of five separate deaths that were widely known to be suicides, but never publicly identified as such, she said.
One possible explanation for physicians’ higher likelihood of becoming depressed or dying by suicide, compared with other professionals, is their hesitance to receive mental health treatment, experts have suggested. Psychiatrist Michael F. Myers, MD, found anecdotal evidence of this tendency when he interviewed the loved ones, friends, and colleagues of physicians who took their own lives.
In this chat we will discuss this topic and other possible reasons for the high rate of depression and suicide among physicians.
Topics of conversation
Question 1: What are the causes of physician depression and suicide in training and practice?
Question 2: How can we end stigma against seeking mental health treatment among physicians?
Question 3: How can we prevent depression and suicide among medical students and physicians?
Question 4: Which institutions or programs are exemplars in providing resources to improve mental health?
Question 5: What organizational and political changes are likely to reduce physician suicides?
Resources
1. Getting Back to Medicine as a Community
2. What stops physicians from getting mental health care?
3. Risk considerations for suicidal physicians
4. Two more and counting: Suicide in medical trainees
5. How to talk with a struggling physician colleague
6. Healthcare industry takes on high physician suicide rates, mental health stigma
7. The Curbsiders episode #129 Depression and Suicide: Occupational Hazards of Practicing Medicine
8. Creating Joy in Medicine in St. Paul, MN: A Case Study
About Dr. Poorman
Dr. Poorman (@DrPoorman) is a primary care physician at the University of Washington in Seattle, a freelance journalist covering issues related to medicine, and a frequent speaker on the causes of and solutions to mental illness among providers.
Her writing has been featured in Self, The Guardian. Medpage Today’s KevinMD.com, and other publications. She produces the blog: https://www.drpoorman.org/what-we-do.
About Dr. Candler
Dr. Candler (@sarahgcandler) is a primary care physician in Houston. She is coeditor of the Annals Fresh Look blog, and a member of Internal Medicine News’ Editorial Advisory Board.
She is currently consulting for a tech firm and will later be joining Iora Health to start a Medicare Advantage clinic.
Posthospitalization thromboprophylaxis with rivaroxaban is unnecessary
Background: Anticoagulation for at-risk medical populations for posthospitalization thromboprophylaxis has been investigated in previous studies demonstrating a benefit in reducing risk of asymptomatic deep-vein thrombosis (DVT) development, but no studies have examined symptomatic DVTs.
Study design: Randomized, double-blind, placebo-controlled, multinational clinical trial.
Setting: 671 multinational hospitals.
Synopsis: 11,962 patients were identified as at-risk patients based on length of hospitalization (3-10 days), diagnosis, and additional risk factors identified by an IMPROVE risk score of greater than 4 or 2-3 with a D-dimer level more than twice the upper limit of normal. Patients were randomly assigned to receive rivaroxaban or placebo for 45 days. Primary outcome was composite of any symptomatic DVT or death related to VTE. Safety outcomes were principally related to bleeding. Symptomatic VTE or death from VTE occurred in 0.83% in the anticoagulation group and 1.1% in the placebo group (95% confidence interval, 0.52-1.09; P = .14). No significant difference was found in safety outcomes. The major limitation of the study was the low incidence of VTE and the need to include lower-risk patients (IMPROVE score 2/3 with elevated D-dimer), which may have decreased the effect of anticoagulation in the high-risk group (IMPROVE score 4 or greater).
Bottom line: No significant improvement in symptomatic VTE complications was found with posthospitalization thromboprophylaxis using rivaroxaban for an at-risk medical population.
Citation: Spyropoulos AC et al. Rivaroxaban for thromboprophylaxis after hospitalization for medical illness. N Eng J Med. 2018 Sep 20;379:1118-27.
Dr. Imber is an assistant professor in the division of hospital medicine, University of New Mexico.
Background: Anticoagulation for at-risk medical populations for posthospitalization thromboprophylaxis has been investigated in previous studies demonstrating a benefit in reducing risk of asymptomatic deep-vein thrombosis (DVT) development, but no studies have examined symptomatic DVTs.
Study design: Randomized, double-blind, placebo-controlled, multinational clinical trial.
Setting: 671 multinational hospitals.
Synopsis: 11,962 patients were identified as at-risk patients based on length of hospitalization (3-10 days), diagnosis, and additional risk factors identified by an IMPROVE risk score of greater than 4 or 2-3 with a D-dimer level more than twice the upper limit of normal. Patients were randomly assigned to receive rivaroxaban or placebo for 45 days. Primary outcome was composite of any symptomatic DVT or death related to VTE. Safety outcomes were principally related to bleeding. Symptomatic VTE or death from VTE occurred in 0.83% in the anticoagulation group and 1.1% in the placebo group (95% confidence interval, 0.52-1.09; P = .14). No significant difference was found in safety outcomes. The major limitation of the study was the low incidence of VTE and the need to include lower-risk patients (IMPROVE score 2/3 with elevated D-dimer), which may have decreased the effect of anticoagulation in the high-risk group (IMPROVE score 4 or greater).
Bottom line: No significant improvement in symptomatic VTE complications was found with posthospitalization thromboprophylaxis using rivaroxaban for an at-risk medical population.
Citation: Spyropoulos AC et al. Rivaroxaban for thromboprophylaxis after hospitalization for medical illness. N Eng J Med. 2018 Sep 20;379:1118-27.
Dr. Imber is an assistant professor in the division of hospital medicine, University of New Mexico.
Background: Anticoagulation for at-risk medical populations for posthospitalization thromboprophylaxis has been investigated in previous studies demonstrating a benefit in reducing risk of asymptomatic deep-vein thrombosis (DVT) development, but no studies have examined symptomatic DVTs.
Study design: Randomized, double-blind, placebo-controlled, multinational clinical trial.
Setting: 671 multinational hospitals.
Synopsis: 11,962 patients were identified as at-risk patients based on length of hospitalization (3-10 days), diagnosis, and additional risk factors identified by an IMPROVE risk score of greater than 4 or 2-3 with a D-dimer level more than twice the upper limit of normal. Patients were randomly assigned to receive rivaroxaban or placebo for 45 days. Primary outcome was composite of any symptomatic DVT or death related to VTE. Safety outcomes were principally related to bleeding. Symptomatic VTE or death from VTE occurred in 0.83% in the anticoagulation group and 1.1% in the placebo group (95% confidence interval, 0.52-1.09; P = .14). No significant difference was found in safety outcomes. The major limitation of the study was the low incidence of VTE and the need to include lower-risk patients (IMPROVE score 2/3 with elevated D-dimer), which may have decreased the effect of anticoagulation in the high-risk group (IMPROVE score 4 or greater).
Bottom line: No significant improvement in symptomatic VTE complications was found with posthospitalization thromboprophylaxis using rivaroxaban for an at-risk medical population.
Citation: Spyropoulos AC et al. Rivaroxaban for thromboprophylaxis after hospitalization for medical illness. N Eng J Med. 2018 Sep 20;379:1118-27.
Dr. Imber is an assistant professor in the division of hospital medicine, University of New Mexico.
Psychiatrists urged to raise awareness about human trafficking
SAN FRANCISCO – Psychiatrists see and interact with people who are being sex and labor trafficked “all the time” – and can learn more about how to identify these individuals, Rachel Robitz, MD, said at the annual meeting of the American Psychiatric Association.
In an exclusive video, Mollie Gordon, MD, interviewed Dr. Robitz about the intersection between trafficking and mental health. “What scares me the most is some of the statistics about self-harm,” said Dr. Robitz. “One study of sex-trafficked adults found that about 40% of them had a history of a suicide attempt. A study of sex-trafficked minors found that about 30% of them had a history of moderate to severe self-harm behavior.”
Dr. Robitz said. Other resources include those provided by the Department of Health & Human Services’s Office on Trafficking in Persons.
Dr. Robitz, who is double boarded in psychiatry and family medicine, is with the University of California, Davis. She previously worked for a program for homeless youth and for many programs aimed at helping adult and youth survivors of human trafficking. Dr. Robitz has no disclosures. Dr. Gordon is associate professor of psychiatry in the Menninger department of behavioral health at Baylor College of Medicine, Houston. She is a founding member of the Houston Area Human Trafficking Health Care Consortium. Dr. Gordon has no disclosures.
SAN FRANCISCO – Psychiatrists see and interact with people who are being sex and labor trafficked “all the time” – and can learn more about how to identify these individuals, Rachel Robitz, MD, said at the annual meeting of the American Psychiatric Association.
