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Adaptive servo ventilation cuts atrial fib burden
ORLANDO – Adaptive servo ventilation produced a significant and clinically meaningful reduction in atrial fibrillation burden in patients with heart failure and sleep apnea in results from an exploratory, prospective, randomized study with 35 patients.
Adaptive servo ventilation (ASV) “may be an effective antiarrhythmic treatment producing a significant reduction in atrial fibrillation without clear evidence of being proarrhythmogenic,” Jonathan P. Piccini, MD, said at the annual scientific meeting of the Heart Failure Society of America. “Given the potential importance of this finding further studies should validate and quantify the efficacy of ASV for reducing atrial fibrillation in patients with or without heart failure.”
“A mound of data has shown that treating sleep apnea reduced arrhythmias, but until now it’s all been observational and retrospective,” Dr. Piccini, an electrophysiologist at Duke University in Durham, N.C., said in an interview. The study he reported is “the first time” the arrhythmia effects of a sleep apnea intervention, in this case ASV, was studied in a prospective, randomized way while using implanted devices to measure the antiarrhythmic effect of the treatment.
The new finding means that additional, larger studies are now needed, he said. “If patients have sleep apnea, treating the apnea may be an incredibly important way to prevent AF or reduce its burden”
The CAT-HF (Cardiovascular Improvements With Minute Ventilation-Targeted ASV Therapy in Heart Failure) trial was originally designed to randomize 215 heart failure patients with sleep disordered breathing – and who were hospitalized for heart failure – to optimal medical therapy with or without ASV at any of 15 centers in the United States and Germany. But in August 2015, results from the SERVE-HF (Treatment of Sleep-Disordered Breathing with Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients with Heart Failure) trial, which generally had a similar design to CAT-HF, showed an unexpected danger from ASV in patients with central sleep apnea and heart failure with reduced ejection fraction (N Engl J Med. 2015 Sept 17;373[12]:1095-105). In SERVE-HF, ASV was associated with significant increases in all-cause and cardiovascular mortality. As a result, enrollment into CAT-HF stopped prematurely with just 126 patients entered, and ASV treatment of patients already enrolled came to a halt.
The primary endpoint in the underpowered and shortened CAT-HF study, survival without cardiovascular hospitalization and with improved functional capacity measured on a 6-minute walk test, showed similar outcomes in both the ASV and control arms. But in a prespecified subgroup analysis by baseline ejection fraction, the 24 patients with heart failure with preserved ejection fraction (19% of the CAT-HF enrollment) showed a statistically significant, 62% relative improvement in the primary endpoint linked with ASV treatment compared with similar patients who did not receive ASV, Christopher M. O’Connor, MD, professor of medicine at Duke University, reported in May 2016 at the European Heart Failure meeting in Florence.
Dr. Piccini’s report focused on a prespecified subgroup analysis of CAT-HF designed to examine the impact of ASV on arrhythmias. Assessment of the impact of ASV on atrial fibrillation was possible in 35 of the 126 patients in CAT-HF who had an implanted cardiac device (pacemaker, defibrillator, or cardiac resynchronization device) with an atrial lead, and assessment of ventricular arrhythmias occurred in 46 of the CAT-HF patients with an implanted high-voltage device (a defibrillator or resynchronization device) that allowed monitoring of ventricular arrhythmias.
For the atrial fibrillation analysis, the 35 patients averaged 60 years of age, and about 90% had a reduced ejection fraction. About two-thirds had an apnea-hypopnea index greater than 30.
The results showed that the 19 patients randomized to receive ASV had an average atrial fibrillation burden of 30% at baseline that dropped to 14% after 6 months of treatment. In contrast, the 16 patients in the control arm had a AF burden of 6% at baseline and 8% after 6 months. The between-group difference for change in AF burden was statistically significant, Dr. Piccini reported, with a burden that decreased by a relative 21% with ASV treatment and increased by a relative 31% in the control arm.
Analysis of the ventricular arrhythmia subgroup showed that ASV had no statistically significant impact for either lowering or raising ventricular tachyarrhythmias or fibrillations.
Trying to reconcile this AF benefit and lack of ventricular arrhythmia harm from ASV in CAT-HF with the excess in cardiovascular deaths seen with ASV in SERVE-HF, Dr. Piccini speculated that some of the SERVE-HF deaths may not have been related to arrhythmia.
“Sudden cardiac death adjudication is profoundly difficult, and does not always equal ventricular arrhythmia,” he said. “We need to consider that some of the adverse events in patients with severe central sleep apnea and low left ventricular ejection fraction [enrolled in SERVE-HF] may have been due to causes other than arrhythmias. The CAT-HF results should motivate investigations of alternative mechanisms of death in SERVE-HF.”
The CAT-HF trial was funded by ResMed, a company that markets adaptive servo ventilation equipment. Dr. Piccini has received research support from ResMed and from Janssen, Gilead, St. Jude, Spectranetics, and he has been a consultant to Janssen, Spectranetics, Medtronic, GSK and BMS-Pfizer. Dr. O’Connor has been a consultant to ResMed and to several other drug and device companies.
[email protected]
On Twitter @mitchelzoler
A small prespecified sub-group of patients in the CAT-HF (Cardiovascuar improvements with minute ventilation-targeted ASV therapy in heart failure) trial randomized to adaptive servo ventilation (ASV) showed a 21% relative reduction in atrial fibrillation burden as compared to the control arm which had only 31% relative reduction. While the CAT-HF study was discontinued following results of SERVE-HF trial, this subgroup analysis included 35 patients (19 ASV arm; 16 control arm), the majority of whom had a reduced ejection fraction. This report poses interesting questions about effects of ASV on atrial fibrillation burden in those with reduced EF given the finding that central sleep apnea and Cheyne-Stokes respiration are shown to be associated with incident atrial fibrillation in older men (May et al. Am J Respir Crit Care Med 2016).
A small prespecified sub-group of patients in the CAT-HF (Cardiovascuar improvements with minute ventilation-targeted ASV therapy in heart failure) trial randomized to adaptive servo ventilation (ASV) showed a 21% relative reduction in atrial fibrillation burden as compared to the control arm which had only 31% relative reduction. While the CAT-HF study was discontinued following results of SERVE-HF trial, this subgroup analysis included 35 patients (19 ASV arm; 16 control arm), the majority of whom had a reduced ejection fraction. This report poses interesting questions about effects of ASV on atrial fibrillation burden in those with reduced EF given the finding that central sleep apnea and Cheyne-Stokes respiration are shown to be associated with incident atrial fibrillation in older men (May et al. Am J Respir Crit Care Med 2016).
A small prespecified sub-group of patients in the CAT-HF (Cardiovascuar improvements with minute ventilation-targeted ASV therapy in heart failure) trial randomized to adaptive servo ventilation (ASV) showed a 21% relative reduction in atrial fibrillation burden as compared to the control arm which had only 31% relative reduction. While the CAT-HF study was discontinued following results of SERVE-HF trial, this subgroup analysis included 35 patients (19 ASV arm; 16 control arm), the majority of whom had a reduced ejection fraction. This report poses interesting questions about effects of ASV on atrial fibrillation burden in those with reduced EF given the finding that central sleep apnea and Cheyne-Stokes respiration are shown to be associated with incident atrial fibrillation in older men (May et al. Am J Respir Crit Care Med 2016).
ORLANDO – Adaptive servo ventilation produced a significant and clinically meaningful reduction in atrial fibrillation burden in patients with heart failure and sleep apnea in results from an exploratory, prospective, randomized study with 35 patients.
Adaptive servo ventilation (ASV) “may be an effective antiarrhythmic treatment producing a significant reduction in atrial fibrillation without clear evidence of being proarrhythmogenic,” Jonathan P. Piccini, MD, said at the annual scientific meeting of the Heart Failure Society of America. “Given the potential importance of this finding further studies should validate and quantify the efficacy of ASV for reducing atrial fibrillation in patients with or without heart failure.”
“A mound of data has shown that treating sleep apnea reduced arrhythmias, but until now it’s all been observational and retrospective,” Dr. Piccini, an electrophysiologist at Duke University in Durham, N.C., said in an interview. The study he reported is “the first time” the arrhythmia effects of a sleep apnea intervention, in this case ASV, was studied in a prospective, randomized way while using implanted devices to measure the antiarrhythmic effect of the treatment.
The new finding means that additional, larger studies are now needed, he said. “If patients have sleep apnea, treating the apnea may be an incredibly important way to prevent AF or reduce its burden”
The CAT-HF (Cardiovascular Improvements With Minute Ventilation-Targeted ASV Therapy in Heart Failure) trial was originally designed to randomize 215 heart failure patients with sleep disordered breathing – and who were hospitalized for heart failure – to optimal medical therapy with or without ASV at any of 15 centers in the United States and Germany. But in August 2015, results from the SERVE-HF (Treatment of Sleep-Disordered Breathing with Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients with Heart Failure) trial, which generally had a similar design to CAT-HF, showed an unexpected danger from ASV in patients with central sleep apnea and heart failure with reduced ejection fraction (N Engl J Med. 2015 Sept 17;373[12]:1095-105). In SERVE-HF, ASV was associated with significant increases in all-cause and cardiovascular mortality. As a result, enrollment into CAT-HF stopped prematurely with just 126 patients entered, and ASV treatment of patients already enrolled came to a halt.
The primary endpoint in the underpowered and shortened CAT-HF study, survival without cardiovascular hospitalization and with improved functional capacity measured on a 6-minute walk test, showed similar outcomes in both the ASV and control arms. But in a prespecified subgroup analysis by baseline ejection fraction, the 24 patients with heart failure with preserved ejection fraction (19% of the CAT-HF enrollment) showed a statistically significant, 62% relative improvement in the primary endpoint linked with ASV treatment compared with similar patients who did not receive ASV, Christopher M. O’Connor, MD, professor of medicine at Duke University, reported in May 2016 at the European Heart Failure meeting in Florence.
Dr. Piccini’s report focused on a prespecified subgroup analysis of CAT-HF designed to examine the impact of ASV on arrhythmias. Assessment of the impact of ASV on atrial fibrillation was possible in 35 of the 126 patients in CAT-HF who had an implanted cardiac device (pacemaker, defibrillator, or cardiac resynchronization device) with an atrial lead, and assessment of ventricular arrhythmias occurred in 46 of the CAT-HF patients with an implanted high-voltage device (a defibrillator or resynchronization device) that allowed monitoring of ventricular arrhythmias.
For the atrial fibrillation analysis, the 35 patients averaged 60 years of age, and about 90% had a reduced ejection fraction. About two-thirds had an apnea-hypopnea index greater than 30.
The results showed that the 19 patients randomized to receive ASV had an average atrial fibrillation burden of 30% at baseline that dropped to 14% after 6 months of treatment. In contrast, the 16 patients in the control arm had a AF burden of 6% at baseline and 8% after 6 months. The between-group difference for change in AF burden was statistically significant, Dr. Piccini reported, with a burden that decreased by a relative 21% with ASV treatment and increased by a relative 31% in the control arm.
Analysis of the ventricular arrhythmia subgroup showed that ASV had no statistically significant impact for either lowering or raising ventricular tachyarrhythmias or fibrillations.
Trying to reconcile this AF benefit and lack of ventricular arrhythmia harm from ASV in CAT-HF with the excess in cardiovascular deaths seen with ASV in SERVE-HF, Dr. Piccini speculated that some of the SERVE-HF deaths may not have been related to arrhythmia.
“Sudden cardiac death adjudication is profoundly difficult, and does not always equal ventricular arrhythmia,” he said. “We need to consider that some of the adverse events in patients with severe central sleep apnea and low left ventricular ejection fraction [enrolled in SERVE-HF] may have been due to causes other than arrhythmias. The CAT-HF results should motivate investigations of alternative mechanisms of death in SERVE-HF.”
The CAT-HF trial was funded by ResMed, a company that markets adaptive servo ventilation equipment. Dr. Piccini has received research support from ResMed and from Janssen, Gilead, St. Jude, Spectranetics, and he has been a consultant to Janssen, Spectranetics, Medtronic, GSK and BMS-Pfizer. Dr. O’Connor has been a consultant to ResMed and to several other drug and device companies.
[email protected]
On Twitter @mitchelzoler
ORLANDO – Adaptive servo ventilation produced a significant and clinically meaningful reduction in atrial fibrillation burden in patients with heart failure and sleep apnea in results from an exploratory, prospective, randomized study with 35 patients.
Adaptive servo ventilation (ASV) “may be an effective antiarrhythmic treatment producing a significant reduction in atrial fibrillation without clear evidence of being proarrhythmogenic,” Jonathan P. Piccini, MD, said at the annual scientific meeting of the Heart Failure Society of America. “Given the potential importance of this finding further studies should validate and quantify the efficacy of ASV for reducing atrial fibrillation in patients with or without heart failure.”
“A mound of data has shown that treating sleep apnea reduced arrhythmias, but until now it’s all been observational and retrospective,” Dr. Piccini, an electrophysiologist at Duke University in Durham, N.C., said in an interview. The study he reported is “the first time” the arrhythmia effects of a sleep apnea intervention, in this case ASV, was studied in a prospective, randomized way while using implanted devices to measure the antiarrhythmic effect of the treatment.
