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CHEST Annual Meeting Highlights 2017
- Sepsis response team not beneficial
- Outcomes better for patients with H1N1 vaccination
- Lung recovery high after ECMO in near-fatal asthma
- Robotic-assisted pulmonary lobectomy removes large tumors
- Aspirin responsiveness improved in some with obstructive sleep apnea
- Solriamfetol improves excessive sleepiness in OSA patients
- Acute kidney injury linked with doubled inpatient VTEs
- Alarm reductions don’t improve ICU response times
- ARDS incidence is declining. Is it a preventable syndrome?
- Balanced crystalloids protect kidney better than saline
- Omalizumab helps asthma COPD overlap patients
- Nebulized glycopyrrolate improves lung function in COPD
- Nebulized LABA safe for long-term use in COPD
- IGRA preferred test for latent TB diagnosis
- Only half of appropriate COPD patients get long-acting bronchodilators
- Rapid influenza test obviates empiric antivirals
- Remimazolam surpasses midazolam
- Revised guidelines raise lung cancer screening age ceiling
- Ultrathin bronchoscopy plus radial EBUS unreliable at making diagnoses
- Phrenic-nerve stimulator maintains benefits for 18 months
- Cardiogenic shock boosts PAH readmissions 10-fold
- Evidence mounts for pulmonary embolism benefit from catheter thrombolysis
- Tracheobronchial tree size changes may predict IPF outcomes
- Shorter walk test predicts IPF outcomes
- Comparing arterial ratios may aid risk assessment in IPF
- FDA’s standards for approving generics are questioned
- Live Streaming at CHEST 2017
- Sepsis response team not beneficial
- Outcomes better for patients with H1N1 vaccination
- Lung recovery high after ECMO in near-fatal asthma
- Robotic-assisted pulmonary lobectomy removes large tumors
- Aspirin responsiveness improved in some with obstructive sleep apnea
- Solriamfetol improves excessive sleepiness in OSA patients
- Acute kidney injury linked with doubled inpatient VTEs
- Alarm reductions don’t improve ICU response times
- ARDS incidence is declining. Is it a preventable syndrome?
- Balanced crystalloids protect kidney better than saline
- Omalizumab helps asthma COPD overlap patients
- Nebulized glycopyrrolate improves lung function in COPD
- Nebulized LABA safe for long-term use in COPD
- IGRA preferred test for latent TB diagnosis
- Only half of appropriate COPD patients get long-acting bronchodilators
- Rapid influenza test obviates empiric antivirals
- Remimazolam surpasses midazolam
- Revised guidelines raise lung cancer screening age ceiling
- Ultrathin bronchoscopy plus radial EBUS unreliable at making diagnoses
- Phrenic-nerve stimulator maintains benefits for 18 months
- Cardiogenic shock boosts PAH readmissions 10-fold
- Evidence mounts for pulmonary embolism benefit from catheter thrombolysis
- Tracheobronchial tree size changes may predict IPF outcomes
- Shorter walk test predicts IPF outcomes
- Comparing arterial ratios may aid risk assessment in IPF
- FDA’s standards for approving generics are questioned
- Live Streaming at CHEST 2017
- Sepsis response team not beneficial
- Outcomes better for patients with H1N1 vaccination
- Lung recovery high after ECMO in near-fatal asthma
- Robotic-assisted pulmonary lobectomy removes large tumors
- Aspirin responsiveness improved in some with obstructive sleep apnea
- Solriamfetol improves excessive sleepiness in OSA patients
- Acute kidney injury linked with doubled inpatient VTEs
- Alarm reductions don’t improve ICU response times
- ARDS incidence is declining. Is it a preventable syndrome?
- Balanced crystalloids protect kidney better than saline
- Omalizumab helps asthma COPD overlap patients
- Nebulized glycopyrrolate improves lung function in COPD
- Nebulized LABA safe for long-term use in COPD
- IGRA preferred test for latent TB diagnosis
- Only half of appropriate COPD patients get long-acting bronchodilators
- Rapid influenza test obviates empiric antivirals
- Remimazolam surpasses midazolam
- Revised guidelines raise lung cancer screening age ceiling
- Ultrathin bronchoscopy plus radial EBUS unreliable at making diagnoses
- Phrenic-nerve stimulator maintains benefits for 18 months
- Cardiogenic shock boosts PAH readmissions 10-fold
- Evidence mounts for pulmonary embolism benefit from catheter thrombolysis
- Tracheobronchial tree size changes may predict IPF outcomes
- Shorter walk test predicts IPF outcomes
- Comparing arterial ratios may aid risk assessment in IPF
- FDA’s standards for approving generics are questioned
- Live Streaming at CHEST 2017
FDA’s standards for approving generics are questioned
TORONTO – The Food and Drug Administration’s standards for demonstrating pharmacokinetic bioequivalence between two inhaled products, which allow for single batch comparisons of approved and generic candidate products, need to be revised to address batch to batch variability, suggested a presenter at the CHEST annual meeting.
Marketing approval of a new generic drug in the United States, including orally inhaled products, generally requires a demonstration of pharmacokinetic bioequivalence to a reference listed product. The standard criterion for statistical bioequivalence applied by the FDA requires the pharmacokinetics of the generic to be within about 10% of the branded product.
In early pharmacokinetic bioequivalence studies, Elise Burmeister Getz, PhD, and her colleagues compared single batches of their generic candidate OT329 Solis 100/50 to single batches of Advair Diskus 100/50 in five individual studies and single batches of Advair Diskus 100/50 to single batches of the same drug. They also found Advair Diskus 100/50 batches that were more than 30% different from each other. 
