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Application of the MASCC and CISNE risk-stratification scores to identify low-risk febrile neutropenic patients in the emergency department
Clinical Question: Does the Multinational Association for Supportive Care in Cancer (MASCC) or Clinical Index of Stable Febrile Neutropenia (CISNE) risk-stratification score better predict patient outcomes in patients presenting to emergency departments with febrile neutropenia?
Background: Risk-stratification metrics like the MASCC and CISNE identify subsets of relatively low-risk patients with febrile neutropenia after chemotherapy for treatment at home with empiric oral antibiotic therapy and close follow-up while awaiting results of infectious work-up. Prior studies have validated these tools for admitted, but not for ED, patients.
Setting: Two academic ED at National Institutes of Health–designated cancer centers.
Synopsis: Included patients (n = 230) were at least 16 years old with a documented fever of 38° C or greater related to chemotherapy and an absolute neutrophil count less than 1,000 cells/μL. MASCC and CISNE risk stratification scores were calculated based on the documentation from the ED and recent oncology clinic visits. Outcome measures included length of stay, upgrade in level of care, positive blood cultures, clinical deterioration, and death and were assessed for up to 30 days following discharge. Low-risk patients were defined as those who experienced no negative endpoints. The CISNE score was more specific than the MASCC in identifying low-risk patients (98.1% vs. 54.2%), suggesting that the CISNE may be useful for hospitalists in identifying patients who may be safely discharged with oral antibiotics and close follow-up.
Limitations include possible misclassification bias from indirect assessment of symptom severity, lack of recent ECOG scores for six patients in the CISNE arm, and possible undocumented symptoms during ED evaluation required for subsequent score calculation. Additionally, most patients in this study reported mild symptoms which weighted their MASCC classification toward low-risk.
Bottom Line: The CISNE score may aid in risk-stratification of patients with chemotherapy-related febrile neutropenia presenting to the ED.
Reference: Coyne CJ, Le V, Brennan JJ, et al. Application of the MASCC and CISNE risk-stratification scores to identify low-risk febrile neutropenic patients in the emergency department. Ann Emerg Med. Published online 29 Dec 2016. doi: 10.1016/j.annemergmed.2016.11.007.
Dr. Frederick is assistant clinical professor in the division of hospital Medicine, department of medicine, University of California, San Diego.
Clinical Question: Does the Multinational Association for Supportive Care in Cancer (MASCC) or Clinical Index of Stable Febrile Neutropenia (CISNE) risk-stratification score better predict patient outcomes in patients presenting to emergency departments with febrile neutropenia?
Background: Risk-stratification metrics like the MASCC and CISNE identify subsets of relatively low-risk patients with febrile neutropenia after chemotherapy for treatment at home with empiric oral antibiotic therapy and close follow-up while awaiting results of infectious work-up. Prior studies have validated these tools for admitted, but not for ED, patients.
Setting: Two academic ED at National Institutes of Health–designated cancer centers.
Synopsis: Included patients (n = 230) were at least 16 years old with a documented fever of 38° C or greater related to chemotherapy and an absolute neutrophil count less than 1,000 cells/μL. MASCC and CISNE risk stratification scores were calculated based on the documentation from the ED and recent oncology clinic visits. Outcome measures included length of stay, upgrade in level of care, positive blood cultures, clinical deterioration, and death and were assessed for up to 30 days following discharge. Low-risk patients were defined as those who experienced no negative endpoints. The CISNE score was more specific than the MASCC in identifying low-risk patients (98.1% vs. 54.2%), suggesting that the CISNE may be useful for hospitalists in identifying patients who may be safely discharged with oral antibiotics and close follow-up.
Limitations include possible misclassification bias from indirect assessment of symptom severity, lack of recent ECOG scores for six patients in the CISNE arm, and possible undocumented symptoms during ED evaluation required for subsequent score calculation. Additionally, most patients in this study reported mild symptoms which weighted their MASCC classification toward low-risk.
Bottom Line: The CISNE score may aid in risk-stratification of patients with chemotherapy-related febrile neutropenia presenting to the ED.
Reference: Coyne CJ, Le V, Brennan JJ, et al. Application of the MASCC and CISNE risk-stratification scores to identify low-risk febrile neutropenic patients in the emergency department. Ann Emerg Med. Published online 29 Dec 2016. doi: 10.1016/j.annemergmed.2016.11.007.
Dr. Frederick is assistant clinical professor in the division of hospital Medicine, department of medicine, University of California, San Diego.
Clinical Question: Does the Multinational Association for Supportive Care in Cancer (MASCC) or Clinical Index of Stable Febrile Neutropenia (CISNE) risk-stratification score better predict patient outcomes in patients presenting to emergency departments with febrile neutropenia?
Background: Risk-stratification metrics like the MASCC and CISNE identify subsets of relatively low-risk patients with febrile neutropenia after chemotherapy for treatment at home with empiric oral antibiotic therapy and close follow-up while awaiting results of infectious work-up. Prior studies have validated these tools for admitted, but not for ED, patients.
Setting: Two academic ED at National Institutes of Health–designated cancer centers.
Synopsis: Included patients (n = 230) were at least 16 years old with a documented fever of 38° C or greater related to chemotherapy and an absolute neutrophil count less than 1,000 cells/μL. MASCC and CISNE risk stratification scores were calculated based on the documentation from the ED and recent oncology clinic visits. Outcome measures included length of stay, upgrade in level of care, positive blood cultures, clinical deterioration, and death and were assessed for up to 30 days following discharge. Low-risk patients were defined as those who experienced no negative endpoints. The CISNE score was more specific than the MASCC in identifying low-risk patients (98.1% vs. 54.2%), suggesting that the CISNE may be useful for hospitalists in identifying patients who may be safely discharged with oral antibiotics and close follow-up.
Limitations include possible misclassification bias from indirect assessment of symptom severity, lack of recent ECOG scores for six patients in the CISNE arm, and possible undocumented symptoms during ED evaluation required for subsequent score calculation. Additionally, most patients in this study reported mild symptoms which weighted their MASCC classification toward low-risk.
Bottom Line: The CISNE score may aid in risk-stratification of patients with chemotherapy-related febrile neutropenia presenting to the ED.
Reference: Coyne CJ, Le V, Brennan JJ, et al. Application of the MASCC and CISNE risk-stratification scores to identify low-risk febrile neutropenic patients in the emergency department. Ann Emerg Med. Published online 29 Dec 2016. doi: 10.1016/j.annemergmed.2016.11.007.
Dr. Frederick is assistant clinical professor in the division of hospital Medicine, department of medicine, University of California, San Diego.
Atrial fibrillation blunts beta-blockers for HFrEF
PARIS – Maximal beta-blocker treatment and lower heart rates are effective at cutting all-cause mortality in patients with heart failure with reduced ejection fraction (HFrEF) who are also in sinus rhythm, but it’s a totally different story for patients with similar heart failure plus atrial fibrillation. In the atrial fibrillation subgroup, treatment with a beta-blocker linked with no mortality benefit, and lower heart rates – below 70 beats per minute – appeared to actually link with worse patient survival, based on a meta-analysis of data from 11 beta-blocker trials with a total of more than 17,000 patients.
“Beta blockers may be doing good in heart failure patients with atrial fibrillation, but they also are doing harm that neutralizes any good they do.” In patients with HFrEF and atrial fibrillation, “I don’t like to see the heart rate below 80 beats per minute,” John G.F. Cleland, MD, said at a meeting held by the Heart Failure Association of the ESC.
“We’ve perhaps been too aggressive with heart-rate control in HFrEF patients with atrial fibrillation,” he added in an interview. In these patients “in the range of 60-100 bpm it doesn’t seem to make a lot of difference what the heart rate is, and, if it is less than 70 bpm, patients seem to do a little worse. When we treat these patients with a beta-blocker we don’t see benefit in any way that we’ve looked at the data.”
In contrast, among HFrEF patients in sinus rhythm “beta-blocker treatment is similarly effective regardless of what the baseline heart rate was. The benefit was as great when the baseline rate was 70 bpm or 90 bpm, so heart rate is not a great predictor of beta-blocker benefit in these patients. Patients who tolerated the full beta-blocker dosage had the greatest benefit, and patients who achieved the slowest heart rates also had the greatest benefit.”
In the multivariate models that Dr. Cleland and his associates tested in their meta-analysis, in HFrEF patients in sinus rhythm, the relationship between reduced heart rate and mortality benefit was stronger statistically than between beta-blocker dosage and reduced mortality, he said. “This suggests to me that, while we should use the targeted beta-blocker dosages when we can, it’s more important to achieve a target heart rate in these patients of 55-65 bpm.”
Dr. Cleland hypothesized, based on a report presented at the same meeting by a different research group, that reduced heart rate is not beneficial in HFrEF patients with atrial fibrillation because in this subgroup slower heart rates linked with an increased number of brief pauses in left ventricular pumping. These pauses may result in ventricular arrhythmias, he speculated. “It may be that beta-blockers are equally effective at slowing heart rate in patients with or without atrial fibrillation, but there is also harm from beta-blockers because they’re causing pauses in patients with atrial fibrillation,” he said.
These days, if he has a HFrEF patient with atrial fibrillation whose heart rate slows to 60 bpm, he will stop digoxin treatment if the patient is on that drug, and he will also reduce the beta-blocker dosage but not discontinue it.
The findings came from the Collaborative Systematic Overview of Randomized Controlled Trials of Beta-Blockers in the Treatment of Heart Failure (BB-META-HF), which included data from 11 large beta-blocker randomized trials in heart failure that had been published during 1993-2005. The analysis included data from 17,378 HFrEF patients, with 14,313 (82%) in sinus rhythm and 3,065 (18%) with atrial fibrillation. Follow-up data of patients on treatment was available for 15,007 of these patients.
Dr. Cleland and his associates showed in multivariate analyses that, when they controlled for several baseline demographic and clinical variables among patients in sinus rhythm who received a beta-blocker, the follow-up all-cause mortality fell by 36%, compared with placebo, in patients with a resting baseline heart rate of less than 70 bpm; by 21%, compared with placebo, in patients with a baseline heart rate of 70-90 bpm; and by 38%, compared with placebo, in patients with a baseline heart rate of more than 90 bpm. All three reductions were statistically significant. In contrast, among patients who also had atrial fibrillation beta-blocker treatment linked with no significant mortality reduction, compared with placebo, for patients with any baseline heart rate.
Concurrently with Dr. Cleland’s report at the meeting the results appeared online (J Amer Coll Cardiol. 2017 Apr 30. doi: 10.1016/j.jacc.2017.04.001).
[email protected]
On Twitter @mitchelzoler
The findings from this analysis have several implications. First, the association of reduced mortality with reduced heart rate occurred only in patients in sinus rhythm. The irregular heart rhythms in patients with atrial fibrillation may counterbalance any reverse remodeling effects that come from reducing heart rate.
