Clinical

MUNICH – Women with cardiac disease who became pregnant had a nearly 100-fold higher mortality rate, compared with pregnant women without cardiac disease, according to the outcomes of more than 5,700 pregnancies in an international registry of women with cardiac disease.

Mitchel L. Zoler/MDedge News

In addition to increased mortality, women with cardiac disease who become pregnant also had a greater than 100-fold higher rate of developing heart failure, compared with pregnant women without cardiac disease.

Despite these highly elevated relative risks, the absolute rate of serious complications from pregnancy for most women with heart disease was relatively modest. The worst prognosis by far was for the 1% of women in the registry who had pulmonary arterial hypertension at the time their pregnancy began. For these women, mortality during pregnancy was about 9%, and new-onset heart failure occurred in about one third. Another subgroup showing particularly poor outcomes were women classified with WHO IV maternal cardiovascular risk by the modified World Health Organization criteria, which corresponds to having an “extremely high risk of maternal mortality or severe morbidity,” according to guidelines published in the European Heart Journal (2011 Dec 1;32[24]:3147-97).These women, constituting 7% of the registry cohort, had a 2.5% mortality rate during pregnancy and a 33% incidence of heart failure.

Across all women with cardiac disease enrolled in the registry, the incidence of death during pregnancy was 0.6% and the incidence of heart failure was 11%. Women without cardiac disease have rates of 0.007% and less than 0.1%, respectively, Jolien Roos-Hesselink, MD, said at the annual congress of the European Society of Cardiology.

“The most important message of my talk is that all patients should be counseled, not just the women at high risk, for whom pregnancy is contraindicated, but also the women at low risk,” who can have a child with relative safety, she said. “Many women [with cardiac disease] can go through pregnancy at low risk.” Counseling is the key so that women know their risk before becoming pregnant, stressed Dr. Roos-Hesselink, a cardiologist at Erasmus Medical Center in Rotterdam, the Netherlands.

Based on the observed rates of mortality and other complications, pulmonary arterial hypertension and the other cardiac conditions that define a WHO IV maternal risk classification remain contraindications for pregnancy, she said. According to the 2011 guidelines from the European Society of Cardiology for managing cardiovascular disease during pregnancy, the full list of conditions that define a WHO IV classification are the following:

• Pulmonary arterial hypertension of any cause.
• Severe systemic ventricular dysfunction (a left ventricular ejection fraction of less than 30%) or New York Heart Association functional class III or IV.
• Previous peripartum cardiomyopathy with any residual impairment of left ventricular function.
• Severe mitral stenosis or severe symptomatic aortic stenosis.
• Marfan syndrome with the aorta dilated to more than 45 mm.
• Aortic dilatation greater than 50 mm in aortic disease associated with a bicuspid aortic valve.
• Native severe coarctation.

The registry data, collected during 2007-2018, showed a clear increase in the percentage of women with WHO class IV cardiovascular disease who became pregnant and entered the registry despite the contraindication designation for that classification, rising from about 1% of enrolled women in 2008 and 2009 to more than 10% of women in 2013, 2016, and 2017. “Individualization is necessary, but all these women are at very high risk and should be counseled against pregnancy,” Dr. Roos-Hesselink said.

The Registry of Pregnancy and Cardiac Disease (ROPAC) enrolled 5,739 pregnant women at any of 138 participating centers in 53 countries including the United States. Clinicians submitted WHO classification of cardiovascular risk for 5,711 of these women. The most common risk was congenital heart disease in 57% of enrolled women, followed by valvular heart disease in 29% and cardiomyopathy in 7%. Nearly 1,200 women in the registry – about 21% of the total – had a WHO I classification, which meant that they would be expected to have no detectable increase in mortality rate during pregnancy, compared with women without cardiac disease, and either no rise in morbidity or a mild effect.

Delivery was by cesarean section in 44% of the pregnancies, roughly twice the rate in women without diagnosed cardiac disease, even though published guidelines don’t advise cesarean delivery because of cardiac disease, Dr. Roos-Hesselink said. “Cesarean sections are used too often, in my opinion,” she commented, but added that many of these women require delivery at a tertiary, specialized center.

Overall fetal mortality was 1%, nearly threefold higher than in pregnancies in women without cardiac disease, and the overall incidence of fetal and neonatal complications was especially high, at 53%, in women with pulmonary arterial hypertension. The incidence of obstetrical complications was roughly similar across the range of cardiac disease type, ranging from 16% to 24%. Premature delivery occurred in 28% of women in the high-risk WHO IV class, compared with a 13% rate among women in the WHO I class. The mortality rate was 0.2% among the WHO class I women, and their heart failure incidence was 5%.

The ROPAC registry is sponsored by the European Society of Cardiology. Dr. Roos-Hesselink had no disclosures.

[email protected]


 

MUNICH – Women with cardiac disease who became pregnant had a nearly 100-fold higher mortality rate, compared with pregnant women without cardiac disease, according to the outcomes of more than 5,700 pregnancies in an international registry of women with cardiac disease.

Mitchel L. Zoler/MDedge News

In addition to increased mortality, women with cardiac disease who become pregnant also had a greater than 100-fold higher rate of developing heart failure, compared with pregnant women without cardiac disease.

Despite these highly elevated relative risks, the absolute rate of serious complications from pregnancy for most women with heart disease was relatively modest. The worst prognosis by far was for the 1% of women in the registry who had pulmonary arterial hypertension at the time their pregnancy began. For these women, mortality during pregnancy was about 9%, and new-onset heart failure occurred in about one third. Another subgroup showing particularly poor outcomes were women classified with WHO IV maternal cardiovascular risk by the modified World Health Organization criteria, which corresponds to having an “extremely high risk of maternal mortality or severe morbidity,” according to guidelines published in the European Heart Journal (2011 Dec 1;32[24]:3147-97).These women, constituting 7% of the registry cohort, had a 2.5% mortality rate during pregnancy and a 33% incidence of heart failure.

Across all women with cardiac disease enrolled in the registry, the incidence of death during pregnancy was 0.6% and the incidence of heart failure was 11%. Women without cardiac disease have rates of 0.007% and less than 0.1%, respectively, Jolien Roos-Hesselink, MD, said at the annual congress of the European Society of Cardiology.

“The most important message of my talk is that all patients should be counseled, not just the women at high risk, for whom pregnancy is contraindicated, but also the women at low risk,” who can have a child with relative safety, she said. “Many women [with cardiac disease] can go through pregnancy at low risk.” Counseling is the key so that women know their risk before becoming pregnant, stressed Dr. Roos-Hesselink, a cardiologist at Erasmus Medical Center in Rotterdam, the Netherlands.

Based on the observed rates of mortality and other complications, pulmonary arterial hypertension and the other cardiac conditions that define a WHO IV maternal risk classification remain contraindications for pregnancy, she said. According to the 2011 guidelines from the European Society of Cardiology for managing cardiovascular disease during pregnancy, the full list of conditions that define a WHO IV classification are the following:

• Pulmonary arterial hypertension of any cause.
• Severe systemic ventricular dysfunction (a left ventricular ejection fraction of less than 30%) or New York Heart Association functional class III or IV.
• Previous peripartum cardiomyopathy with any residual impairment of left ventricular function.
• Severe mitral stenosis or severe symptomatic aortic stenosis.
• Marfan syndrome with the aorta dilated to more than 45 mm.
• Aortic dilatation greater than 50 mm in aortic disease associated with a bicuspid aortic valve.
• Native severe coarctation.

The registry data, collected during 2007-2018, showed a clear increase in the percentage of women with WHO class IV cardiovascular disease who became pregnant and entered the registry despite the contraindication designation for that classification, rising from about 1% of enrolled women in 2008 and 2009 to more than 10% of women in 2013, 2016, and 2017. “Individualization is necessary, but all these women are at very high risk and should be counseled against pregnancy,” Dr. Roos-Hesselink said.

The Registry of Pregnancy and Cardiac Disease (ROPAC) enrolled 5,739 pregnant women at any of 138 participating centers in 53 countries including the United States. Clinicians submitted WHO classification of cardiovascular risk for 5,711 of these women. The most common risk was congenital heart disease in 57% of enrolled women, followed by valvular heart disease in 29% and cardiomyopathy in 7%. Nearly 1,200 women in the registry – about 21% of the total – had a WHO I classification, which meant that they would be expected to have no detectable increase in mortality rate during pregnancy, compared with women without cardiac disease, and either no rise in morbidity or a mild effect.

Delivery was by cesarean section in 44% of the pregnancies, roughly twice the rate in women without diagnosed cardiac disease, even though published guidelines don’t advise cesarean delivery because of cardiac disease, Dr. Roos-Hesselink said. “Cesarean sections are used too often, in my opinion,” she commented, but added that many of these women require delivery at a tertiary, specialized center.

Overall fetal mortality was 1%, nearly threefold higher than in pregnancies in women without cardiac disease, and the overall incidence of fetal and neonatal complications was especially high, at 53%, in women with pulmonary arterial hypertension. The incidence of obstetrical complications was roughly similar across the range of cardiac disease type, ranging from 16% to 24%. Premature delivery occurred in 28% of women in the high-risk WHO IV class, compared with a 13% rate among women in the WHO I class. The mortality rate was 0.2% among the WHO class I women, and their heart failure incidence was 5%.

The ROPAC registry is sponsored by the European Society of Cardiology. Dr. Roos-Hesselink had no disclosures.

[email protected]


 

MUNICH – Women with cardiac disease who became pregnant had a nearly 100-fold higher mortality rate, compared with pregnant women without cardiac disease, according to the outcomes of more than 5,700 pregnancies in an international registry of women with cardiac disease.

Mitchel L. Zoler/MDedge News

In addition to increased mortality, women with cardiac disease who become pregnant also had a greater than 100-fold higher rate of developing heart failure, compared with pregnant women without cardiac disease.

Despite these highly elevated relative risks, the absolute rate of serious complications from pregnancy for most women with heart disease was relatively modest. The worst prognosis by far was for the 1% of women in the registry who had pulmonary arterial hypertension at the time their pregnancy began. For these women, mortality during pregnancy was about 9%, and new-onset heart failure occurred in about one third. Another subgroup showing particularly poor outcomes were women classified with WHO IV maternal cardiovascular risk by the modified World Health Organization criteria, which corresponds to having an “extremely high risk of maternal mortality or severe morbidity,” according to guidelines published in the European Heart Journal (2011 Dec 1;32[24]:3147-97).These women, constituting 7% of the registry cohort, had a 2.5% mortality rate during pregnancy and a 33% incidence of heart failure.

Across all women with cardiac disease enrolled in the registry, the incidence of death during pregnancy was 0.6% and the incidence of heart failure was 11%. Women without cardiac disease have rates of 0.007% and less than 0.1%, respectively, Jolien Roos-Hesselink, MD, said at the annual congress of the European Society of Cardiology.

“The most important message of my talk is that all patients should be counseled, not just the women at high risk, for whom pregnancy is contraindicated, but also the women at low risk,” who can have a child with relative safety, she said. “Many women [with cardiac disease] can go through pregnancy at low risk.” Counseling is the key so that women know their risk before becoming pregnant, stressed Dr. Roos-Hesselink, a cardiologist at Erasmus Medical Center in Rotterdam, the Netherlands.