The new finding means that additional, larger studies are now needed, he said. “If patients have sleep apnea, treating the apnea may be an incredibly important way to prevent AF or reduce its burden”
The CAT-HF (Cardiovascular Improvements With Minute Ventilation-Targeted ASV Therapy in Heart Failure) trial was originally designed to randomize 215 heart failure patients with sleep disordered breathing – and who were hospitalized for heart failure – to optimal medical therapy with or without ASV at any of 15 centers in the United States and Germany. But in August 2015, results from the SERVE-HF (Treatment of Sleep-Disordered Breathing with Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients with Heart Failure) trial, which generally had a similar design to CAT-HF, showed an unexpected danger from ASV in patients with central sleep apnea and heart failure with reduced ejection fraction (N Engl J Med. 2015 Sept 17;373[12]:1095-105). In SERVE-HF, ASV was associated with significant increases in all-cause and cardiovascular mortality. As a result, enrollment into CAT-HF stopped prematurely with just 126 patients entered, and ASV treatment of patients already enrolled came to a halt.
The primary endpoint in the underpowered and shortened CAT-HF study, survival without cardiovascular hospitalization and with improved functional capacity measured on a 6-minute walk test, showed similar outcomes in both the ASV and control arms. But in a prespecified subgroup analysis by baseline ejection fraction, the 24 patients with heart failure with preserved ejection fraction (19% of the CAT-HF enrollment) showed a statistically significant, 62% relative improvement in the primary endpoint linked with ASV treatment compared with similar patients who did not receive ASV, Christopher M. O’Connor, MD, professor of medicine at Duke University, reported in May 2016 at the European Heart Failure meeting in Florence.
Dr. Piccini’s report focused on a prespecified subgroup analysis of CAT-HF designed to examine the impact of ASV on arrhythmias. Assessment of the impact of ASV on atrial fibrillation was possible in 35 of the 126 patients in CAT-HF who had an implanted cardiac device (pacemaker, defibrillator, or cardiac resynchronization device) with an atrial lead, and assessment of ventricular arrhythmias occurred in 46 of the CAT-HF patients with an implanted high-voltage device (a defibrillator or resynchronization device) that allowed monitoring of ventricular arrhythmias.
For the atrial fibrillation analysis, the 35 patients averaged 60 years of age, and about 90% had a reduced ejection fraction. About two-thirds had an apnea-hypopnea index greater than 30.
The results showed that the 19 patients randomized to receive ASV had an average atrial fibrillation burden of 30% at baseline that dropped to 14% after 6 months of treatment. In contrast, the 16 patients in the control arm had a AF burden of 6% at baseline and 8% after 6 months. The between-group difference for change in AF burden was statistically significant, Dr. Piccini reported, with a burden that decreased by a relative 21% with ASV treatment and increased by a relative 31% in the control arm.
Analysis of the ventricular arrhythmia subgroup showed that ASV had no statistically significant impact for either lowering or raising ventricular tachyarrhythmias or fibrillations.
Trying to reconcile this AF benefit and lack of ventricular arrhythmia harm from ASV in CAT-HF with the excess in cardiovascular deaths seen with ASV in SERVE-HF, Dr. Piccini speculated that some of the SERVE-HF deaths may not have been related to arrhythmia.
“Sudden cardiac death adjudication is profoundly difficult, and does not always equal ventricular arrhythmia,” he said. “We need to consider that some of the adverse events in patients with severe central sleep apnea and low left ventricular ejection fraction [enrolled in SERVE-HF] may have been due to causes other than arrhythmias. The CAT-HF results should motivate investigations of alternative mechanisms of death in SERVE-HF.”
The CAT-HF trial was funded by ResMed, a company that markets adaptive servo ventilation equipment. Dr. Piccini has received research support from ResMed and from Janssen, Gilead, St. Jude, Spectranetics, and he has been a consultant to Janssen, Spectranetics, Medtronic, GSK and BMS-Pfizer. Dr. O’Connor has been a consultant to ResMed and to several other drug and device companies.
[email protected]
On Twitter @mitchelzoler
Key clinical point:
Major finding: After 6 months, ASV produced a relative 21% drop in atrial fibrillation burden, compared with increased burden in control patients.
Data source: CAT-HF, a multicenter randomized trial that enrolled 126 heart failure patients with sleep apnea.
Disclosures: The CAT-HF trial was funded by ResMed, a company that markets adaptive servo ventilation equipment. Dr. Piccini has received research support and/or consultant fees from ResMed, Janssen, Gilead, St. Jude, Spectranetics, Medtronic, GSK and BMS-Pfizer.
Recognizing anti-NMDA receptor encephalitis psychosis on the psych ward
VIENNA – Prominent psychiatric symptoms are common in patients with anti-N-methyl-D-asparate receptor (NMDAR) encephalitis and often occur prior to onset of obvious neurologic symptoms, Maarten J. Titulaer, MD, PhD, said at the annual congress of the European College of Neuropsychopharmacology.
Moreover, occasionally the psychiatric symptoms occur in isolation without neurologic involvement, as was the case in 4% of a series of 501 patients with confirmed anti-NMDAR encephalitis reported by Dr. Titulaer and coinvestigators. The most prominent symptoms included delusional thinking, aggression, and mood disturbances, which were usually manic (JAMA Neurol. 2013 Sep 1;70[9]:1133-9).
Anti-NMDAR encephalitis is an autoimmune disorder in which autoantibodies directed at NMDA receptors on neuronal plasma membranes induce severe neurologic and often psychiatric symptoms.
Red flags that raise the chance that a patient on the psychiatric ward with new-onset psychosis or mania might have primary anti-NMDAR encephalitis and should undergo diagnostic testing include autonomic disturbances such as tachycardia, fever, or hypertension, mild neurologic symptoms such as facial twitching, as well as catatonia, seizures, mutism, or development of extrapyramidal symptoms when placed on an antipsychotic agent. Anti-NMDAR encephalitis can have a relapsing course, so any behavioral change in a patient with a history of the disorder might signal relapse.
Certain cancers are strongly associated with anti-NMDAR encephalitis. New-onset psychotic or manic patients with a history of ovarian teratoma, small cell lung cancer, breast cancer, or thymoma should be tested for anti-NMDAR encephalitis. And conversely, screening for those tumors in occult form is warranted in patients with confirmed anti-NMDAR encephalitis, according to Dr. Titulaer.
Systematic screening for anti-NMDAR encephalitis should also be considered in women with severe acute psychosis during the postpartum period, particularly in the setting of extrapyramidal side effects of antipsychotic agents. Two of 96 consecutive women with acute-onset postpartum psychosis in a series reported by Dr. Titulaer and colleagues were antibody-positive for the disorder, and neither had an ovarian teratoma (Am J Psychiatry. 2015 Sep 1;172[9]:901-8).
If a patient hasn’t developed neurologic symptoms within 4 weeks after onset of psychiatric symptoms, anti-NMDAR psychosis becomes far less likely.
Some neurologists have suggested the presence of other autoimmune disorders in psychiatric patients is associated with increased likelihood that the psychiatric symptoms are secondary to anti-NMDAR encephalitis, but Dr. Titulaer doesn’t find the evidence to date persuasive.
The diagnosis of anti-NMDAR encephalitis hinges on the finding of IgG antibodies against the NR1 subunit of the NMDAR. But Dr. Titulaer and coinvestigators have shown there are testing pitfalls: The first-line commercially available cell-based serum assays have a sensitivity of roughly 75% along with 97%-99% specificity, so by relying solely on the cell-based assays a physician might miss one in four cases of anti-NMDAR encephalitis and wrongly diagnose the disease in 0.4%-3% of healthy individuals (Lancet Neurol. 2014 Feb;13[2]:167-77).
For this reason, a positive serum test should be confirmed by a cell-based assay of a cerebrospinal fluid (CSF) sample, which has 100% sensitivity and specificity. And if the serum assay is negative but anti-NMDAR is suspected based on clinical grounds or history, go ahead and test the CSF, the neurologist advised.
Other tools that can be helpful in making the diagnosis include the EEG, which is abnormal in 89% of patients with anti-NMDAR encephalitis. Thirty percent of affected patients will display a highly specific EEG abnormality called extreme delta brushes (Neurology. 2012 Sep 11;79[11]:1094-100).
Dr. Titulaer said that this extreme delta brushes pattern is not seen on the regular psychiatry ward, but only in the ICU, when the patient is severely ill. He has yet to see the first convincing extreme delta brushes pattern in a patient outside the ICU.
Brain MRI has proved “very disappointing,” as it’s abnormal in only one-third of patients with anti-NMDAR encephalitis, he continued.
First-line immunotherapy is corticosteroids, plasmapheresis, and/or intravenous immunoglobulin. In a series of 501 patients who received first-line immunotherapy or tumor removal, 53% improved within 4 weeks. Fifty-seven percent of those who didn’t then got second-line immunotherapy with rituximab (Rituxan) or cyclophosphamide. Outcomes continued to improve for up to 18 months following symptom onset. At 24 months of follow-up, just over 80% of patients in this observational study had a good outcome as defined by a modified Rankin scale score of 0-2, meaning they were living independently with no or minimal disability.
“Not bad, especially considering that the patients who didn’t improve on first-line therapy were in the ICU for a median of 6 weeks,” the neurologist observed.
“It’s important to diagnose patients with anti-NMDAR encephalitis,” he stressed. “Treatment might be difficult. You might need to be very aggressive. But in the end there are very good outcomes. It’s very rewarding to treat these patients.”
In multivariate analysis, Dr. Titulaer and coworkers identified earlier treatment and milder illness as reflected in no ICU admission as significant predictors of good outcome in the study population. Also, the use of second-line immunotherapy in nonresponders to first-line therapy was independently associated with a 2.69-fold increased likelihood of good outcome (Lancet Neurol. 2013 Feb;12[2]:157-65).
Twelve percent of patients experienced one or more relapses within 2 years.
In a separate study of 661 patients with anti-NMDAR encephalitis, only 31 were aged 45 years or older. They had less severe disease than the younger adults but a paradoxically worse outcome, possibly because their median time to diagnosis was twice as long. At 2 years, 60% of the patients aged 45 and up had full or substantial recovery (Neurology. 2013 Sep 17;81[12]:1058-63).
He stressed that treatment of anti-NMDAR encephalitis ought to be an interdisciplinary effort. Psychiatrists will typically not be the ones who administer the potent immunotherapy. But most patients will have behavioral problems in the very early and late phases that warrant psychiatric therapy. Dr. Titulaer suggested psychiatrists steer clear of haloperidol in these patients because it can exacerbate motor symptoms.
Asked if there are any specific patterns of movement disorders linked to anti-NMDAR encephalitis that might raise a psychiatrist’s index of suspicion, the neurologist replied no. Almost all the movement disorders have been seen in psychiatric patients with anti-NMDAR encephalitis. The one specific movement disorder that strongly suggests anti-NMDAR encephalitis is post–herpes simplex virus (HSV) encephalitis choreoathetosis. It appears that HSV encephalitis can trigger formation of NMDAR autoantibodies, resulting in onset of choreoathetosis 3-6 weeks after the HSV encephalopathy.
Dr. Titulaer reported having no financial conflicts of interest in regard to his presentation.
*This story was updated 1/26/2017.
VIENNA – Prominent psychiatric symptoms are common in patients with anti-N-methyl-D-asparate receptor (NMDAR) encephalitis and often occur prior to onset of obvious neurologic symptoms, Maarten J. Titulaer, MD, PhD, said at the annual congress of the European College of Neuropsychopharmacology.
Moreover, occasionally the psychiatric symptoms occur in isolation without neurologic involvement, as was the case in 4% of a series of 501 patients with confirmed anti-NMDAR encephalitis reported by Dr. Titulaer and coinvestigators. The most prominent symptoms included delusional thinking, aggression, and mood disturbances, which were usually manic (JAMA Neurol. 2013 Sep 1;70[9]:1133-9).
Anti-NMDAR encephalitis is an autoimmune disorder in which autoantibodies directed at NMDA receptors on neuronal plasma membranes induce severe neurologic and often psychiatric symptoms.
Red flags that raise the chance that a patient on the psychiatric ward with new-onset psychosis or mania might have primary anti-NMDAR encephalitis and should undergo diagnostic testing include autonomic disturbances such as tachycardia, fever, or hypertension, mild neurologic symptoms such as facial twitching, as well as catatonia, seizures, mutism, or development of extrapyramidal symptoms when placed on an antipsychotic agent. Anti-NMDAR encephalitis can have a relapsing course, so any behavioral change in a patient with a history of the disorder might signal relapse.
Certain cancers are strongly associated with anti-NMDAR encephalitis. New-onset psychotic or manic patients with a history of ovarian teratoma, small cell lung cancer, breast cancer, or thymoma should be tested for anti-NMDAR encephalitis. And conversely, screening for those tumors in occult form is warranted in patients with confirmed anti-NMDAR encephalitis, according to Dr. Titulaer.
Systematic screening for anti-NMDAR encephalitis should also be considered in women with severe acute psychosis during the postpartum period, particularly in the setting of extrapyramidal side effects of antipsychotic agents. Two of 96 consecutive women with acute-onset postpartum psychosis in a series reported by Dr. Titulaer and colleagues were antibody-positive for the disorder, and neither had an ovarian teratoma (Am J Psychiatry. 2015 Sep 1;172[9]:901-8).