In an exclusive video, Mollie Gordon, MD, interviewed Dr. Robitz about the intersection between trafficking and mental health. “What scares me the most is some of the statistics about self-harm,” said Dr. Robitz. “One study of sex-trafficked adults found that about 40% of them had a history of a suicide attempt. A study of sex-trafficked minors found that about 30% of them had a history of moderate to severe self-harm behavior.”
Dr. Robitz said. Other resources include those provided by the Department of Health & Human Services’s Office on Trafficking in Persons.
Dr. Robitz, who is double boarded in psychiatry and family medicine, is with the University of California, Davis. She previously worked for a program for homeless youth and for many programs aimed at helping adult and youth survivors of human trafficking. Dr. Robitz has no disclosures. Dr. Gordon is associate professor of psychiatry in the Menninger department of behavioral health at Baylor College of Medicine, Houston. She is a founding member of the Houston Area Human Trafficking Health Care Consortium. Dr. Gordon has no disclosures.
SAN FRANCISCO – Psychiatrists see and interact with people who are being sex and labor trafficked “all the time” – and can learn more about how to identify these individuals, Rachel Robitz, MD, said at the annual meeting of the American Psychiatric Association.
In an exclusive video, Mollie Gordon, MD, interviewed Dr. Robitz about the intersection between trafficking and mental health. “What scares me the most is some of the statistics about self-harm,” said Dr. Robitz. “One study of sex-trafficked adults found that about 40% of them had a history of a suicide attempt. A study of sex-trafficked minors found that about 30% of them had a history of moderate to severe self-harm behavior.”
Dr. Robitz said. Other resources include those provided by the Department of Health & Human Services’s Office on Trafficking in Persons.
Dr. Robitz, who is double boarded in psychiatry and family medicine, is with the University of California, Davis. She previously worked for a program for homeless youth and for many programs aimed at helping adult and youth survivors of human trafficking. Dr. Robitz has no disclosures. Dr. Gordon is associate professor of psychiatry in the Menninger department of behavioral health at Baylor College of Medicine, Houston. She is a founding member of the Houston Area Human Trafficking Health Care Consortium. Dr. Gordon has no disclosures.
REPORTING FROM APA 2019
In duodenal neuroendocrine tumors, resection technique matters
SAN DIEGO – according to a study presented at the annual Digestive Disease Week.
In a retrospective case series of 20 patients, local recurrence was seen primarily in patients who had cold forceps, rather than deeper, excision techniques. However, most patients who had cold forceps resections also remained recurrence-free, said Jonathan Ragheb, MD, a resident physician at the Cleveland Clinic.
Duodenal neuroendocrine tumors are becoming increasingly prevalent, so Dr. Ragheb and colleagues were interested in “seeing what we should do with them when we encounter them in clinical practice – whether it be surgery or endoscopic intervention,” he said.
In an interview, Dr. Ragheb said that he and his colleagues structured the study to answer the question: “What is the impact of the margin status on the recurrence of the tumor?” This relationship is important in guiding neuroendocrine tumor (NET) management, he said. The technique used for NET removal may also have effects on recurrence rates, so Dr. Ragheb and his collaborators were also interested in answering that question.
The investigators looked at patients at two facilities with a histopathologic diagnosis of duodenal NET who had endoscopic tumor resection during 2004-2018. They excluded patients who had cold forceps endoscopic resection (ER) and clear margins, patients who had further surgical therapy, and those who were lost to endoscopic follow-up.
Assessment of resection margin status was performed independently by pathologists at each study center.
“We found that people with clear margins tend not to have any recurrence, and this is over the course of a year to a year and a half of follow-up,” said Dr. Ragheb, adding, “Those patients who did have some positive margins – whether lateral margins or vertical margins – the majority of them did not have recurrence over that time period.” However, 4 of the patients in the 20-patient cohort did have some tumor recurrence, and all of these patients had an incomplete initial resection.
The investigators took a closer look at which resection techniques were most likely to result in clear margins and no recurrences, and they found that deeper techniques were associated with fewer recurrences. These included endoscopic submucosal or mucosal resection and en bloc snare polypectomy; all were associated with fewer recurrences than resections performed with cold forceps biopsy.
In all, 7 patients had clear (R0) margins, while 13 patients had an incomplete (R1) resection from the biopsy. Of the patients who had R1 margins with local recurrence, three had received a cold forceps biopsy. The other recurrence was in a patient who had endoscopic mucosal resection.
“Margin status is not the sole contributor to recurrence rates of these duodenal neuroendocrine tumors,” said Dr. Ragheb, noting that previous work has identified other possible factors, including tumor grade and biology, that can affect recurrence.
Knowledge gaps still exist regarding best practices for biopsy and decision of duodenal NETs, acknowledged Dr. Ragheb. The present study only followed patients for about a year and a half, so longer-term recurrence patterns and their relationship with various resection techniques aren’t known.
“Larger studies considering tumor grading and ER [endoscopic resection] technique are needed to fully elucidate the risk of local recurrences after ER,” wrote Dr. Ragheb and colleagues.
Dr. Ragheb reported no outside sources of funding and no conflicts of interest.
SAN DIEGO – according to a study presented at the annual Digestive Disease Week.
In a retrospective case series of 20 patients, local recurrence was seen primarily in patients who had cold forceps, rather than deeper, excision techniques. However, most patients who had cold forceps resections also remained recurrence-free, said Jonathan Ragheb, MD, a resident physician at the Cleveland Clinic.
Duodenal neuroendocrine tumors are becoming increasingly prevalent, so Dr. Ragheb and colleagues were interested in “seeing what we should do with them when we encounter them in clinical practice – whether it be surgery or endoscopic intervention,” he said.
In an interview, Dr. Ragheb said that he and his colleagues structured the study to answer the question: “What is the impact of the margin status on the recurrence of the tumor?” This relationship is important in guiding neuroendocrine tumor (NET) management, he said. The technique used for NET removal may also have effects on recurrence rates, so Dr. Ragheb and his collaborators were also interested in answering that question.
The investigators looked at patients at two facilities with a histopathologic diagnosis of duodenal NET who had endoscopic tumor resection during 2004-2018. They excluded patients who had cold forceps endoscopic resection (ER) and clear margins, patients who had further surgical therapy, and those who were lost to endoscopic follow-up.
Assessment of resection margin status was performed independently by pathologists at each study center.
“We found that people with clear margins tend not to have any recurrence, and this is over the course of a year to a year and a half of follow-up,” said Dr. Ragheb, adding, “Those patients who did have some positive margins – whether lateral margins or vertical margins – the majority of them did not have recurrence over that time period.” However, 4 of the patients in the 20-patient cohort did have some tumor recurrence, and all of these patients had an incomplete initial resection.
The investigators took a closer look at which resection techniques were most likely to result in clear margins and no recurrences, and they found that deeper techniques were associated with fewer recurrences. These included endoscopic submucosal or mucosal resection and en bloc snare polypectomy; all were associated with fewer recurrences than resections performed with cold forceps biopsy.
In all, 7 patients had clear (R0) margins, while 13 patients had an incomplete (R1) resection from the biopsy. Of the patients who had R1 margins with local recurrence, three had received a cold forceps biopsy. The other recurrence was in a patient who had endoscopic mucosal resection.
“Margin status is not the sole contributor to recurrence rates of these duodenal neuroendocrine tumors,” said Dr. Ragheb, noting that previous work has identified other possible factors, including tumor grade and biology, that can affect recurrence.
Knowledge gaps still exist regarding best practices for biopsy and decision of duodenal NETs, acknowledged Dr. Ragheb. The present study only followed patients for about a year and a half, so longer-term recurrence patterns and their relationship with various resection techniques aren’t known.
“Larger studies considering tumor grading and ER [endoscopic resection] technique are needed to fully elucidate the risk of local recurrences after ER,” wrote Dr. Ragheb and colleagues.
Dr. Ragheb reported no outside sources of funding and no conflicts of interest.
SAN DIEGO – according to a study presented at the annual Digestive Disease Week.
In a retrospective case series of 20 patients, local recurrence was seen primarily in patients who had cold forceps, rather than deeper, excision techniques. However, most patients who had cold forceps resections also remained recurrence-free, said Jonathan Ragheb, MD, a resident physician at the Cleveland Clinic.
Duodenal neuroendocrine tumors are becoming increasingly prevalent, so Dr. Ragheb and colleagues were interested in “seeing what we should do with them when we encounter them in clinical practice – whether it be surgery or endoscopic intervention,” he said.