Also, the beneficial effect of beta-blocker treatment was roughly similar regardless of whether baseline heart rate was high or low. This distinguishes beta-blockers from ivabradine, a drug that only reduces heart rate. The magnitude of benefit from ivabradine treatment depends on a patient’s baseline heart rate. The observation that beta-blockers do not have the same limitation suggests that the mechanism of action of beta-blockers may go beyond their heart rate effect. It may also result from the effect of beta-blockers on antagonizing toxic effects from beta-adrenergic stimulation.
The pooled analysis also showed that many patients with HFrEF in sinus rhythm continued to have a high heart rate despite beta-blocker treatment. These patients may get additional benefit from further treatment to reduce their heart rate, with an agent like ivabradine.
But we must be cautious in interpreting the findings because they represent a secondary analysis, and the endpoint studied does not take into account quality of life, exercise tolerance, heart rate control, and tachyarrhythmias. We need prospective, randomized trials of HFrEF patients in sinus rhythm and with atrial fibrillation to better understand how to optimally treat these different types of patients.
The findings highlight that beta-blockers remain a mainstay of treatment for patients with HFrEF in sinus rhythm, and that we have more limited treatment options for HFrEF patients with atrial fibrillation.
Michael Böhm, MD, is professor and director of the cardiology clinic at Saarland University Hospital in Homburg, Germany. He has received honoraria from Bayer, Medtronic, Servier, and Pfizer, and he was a coauthor on the report presented by Dr. Cleland. He made these comments as designated discussant for the study.
The findings from this analysis have several implications. First, the association of reduced mortality with reduced heart rate occurred only in patients in sinus rhythm. The irregular heart rhythms in patients with atrial fibrillation may counterbalance any reverse remodeling effects that come from reducing heart rate.
Also, the beneficial effect of beta-blocker treatment was roughly similar regardless of whether baseline heart rate was high or low. This distinguishes beta-blockers from ivabradine, a drug that only reduces heart rate. The magnitude of benefit from ivabradine treatment depends on a patient’s baseline heart rate. The observation that beta-blockers do not have the same limitation suggests that the mechanism of action of beta-blockers may go beyond their heart rate effect. It may also result from the effect of beta-blockers on antagonizing toxic effects from beta-adrenergic stimulation.
The pooled analysis also showed that many patients with HFrEF in sinus rhythm continued to have a high heart rate despite beta-blocker treatment. These patients may get additional benefit from further treatment to reduce their heart rate, with an agent like ivabradine.
But we must be cautious in interpreting the findings because they represent a secondary analysis, and the endpoint studied does not take into account quality of life, exercise tolerance, heart rate control, and tachyarrhythmias. We need prospective, randomized trials of HFrEF patients in sinus rhythm and with atrial fibrillation to better understand how to optimally treat these different types of patients.
The findings highlight that beta-blockers remain a mainstay of treatment for patients with HFrEF in sinus rhythm, and that we have more limited treatment options for HFrEF patients with atrial fibrillation.
Michael Böhm, MD, is professor and director of the cardiology clinic at Saarland University Hospital in Homburg, Germany. He has received honoraria from Bayer, Medtronic, Servier, and Pfizer, and he was a coauthor on the report presented by Dr. Cleland. He made these comments as designated discussant for the study.
The findings from this analysis have several implications. First, the association of reduced mortality with reduced heart rate occurred only in patients in sinus rhythm. The irregular heart rhythms in patients with atrial fibrillation may counterbalance any reverse remodeling effects that come from reducing heart rate.
Also, the beneficial effect of beta-blocker treatment was roughly similar regardless of whether baseline heart rate was high or low. This distinguishes beta-blockers from ivabradine, a drug that only reduces heart rate. The magnitude of benefit from ivabradine treatment depends on a patient’s baseline heart rate. The observation that beta-blockers do not have the same limitation suggests that the mechanism of action of beta-blockers may go beyond their heart rate effect. It may also result from the effect of beta-blockers on antagonizing toxic effects from beta-adrenergic stimulation.
The pooled analysis also showed that many patients with HFrEF in sinus rhythm continued to have a high heart rate despite beta-blocker treatment. These patients may get additional benefit from further treatment to reduce their heart rate, with an agent like ivabradine.
But we must be cautious in interpreting the findings because they represent a secondary analysis, and the endpoint studied does not take into account quality of life, exercise tolerance, heart rate control, and tachyarrhythmias. We need prospective, randomized trials of HFrEF patients in sinus rhythm and with atrial fibrillation to better understand how to optimally treat these different types of patients.
The findings highlight that beta-blockers remain a mainstay of treatment for patients with HFrEF in sinus rhythm, and that we have more limited treatment options for HFrEF patients with atrial fibrillation.
Michael Böhm, MD, is professor and director of the cardiology clinic at Saarland University Hospital in Homburg, Germany. He has received honoraria from Bayer, Medtronic, Servier, and Pfizer, and he was a coauthor on the report presented by Dr. Cleland. He made these comments as designated discussant for the study.
PARIS – Maximal beta-blocker treatment and lower heart rates are effective at cutting all-cause mortality in patients with heart failure with reduced ejection fraction (HFrEF) who are also in sinus rhythm, but it’s a totally different story for patients with similar heart failure plus atrial fibrillation. In the atrial fibrillation subgroup, treatment with a beta-blocker linked with no mortality benefit, and lower heart rates – below 70 beats per minute – appeared to actually link with worse patient survival, based on a meta-analysis of data from 11 beta-blocker trials with a total of more than 17,000 patients.
“Beta blockers may be doing good in heart failure patients with atrial fibrillation, but they also are doing harm that neutralizes any good they do.” In patients with HFrEF and atrial fibrillation, “I don’t like to see the heart rate below 80 beats per minute,” John G.F. Cleland, MD, said at a meeting held by the Heart Failure Association of the ESC.
“We’ve perhaps been too aggressive with heart-rate control in HFrEF patients with atrial fibrillation,” he added in an interview. In these patients “in the range of 60-100 bpm it doesn’t seem to make a lot of difference what the heart rate is, and, if it is less than 70 bpm, patients seem to do a little worse. When we treat these patients with a beta-blocker we don’t see benefit in any way that we’ve looked at the data.”
In contrast, among HFrEF patients in sinus rhythm “beta-blocker treatment is similarly effective regardless of what the baseline heart rate was. The benefit was as great when the baseline rate was 70 bpm or 90 bpm, so heart rate is not a great predictor of beta-blocker benefit in these patients. Patients who tolerated the full beta-blocker dosage had the greatest benefit, and patients who achieved the slowest heart rates also had the greatest benefit.”
In the multivariate models that Dr. Cleland and his associates tested in their meta-analysis, in HFrEF patients in sinus rhythm, the relationship between reduced heart rate and mortality benefit was stronger statistically than between beta-blocker dosage and reduced mortality, he said. “This suggests to me that, while we should use the targeted beta-blocker dosages when we can, it’s more important to achieve a target heart rate in these patients of 55-65 bpm.”
Dr. Cleland hypothesized, based on a report presented at the same meeting by a different research group, that reduced heart rate is not beneficial in HFrEF patients with atrial fibrillation because in this subgroup slower heart rates linked with an increased number of brief pauses in left ventricular pumping. These pauses may result in ventricular arrhythmias, he speculated. “It may be that beta-blockers are equally effective at slowing heart rate in patients with or without atrial fibrillation, but there is also harm from beta-blockers because they’re causing pauses in patients with atrial fibrillation,” he said.
These days, if he has a HFrEF patient with atrial fibrillation whose heart rate slows to 60 bpm, he will stop digoxin treatment if the patient is on that drug, and he will also reduce the beta-blocker dosage but not discontinue it.
The findings came from the Collaborative Systematic Overview of Randomized Controlled Trials of Beta-Blockers in the Treatment of Heart Failure (BB-META-HF), which included data from 11 large beta-blocker randomized trials in heart failure that had been published during 1993-2005. The analysis included data from 17,378 HFrEF patients, with 14,313 (82%) in sinus rhythm and 3,065 (18%) with atrial fibrillation. Follow-up data of patients on treatment was available for 15,007 of these patients.
Dr. Cleland and his associates showed in multivariate analyses that, when they controlled for several baseline demographic and clinical variables among patients in sinus rhythm who received a beta-blocker, the follow-up all-cause mortality fell by 36%, compared with placebo, in patients with a resting baseline heart rate of less than 70 bpm; by 21%, compared with placebo, in patients with a baseline heart rate of 70-90 bpm; and by 38%, compared with placebo, in patients with a baseline heart rate of more than 90 bpm. All three reductions were statistically significant. In contrast, among patients who also had atrial fibrillation beta-blocker treatment linked with no significant mortality reduction, compared with placebo, for patients with any baseline heart rate.
Concurrently with Dr. Cleland’s report at the meeting the results appeared online (J Amer Coll Cardiol. 2017 Apr 30. doi: 10.1016/j.jacc.2017.04.001).
[email protected]
On Twitter @mitchelzoler
PARIS – Maximal beta-blocker treatment and lower heart rates are effective at cutting all-cause mortality in patients with heart failure with reduced ejection fraction (HFrEF) who are also in sinus rhythm, but it’s a totally different story for patients with similar heart failure plus atrial fibrillation. In the atrial fibrillation subgroup, treatment with a beta-blocker linked with no mortality benefit, and lower heart rates – below 70 beats per minute – appeared to actually link with worse patient survival, based on a meta-analysis of data from 11 beta-blocker trials with a total of more than 17,000 patients.
“Beta blockers may be doing good in heart failure patients with atrial fibrillation, but they also are doing harm that neutralizes any good they do.” In patients with HFrEF and atrial fibrillation, “I don’t like to see the heart rate below 80 beats per minute,” John G.F. Cleland, MD, said at a meeting held by the Heart Failure Association of the ESC.
“We’ve perhaps been too aggressive with heart-rate control in HFrEF patients with atrial fibrillation,” he added in an interview. In these patients “in the range of 60-100 bpm it doesn’t seem to make a lot of difference what the heart rate is, and, if it is less than 70 bpm, patients seem to do a little worse. When we treat these patients with a beta-blocker we don’t see benefit in any way that we’ve looked at the data.”
In contrast, among HFrEF patients in sinus rhythm “beta-blocker treatment is similarly effective regardless of what the baseline heart rate was. The benefit was as great when the baseline rate was 70 bpm or 90 bpm, so heart rate is not a great predictor of beta-blocker benefit in these patients. Patients who tolerated the full beta-blocker dosage had the greatest benefit, and patients who achieved the slowest heart rates also had the greatest benefit.”
In the multivariate models that Dr. Cleland and his associates tested in their meta-analysis, in HFrEF patients in sinus rhythm, the relationship between reduced heart rate and mortality benefit was stronger statistically than between beta-blocker dosage and reduced mortality, he said. “This suggests to me that, while we should use the targeted beta-blocker dosages when we can, it’s more important to achieve a target heart rate in these patients of 55-65 bpm.”