If a patient hasn’t developed neurologic symptoms within 4 weeks after onset of psychiatric symptoms, anti-NMDAR psychosis becomes far less likely.
Some neurologists have suggested the presence of other autoimmune disorders in psychiatric patients is associated with increased likelihood that the psychiatric symptoms are secondary to anti-NMDAR encephalitis, but Dr. Titulaer doesn’t find the evidence to date persuasive.
The diagnosis of anti-NMDAR encephalitis hinges on the finding of IgG antibodies against the NR1 subunit of the NMDAR. But Dr. Titulaer and coinvestigators have shown there are testing pitfalls: The first-line commercially available cell-based serum assays have a sensitivity of roughly 75% along with 97%-99% specificity, so by relying solely on the cell-based assays a physician might miss one in four cases of anti-NMDAR encephalitis and wrongly diagnose the disease in 0.4%-3% of healthy individuals (Lancet Neurol. 2014 Feb;13[2]:167-77).
For this reason, a positive serum test should be confirmed by a cell-based assay of a cerebrospinal fluid (CSF) sample, which has 100% sensitivity and specificity. And if the serum assay is negative but anti-NMDAR is suspected based on clinical grounds or history, go ahead and test the CSF, the neurologist advised.
Other tools that can be helpful in making the diagnosis include the EEG, which is abnormal in 89% of patients with anti-NMDAR encephalitis. Thirty percent of affected patients will display a highly specific EEG abnormality called extreme delta brushes (Neurology. 2012 Sep 11;79[11]:1094-100).
Dr. Titulaer said that this extreme delta brushes pattern is not seen on the regular psychiatry ward, but only in the ICU, when the patient is severely ill. He has yet to see the first convincing extreme delta brushes pattern in a patient outside the ICU.
Brain MRI has proved “very disappointing,” as it’s abnormal in only one-third of patients with anti-NMDAR encephalitis, he continued.
First-line immunotherapy is corticosteroids, plasmapheresis, and/or intravenous immunoglobulin. In a series of 501 patients who received first-line immunotherapy or tumor removal, 53% improved within 4 weeks. Fifty-seven percent of those who didn’t then got second-line immunotherapy with rituximab (Rituxan) or cyclophosphamide. Outcomes continued to improve for up to 18 months following symptom onset. At 24 months of follow-up, just over 80% of patients in this observational study had a good outcome as defined by a modified Rankin scale score of 0-2, meaning they were living independently with no or minimal disability.
“Not bad, especially considering that the patients who didn’t improve on first-line therapy were in the ICU for a median of 6 weeks,” the neurologist observed.
“It’s important to diagnose patients with anti-NMDAR encephalitis,” he stressed. “Treatment might be difficult. You might need to be very aggressive. But in the end there are very good outcomes. It’s very rewarding to treat these patients.”
In multivariate analysis, Dr. Titulaer and coworkers identified earlier treatment and milder illness as reflected in no ICU admission as significant predictors of good outcome in the study population. Also, the use of second-line immunotherapy in nonresponders to first-line therapy was independently associated with a 2.69-fold increased likelihood of good outcome (Lancet Neurol. 2013 Feb;12[2]:157-65).
Twelve percent of patients experienced one or more relapses within 2 years.
In a separate study of 661 patients with anti-NMDAR encephalitis, only 31 were aged 45 years or older. They had less severe disease than the younger adults but a paradoxically worse outcome, possibly because their median time to diagnosis was twice as long. At 2 years, 60% of the patients aged 45 and up had full or substantial recovery (Neurology. 2013 Sep 17;81[12]:1058-63).
He stressed that treatment of anti-NMDAR encephalitis ought to be an interdisciplinary effort. Psychiatrists will typically not be the ones who administer the potent immunotherapy. But most patients will have behavioral problems in the very early and late phases that warrant psychiatric therapy. Dr. Titulaer suggested psychiatrists steer clear of haloperidol in these patients because it can exacerbate motor symptoms.
Asked if there are any specific patterns of movement disorders linked to anti-NMDAR encephalitis that might raise a psychiatrist’s index of suspicion, the neurologist replied no. Almost all the movement disorders have been seen in psychiatric patients with anti-NMDAR encephalitis. The one specific movement disorder that strongly suggests anti-NMDAR encephalitis is post–herpes simplex virus (HSV) encephalitis choreoathetosis. It appears that HSV encephalitis can trigger formation of NMDAR autoantibodies, resulting in onset of choreoathetosis 3-6 weeks after the HSV encephalopathy.
Dr. Titulaer reported having no financial conflicts of interest in regard to his presentation.
*This story was updated 1/26/2017.
VIENNA – Prominent psychiatric symptoms are common in patients with anti-N-methyl-D-asparate receptor (NMDAR) encephalitis and often occur prior to onset of obvious neurologic symptoms, Maarten J. Titulaer, MD, PhD, said at the annual congress of the European College of Neuropsychopharmacology.
Moreover, occasionally the psychiatric symptoms occur in isolation without neurologic involvement, as was the case in 4% of a series of 501 patients with confirmed anti-NMDAR encephalitis reported by Dr. Titulaer and coinvestigators. The most prominent symptoms included delusional thinking, aggression, and mood disturbances, which were usually manic (JAMA Neurol. 2013 Sep 1;70[9]:1133-9).
Anti-NMDAR encephalitis is an autoimmune disorder in which autoantibodies directed at NMDA receptors on neuronal plasma membranes induce severe neurologic and often psychiatric symptoms.
Red flags that raise the chance that a patient on the psychiatric ward with new-onset psychosis or mania might have primary anti-NMDAR encephalitis and should undergo diagnostic testing include autonomic disturbances such as tachycardia, fever, or hypertension, mild neurologic symptoms such as facial twitching, as well as catatonia, seizures, mutism, or development of extrapyramidal symptoms when placed on an antipsychotic agent. Anti-NMDAR encephalitis can have a relapsing course, so any behavioral change in a patient with a history of the disorder might signal relapse.
Certain cancers are strongly associated with anti-NMDAR encephalitis. New-onset psychotic or manic patients with a history of ovarian teratoma, small cell lung cancer, breast cancer, or thymoma should be tested for anti-NMDAR encephalitis. And conversely, screening for those tumors in occult form is warranted in patients with confirmed anti-NMDAR encephalitis, according to Dr. Titulaer.
Systematic screening for anti-NMDAR encephalitis should also be considered in women with severe acute psychosis during the postpartum period, particularly in the setting of extrapyramidal side effects of antipsychotic agents. Two of 96 consecutive women with acute-onset postpartum psychosis in a series reported by Dr. Titulaer and colleagues were antibody-positive for the disorder, and neither had an ovarian teratoma (Am J Psychiatry. 2015 Sep 1;172[9]:901-8).
If a patient hasn’t developed neurologic symptoms within 4 weeks after onset of psychiatric symptoms, anti-NMDAR psychosis becomes far less likely.
Some neurologists have suggested the presence of other autoimmune disorders in psychiatric patients is associated with increased likelihood that the psychiatric symptoms are secondary to anti-NMDAR encephalitis, but Dr. Titulaer doesn’t find the evidence to date persuasive.
The diagnosis of anti-NMDAR encephalitis hinges on the finding of IgG antibodies against the NR1 subunit of the NMDAR. But Dr. Titulaer and coinvestigators have shown there are testing pitfalls: The first-line commercially available cell-based serum assays have a sensitivity of roughly 75% along with 97%-99% specificity, so by relying solely on the cell-based assays a physician might miss one in four cases of anti-NMDAR encephalitis and wrongly diagnose the disease in 0.4%-3% of healthy individuals (Lancet Neurol. 2014 Feb;13[2]:167-77).
For this reason, a positive serum test should be confirmed by a cell-based assay of a cerebrospinal fluid (CSF) sample, which has 100% sensitivity and specificity. And if the serum assay is negative but anti-NMDAR is suspected based on clinical grounds or history, go ahead and test the CSF, the neurologist advised.
Other tools that can be helpful in making the diagnosis include the EEG, which is abnormal in 89% of patients with anti-NMDAR encephalitis. Thirty percent of affected patients will display a highly specific EEG abnormality called extreme delta brushes (Neurology. 2012 Sep 11;79[11]:1094-100).
Dr. Titulaer said that this extreme delta brushes pattern is not seen on the regular psychiatry ward, but only in the ICU, when the patient is severely ill. He has yet to see the first convincing extreme delta brushes pattern in a patient outside the ICU.
Brain MRI has proved “very disappointing,” as it’s abnormal in only one-third of patients with anti-NMDAR encephalitis, he continued.
First-line immunotherapy is corticosteroids, plasmapheresis, and/or intravenous immunoglobulin. In a series of 501 patients who received first-line immunotherapy or tumor removal, 53% improved within 4 weeks. Fifty-seven percent of those who didn’t then got second-line immunotherapy with rituximab (Rituxan) or cyclophosphamide. Outcomes continued to improve for up to 18 months following symptom onset. At 24 months of follow-up, just over 80% of patients in this observational study had a good outcome as defined by a modified Rankin scale score of 0-2, meaning they were living independently with no or minimal disability.
“Not bad, especially considering that the patients who didn’t improve on first-line therapy were in the ICU for a median of 6 weeks,” the neurologist observed.
“It’s important to diagnose patients with anti-NMDAR encephalitis,” he stressed. “Treatment might be difficult. You might need to be very aggressive. But in the end there are very good outcomes. It’s very rewarding to treat these patients.”
In multivariate analysis, Dr. Titulaer and coworkers identified earlier treatment and milder illness as reflected in no ICU admission as significant predictors of good outcome in the study population. Also, the use of second-line immunotherapy in nonresponders to first-line therapy was independently associated with a 2.69-fold increased likelihood of good outcome (Lancet Neurol. 2013 Feb;12[2]:157-65).
Twelve percent of patients experienced one or more relapses within 2 years.
In a separate study of 661 patients with anti-NMDAR encephalitis, only 31 were aged 45 years or older. They had less severe disease than the younger adults but a paradoxically worse outcome, possibly because their median time to diagnosis was twice as long. At 2 years, 60% of the patients aged 45 and up had full or substantial recovery (Neurology. 2013 Sep 17;81[12]:1058-63).
He stressed that treatment of anti-NMDAR encephalitis ought to be an interdisciplinary effort. Psychiatrists will typically not be the ones who administer the potent immunotherapy. But most patients will have behavioral problems in the very early and late phases that warrant psychiatric therapy. Dr. Titulaer suggested psychiatrists steer clear of haloperidol in these patients because it can exacerbate motor symptoms.
Asked if there are any specific patterns of movement disorders linked to anti-NMDAR encephalitis that might raise a psychiatrist’s index of suspicion, the neurologist replied no. Almost all the movement disorders have been seen in psychiatric patients with anti-NMDAR encephalitis. The one specific movement disorder that strongly suggests anti-NMDAR encephalitis is post–herpes simplex virus (HSV) encephalitis choreoathetosis. It appears that HSV encephalitis can trigger formation of NMDAR autoantibodies, resulting in onset of choreoathetosis 3-6 weeks after the HSV encephalopathy.
Dr. Titulaer reported having no financial conflicts of interest in regard to his presentation.
*This story was updated 1/26/2017.
Advanced heart failure symptoms linked to mortality
ORLANDO – Advanced heart failure patients who are hospitalized for heart failure and have a higher symptom burden at discharge have a significantly increased rate of death or rehospitalization over the next 6 months, based on an analysis of 393 patients enrolled in a heart failure trial.
The strong link between severe symptom burden and poor near-term outcomes persisted despite adjustment for various markers of heart failure severity, suggesting that treatment aimed at reducing symptoms may be able to reduce mortality or heart failure hospitalization in advanced heart failure patients, Ellen K. Hummel, MD, said at the annual scientific meeting of the Heart Failure Society of America.
In her analysis, a severe symptom burden at the time of hospital discharge linked with an adjusted 2.9-fold increased mortality rate and a 2.5-fold increased rate of days dead or hospitalized during the next 6 months, said Dr. Hummel, a geriatric and palliative care specialist at the University of Michigan in Ann Arbor. These elevated rate ratios for patients with severe symptoms at hospital discharge were in comparison to the ratios for advanced heart failure patients in the study with no symptoms at discharge.
Three symptoms contributed to the symptom score she used in her analysis: fatigue, scored on a scale of 0-3; dyspnea, also scored 0-3; and gastrointestinal distress, scored as 0-2, creating a maximum score of 8. Her analysis categorized mild as a total score of 1-4 and severe as 5 or greater. In the study population she used for her analysis, patients enrolled in the multicenter ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) trial, 111 of the 393 evaluable patients (28%) had none of these symptoms, 239 (61%) had mild symptoms, and 43 (11%) had severe symptoms. Scoring was done by patients based on their subjective self-assessment at the time of hospital discharge.
The absolute, observed 6-month mortality rates were roughly 45% among patients with severe symptoms, about 17% in patients with mild symptoms, and about 12% in those with no symptoms.
The primary purpose of ESCAPE was to assess the impact that routine collection of data from a pulmonary artery catheter during hospitalization has on outcomes; the results showed no significant link between improved outcomes and getting these data (JAMA. 2005 Oct 5;294[13]:1625-33). The study ran during 2000-2003 at 26 centers in the United States and Canada. Of the 433 advanced heart failure patients enrolled in ESCAPE, 393 had complete records to allow the current analysis.