Based on the observed rates of mortality and other complications, pulmonary arterial hypertension and the other cardiac conditions that define a WHO IV maternal risk classification remain contraindications for pregnancy, she said. According to the 2011 guidelines from the European Society of Cardiology for managing cardiovascular disease during pregnancy, the full list of conditions that define a WHO IV classification are the following:

• Pulmonary arterial hypertension of any cause.
• Severe systemic ventricular dysfunction (a left ventricular ejection fraction of less than 30%) or New York Heart Association functional class III or IV.
• Previous peripartum cardiomyopathy with any residual impairment of left ventricular function.
• Severe mitral stenosis or severe symptomatic aortic stenosis.
• Marfan syndrome with the aorta dilated to more than 45 mm.
• Aortic dilatation greater than 50 mm in aortic disease associated with a bicuspid aortic valve.
• Native severe coarctation.

The registry data, collected during 2007-2018, showed a clear increase in the percentage of women with WHO class IV cardiovascular disease who became pregnant and entered the registry despite the contraindication designation for that classification, rising from about 1% of enrolled women in 2008 and 2009 to more than 10% of women in 2013, 2016, and 2017. “Individualization is necessary, but all these women are at very high risk and should be counseled against pregnancy,” Dr. Roos-Hesselink said.

The Registry of Pregnancy and Cardiac Disease (ROPAC) enrolled 5,739 pregnant women at any of 138 participating centers in 53 countries including the United States. Clinicians submitted WHO classification of cardiovascular risk for 5,711 of these women. The most common risk was congenital heart disease in 57% of enrolled women, followed by valvular heart disease in 29% and cardiomyopathy in 7%. Nearly 1,200 women in the registry – about 21% of the total – had a WHO I classification, which meant that they would be expected to have no detectable increase in mortality rate during pregnancy, compared with women without cardiac disease, and either no rise in morbidity or a mild effect.

Delivery was by cesarean section in 44% of the pregnancies, roughly twice the rate in women without diagnosed cardiac disease, even though published guidelines don’t advise cesarean delivery because of cardiac disease, Dr. Roos-Hesselink said. “Cesarean sections are used too often, in my opinion,” she commented, but added that many of these women require delivery at a tertiary, specialized center.

Overall fetal mortality was 1%, nearly threefold higher than in pregnancies in women without cardiac disease, and the overall incidence of fetal and neonatal complications was especially high, at 53%, in women with pulmonary arterial hypertension. The incidence of obstetrical complications was roughly similar across the range of cardiac disease type, ranging from 16% to 24%. Premature delivery occurred in 28% of women in the high-risk WHO IV class, compared with a 13% rate among women in the WHO I class. The mortality rate was 0.2% among the WHO class I women, and their heart failure incidence was 5%.

The ROPAC registry is sponsored by the European Society of Cardiology. Dr. Roos-Hesselink had no disclosures.

[email protected]


 

ATLANTA – Ongoing vigilance regarding the role of medical devices in health care–associated infections (HAIs) and transmission of antimicrobial-resistant pathogen is needed, according to Isaac Benowitz, MD, of the Centers for Disease Control and Prevention’s Division of Healthcare Quality Promotion (DHQP).

CDC/ Margaret M. Williams; Janice Haney Carr

A review of records from the DHQP, which investigates and responds to infections and related adverse events in health care settings upon invitation, showed that in 2017 environmental pathogens were most often the triggers for these investigations, said Dr. Benowitz, a medical epidemiologist.

He reviewed internal records for consultations with state and local health departments involving medical devices and collected data on health care setting, pathogen, investigation findings including possible exposure or transmission, and public health actions.

Of 285 consultations, 48 involved a specific medical device or general medical device reprocessing, he said, noting that most of those 48 were in an acute care hospital (63%) or clinic (19%).

“The most frequent pathogens noted in these consultations were nontuberculous mycobacteria at 21%, Candida species ... at 10%, and Burkholderia species ... at 8%,” he said, noting that a wide variety of devices were implicated.

In the inpatient setting these devices included ventilators, dialysis machines, breast pumps, central lines, and respiratory therapy equipment. In the outpatient setting they included glucometers and opthalmic equipment.

“In many settings we saw issues with endoscopes, including duodenoscopes, but also bronchoscopes,” he added.

Actions taken as part of the investigations included medical device recalls, improved infection control and reprocessing procedures, and patient notification, education, guidance, testing, and treatment.

In some cases there was disciplinary action or oversight for health care professionals, he added.

Investigations identified medical devices contaminated in manufacturing, incorrect reprocessing of endoscopes or ventilators, and inappropriate medical device use or reuse, he said.

A number of lessons can be learned from these and other investigations, he added.

“First, devices can be reservoirs and transmission vectors for health care–associated infections. Second, health care facilities, health care facility staff, and public health partners should take opportunities to review protocols and the practices within those protocol,” he said. “These are opportunities to strengthen infection control practices even in the absence of documented transmission.”

In fact, in most of the investigations he discussed, transmission was rarely confirmed to be associated with a medical device. This was largely because of a lack of “epidemiological rigor,” but associations between health care–associated infections and medical devices “are still quite meaningful and often actionable,” he said.

Dr. Benowitz stressed the importance of engaging public health partners to discuss findings and actions, explaining that “what may look like a single-facility issue may have a very different perspective when you realize that there’s a similar issue at another facility elsewhere.”

“For all devices, it’s important to ensure adherence to the device reprocessing guidelines, “ he added, noting that these include a combination of facility protocols, manufacturer instructions for use, and guidance from organizations like the Food and Drug Administration and the CDC.

Dr. Benowitz reported having no disclosures.

[email protected]

SOURCE: Benowitz I et al. ICEID 2018, Oral Abstract Presentation E2.

ATLANTA – Ongoing vigilance regarding the role of medical devices in health care–associated infections (HAIs) and transmission of antimicrobial-resistant pathogen is needed, according to Isaac Benowitz, MD, of the Centers for Disease Control and Prevention’s Division of Healthcare Quality Promotion (DHQP).

CDC/ Margaret M. Williams; Janice Haney Carr

A review of records from the DHQP, which investigates and responds to infections and related adverse events in health care settings upon invitation, showed that in 2017 environmental pathogens were most often the triggers for these investigations, said Dr. Benowitz, a medical epidemiologist.

He reviewed internal records for consultations with state and local health departments involving medical devices and collected data on health care setting, pathogen, investigation findings including possible exposure or transmission, and public health actions.

Of 285 consultations, 48 involved a specific medical device or general medical device reprocessing, he said, noting that most of those 48 were in an acute care hospital (63%) or clinic (19%).

“The most frequent pathogens noted in these consultations were nontuberculous mycobacteria at 21%, Candida species ... at 10%, and Burkholderia species ... at 8%,” he said, noting that a wide variety of devices were implicated.

In the inpatient setting these devices included ventilators, dialysis machines, breast pumps, central lines, and respiratory therapy equipment. In the outpatient setting they included glucometers and opthalmic equipment.

“In many settings we saw issues with endoscopes, including duodenoscopes, but also bronchoscopes,” he added.

Actions taken as part of the investigations included medical device recalls, improved infection control and reprocessing procedures, and patient notification, education, guidance, testing, and treatment.

In some cases there was disciplinary action or oversight for health care professionals, he added.

Investigations identified medical devices contaminated in manufacturing, incorrect reprocessing of endoscopes or ventilators, and inappropriate medical device use or reuse, he said.

A number of lessons can be learned from these and other investigations, he added.

“First, devices can be reservoirs and transmission vectors for health care–associated infections. Second, health care facilities, health care facility staff, and public health partners should take opportunities to review protocols and the practices within those protocol,” he said. “These are opportunities to strengthen infection control practices even in the absence of documented transmission.”

In fact, in most of the investigations he discussed, transmission was rarely confirmed to be associated with a medical device. This was largely because of a lack of “epidemiological rigor,” but associations between health care–associated infections and medical devices “are still quite meaningful and often actionable,” he said.

Dr. Benowitz stressed the importance of engaging public health partners to discuss findings and actions, explaining that “what may look like a single-facility issue may have a very different perspective when you realize that there’s a similar issue at another facility elsewhere.”

“For all devices, it’s important to ensure adherence to the device reprocessing guidelines, “ he added, noting that these include a combination of facility protocols, manufacturer instructions for use, and guidance from organizations like the Food and Drug Administration and the CDC.

Dr. Benowitz reported having no disclosures.

[email protected]

SOURCE: Benowitz I et al. ICEID 2018, Oral Abstract Presentation E2.

ATLANTA – Ongoing vigilance regarding the role of medical devices in health care–associated infections (HAIs) and transmission of antimicrobial-resistant pathogen is needed, according to Isaac Benowitz, MD, of the Centers for Disease Control and Prevention’s Division of Healthcare Quality Promotion (DHQP).

CDC/ Margaret M. Williams; Janice Haney Carr

A review of records from the DHQP, which investigates and responds to infections and related adverse events in health care settings upon invitation, showed that in 2017 environmental pathogens were most often the triggers for these investigations, said Dr. Benowitz, a medical epidemiologist.

He reviewed internal records for consultations with state and local health departments involving medical devices and collected data on health care setting, pathogen, investigation findings including possible exposure or transmission, and public health actions.

Of 285 consultations, 48 involved a specific medical device or general medical device reprocessing, he said, noting that most of those 48 were in an acute care hospital (63%) or clinic (19%).

“The most frequent pathogens noted in these consultations were nontuberculous mycobacteria at 21%, Candida species ... at 10%, and Burkholderia species ... at 8%,” he said, noting that a wide variety of devices were implicated.

In the inpatient setting these devices included ventilators, dialysis machines, breast pumps, central lines, and respiratory therapy equipment. In the outpatient setting they included glucometers and opthalmic equipment.

“In many settings we saw issues with endoscopes, including duodenoscopes, but also bronchoscopes,” he added.

Actions taken as part of the investigations included medical device recalls, improved infection control and reprocessing procedures, and patient notification, education, guidance, testing, and treatment.

In some cases there was disciplinary action or oversight for health care professionals, he added.

Investigations identified medical devices contaminated in manufacturing, incorrect reprocessing of endoscopes or ventilators, and inappropriate medical device use or reuse, he said.

A number of lessons can be learned from these and other investigations, he added.

“First, devices can be reservoirs and transmission vectors for health care–associated infections. Second, health care facilities, health care facility staff, and public health partners should take opportunities to review protocols and the practices within those protocol,” he said. “These are opportunities to strengthen infection control practices even in the absence of documented transmission.”

In fact, in most of the investigations he discussed, transmission was rarely confirmed to be associated with a medical device. This was largely because of a lack of “epidemiological rigor,” but associations between health care–associated infections and medical devices “are still quite meaningful and often actionable,” he said.

Dr. Benowitz stressed the importance of engaging public health partners to discuss findings and actions, explaining that “what may look like a single-facility issue may have a very different perspective when you realize that there’s a similar issue at another facility elsewhere.”