Dr. Cleland hypothesized, based on a report presented at the same meeting by a different research group, that reduced heart rate is not beneficial in HFrEF patients with atrial fibrillation because in this subgroup slower heart rates linked with an increased number of brief pauses in left ventricular pumping. These pauses may result in ventricular arrhythmias, he speculated. “It may be that beta-blockers are equally effective at slowing heart rate in patients with or without atrial fibrillation, but there is also harm from beta-blockers because they’re causing pauses in patients with atrial fibrillation,” he said.
These days, if he has a HFrEF patient with atrial fibrillation whose heart rate slows to 60 bpm, he will stop digoxin treatment if the patient is on that drug, and he will also reduce the beta-blocker dosage but not discontinue it.
The findings came from the Collaborative Systematic Overview of Randomized Controlled Trials of Beta-Blockers in the Treatment of Heart Failure (BB-META-HF), which included data from 11 large beta-blocker randomized trials in heart failure that had been published during 1993-2005. The analysis included data from 17,378 HFrEF patients, with 14,313 (82%) in sinus rhythm and 3,065 (18%) with atrial fibrillation. Follow-up data of patients on treatment was available for 15,007 of these patients.
Dr. Cleland and his associates showed in multivariate analyses that, when they controlled for several baseline demographic and clinical variables among patients in sinus rhythm who received a beta-blocker, the follow-up all-cause mortality fell by 36%, compared with placebo, in patients with a resting baseline heart rate of less than 70 bpm; by 21%, compared with placebo, in patients with a baseline heart rate of 70-90 bpm; and by 38%, compared with placebo, in patients with a baseline heart rate of more than 90 bpm. All three reductions were statistically significant. In contrast, among patients who also had atrial fibrillation beta-blocker treatment linked with no significant mortality reduction, compared with placebo, for patients with any baseline heart rate.
Concurrently with Dr. Cleland’s report at the meeting the results appeared online (J Amer Coll Cardiol. 2017 Apr 30. doi: 10.1016/j.jacc.2017.04.001).
[email protected]
On Twitter @mitchelzoler
AT HEART FAILURE 2017
Key clinical point:
Major finding: All-cause mortality was similar in patients with HFrEF and atrial fibrillation regardless of whether they received a beta-blocker or placebo.
Data source: BB-META-HF, a meta-analysis of 11 beta-blocker treatment trials with 17,378 HFrEF patients.
Disclosures: BB-META-HF received funding from Menarini and GlaxoSmithKline. Dr. Cleland has received research funding and honoraria from GlaxoSmithKline.
Bedside CGM boosts glucose control in hospital
BY RANDY DOTINGA
SAN DIEGO – Bedside continuous glucose monitoring (CGM) with a wireless hookup to a response team allowed doctors and nurses to gain better blood sugar control in hospitalized high-risk patients with diabetes, according to research reported at the annual scientific sessions of the American Diabetes Association.
“Continuous glucose monitoring and wireless connections can be useful in the hospital setting, not just in the outpatient setting,” said Maria Isabel Garcia, RN, of Scripps Whittier Diabetes Institute. “They help us to prevent problems rather than fixing them after they happen.”
Research suggests that complications due to dangerous blood sugar levels can lead to longer hospital stays, she noted.
For the study, researchers assigned 45 high-risk hospitalized patients with type 2 diabetes to be monitored by DexCom G4 CGM devices. The patients were being treated for a variety of conditions, and all were expected to be hospitalized for more than 2 days.
Researchers housed the normal-sized CGM devices in toolbox-sized containers at bedside. “We don’t want the equipment to get misplaced if the patient has to go from room to room or if the patient is discharged and takes the equipment by mistake,” Ms. Garcia said.
The patients were 43-82 years old (median, 61.4 years; standard deviation, 9.8), 56% male, 73% Hispanic (with 60% preferring to speak Spanish). The mean hemoglobin A1c was 10.2% (SD, 2.3), and the mean body mass index was 32.9 (SD, 8).
The patients were randomized to two groups. In both, the CGM devices were operative and tracked blood sugar levels. In one group, the information was transmitted via wireless hookup to a team of researchers (during the day) or a telemetry team (at night), who were alerted via alarms if blood sugar levels seemed too high or low. The teams would then alert nurses who’d confirm the levels via bedside testing and take appropriate action.
CGM data were gathered from the patients for an average of 4.2 days each (SD, 2.49; range 2-10), and the number of readings per patient ranged from 102 to 2,334 each (median 859.4; SD, 627.8).
The findings suggest that wireless transmission of CGM allowed hospital staff to improve blood sugar control. Readings under 70 mg/dL occurred 0.7% of the time in patients monitored via wireless hookup and 1.4% in the others. Readings over 250 mg/dL appeared 9.8% and 13.2% of the time, respectively and readings over 300 mg/dL appeared 2.6% and 5.1% of the time, respectively.
The investigators plan to recruit 460 patients for the study, Ms. Garcia said. Results may be available within a couple of years, she said.
DexCom provided the CGM devices for the study, which was funded by Diabetes Research Connection and the Confidence Foundation. Ms. Garcia reports no disclosures.
BY RANDY DOTINGA
SAN DIEGO – Bedside continuous glucose monitoring (CGM) with a wireless hookup to a response team allowed doctors and nurses to gain better blood sugar control in hospitalized high-risk patients with diabetes, according to research reported at the annual scientific sessions of the American Diabetes Association.
“Continuous glucose monitoring and wireless connections can be useful in the hospital setting, not just in the outpatient setting,” said Maria Isabel Garcia, RN, of Scripps Whittier Diabetes Institute. “They help us to prevent problems rather than fixing them after they happen.”
Research suggests that complications due to dangerous blood sugar levels can lead to longer hospital stays, she noted.
For the study, researchers assigned 45 high-risk hospitalized patients with type 2 diabetes to be monitored by DexCom G4 CGM devices. The patients were being treated for a variety of conditions, and all were expected to be hospitalized for more than 2 days.
Researchers housed the normal-sized CGM devices in toolbox-sized containers at bedside. “We don’t want the equipment to get misplaced if the patient has to go from room to room or if the patient is discharged and takes the equipment by mistake,” Ms. Garcia said.
The patients were 43-82 years old (median, 61.4 years; standard deviation, 9.8), 56% male, 73% Hispanic (with 60% preferring to speak Spanish). The mean hemoglobin A1c was 10.2% (SD, 2.3), and the mean body mass index was 32.9 (SD, 8).
The patients were randomized to two groups. In both, the CGM devices were operative and tracked blood sugar levels. In one group, the information was transmitted via wireless hookup to a team of researchers (during the day) or a telemetry team (at night), who were alerted via alarms if blood sugar levels seemed too high or low. The teams would then alert nurses who’d confirm the levels via bedside testing and take appropriate action.
CGM data were gathered from the patients for an average of 4.2 days each (SD, 2.49; range 2-10), and the number of readings per patient ranged from 102 to 2,334 each (median 859.4; SD, 627.8).
The findings suggest that wireless transmission of CGM allowed hospital staff to improve blood sugar control. Readings under 70 mg/dL occurred 0.7% of the time in patients monitored via wireless hookup and 1.4% in the others. Readings over 250 mg/dL appeared 9.8% and 13.2% of the time, respectively and readings over 300 mg/dL appeared 2.6% and 5.1% of the time, respectively.
The investigators plan to recruit 460 patients for the study, Ms. Garcia said. Results may be available within a couple of years, she said.
DexCom provided the CGM devices for the study, which was funded by Diabetes Research Connection and the Confidence Foundation. Ms. Garcia reports no disclosures.
BY RANDY DOTINGA
SAN DIEGO – Bedside continuous glucose monitoring (CGM) with a wireless hookup to a response team allowed doctors and nurses to gain better blood sugar control in hospitalized high-risk patients with diabetes, according to research reported at the annual scientific sessions of the American Diabetes Association.
“Continuous glucose monitoring and wireless connections can be useful in the hospital setting, not just in the outpatient setting,” said Maria Isabel Garcia, RN, of Scripps Whittier Diabetes Institute. “They help us to prevent problems rather than fixing them after they happen.”
Research suggests that complications due to dangerous blood sugar levels can lead to longer hospital stays, she noted.
For the study, researchers assigned 45 high-risk hospitalized patients with type 2 diabetes to be monitored by DexCom G4 CGM devices. The patients were being treated for a variety of conditions, and all were expected to be hospitalized for more than 2 days.
Researchers housed the normal-sized CGM devices in toolbox-sized containers at bedside. “We don’t want the equipment to get misplaced if the patient has to go from room to room or if the patient is discharged and takes the equipment by mistake,” Ms. Garcia said.
The patients were 43-82 years old (median, 61.4 years; standard deviation, 9.8), 56% male, 73% Hispanic (with 60% preferring to speak Spanish). The mean hemoglobin A1c was 10.2% (SD, 2.3), and the mean body mass index was 32.9 (SD, 8).
The patients were randomized to two groups. In both, the CGM devices were operative and tracked blood sugar levels. In one group, the information was transmitted via wireless hookup to a team of researchers (during the day) or a telemetry team (at night), who were alerted via alarms if blood sugar levels seemed too high or low. The teams would then alert nurses who’d confirm the levels via bedside testing and take appropriate action.
CGM data were gathered from the patients for an average of 4.2 days each (SD, 2.49; range 2-10), and the number of readings per patient ranged from 102 to 2,334 each (median 859.4; SD, 627.8).
The findings suggest that wireless transmission of CGM allowed hospital staff to improve blood sugar control. Readings under 70 mg/dL occurred 0.7% of the time in patients monitored via wireless hookup and 1.4% in the others. Readings over 250 mg/dL appeared 9.8% and 13.2% of the time, respectively and readings over 300 mg/dL appeared 2.6% and 5.1% of the time, respectively.
The investigators plan to recruit 460 patients for the study, Ms. Garcia said. Results may be available within a couple of years, she said.
DexCom provided the CGM devices for the study, which was funded by Diabetes Research Connection and the Confidence Foundation. Ms. Garcia reports no disclosures.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: about high or low readings.
Major finding: Readings under 70 mg/dL occurred 0.7% of the time in patients monitored via wireless hookup and 1.4% in other patients. Readings over 250 mg/dL appeared 9.8% and 13.2% of the time, respectively, and readings over 300 mg/dL appeared 2.6% and 5.1% of the time, respectively.
Data source: Early results from a pilot randomized, controlled study of 45 hospitalized, high-risk patients with type 2 diabetes. CGM devices measured glucose levels in all patients, but they were only transmitted via wireless hookup to teams in one group.
Disclosures: DexCom provided the CGM machines for the study, which was funded by Diabetes Research Connection and the Confidence Foundation. Garcia reports no disclosures.
Low-dose aspirin bests dual-antiplatelet therapy in TAVR
PARIS – Single-antiplatelet therapy with low-dose aspirin following transcatheter aortic valve replacement (TAVR) reduced the occurrence of major adverse events, compared with guideline-recommended dual-antiplatelet therapy (DAPT), in the randomized ARTE trial.