The adjustments that Dr. Hummel made in the proportional hazard analysis took into account New York Heart Association class, and severity of disease at the time of hospital discharge measured by the ESCAPE Discharge Risk Score. This score takes into account age, 6-minute walk distance, blood urea nitrogen, brain natriuretic peptide levels, blood pressure, selected drug treatments, sodium level, and history of cardiopulmonary resuscitation or mechanical ventilation.
Dr. Hummel had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
ORLANDO – Advanced heart failure patients who are hospitalized for heart failure and have a higher symptom burden at discharge have a significantly increased rate of death or rehospitalization over the next 6 months, based on an analysis of 393 patients enrolled in a heart failure trial.
The strong link between severe symptom burden and poor near-term outcomes persisted despite adjustment for various markers of heart failure severity, suggesting that treatment aimed at reducing symptoms may be able to reduce mortality or heart failure hospitalization in advanced heart failure patients, Ellen K. Hummel, MD, said at the annual scientific meeting of the Heart Failure Society of America.
In her analysis, a severe symptom burden at the time of hospital discharge linked with an adjusted 2.9-fold increased mortality rate and a 2.5-fold increased rate of days dead or hospitalized during the next 6 months, said Dr. Hummel, a geriatric and palliative care specialist at the University of Michigan in Ann Arbor. These elevated rate ratios for patients with severe symptoms at hospital discharge were in comparison to the ratios for advanced heart failure patients in the study with no symptoms at discharge.
Three symptoms contributed to the symptom score she used in her analysis: fatigue, scored on a scale of 0-3; dyspnea, also scored 0-3; and gastrointestinal distress, scored as 0-2, creating a maximum score of 8. Her analysis categorized mild as a total score of 1-4 and severe as 5 or greater. In the study population she used for her analysis, patients enrolled in the multicenter ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) trial, 111 of the 393 evaluable patients (28%) had none of these symptoms, 239 (61%) had mild symptoms, and 43 (11%) had severe symptoms. Scoring was done by patients based on their subjective self-assessment at the time of hospital discharge.
The absolute, observed 6-month mortality rates were roughly 45% among patients with severe symptoms, about 17% in patients with mild symptoms, and about 12% in those with no symptoms.
The primary purpose of ESCAPE was to assess the impact that routine collection of data from a pulmonary artery catheter during hospitalization has on outcomes; the results showed no significant link between improved outcomes and getting these data (JAMA. 2005 Oct 5;294[13]:1625-33). The study ran during 2000-2003 at 26 centers in the United States and Canada. Of the 433 advanced heart failure patients enrolled in ESCAPE, 393 had complete records to allow the current analysis.
The adjustments that Dr. Hummel made in the proportional hazard analysis took into account New York Heart Association class, and severity of disease at the time of hospital discharge measured by the ESCAPE Discharge Risk Score. This score takes into account age, 6-minute walk distance, blood urea nitrogen, brain natriuretic peptide levels, blood pressure, selected drug treatments, sodium level, and history of cardiopulmonary resuscitation or mechanical ventilation.
Dr. Hummel had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
ORLANDO – Advanced heart failure patients who are hospitalized for heart failure and have a higher symptom burden at discharge have a significantly increased rate of death or rehospitalization over the next 6 months, based on an analysis of 393 patients enrolled in a heart failure trial.
The strong link between severe symptom burden and poor near-term outcomes persisted despite adjustment for various markers of heart failure severity, suggesting that treatment aimed at reducing symptoms may be able to reduce mortality or heart failure hospitalization in advanced heart failure patients, Ellen K. Hummel, MD, said at the annual scientific meeting of the Heart Failure Society of America.
In her analysis, a severe symptom burden at the time of hospital discharge linked with an adjusted 2.9-fold increased mortality rate and a 2.5-fold increased rate of days dead or hospitalized during the next 6 months, said Dr. Hummel, a geriatric and palliative care specialist at the University of Michigan in Ann Arbor. These elevated rate ratios for patients with severe symptoms at hospital discharge were in comparison to the ratios for advanced heart failure patients in the study with no symptoms at discharge.
Three symptoms contributed to the symptom score she used in her analysis: fatigue, scored on a scale of 0-3; dyspnea, also scored 0-3; and gastrointestinal distress, scored as 0-2, creating a maximum score of 8. Her analysis categorized mild as a total score of 1-4 and severe as 5 or greater. In the study population she used for her analysis, patients enrolled in the multicenter ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) trial, 111 of the 393 evaluable patients (28%) had none of these symptoms, 239 (61%) had mild symptoms, and 43 (11%) had severe symptoms. Scoring was done by patients based on their subjective self-assessment at the time of hospital discharge.
The absolute, observed 6-month mortality rates were roughly 45% among patients with severe symptoms, about 17% in patients with mild symptoms, and about 12% in those with no symptoms.
The primary purpose of ESCAPE was to assess the impact that routine collection of data from a pulmonary artery catheter during hospitalization has on outcomes; the results showed no significant link between improved outcomes and getting these data (JAMA. 2005 Oct 5;294[13]:1625-33). The study ran during 2000-2003 at 26 centers in the United States and Canada. Of the 433 advanced heart failure patients enrolled in ESCAPE, 393 had complete records to allow the current analysis.
The adjustments that Dr. Hummel made in the proportional hazard analysis took into account New York Heart Association class, and severity of disease at the time of hospital discharge measured by the ESCAPE Discharge Risk Score. This score takes into account age, 6-minute walk distance, blood urea nitrogen, brain natriuretic peptide levels, blood pressure, selected drug treatments, sodium level, and history of cardiopulmonary resuscitation or mechanical ventilation.
Dr. Hummel had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE HFSA ANNUAL SCIENTIFIC MEETING
Key clinical point:
Major finding: Patients with severe symptoms at discharge had a 2.9-fold increased rate of death, compared with those with no symptoms.
Data source: A post hoc analysis of data collected from 393 patients enrolled in the ESCAPE trial.
Disclosures: Dr. Hummel had no relevant financial disclosures.
Telehealth has value in Parkinson’s and poststroke care
BALTIMORE – The broadening of access to medical care through telemedicine that’s been occurring for acute neurologic conditions such as stroke has begun to expand to care for more chronic conditions such as Parkinson’s disease and poststroke recovery, according to presentations given at the annual meeting of the American Neurological Association.
Telemedicine care for patients with Parkinson’s appears feasible and acceptable to both patients and clinicians alike, based on recent findings. Ray Dorsey, MD, of the University of Rochester (N.Y.) initiated the Connect.Parkinson study with his colleagues in 2014 to compare usual care enhanced with educational materials against others who received usual care, educational materials, and four virtual sessions with a Parkinson’s disease specialist from 1 of 18 neurology centers nationwide. Some of the participants who lived far away from one of these centers would not otherwise have received such specialized care (Telemed J E Health. 2016;22[7]:590-8).
The participating physicians had concerns about the quality of the video connection, but otherwise were satisfied with the care delivered to the patients. Surveys of participants revealed no differences between the two groups in quality of life and quality of care. About 80% of those who received virtual calls preferred this contact to the regular office visits.
The development of smartphone apps that allow aspects of diseases like Parkinson’s to be monitored are also enabling high-quality, diagnostic telecare. A pilot study of an Android smartphone Parkinson’s disease app by Dr. Dorsey and his colleagues demonstrated its utility in tests of voice, postural sway, gait, finger tapping, and reaction time (Parkinsonism Relat Disord. 2015;21[6]:650-3).
Since that study was completed, an iOS smartphone version of the app, called mPower, has been developed and has enrolled many Parkinson’s disease patients. The technology is being tested to virtually gauge Parkinson’s disease symptoms and the effects of medications on them. This has opened the door to the world of virtual clinical trials and longitudinal studies targeting genetic subpopulations, Dr. Dorsey said at the meeting.
The telehealth portion of COMPASS – in the form of regular phone calls and web-based feedback – enables better stroke care following hospital discharge by keeping track of common complications that are partly responsible for a readmittance rate of around 25% within 90 days of hospital discharge and tracking physiological aspects like blood pressure, diabetes, diet, exercise, and smoking.
The pilot demonstration of the potential of the program was pivotal in securing funding for a cluster-randomized pragmatic trial. The trial will randomize hospitals to normal discharge or discharge followed by regular poststroke contact. Patient functional status at 90 days post stroke will be assessed for 1 year. After the year, the hospitals randomized to COMPASS care delivery will continue this care, and the hospitals offering normal discharge will also adopt this poststroke service care. Patient outcome will be followed for another year.
The anticipated patient enrollment is 5,400. Results from the first year of the 2-year study are expected in Spring 2018. “COMPASS will have an impact on the post-acute stroke care pathway. After evaluating the effectiveness, the goal is to disseminate and scale to other settings,” Dr. Bushnell said at the meeting.
Dr. Dorsey receives research support from Excellus BlueCross BlueShield, Google, and the Verizon Foundation. He has received compensation for consulting services for Medtronic and owns stock options in ConsultingMD. Dr. Bushnell acknowledged salary support from the COMPASS program, which receives funding from the Patient-Centered Outcomes Research Institute.
BALTIMORE – The broadening of access to medical care through telemedicine that’s been occurring for acute neurologic conditions such as stroke has begun to expand to care for more chronic conditions such as Parkinson’s disease and poststroke recovery, according to presentations given at the annual meeting of the American Neurological Association.
Telemedicine care for patients with Parkinson’s appears feasible and acceptable to both patients and clinicians alike, based on recent findings. Ray Dorsey, MD, of the University of Rochester (N.Y.) initiated the Connect.Parkinson study with his colleagues in 2014 to compare usual care enhanced with educational materials against others who received usual care, educational materials, and four virtual sessions with a Parkinson’s disease specialist from 1 of 18 neurology centers nationwide. Some of the participants who lived far away from one of these centers would not otherwise have received such specialized care (Telemed J E Health. 2016;22[7]:590-8).
The participating physicians had concerns about the quality of the video connection, but otherwise were satisfied with the care delivered to the patients. Surveys of participants revealed no differences between the two groups in quality of life and quality of care. About 80% of those who received virtual calls preferred this contact to the regular office visits.
The development of smartphone apps that allow aspects of diseases like Parkinson’s to be monitored are also enabling high-quality, diagnostic telecare. A pilot study of an Android smartphone Parkinson’s disease app by Dr. Dorsey and his colleagues demonstrated its utility in tests of voice, postural sway, gait, finger tapping, and reaction time (Parkinsonism Relat Disord. 2015;21[6]:650-3).
Since that study was completed, an iOS smartphone version of the app, called mPower, has been developed and has enrolled many Parkinson’s disease patients. The technology is being tested to virtually gauge Parkinson’s disease symptoms and the effects of medications on them. This has opened the door to the world of virtual clinical trials and longitudinal studies targeting genetic subpopulations, Dr. Dorsey said at the meeting.
The telehealth portion of COMPASS – in the form of regular phone calls and web-based feedback – enables better stroke care following hospital discharge by keeping track of common complications that are partly responsible for a readmittance rate of around 25% within 90 days of hospital discharge and tracking physiological aspects like blood pressure, diabetes, diet, exercise, and smoking.
The pilot demonstration of the potential of the program was pivotal in securing funding for a cluster-randomized pragmatic trial. The trial will randomize hospitals to normal discharge or discharge followed by regular poststroke contact. Patient functional status at 90 days post stroke will be assessed for 1 year. After the year, the hospitals randomized to COMPASS care delivery will continue this care, and the hospitals offering normal discharge will also adopt this poststroke service care. Patient outcome will be followed for another year.
The anticipated patient enrollment is 5,400. Results from the first year of the 2-year study are expected in Spring 2018. “COMPASS will have an impact on the post-acute stroke care pathway. After evaluating the effectiveness, the goal is to disseminate and scale to other settings,” Dr. Bushnell said at the meeting.
Dr. Dorsey receives research support from Excellus BlueCross BlueShield, Google, and the Verizon Foundation. He has received compensation for consulting services for Medtronic and owns stock options in ConsultingMD. Dr. Bushnell acknowledged salary support from the COMPASS program, which receives funding from the Patient-Centered Outcomes Research Institute.
BALTIMORE – The broadening of access to medical care through telemedicine that’s been occurring for acute neurologic conditions such as stroke has begun to expand to care for more chronic conditions such as Parkinson’s disease and poststroke recovery, according to presentations given at the annual meeting of the American Neurological Association.
Telemedicine care for patients with Parkinson’s appears feasible and acceptable to both patients and clinicians alike, based on recent findings. Ray Dorsey, MD, of the University of Rochester (N.Y.) initiated the Connect.Parkinson study with his colleagues in 2014 to compare usual care enhanced with educational materials against others who received usual care, educational materials, and four virtual sessions with a Parkinson’s disease specialist from 1 of 18 neurology centers nationwide. Some of the participants who lived far away from one of these centers would not otherwise have received such specialized care (Telemed J E Health. 2016;22[7]:590-8).
The participating physicians had concerns about the quality of the video connection, but otherwise were satisfied with the care delivered to the patients. Surveys of participants revealed no differences between the two groups in quality of life and quality of care. About 80% of those who received virtual calls preferred this contact to the regular office visits.