“For all devices, it’s important to ensure adherence to the device reprocessing guidelines, “ he added, noting that these include a combination of facility protocols, manufacturer instructions for use, and guidance from organizations like the Food and Drug Administration and the CDC.

Dr. Benowitz reported having no disclosures.

[email protected]

SOURCE: Benowitz I et al. ICEID 2018, Oral Abstract Presentation E2.

MUNICH – The median radiation dosage received by patients worldwide undergoing coronary CT angiography fell by 78% from 2007 to 2017, according to a prospective study with more than 4,500 patients.

Mitchel L. Zoler/MDedge News

This substantial drop in radiation occurred with a steady rate of nondiagnostic CT scans, less than 2% in both 2007 and 2017.

“Given the high diagnostic accuracy and the low radiation dose, coronary CT angiography should be considered as a first-line diagnostic test,” Jörg Hausleiter, MD, said at the annual congress of the European Society of Cardiology.

The results also showed a huge disparity in the range of radiation doses used worldwide, with a 37-fold intersite variability in the median dose. This finding “underlines the need for further site-specific training and adaptation of contemporary cardiac scan protocols,” said Dr. Hausleiter, professor of medicine at the University of Munich Clinic. He suggested updated imaging guidelines on radiation levels, more educational sessions on how to perform coronary CT angiography, and actions by vendors to adjust their standard imaging protocols.

The Prospective Multicenter Registry on Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION-VI) study included 4,502 patients from a total of 61 sites in 32 countries. At each participating site, investigators enrolled consecutive adults during a randomly selected month in 2017, with a median of 51 patients enrolled at each site undergoing diagnostic coronary CT angiography. Comparison data for 2007 came from a similar study run by Dr. Hausleiter and his associates at that time, with 1,965 patients undergoing coronary CT angiography (JAMA. 2009 Feb 4;301[5]:500-7). In 2007, the median dose-length product of radiation for each scan was 885 mGy x cm, which corresponds to a radiation dose of about 12.4 mSv. In 2017, the median dose-length product was 195 mGy x cm, corresponding to a dose of about 2.7 mSv. By both measures the median dose dropped by roughly 78%.

A multivariate analysis identified three changes in the way clinicians obtained most of the CT scans during the two studied time periods that seemed to explain the drop in radiation dose. First, more scan protocols in 2017 used low tube potential; second, more protocols in 2017 used prospectively ECG-triggered axial high-pitch scans; and third, 2017 had increased use of iterative image reconstruction, Dr. Hausleiter said. Patient variables that had modest but significant links with increased radiation doses were higher body weight, higher heart rate, and no sinus rhythm.

Concurrently with Dr. Hausleiter’s talk at the congress, the results appeared in an article online (Euro Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy546).

[email protected]

MUNICH – The median radiation dosage received by patients worldwide undergoing coronary CT angiography fell by 78% from 2007 to 2017, according to a prospective study with more than 4,500 patients.

Mitchel L. Zoler/MDedge News

This substantial drop in radiation occurred with a steady rate of nondiagnostic CT scans, less than 2% in both 2007 and 2017.

“Given the high diagnostic accuracy and the low radiation dose, coronary CT angiography should be considered as a first-line diagnostic test,” Jörg Hausleiter, MD, said at the annual congress of the European Society of Cardiology.

The results also showed a huge disparity in the range of radiation doses used worldwide, with a 37-fold intersite variability in the median dose. This finding “underlines the need for further site-specific training and adaptation of contemporary cardiac scan protocols,” said Dr. Hausleiter, professor of medicine at the University of Munich Clinic. He suggested updated imaging guidelines on radiation levels, more educational sessions on how to perform coronary CT angiography, and actions by vendors to adjust their standard imaging protocols.

The Prospective Multicenter Registry on Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION-VI) study included 4,502 patients from a total of 61 sites in 32 countries. At each participating site, investigators enrolled consecutive adults during a randomly selected month in 2017, with a median of 51 patients enrolled at each site undergoing diagnostic coronary CT angiography. Comparison data for 2007 came from a similar study run by Dr. Hausleiter and his associates at that time, with 1,965 patients undergoing coronary CT angiography (JAMA. 2009 Feb 4;301[5]:500-7). In 2007, the median dose-length product of radiation for each scan was 885 mGy x cm, which corresponds to a radiation dose of about 12.4 mSv. In 2017, the median dose-length product was 195 mGy x cm, corresponding to a dose of about 2.7 mSv. By both measures the median dose dropped by roughly 78%.

A multivariate analysis identified three changes in the way clinicians obtained most of the CT scans during the two studied time periods that seemed to explain the drop in radiation dose. First, more scan protocols in 2017 used low tube potential; second, more protocols in 2017 used prospectively ECG-triggered axial high-pitch scans; and third, 2017 had increased use of iterative image reconstruction, Dr. Hausleiter said. Patient variables that had modest but significant links with increased radiation doses were higher body weight, higher heart rate, and no sinus rhythm.

Concurrently with Dr. Hausleiter’s talk at the congress, the results appeared in an article online (Euro Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy546).

[email protected]

MUNICH – The median radiation dosage received by patients worldwide undergoing coronary CT angiography fell by 78% from 2007 to 2017, according to a prospective study with more than 4,500 patients.

Mitchel L. Zoler/MDedge News

This substantial drop in radiation occurred with a steady rate of nondiagnostic CT scans, less than 2% in both 2007 and 2017.

“Given the high diagnostic accuracy and the low radiation dose, coronary CT angiography should be considered as a first-line diagnostic test,” Jörg Hausleiter, MD, said at the annual congress of the European Society of Cardiology.

The results also showed a huge disparity in the range of radiation doses used worldwide, with a 37-fold intersite variability in the median dose. This finding “underlines the need for further site-specific training and adaptation of contemporary cardiac scan protocols,” said Dr. Hausleiter, professor of medicine at the University of Munich Clinic. He suggested updated imaging guidelines on radiation levels, more educational sessions on how to perform coronary CT angiography, and actions by vendors to adjust their standard imaging protocols.

The Prospective Multicenter Registry on Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION-VI) study included 4,502 patients from a total of 61 sites in 32 countries. At each participating site, investigators enrolled consecutive adults during a randomly selected month in 2017, with a median of 51 patients enrolled at each site undergoing diagnostic coronary CT angiography. Comparison data for 2007 came from a similar study run by Dr. Hausleiter and his associates at that time, with 1,965 patients undergoing coronary CT angiography (JAMA. 2009 Feb 4;301[5]:500-7). In 2007, the median dose-length product of radiation for each scan was 885 mGy x cm, which corresponds to a radiation dose of about 12.4 mSv. In 2017, the median dose-length product was 195 mGy x cm, corresponding to a dose of about 2.7 mSv. By both measures the median dose dropped by roughly 78%.

A multivariate analysis identified three changes in the way clinicians obtained most of the CT scans during the two studied time periods that seemed to explain the drop in radiation dose. First, more scan protocols in 2017 used low tube potential; second, more protocols in 2017 used prospectively ECG-triggered axial high-pitch scans; and third, 2017 had increased use of iterative image reconstruction, Dr. Hausleiter said. Patient variables that had modest but significant links with increased radiation doses were higher body weight, higher heart rate, and no sinus rhythm.

Concurrently with Dr. Hausleiter’s talk at the congress, the results appeared in an article online (Euro Heart J. 2018 Aug 25. doi: 10.1093/eurheartj/ehy546).

[email protected]

ATLANTA – Seven cases of imported Corynebacterium diphtheriae in Minnesota highlight the importance of maintaining suspicion that cutaneous lesions in individuals with recent travel to endemic countries might be associated with C. diphtheriae infection.

CDC

The cases also underscore the importance of referring C. diphtheriae isolates to state health departments for confirmatory testing, Jayne Griffith, of the Minnesota Department of Health, and her colleagues reported in a poster at the International Conference on Emerging Infectious Diseases.

“C. diphtheriae infections was not clinically suspected in any of these case-patients. All infections were initially identified solely by [matrix-assisted laser desorption/ionization time-of-flight spectrometry] testing performed at the clinical institutions,” the investigators wrote. “Confirmation and further toxigenicity testing allowed for prompt case investigation and public health response, preventing disease spread.”

Infections caused by toxigenic C. diphtheriae are rare in the United States because of widespread vaccination, but remain endemic in countries with suboptimal vaccine coverage. For this reason, infection is a concern for unvaccinated individuals traveling to diphtheria-endemic countries as well as for those who have contact with people from these areas. The investigators noted that “infections are primarily respiratory or cutaneous; respiratory infections can be life-threatening and cutaneous wounds may serve as a reservoir from which bacteria can be transmitted to susceptible contacts.”

The Minnesota cases involved patients who presented with cutaneous ulcers between 2014 and 2017. The Minnesota Department of Health confirmed C. diphtheriae status by culture after the initial identification at private institutions or providers using matrix-assisted laser desorption/ionization time-of-flight spectrometry. Isolates were sent to the Centers for Disease Control and Prevention Pertussis and Diphtheria Laboratory for biotyping and confirmation of toxigenicity.

The CDC confirmed that isolates from two patients were toxigenic C. diphtheriae biotype mitis. The remaining cases were nontoxigenic diphtheria, including C. diphtheriae mitis (three case-patients, including one who also had Staphylococcus aureus, and another who also had methicillin-resistant S. aureus) and two case-patients with C. diphtheriae belfanti.

The patients with toxigenic infection included a 35-year-old woman who developed an abdominal boil after spending months in Somalia, and a 48-year-old man who cut his leg while in Ethiopia.

The patients with nontoxigenic infection included four foreign-born individuals ranging in age from 7 to 66 years and one 24-year-old man from the United States. One of the foreign-born individuals had immigrated from a diphtheria-endemic country 3 months prior to his diagnosis, but none of the remaining four had traveled outside the United States in the 6 months prior to infection onset. One, however, lived in a home with family members who traveled frequently to eastern Africa. The vaccination status of these patients was unknown.

Contact tracing was conducted and prophylactic antibiotics were recommended as appropriate. Vaccination was recommended when a case-patient and/or contact was inadequately immunized.

Both patients with toxigenic infection experienced wound healing after appropriate antibiotic therapy.

Ms. Griffith reported having no disclosures.

[email protected]

ATLANTA – Seven cases of imported Corynebacterium diphtheriae in Minnesota highlight the importance of maintaining suspicion that cutaneous lesions in individuals with recent travel to endemic countries might be associated with C. diphtheriae infection.

CDC

The cases also underscore the importance of referring C. diphtheriae isolates to state health departments for confirmatory testing, Jayne Griffith, of the Minnesota Department of Health, and her colleagues reported in a poster at the International Conference on Emerging Infectious Diseases.

“C. diphtheriae infections was not clinically suspected in any of these case-patients. All infections were initially identified solely by [matrix-assisted laser desorption/ionization time-of-flight spectrometry] testing performed at the clinical institutions,” the investigators wrote. “Confirmation and further toxigenicity testing allowed for prompt case investigation and public health response, preventing disease spread.”