The TAVR guideline recommendation for DAPT with low-dose aspirin plus clopidogrel is not based on evidence. It relies on expert opinion. ARTE (Aspirin Versus Aspirin + Clopidogrel Following TAVR) is the first sizable randomized trial to address the safety and efficacy of aspirin alone versus DAPT in the setting of TAVR, Josep Rodés-Cabau, MD, noted in presenting the ARTE results at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
ARTE was a multicenter, prospective, international open-label study of 222 TAVR patients who were randomized to 3 months of single-antiplatelet therapy (SAPT) with aspirin at 80-100 mg/day or to DAPT with aspirin at 80-100 mg/day plus clopidogrel at 75 mg/day after a single 300-mg loading dose. Participants had a mean Society of Thoracic Surgery Predicted Risk of Mortality score of 6.3%. The vast majority of participants received the balloon-expandable Edwards Lifesciences Sapien XT valve. The remainder got the Sapien 3 valve.
The primary outcome was the 3-month composite of death, MI, major or life-threatening bleeding, or stroke or transient ischemic attack. It occurred in 15.3% of the DAPT group and 7.2% on SAPT, a difference that didn’t reach statistical significance (P = .065) because of small patient numbers.
All subjects were on a proton pump inhibitor. The type, timing, and severity of bleeding events differed between the two study arms. All 4 bleeding events in the SAPT group were vascular in nature, while 5 of the 12 in the DAPT group were gastrointestinal. All the bleeding events in the SAPT group occurred within 72 hours after TAVR, whereas 5 of 12 in the DAPT recipients occurred later. Only one patient on SAPT experienced life-threatening bleeding, compared with seven DAPT patients who did.
“There were two prior smaller studies before ours,” according to Dr. Rodés-Cabau of Laval University in Quebec City. “One showed no differences, and an Italian one showed a tendency toward more bleeding with DAPT. So, I think there has been no sign to date that adding clopidogrel protects this group of patients from anything.”
Discussant Luis Nombela-Franco, MD, an interventional cardiologist at San Carlos Hospital in Madrid, pronounced the ARTE trial guideline-changing despite its limitations.
ARTE was supported by grants from Edwards Lifesciences and the Quebec Heart and Lung Institute.
Simultaneous with Dr. Rodés-Cabau’s presentation in Paris, the ARTE trial was published online (JACC Cardiovasc Interv. 2017 May 11. pii: S1936-8798[17]30812-9).
PARIS – Single-antiplatelet therapy with low-dose aspirin following transcatheter aortic valve replacement (TAVR) reduced the occurrence of major adverse events, compared with guideline-recommended dual-antiplatelet therapy (DAPT), in the randomized ARTE trial.
The TAVR guideline recommendation for DAPT with low-dose aspirin plus clopidogrel is not based on evidence. It relies on expert opinion. ARTE (Aspirin Versus Aspirin + Clopidogrel Following TAVR) is the first sizable randomized trial to address the safety and efficacy of aspirin alone versus DAPT in the setting of TAVR, Josep Rodés-Cabau, MD, noted in presenting the ARTE results at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
ARTE was a multicenter, prospective, international open-label study of 222 TAVR patients who were randomized to 3 months of single-antiplatelet therapy (SAPT) with aspirin at 80-100 mg/day or to DAPT with aspirin at 80-100 mg/day plus clopidogrel at 75 mg/day after a single 300-mg loading dose. Participants had a mean Society of Thoracic Surgery Predicted Risk of Mortality score of 6.3%. The vast majority of participants received the balloon-expandable Edwards Lifesciences Sapien XT valve. The remainder got the Sapien 3 valve.
The primary outcome was the 3-month composite of death, MI, major or life-threatening bleeding, or stroke or transient ischemic attack. It occurred in 15.3% of the DAPT group and 7.2% on SAPT, a difference that didn’t reach statistical significance (P = .065) because of small patient numbers.
All subjects were on a proton pump inhibitor. The type, timing, and severity of bleeding events differed between the two study arms. All 4 bleeding events in the SAPT group were vascular in nature, while 5 of the 12 in the DAPT group were gastrointestinal. All the bleeding events in the SAPT group occurred within 72 hours after TAVR, whereas 5 of 12 in the DAPT recipients occurred later. Only one patient on SAPT experienced life-threatening bleeding, compared with seven DAPT patients who did.
“There were two prior smaller studies before ours,” according to Dr. Rodés-Cabau of Laval University in Quebec City. “One showed no differences, and an Italian one showed a tendency toward more bleeding with DAPT. So, I think there has been no sign to date that adding clopidogrel protects this group of patients from anything.”
Discussant Luis Nombela-Franco, MD, an interventional cardiologist at San Carlos Hospital in Madrid, pronounced the ARTE trial guideline-changing despite its limitations.
ARTE was supported by grants from Edwards Lifesciences and the Quebec Heart and Lung Institute.
Simultaneous with Dr. Rodés-Cabau’s presentation in Paris, the ARTE trial was published online (JACC Cardiovasc Interv. 2017 May 11. pii: S1936-8798[17]30812-9).
PARIS – Single-antiplatelet therapy with low-dose aspirin following transcatheter aortic valve replacement (TAVR) reduced the occurrence of major adverse events, compared with guideline-recommended dual-antiplatelet therapy (DAPT), in the randomized ARTE trial.
The TAVR guideline recommendation for DAPT with low-dose aspirin plus clopidogrel is not based on evidence. It relies on expert opinion. ARTE (Aspirin Versus Aspirin + Clopidogrel Following TAVR) is the first sizable randomized trial to address the safety and efficacy of aspirin alone versus DAPT in the setting of TAVR, Josep Rodés-Cabau, MD, noted in presenting the ARTE results at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
ARTE was a multicenter, prospective, international open-label study of 222 TAVR patients who were randomized to 3 months of single-antiplatelet therapy (SAPT) with aspirin at 80-100 mg/day or to DAPT with aspirin at 80-100 mg/day plus clopidogrel at 75 mg/day after a single 300-mg loading dose. Participants had a mean Society of Thoracic Surgery Predicted Risk of Mortality score of 6.3%. The vast majority of participants received the balloon-expandable Edwards Lifesciences Sapien XT valve. The remainder got the Sapien 3 valve.
The primary outcome was the 3-month composite of death, MI, major or life-threatening bleeding, or stroke or transient ischemic attack. It occurred in 15.3% of the DAPT group and 7.2% on SAPT, a difference that didn’t reach statistical significance (P = .065) because of small patient numbers.
All subjects were on a proton pump inhibitor. The type, timing, and severity of bleeding events differed between the two study arms. All 4 bleeding events in the SAPT group were vascular in nature, while 5 of the 12 in the DAPT group were gastrointestinal. All the bleeding events in the SAPT group occurred within 72 hours after TAVR, whereas 5 of 12 in the DAPT recipients occurred later. Only one patient on SAPT experienced life-threatening bleeding, compared with seven DAPT patients who did.
“There were two prior smaller studies before ours,” according to Dr. Rodés-Cabau of Laval University in Quebec City. “One showed no differences, and an Italian one showed a tendency toward more bleeding with DAPT. So, I think there has been no sign to date that adding clopidogrel protects this group of patients from anything.”
Discussant Luis Nombela-Franco, MD, an interventional cardiologist at San Carlos Hospital in Madrid, pronounced the ARTE trial guideline-changing despite its limitations.
ARTE was supported by grants from Edwards Lifesciences and the Quebec Heart and Lung Institute.
Simultaneous with Dr. Rodés-Cabau’s presentation in Paris, the ARTE trial was published online (JACC Cardiovasc Interv. 2017 May 11. pii: S1936-8798[17]30812-9).
AT EUROPCR
Key clinical point:
Major finding: The 3-month composite of death, MI, major or life-threatening bleeding, or stroke or transient ischemic attack occurred in 15.3% of TAVR patients randomized to DAPT with low-dose aspirin plus clopidogrel, compared with 7.2% on aspirin only.
Data source: A randomized, multicenter, international, prospective open-label trial in 222 TAVR patients.
Disclosures: The presenter reported receiving research grants from Edwards Lifesciences and the Quebec Heart and Lung Institute, which supported the ARTE trial.
Everything We Say and Do: Setting discharge goals and visit expectations
Editor’s note: “Everything We Say and Do” is an informational series developed by SHM’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”
What I say and do
I always ensure at the end of my visit with a patient and their family that they know when to expect me to return to see their child again.
Why I do it
One of the biggest frustrations I hear from families pertains to the discharge process. In talking with families, they want to know the approximate time for discharge. Often, during morning rounds, we mention that the patient may be able to go home later in the day and we say that we will come in again later to check on them. However, unless we give families a time frame for when we will come back and do that check, they are left waiting without any clear expectations.
How I do it
One of our goals during morning family-centered rounds is to discuss discharge for every patient, every day. Along with discussing the possibility of going home, we try to give the family goals that they can work on throughout the day that are tied to discharge – for example, the approximate by-mouth intake for a toddler admitted for gastroenteritis and dehydration.
I also give the family an approximate time when either I or the resident team will come back to see if they have achieved this goal. This may be either late afternoon or first thing in the morning if we are planning an early-morning discharge before rounds. The families seem to find this helpful because they are not tied to the room all day waiting for the doctor to come back.
I also make sure that the families know they can contact their nurse any time if they need to see any of the doctors sooner than we planned. I let them know that a physician is here on the floor 24 hours a day and that the nurses can easily reach us at any time if they have further concerns. In my experience, this is reassuring to our families.
Christine Hrach is a pediatric hospitalist at Washington University School of Medicine in St. Louis.
Editor’s note: “Everything We Say and Do” is an informational series developed by SHM’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”
What I say and do
I always ensure at the end of my visit with a patient and their family that they know when to expect me to return to see their child again.
Why I do it
One of the biggest frustrations I hear from families pertains to the discharge process. In talking with families, they want to know the approximate time for discharge. Often, during morning rounds, we mention that the patient may be able to go home later in the day and we say that we will come in again later to check on them. However, unless we give families a time frame for when we will come back and do that check, they are left waiting without any clear expectations.
How I do it
One of our goals during morning family-centered rounds is to discuss discharge for every patient, every day. Along with discussing the possibility of going home, we try to give the family goals that they can work on throughout the day that are tied to discharge – for example, the approximate by-mouth intake for a toddler admitted for gastroenteritis and dehydration.
I also give the family an approximate time when either I or the resident team will come back to see if they have achieved this goal. This may be either late afternoon or first thing in the morning if we are planning an early-morning discharge before rounds. The families seem to find this helpful because they are not tied to the room all day waiting for the doctor to come back.
I also make sure that the families know they can contact their nurse any time if they need to see any of the doctors sooner than we planned. I let them know that a physician is here on the floor 24 hours a day and that the nurses can easily reach us at any time if they have further concerns. In my experience, this is reassuring to our families.