The development of smartphone apps that allow aspects of diseases like Parkinson’s to be monitored are also enabling high-quality, diagnostic telecare. A pilot study of an Android smartphone Parkinson’s disease app by Dr. Dorsey and his colleagues demonstrated its utility in tests of voice, postural sway, gait, finger tapping, and reaction time (Parkinsonism Relat Disord. 2015;21[6]:650-3).
Since that study was completed, an iOS smartphone version of the app, called mPower, has been developed and has enrolled many Parkinson’s disease patients. The technology is being tested to virtually gauge Parkinson’s disease symptoms and the effects of medications on them. This has opened the door to the world of virtual clinical trials and longitudinal studies targeting genetic subpopulations, Dr. Dorsey said at the meeting.
The telehealth portion of COMPASS – in the form of regular phone calls and web-based feedback – enables better stroke care following hospital discharge by keeping track of common complications that are partly responsible for a readmittance rate of around 25% within 90 days of hospital discharge and tracking physiological aspects like blood pressure, diabetes, diet, exercise, and smoking.
The pilot demonstration of the potential of the program was pivotal in securing funding for a cluster-randomized pragmatic trial. The trial will randomize hospitals to normal discharge or discharge followed by regular poststroke contact. Patient functional status at 90 days post stroke will be assessed for 1 year. After the year, the hospitals randomized to COMPASS care delivery will continue this care, and the hospitals offering normal discharge will also adopt this poststroke service care. Patient outcome will be followed for another year.
The anticipated patient enrollment is 5,400. Results from the first year of the 2-year study are expected in Spring 2018. “COMPASS will have an impact on the post-acute stroke care pathway. After evaluating the effectiveness, the goal is to disseminate and scale to other settings,” Dr. Bushnell said at the meeting.
Dr. Dorsey receives research support from Excellus BlueCross BlueShield, Google, and the Verizon Foundation. He has received compensation for consulting services for Medtronic and owns stock options in ConsultingMD. Dr. Bushnell acknowledged salary support from the COMPASS program, which receives funding from the Patient-Centered Outcomes Research Institute.
EXPERT ANALYSIS FROM ANA 2016
Ezetimibe’s ACS benefit centers on high-risk, post-CABG patients
ROME – Patients who have undergone coronary artery bypass surgery and who later have an acute coronary syndrome event gain the most from an aggressive lipid-lowering regimen, according to an exploratory analysis of data from more than 18,000 patients enrolled in the IMPROVE-IT trial that tested the incremental benefit from ezetimibe treatment when added to a statin.
Additional exploratory analyses further showed that high-risk acute coronary syndrome (ACS) patients without a history of coronary artery bypass grafting (CABG) also benefited from adding ezetimibe to a background regimen of simvastatin, but the benefit from adding ezetimibe completely disappeared in low-risk ACS patients, Alon Eisen, MD, said at the annual congress of the European Society of Cardiology.
‘The benefit of adding ezetimibe to a statin was enhanced in patients with prior CABG and in other high-risk patients with no prior CABG, supporting the use of more intensive lipid-lowering therapy in these high-risk patients,” said Dr. Eisen, a cardiologist at Brigham and Women’s Hospital in Boston. He also highlighted that ezetimibe is “a safe drug that is coming off patent.” Adding ezetimibe had a moderate effect on LDL cholesterol levels, cutting them from a median of 70 mg/dL in patients in the placebo arm to a median of 54 mg/dL in the group who received ezetimibe.
These results “show that if we pick the right patients, a very benign drug can have a great benefit,” said Eugene Braunwald, MD, a coinvestigator on the IMPROVE-IT trial and a collaborator with Dr. Eisen on the new analysis. The new findings “emphasize that the higher a patient’s risk, the more effect they get from cholesterol-lowering treatment,” said Dr. Braunwald, professor of medicine at Harvard University and a cardiologist at Brigham and Women’s Hospital, both in Boston.
The second exploratory analysis reported by Dr. Eisen looked at the more than 16,000 patients in IMPROVE-IT without history of CABG. The analysis applied a newly developed, nine-item formula for stratifying atherothrombotic risk (Circulation. 2016 July 26;134[4];304-13) to divide these patients into low-, intermediate- and high-risk subgroups. Patients in the high-risk subgroup (20% of the IMPROVE-IT subgroup) had a 6–percentage point reduction in their primary endpoint event rate with added ezetimibe treatment, while those at intermediate risk (31%) got a 2–percentage point decrease in endpoint events, and low-risk patients (49%) actually showed a small, less than 1–percentage point increase in endpoint events with added ezetimibe, Dr. Eisen reported.
IMPROVE-IT was funded by MERCK, the company that markets ezetimibe (Zetia). Dr. Eisen had no disclosures. Dr. Braunwald has been a consultant to Merck as well as to Bayer, Daiichi Sankyo, The Medicines Company, Novartis, and Sanofi.
[email protected]
On Twitter @mitchelzoler
I suspect that the patients in IMPROVE-IT with a history of coronary artery bypass graft surgery were more likely than the other enrolled acute coronary syndrome patients to have more extensive and systemic atherosclerotic disease. Although coronary artery bypass addresses the most acute obstructions to coronary flow that exist at the time of surgery, the procedure does not cure the patient’s underlying vascular disease. We know that a substantial majority of coronary events occur in arteries that are not heavily stenosed.
Another important limitation to keep in mind about the IMPROVE-IT trial was that the background statin treatment all patients received was modest – 40 mg of simvastatin daily. In real-world practice, high-risk patients should go on the most potent statin regimen they can tolerate – ideally, 40 mg daily of rosuvastatin. The need for additional lipid-lowering interventions, with ezetimibe or other drugs, can then be considered as an add-on to aggressive statin therapy.
Richard A. Chazal, MD, is an invasive cardiologist and medical director of the Heart and Vascular Institute of Lee Memorial Health System in Fort Myers, Fla. He is also the current president of the American College of Cardiology. He had no disclosures. He made these comments in an interview.
I suspect that the patients in IMPROVE-IT with a history of coronary artery bypass graft surgery were more likely than the other enrolled acute coronary syndrome patients to have more extensive and systemic atherosclerotic disease. Although coronary artery bypass addresses the most acute obstructions to coronary flow that exist at the time of surgery, the procedure does not cure the patient’s underlying vascular disease. We know that a substantial majority of coronary events occur in arteries that are not heavily stenosed.
Another important limitation to keep in mind about the IMPROVE-IT trial was that the background statin treatment all patients received was modest – 40 mg of simvastatin daily. In real-world practice, high-risk patients should go on the most potent statin regimen they can tolerate – ideally, 40 mg daily of rosuvastatin. The need for additional lipid-lowering interventions, with ezetimibe or other drugs, can then be considered as an add-on to aggressive statin therapy.
Richard A. Chazal, MD, is an invasive cardiologist and medical director of the Heart and Vascular Institute of Lee Memorial Health System in Fort Myers, Fla. He is also the current president of the American College of Cardiology. He had no disclosures. He made these comments in an interview.
I suspect that the patients in IMPROVE-IT with a history of coronary artery bypass graft surgery were more likely than the other enrolled acute coronary syndrome patients to have more extensive and systemic atherosclerotic disease. Although coronary artery bypass addresses the most acute obstructions to coronary flow that exist at the time of surgery, the procedure does not cure the patient’s underlying vascular disease. We know that a substantial majority of coronary events occur in arteries that are not heavily stenosed.
Another important limitation to keep in mind about the IMPROVE-IT trial was that the background statin treatment all patients received was modest – 40 mg of simvastatin daily. In real-world practice, high-risk patients should go on the most potent statin regimen they can tolerate – ideally, 40 mg daily of rosuvastatin. The need for additional lipid-lowering interventions, with ezetimibe or other drugs, can then be considered as an add-on to aggressive statin therapy.
Richard A. Chazal, MD, is an invasive cardiologist and medical director of the Heart and Vascular Institute of Lee Memorial Health System in Fort Myers, Fla. He is also the current president of the American College of Cardiology. He had no disclosures. He made these comments in an interview.
ROME – Patients who have undergone coronary artery bypass surgery and who later have an acute coronary syndrome event gain the most from an aggressive lipid-lowering regimen, according to an exploratory analysis of data from more than 18,000 patients enrolled in the IMPROVE-IT trial that tested the incremental benefit from ezetimibe treatment when added to a statin.
Additional exploratory analyses further showed that high-risk acute coronary syndrome (ACS) patients without a history of coronary artery bypass grafting (CABG) also benefited from adding ezetimibe to a background regimen of simvastatin, but the benefit from adding ezetimibe completely disappeared in low-risk ACS patients, Alon Eisen, MD, said at the annual congress of the European Society of Cardiology.
‘The benefit of adding ezetimibe to a statin was enhanced in patients with prior CABG and in other high-risk patients with no prior CABG, supporting the use of more intensive lipid-lowering therapy in these high-risk patients,” said Dr. Eisen, a cardiologist at Brigham and Women’s Hospital in Boston. He also highlighted that ezetimibe is “a safe drug that is coming off patent.” Adding ezetimibe had a moderate effect on LDL cholesterol levels, cutting them from a median of 70 mg/dL in patients in the placebo arm to a median of 54 mg/dL in the group who received ezetimibe.
These results “show that if we pick the right patients, a very benign drug can have a great benefit,” said Eugene Braunwald, MD, a coinvestigator on the IMPROVE-IT trial and a collaborator with Dr. Eisen on the new analysis. The new findings “emphasize that the higher a patient’s risk, the more effect they get from cholesterol-lowering treatment,” said Dr. Braunwald, professor of medicine at Harvard University and a cardiologist at Brigham and Women’s Hospital, both in Boston.
The second exploratory analysis reported by Dr. Eisen looked at the more than 16,000 patients in IMPROVE-IT without history of CABG. The analysis applied a newly developed, nine-item formula for stratifying atherothrombotic risk (Circulation. 2016 July 26;134[4];304-13) to divide these patients into low-, intermediate- and high-risk subgroups. Patients in the high-risk subgroup (20% of the IMPROVE-IT subgroup) had a 6–percentage point reduction in their primary endpoint event rate with added ezetimibe treatment, while those at intermediate risk (31%) got a 2–percentage point decrease in endpoint events, and low-risk patients (49%) actually showed a small, less than 1–percentage point increase in endpoint events with added ezetimibe, Dr. Eisen reported.
IMPROVE-IT was funded by MERCK, the company that markets ezetimibe (Zetia). Dr. Eisen had no disclosures. Dr. Braunwald has been a consultant to Merck as well as to Bayer, Daiichi Sankyo, The Medicines Company, Novartis, and Sanofi.
[email protected]
On Twitter @mitchelzoler
ROME – Patients who have undergone coronary artery bypass surgery and who later have an acute coronary syndrome event gain the most from an aggressive lipid-lowering regimen, according to an exploratory analysis of data from more than 18,000 patients enrolled in the IMPROVE-IT trial that tested the incremental benefit from ezetimibe treatment when added to a statin.
Additional exploratory analyses further showed that high-risk acute coronary syndrome (ACS) patients without a history of coronary artery bypass grafting (CABG) also benefited from adding ezetimibe to a background regimen of simvastatin, but the benefit from adding ezetimibe completely disappeared in low-risk ACS patients, Alon Eisen, MD, said at the annual congress of the European Society of Cardiology.
‘The benefit of adding ezetimibe to a statin was enhanced in patients with prior CABG and in other high-risk patients with no prior CABG, supporting the use of more intensive lipid-lowering therapy in these high-risk patients,” said Dr. Eisen, a cardiologist at Brigham and Women’s Hospital in Boston. He also highlighted that ezetimibe is “a safe drug that is coming off patent.” Adding ezetimibe had a moderate effect on LDL cholesterol levels, cutting them from a median of 70 mg/dL in patients in the placebo arm to a median of 54 mg/dL in the group who received ezetimibe.
These results “show that if we pick the right patients, a very benign drug can have a great benefit,” said Eugene Braunwald, MD, a coinvestigator on the IMPROVE-IT trial and a collaborator with Dr. Eisen on the new analysis. The new findings “emphasize that the higher a patient’s risk, the more effect they get from cholesterol-lowering treatment,” said Dr. Braunwald, professor of medicine at Harvard University and a cardiologist at Brigham and Women’s Hospital, both in Boston.
The second exploratory analysis reported by Dr. Eisen looked at the more than 16,000 patients in IMPROVE-IT without history of CABG. The analysis applied a newly developed, nine-item formula for stratifying atherothrombotic risk (Circulation. 2016 July 26;134[4];304-13) to divide these patients into low-, intermediate- and high-risk subgroups. Patients in the high-risk subgroup (20% of the IMPROVE-IT subgroup) had a 6–percentage point reduction in their primary endpoint event rate with added ezetimibe treatment, while those at intermediate risk (31%) got a 2–percentage point decrease in endpoint events, and low-risk patients (49%) actually showed a small, less than 1–percentage point increase in endpoint events with added ezetimibe, Dr. Eisen reported.
IMPROVE-IT was funded by MERCK, the company that markets ezetimibe (Zetia). Dr. Eisen had no disclosures. Dr. Braunwald has been a consultant to Merck as well as to Bayer, Daiichi Sankyo, The Medicines Company, Novartis, and Sanofi.
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On Twitter @mitchelzoler
AT THE ESC CONGRESS 2016
Key clinical point:
Major finding: The absolute primary-event risk reduction was 9% in post-CABG patients and 1% in all other patients.