Infections caused by toxigenic C. diphtheriae are rare in the United States because of widespread vaccination, but remain endemic in countries with suboptimal vaccine coverage. For this reason, infection is a concern for unvaccinated individuals traveling to diphtheria-endemic countries as well as for those who have contact with people from these areas. The investigators noted that “infections are primarily respiratory or cutaneous; respiratory infections can be life-threatening and cutaneous wounds may serve as a reservoir from which bacteria can be transmitted to susceptible contacts.”

The Minnesota cases involved patients who presented with cutaneous ulcers between 2014 and 2017. The Minnesota Department of Health confirmed C. diphtheriae status by culture after the initial identification at private institutions or providers using matrix-assisted laser desorption/ionization time-of-flight spectrometry. Isolates were sent to the Centers for Disease Control and Prevention Pertussis and Diphtheria Laboratory for biotyping and confirmation of toxigenicity.

The CDC confirmed that isolates from two patients were toxigenic C. diphtheriae biotype mitis. The remaining cases were nontoxigenic diphtheria, including C. diphtheriae mitis (three case-patients, including one who also had Staphylococcus aureus, and another who also had methicillin-resistant S. aureus) and two case-patients with C. diphtheriae belfanti.

The patients with toxigenic infection included a 35-year-old woman who developed an abdominal boil after spending months in Somalia, and a 48-year-old man who cut his leg while in Ethiopia.

The patients with nontoxigenic infection included four foreign-born individuals ranging in age from 7 to 66 years and one 24-year-old man from the United States. One of the foreign-born individuals had immigrated from a diphtheria-endemic country 3 months prior to his diagnosis, but none of the remaining four had traveled outside the United States in the 6 months prior to infection onset. One, however, lived in a home with family members who traveled frequently to eastern Africa. The vaccination status of these patients was unknown.

Contact tracing was conducted and prophylactic antibiotics were recommended as appropriate. Vaccination was recommended when a case-patient and/or contact was inadequately immunized.

Both patients with toxigenic infection experienced wound healing after appropriate antibiotic therapy.

Ms. Griffith reported having no disclosures.

[email protected]

ATLANTA – Seven cases of imported Corynebacterium diphtheriae in Minnesota highlight the importance of maintaining suspicion that cutaneous lesions in individuals with recent travel to endemic countries might be associated with C. diphtheriae infection.

CDC

The cases also underscore the importance of referring C. diphtheriae isolates to state health departments for confirmatory testing, Jayne Griffith, of the Minnesota Department of Health, and her colleagues reported in a poster at the International Conference on Emerging Infectious Diseases.

“C. diphtheriae infections was not clinically suspected in any of these case-patients. All infections were initially identified solely by [matrix-assisted laser desorption/ionization time-of-flight spectrometry] testing performed at the clinical institutions,” the investigators wrote. “Confirmation and further toxigenicity testing allowed for prompt case investigation and public health response, preventing disease spread.”

Infections caused by toxigenic C. diphtheriae are rare in the United States because of widespread vaccination, but remain endemic in countries with suboptimal vaccine coverage. For this reason, infection is a concern for unvaccinated individuals traveling to diphtheria-endemic countries as well as for those who have contact with people from these areas. The investigators noted that “infections are primarily respiratory or cutaneous; respiratory infections can be life-threatening and cutaneous wounds may serve as a reservoir from which bacteria can be transmitted to susceptible contacts.”

The Minnesota cases involved patients who presented with cutaneous ulcers between 2014 and 2017. The Minnesota Department of Health confirmed C. diphtheriae status by culture after the initial identification at private institutions or providers using matrix-assisted laser desorption/ionization time-of-flight spectrometry. Isolates were sent to the Centers for Disease Control and Prevention Pertussis and Diphtheria Laboratory for biotyping and confirmation of toxigenicity.

The CDC confirmed that isolates from two patients were toxigenic C. diphtheriae biotype mitis. The remaining cases were nontoxigenic diphtheria, including C. diphtheriae mitis (three case-patients, including one who also had Staphylococcus aureus, and another who also had methicillin-resistant S. aureus) and two case-patients with C. diphtheriae belfanti.

The patients with toxigenic infection included a 35-year-old woman who developed an abdominal boil after spending months in Somalia, and a 48-year-old man who cut his leg while in Ethiopia.

The patients with nontoxigenic infection included four foreign-born individuals ranging in age from 7 to 66 years and one 24-year-old man from the United States. One of the foreign-born individuals had immigrated from a diphtheria-endemic country 3 months prior to his diagnosis, but none of the remaining four had traveled outside the United States in the 6 months prior to infection onset. One, however, lived in a home with family members who traveled frequently to eastern Africa. The vaccination status of these patients was unknown.

Contact tracing was conducted and prophylactic antibiotics were recommended as appropriate. Vaccination was recommended when a case-patient and/or contact was inadequately immunized.

Both patients with toxigenic infection experienced wound healing after appropriate antibiotic therapy.

Ms. Griffith reported having no disclosures.

[email protected]

MUNICH – Patients with left-sided endocarditis who are clinically stable after a couple weeks of inpatient intravenous antibiotics may at that point become candidates for discharge on oral antibiotics for the remainder of their treatment course, according to the findings of the randomized, multicenter, Danish POET trial.

Bruce Jancin/MDedge News

“Shifting to oral antibiotic treatment in stabilized patients with endocarditis was as effective and safe as continued intravenous antibiotic treatment and was given during half the antibiotic treatment period. These novel findings may have a significant impact on future clinical practice for the management of patients who are stable,” Henning Bundgård, MD, said at the annual congress of the European Society of Cardiology.

Both ESC and American Heart Association/American College of Cardiology guidelines now recommend treatment of infective endocarditis with intravenous antibiotics for up to 6 weeks. Safely cutting the duration of in-hospital intravenous antibiotics in half is likely to generate major cost savings while improving patient quality of life and avoiding prolonged exposure to the iatrogenic risks inherent to the hospital environment, noted Dr. Bundgård, a cardiologist at Copenhagen University Hospital.

The rationale for the POET (Partial Oral Treatment of Endocarditis) trial was the investigators’ recognition that, even though infectious endocarditis is a feared disease with an in-hospital mortality of 15% or more, the great majority of serious complications occur in the early critical phase of therapy; that is, during the first 10 days or so of inpatient intravenous antibiotic therapy.

“After stabilization, the main reason for staying in the hospital is just to receive IV antibiotics,” Dr. Bundgård noted.

POET included 400 patients with left-sided endocarditis hospitalized at multiple cardiac centers across Denmark, 35% of whom had at least one major comorbid condition. When this reporter observed that this was the smallest study he’d ever seen reported from Denmark, where researchers famously like to utilize interconnected national databases to conduct nationwide observational studies incorporating the country’s entire population, the cardiologist replied, “Denmark is a small country, but we like to make big trials. And this is actually the largest-ever clinical trial in endocarditis, so we are still going big.”

Important to the generalizability of the POET results was the requirement that all 400 participants had to be infected with streptococcus, Staphylococcus aureus, Enterococcus faecalis, or coagulase-negative staphylococci – the major pathogens responsible for three-quarters of all cases of infectious endocarditis.

Once participants were clinically stable after a median of 17 days of intravenous antibiotics, they were randomized to continued in-hospital intravenous antibiotic therapy for a median of another 19 days or to discharge on two oral antibiotics from different classes with different mechanisms of action administered for a median of 17 days, with selection of the oral agents being guided by the results of bacterial susceptibility testing.

The primary outcome was a composite of all-cause mortality, embolic events, unplanned cardiac surgery, and relapse of bacteremia from randomization through 6 months after completion of antibiotic therapy. This occurred in 9.0% of the orally treated group and 12.1% of patients on full-course intravenous therapy for a 28% relative risk reduction, which statistically established the noninferioritiy of the partial oral regimen. The results were similar in patients with native as compared with prosthetic valves, with or without major comorbidities, and in surgically as opposed to conservatively treated patients.

Rates of three of the four components of the composite endpoint were similar in both groups. However, all-cause mortality occurred in 3.5% of the oral therapy group, compared with 6.5% of those on intravenous therapy. Dr. Bundgård said he and his coinvestigators think the disparity in mortality was probably caused by play of chance, although he added that they were struck that four sudden deaths occurred in the intravenous group and none in patients who got oral antibiotics.

Side effects were similarly mild and low frequency in both study arms.

Audience members were eager for details on how the Danish investigators decided patients were clinically stable on intravenous antibiotics and thus ready for randomization, as well as the outpatient follow-up procedures employed in those discharged on oral therapy.

Dr. Bundgård explained that clinical stability required that a patient be afebrile, have C-reactive protein and leukocyte levels less than 35% of their peaks, and needed to have been on intravenous antibiotics for a minimum of 10 days. Moreover, patients who underwent valve surgery during their hospitalization, as did 38% of POET participants, had to wait a minimum of 7 days afterwards before they could be declared clinically stable. Lastly, just prior to randomization all participants underwent transesophageal echocardiography to rule out abscess formation or other valve abnormalities requiring surgery.

Outpatient follow-up required that patients drop in two or three times per week to be checked by a familiar physician or nurse at the hospital ward where they had stayed. Compliance was very good, although it should be noted that only five patients in the POET study were intravenous drug abusers.

Asked why investigators discharged patients on oral therapy rather than on home intravenous antibiotics, Dr. Bundgård explained that home intravenous antibiotic therapy isn’t utilized in Denmark because of the expense and logistic complexity.

Bruce Jancin/MDedge News

Discussant Chris P. Gale, MD, urged care in generalizing the study findings.

“The ‘O’ in POET does not stand for ‘outpatient.’ Outpatients were only selected for oral therapy if they had no heart failure, no emboli, no arrhythmia, no complicating comorbidities, and they were strictly monitored – and frequently. Should we elect to adopt POET into practice, I would recommend strict adherence to the study’s patient selection and monitoring criteria,” said Dr. Gale, a cardiologist at the University of Leeds (England).

The POET results clearly swayed the full-house audience attending the late-breaking Hot Line session in the conference main arena. Immediately before Dr. Bundgård’s presentation, 66% of the audience indicated electronically that they would continue intravenous antibiotics for another 2-4 weeks in a patient with infectious endocarditis who had responded well to 2 weeks of such therapy. After seeing the study results, however, only 19% would still follow that course of action, while 59% of the audience would switch to oral antibiotics and discharge the patient.

Dr. Bundgård reported having no financial conflicts regarding the POET study, which was funded by the Danish Heart Foundation and other research foundations.

Simultaneous with Dr. Bundgård’s presentation in Munich, the POET results were published online by the New England Journal of Medicine (2018 Aug 28. doi: 10.1056/NEJMoa1808312).

[email protected]

MUNICH – Patients with left-sided endocarditis who are clinically stable after a couple weeks of inpatient intravenous antibiotics may at that point become candidates for discharge on oral antibiotics for the remainder of their treatment course, according to the findings of the randomized, multicenter, Danish POET trial.