In an interview, Dr. Ragheb said that he and his colleagues structured the study to answer the question: “What is the impact of the margin status on the recurrence of the tumor?” This relationship is important in guiding neuroendocrine tumor (NET) management, he said. The technique used for NET removal may also have effects on recurrence rates, so Dr. Ragheb and his collaborators were also interested in answering that question.
The investigators looked at patients at two facilities with a histopathologic diagnosis of duodenal NET who had endoscopic tumor resection during 2004-2018. They excluded patients who had cold forceps endoscopic resection (ER) and clear margins, patients who had further surgical therapy, and those who were lost to endoscopic follow-up.
Assessment of resection margin status was performed independently by pathologists at each study center.
“We found that people with clear margins tend not to have any recurrence, and this is over the course of a year to a year and a half of follow-up,” said Dr. Ragheb, adding, “Those patients who did have some positive margins – whether lateral margins or vertical margins – the majority of them did not have recurrence over that time period.” However, 4 of the patients in the 20-patient cohort did have some tumor recurrence, and all of these patients had an incomplete initial resection.
The investigators took a closer look at which resection techniques were most likely to result in clear margins and no recurrences, and they found that deeper techniques were associated with fewer recurrences. These included endoscopic submucosal or mucosal resection and en bloc snare polypectomy; all were associated with fewer recurrences than resections performed with cold forceps biopsy.
In all, 7 patients had clear (R0) margins, while 13 patients had an incomplete (R1) resection from the biopsy. Of the patients who had R1 margins with local recurrence, three had received a cold forceps biopsy. The other recurrence was in a patient who had endoscopic mucosal resection.
“Margin status is not the sole contributor to recurrence rates of these duodenal neuroendocrine tumors,” said Dr. Ragheb, noting that previous work has identified other possible factors, including tumor grade and biology, that can affect recurrence.
Knowledge gaps still exist regarding best practices for biopsy and decision of duodenal NETs, acknowledged Dr. Ragheb. The present study only followed patients for about a year and a half, so longer-term recurrence patterns and their relationship with various resection techniques aren’t known.
“Larger studies considering tumor grading and ER [endoscopic resection] technique are needed to fully elucidate the risk of local recurrences after ER,” wrote Dr. Ragheb and colleagues.
Dr. Ragheb reported no outside sources of funding and no conflicts of interest.
REPORTING FROM DDW 2019
SCAI releases first definition of cardiogenic shock
LAS VEGAS – The Society for Cardiovascular Angiography & Interventions released on May 19 the first-ever classification scheme for cardiogenic shock, dividing the condition into five severity levels.
The expert consensus panel that devised the new definition and classification model hopes it will spearhead a reset of research into the management of cardiogenic shock so that clinicians can assess interventions and introduce them into practice in a more precise, reproducible, and systematic way, Srihari S. Naidu, MD, said while presenting the proposal at the society’s annual scientific sessions.
The writing panel’s hope is that the new definition will “drive earlier recognition of shock and at a more precise stage to guide appropriate and timely escalation of care” and to “better define prospectively the value of mechanical circulatory support, extracorporeal membrane oxygenation, and other therapies,” said Dr. Naidu, chair of the writing group, as well as professor of medicine at New York Medical College and director of the cardiac catheterization laboratory at Westchester Medical Center, both in Valhalla, N.Y.
At the core of the classification scheme are the definitions for five strata of disease, which start at stage A, the “at-risk” patients before shock onset, and progress through stage B, “beginning”; stage C, “classic”; stage D, “deteriorating”; and stage E, “extremis,” which defines a patient with circulatory collapse (Catheter Cardiovasc Interv. 2019 May 19; doi: 10.1002/ccd.28329). Another key element of the classification model is the cardiac arrest “modifier,” designated by a subscripted letter A, which identifies patients who have had a cardiac arrest, regardless of duration. So a patient could be a stage BA, which identifies a patient with clinical evidence of relative hypotension or tachycardia without hypoperfusion and with a history of cardiac arrest.
The statement also itemizes several biomarkers and hemodynamic measurements that need regular, serial monitoring, such as blood lactate and right arterial pressure. Although the document leaves specific, defining values for some of these measures vaguely defined – the intent is that future research will fill in these gaps – the overall message is that clinicians caring for cardiogenic shock patients “need to be aggressive and look for these things,” Dr. Naidu said in a video interview.
“Until we agree on a definition of cardiogenic shock, we can’t go anywhere,” commented Larry S. Dean, MD, professor of medicine at and director of the Regional Heart Center of the University of Washington in Seattle. “There are a lot of conflicting data out there, and until we have a shared definition, we can’t advance our practice. We need to start looking at shock patients in a more precise way.”
“Without a clear definition of cardiogenic shock we will never improve patient outcomes. Every shock trial must define shock. If investigators just say ‘patients were in shock,’ I don’t know what that means,” noted Navin K. Kapur, MD, director of the Interventional Research Laboratories at Tufts Medical Center in Boston and a member of the writing panel.
Dr. Naidu and others on the panel highlighted the need to now validate the classification scheme’s ability to consistently categorize patients and predict their disease trajectories. They have begun the validation process with a 10,000-patient database of “all-comers” with cardiogenic shock maintained by the Mayo Clinic. Full results from this analysis will be out soon, but Dr. Naidu revealed in passing that it successfully provided validation of the proposed scheme.
The new definition received endorsements from the American College of Cardiology, the American Heart Association, the Society of Critical Care Medicine, and the Society of Thoracic Surgeons.
Dr. Naidu had no disclosures.
LAS VEGAS – The Society for Cardiovascular Angiography & Interventions released on May 19 the first-ever classification scheme for cardiogenic shock, dividing the condition into five severity levels.
The expert consensus panel that devised the new definition and classification model hopes it will spearhead a reset of research into the management of cardiogenic shock so that clinicians can assess interventions and introduce them into practice in a more precise, reproducible, and systematic way, Srihari S. Naidu, MD, said while presenting the proposal at the society’s annual scientific sessions.
The writing panel’s hope is that the new definition will “drive earlier recognition of shock and at a more precise stage to guide appropriate and timely escalation of care” and to “better define prospectively the value of mechanical circulatory support, extracorporeal membrane oxygenation, and other therapies,” said Dr. Naidu, chair of the writing group, as well as professor of medicine at New York Medical College and director of the cardiac catheterization laboratory at Westchester Medical Center, both in Valhalla, N.Y.
At the core of the classification scheme are the definitions for five strata of disease, which start at stage A, the “at-risk” patients before shock onset, and progress through stage B, “beginning”; stage C, “classic”; stage D, “deteriorating”; and stage E, “extremis,” which defines a patient with circulatory collapse (Catheter Cardiovasc Interv. 2019 May 19; doi: 10.1002/ccd.28329). Another key element of the classification model is the cardiac arrest “modifier,” designated by a subscripted letter A, which identifies patients who have had a cardiac arrest, regardless of duration. So a patient could be a stage BA, which identifies a patient with clinical evidence of relative hypotension or tachycardia without hypoperfusion and with a history of cardiac arrest.
The statement also itemizes several biomarkers and hemodynamic measurements that need regular, serial monitoring, such as blood lactate and right arterial pressure. Although the document leaves specific, defining values for some of these measures vaguely defined – the intent is that future research will fill in these gaps – the overall message is that clinicians caring for cardiogenic shock patients “need to be aggressive and look for these things,” Dr. Naidu said in a video interview.
“Until we agree on a definition of cardiogenic shock, we can’t go anywhere,” commented Larry S. Dean, MD, professor of medicine at and director of the Regional Heart Center of the University of Washington in Seattle. “There are a lot of conflicting data out there, and until we have a shared definition, we can’t advance our practice. We need to start looking at shock patients in a more precise way.”
“Without a clear definition of cardiogenic shock we will never improve patient outcomes. Every shock trial must define shock. If investigators just say ‘patients were in shock,’ I don’t know what that means,” noted Navin K. Kapur, MD, director of the Interventional Research Laboratories at Tufts Medical Center in Boston and a member of the writing panel.
Dr. Naidu and others on the panel highlighted the need to now validate the classification scheme’s ability to consistently categorize patients and predict their disease trajectories. They have begun the validation process with a 10,000-patient database of “all-comers” with cardiogenic shock maintained by the Mayo Clinic. Full results from this analysis will be out soon, but Dr. Naidu revealed in passing that it successfully provided validation of the proposed scheme.