Christine Hrach is a pediatric hospitalist at Washington University School of Medicine in St. Louis.
Editor’s note: “Everything We Say and Do” is an informational series developed by SHM’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”
What I say and do
I always ensure at the end of my visit with a patient and their family that they know when to expect me to return to see their child again.
Why I do it
One of the biggest frustrations I hear from families pertains to the discharge process. In talking with families, they want to know the approximate time for discharge. Often, during morning rounds, we mention that the patient may be able to go home later in the day and we say that we will come in again later to check on them. However, unless we give families a time frame for when we will come back and do that check, they are left waiting without any clear expectations.
How I do it
One of our goals during morning family-centered rounds is to discuss discharge for every patient, every day. Along with discussing the possibility of going home, we try to give the family goals that they can work on throughout the day that are tied to discharge – for example, the approximate by-mouth intake for a toddler admitted for gastroenteritis and dehydration.
I also give the family an approximate time when either I or the resident team will come back to see if they have achieved this goal. This may be either late afternoon or first thing in the morning if we are planning an early-morning discharge before rounds. The families seem to find this helpful because they are not tied to the room all day waiting for the doctor to come back.
I also make sure that the families know they can contact their nurse any time if they need to see any of the doctors sooner than we planned. I let them know that a physician is here on the floor 24 hours a day and that the nurses can easily reach us at any time if they have further concerns. In my experience, this is reassuring to our families.
Christine Hrach is a pediatric hospitalist at Washington University School of Medicine in St. Louis.
Noninvasive therapy cut COPD readmissions
WASHINGTON – The addition of noninvasive ventilation to home oxygen therapy regimens correlated with increased time to readmission or death among patients with exacerbated chronic obstructive pulmonary diseases (COPD), according to a study presented at an international conference of the American Thoracic Society.
Among 116 patients observed with COPD, the 57 patients given home oxygen and noninvasive ventilation reported an average time to readmission of 4.3 months, compared with 1.4 months among the 59 patients given only home oxygen, according to Patrick B. Murphy, PhD, of St. Thomas’ Hospital, London (JAMA. 2017 May 21. doi: 10.1001/jama.2017.4451), who presented this research on the same day it was published in JAMA. 
Dr. Murphy said the findings are encouraging for patients with COPD suffering from exacerbations from the disease.
“Patients with established chronic respiratory failure secondary to COPD have poor outcomes with limited treatment options available,” the investigators noted. “The results of the current trial are reassuring, suggesting that home noninvasive ventilation added to home oxygen therapy in this population improved the overall clinical outcome without adding to the health burden of the patient.”
In this 12-month, phase III, multicenter, randomized clinical trial, the average age of the patients was 67 years, and the average body mass index was 21.6 mg/k2. The patients had an average partial pressure of carbon dioxide (PaCo2) level of 59, indicating persistent hypercapnia.
The investigators gave those in the intervention group one of three noninvasive home ventilators – nasal, oronasal, or total face mask – to use for a minimum of 6 hours nightly. Patients in both groups received 15 hours of oxygen therapy daily.
Doctors gathered data from patients after 6 weeks, 3 months, 6 months, and 12 months.
After 12 months, risk of readmission or death in the intervention group was 63.4%, while those in the oxygen-only group reported a risk of 80.4%. Despite a 17% risk reduction, a similar number of patients died during the experiment in both groups: five in the noninvasive intervention group and four in the control group, according to the investigators.
At the end of the trial, 16 patients (28%) in the intervention group and 19 (32%) in the control group died.
Dr. Murphy and his peers asserted that these deaths do not take away from the success of the treatment, as the focus of the study was to find a way to reduce readmissions, not necessarily mortality.
“The driver of the clinical improvement in the home oxygen therapy plus home noninvasive ventilation group was readmission avoidance with no significant difference in mortality,” they wrote. “This study has major clinical relevance because readmission avoidance is beneficial to the patient in terms of preservation of lung function and health-related quality of life, as well as providing a direct and indirect cost saving.”
The study was limited by the lack of a double-blind design; however, investigators said that a sham device may have made patients’ respiratory failure worse.
Some patients in the control group were later given ventilation treatment for safety reasons. Eighteen patients were given noninvasive ventilation, although reportedly after the primary endpoint was reached.
Philips Respironics, ResMed, the ResMed Foundation, and the Guy’s and St. Thomas’ Charity funded the study. Dr. Murphy and his coinvestigators reported receiving some manner of financial support from ResMed, Philips Respironics, and B&D Electromedical.
[email protected]
On Twitter @eaztweets
Vera A. De Palo, MD, FCCP, MBA, comments: A goal for any patient with a chronic disease is the best possible quality of life. Increasing hospital-free and exacerbation-free days helps to improve that quality of life. The authors report that the addition of noninvasive ventilation therapy increased the time to readmission due to COPD exacerbation. This adds another tool to the armamentarium to help improve outcomes for our COPD patients.
Vera A. De Palo, MD, FCCP, MBA, comments: A goal for any patient with a chronic disease is the best possible quality of life. Increasing hospital-free and exacerbation-free days helps to improve that quality of life. The authors report that the addition of noninvasive ventilation therapy increased the time to readmission due to COPD exacerbation. This adds another tool to the armamentarium to help improve outcomes for our COPD patients.
Vera A. De Palo, MD, FCCP, MBA, comments: A goal for any patient with a chronic disease is the best possible quality of life. Increasing hospital-free and exacerbation-free days helps to improve that quality of life. The authors report that the addition of noninvasive ventilation therapy increased the time to readmission due to COPD exacerbation. This adds another tool to the armamentarium to help improve outcomes for our COPD patients.
WASHINGTON – The addition of noninvasive ventilation to home oxygen therapy regimens correlated with increased time to readmission or death among patients with exacerbated chronic obstructive pulmonary diseases (COPD), according to a study presented at an international conference of the American Thoracic Society.
Among 116 patients observed with COPD, the 57 patients given home oxygen and noninvasive ventilation reported an average time to readmission of 4.3 months, compared with 1.4 months among the 59 patients given only home oxygen, according to Patrick B. Murphy, PhD, of St. Thomas’ Hospital, London (JAMA. 2017 May 21. doi: 10.1001/jama.2017.4451), who presented this research on the same day it was published in JAMA.
Dr. Murphy said the findings are encouraging for patients with COPD suffering from exacerbations from the disease.
“Patients with established chronic respiratory failure secondary to COPD have poor outcomes with limited treatment options available,” the investigators noted. “The results of the current trial are reassuring, suggesting that home noninvasive ventilation added to home oxygen therapy in this population improved the overall clinical outcome without adding to the health burden of the patient.”
In this 12-month, phase III, multicenter, randomized clinical trial, the average age of the patients was 67 years, and the average body mass index was 21.6 mg/k2. The patients had an average partial pressure of carbon dioxide (PaCo2) level of 59, indicating persistent hypercapnia.
The investigators gave those in the intervention group one of three noninvasive home ventilators – nasal, oronasal, or total face mask – to use for a minimum of 6 hours nightly. Patients in both groups received 15 hours of oxygen therapy daily.
Doctors gathered data from patients after 6 weeks, 3 months, 6 months, and 12 months.
After 12 months, risk of readmission or death in the intervention group was 63.4%, while those in the oxygen-only group reported a risk of 80.4%. Despite a 17% risk reduction, a similar number of patients died during the experiment in both groups: five in the noninvasive intervention group and four in the control group, according to the investigators.
At the end of the trial, 16 patients (28%) in the intervention group and 19 (32%) in the control group died.
Dr. Murphy and his peers asserted that these deaths do not take away from the success of the treatment, as the focus of the study was to find a way to reduce readmissions, not necessarily mortality.
“The driver of the clinical improvement in the home oxygen therapy plus home noninvasive ventilation group was readmission avoidance with no significant difference in mortality,” they wrote. “This study has major clinical relevance because readmission avoidance is beneficial to the patient in terms of preservation of lung function and health-related quality of life, as well as providing a direct and indirect cost saving.”
The study was limited by the lack of a double-blind design; however, investigators said that a sham device may have made patients’ respiratory failure worse.
Some patients in the control group were later given ventilation treatment for safety reasons. Eighteen patients were given noninvasive ventilation, although reportedly after the primary endpoint was reached.
Philips Respironics, ResMed, the ResMed Foundation, and the Guy’s and St. Thomas’ Charity funded the study. Dr. Murphy and his coinvestigators reported receiving some manner of financial support from ResMed, Philips Respironics, and B&D Electromedical.
[email protected]
On Twitter @eaztweets
WASHINGTON – The addition of noninvasive ventilation to home oxygen therapy regimens correlated with increased time to readmission or death among patients with exacerbated chronic obstructive pulmonary diseases (COPD), according to a study presented at an international conference of the American Thoracic Society.
Among 116 patients observed with COPD, the 57 patients given home oxygen and noninvasive ventilation reported an average time to readmission of 4.3 months, compared with 1.4 months among the 59 patients given only home oxygen, according to Patrick B. Murphy, PhD, of St. Thomas’ Hospital, London (JAMA. 2017 May 21. doi: 10.1001/jama.2017.4451), who presented this research on the same day it was published in JAMA.
Dr. Murphy said the findings are encouraging for patients with COPD suffering from exacerbations from the disease.
“Patients with established chronic respiratory failure secondary to COPD have poor outcomes with limited treatment options available,” the investigators noted. “The results of the current trial are reassuring, suggesting that home noninvasive ventilation added to home oxygen therapy in this population improved the overall clinical outcome without adding to the health burden of the patient.”
In this 12-month, phase III, multicenter, randomized clinical trial, the average age of the patients was 67 years, and the average body mass index was 21.6 mg/k2. The patients had an average partial pressure of carbon dioxide (PaCo2) level of 59, indicating persistent hypercapnia.
The investigators gave those in the intervention group one of three noninvasive home ventilators – nasal, oronasal, or total face mask – to use for a minimum of 6 hours nightly. Patients in both groups received 15 hours of oxygen therapy daily.
Doctors gathered data from patients after 6 weeks, 3 months, 6 months, and 12 months.
After 12 months, risk of readmission or death in the intervention group was 63.4%, while those in the oxygen-only group reported a risk of 80.4%. Despite a 17% risk reduction, a similar number of patients died during the experiment in both groups: five in the noninvasive intervention group and four in the control group, according to the investigators.
At the end of the trial, 16 patients (28%) in the intervention group and 19 (32%) in the control group died.
Dr. Murphy and his peers asserted that these deaths do not take away from the success of the treatment, as the focus of the study was to find a way to reduce readmissions, not necessarily mortality.
“The driver of the clinical improvement in the home oxygen therapy plus home noninvasive ventilation group was readmission avoidance with no significant difference in mortality,” they wrote. “This study has major clinical relevance because readmission avoidance is beneficial to the patient in terms of preservation of lung function and health-related quality of life, as well as providing a direct and indirect cost saving.”