Bruce Jancin/MDedge News

“Shifting to oral antibiotic treatment in stabilized patients with endocarditis was as effective and safe as continued intravenous antibiotic treatment and was given during half the antibiotic treatment period. These novel findings may have a significant impact on future clinical practice for the management of patients who are stable,” Henning Bundgård, MD, said at the annual congress of the European Society of Cardiology.

Both ESC and American Heart Association/American College of Cardiology guidelines now recommend treatment of infective endocarditis with intravenous antibiotics for up to 6 weeks. Safely cutting the duration of in-hospital intravenous antibiotics in half is likely to generate major cost savings while improving patient quality of life and avoiding prolonged exposure to the iatrogenic risks inherent to the hospital environment, noted Dr. Bundgård, a cardiologist at Copenhagen University Hospital.

The rationale for the POET (Partial Oral Treatment of Endocarditis) trial was the investigators’ recognition that, even though infectious endocarditis is a feared disease with an in-hospital mortality of 15% or more, the great majority of serious complications occur in the early critical phase of therapy; that is, during the first 10 days or so of inpatient intravenous antibiotic therapy.

“After stabilization, the main reason for staying in the hospital is just to receive IV antibiotics,” Dr. Bundgård noted.

POET included 400 patients with left-sided endocarditis hospitalized at multiple cardiac centers across Denmark, 35% of whom had at least one major comorbid condition. When this reporter observed that this was the smallest study he’d ever seen reported from Denmark, where researchers famously like to utilize interconnected national databases to conduct nationwide observational studies incorporating the country’s entire population, the cardiologist replied, “Denmark is a small country, but we like to make big trials. And this is actually the largest-ever clinical trial in endocarditis, so we are still going big.”

Important to the generalizability of the POET results was the requirement that all 400 participants had to be infected with streptococcus, Staphylococcus aureus, Enterococcus faecalis, or coagulase-negative staphylococci – the major pathogens responsible for three-quarters of all cases of infectious endocarditis.

Once participants were clinically stable after a median of 17 days of intravenous antibiotics, they were randomized to continued in-hospital intravenous antibiotic therapy for a median of another 19 days or to discharge on two oral antibiotics from different classes with different mechanisms of action administered for a median of 17 days, with selection of the oral agents being guided by the results of bacterial susceptibility testing.

The primary outcome was a composite of all-cause mortality, embolic events, unplanned cardiac surgery, and relapse of bacteremia from randomization through 6 months after completion of antibiotic therapy. This occurred in 9.0% of the orally treated group and 12.1% of patients on full-course intravenous therapy for a 28% relative risk reduction, which statistically established the noninferioritiy of the partial oral regimen. The results were similar in patients with native as compared with prosthetic valves, with or without major comorbidities, and in surgically as opposed to conservatively treated patients.

Rates of three of the four components of the composite endpoint were similar in both groups. However, all-cause mortality occurred in 3.5% of the oral therapy group, compared with 6.5% of those on intravenous therapy. Dr. Bundgård said he and his coinvestigators think the disparity in mortality was probably caused by play of chance, although he added that they were struck that four sudden deaths occurred in the intravenous group and none in patients who got oral antibiotics.

Side effects were similarly mild and low frequency in both study arms.

Audience members were eager for details on how the Danish investigators decided patients were clinically stable on intravenous antibiotics and thus ready for randomization, as well as the outpatient follow-up procedures employed in those discharged on oral therapy.

Dr. Bundgård explained that clinical stability required that a patient be afebrile, have C-reactive protein and leukocyte levels less than 35% of their peaks, and needed to have been on intravenous antibiotics for a minimum of 10 days. Moreover, patients who underwent valve surgery during their hospitalization, as did 38% of POET participants, had to wait a minimum of 7 days afterwards before they could be declared clinically stable. Lastly, just prior to randomization all participants underwent transesophageal echocardiography to rule out abscess formation or other valve abnormalities requiring surgery.

Outpatient follow-up required that patients drop in two or three times per week to be checked by a familiar physician or nurse at the hospital ward where they had stayed. Compliance was very good, although it should be noted that only five patients in the POET study were intravenous drug abusers.

Asked why investigators discharged patients on oral therapy rather than on home intravenous antibiotics, Dr. Bundgård explained that home intravenous antibiotic therapy isn’t utilized in Denmark because of the expense and logistic complexity.

Bruce Jancin/MDedge News

Discussant Chris P. Gale, MD, urged care in generalizing the study findings.

“The ‘O’ in POET does not stand for ‘outpatient.’ Outpatients were only selected for oral therapy if they had no heart failure, no emboli, no arrhythmia, no complicating comorbidities, and they were strictly monitored – and frequently. Should we elect to adopt POET into practice, I would recommend strict adherence to the study’s patient selection and monitoring criteria,” said Dr. Gale, a cardiologist at the University of Leeds (England).

The POET results clearly swayed the full-house audience attending the late-breaking Hot Line session in the conference main arena. Immediately before Dr. Bundgård’s presentation, 66% of the audience indicated electronically that they would continue intravenous antibiotics for another 2-4 weeks in a patient with infectious endocarditis who had responded well to 2 weeks of such therapy. After seeing the study results, however, only 19% would still follow that course of action, while 59% of the audience would switch to oral antibiotics and discharge the patient.

Dr. Bundgård reported having no financial conflicts regarding the POET study, which was funded by the Danish Heart Foundation and other research foundations.

Simultaneous with Dr. Bundgård’s presentation in Munich, the POET results were published online by the New England Journal of Medicine (2018 Aug 28. doi: 10.1056/NEJMoa1808312).

[email protected]

MUNICH – Patients with left-sided endocarditis who are clinically stable after a couple weeks of inpatient intravenous antibiotics may at that point become candidates for discharge on oral antibiotics for the remainder of their treatment course, according to the findings of the randomized, multicenter, Danish POET trial.

Bruce Jancin/MDedge News

“Shifting to oral antibiotic treatment in stabilized patients with endocarditis was as effective and safe as continued intravenous antibiotic treatment and was given during half the antibiotic treatment period. These novel findings may have a significant impact on future clinical practice for the management of patients who are stable,” Henning Bundgård, MD, said at the annual congress of the European Society of Cardiology.

Both ESC and American Heart Association/American College of Cardiology guidelines now recommend treatment of infective endocarditis with intravenous antibiotics for up to 6 weeks. Safely cutting the duration of in-hospital intravenous antibiotics in half is likely to generate major cost savings while improving patient quality of life and avoiding prolonged exposure to the iatrogenic risks inherent to the hospital environment, noted Dr. Bundgård, a cardiologist at Copenhagen University Hospital.

The rationale for the POET (Partial Oral Treatment of Endocarditis) trial was the investigators’ recognition that, even though infectious endocarditis is a feared disease with an in-hospital mortality of 15% or more, the great majority of serious complications occur in the early critical phase of therapy; that is, during the first 10 days or so of inpatient intravenous antibiotic therapy.

“After stabilization, the main reason for staying in the hospital is just to receive IV antibiotics,” Dr. Bundgård noted.

POET included 400 patients with left-sided endocarditis hospitalized at multiple cardiac centers across Denmark, 35% of whom had at least one major comorbid condition. When this reporter observed that this was the smallest study he’d ever seen reported from Denmark, where researchers famously like to utilize interconnected national databases to conduct nationwide observational studies incorporating the country’s entire population, the cardiologist replied, “Denmark is a small country, but we like to make big trials. And this is actually the largest-ever clinical trial in endocarditis, so we are still going big.”

Important to the generalizability of the POET results was the requirement that all 400 participants had to be infected with streptococcus, Staphylococcus aureus, Enterococcus faecalis, or coagulase-negative staphylococci – the major pathogens responsible for three-quarters of all cases of infectious endocarditis.

Once participants were clinically stable after a median of 17 days of intravenous antibiotics, they were randomized to continued in-hospital intravenous antibiotic therapy for a median of another 19 days or to discharge on two oral antibiotics from different classes with different mechanisms of action administered for a median of 17 days, with selection of the oral agents being guided by the results of bacterial susceptibility testing.

The primary outcome was a composite of all-cause mortality, embolic events, unplanned cardiac surgery, and relapse of bacteremia from randomization through 6 months after completion of antibiotic therapy. This occurred in 9.0% of the orally treated group and 12.1% of patients on full-course intravenous therapy for a 28% relative risk reduction, which statistically established the noninferioritiy of the partial oral regimen. The results were similar in patients with native as compared with prosthetic valves, with or without major comorbidities, and in surgically as opposed to conservatively treated patients.

Rates of three of the four components of the composite endpoint were similar in both groups. However, all-cause mortality occurred in 3.5% of the oral therapy group, compared with 6.5% of those on intravenous therapy. Dr. Bundgård said he and his coinvestigators think the disparity in mortality was probably caused by play of chance, although he added that they were struck that four sudden deaths occurred in the intravenous group and none in patients who got oral antibiotics.

Side effects were similarly mild and low frequency in both study arms.

Audience members were eager for details on how the Danish investigators decided patients were clinically stable on intravenous antibiotics and thus ready for randomization, as well as the outpatient follow-up procedures employed in those discharged on oral therapy.

Dr. Bundgård explained that clinical stability required that a patient be afebrile, have C-reactive protein and leukocyte levels less than 35% of their peaks, and needed to have been on intravenous antibiotics for a minimum of 10 days. Moreover, patients who underwent valve surgery during their hospitalization, as did 38% of POET participants, had to wait a minimum of 7 days afterwards before they could be declared clinically stable. Lastly, just prior to randomization all participants underwent transesophageal echocardiography to rule out abscess formation or other valve abnormalities requiring surgery.

Outpatient follow-up required that patients drop in two or three times per week to be checked by a familiar physician or nurse at the hospital ward where they had stayed. Compliance was very good, although it should be noted that only five patients in the POET study were intravenous drug abusers.

Asked why investigators discharged patients on oral therapy rather than on home intravenous antibiotics, Dr. Bundgård explained that home intravenous antibiotic therapy isn’t utilized in Denmark because of the expense and logistic complexity.

Bruce Jancin/MDedge News

Discussant Chris P. Gale, MD, urged care in generalizing the study findings.

“The ‘O’ in POET does not stand for ‘outpatient.’ Outpatients were only selected for oral therapy if they had no heart failure, no emboli, no arrhythmia, no complicating comorbidities, and they were strictly monitored – and frequently. Should we elect to adopt POET into practice, I would recommend strict adherence to the study’s patient selection and monitoring criteria,” said Dr. Gale, a cardiologist at the University of Leeds (England).

The POET results clearly swayed the full-house audience attending the late-breaking Hot Line session in the conference main arena. Immediately before Dr. Bundgård’s presentation, 66% of the audience indicated electronically that they would continue intravenous antibiotics for another 2-4 weeks in a patient with infectious endocarditis who had responded well to 2 weeks of such therapy. After seeing the study results, however, only 19% would still follow that course of action, while 59% of the audience would switch to oral antibiotics and discharge the patient.

Dr. Bundgård reported having no financial conflicts regarding the POET study, which was funded by the Danish Heart Foundation and other research foundations.