Data source: An exploratory, post-hoc analysis of data collected in IMPROVE-IT, a multicenter trial with 18,144 patients.
Disclosures: IMPROVE-IT was funded by MERCK, the company that markets ezetimibe (Zetia). Dr. Eisen had no disclosures. Dr. Braunwald has been a consultant to Merck as well as to Bayer, Daiichi Sankyo, The Medicines Company, Novartis, and Sanofi.
Drug prices, not the health law, top voters’ health priorities for 2017
Until this week, when big increases in insurance premiums were unveiled for next year, the federal health law has not been a major issue in the presidential election. In fact, fixing what ails the Affordable Care Act isn’t even among voters’ top priorities for health issues for next year, according to a new poll.
The monthly October tracking poll from the Kaiser Family Foundation finds that, when voters are asked about what the next president and Congress should do about health care, issues relating to prescription drug prices and out-of-pocket spending far outrank proposals to address the shortcomings of the health law. (Kaiser Health News is an editorially independent project of the foundation.)
By contrast, fewer than a third of all voters favored proposals to repeal requirements in the health law for employers to provide health insurance to their workers or pay a fine; reduce the tax subsidies that help people pay their insurance premiums, and eliminate a tax on high-cost health plans.
Republicans (but not Democrats or independents) still overwhelmingly want to repeal the entire health law, with 60% supporting that action. But Republicans are fractured on why they don’t like the law. Asked what their main reason is for their disapproval, nearly a third (31%) said the law “gives government too big a role in the health care system,” while 27% said “the law is just one of many indications that President Obama took the country in the wrong direction.”
The poll also asked voters about adding a government-sponsored “public option” to health plans available to those purchasing insurance in the health law’s marketplaces. Both President Barack Obama and Democratic nominee Hillary Clinton have called for reconsideration of the idea, which narrowly failed to be included in the original law in 2010.
As with the health law itself, semantics matter in this debate over whether to include a government plan to compete with private plans. Even in describing the same concept, a much larger majority (70%) favored the idea of “creating a public health insurance option to compete with private health insurance plans” than favored “creating a government-administered public health insurance option to compete with private health insurance plans” (53%).
Opinions about a public option are also relatively easily swayed when voters are presented with arguments for and against the idea. For example, 21% of supporters shifted to opposition when told that doctors and hospitals might be paid less under a public option, while 13% shifted from opposition to support when told that having a public plan compete with private plans might help drive down costs.
The survey was conducted between Oct. 12 and Oct. 18 among 1,205 adults, using both land lines and cell phones. The margin of error was plus or minus 3%.
This story was produced by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Until this week, when big increases in insurance premiums were unveiled for next year, the federal health law has not been a major issue in the presidential election. In fact, fixing what ails the Affordable Care Act isn’t even among voters’ top priorities for health issues for next year, according to a new poll.
The monthly October tracking poll from the Kaiser Family Foundation finds that, when voters are asked about what the next president and Congress should do about health care, issues relating to prescription drug prices and out-of-pocket spending far outrank proposals to address the shortcomings of the health law. (Kaiser Health News is an editorially independent project of the foundation.)
By contrast, fewer than a third of all voters favored proposals to repeal requirements in the health law for employers to provide health insurance to their workers or pay a fine; reduce the tax subsidies that help people pay their insurance premiums, and eliminate a tax on high-cost health plans.
Republicans (but not Democrats or independents) still overwhelmingly want to repeal the entire health law, with 60% supporting that action. But Republicans are fractured on why they don’t like the law. Asked what their main reason is for their disapproval, nearly a third (31%) said the law “gives government too big a role in the health care system,” while 27% said “the law is just one of many indications that President Obama took the country in the wrong direction.”
The poll also asked voters about adding a government-sponsored “public option” to health plans available to those purchasing insurance in the health law’s marketplaces. Both President Barack Obama and Democratic nominee Hillary Clinton have called for reconsideration of the idea, which narrowly failed to be included in the original law in 2010.
As with the health law itself, semantics matter in this debate over whether to include a government plan to compete with private plans. Even in describing the same concept, a much larger majority (70%) favored the idea of “creating a public health insurance option to compete with private health insurance plans” than favored “creating a government-administered public health insurance option to compete with private health insurance plans” (53%).
Opinions about a public option are also relatively easily swayed when voters are presented with arguments for and against the idea. For example, 21% of supporters shifted to opposition when told that doctors and hospitals might be paid less under a public option, while 13% shifted from opposition to support when told that having a public plan compete with private plans might help drive down costs.
The survey was conducted between Oct. 12 and Oct. 18 among 1,205 adults, using both land lines and cell phones. The margin of error was plus or minus 3%.
This story was produced by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Until this week, when big increases in insurance premiums were unveiled for next year, the federal health law has not been a major issue in the presidential election. In fact, fixing what ails the Affordable Care Act isn’t even among voters’ top priorities for health issues for next year, according to a new poll.
The monthly October tracking poll from the Kaiser Family Foundation finds that, when voters are asked about what the next president and Congress should do about health care, issues relating to prescription drug prices and out-of-pocket spending far outrank proposals to address the shortcomings of the health law. (Kaiser Health News is an editorially independent project of the foundation.)
By contrast, fewer than a third of all voters favored proposals to repeal requirements in the health law for employers to provide health insurance to their workers or pay a fine; reduce the tax subsidies that help people pay their insurance premiums, and eliminate a tax on high-cost health plans.
Republicans (but not Democrats or independents) still overwhelmingly want to repeal the entire health law, with 60% supporting that action. But Republicans are fractured on why they don’t like the law. Asked what their main reason is for their disapproval, nearly a third (31%) said the law “gives government too big a role in the health care system,” while 27% said “the law is just one of many indications that President Obama took the country in the wrong direction.”
The poll also asked voters about adding a government-sponsored “public option” to health plans available to those purchasing insurance in the health law’s marketplaces. Both President Barack Obama and Democratic nominee Hillary Clinton have called for reconsideration of the idea, which narrowly failed to be included in the original law in 2010.
As with the health law itself, semantics matter in this debate over whether to include a government plan to compete with private plans. Even in describing the same concept, a much larger majority (70%) favored the idea of “creating a public health insurance option to compete with private health insurance plans” than favored “creating a government-administered public health insurance option to compete with private health insurance plans” (53%).
Opinions about a public option are also relatively easily swayed when voters are presented with arguments for and against the idea. For example, 21% of supporters shifted to opposition when told that doctors and hospitals might be paid less under a public option, while 13% shifted from opposition to support when told that having a public plan compete with private plans might help drive down costs.
The survey was conducted between Oct. 12 and Oct. 18 among 1,205 adults, using both land lines and cell phones. The margin of error was plus or minus 3%.
This story was produced by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Diabetes, stroke linked to recurrent C. difficile
LAS VEGAS – Diabetes and stroke are risk factors for recurrent Clostridium difficile infection (CDI), with stroke patients at about 10 times the risk of recurrence.
The underlying cause for the association is a mystery, but one-sided paralysis is one possibility. “A lot of stroke patients may be hemiplegic, and they may be bedridden, so that may be a risk factor by itself. It’s something that may need to be studied in the future,” Alan Putrus, MD, a gastroenterology fellow at St. John Providence Hospital, Detroit, said in an interview.
CDI recurrence rates range from 5% to 47%, depending on the institution. Although risk factors of initial CDI have been well defined, few studies have looked at risk factors associated with recurrence.
In order to get at the question, the researchers conducted a study of 108 initial CDIs and 113 recurrences at two urban and one suburban hospital. Patients who experienced recurrence were matched 1:1 to age- and gender-matched controls with no recurrent CDI.
CDI recurrence rates were 16.5% and 15.9% in the two urban hospitals, and 14.9% in the suburban hospital.
Logistic regression revealed risk factors associated with CDI recurrence, including diabetes (odds ratio, 1.91; 95% confidence interval, 1.05-3.47; P = .04), stroke (OR, 9.73; 95% CI, 1.15-82.35; P = .04), exposure to proton pump inhibitors in the past 3 months (OR, 1.82; 95% CI, 1.03-3.23; P = .04), and admission to an intensive care unit in the past 3 months (OR, 1.95; 95% CI, 1.0-3.83; P = .04).
The results suggest that diabetes and especially stroke may be important risk factors for CDI recurrence, and their presence should prompt physicians to alter patient care accordingly, according to Dr. Putrus.
He stressed the importance of antibiotic stewardship. “Once you find a certain bug or pathogen, try to deescalate the antibiotics as soon as you can. If a patient is diabetic, controlling their blood sugar may also help,” Dr. Putrus said.
Finally, physicians should consider whether proton pump inhibitors are really necessary. Some patients start on PPIs but remain on the drugs long after symptoms have abated. “A lot of patients just have some discomfort in their abdomen, and they never stop taking it. They keep refilling it. So that’s a problem,” said Dr. Putrus.
Dr. Putrus has declared no conflicts of interest.
LAS VEGAS – Diabetes and stroke are risk factors for recurrent Clostridium difficile infection (CDI), with stroke patients at about 10 times the risk of recurrence.
The underlying cause for the association is a mystery, but one-sided paralysis is one possibility. “A lot of stroke patients may be hemiplegic, and they may be bedridden, so that may be a risk factor by itself. It’s something that may need to be studied in the future,” Alan Putrus, MD, a gastroenterology fellow at St. John Providence Hospital, Detroit, said in an interview.
CDI recurrence rates range from 5% to 47%, depending on the institution. Although risk factors of initial CDI have been well defined, few studies have looked at risk factors associated with recurrence.
In order to get at the question, the researchers conducted a study of 108 initial CDIs and 113 recurrences at two urban and one suburban hospital. Patients who experienced recurrence were matched 1:1 to age- and gender-matched controls with no recurrent CDI.
CDI recurrence rates were 16.5% and 15.9% in the two urban hospitals, and 14.9% in the suburban hospital.
Logistic regression revealed risk factors associated with CDI recurrence, including diabetes (odds ratio, 1.91; 95% confidence interval, 1.05-3.47; P = .04), stroke (OR, 9.73; 95% CI, 1.15-82.35; P = .04), exposure to proton pump inhibitors in the past 3 months (OR, 1.82; 95% CI, 1.03-3.23; P = .04), and admission to an intensive care unit in the past 3 months (OR, 1.95; 95% CI, 1.0-3.83; P = .04).
The results suggest that diabetes and especially stroke may be important risk factors for CDI recurrence, and their presence should prompt physicians to alter patient care accordingly, according to Dr. Putrus.
He stressed the importance of antibiotic stewardship. “Once you find a certain bug or pathogen, try to deescalate the antibiotics as soon as you can. If a patient is diabetic, controlling their blood sugar may also help,” Dr. Putrus said.
Finally, physicians should consider whether proton pump inhibitors are really necessary. Some patients start on PPIs but remain on the drugs long after symptoms have abated. “A lot of patients just have some discomfort in their abdomen, and they never stop taking it. They keep refilling it. So that’s a problem,” said Dr. Putrus.
Dr. Putrus has declared no conflicts of interest.
LAS VEGAS – Diabetes and stroke are risk factors for recurrent Clostridium difficile infection (CDI), with stroke patients at about 10 times the risk of recurrence.
The underlying cause for the association is a mystery, but one-sided paralysis is one possibility. “A lot of stroke patients may be hemiplegic, and they may be bedridden, so that may be a risk factor by itself. It’s something that may need to be studied in the future,” Alan Putrus, MD, a gastroenterology fellow at St. John Providence Hospital, Detroit, said in an interview.
CDI recurrence rates range from 5% to 47%, depending on the institution. Although risk factors of initial CDI have been well defined, few studies have looked at risk factors associated with recurrence.
In order to get at the question, the researchers conducted a study of 108 initial CDIs and 113 recurrences at two urban and one suburban hospital. Patients who experienced recurrence were matched 1:1 to age- and gender-matched controls with no recurrent CDI.
CDI recurrence rates were 16.5% and 15.9% in the two urban hospitals, and 14.9% in the suburban hospital.
Logistic regression revealed risk factors associated with CDI recurrence, including diabetes (odds ratio, 1.91; 95% confidence interval, 1.05-3.47; P = .04), stroke (OR, 9.73; 95% CI, 1.15-82.35; P = .04), exposure to proton pump inhibitors in the past 3 months (OR, 1.82; 95% CI, 1.03-3.23; P = .04), and admission to an intensive care unit in the past 3 months (OR, 1.95; 95% CI, 1.0-3.83; P = .04).
The results suggest that diabetes and especially stroke may be important risk factors for CDI recurrence, and their presence should prompt physicians to alter patient care accordingly, according to Dr. Putrus.
He stressed the importance of antibiotic stewardship. “Once you find a certain bug or pathogen, try to deescalate the antibiotics as soon as you can. If a patient is diabetic, controlling their blood sugar may also help,” Dr. Putrus said.
Finally, physicians should consider whether proton pump inhibitors are really necessary. Some patients start on PPIs but remain on the drugs long after symptoms have abated. “A lot of patients just have some discomfort in their abdomen, and they never stop taking it. They keep refilling it. So that’s a problem,” said Dr. Putrus.
Dr. Putrus has declared no conflicts of interest.