The study was limited by the lack of a double-blind design; however, investigators said that a sham device may have made patients’ respiratory failure worse.
Some patients in the control group were later given ventilation treatment for safety reasons. Eighteen patients were given noninvasive ventilation, although reportedly after the primary endpoint was reached.
Philips Respironics, ResMed, the ResMed Foundation, and the Guy’s and St. Thomas’ Charity funded the study. Dr. Murphy and his coinvestigators reported receiving some manner of financial support from ResMed, Philips Respironics, and B&D Electromedical.
[email protected]
On Twitter @eaztweets
FROM ATS 2017
Key clinical point:
Major finding: The average time until readmission or death was 4.3 months for patients using both oxygen therapy and ventilation, compared with an average of 1.4 months for patients using only oxygen therapy.
Data source: Phase III, multicenter, randomized clinical trial of 116 COPD patients gathered from 13 U.K. medical centers between February, 2010, and April, 2015.
Disclosures: Philips Respironics, ResMed, the ResMed Foundation, and the Guy’s and St. Thomas’ Charity funded the study. Dr. Patrick B. Murphy and his coinvestigators reported receiving some manner of financial support from ResMed, Philips Respironics, and B&D Electromedical.
A prescription for heart failure success: Change the name
PARIS – Does heart failure’s name doom any progress against the disease?
That was the provocative premise advanced by Lynne Warner Stevenson, MD, who suggested that efforts to prevent, diagnose, and treat the disease would go better if it could only jettison that unfortunate word “failure,” its hard-wired albatross.
Dr. Stevenson offered several potentially superior alternatives, including cardiac insufficiency, heart dysfunction, and her favorite, cardiomyopathy.
“Is heart failure still the best diagnosis” for the entire spectrum of disease that most patients progress through ,including the many patients in earlier stages of the disease who do not have a truly failing heart? “Perhaps cardiomyopathy is the condition and heart failure is the transition,” she proposed.
To Dr. Stevenson, it’s more than just semantics.
“Words are hugely powerful,” she explained in an interview following her talk. “I think patients do not want to be seen as having heart failure. They don’t want to think of themselves as having heart failure. I think it can make them delay getting care, and it makes them ignore the disease. I worry about that a lot. I also worry that patients don’t provide support to each other that they could. Patients tend to hide that they have heart failure. We need to come up with a term that does not make patients ashamed of their disease.”
Part of the problem, Dr. Stevenson said, is that the name heart failure can be very misleading depending on the stage of the disease that patients have. Patients with stage B (presymptomatic) disease and those with mild stage C disease “don’t see themselves as having heart failure,” as having a heart that has failed them. “We need to be able to convince these patients that they have a disease that we need to treat carefully and aggressively.”
Additionally, labeling tens of millions of people as having stage A heart failure, which is presymptomatic and occurs before the heart shows any sign of damage or dysfunction, is also counterproductive, maintained Dr. Stevenson, professor of medicine at Harvard Medical School and director of the Cardiomyopathy and Heart Failure Program at Brigham and Women’s Hospital in Boston.
“So many people are at risk of developing heart failure,” she noted, including patients with hypertension, diabetes, or coronary artery disease. To label them all as already also having heart failure at that stage “tends to make them ignore the disease that we are trying to get them to pay attention to. Telling patients they have the disease that we are trying to prevent doesn’t help.”
Calling the whole range of the disease heart failure also confuses patients and others. “Patients ask me, ‘How can I have heart failure without any symptoms?’ ‘My ejection fraction improved to almost normal; do I still have heart failure?’ and ‘I don’t understand how my heart muscle is strong but my heart is failing,’ ” she said
For Dr. Stevenson, perhaps the biggest problem is the stigma of failure and the way that word ties a huge weight to the disease that prompts patients and caregivers alike to relegate it to a hidden and neglected place.
“It’s failure. Who is proud to have heart failure? Where are the marches for heart failure? Where are the celebrity champions for heart failure? We have celebrities who are happy to admit that they have Parkinson’s disease, ALS [amyotrophic lateral sclerosis], drug addiction, and even erectile dysfunction, but no one wants to say they have heart failure. We can’t get any traction behind heart failure. It doesn’t sound very inspiring,” an issue that even percolates down to dissuading clinicians from pursuing a career in heart failure care. Young people do not aspire to go into failure, she said.
“We need to call it something else.”
[email protected]
On Twitter @mitchelzoler
PARIS – Does heart failure’s name doom any progress against the disease?
That was the provocative premise advanced by Lynne Warner Stevenson, MD, who suggested that efforts to prevent, diagnose, and treat the disease would go better if it could only jettison that unfortunate word “failure,” its hard-wired albatross.
Dr. Stevenson offered several potentially superior alternatives, including cardiac insufficiency, heart dysfunction, and her favorite, cardiomyopathy.
“Is heart failure still the best diagnosis” for the entire spectrum of disease that most patients progress through ,including the many patients in earlier stages of the disease who do not have a truly failing heart? “Perhaps cardiomyopathy is the condition and heart failure is the transition,” she proposed.
To Dr. Stevenson, it’s more than just semantics.
“Words are hugely powerful,” she explained in an interview following her talk. “I think patients do not want to be seen as having heart failure. They don’t want to think of themselves as having heart failure. I think it can make them delay getting care, and it makes them ignore the disease. I worry about that a lot. I also worry that patients don’t provide support to each other that they could. Patients tend to hide that they have heart failure. We need to come up with a term that does not make patients ashamed of their disease.”
Part of the problem, Dr. Stevenson said, is that the name heart failure can be very misleading depending on the stage of the disease that patients have. Patients with stage B (presymptomatic) disease and those with mild stage C disease “don’t see themselves as having heart failure,” as having a heart that has failed them. “We need to be able to convince these patients that they have a disease that we need to treat carefully and aggressively.”
Additionally, labeling tens of millions of people as having stage A heart failure, which is presymptomatic and occurs before the heart shows any sign of damage or dysfunction, is also counterproductive, maintained Dr. Stevenson, professor of medicine at Harvard Medical School and director of the Cardiomyopathy and Heart Failure Program at Brigham and Women’s Hospital in Boston.
“So many people are at risk of developing heart failure,” she noted, including patients with hypertension, diabetes, or coronary artery disease. To label them all as already also having heart failure at that stage “tends to make them ignore the disease that we are trying to get them to pay attention to. Telling patients they have the disease that we are trying to prevent doesn’t help.”
Calling the whole range of the disease heart failure also confuses patients and others. “Patients ask me, ‘How can I have heart failure without any symptoms?’ ‘My ejection fraction improved to almost normal; do I still have heart failure?’ and ‘I don’t understand how my heart muscle is strong but my heart is failing,’ ” she said
For Dr. Stevenson, perhaps the biggest problem is the stigma of failure and the way that word ties a huge weight to the disease that prompts patients and caregivers alike to relegate it to a hidden and neglected place.
“It’s failure. Who is proud to have heart failure? Where are the marches for heart failure? Where are the celebrity champions for heart failure? We have celebrities who are happy to admit that they have Parkinson’s disease, ALS [amyotrophic lateral sclerosis], drug addiction, and even erectile dysfunction, but no one wants to say they have heart failure. We can’t get any traction behind heart failure. It doesn’t sound very inspiring,” an issue that even percolates down to dissuading clinicians from pursuing a career in heart failure care. Young people do not aspire to go into failure, she said.
“We need to call it something else.”
[email protected]
On Twitter @mitchelzoler
PARIS – Does heart failure’s name doom any progress against the disease?
That was the provocative premise advanced by Lynne Warner Stevenson, MD, who suggested that efforts to prevent, diagnose, and treat the disease would go better if it could only jettison that unfortunate word “failure,” its hard-wired albatross.
Dr. Stevenson offered several potentially superior alternatives, including cardiac insufficiency, heart dysfunction, and her favorite, cardiomyopathy.
“Is heart failure still the best diagnosis” for the entire spectrum of disease that most patients progress through ,including the many patients in earlier stages of the disease who do not have a truly failing heart? “Perhaps cardiomyopathy is the condition and heart failure is the transition,” she proposed.
To Dr. Stevenson, it’s more than just semantics.
“Words are hugely powerful,” she explained in an interview following her talk. “I think patients do not want to be seen as having heart failure. They don’t want to think of themselves as having heart failure. I think it can make them delay getting care, and it makes them ignore the disease. I worry about that a lot. I also worry that patients don’t provide support to each other that they could. Patients tend to hide that they have heart failure. We need to come up with a term that does not make patients ashamed of their disease.”
Part of the problem, Dr. Stevenson said, is that the name heart failure can be very misleading depending on the stage of the disease that patients have. Patients with stage B (presymptomatic) disease and those with mild stage C disease “don’t see themselves as having heart failure,” as having a heart that has failed them. “We need to be able to convince these patients that they have a disease that we need to treat carefully and aggressively.”
Additionally, labeling tens of millions of people as having stage A heart failure, which is presymptomatic and occurs before the heart shows any sign of damage or dysfunction, is also counterproductive, maintained Dr. Stevenson, professor of medicine at Harvard Medical School and director of the Cardiomyopathy and Heart Failure Program at Brigham and Women’s Hospital in Boston.
“So many people are at risk of developing heart failure,” she noted, including patients with hypertension, diabetes, or coronary artery disease. To label them all as already also having heart failure at that stage “tends to make them ignore the disease that we are trying to get them to pay attention to. Telling patients they have the disease that we are trying to prevent doesn’t help.”
Calling the whole range of the disease heart failure also confuses patients and others. “Patients ask me, ‘How can I have heart failure without any symptoms?’ ‘My ejection fraction improved to almost normal; do I still have heart failure?’ and ‘I don’t understand how my heart muscle is strong but my heart is failing,’ ” she said
For Dr. Stevenson, perhaps the biggest problem is the stigma of failure and the way that word ties a huge weight to the disease that prompts patients and caregivers alike to relegate it to a hidden and neglected place.
“It’s failure. Who is proud to have heart failure? Where are the marches for heart failure? Where are the celebrity champions for heart failure? We have celebrities who are happy to admit that they have Parkinson’s disease, ALS [amyotrophic lateral sclerosis], drug addiction, and even erectile dysfunction, but no one wants to say they have heart failure. We can’t get any traction behind heart failure. It doesn’t sound very inspiring,” an issue that even percolates down to dissuading clinicians from pursuing a career in heart failure care. Young people do not aspire to go into failure, she said.
“We need to call it something else.”
[email protected]
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM HEART FAILURE 2017
Short Takes
Community-based palliative care reduces emergency department visits
By Bryan J. Huang, MD, FHM
Retrospective cohort study showed that patients receiving community-based palliative care were less likely to seek ED care. The reduction was greater for older patients and for patients living in areas of higher socioeconomic status.
Time to intubation after cardiac arrest: Earlier may not be better
By Sarah Horman, MD
In a retrospective, observational, cohort study of 86,628 adults with in-hospital cardiac arrest, intubation during the first 15 minutes was associated with decreased survival, compared with no intubation.