Simultaneous with Dr. Bundgård’s presentation in Munich, the POET results were published online by the New England Journal of Medicine (2018 Aug 28. doi: 10.1056/NEJMoa1808312).

[email protected]

Clinical question: Do factor Xa inhibitors reduce the incidence of strokes and systemic embolic events, compared with warfarin, in people with atrial fibrillation?

Background: Factor Xa inhibitors, called DOACs or direct-acting anticoagulants, and vitamin K antagonists (VKAs) are part of treatment guidelines for preventing stroke and systemic embolic events in people with atrial fibrillation (AF). This study assessed the effectiveness and safety of treatment with factor Xa inhibitors versus VKAs for preventing cerebral or systemic embolic events in AF.

Study design: Cochrane Review update.

Setting: Data obtained from trial registers of the Cochrane Central Register of Controlled Trials (August 2017), the Cochrane Heart Group and the Cochrane Stroke Group (September 2016), Embase (1980 to April 2017), and MEDLINE (1950 to April 2017). Authors also screened reference lists and contacted pharmaceutical companies, authors, and sponsors of relevant published trials.

Synopsis: The study included 42,084 participants from 10 trials with a diagnosis of AF who were eligible for long-term anticoagulation with warfarin (target INR 2-3).

The trials directly compared dose-adjusted warfarin with factor Xa inhibitors. Median follow-up ranged from 12 weeks to 1.9 years, and composite primary endpoint was all strokes (both ischemic and hemorrhagic) and non–central nervous systemic embolic events. Factor Xa inhibitor significantly decreased the number of strokes and systemic embolic events, compared with dose-adjusted warfarin (odds ratio, 0.81; 95% confidence interval, 0.72-0.91), reduced the number of major bleeding events (OR, 0.92; 95% CI, 0.63-1.34), and significantly reduced the risk of intracranial hemorrhage (OR, 0.56; 95% CI, 0.45-0.70). They also significantly reduced the number of all-cause deaths (OR, 0.88; 95% CI, 0.81-0.97). One limitation of this study is the heterogeneity and hence lower quality of evidence. This study shows a small net clinical benefit of using factor Xa inhibitors in AF because of a reduction in strokes and systemic embolic events and also a lower risk of bleeding (including intracranial hemorrhages), compared with using warfarin.

Bottom line: Patients with AF have a lower incidence of strokes and systemic embolic events when treated with factor Xa inhibitors, compared with those treated with warfarin.

Citation: Bruins Slot KM et al. Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation. Cochrane Database Syst Rev. 2018 Mar 6. doi: 10.1002/14651858.CD008980.pub3.

Dr. Veedu is a hospitalist and instructor in the division of hospital medicine at the University of Kentucky, Lexington.

Clinical question: Do factor Xa inhibitors reduce the incidence of strokes and systemic embolic events, compared with warfarin, in people with atrial fibrillation?

Background: Factor Xa inhibitors, called DOACs or direct-acting anticoagulants, and vitamin K antagonists (VKAs) are part of treatment guidelines for preventing stroke and systemic embolic events in people with atrial fibrillation (AF). This study assessed the effectiveness and safety of treatment with factor Xa inhibitors versus VKAs for preventing cerebral or systemic embolic events in AF.

Study design: Cochrane Review update.

Setting: Data obtained from trial registers of the Cochrane Central Register of Controlled Trials (August 2017), the Cochrane Heart Group and the Cochrane Stroke Group (September 2016), Embase (1980 to April 2017), and MEDLINE (1950 to April 2017). Authors also screened reference lists and contacted pharmaceutical companies, authors, and sponsors of relevant published trials.

Synopsis: The study included 42,084 participants from 10 trials with a diagnosis of AF who were eligible for long-term anticoagulation with warfarin (target INR 2-3).

The trials directly compared dose-adjusted warfarin with factor Xa inhibitors. Median follow-up ranged from 12 weeks to 1.9 years, and composite primary endpoint was all strokes (both ischemic and hemorrhagic) and non–central nervous systemic embolic events. Factor Xa inhibitor significantly decreased the number of strokes and systemic embolic events, compared with dose-adjusted warfarin (odds ratio, 0.81; 95% confidence interval, 0.72-0.91), reduced the number of major bleeding events (OR, 0.92; 95% CI, 0.63-1.34), and significantly reduced the risk of intracranial hemorrhage (OR, 0.56; 95% CI, 0.45-0.70). They also significantly reduced the number of all-cause deaths (OR, 0.88; 95% CI, 0.81-0.97). One limitation of this study is the heterogeneity and hence lower quality of evidence. This study shows a small net clinical benefit of using factor Xa inhibitors in AF because of a reduction in strokes and systemic embolic events and also a lower risk of bleeding (including intracranial hemorrhages), compared with using warfarin.

Bottom line: Patients with AF have a lower incidence of strokes and systemic embolic events when treated with factor Xa inhibitors, compared with those treated with warfarin.

Citation: Bruins Slot KM et al. Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation. Cochrane Database Syst Rev. 2018 Mar 6. doi: 10.1002/14651858.CD008980.pub3.

Dr. Veedu is a hospitalist and instructor in the division of hospital medicine at the University of Kentucky, Lexington.

Clinical question: Do factor Xa inhibitors reduce the incidence of strokes and systemic embolic events, compared with warfarin, in people with atrial fibrillation?

Background: Factor Xa inhibitors, called DOACs or direct-acting anticoagulants, and vitamin K antagonists (VKAs) are part of treatment guidelines for preventing stroke and systemic embolic events in people with atrial fibrillation (AF). This study assessed the effectiveness and safety of treatment with factor Xa inhibitors versus VKAs for preventing cerebral or systemic embolic events in AF.

Study design: Cochrane Review update.

Setting: Data obtained from trial registers of the Cochrane Central Register of Controlled Trials (August 2017), the Cochrane Heart Group and the Cochrane Stroke Group (September 2016), Embase (1980 to April 2017), and MEDLINE (1950 to April 2017). Authors also screened reference lists and contacted pharmaceutical companies, authors, and sponsors of relevant published trials.

Synopsis: The study included 42,084 participants from 10 trials with a diagnosis of AF who were eligible for long-term anticoagulation with warfarin (target INR 2-3).

The trials directly compared dose-adjusted warfarin with factor Xa inhibitors. Median follow-up ranged from 12 weeks to 1.9 years, and composite primary endpoint was all strokes (both ischemic and hemorrhagic) and non–central nervous systemic embolic events. Factor Xa inhibitor significantly decreased the number of strokes and systemic embolic events, compared with dose-adjusted warfarin (odds ratio, 0.81; 95% confidence interval, 0.72-0.91), reduced the number of major bleeding events (OR, 0.92; 95% CI, 0.63-1.34), and significantly reduced the risk of intracranial hemorrhage (OR, 0.56; 95% CI, 0.45-0.70). They also significantly reduced the number of all-cause deaths (OR, 0.88; 95% CI, 0.81-0.97). One limitation of this study is the heterogeneity and hence lower quality of evidence. This study shows a small net clinical benefit of using factor Xa inhibitors in AF because of a reduction in strokes and systemic embolic events and also a lower risk of bleeding (including intracranial hemorrhages), compared with using warfarin.

Bottom line: Patients with AF have a lower incidence of strokes and systemic embolic events when treated with factor Xa inhibitors, compared with those treated with warfarin.

Citation: Bruins Slot KM et al. Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation. Cochrane Database Syst Rev. 2018 Mar 6. doi: 10.1002/14651858.CD008980.pub3.

Dr. Veedu is a hospitalist and instructor in the division of hospital medicine at the University of Kentucky, Lexington.

ATLANTA – Everyone has to be on the same page when it comes to anorexia nervosa in a community hospital, according to pediatric hospitalists at Moses H. Cone Memorial Hospital in Greensboro, N.C.

M. Alexander Otto/MDedge News

Anorexia cases used to be rare there. When one came in, “everyone was anxious because we just didn’t know quite what to do,” said Suresh Nagappan, MD, a pediatrician and member of the teaching faculty at the hospital. Parents would hear one thing from one provider, something else from the next, and leave angry and confused. “Basically, it was a mess. We needed to standardize it,” he added.

So Dr. Nagappan and his colleagues created guidelines for treating patients with eating disorders about 3 years ago. “It was meeting after meeting for months, but well worth it,” he said at Pediatric Hospital Medicine.

Word of the hospital’s newfound expertise in anorexia has spread since then, and now it’s not unusual for Moses H. Cone to handle a few cases a week.

The pediatric hospitalist team has come to realize that, first and foremost, patients and families need to know why they are there; it’s about medical stabilization, not treating the eating disorder. That comes after discharge. Families need help sometimes to understand that it’s not a quick fix.

To make things clear, there’s strict criteria now for admission, based on American Academy of Pediatrics guidance. The main trigger is being under 75% of ideal body weight, but patients must also have systolic blood pressure below 90 mm Hg and other worrisome signs. “Sometimes, it feels like we’re splitting hairs” on who gets admitted, “but if we don’t have strict criteria on admission, we don’t have an end goal for discharge,” said pediatrician Maggie S. Hall, MD, also on the Moses H. Cone teaching faculty.

As for treatment, “food is medicine, and it’s not negotiable. We make that clear to everyone on day 1. If patients don’t eat their actual meal, they have 20 minutes to drink a supplement. If they can’t do that, they get a nasogastric tube,” Dr. Nagappan said. The tube is pulled after each meal, so that it remains an incentive to eat.

The team start patients with 1,600 calories a day and increase the intake by 200-250 calories a day. The goal is for a patient to gain 100-200 grams per day. Patients pick out what they want to eat with the help of a dietitian. When meals set off overwhelming anxiety, the Moses H. Cone team has learned that benzodiazepines can help.

Ironically, the initiation of regular meals is the most dangerous time for patients. As anorexic bodies switch from catabolic to anabolic metabolism, electrolytes can drop to dangerously low levels, causing arrhythmias, heart failure, and death. In general, “the reason these kids die is cardiac,” Dr. Nagappan said at the meeting, sponsored by the Society of Hospital Medicine, the AAP, and the Academic Pediatric Association.

Refeeding syndrome, as it’s known, is clinically significant in perhaps 6% of patients. The risk goes up if they are below 70% of their ideal body weight; have a prolonged QTc interval; or begin treatment with low phosphorous, magnesium, or potassium.

M. Alexander Otto/MDedge News

To counter the threat, electrolytes are measured twice a day at Moses H. Cone during the first week of treatment, and ECGs are taken daily for the first few days. “One thing to be really careful about is when you notice their heart rate beginning to creep up during rest. That can be a sign of developing cardiomyopathy; it’s an indication for us to get echocardiograms,” Dr. Hall said.

The Moses H. Cone team like to include families in meal times – it’s been shown to help – but family members need to be coached beforehand. They can’t be punitive. Mealtime talk has to be positive, and can’t focus on eating. Parents often need help handling their own anger and guilt before trying to eat with their child. Progress has to be monitored, but Dr. Nagappan cautioned that “you have to be really careful about how you get weights”; it should always be in the morning after the first void. Urine needs to be checked to make sure patients aren’t water loading.