The new definition received endorsements from the American College of Cardiology, the American Heart Association, the Society of Critical Care Medicine, and the Society of Thoracic Surgeons.
Dr. Naidu had no disclosures.
LAS VEGAS – The Society for Cardiovascular Angiography & Interventions released on May 19 the first-ever classification scheme for cardiogenic shock, dividing the condition into five severity levels.
The expert consensus panel that devised the new definition and classification model hopes it will spearhead a reset of research into the management of cardiogenic shock so that clinicians can assess interventions and introduce them into practice in a more precise, reproducible, and systematic way, Srihari S. Naidu, MD, said while presenting the proposal at the society’s annual scientific sessions.
The writing panel’s hope is that the new definition will “drive earlier recognition of shock and at a more precise stage to guide appropriate and timely escalation of care” and to “better define prospectively the value of mechanical circulatory support, extracorporeal membrane oxygenation, and other therapies,” said Dr. Naidu, chair of the writing group, as well as professor of medicine at New York Medical College and director of the cardiac catheterization laboratory at Westchester Medical Center, both in Valhalla, N.Y.
At the core of the classification scheme are the definitions for five strata of disease, which start at stage A, the “at-risk” patients before shock onset, and progress through stage B, “beginning”; stage C, “classic”; stage D, “deteriorating”; and stage E, “extremis,” which defines a patient with circulatory collapse (Catheter Cardiovasc Interv. 2019 May 19; doi: 10.1002/ccd.28329). Another key element of the classification model is the cardiac arrest “modifier,” designated by a subscripted letter A, which identifies patients who have had a cardiac arrest, regardless of duration. So a patient could be a stage BA, which identifies a patient with clinical evidence of relative hypotension or tachycardia without hypoperfusion and with a history of cardiac arrest.
The statement also itemizes several biomarkers and hemodynamic measurements that need regular, serial monitoring, such as blood lactate and right arterial pressure. Although the document leaves specific, defining values for some of these measures vaguely defined – the intent is that future research will fill in these gaps – the overall message is that clinicians caring for cardiogenic shock patients “need to be aggressive and look for these things,” Dr. Naidu said in a video interview.
“Until we agree on a definition of cardiogenic shock, we can’t go anywhere,” commented Larry S. Dean, MD, professor of medicine at and director of the Regional Heart Center of the University of Washington in Seattle. “There are a lot of conflicting data out there, and until we have a shared definition, we can’t advance our practice. We need to start looking at shock patients in a more precise way.”
“Without a clear definition of cardiogenic shock we will never improve patient outcomes. Every shock trial must define shock. If investigators just say ‘patients were in shock,’ I don’t know what that means,” noted Navin K. Kapur, MD, director of the Interventional Research Laboratories at Tufts Medical Center in Boston and a member of the writing panel.
Dr. Naidu and others on the panel highlighted the need to now validate the classification scheme’s ability to consistently categorize patients and predict their disease trajectories. They have begun the validation process with a 10,000-patient database of “all-comers” with cardiogenic shock maintained by the Mayo Clinic. Full results from this analysis will be out soon, but Dr. Naidu revealed in passing that it successfully provided validation of the proposed scheme.
The new definition received endorsements from the American College of Cardiology, the American Heart Association, the Society of Critical Care Medicine, and the Society of Thoracic Surgeons.
Dr. Naidu had no disclosures.
REPORTING FROM SCAI 2019
FDA issues warning about use of unauthorized diabetes devices
This safety communication applies to continuous glucose monitors, insulin pumps, and automated insulin-dosing systems and is intended for both patients who manage their diabetes with any of various devices and the health care providers who treat and manage those patients.
The agency’s concerns were underscored by a recent report it received about a patient who used a combination of unauthorized devices and who needed medical intervention as a result.
“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended, or when [patients] use devices not authorized for sale in the [United States],” Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a news release. “[This] warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”
The release noted that the agency reviews some of the diabetes management devices as an entity, or system, or as being compatible with other approved components, such as integrated continuous glucose-monitoring systems. “This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together,” it said.
However, the agency said it is aware that some manufacturers are illegally marketing devices that it hasn’t reviewed for safety and effectiveness and that some patients combine devices or components that are not intended for use with each other in an effort to cut costs or because of personal preferences. When patients do that, it introduces new risks that “could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis, and death,” it warned.
The agency said it realized that patients with chronic conditions such as diabetes preferred having a range of options so that they could tailor their treatment and management to their specific needs, but that it was important that they were fully aware of the risks of doing so.
It recommended that patients speak to their doctor about their device and component needs and use only those that the FDA has reviewed for safety and effectiveness. In addition, any concerns about the cost or availability of approved systems should be taken up with the treating doctor and insurance provider, who can advise on coverage and acceptable, alternative options.
Any adverse events should be reported to the agency through its MedWatch reporting system.
More information about safety in diabetes management devices and components is available at safety communication and the agency’s news release.
This safety communication applies to continuous glucose monitors, insulin pumps, and automated insulin-dosing systems and is intended for both patients who manage their diabetes with any of various devices and the health care providers who treat and manage those patients.
The agency’s concerns were underscored by a recent report it received about a patient who used a combination of unauthorized devices and who needed medical intervention as a result.
“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended, or when [patients] use devices not authorized for sale in the [United States],” Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a news release. “[This] warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”
The release noted that the agency reviews some of the diabetes management devices as an entity, or system, or as being compatible with other approved components, such as integrated continuous glucose-monitoring systems. “This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together,” it said.
However, the agency said it is aware that some manufacturers are illegally marketing devices that it hasn’t reviewed for safety and effectiveness and that some patients combine devices or components that are not intended for use with each other in an effort to cut costs or because of personal preferences. When patients do that, it introduces new risks that “could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis, and death,” it warned.
The agency said it realized that patients with chronic conditions such as diabetes preferred having a range of options so that they could tailor their treatment and management to their specific needs, but that it was important that they were fully aware of the risks of doing so.
It recommended that patients speak to their doctor about their device and component needs and use only those that the FDA has reviewed for safety and effectiveness. In addition, any concerns about the cost or availability of approved systems should be taken up with the treating doctor and insurance provider, who can advise on coverage and acceptable, alternative options.
Any adverse events should be reported to the agency through its MedWatch reporting system.
More information about safety in diabetes management devices and components is available at safety communication and the agency’s news release.
This safety communication applies to continuous glucose monitors, insulin pumps, and automated insulin-dosing systems and is intended for both patients who manage their diabetes with any of various devices and the health care providers who treat and manage those patients.
The agency’s concerns were underscored by a recent report it received about a patient who used a combination of unauthorized devices and who needed medical intervention as a result.
“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended, or when [patients] use devices not authorized for sale in the [United States],” Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a news release. “[This] warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”
The release noted that the agency reviews some of the diabetes management devices as an entity, or system, or as being compatible with other approved components, such as integrated continuous glucose-monitoring systems. “This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together,” it said.
However, the agency said it is aware that some manufacturers are illegally marketing devices that it hasn’t reviewed for safety and effectiveness and that some patients combine devices or components that are not intended for use with each other in an effort to cut costs or because of personal preferences. When patients do that, it introduces new risks that “could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis, and death,” it warned.
The agency said it realized that patients with chronic conditions such as diabetes preferred having a range of options so that they could tailor their treatment and management to their specific needs, but that it was important that they were fully aware of the risks of doing so.
It recommended that patients speak to their doctor about their device and component needs and use only those that the FDA has reviewed for safety and effectiveness. In addition, any concerns about the cost or availability of approved systems should be taken up with the treating doctor and insurance provider, who can advise on coverage and acceptable, alternative options.
Any adverse events should be reported to the agency through its MedWatch reporting system.
More information about safety in diabetes management devices and components is available at safety communication and the agency’s news release.
HM19: Pediatric sepsis
Improving recognition and treatment
Presenters
Elise van der Jagt, MD, MPH
Workshop title
What you need to know about pediatric sepsis
Session summary
Dr. Elise van der Jagt of the University of Rochester (N.Y.) Medical Center, introduced the topic of pediatric sepsis and its epidemiology with the story of 12-year-old Rory Staunton, who died in 2012 of sepsis. In pediatrics, sepsis is the 10th leading cause of death, with severe sepsis having a mortality rate of 4%-10%. As a response to Rory Staunton’s death from sepsis, New York Governor Andrew Cuomo mandated all hospitals to implement ways to improve recognition and treatment of septic shock, especially in children.