AT ACG 2016
Key clinical point:
Major finding: Diabetes, stroke, and a history of PPI use were all associated with higher risks of recurrence.
Data source: Case-control, retrospective study.
Disclosures: Dr. Putrus has declared no conflicts of interest.
Higher-volume facilities show better myeloma outcomes
Patients with multiple myeloma who received treatment from facilities that see a greater number of multiple myeloma patients have significantly lower overall mortality, compared with those who attend lower-volume facilities, new research suggests.
There is a strong body of evidence showing higher-volume surgical oncology is associated with better clinical outcomes, but there is a lack of similar studies for medical oncology, wrote Dr. Ronald S. Go and his colleagues at the Mayo Clinic in Rochester, Minn.
To investigate, researchers analyzed National Cancer Database data from 94,722 patients with multiple myeloma who were treated at 1,333 facilities. The median number of new multiple myeloma patients seen across all facilities each year was 6.1 patients, with a quartile range of 3.6 patients per year to 10.3.
Patients treated at facilities in the lowest quartile of patient volume had a 22% higher risk of death, compared with patients treated in the highest-volume–quartile facilities, Dr. Go and his colleagues reported (J Clin Oncol. 2016 Oct 26. doi: 10.1200/JCO.2016.68.3805).
Those in the third-lowest volume quartile had a 17% increased risk of death and those in the second-lowest volume quartile had a 12% increased risk, compared with the highest-volume quartile.
Overall, median survival times were 26.9 months for the lowest-volume quartile, then 29.1 months, 31.9 months, and 49.1 months for the second-lowest, second-highest, and highest-volume quartiles, respectively.
“Compared with facilities treating 10 patients per year, facilities treating 20, 30, and 40 patients per year had approximately 10%, 15%, and 20% lower overall mortality rates,” the authors wrote.
They noted that the relationship between patient volume and mortality was almost linear, with no obvious sign of a plateau. The magnitude of difference in mortality between the high- and low-volume institutions was also similar to that seen in studies of lung and rectal cancer surgery.
This relationship between patient volume and outcomes was independent of potential confounders, such as sociodemographic and geographic factors, comorbidities, and clustering of outcome within hospitals.
More than 60% of patients were treated in facilities within the top-quartile facilities with an annual patient volume of greater than 10.3 new patients a year, but only 18 of the 1,333 facilities treated more than 50 new patients with multiple myeloma each year, the investigators said.
Facilities in the top two quartiles were more likely to be academic, and their patients were more likely to be younger, black, and privately insured and to reside in metropolitan areas.
Commenting on their findings, the authors suggested that it should come as no surprise to see such a link between patient volume and outcomes, especially given the unprecedented rate of new drugs becoming available for the treatment of multiple myeloma and of new information being published about the disease.
“Keeping up with pertinent new knowledge in [multiple myeloma], which comprises only 2% of all cancers, and at the same time maintaining proficiency in its management, is becoming more difficult, especially if one also has to stay current in all the other cancers,” Dr. Go and his associates wrote.
They suggested an approach similar to that taken for oncologic surgery, with patients being referred to centers of excellence, although they noted that this approach should move beyond NCI-designated cancer centers alone.
Given the challenges inherent in setting up such a system to deal with rare chronic cancers, they also suggested an interim option of comanagement with a high-volume facility. “This model of care can be further enhanced by preferentially funneling patients with hematologic cancer to a limited number of hematologist-oncologists per practice to accelerate accumulation of clinical experience and development of treatment proficiency.”
The study was supported by the Eagles Cancer Research Fund Pilot Grant, Mayo Clinic division of hematology, and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. One author declared research funding from Genentech, but no other conflicts were declared.
Patients with multiple myeloma who received treatment from facilities that see a greater number of multiple myeloma patients have significantly lower overall mortality, compared with those who attend lower-volume facilities, new research suggests.
There is a strong body of evidence showing higher-volume surgical oncology is associated with better clinical outcomes, but there is a lack of similar studies for medical oncology, wrote Dr. Ronald S. Go and his colleagues at the Mayo Clinic in Rochester, Minn.
To investigate, researchers analyzed National Cancer Database data from 94,722 patients with multiple myeloma who were treated at 1,333 facilities. The median number of new multiple myeloma patients seen across all facilities each year was 6.1 patients, with a quartile range of 3.6 patients per year to 10.3.
Patients treated at facilities in the lowest quartile of patient volume had a 22% higher risk of death, compared with patients treated in the highest-volume–quartile facilities, Dr. Go and his colleagues reported (J Clin Oncol. 2016 Oct 26. doi: 10.1200/JCO.2016.68.3805).
Those in the third-lowest volume quartile had a 17% increased risk of death and those in the second-lowest volume quartile had a 12% increased risk, compared with the highest-volume quartile.
Overall, median survival times were 26.9 months for the lowest-volume quartile, then 29.1 months, 31.9 months, and 49.1 months for the second-lowest, second-highest, and highest-volume quartiles, respectively.
“Compared with facilities treating 10 patients per year, facilities treating 20, 30, and 40 patients per year had approximately 10%, 15%, and 20% lower overall mortality rates,” the authors wrote.
They noted that the relationship between patient volume and mortality was almost linear, with no obvious sign of a plateau. The magnitude of difference in mortality between the high- and low-volume institutions was also similar to that seen in studies of lung and rectal cancer surgery.
This relationship between patient volume and outcomes was independent of potential confounders, such as sociodemographic and geographic factors, comorbidities, and clustering of outcome within hospitals.
More than 60% of patients were treated in facilities within the top-quartile facilities with an annual patient volume of greater than 10.3 new patients a year, but only 18 of the 1,333 facilities treated more than 50 new patients with multiple myeloma each year, the investigators said.
Facilities in the top two quartiles were more likely to be academic, and their patients were more likely to be younger, black, and privately insured and to reside in metropolitan areas.
Commenting on their findings, the authors suggested that it should come as no surprise to see such a link between patient volume and outcomes, especially given the unprecedented rate of new drugs becoming available for the treatment of multiple myeloma and of new information being published about the disease.
“Keeping up with pertinent new knowledge in [multiple myeloma], which comprises only 2% of all cancers, and at the same time maintaining proficiency in its management, is becoming more difficult, especially if one also has to stay current in all the other cancers,” Dr. Go and his associates wrote.
They suggested an approach similar to that taken for oncologic surgery, with patients being referred to centers of excellence, although they noted that this approach should move beyond NCI-designated cancer centers alone.
Given the challenges inherent in setting up such a system to deal with rare chronic cancers, they also suggested an interim option of comanagement with a high-volume facility. “This model of care can be further enhanced by preferentially funneling patients with hematologic cancer to a limited number of hematologist-oncologists per practice to accelerate accumulation of clinical experience and development of treatment proficiency.”
The study was supported by the Eagles Cancer Research Fund Pilot Grant, Mayo Clinic division of hematology, and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. One author declared research funding from Genentech, but no other conflicts were declared.
Patients with multiple myeloma who received treatment from facilities that see a greater number of multiple myeloma patients have significantly lower overall mortality, compared with those who attend lower-volume facilities, new research suggests.
There is a strong body of evidence showing higher-volume surgical oncology is associated with better clinical outcomes, but there is a lack of similar studies for medical oncology, wrote Dr. Ronald S. Go and his colleagues at the Mayo Clinic in Rochester, Minn.
To investigate, researchers analyzed National Cancer Database data from 94,722 patients with multiple myeloma who were treated at 1,333 facilities. The median number of new multiple myeloma patients seen across all facilities each year was 6.1 patients, with a quartile range of 3.6 patients per year to 10.3.
Patients treated at facilities in the lowest quartile of patient volume had a 22% higher risk of death, compared with patients treated in the highest-volume–quartile facilities, Dr. Go and his colleagues reported (J Clin Oncol. 2016 Oct 26. doi: 10.1200/JCO.2016.68.3805).
Those in the third-lowest volume quartile had a 17% increased risk of death and those in the second-lowest volume quartile had a 12% increased risk, compared with the highest-volume quartile.
Overall, median survival times were 26.9 months for the lowest-volume quartile, then 29.1 months, 31.9 months, and 49.1 months for the second-lowest, second-highest, and highest-volume quartiles, respectively.
“Compared with facilities treating 10 patients per year, facilities treating 20, 30, and 40 patients per year had approximately 10%, 15%, and 20% lower overall mortality rates,” the authors wrote.
They noted that the relationship between patient volume and mortality was almost linear, with no obvious sign of a plateau. The magnitude of difference in mortality between the high- and low-volume institutions was also similar to that seen in studies of lung and rectal cancer surgery.
This relationship between patient volume and outcomes was independent of potential confounders, such as sociodemographic and geographic factors, comorbidities, and clustering of outcome within hospitals.
More than 60% of patients were treated in facilities within the top-quartile facilities with an annual patient volume of greater than 10.3 new patients a year, but only 18 of the 1,333 facilities treated more than 50 new patients with multiple myeloma each year, the investigators said.
Facilities in the top two quartiles were more likely to be academic, and their patients were more likely to be younger, black, and privately insured and to reside in metropolitan areas.
Commenting on their findings, the authors suggested that it should come as no surprise to see such a link between patient volume and outcomes, especially given the unprecedented rate of new drugs becoming available for the treatment of multiple myeloma and of new information being published about the disease.
“Keeping up with pertinent new knowledge in [multiple myeloma], which comprises only 2% of all cancers, and at the same time maintaining proficiency in its management, is becoming more difficult, especially if one also has to stay current in all the other cancers,” Dr. Go and his associates wrote.
They suggested an approach similar to that taken for oncologic surgery, with patients being referred to centers of excellence, although they noted that this approach should move beyond NCI-designated cancer centers alone.
Given the challenges inherent in setting up such a system to deal with rare chronic cancers, they also suggested an interim option of comanagement with a high-volume facility. “This model of care can be further enhanced by preferentially funneling patients with hematologic cancer to a limited number of hematologist-oncologists per practice to accelerate accumulation of clinical experience and development of treatment proficiency.”
The study was supported by the Eagles Cancer Research Fund Pilot Grant, Mayo Clinic division of hematology, and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. One author declared research funding from Genentech, but no other conflicts were declared.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: .
Major finding: Individuals with multiple myeloma treated at facilities in the lowest quartile of patient volume had a 22% higher risk of death, compared with patients treated in the highest-volume–quartile facilities.
Data source: Analysis of National Cancer Database data from 94,722 patients with multiple myeloma treated at 1,333 facilities.
Disclosures: The study was supported by the Eagles Cancer Research Fund Pilot Grant, Mayo Clinic division of hematology, and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. One author declared research funding from Genentech, but no other conflicts were declared.
TOPCAT, a third time around
Shakespeare, in Romeo and Juliet, refers to the proverb, “A cat has nine lives. For three he plays, for three he strays, and for the last he stays.”
TOPCAT is back again, having randomized its first patient with heart failure with preserved ejection fraction (HFpEF) almost 10 years ago for its treatment with spironolactone (SPIRO), a mineralocorticoid receptor antagonist.
The first report of the results of TOPCAT in 2014 indicated that there was no benefit associate with SPIRO therapy tested in the 3,445 patients randomized in 244 sites around the world (N Engl J Med. 2014 Apr 10;370[15]:1383-92). A subsequent analysis of data carried out in 2015 reported a striking regional difference in the outcome of patients randomized in the 1,767 patients in the Americas, compared with the 1,678 randomized in Russia and Georgia (Circulation. 2015 Jan 6;131[1]:34-42). In the Americas, there was an 18% decrease in the primary event of death and heart failure rehospitalization (3.6% in the SPIRO vs. 4.9% in the placebo; hazard ratio, 0.82; P = .026). There was essentially no difference in the groups randomized in Russia and Georgia, which had a 1.6% placebo event rate.
And now in 2016, at the recent meeting of the Heart Failure Society of America, we were informed that there was no detectable level of blood canrenone, a metabolite of SPIRO, in 30% of the 66 randomized patients in Russia and Georgia, compared with 3% of the patients randomized in the Americas (Cardiology News. Oct 2016. p 8). These data tend to confirm that the patients randomized in Russia and Georgia were either undertreated or not treated. In fact, after examination of the baseline characteristics of the two groups it is possible that many of the patients may not have had heart failure at all.
So what are we left with? One thing that is clear is that the management of TOPCAT was flawed and constitutes an example of how not to run an international clinical trial. Can we make any conclusion about the benefit of SPIRO? TOPCAT initially was powered for over 3,515 patients and 630 events in order to achieve a 85% benefit. The current analysis has now narrowed the population down to 1,787 patients with 522 events with an 18% decrease (P = .02) in the primary end point. During the mean follow-up of 3.3 years there was a placebo mortality of 4.9%, which is impressive in the setting of concomitant beta-blocker and renin angiotensin-converting enzyme inhibitor therapy. The only significant adverse observation was a threefold occurrence in hyperkalemia (potassium greater than 5.5 mmols/L) in the 25.2% in the Americas group treated with SPIRO, compared with the Russian-Georgian patients
Unfortunately the answer is not entirely clear. We all know who HFpEF patients are when they walk into the clinic but identifying them for a clinical trial has been difficult if not impossible. As for me, I will choose to treat their hypertension aggressively (not an easy task) and prevent or suppress their arrhythmias. In that project I will use beta-blockers and SPIRO to prevent their next heart failure episode and hope for the best.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Shakespeare, in Romeo and Juliet, refers to the proverb, “A cat has nine lives. For three he plays, for three he strays, and for the last he stays.”