Reference: Andersen, LW, Granfeldt, A, Callaway, CW, et al. Association between Tracheal intubation during adult in-hospital cardiac arrest and survival. JAMA. 2017;317(5):494-506.
DNR orders often not transferred to ED from outside care facilities
By Leslie M. Martin, MD
Prospective chart review of patients presenting from extended care facilities to an urban trauma center found hospital staff did a poor job of noting do not resuscitate preferences, and extended care facilities were inconsistent in providing their patients’ DNR forms.
Reference: McQuown CM, Frey JA, Amireh A, Chaudhary A. Transfer of do not resuscitate orders to the emergency department from extended care facilities. Am J Emerg Med. Published on 4 Feb 2017. doi: 10.1016/j.ajem.2017.02.007.
A quasi-experimental, before-after trial examining the impact of an emergency department mechanical ventilator protocol on clinical outcomes and lung-protective ventilation in acute respiratory distress syndrome
By William James Frederick III, MD, PhD
A single center, quasi-experimental, before-after trial shows a lung-protective mechanical ventilation protocol for emergency department and intensive care patients with Acute Respiratory Distress Syndrome reduced mortality and increased ventilator-free days.
Reference: Fuller BM, Ferguson IT, Mohr NM, et al. A Quasi-Experimental, Before-After Trial Examining the Impact of an Emergency Department Mechanical Ventilator Protocol on Clinical Outcomes and Lung-Protective Ventilation in Acute Respiratory Distress Syndrome. Crit Care Med. 2017;45(4);645-52.
Community-based palliative care reduces emergency department visits
By Bryan J. Huang, MD, FHM
Retrospective cohort study showed that patients receiving community-based palliative care were less likely to seek ED care. The reduction was greater for older patients and for patients living in areas of higher socioeconomic status.
Time to intubation after cardiac arrest: Earlier may not be better
By Sarah Horman, MD
In a retrospective, observational, cohort study of 86,628 adults with in-hospital cardiac arrest, intubation during the first 15 minutes was associated with decreased survival, compared with no intubation.
Reference: Andersen, LW, Granfeldt, A, Callaway, CW, et al. Association between Tracheal intubation during adult in-hospital cardiac arrest and survival. JAMA. 2017;317(5):494-506.
DNR orders often not transferred to ED from outside care facilities
By Leslie M. Martin, MD
Prospective chart review of patients presenting from extended care facilities to an urban trauma center found hospital staff did a poor job of noting do not resuscitate preferences, and extended care facilities were inconsistent in providing their patients’ DNR forms.
Reference: McQuown CM, Frey JA, Amireh A, Chaudhary A. Transfer of do not resuscitate orders to the emergency department from extended care facilities. Am J Emerg Med. Published on 4 Feb 2017. doi: 10.1016/j.ajem.2017.02.007.
A quasi-experimental, before-after trial examining the impact of an emergency department mechanical ventilator protocol on clinical outcomes and lung-protective ventilation in acute respiratory distress syndrome
By William James Frederick III, MD, PhD
A single center, quasi-experimental, before-after trial shows a lung-protective mechanical ventilation protocol for emergency department and intensive care patients with Acute Respiratory Distress Syndrome reduced mortality and increased ventilator-free days.
Reference: Fuller BM, Ferguson IT, Mohr NM, et al. A Quasi-Experimental, Before-After Trial Examining the Impact of an Emergency Department Mechanical Ventilator Protocol on Clinical Outcomes and Lung-Protective Ventilation in Acute Respiratory Distress Syndrome. Crit Care Med. 2017;45(4);645-52.
Community-based palliative care reduces emergency department visits
By Bryan J. Huang, MD, FHM
Retrospective cohort study showed that patients receiving community-based palliative care were less likely to seek ED care. The reduction was greater for older patients and for patients living in areas of higher socioeconomic status.
Time to intubation after cardiac arrest: Earlier may not be better
By Sarah Horman, MD
In a retrospective, observational, cohort study of 86,628 adults with in-hospital cardiac arrest, intubation during the first 15 minutes was associated with decreased survival, compared with no intubation.
Reference: Andersen, LW, Granfeldt, A, Callaway, CW, et al. Association between Tracheal intubation during adult in-hospital cardiac arrest and survival. JAMA. 2017;317(5):494-506.
DNR orders often not transferred to ED from outside care facilities
By Leslie M. Martin, MD
Prospective chart review of patients presenting from extended care facilities to an urban trauma center found hospital staff did a poor job of noting do not resuscitate preferences, and extended care facilities were inconsistent in providing their patients’ DNR forms.
Reference: McQuown CM, Frey JA, Amireh A, Chaudhary A. Transfer of do not resuscitate orders to the emergency department from extended care facilities. Am J Emerg Med. Published on 4 Feb 2017. doi: 10.1016/j.ajem.2017.02.007.
A quasi-experimental, before-after trial examining the impact of an emergency department mechanical ventilator protocol on clinical outcomes and lung-protective ventilation in acute respiratory distress syndrome
By William James Frederick III, MD, PhD
A single center, quasi-experimental, before-after trial shows a lung-protective mechanical ventilation protocol for emergency department and intensive care patients with Acute Respiratory Distress Syndrome reduced mortality and increased ventilator-free days.
Reference: Fuller BM, Ferguson IT, Mohr NM, et al. A Quasi-Experimental, Before-After Trial Examining the Impact of an Emergency Department Mechanical Ventilator Protocol on Clinical Outcomes and Lung-Protective Ventilation in Acute Respiratory Distress Syndrome. Crit Care Med. 2017;45(4);645-52.
Lactulose plus albumin is more effective than lactulose alone for treatment of hepatic encephalopathy
Clinical Question: Is the combination of lactulose plus albumin more effective than lactulose alone for treatment of hepatic encephalopathy?
Background: Hepatic encephalopathy is caused by the effect of toxins that build up in the bloodstream when the liver is not able to perform its normal functions. Lactulose is primarily directed at the reduction of blood ammonia levels. Albumin is thought to minimize oxidative injury and improve circulatory dysfunction present in cirrhosis.
Setting: Tertiary care centers in India.
Synopsis: 120 patients with overt hepatic encephalopathy were randomized to treatment with lactulose plus albumin (1.5 gm/kg/day; n = 60), versus lactulose alone (n = 60). Patients with serum creatinine greater than 1.5 mg/dL on admission, active alcohol intake less than 4 weeks prior to presentation, other metabolic encephalopathies, or hepatocellular carcinoma were excluded. Treatment was continued up to a maximum of 10 days until complete resolution of hepatic encephalopathy as assessed independently by two expert hepatologists.
Of patients receiving lactulose plus albumin, 75% had complete reversal of hepatic encephalopathy within 10 days, compared with 53% of patients receiving lactulose alone (P = .03). Patients in lactulose plus albumin group had shorter hospital length-of-stay (6.4 vs. 8.6 days; P = .01). There was lower mortality at 10 days in the lactulose plus albumin group (18.3% vs. 31.6%; P = .04).
Limitations of the study include the noted exclusion factors, including presence of alcohol intake, limitation to a single country (India), and a relatively high mortality rate in both groups.
Bottom Line: Combination of lactulose plus albumin is more effective than lactulose alone at reversing hepatic encephalopathy and is also associated with decreased length-of-stay and mortality.
Reference: Sharma BC, Singh J, Srivastava S, et al. A randomized controlled trial comparing lactulose plus albumin with lactulose alone for treatment of hepatic encephalopathy. J Gastroenterol Hepatol. Published online Nov 25, 2016. doi: 10.1111/jgh.13666.
Dr. Huang is associate clinical professor in the division of hospital medicine, department of medicine, University of California, San Diego.
Clinical Question: Is the combination of lactulose plus albumin more effective than lactulose alone for treatment of hepatic encephalopathy?
Background: Hepatic encephalopathy is caused by the effect of toxins that build up in the bloodstream when the liver is not able to perform its normal functions. Lactulose is primarily directed at the reduction of blood ammonia levels. Albumin is thought to minimize oxidative injury and improve circulatory dysfunction present in cirrhosis.
Setting: Tertiary care centers in India.
Synopsis: 120 patients with overt hepatic encephalopathy were randomized to treatment with lactulose plus albumin (1.5 gm/kg/day; n = 60), versus lactulose alone (n = 60). Patients with serum creatinine greater than 1.5 mg/dL on admission, active alcohol intake less than 4 weeks prior to presentation, other metabolic encephalopathies, or hepatocellular carcinoma were excluded. Treatment was continued up to a maximum of 10 days until complete resolution of hepatic encephalopathy as assessed independently by two expert hepatologists.
Of patients receiving lactulose plus albumin, 75% had complete reversal of hepatic encephalopathy within 10 days, compared with 53% of patients receiving lactulose alone (P = .03). Patients in lactulose plus albumin group had shorter hospital length-of-stay (6.4 vs. 8.6 days; P = .01). There was lower mortality at 10 days in the lactulose plus albumin group (18.3% vs. 31.6%; P = .04).
Limitations of the study include the noted exclusion factors, including presence of alcohol intake, limitation to a single country (India), and a relatively high mortality rate in both groups.
Bottom Line: Combination of lactulose plus albumin is more effective than lactulose alone at reversing hepatic encephalopathy and is also associated with decreased length-of-stay and mortality.
Reference: Sharma BC, Singh J, Srivastava S, et al. A randomized controlled trial comparing lactulose plus albumin with lactulose alone for treatment of hepatic encephalopathy. J Gastroenterol Hepatol. Published online Nov 25, 2016. doi: 10.1111/jgh.13666.
Dr. Huang is associate clinical professor in the division of hospital medicine, department of medicine, University of California, San Diego.
Clinical Question: Is the combination of lactulose plus albumin more effective than lactulose alone for treatment of hepatic encephalopathy?
Background: Hepatic encephalopathy is caused by the effect of toxins that build up in the bloodstream when the liver is not able to perform its normal functions. Lactulose is primarily directed at the reduction of blood ammonia levels. Albumin is thought to minimize oxidative injury and improve circulatory dysfunction present in cirrhosis.
Setting: Tertiary care centers in India.
Synopsis: 120 patients with overt hepatic encephalopathy were randomized to treatment with lactulose plus albumin (1.5 gm/kg/day; n = 60), versus lactulose alone (n = 60). Patients with serum creatinine greater than 1.5 mg/dL on admission, active alcohol intake less than 4 weeks prior to presentation, other metabolic encephalopathies, or hepatocellular carcinoma were excluded. Treatment was continued up to a maximum of 10 days until complete resolution of hepatic encephalopathy as assessed independently by two expert hepatologists.
Of patients receiving lactulose plus albumin, 75% had complete reversal of hepatic encephalopathy within 10 days, compared with 53% of patients receiving lactulose alone (P = .03). Patients in lactulose plus albumin group had shorter hospital length-of-stay (6.4 vs. 8.6 days; P = .01). There was lower mortality at 10 days in the lactulose plus albumin group (18.3% vs. 31.6%; P = .04).