The definition and management of sepsis in pediatrics is complex, and forms a spectrum of disease from sepsis to severe sepsis, and septic shock. Dr. van der Jagt advised not to use the adult sepsis definition in children. Sepsis, stated Dr. van der Jagt, is systemic inflammatory response syndrome in association with suspected or proven infection. Severe sepsis is sepsis with cardiovascular dysfunction, respiratory dysfunction, or dysfunction of two other systems. Septic shock is sepsis with cardiovascular dysfunction that persists despite 40 mL/kg of fluid bolus in 1 hour.
Early recognition and management of sepsis decreases mortality. Early recognition can be improved by initiating a recognition bundle. Multiple trigger tools are available such as pSOFA (Pediatric Sequential Organ Failure Assessment). Any trigger tool, however, must be combined with physician evaluation. This clinician assessment should be initiated within 15 minutes for any patient who screens positive with a trigger tool.
Resuscitation bundles also decrease mortality. A good goal is establishing intravenous or intraosseous access within 5 minutes, fluid administration within 30 minutes, and antibiotics and inotrope administration (if needed) in 60 minutes. Resuscitation bundles could include a sepsis clock, rapid response team, check list, protocol, and order set. Additional studies are needed to determine which of the components of a sepsis bundle is most important. Studies show that mortality increases with delays in initiating fluids and less fluids given. However, giving too much fluid also increases morbidity. It is imperative, stated Dr. van der Jagt, to reassess after fluid boluses. Use of lactate measurement can be problematic in pediatrics, as normal lactate can be seen with florid sepsis.
Stabilization bundles are more common in the ICU setting. They include an arterial line, central venous pressure, cardiopulmonary monitor, urinary catheter, and pulse oximeter. A performance bundle is important to assess adherence to the other bundles. This could include providing debriefing, data review, feedback, and formal quality improvement projects. Assigning a sepsis champion in each area helps to overcome barriers and continue performance bundles.
Key takeaways for HM
- Patients with severe sepsis/septic shock should be rapidly identified with the 2014/2017 American College of Critical Care Medicine consensus criteria.
- Efficient, time-based care should be provided during the first hour after recognizing pediatric severe sepsis/septic shock.
- Overcoming systems barriers to rapid sepsis recognition and treatment requires sepsis champions in each area, continuous data collection and feedback, persistence, and patience.
Dr. Eboh is a pediatric hospitalist at Covenant Children’s Hospital in Lubbock, Texas, and assistant professor of pediatrics at Texas Tech University Health Sciences Center. Dr. Wright is a pediatric hospitalist at Texas Tech University Health Sciences Center.
Improving recognition and treatment
Improving recognition and treatment
Presenters
Elise van der Jagt, MD, MPH
Workshop title
What you need to know about pediatric sepsis
Session summary
Dr. Elise van der Jagt of the University of Rochester (N.Y.) Medical Center, introduced the topic of pediatric sepsis and its epidemiology with the story of 12-year-old Rory Staunton, who died in 2012 of sepsis. In pediatrics, sepsis is the 10th leading cause of death, with severe sepsis having a mortality rate of 4%-10%. As a response to Rory Staunton’s death from sepsis, New York Governor Andrew Cuomo mandated all hospitals to implement ways to improve recognition and treatment of septic shock, especially in children.
The definition and management of sepsis in pediatrics is complex, and forms a spectrum of disease from sepsis to severe sepsis, and septic shock. Dr. van der Jagt advised not to use the adult sepsis definition in children. Sepsis, stated Dr. van der Jagt, is systemic inflammatory response syndrome in association with suspected or proven infection. Severe sepsis is sepsis with cardiovascular dysfunction, respiratory dysfunction, or dysfunction of two other systems. Septic shock is sepsis with cardiovascular dysfunction that persists despite 40 mL/kg of fluid bolus in 1 hour.
Early recognition and management of sepsis decreases mortality. Early recognition can be improved by initiating a recognition bundle. Multiple trigger tools are available such as pSOFA (Pediatric Sequential Organ Failure Assessment). Any trigger tool, however, must be combined with physician evaluation. This clinician assessment should be initiated within 15 minutes for any patient who screens positive with a trigger tool.
Resuscitation bundles also decrease mortality. A good goal is establishing intravenous or intraosseous access within 5 minutes, fluid administration within 30 minutes, and antibiotics and inotrope administration (if needed) in 60 minutes. Resuscitation bundles could include a sepsis clock, rapid response team, check list, protocol, and order set. Additional studies are needed to determine which of the components of a sepsis bundle is most important. Studies show that mortality increases with delays in initiating fluids and less fluids given. However, giving too much fluid also increases morbidity. It is imperative, stated Dr. van der Jagt, to reassess after fluid boluses. Use of lactate measurement can be problematic in pediatrics, as normal lactate can be seen with florid sepsis.
Stabilization bundles are more common in the ICU setting. They include an arterial line, central venous pressure, cardiopulmonary monitor, urinary catheter, and pulse oximeter. A performance bundle is important to assess adherence to the other bundles. This could include providing debriefing, data review, feedback, and formal quality improvement projects. Assigning a sepsis champion in each area helps to overcome barriers and continue performance bundles.
Key takeaways for HM
- Patients with severe sepsis/septic shock should be rapidly identified with the 2014/2017 American College of Critical Care Medicine consensus criteria.
- Efficient, time-based care should be provided during the first hour after recognizing pediatric severe sepsis/septic shock.
- Overcoming systems barriers to rapid sepsis recognition and treatment requires sepsis champions in each area, continuous data collection and feedback, persistence, and patience.
Dr. Eboh is a pediatric hospitalist at Covenant Children’s Hospital in Lubbock, Texas, and assistant professor of pediatrics at Texas Tech University Health Sciences Center. Dr. Wright is a pediatric hospitalist at Texas Tech University Health Sciences Center.
Presenters
Elise van der Jagt, MD, MPH
Workshop title
What you need to know about pediatric sepsis
Session summary
Dr. Elise van der Jagt of the University of Rochester (N.Y.) Medical Center, introduced the topic of pediatric sepsis and its epidemiology with the story of 12-year-old Rory Staunton, who died in 2012 of sepsis. In pediatrics, sepsis is the 10th leading cause of death, with severe sepsis having a mortality rate of 4%-10%. As a response to Rory Staunton’s death from sepsis, New York Governor Andrew Cuomo mandated all hospitals to implement ways to improve recognition and treatment of septic shock, especially in children.
The definition and management of sepsis in pediatrics is complex, and forms a spectrum of disease from sepsis to severe sepsis, and septic shock. Dr. van der Jagt advised not to use the adult sepsis definition in children. Sepsis, stated Dr. van der Jagt, is systemic inflammatory response syndrome in association with suspected or proven infection. Severe sepsis is sepsis with cardiovascular dysfunction, respiratory dysfunction, or dysfunction of two other systems. Septic shock is sepsis with cardiovascular dysfunction that persists despite 40 mL/kg of fluid bolus in 1 hour.
Early recognition and management of sepsis decreases mortality. Early recognition can be improved by initiating a recognition bundle. Multiple trigger tools are available such as pSOFA (Pediatric Sequential Organ Failure Assessment). Any trigger tool, however, must be combined with physician evaluation. This clinician assessment should be initiated within 15 minutes for any patient who screens positive with a trigger tool.
Resuscitation bundles also decrease mortality. A good goal is establishing intravenous or intraosseous access within 5 minutes, fluid administration within 30 minutes, and antibiotics and inotrope administration (if needed) in 60 minutes. Resuscitation bundles could include a sepsis clock, rapid response team, check list, protocol, and order set. Additional studies are needed to determine which of the components of a sepsis bundle is most important. Studies show that mortality increases with delays in initiating fluids and less fluids given. However, giving too much fluid also increases morbidity. It is imperative, stated Dr. van der Jagt, to reassess after fluid boluses. Use of lactate measurement can be problematic in pediatrics, as normal lactate can be seen with florid sepsis.
Stabilization bundles are more common in the ICU setting. They include an arterial line, central venous pressure, cardiopulmonary monitor, urinary catheter, and pulse oximeter. A performance bundle is important to assess adherence to the other bundles. This could include providing debriefing, data review, feedback, and formal quality improvement projects. Assigning a sepsis champion in each area helps to overcome barriers and continue performance bundles.
Key takeaways for HM
- Patients with severe sepsis/septic shock should be rapidly identified with the 2014/2017 American College of Critical Care Medicine consensus criteria.