Staff should be neutral about weight results, and keep them to themselves. Even something as benign as “good job” can be a problem. “You don’t want these patients focused on their weight. You want them focused on getting better and eating and taking it step by step,” he said.

The presenters had no disclosures to report.

[email protected]

ATLANTA – Everyone has to be on the same page when it comes to anorexia nervosa in a community hospital, according to pediatric hospitalists at Moses H. Cone Memorial Hospital in Greensboro, N.C.

M. Alexander Otto/MDedge News

Anorexia cases used to be rare there. When one came in, “everyone was anxious because we just didn’t know quite what to do,” said Suresh Nagappan, MD, a pediatrician and member of the teaching faculty at the hospital. Parents would hear one thing from one provider, something else from the next, and leave angry and confused. “Basically, it was a mess. We needed to standardize it,” he added.

So Dr. Nagappan and his colleagues created guidelines for treating patients with eating disorders about 3 years ago. “It was meeting after meeting for months, but well worth it,” he said at Pediatric Hospital Medicine.

Word of the hospital’s newfound expertise in anorexia has spread since then, and now it’s not unusual for Moses H. Cone to handle a few cases a week.

The pediatric hospitalist team has come to realize that, first and foremost, patients and families need to know why they are there; it’s about medical stabilization, not treating the eating disorder. That comes after discharge. Families need help sometimes to understand that it’s not a quick fix.

To make things clear, there’s strict criteria now for admission, based on American Academy of Pediatrics guidance. The main trigger is being under 75% of ideal body weight, but patients must also have systolic blood pressure below 90 mm Hg and other worrisome signs. “Sometimes, it feels like we’re splitting hairs” on who gets admitted, “but if we don’t have strict criteria on admission, we don’t have an end goal for discharge,” said pediatrician Maggie S. Hall, MD, also on the Moses H. Cone teaching faculty.

As for treatment, “food is medicine, and it’s not negotiable. We make that clear to everyone on day 1. If patients don’t eat their actual meal, they have 20 minutes to drink a supplement. If they can’t do that, they get a nasogastric tube,” Dr. Nagappan said. The tube is pulled after each meal, so that it remains an incentive to eat.

The team start patients with 1,600 calories a day and increase the intake by 200-250 calories a day. The goal is for a patient to gain 100-200 grams per day. Patients pick out what they want to eat with the help of a dietitian. When meals set off overwhelming anxiety, the Moses H. Cone team has learned that benzodiazepines can help.

Ironically, the initiation of regular meals is the most dangerous time for patients. As anorexic bodies switch from catabolic to anabolic metabolism, electrolytes can drop to dangerously low levels, causing arrhythmias, heart failure, and death. In general, “the reason these kids die is cardiac,” Dr. Nagappan said at the meeting, sponsored by the Society of Hospital Medicine, the AAP, and the Academic Pediatric Association.

Refeeding syndrome, as it’s known, is clinically significant in perhaps 6% of patients. The risk goes up if they are below 70% of their ideal body weight; have a prolonged QTc interval; or begin treatment with low phosphorous, magnesium, or potassium.

M. Alexander Otto/MDedge News

To counter the threat, electrolytes are measured twice a day at Moses H. Cone during the first week of treatment, and ECGs are taken daily for the first few days. “One thing to be really careful about is when you notice their heart rate beginning to creep up during rest. That can be a sign of developing cardiomyopathy; it’s an indication for us to get echocardiograms,” Dr. Hall said.

The Moses H. Cone team like to include families in meal times – it’s been shown to help – but family members need to be coached beforehand. They can’t be punitive. Mealtime talk has to be positive, and can’t focus on eating. Parents often need help handling their own anger and guilt before trying to eat with their child. Progress has to be monitored, but Dr. Nagappan cautioned that “you have to be really careful about how you get weights”; it should always be in the morning after the first void. Urine needs to be checked to make sure patients aren’t water loading.

Staff should be neutral about weight results, and keep them to themselves. Even something as benign as “good job” can be a problem. “You don’t want these patients focused on their weight. You want them focused on getting better and eating and taking it step by step,” he said.

The presenters had no disclosures to report.

[email protected]

ATLANTA – Everyone has to be on the same page when it comes to anorexia nervosa in a community hospital, according to pediatric hospitalists at Moses H. Cone Memorial Hospital in Greensboro, N.C.

M. Alexander Otto/MDedge News

Anorexia cases used to be rare there. When one came in, “everyone was anxious because we just didn’t know quite what to do,” said Suresh Nagappan, MD, a pediatrician and member of the teaching faculty at the hospital. Parents would hear one thing from one provider, something else from the next, and leave angry and confused. “Basically, it was a mess. We needed to standardize it,” he added.

So Dr. Nagappan and his colleagues created guidelines for treating patients with eating disorders about 3 years ago. “It was meeting after meeting for months, but well worth it,” he said at Pediatric Hospital Medicine.

Word of the hospital’s newfound expertise in anorexia has spread since then, and now it’s not unusual for Moses H. Cone to handle a few cases a week.

The pediatric hospitalist team has come to realize that, first and foremost, patients and families need to know why they are there; it’s about medical stabilization, not treating the eating disorder. That comes after discharge. Families need help sometimes to understand that it’s not a quick fix.

To make things clear, there’s strict criteria now for admission, based on American Academy of Pediatrics guidance. The main trigger is being under 75% of ideal body weight, but patients must also have systolic blood pressure below 90 mm Hg and other worrisome signs. “Sometimes, it feels like we’re splitting hairs” on who gets admitted, “but if we don’t have strict criteria on admission, we don’t have an end goal for discharge,” said pediatrician Maggie S. Hall, MD, also on the Moses H. Cone teaching faculty.

As for treatment, “food is medicine, and it’s not negotiable. We make that clear to everyone on day 1. If patients don’t eat their actual meal, they have 20 minutes to drink a supplement. If they can’t do that, they get a nasogastric tube,” Dr. Nagappan said. The tube is pulled after each meal, so that it remains an incentive to eat.

The team start patients with 1,600 calories a day and increase the intake by 200-250 calories a day. The goal is for a patient to gain 100-200 grams per day. Patients pick out what they want to eat with the help of a dietitian. When meals set off overwhelming anxiety, the Moses H. Cone team has learned that benzodiazepines can help.

Ironically, the initiation of regular meals is the most dangerous time for patients. As anorexic bodies switch from catabolic to anabolic metabolism, electrolytes can drop to dangerously low levels, causing arrhythmias, heart failure, and death. In general, “the reason these kids die is cardiac,” Dr. Nagappan said at the meeting, sponsored by the Society of Hospital Medicine, the AAP, and the Academic Pediatric Association.

Refeeding syndrome, as it’s known, is clinically significant in perhaps 6% of patients. The risk goes up if they are below 70% of their ideal body weight; have a prolonged QTc interval; or begin treatment with low phosphorous, magnesium, or potassium.

M. Alexander Otto/MDedge News

To counter the threat, electrolytes are measured twice a day at Moses H. Cone during the first week of treatment, and ECGs are taken daily for the first few days. “One thing to be really careful about is when you notice their heart rate beginning to creep up during rest. That can be a sign of developing cardiomyopathy; it’s an indication for us to get echocardiograms,” Dr. Hall said.

The Moses H. Cone team like to include families in meal times – it’s been shown to help – but family members need to be coached beforehand. They can’t be punitive. Mealtime talk has to be positive, and can’t focus on eating. Parents often need help handling their own anger and guilt before trying to eat with their child. Progress has to be monitored, but Dr. Nagappan cautioned that “you have to be really careful about how you get weights”; it should always be in the morning after the first void. Urine needs to be checked to make sure patients aren’t water loading.

Staff should be neutral about weight results, and keep them to themselves. Even something as benign as “good job” can be a problem. “You don’t want these patients focused on their weight. You want them focused on getting better and eating and taking it step by step,” he said.

The presenters had no disclosures to report.

[email protected]

Clinical question: Can aromatherapy with isopropyl alcohol confer an adjunctive and lasting benefit as an antiemetic in ED patients who do not otherwise need IV access?

Background: Prior studies have shown a benefit of aromatherapy with isopropyl alcohol for postoperative nausea and vomiting, and it is both widely available and safe. Only one randomized, controlled study exists documenting use of aromatherapy with isopropyl alcohol in the ED, but this monitored for effects for only 10 minutes and did not compare it with other antiemetic therapies used in the emergency department.

Study design: Randomized, double-blinded, placebo-controlled trial.

Setting: Single urban tertiary care center emergency department.

Synopsis: The study separated 120 patients with nausea who did not otherwise need intravenous access into three treatment groups. They were assessed for improvement in nausea using a visual analog scale 30 minutes after administration of either oral ondansetron 4 mg and inhaled isopropyl alcohol, oral placebo and inhaled isopropyl alcohol, or oral ondansetron and inhaled saline. The mean decrease in nausea visual analog scale score was 30 mm (95% confidence interval, 22-37 mm), 32 mm (95% CI, 25-39 mm), and 9 mm (95% CI, 5-14 mm), respectively. The need for rescue antiemetics was 27.5%, 25%, and 45%, respectively. This study is limited by its small size, its relatively healthy population with a predominant diagnosis of gastroenteritis, and that patients who required IV catheters were excluded; therefore, it may not be generalizable to sicker patients with alternative etiologies for nausea. Furthermore, many patients were able to distinguish isopropyl alcohol from placebo inhalant by smell so the blinding was possibly ineffective. However, since isopropyl alcohol is low risk, inexpensive, and readily available, it may be reasonable to consider this as a therapeutic option for some patients.

Bottom line: In ED patients who did not otherwise need intravenous access, aromatherapy with inhaled isopropyl alcohol alone or with ondansetron was superior for nausea relief when compared with ondansetron alone.

Citation: April MD et al. Aromatherapy versus oral ondansetron for antiemetic therapy among adult emergency department patients: A randomized controlled trial. Ann Emerg Med. 2018 Feb 17. doi: 10.1016/j.annemergmed.2018.01.016.
 

Dr. Sayers is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Clinical question: Can aromatherapy with isopropyl alcohol confer an adjunctive and lasting benefit as an antiemetic in ED patients who do not otherwise need IV access?

Background: Prior studies have shown a benefit of aromatherapy with isopropyl alcohol for postoperative nausea and vomiting, and it is both widely available and safe. Only one randomized, controlled study exists documenting use of aromatherapy with isopropyl alcohol in the ED, but this monitored for effects for only 10 minutes and did not compare it with other antiemetic therapies used in the emergency department.

Study design: Randomized, double-blinded, placebo-controlled trial.

Setting: Single urban tertiary care center emergency department.