Limitations of the study include the noted exclusion factors, including presence of alcohol intake, limitation to a single country (India), and a relatively high mortality rate in both groups.
Bottom Line: Combination of lactulose plus albumin is more effective than lactulose alone at reversing hepatic encephalopathy and is also associated with decreased length-of-stay and mortality.
Reference: Sharma BC, Singh J, Srivastava S, et al. A randomized controlled trial comparing lactulose plus albumin with lactulose alone for treatment of hepatic encephalopathy. J Gastroenterol Hepatol. Published online Nov 25, 2016. doi: 10.1111/jgh.13666.
Dr. Huang is associate clinical professor in the division of hospital medicine, department of medicine, University of California, San Diego.
VIDEO: Software predicts septic shock in hospitalized patients
WASHINGTON – Researchers have devised a program that can predict severe sepsis or septic shock about 12-30 hours in advance of its onset in hospitalized patients, a feat they hope will allow them to apply early interventions to stave off impending sepsis.
“We’d love to see a change in sepsis mortality. Will earlier recognition and implementation of the sepsis bundle – fluids, antibiotics, etc. – improve outcomes?” wondered Heather M. Giannini, MD, in a video interview at an international conference of the American Thoracic Society.
The computer program works by monitoring all the data that enter a patient’s electronic health record during hospitalization. Researchers developed it and designed it specifically for inpatients who are not in the intensive care unit or emergency department.
Results from initial testing during October-December 2015 in 10,448 patients hospitalized at one of three participating Philadelphia hospitals showed the program predicted subsequent severe sepsis or septic shock with a sensitivity of 26% and a specificity of 98%, reported Dr. Giannini, a researcher in the Center for Evidence-Based Practice at the University of Pennsylvania in Philadelphia. Analysis also showed a positive likelihood ratio of 13 for severe sepsis or septic shock actually occurring following an alert generated by the computer program, a level indicating a “very strong” ability to predict sepsis, she said.
Dr. Giannini and her associates developed the prediction program using a technique called “computational machine learning,” an alternative to standard logistic regression modeling that is better suited to analyzing large data sets and can better integrate outlier data points. They took EHR data for all non-ICU, non-ED inpatients at three Philadelphia hospitals during a 3-year period during 2011-2014 and had the program focus particularly on EHR data gleaned from the nearly 1,000 patients who developed severe sepsis or septic shock during the 12 hours preceding the start of these sepsis events. The analysis identified patients as having developed severe sepsis or shock if they had a blood draw positive for infection at the same time as having a blood lactate level above 2.2 mmol/L or a systolic blood pressure below 90 mm Hg.
To create the algorithm the machine-learning device compared the EHR entries for patients who developed severe sepsis or septic shock with EHR data from patients who did not, a process that involved hundred of thousands of data points, Dr. Giannini said. This identified 587 individual types of relevant EHR data entries and ranked them from most important to least important. Important, novel determinants of impending severe sepsis identified this way included anion gap, blood urea nitrogen, and platelet count. The development process also confirmed an important role for many classic markers of septic shock, such as respiration rate, heart rate, and temperature.
The researchers designed the algorithm to have a moderate level of sensitivity to avoid “alert fatigue” from generating too many alarms for impending severe sepsis. Their goal was for clinicians to receive no more than about 10 alerts per day for each hospital.
“We are satisfied with the sensitivity. We felt it was better to have too few alerts rather than overwhelm clinicians. About 10 alerts a day is reasonable,” Dr. Giannini explained. During initial 2015 testing, the system generated a daily average of 11 alerts.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
Development of this algorithm is tremendously important and exciting. It is an example of how researchers can use big data to predict patient outcomes and use that information to help deliver better patient care.
The algorithm’s performance so far is laudable and extremely promising, and has great potential to help deliver better care to patients when they need it, but it requires further validation. The potential importance of earlier identification of septic shock is huge.
Michelle N. Gong, MD, is professor of medicine and chief of research in the division of critical care at Albert Einstein College of Medicine and Montefiore Medical Center in New York. She had no disclosures. She made these comments in an interview.
Development of this algorithm is tremendously important and exciting. It is an example of how researchers can use big data to predict patient outcomes and use that information to help deliver better patient care.
The algorithm’s performance so far is laudable and extremely promising, and has great potential to help deliver better care to patients when they need it, but it requires further validation. The potential importance of earlier identification of septic shock is huge.
Michelle N. Gong, MD, is professor of medicine and chief of research in the division of critical care at Albert Einstein College of Medicine and Montefiore Medical Center in New York. She had no disclosures. She made these comments in an interview.
Development of this algorithm is tremendously important and exciting. It is an example of how researchers can use big data to predict patient outcomes and use that information to help deliver better patient care.
The algorithm’s performance so far is laudable and extremely promising, and has great potential to help deliver better care to patients when they need it, but it requires further validation. The potential importance of earlier identification of septic shock is huge.
Michelle N. Gong, MD, is professor of medicine and chief of research in the division of critical care at Albert Einstein College of Medicine and Montefiore Medical Center in New York. She had no disclosures. She made these comments in an interview.
WASHINGTON – Researchers have devised a program that can predict severe sepsis or septic shock about 12-30 hours in advance of its onset in hospitalized patients, a feat they hope will allow them to apply early interventions to stave off impending sepsis.
“We’d love to see a change in sepsis mortality. Will earlier recognition and implementation of the sepsis bundle – fluids, antibiotics, etc. – improve outcomes?” wondered Heather M. Giannini, MD, in a video interview at an international conference of the American Thoracic Society.
The computer program works by monitoring all the data that enter a patient’s electronic health record during hospitalization. Researchers developed it and designed it specifically for inpatients who are not in the intensive care unit or emergency department.
Results from initial testing during October-December 2015 in 10,448 patients hospitalized at one of three participating Philadelphia hospitals showed the program predicted subsequent severe sepsis or septic shock with a sensitivity of 26% and a specificity of 98%, reported Dr. Giannini, a researcher in the Center for Evidence-Based Practice at the University of Pennsylvania in Philadelphia. Analysis also showed a positive likelihood ratio of 13 for severe sepsis or septic shock actually occurring following an alert generated by the computer program, a level indicating a “very strong” ability to predict sepsis, she said.
Dr. Giannini and her associates developed the prediction program using a technique called “computational machine learning,” an alternative to standard logistic regression modeling that is better suited to analyzing large data sets and can better integrate outlier data points. They took EHR data for all non-ICU, non-ED inpatients at three Philadelphia hospitals during a 3-year period during 2011-2014 and had the program focus particularly on EHR data gleaned from the nearly 1,000 patients who developed severe sepsis or septic shock during the 12 hours preceding the start of these sepsis events. The analysis identified patients as having developed severe sepsis or shock if they had a blood draw positive for infection at the same time as having a blood lactate level above 2.2 mmol/L or a systolic blood pressure below 90 mm Hg.
To create the algorithm the machine-learning device compared the EHR entries for patients who developed severe sepsis or septic shock with EHR data from patients who did not, a process that involved hundred of thousands of data points, Dr. Giannini said. This identified 587 individual types of relevant EHR data entries and ranked them from most important to least important. Important, novel determinants of impending severe sepsis identified this way included anion gap, blood urea nitrogen, and platelet count. The development process also confirmed an important role for many classic markers of septic shock, such as respiration rate, heart rate, and temperature.
The researchers designed the algorithm to have a moderate level of sensitivity to avoid “alert fatigue” from generating too many alarms for impending severe sepsis. Their goal was for clinicians to receive no more than about 10 alerts per day for each hospital.
“We are satisfied with the sensitivity. We felt it was better to have too few alerts rather than overwhelm clinicians. About 10 alerts a day is reasonable,” Dr. Giannini explained. During initial 2015 testing, the system generated a daily average of 11 alerts.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
WASHINGTON – Researchers have devised a program that can predict severe sepsis or septic shock about 12-30 hours in advance of its onset in hospitalized patients, a feat they hope will allow them to apply early interventions to stave off impending sepsis.
“We’d love to see a change in sepsis mortality. Will earlier recognition and implementation of the sepsis bundle – fluids, antibiotics, etc. – improve outcomes?” wondered Heather M. Giannini, MD, in a video interview at an international conference of the American Thoracic Society.
The computer program works by monitoring all the data that enter a patient’s electronic health record during hospitalization. Researchers developed it and designed it specifically for inpatients who are not in the intensive care unit or emergency department.
Results from initial testing during October-December 2015 in 10,448 patients hospitalized at one of three participating Philadelphia hospitals showed the program predicted subsequent severe sepsis or septic shock with a sensitivity of 26% and a specificity of 98%, reported Dr. Giannini, a researcher in the Center for Evidence-Based Practice at the University of Pennsylvania in Philadelphia. Analysis also showed a positive likelihood ratio of 13 for severe sepsis or septic shock actually occurring following an alert generated by the computer program, a level indicating a “very strong” ability to predict sepsis, she said.
Dr. Giannini and her associates developed the prediction program using a technique called “computational machine learning,” an alternative to standard logistic regression modeling that is better suited to analyzing large data sets and can better integrate outlier data points. They took EHR data for all non-ICU, non-ED inpatients at three Philadelphia hospitals during a 3-year period during 2011-2014 and had the program focus particularly on EHR data gleaned from the nearly 1,000 patients who developed severe sepsis or septic shock during the 12 hours preceding the start of these sepsis events. The analysis identified patients as having developed severe sepsis or shock if they had a blood draw positive for infection at the same time as having a blood lactate level above 2.2 mmol/L or a systolic blood pressure below 90 mm Hg.
To create the algorithm the machine-learning device compared the EHR entries for patients who developed severe sepsis or septic shock with EHR data from patients who did not, a process that involved hundred of thousands of data points, Dr. Giannini said. This identified 587 individual types of relevant EHR data entries and ranked them from most important to least important. Important, novel determinants of impending severe sepsis identified this way included anion gap, blood urea nitrogen, and platelet count. The development process also confirmed an important role for many classic markers of septic shock, such as respiration rate, heart rate, and temperature.
The researchers designed the algorithm to have a moderate level of sensitivity to avoid “alert fatigue” from generating too many alarms for impending severe sepsis. Their goal was for clinicians to receive no more than about 10 alerts per day for each hospital.
“We are satisfied with the sensitivity. We felt it was better to have too few alerts rather than overwhelm clinicians. About 10 alerts a day is reasonable,” Dr. Giannini explained. During initial 2015 testing, the system generated a daily average of 11 alerts.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
AT ATS 2017
Key clinical point:
Major finding: The program predicted severe sepsis with a sensitivity of 26% and specificity of 98%.
Data source: A total of 10,448 inpatients at three Philadelphia hospitals during October-December 2015.
Disclosures: Dr. Giannini had no disclosures.