- Efficient, time-based care should be provided during the first hour after recognizing pediatric severe sepsis/septic shock.
- Overcoming systems barriers to rapid sepsis recognition and treatment requires sepsis champions in each area, continuous data collection and feedback, persistence, and patience.
Dr. Eboh is a pediatric hospitalist at Covenant Children’s Hospital in Lubbock, Texas, and assistant professor of pediatrics at Texas Tech University Health Sciences Center. Dr. Wright is a pediatric hospitalist at Texas Tech University Health Sciences Center.
Call for 2019 AVAHO Abstracts
The AVAHO Program Planning Committee is pleased to announce the call for abstracts for our meeting in Minneapolis, Minnesota, September 20-22, 2019. Abstracts should be submitted online here: https://www.avaho.org/call-for-abstracts.
Abstracts should not exceed 350 words, excluding title and titles should not exceed 300 characters. Illustrations, tables or bullet points are not permitted.
The following categories of abstracts are suitable for submission:
- Research (eg, clinical trials, laboratory studies, translational studies, descriptive studies, qualitative studies)
- Evidence-Based Projects
- Quality Improvement Projects and initiatives
- Clinical Practice (eg, best clinical practice exemplar, case study, disease management, palliative care (non-research), survivorship (nonresearch), symptom management (non-research)
- Program Initiatives (eg, workforce, infrastructure, workflow)
- Projects in Progress
The first author is considered the primary author, is responsible for the content and integrity of the project, and will serve as the contact person by the AVAHO administrator and Planning Committee. Authors may submit more than one abstract; however, they may be first author on only one abstract. At least one author must be a member of AVAHO. One author must present the abstract at the meeting. Accepted abstracts will be published in a special edition of Federal Practitioner.
The electronic poster session was viewed very favorably by attendees last year and will be used again this year. This requires more logistic hurdles and thus, the June 1 submission deadline is firm.
Each poster will be assigned to one of two time slots for presentation. One author must be present to give a brief presentation of the poster. Authors are encouraged to record their poster presentation to provide attendees another option for viewing your poster. This recording does NOT replace the obligation to be present IN PERSON during the assigned poster session. Details regarding this recording will be forthcoming.
All abstracts must be submitted by June 1, 2019. This is a firm deadline. No extensions.
The AVAHO Program Planning Committee is pleased to announce the call for abstracts for our meeting in Minneapolis, Minnesota, September 20-22, 2019. Abstracts should be submitted online here: https://www.avaho.org/call-for-abstracts.
Abstracts should not exceed 350 words, excluding title and titles should not exceed 300 characters. Illustrations, tables or bullet points are not permitted.
The following categories of abstracts are suitable for submission:
- Research (eg, clinical trials, laboratory studies, translational studies, descriptive studies, qualitative studies)
- Evidence-Based Projects
- Quality Improvement Projects and initiatives
- Clinical Practice (eg, best clinical practice exemplar, case study, disease management, palliative care (non-research), survivorship (nonresearch), symptom management (non-research)
- Program Initiatives (eg, workforce, infrastructure, workflow)
- Projects in Progress
The first author is considered the primary author, is responsible for the content and integrity of the project, and will serve as the contact person by the AVAHO administrator and Planning Committee. Authors may submit more than one abstract; however, they may be first author on only one abstract. At least one author must be a member of AVAHO. One author must present the abstract at the meeting. Accepted abstracts will be published in a special edition of Federal Practitioner.
The electronic poster session was viewed very favorably by attendees last year and will be used again this year. This requires more logistic hurdles and thus, the June 1 submission deadline is firm.
Each poster will be assigned to one of two time slots for presentation. One author must be present to give a brief presentation of the poster. Authors are encouraged to record their poster presentation to provide attendees another option for viewing your poster. This recording does NOT replace the obligation to be present IN PERSON during the assigned poster session. Details regarding this recording will be forthcoming.
All abstracts must be submitted by June 1, 2019. This is a firm deadline. No extensions.
The AVAHO Program Planning Committee is pleased to announce the call for abstracts for our meeting in Minneapolis, Minnesota, September 20-22, 2019. Abstracts should be submitted online here: https://www.avaho.org/call-for-abstracts.
Abstracts should not exceed 350 words, excluding title and titles should not exceed 300 characters. Illustrations, tables or bullet points are not permitted.
The following categories of abstracts are suitable for submission:
- Research (eg, clinical trials, laboratory studies, translational studies, descriptive studies, qualitative studies)
- Evidence-Based Projects
- Quality Improvement Projects and initiatives
- Clinical Practice (eg, best clinical practice exemplar, case study, disease management, palliative care (non-research), survivorship (nonresearch), symptom management (non-research)
- Program Initiatives (eg, workforce, infrastructure, workflow)
- Projects in Progress
The first author is considered the primary author, is responsible for the content and integrity of the project, and will serve as the contact person by the AVAHO administrator and Planning Committee. Authors may submit more than one abstract; however, they may be first author on only one abstract. At least one author must be a member of AVAHO. One author must present the abstract at the meeting. Accepted abstracts will be published in a special edition of Federal Practitioner.
The electronic poster session was viewed very favorably by attendees last year and will be used again this year. This requires more logistic hurdles and thus, the June 1 submission deadline is firm.
Each poster will be assigned to one of two time slots for presentation. One author must be present to give a brief presentation of the poster. Authors are encouraged to record their poster presentation to provide attendees another option for viewing your poster. This recording does NOT replace the obligation to be present IN PERSON during the assigned poster session. Details regarding this recording will be forthcoming.
All abstracts must be submitted by June 1, 2019. This is a firm deadline. No extensions.
CABANA: Heart failure patients got biggest bang from AFib ablation
SAN FRANCISCO – Catheter ablation of atrial fibrillation (AFib) in the roughly one-third of patients with heart failure enrolled in the CABANA multicenter, randomized trial produced striking, statistically significant improvements both in the study’s primary, combined endpoint and in all-cause mortality in intention-to-treat analyses.
These findings, from prespecified secondary analyses, contrasted with the study’s overall result, which showed no benefit in the primary endpoint analysis in the total study population of 2,204 patients with AFib (JAMA. 2019 Apr 2;321[13]:1261-74). They are also at odds with the primary endpoint result in the two-thirds of enrolled patients without heart failure, which showed no significant between-group differences in these two outcome measures among the patients assigned to the catheter ablation arm and the study’s control, which was medical management arm.
Among the 778 AFib patients enrolled in CABANA with any form of heart failure (35% of the total study enrollment), the incidence of the study’s primary endpoint – the combined rate of death, disabling stroke, serious bleeding, or cardiac arrest during a median follow-up of slightly more than 4 years – was 36% lower among the catheter-ablated heart failure patients than in the heart failure patients assigned to medical treatment, according to an intention-to-treat analysis, which was a statistically significant difference. The incidence of all-cause mortality during follow-up was 43% lower in the ablated heart failure patients, compared with the controls, Douglas L. Packer, MD, said at the annual scientific sessions of the Heart Rhythm Society.
In contrast, among enrolled patients without heart failure, the intention-to-treat primary endpoint was 6% higher in the ablated patients, and all-cause mortality was a relative 27% higher, although neither difference was statistically significant.
It’s a “little surprising” that the results showed this much benefit in the patients with heart failure, said Dr. Packer, professor of medicine at the Mayo Clinic in Rochester, Minn., and lead investigator of the CABANA (Catheter Ablation vs Anti-Arrhythmic Drug Therapy for Atrial Fibrillation) trial. “I think these data confirm the results of the CASTLE-AF trial, but without some of the glitches some people have cited” about that study, such as concerns about a high level of patient selection in CASTLE-AF and its relatively modest number of enrolled patients, he said in an interview.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) study, run entirely in patients with heart failure with reduced ejection fraction and AFib, showed a statistically significant improvement in patient survival and heart failure hospitalization after catheter ablation compared with medical management (N Engl J Med. 2018 Feb 1;378[5]:417-27). Prior to the CASTLE-AF report, results from several other small studies (J Interv Card Electrophysiol. 2018 Oct;53[1]:19-29), as well as those from the AATAC trial (Circulation. 2016 Apr 26;133[17]:1637-44), also showed consistent evidence for benefit from catheter ablation in patients with heart failure and AFib, noted CABANA coinvestigator Jonathan P. Piccini, MD, during a separate talk at the meeting.
“The improvement of cardiovascular outcomes with ablation in patients with heart failure and AFib is consistent across multiple trials, at least with respect to heart failure with reduced ejection fraction” concluded Dr. Piccini, a cardiac electrophysiologist at Duke University in Durham, N.C.