TOPCAT is back again, having randomized its first patient with heart failure with preserved ejection fraction (HFpEF) almost 10 years ago for its treatment with spironolactone (SPIRO), a mineralocorticoid receptor antagonist.
The first report of the results of TOPCAT in 2014 indicated that there was no benefit associate with SPIRO therapy tested in the 3,445 patients randomized in 244 sites around the world (N Engl J Med. 2014 Apr 10;370[15]:1383-92). A subsequent analysis of data carried out in 2015 reported a striking regional difference in the outcome of patients randomized in the 1,767 patients in the Americas, compared with the 1,678 randomized in Russia and Georgia (Circulation. 2015 Jan 6;131[1]:34-42). In the Americas, there was an 18% decrease in the primary event of death and heart failure rehospitalization (3.6% in the SPIRO vs. 4.9% in the placebo; hazard ratio, 0.82; P = .026). There was essentially no difference in the groups randomized in Russia and Georgia, which had a 1.6% placebo event rate.
And now in 2016, at the recent meeting of the Heart Failure Society of America, we were informed that there was no detectable level of blood canrenone, a metabolite of SPIRO, in 30% of the 66 randomized patients in Russia and Georgia, compared with 3% of the patients randomized in the Americas (Cardiology News. Oct 2016. p 8). These data tend to confirm that the patients randomized in Russia and Georgia were either undertreated or not treated. In fact, after examination of the baseline characteristics of the two groups it is possible that many of the patients may not have had heart failure at all.
So what are we left with? One thing that is clear is that the management of TOPCAT was flawed and constitutes an example of how not to run an international clinical trial. Can we make any conclusion about the benefit of SPIRO? TOPCAT initially was powered for over 3,515 patients and 630 events in order to achieve a 85% benefit. The current analysis has now narrowed the population down to 1,787 patients with 522 events with an 18% decrease (P = .02) in the primary end point. During the mean follow-up of 3.3 years there was a placebo mortality of 4.9%, which is impressive in the setting of concomitant beta-blocker and renin angiotensin-converting enzyme inhibitor therapy. The only significant adverse observation was a threefold occurrence in hyperkalemia (potassium greater than 5.5 mmols/L) in the 25.2% in the Americas group treated with SPIRO, compared with the Russian-Georgian patients
Unfortunately the answer is not entirely clear. We all know who HFpEF patients are when they walk into the clinic but identifying them for a clinical trial has been difficult if not impossible. As for me, I will choose to treat their hypertension aggressively (not an easy task) and prevent or suppress their arrhythmias. In that project I will use beta-blockers and SPIRO to prevent their next heart failure episode and hope for the best.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Shakespeare, in Romeo and Juliet, refers to the proverb, “A cat has nine lives. For three he plays, for three he strays, and for the last he stays.”
TOPCAT is back again, having randomized its first patient with heart failure with preserved ejection fraction (HFpEF) almost 10 years ago for its treatment with spironolactone (SPIRO), a mineralocorticoid receptor antagonist.
The first report of the results of TOPCAT in 2014 indicated that there was no benefit associate with SPIRO therapy tested in the 3,445 patients randomized in 244 sites around the world (N Engl J Med. 2014 Apr 10;370[15]:1383-92). A subsequent analysis of data carried out in 2015 reported a striking regional difference in the outcome of patients randomized in the 1,767 patients in the Americas, compared with the 1,678 randomized in Russia and Georgia (Circulation. 2015 Jan 6;131[1]:34-42). In the Americas, there was an 18% decrease in the primary event of death and heart failure rehospitalization (3.6% in the SPIRO vs. 4.9% in the placebo; hazard ratio, 0.82; P = .026). There was essentially no difference in the groups randomized in Russia and Georgia, which had a 1.6% placebo event rate.
And now in 2016, at the recent meeting of the Heart Failure Society of America, we were informed that there was no detectable level of blood canrenone, a metabolite of SPIRO, in 30% of the 66 randomized patients in Russia and Georgia, compared with 3% of the patients randomized in the Americas (Cardiology News. Oct 2016. p 8). These data tend to confirm that the patients randomized in Russia and Georgia were either undertreated or not treated. In fact, after examination of the baseline characteristics of the two groups it is possible that many of the patients may not have had heart failure at all.
So what are we left with? One thing that is clear is that the management of TOPCAT was flawed and constitutes an example of how not to run an international clinical trial. Can we make any conclusion about the benefit of SPIRO? TOPCAT initially was powered for over 3,515 patients and 630 events in order to achieve a 85% benefit. The current analysis has now narrowed the population down to 1,787 patients with 522 events with an 18% decrease (P = .02) in the primary end point. During the mean follow-up of 3.3 years there was a placebo mortality of 4.9%, which is impressive in the setting of concomitant beta-blocker and renin angiotensin-converting enzyme inhibitor therapy. The only significant adverse observation was a threefold occurrence in hyperkalemia (potassium greater than 5.5 mmols/L) in the 25.2% in the Americas group treated with SPIRO, compared with the Russian-Georgian patients
Unfortunately the answer is not entirely clear. We all know who HFpEF patients are when they walk into the clinic but identifying them for a clinical trial has been difficult if not impossible. As for me, I will choose to treat their hypertension aggressively (not an easy task) and prevent or suppress their arrhythmias. In that project I will use beta-blockers and SPIRO to prevent their next heart failure episode and hope for the best.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Few non-ICU patients receive palliative care consults
LOS ANGELES – A significant percentage of patients who meet criteria for palliative care consultations do not receive a consult during their hospital stay, results from a single-center retrospective analysis showed.
“Physicians need to recognize the palliative care needs of patients with chronic illnesses other than malignancy before they get admitted to the ICU, especially when these patients are admitted repeatedly for the same problem [and] have a significant decline in functional status with a large symptom burden,” Mohleen Kang, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “There is a potential missed opportunity for these conversations to occur with the patients and their family prior to their decompensation and crisis.”
Twenty-nine percent (132) of the patients studied met an indication for a palliative care consult (PCC), with only 35 (27%) of such patients having received a PCC. Patients with metastatic cancer were significantly more likely to have received a PCC, compared with non-cancer patients (64% vs. 21%, respectively; P less than .001), while patients with New York Heart Association Class III or IV congestive heart failure were less likely to receive a PCC, compared with those who did not have congestive heart failure (5.6% vs. 29.8%; P = .014).
Criteria for PCC on admission include a life-limiting diagnosis and more than one admission in the past 3 months, decline in function, or complex care requirements. Criteria for PCC during hospitalization include life-limiting diagnosis and uncertainty about decisions, an ICU stay greater than 7 days, or lack of goals of care.
Dr. Kang, chief resident in the department of medicine at New Jersey Medical School, Newark, presented the results, which were of patients admitted to the department of medicine at University Hospital in Newark in 2015. Those admitted to the ICU within 24 hours of admission were excluded from the analysis, leaving 461 patient charts that were screened for PCC needs based on the consensus report from the Center to Advance Palliative Care.
The patients who met an indication for PCC had a mean age of 60 years and an average length of stay of 7 days. The percentages of these patients who were female, African American, and Hispanic were 45%, 40%, and 21%, respectively.
On multivariate analysis, patients who had a PCC within 72 hours of admission were eight times more likely to have a hospital length of stay less than 7 days (P = .019), while those who had a PCC within 48 hours of admission were 20 times more likely to have a hospital length of stay less than 7 days (P = .017). “So if we intervened early, we were able to decrease their length of stay to less than 7 days,” Dr. Kang said at the meeting.
She acknowledged certain limitations of the study, including its small sample size, retrospective design, and lack of follow-up. “This study also has a lot of confounding socioeconomic factors that do not make it applicable to every hospital across the country,” she said. “This is not a homogeneous patient population.”
The study’s principal investigator was Anne Sutherland, MD, medical intensive care unit director at University Hospital. Dr. Kang reported having no financial disclosures.
LOS ANGELES – A significant percentage of patients who meet criteria for palliative care consultations do not receive a consult during their hospital stay, results from a single-center retrospective analysis showed.
“Physicians need to recognize the palliative care needs of patients with chronic illnesses other than malignancy before they get admitted to the ICU, especially when these patients are admitted repeatedly for the same problem [and] have a significant decline in functional status with a large symptom burden,” Mohleen Kang, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “There is a potential missed opportunity for these conversations to occur with the patients and their family prior to their decompensation and crisis.”
Twenty-nine percent (132) of the patients studied met an indication for a palliative care consult (PCC), with only 35 (27%) of such patients having received a PCC. Patients with metastatic cancer were significantly more likely to have received a PCC, compared with non-cancer patients (64% vs. 21%, respectively; P less than .001), while patients with New York Heart Association Class III or IV congestive heart failure were less likely to receive a PCC, compared with those who did not have congestive heart failure (5.6% vs. 29.8%; P = .014).
Criteria for PCC on admission include a life-limiting diagnosis and more than one admission in the past 3 months, decline in function, or complex care requirements. Criteria for PCC during hospitalization include life-limiting diagnosis and uncertainty about decisions, an ICU stay greater than 7 days, or lack of goals of care.
Dr. Kang, chief resident in the department of medicine at New Jersey Medical School, Newark, presented the results, which were of patients admitted to the department of medicine at University Hospital in Newark in 2015. Those admitted to the ICU within 24 hours of admission were excluded from the analysis, leaving 461 patient charts that were screened for PCC needs based on the consensus report from the Center to Advance Palliative Care.
The patients who met an indication for PCC had a mean age of 60 years and an average length of stay of 7 days. The percentages of these patients who were female, African American, and Hispanic were 45%, 40%, and 21%, respectively.
On multivariate analysis, patients who had a PCC within 72 hours of admission were eight times more likely to have a hospital length of stay less than 7 days (P = .019), while those who had a PCC within 48 hours of admission were 20 times more likely to have a hospital length of stay less than 7 days (P = .017). “So if we intervened early, we were able to decrease their length of stay to less than 7 days,” Dr. Kang said at the meeting.
She acknowledged certain limitations of the study, including its small sample size, retrospective design, and lack of follow-up. “This study also has a lot of confounding socioeconomic factors that do not make it applicable to every hospital across the country,” she said. “This is not a homogeneous patient population.”
The study’s principal investigator was Anne Sutherland, MD, medical intensive care unit director at University Hospital. Dr. Kang reported having no financial disclosures.
LOS ANGELES – A significant percentage of patients who meet criteria for palliative care consultations do not receive a consult during their hospital stay, results from a single-center retrospective analysis showed.
“Physicians need to recognize the palliative care needs of patients with chronic illnesses other than malignancy before they get admitted to the ICU, especially when these patients are admitted repeatedly for the same problem [and] have a significant decline in functional status with a large symptom burden,” Mohleen Kang, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “There is a potential missed opportunity for these conversations to occur with the patients and their family prior to their decompensation and crisis.”
Twenty-nine percent (132) of the patients studied met an indication for a palliative care consult (PCC), with only 35 (27%) of such patients having received a PCC. Patients with metastatic cancer were significantly more likely to have received a PCC, compared with non-cancer patients (64% vs. 21%, respectively; P less than .001), while patients with New York Heart Association Class III or IV congestive heart failure were less likely to receive a PCC, compared with those who did not have congestive heart failure (5.6% vs. 29.8%; P = .014).
Criteria for PCC on admission include a life-limiting diagnosis and more than one admission in the past 3 months, decline in function, or complex care requirements. Criteria for PCC during hospitalization include life-limiting diagnosis and uncertainty about decisions, an ICU stay greater than 7 days, or lack of goals of care.
Dr. Kang, chief resident in the department of medicine at New Jersey Medical School, Newark, presented the results, which were of patients admitted to the department of medicine at University Hospital in Newark in 2015. Those admitted to the ICU within 24 hours of admission were excluded from the analysis, leaving 461 patient charts that were screened for PCC needs based on the consensus report from the Center to Advance Palliative Care.
The patients who met an indication for PCC had a mean age of 60 years and an average length of stay of 7 days. The percentages of these patients who were female, African American, and Hispanic were 45%, 40%, and 21%, respectively.
On multivariate analysis, patients who had a PCC within 72 hours of admission were eight times more likely to have a hospital length of stay less than 7 days (P = .019), while those who had a PCC within 48 hours of admission were 20 times more likely to have a hospital length of stay less than 7 days (P = .017). “So if we intervened early, we were able to decrease their length of stay to less than 7 days,” Dr. Kang said at the meeting.
She acknowledged certain limitations of the study, including its small sample size, retrospective design, and lack of follow-up. “This study also has a lot of confounding socioeconomic factors that do not make it applicable to every hospital across the country,” she said. “This is not a homogeneous patient population.”
The study’s principal investigator was Anne Sutherland, MD, medical intensive care unit director at University Hospital. Dr. Kang reported having no financial disclosures.
AT CHEST 2016
Key clinical point:
Major finding: Patients with metastatic cancer were significantly more likely to have received a PCC, compared with non-cancer patients (64% vs. 21%, respectively; P less than .001).
Data source: A retrospective study of 132 patients admitted to the department of medicine at University Hospital in Newark, N.J., in 2015.
Disclosures: Dr. Kang reported having no financial disclosures.