Synopsis: The study separated 120 patients with nausea who did not otherwise need intravenous access into three treatment groups. They were assessed for improvement in nausea using a visual analog scale 30 minutes after administration of either oral ondansetron 4 mg and inhaled isopropyl alcohol, oral placebo and inhaled isopropyl alcohol, or oral ondansetron and inhaled saline. The mean decrease in nausea visual analog scale score was 30 mm (95% confidence interval, 22-37 mm), 32 mm (95% CI, 25-39 mm), and 9 mm (95% CI, 5-14 mm), respectively. The need for rescue antiemetics was 27.5%, 25%, and 45%, respectively. This study is limited by its small size, its relatively healthy population with a predominant diagnosis of gastroenteritis, and that patients who required IV catheters were excluded; therefore, it may not be generalizable to sicker patients with alternative etiologies for nausea. Furthermore, many patients were able to distinguish isopropyl alcohol from placebo inhalant by smell so the blinding was possibly ineffective. However, since isopropyl alcohol is low risk, inexpensive, and readily available, it may be reasonable to consider this as a therapeutic option for some patients.

Bottom line: In ED patients who did not otherwise need intravenous access, aromatherapy with inhaled isopropyl alcohol alone or with ondansetron was superior for nausea relief when compared with ondansetron alone.

Citation: April MD et al. Aromatherapy versus oral ondansetron for antiemetic therapy among adult emergency department patients: A randomized controlled trial. Ann Emerg Med. 2018 Feb 17. doi: 10.1016/j.annemergmed.2018.01.016.
 

Dr. Sayers is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Clinical question: Can aromatherapy with isopropyl alcohol confer an adjunctive and lasting benefit as an antiemetic in ED patients who do not otherwise need IV access?

Background: Prior studies have shown a benefit of aromatherapy with isopropyl alcohol for postoperative nausea and vomiting, and it is both widely available and safe. Only one randomized, controlled study exists documenting use of aromatherapy with isopropyl alcohol in the ED, but this monitored for effects for only 10 minutes and did not compare it with other antiemetic therapies used in the emergency department.

Study design: Randomized, double-blinded, placebo-controlled trial.

Setting: Single urban tertiary care center emergency department.

Synopsis: The study separated 120 patients with nausea who did not otherwise need intravenous access into three treatment groups. They were assessed for improvement in nausea using a visual analog scale 30 minutes after administration of either oral ondansetron 4 mg and inhaled isopropyl alcohol, oral placebo and inhaled isopropyl alcohol, or oral ondansetron and inhaled saline. The mean decrease in nausea visual analog scale score was 30 mm (95% confidence interval, 22-37 mm), 32 mm (95% CI, 25-39 mm), and 9 mm (95% CI, 5-14 mm), respectively. The need for rescue antiemetics was 27.5%, 25%, and 45%, respectively. This study is limited by its small size, its relatively healthy population with a predominant diagnosis of gastroenteritis, and that patients who required IV catheters were excluded; therefore, it may not be generalizable to sicker patients with alternative etiologies for nausea. Furthermore, many patients were able to distinguish isopropyl alcohol from placebo inhalant by smell so the blinding was possibly ineffective. However, since isopropyl alcohol is low risk, inexpensive, and readily available, it may be reasonable to consider this as a therapeutic option for some patients.

Bottom line: In ED patients who did not otherwise need intravenous access, aromatherapy with inhaled isopropyl alcohol alone or with ondansetron was superior for nausea relief when compared with ondansetron alone.

Citation: April MD et al. Aromatherapy versus oral ondansetron for antiemetic therapy among adult emergency department patients: A randomized controlled trial. Ann Emerg Med. 2018 Feb 17. doi: 10.1016/j.annemergmed.2018.01.016.
 

Dr. Sayers is an assistant professor in the division of hospital medicine at the University of Kentucky, Lexington.

Compared with younger patients, elderly patients admitted for acute biliary pancreatitis have increased rates of severe acute pancreatitis and mortality, according to an analysis of a nationally representative database.

Mortality was almost three times as high in elderly patients after stringent matching for confounding variables, wrote researcher Kishan Patel, MD, of the Ohio State University, Columbus, and coauthors.

These findings represent a “current health care concern,” since the elderly population in the United States is expected to double within the next several decades and the prevalence of acute pancreatitis is on the rise, Dr. Patel and colleagues wrote in a report on the analysis in the Journal of Clinical Gastroenterology.

The analysis is the first, to the investigators’ knowledge, that addresses national-level outcomes associated with acute biliary pancreatitis in elderly patients.

To evaluate clinical outcomes of elderly patients with acute biliary pancreatitis, Dr. Patel and colleagues queried the Nationwide Readmissions Database, which is the largest inpatient readmission database in the United States.

The investigators looked at outcomes associated with index hospitalizations, defined as a patient’s first hospitalization in a calendar year, and found 184,763 adult patients who received a diagnosis of acute biliary pancreatitis between 2011 and 2014. Of those, 41% were elderly.

The mortality rate associated with the index admission was 1.96% (n = 356) for the elderly patients, compared with just 0.32% (n = 1,473) for nonelderly patients (P less than .001), according to the report.

Mortality was increased in the elderly versus nonelderly patients, with an odds ratio of 2.8 (95% CI, 2.2-3.5), according to results of a propensity score matched analysis. Likewise, severe acute pancreatitis was increased in the elderly, with an OR of 1.2 (95% CI: 1.1-1.3) in that analysis.

By contrast, patient age did not impact 30-day readmission rates, according to results of a multivariate analysis that adjusted for confounding factors.

Mortality and severe acute pancreatitis both increased with age within the elderly cohort, further multivariate analysis showed. For example, the ORs for mortality were 1.39 for patients aged 75-84 years and 2.21 for patients aged 85 years and older, the results show.

The elderly population in the United States is expected to almost double by 2050, rising from 48 to 88 million, Dr. Patel and colleagues said. The number of those aged 85 years or older is expected to increase from 5.9 to 18 million by 2050, at which time they will make up nearly 5% of the total U.S. population.

“This specific demographic is more susceptible to common medical ailments, more troubling is acute pancreatitis is one of the most frequent causes of hospitalization in gastroenterology,” Dr. Patel and colleagues wrote.

Dr. Patel and coauthors reported no conflicts of interest related to the analysis.

SOURCE: Patel K et al. J Clin Gastroenterol. 2018 Aug 28. doi: 10.1097/MCG.0000000000001108.

Compared with younger patients, elderly patients admitted for acute biliary pancreatitis have increased rates of severe acute pancreatitis and mortality, according to an analysis of a nationally representative database.

Mortality was almost three times as high in elderly patients after stringent matching for confounding variables, wrote researcher Kishan Patel, MD, of the Ohio State University, Columbus, and coauthors.

These findings represent a “current health care concern,” since the elderly population in the United States is expected to double within the next several decades and the prevalence of acute pancreatitis is on the rise, Dr. Patel and colleagues wrote in a report on the analysis in the Journal of Clinical Gastroenterology.

The analysis is the first, to the investigators’ knowledge, that addresses national-level outcomes associated with acute biliary pancreatitis in elderly patients.

To evaluate clinical outcomes of elderly patients with acute biliary pancreatitis, Dr. Patel and colleagues queried the Nationwide Readmissions Database, which is the largest inpatient readmission database in the United States.

The investigators looked at outcomes associated with index hospitalizations, defined as a patient’s first hospitalization in a calendar year, and found 184,763 adult patients who received a diagnosis of acute biliary pancreatitis between 2011 and 2014. Of those, 41% were elderly.

The mortality rate associated with the index admission was 1.96% (n = 356) for the elderly patients, compared with just 0.32% (n = 1,473) for nonelderly patients (P less than .001), according to the report.

Mortality was increased in the elderly versus nonelderly patients, with an odds ratio of 2.8 (95% CI, 2.2-3.5), according to results of a propensity score matched analysis. Likewise, severe acute pancreatitis was increased in the elderly, with an OR of 1.2 (95% CI: 1.1-1.3) in that analysis.

By contrast, patient age did not impact 30-day readmission rates, according to results of a multivariate analysis that adjusted for confounding factors.

Mortality and severe acute pancreatitis both increased with age within the elderly cohort, further multivariate analysis showed. For example, the ORs for mortality were 1.39 for patients aged 75-84 years and 2.21 for patients aged 85 years and older, the results show.

The elderly population in the United States is expected to almost double by 2050, rising from 48 to 88 million, Dr. Patel and colleagues said. The number of those aged 85 years or older is expected to increase from 5.9 to 18 million by 2050, at which time they will make up nearly 5% of the total U.S. population.

“This specific demographic is more susceptible to common medical ailments, more troubling is acute pancreatitis is one of the most frequent causes of hospitalization in gastroenterology,” Dr. Patel and colleagues wrote.

Dr. Patel and coauthors reported no conflicts of interest related to the analysis.

SOURCE: Patel K et al. J Clin Gastroenterol. 2018 Aug 28. doi: 10.1097/MCG.0000000000001108.

Compared with younger patients, elderly patients admitted for acute biliary pancreatitis have increased rates of severe acute pancreatitis and mortality, according to an analysis of a nationally representative database.

Mortality was almost three times as high in elderly patients after stringent matching for confounding variables, wrote researcher Kishan Patel, MD, of the Ohio State University, Columbus, and coauthors.

These findings represent a “current health care concern,” since the elderly population in the United States is expected to double within the next several decades and the prevalence of acute pancreatitis is on the rise, Dr. Patel and colleagues wrote in a report on the analysis in the Journal of Clinical Gastroenterology.

The analysis is the first, to the investigators’ knowledge, that addresses national-level outcomes associated with acute biliary pancreatitis in elderly patients.

To evaluate clinical outcomes of elderly patients with acute biliary pancreatitis, Dr. Patel and colleagues queried the Nationwide Readmissions Database, which is the largest inpatient readmission database in the United States.

The investigators looked at outcomes associated with index hospitalizations, defined as a patient’s first hospitalization in a calendar year, and found 184,763 adult patients who received a diagnosis of acute biliary pancreatitis between 2011 and 2014. Of those, 41% were elderly.

The mortality rate associated with the index admission was 1.96% (n = 356) for the elderly patients, compared with just 0.32% (n = 1,473) for nonelderly patients (P less than .001), according to the report.

Mortality was increased in the elderly versus nonelderly patients, with an odds ratio of 2.8 (95% CI, 2.2-3.5), according to results of a propensity score matched analysis. Likewise, severe acute pancreatitis was increased in the elderly, with an OR of 1.2 (95% CI: 1.1-1.3) in that analysis.

By contrast, patient age did not impact 30-day readmission rates, according to results of a multivariate analysis that adjusted for confounding factors.

Mortality and severe acute pancreatitis both increased with age within the elderly cohort, further multivariate analysis showed. For example, the ORs for mortality were 1.39 for patients aged 75-84 years and 2.21 for patients aged 85 years and older, the results show.

The elderly population in the United States is expected to almost double by 2050, rising from 48 to 88 million, Dr. Patel and colleagues said. The number of those aged 85 years or older is expected to increase from 5.9 to 18 million by 2050, at which time they will make up nearly 5% of the total U.S. population.

“This specific demographic is more susceptible to common medical ailments, more troubling is acute pancreatitis is one of the most frequent causes of hospitalization in gastroenterology,” Dr. Patel and colleagues wrote.

Dr. Patel and coauthors reported no conflicts of interest related to the analysis.

SOURCE: Patel K et al. J Clin Gastroenterol. 2018 Aug 28. doi: 10.1097/MCG.0000000000001108.