As a result of the new heart failure analysis, “I think the guidelines will change,” predicted Dr. Packer, with catheter ablation receiving a firmer endorsement for patients with heart failure the next time U.S. guidelines for heart failure and AFib management are updated. The findings say “there is substantial benefit of catheter ablation in heart failure patients, but I don’t think our findings lessen the utility of ablation in patients without heart failure,” he stressed. Even patients without heart failure showed reduction in AFib burden and improvement in quality of life that were similar to what was seen in the heart failure patients.
The new report from CABANA of benefit from AFib catheter ablation in patients with heart failure “absolutely advances the evidence,” commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago. “A number of us were quite circumspect about this based on the CASTLE-AF data, but the new CABANA analyses have addressed our anxiety that the CASTLE-AF results were just by chance.” The new CABANA analyses “may not confirm CASTLE-AF, but it enriches the conversation and makes it possible that we are seeing benefit in some patients with heart failure who get ablated.”
Dr. Yancy, who chaired the most recent update to the U.S. heart failure management guideline (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803) stopped short of saying that the cumulative evidence now supports a guideline change, but he acknowledged in an interview that the evidence could legitimately influence practice. Catheter ablation should now be “strongly considered” in patients with heart failure and AFib, he said, although he also had three qualifications for opting for this approach: Patients must already be on guideline-directed medical therapy for their heart failure, the catheter ablation needs to be performed by an experienced and skilled operator, and follow-up surveillance must focus on both the patient’s AFib and heart failure. “It’s absolutely appropriate to consider catheter ablation” for heart failure patients, but the evidence is not yet there for guideline change, Dr. Yancy concluded.
It remains uncertain why catheter ablation of AFib should be more effective in patients with heart failure than in those without. Dr. Packer speculated that one reason may be the heart rate reduction that AFib ablation produces may especially benefit heart failure patients. An additional helpful effect of ablation in heart failure patients may be reducing heart rate variability. Another notable finding of the new analysis was that 79% of patients with heart failure in CABANA had heart failure with preserved ejection fraction, with a left ventricular ejection fraction of at least 50%. “Getting rid of AFib in patients with heart failure with preserved ejection fraction will be more important than we have thought,” Dr. Packer said.
Other new CABANA analyses presented for the first time in separate talks at the meeting also showed that, while catheter ablation had no meaningful difference in effect on outcomes based on the sex of patients, both age and minority ethnic and racial status appeared to make a substantial difference. For CABANA’s primary endpoint, catheter ablation was especially effective for improving outcomes in patients 64 years old or younger, and the analysis showed a signal of possibly worse outcomes in patients who were at least 75 years old. The “substantially” better outcomes in minority-group patients represented the largest between-group difference among subgroups seen in CABANA and is a “big deal,” said Dr. Packer, who predicted that future catheter ablation use will likely rise in patients with heart failure, in younger patients, and in minority patients.
Dr. Piccini noted that, “it’s possible that CABANA identified some patient subgroups that do really well after ablation, but the problem is that, in the United States, we now often don’t treat” minority patients or those with reduced left ventricular ejection fractions with ablation, according to recent registry findings.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Dr. Piccini has ties Boston Scientific, Medtronic, and numerous other drug and device companies, and disclosed an unspecified relationship with GlaxoSmithKline. Dr. Yancy disclosed an unspecified relationship with Abbott Laboratories.
SOURCE: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
SAN FRANCISCO – Catheter ablation of atrial fibrillation (AFib) in the roughly one-third of patients with heart failure enrolled in the CABANA multicenter, randomized trial produced striking, statistically significant improvements both in the study’s primary, combined endpoint and in all-cause mortality in intention-to-treat analyses.
These findings, from prespecified secondary analyses, contrasted with the study’s overall result, which showed no benefit in the primary endpoint analysis in the total study population of 2,204 patients with AFib (JAMA. 2019 Apr 2;321[13]:1261-74). They are also at odds with the primary endpoint result in the two-thirds of enrolled patients without heart failure, which showed no significant between-group differences in these two outcome measures among the patients assigned to the catheter ablation arm and the study’s control, which was medical management arm.
Among the 778 AFib patients enrolled in CABANA with any form of heart failure (35% of the total study enrollment), the incidence of the study’s primary endpoint – the combined rate of death, disabling stroke, serious bleeding, or cardiac arrest during a median follow-up of slightly more than 4 years – was 36% lower among the catheter-ablated heart failure patients than in the heart failure patients assigned to medical treatment, according to an intention-to-treat analysis, which was a statistically significant difference. The incidence of all-cause mortality during follow-up was 43% lower in the ablated heart failure patients, compared with the controls, Douglas L. Packer, MD, said at the annual scientific sessions of the Heart Rhythm Society.
In contrast, among enrolled patients without heart failure, the intention-to-treat primary endpoint was 6% higher in the ablated patients, and all-cause mortality was a relative 27% higher, although neither difference was statistically significant.
It’s a “little surprising” that the results showed this much benefit in the patients with heart failure, said Dr. Packer, professor of medicine at the Mayo Clinic in Rochester, Minn., and lead investigator of the CABANA (Catheter Ablation vs Anti-Arrhythmic Drug Therapy for Atrial Fibrillation) trial. “I think these data confirm the results of the CASTLE-AF trial, but without some of the glitches some people have cited” about that study, such as concerns about a high level of patient selection in CASTLE-AF and its relatively modest number of enrolled patients, he said in an interview.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) study, run entirely in patients with heart failure with reduced ejection fraction and AFib, showed a statistically significant improvement in patient survival and heart failure hospitalization after catheter ablation compared with medical management (N Engl J Med. 2018 Feb 1;378[5]:417-27). Prior to the CASTLE-AF report, results from several other small studies (J Interv Card Electrophysiol. 2018 Oct;53[1]:19-29), as well as those from the AATAC trial (Circulation. 2016 Apr 26;133[17]:1637-44), also showed consistent evidence for benefit from catheter ablation in patients with heart failure and AFib, noted CABANA coinvestigator Jonathan P. Piccini, MD, during a separate talk at the meeting.
“The improvement of cardiovascular outcomes with ablation in patients with heart failure and AFib is consistent across multiple trials, at least with respect to heart failure with reduced ejection fraction” concluded Dr. Piccini, a cardiac electrophysiologist at Duke University in Durham, N.C.
As a result of the new heart failure analysis, “I think the guidelines will change,” predicted Dr. Packer, with catheter ablation receiving a firmer endorsement for patients with heart failure the next time U.S. guidelines for heart failure and AFib management are updated. The findings say “there is substantial benefit of catheter ablation in heart failure patients, but I don’t think our findings lessen the utility of ablation in patients without heart failure,” he stressed. Even patients without heart failure showed reduction in AFib burden and improvement in quality of life that were similar to what was seen in the heart failure patients.
The new report from CABANA of benefit from AFib catheter ablation in patients with heart failure “absolutely advances the evidence,” commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago. “A number of us were quite circumspect about this based on the CASTLE-AF data, but the new CABANA analyses have addressed our anxiety that the CASTLE-AF results were just by chance.” The new CABANA analyses “may not confirm CASTLE-AF, but it enriches the conversation and makes it possible that we are seeing benefit in some patients with heart failure who get ablated.”
Dr. Yancy, who chaired the most recent update to the U.S. heart failure management guideline (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803) stopped short of saying that the cumulative evidence now supports a guideline change, but he acknowledged in an interview that the evidence could legitimately influence practice. Catheter ablation should now be “strongly considered” in patients with heart failure and AFib, he said, although he also had three qualifications for opting for this approach: Patients must already be on guideline-directed medical therapy for their heart failure, the catheter ablation needs to be performed by an experienced and skilled operator, and follow-up surveillance must focus on both the patient’s AFib and heart failure. “It’s absolutely appropriate to consider catheter ablation” for heart failure patients, but the evidence is not yet there for guideline change, Dr. Yancy concluded.
It remains uncertain why catheter ablation of AFib should be more effective in patients with heart failure than in those without. Dr. Packer speculated that one reason may be the heart rate reduction that AFib ablation produces may especially benefit heart failure patients. An additional helpful effect of ablation in heart failure patients may be reducing heart rate variability. Another notable finding of the new analysis was that 79% of patients with heart failure in CABANA had heart failure with preserved ejection fraction, with a left ventricular ejection fraction of at least 50%. “Getting rid of AFib in patients with heart failure with preserved ejection fraction will be more important than we have thought,” Dr. Packer said.
Other new CABANA analyses presented for the first time in separate talks at the meeting also showed that, while catheter ablation had no meaningful difference in effect on outcomes based on the sex of patients, both age and minority ethnic and racial status appeared to make a substantial difference. For CABANA’s primary endpoint, catheter ablation was especially effective for improving outcomes in patients 64 years old or younger, and the analysis showed a signal of possibly worse outcomes in patients who were at least 75 years old. The “substantially” better outcomes in minority-group patients represented the largest between-group difference among subgroups seen in CABANA and is a “big deal,” said Dr. Packer, who predicted that future catheter ablation use will likely rise in patients with heart failure, in younger patients, and in minority patients.
Dr. Piccini noted that, “it’s possible that CABANA identified some patient subgroups that do really well after ablation, but the problem is that, in the United States, we now often don’t treat” minority patients or those with reduced left ventricular ejection fractions with ablation, according to recent registry findings.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Dr. Piccini has ties Boston Scientific, Medtronic, and numerous other drug and device companies, and disclosed an unspecified relationship with GlaxoSmithKline. Dr. Yancy disclosed an unspecified relationship with Abbott Laboratories.
SOURCE: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
SAN FRANCISCO – Catheter ablation of atrial fibrillation (AFib) in the roughly one-third of patients with heart failure enrolled in the CABANA multicenter, randomized trial produced striking, statistically significant improvements both in the study’s primary, combined endpoint and in all-cause mortality in intention-to-treat analyses.
These findings, from prespecified secondary analyses, contrasted with the study’s overall result, which showed no benefit in the primary endpoint analysis in the total study population of 2,204 patients with AFib (JAMA. 2019 Apr 2;321[13]:1261-74). They are also at odds with the primary endpoint result in the two-thirds of enrolled patients without heart failure, which showed no significant between-group differences in these two outcome measures among the patients assigned to the catheter ablation arm and the study’s control, which was medical management arm.
Among the 778 AFib patients enrolled in CABANA with any form of heart failure (35% of the total study enrollment), the incidence of the study’s primary endpoint – the combined rate of death, disabling stroke, serious bleeding, or cardiac arrest during a median follow-up of slightly more than 4 years – was 36% lower among the catheter-ablated heart failure patients than in the heart failure patients assigned to medical treatment, according to an intention-to-treat analysis, which was a statistically significant difference. The incidence of all-cause mortality during follow-up was 43% lower in the ablated heart failure patients, compared with the controls, Douglas L. Packer, MD, said at the annual scientific sessions of the Heart Rhythm Society.
In contrast, among enrolled patients without heart failure, the intention-to-treat primary endpoint was 6% higher in the ablated patients, and all-cause mortality was a relative 27% higher, although neither difference was statistically significant.
It’s a “little surprising” that the results showed this much benefit in the patients with heart failure, said Dr. Packer, professor of medicine at the Mayo Clinic in Rochester, Minn., and lead investigator of the CABANA (Catheter Ablation vs Anti-Arrhythmic Drug Therapy for Atrial Fibrillation) trial. “I think these data confirm the results of the CASTLE-AF trial, but without some of the glitches some people have cited” about that study, such as concerns about a high level of patient selection in CASTLE-AF and its relatively modest number of enrolled patients, he said in an interview.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) study, run entirely in patients with heart failure with reduced ejection fraction and AFib, showed a statistically significant improvement in patient survival and heart failure hospitalization after catheter ablation compared with medical management (N Engl J Med. 2018 Feb 1;378[5]:417-27). Prior to the CASTLE-AF report, results from several other small studies (J Interv Card Electrophysiol. 2018 Oct;53[1]:19-29), as well as those from the AATAC trial (Circulation. 2016 Apr 26;133[17]:1637-44), also showed consistent evidence for benefit from catheter ablation in patients with heart failure and AFib, noted CABANA coinvestigator Jonathan P. Piccini, MD, during a separate talk at the meeting.
“The improvement of cardiovascular outcomes with ablation in patients with heart failure and AFib is consistent across multiple trials, at least with respect to heart failure with reduced ejection fraction” concluded Dr. Piccini, a cardiac electrophysiologist at Duke University in Durham, N.C.
As a result of the new heart failure analysis, “I think the guidelines will change,” predicted Dr. Packer, with catheter ablation receiving a firmer endorsement for patients with heart failure the next time U.S. guidelines for heart failure and AFib management are updated. The findings say “there is substantial benefit of catheter ablation in heart failure patients, but I don’t think our findings lessen the utility of ablation in patients without heart failure,” he stressed. Even patients without heart failure showed reduction in AFib burden and improvement in quality of life that were similar to what was seen in the heart failure patients.
The new report from CABANA of benefit from AFib catheter ablation in patients with heart failure “absolutely advances the evidence,” commented Clyde W. Yancy, MD, professor of medicine and chief of cardiology at Northwestern University in Chicago. “A number of us were quite circumspect about this based on the CASTLE-AF data, but the new CABANA analyses have addressed our anxiety that the CASTLE-AF results were just by chance.” The new CABANA analyses “may not confirm CASTLE-AF, but it enriches the conversation and makes it possible that we are seeing benefit in some patients with heart failure who get ablated.”
Dr. Yancy, who chaired the most recent update to the U.S. heart failure management guideline (J Am Coll Cardiol. 2017 Aug 8;70[6]:776-803) stopped short of saying that the cumulative evidence now supports a guideline change, but he acknowledged in an interview that the evidence could legitimately influence practice. Catheter ablation should now be “strongly considered” in patients with heart failure and AFib, he said, although he also had three qualifications for opting for this approach: Patients must already be on guideline-directed medical therapy for their heart failure, the catheter ablation needs to be performed by an experienced and skilled operator, and follow-up surveillance must focus on both the patient’s AFib and heart failure. “It’s absolutely appropriate to consider catheter ablation” for heart failure patients, but the evidence is not yet there for guideline change, Dr. Yancy concluded.
It remains uncertain why catheter ablation of AFib should be more effective in patients with heart failure than in those without. Dr. Packer speculated that one reason may be the heart rate reduction that AFib ablation produces may especially benefit heart failure patients. An additional helpful effect of ablation in heart failure patients may be reducing heart rate variability. Another notable finding of the new analysis was that 79% of patients with heart failure in CABANA had heart failure with preserved ejection fraction, with a left ventricular ejection fraction of at least 50%. “Getting rid of AFib in patients with heart failure with preserved ejection fraction will be more important than we have thought,” Dr. Packer said.
Other new CABANA analyses presented for the first time in separate talks at the meeting also showed that, while catheter ablation had no meaningful difference in effect on outcomes based on the sex of patients, both age and minority ethnic and racial status appeared to make a substantial difference. For CABANA’s primary endpoint, catheter ablation was especially effective for improving outcomes in patients 64 years old or younger, and the analysis showed a signal of possibly worse outcomes in patients who were at least 75 years old. The “substantially” better outcomes in minority-group patients represented the largest between-group difference among subgroups seen in CABANA and is a “big deal,” said Dr. Packer, who predicted that future catheter ablation use will likely rise in patients with heart failure, in younger patients, and in minority patients.
Dr. Piccini noted that, “it’s possible that CABANA identified some patient subgroups that do really well after ablation, but the problem is that, in the United States, we now often don’t treat” minority patients or those with reduced left ventricular ejection fractions with ablation, according to recent registry findings.
CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Dr. Piccini has ties Boston Scientific, Medtronic, and numerous other drug and device companies, and disclosed an unspecified relationship with GlaxoSmithKline. Dr. Yancy disclosed an unspecified relationship with Abbott Laboratories.
SOURCE: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.
REPORTING FROM HEART RHYTHM 2019
Key clinical point: Catheter ablation for atrial fibrillation is especially effective in patients with heart failure.
Major finding: Heart failure patients treated with catheter ablation had a 36% relative cut in the primary endpoint, compared with control patients.
Study details: CABANA, a multicenter, randomized trial with 2,204 patients, including 778 patients with heart failure.
Disclosures: CABANA received partial funding from Biosense Webster, Boston Scientific, Medtronic, and St. Jude. Dr. Packer has been a consultant to and/or received research funding from these four companies, as well as numerous drug and device companies, and has a financial interest in a licensed AFib mapping technology. Source: Packer DL. Heart Rhythm 2019, Abstract S-AB14-06.