“When patients differ from one another, we put many patients in the trial. And when batches differ from one another, we should be putting many batches in the trial,” Dr. Burmeister Getz, director of clinical pharmacology at Oriel Therapeutics, said at the CHEST meeting. “If we want a robust assessment of bioequivalence and not just a check the box exercise, we really need to have product sampling that’s aligned with product variability.”
When the researchers combined the data in a meta-analysis, bioequivalence was demonstrated, but the pooled analysis could not be used for FDA registration because of its retrospective nature.
They later conducted a prospective study with multiple batches of both the generic and branded drugs. This multiple-batch bioequivalence study involved 96 healthy subjects using 16 batches each of Advair Diskus and Oriel’s OT329 Solis 100/50. A single inhalation was administered to healthy adult subjects in a randomized crossover design and blood samples were collected pre dose and up to 48 hours after inhalation.
With the FDA’s definition of bioequivalence, the generic candidate fell within the bioequivalence goalposts, Dr. Burmeister Getz noted.
The issue of pharmacokinetic variance is not unique to Advair Diskus, but she and her colleagues don’t understand why different batches show such wide variability, Dr. Burmeister Getz noted.
“The advantage of this multibatch approach is that the results of the bioequivalence assessment aren’t dependent on the single batch that happened to be chosen for the study. They are generalizable to the product because the product has been robustly represented in the study,” Dr. Burmeister Getz told attendees.
Oriel makes OT329 Solis 100/50, a fully substitutable generic to Advair Diskus 100/50, which is indicated for treating asthma. Both are multidose dry powder oral inhalation products containing fluticasone propionate, to reduce inflammation in the lungs, and salmeterol, to relax muscles in the airways, for the maintenance treatment of asthma. Advair Diskus at higher doses is indicated for asthma and COPD.
An FDA response?
Asked what the FDA makes of the batch-to-batch variability data, Dr. Burmeister Getz answered simply, “We don’t know.” Before she and her colleagues ran the 16 batch per product study, they submitted their protocol to the FDA for review, but 1 year later, they still hadn’t heard any response.
“Sponsors are apparently allowed to simply pick their batch in a careful and, dare I say manipulative way, to gain the result they want. With a single batch study the selection of batch will absolutely determine the outcome of the study.”
In vitro bioequivalence studies are already required to use multiple batches, she noted.
This research was funded by Oriel Therapeutics, an indirect wholly-owned subsidiary of Novartis AG.
TORONTO – The Food and Drug Administration’s standards for demonstrating pharmacokinetic bioequivalence between two inhaled products, which allow for single batch comparisons of approved and generic candidate products, need to be revised to address batch to batch variability, suggested a presenter at the CHEST annual meeting.
Marketing approval of a new generic drug in the United States, including orally inhaled products, generally requires a demonstration of pharmacokinetic bioequivalence to a reference listed product. The standard criterion for statistical bioequivalence applied by the FDA requires the pharmacokinetics of the generic to be within about 10% of the branded product.
In early pharmacokinetic bioequivalence studies, Elise Burmeister Getz, PhD, and her colleagues compared single batches of their generic candidate OT329 Solis 100/50 to single batches of Advair Diskus 100/50 in five individual studies and single batches of Advair Diskus 100/50 to single batches of the same drug. They also found Advair Diskus 100/50 batches that were more than 30% different from each other.
“When patients differ from one another, we put many patients in the trial. And when batches differ from one another, we should be putting many batches in the trial,” Dr. Burmeister Getz, director of clinical pharmacology at Oriel Therapeutics, said at the CHEST meeting. “If we want a robust assessment of bioequivalence and not just a check the box exercise, we really need to have product sampling that’s aligned with product variability.”
When the researchers combined the data in a meta-analysis, bioequivalence was demonstrated, but the pooled analysis could not be used for FDA registration because of its retrospective nature.
They later conducted a prospective study with multiple batches of both the generic and branded drugs. This multiple-batch bioequivalence study involved 96 healthy subjects using 16 batches each of Advair Diskus and Oriel’s OT329 Solis 100/50. A single inhalation was administered to healthy adult subjects in a randomized crossover design and blood samples were collected pre dose and up to 48 hours after inhalation.
With the FDA’s definition of bioequivalence, the generic candidate fell within the bioequivalence goalposts, Dr. Burmeister Getz noted.
The issue of pharmacokinetic variance is not unique to Advair Diskus, but she and her colleagues don’t understand why different batches show such wide variability, Dr. Burmeister Getz noted.
“The advantage of this multibatch approach is that the results of the bioequivalence assessment aren’t dependent on the single batch that happened to be chosen for the study. They are generalizable to the product because the product has been robustly represented in the study,” Dr. Burmeister Getz told attendees.
Oriel makes OT329 Solis 100/50, a fully substitutable generic to Advair Diskus 100/50, which is indicated for treating asthma. Both are multidose dry powder oral inhalation products containing fluticasone propionate, to reduce inflammation in the lungs, and salmeterol, to relax muscles in the airways, for the maintenance treatment of asthma. Advair Diskus at higher doses is indicated for asthma and COPD.
An FDA response?
Asked what the FDA makes of the batch-to-batch variability data, Dr. Burmeister Getz answered simply, “We don’t know.” Before she and her colleagues ran the 16 batch per product study, they submitted their protocol to the FDA for review, but 1 year later, they still hadn’t heard any response.
“Sponsors are apparently allowed to simply pick their batch in a careful and, dare I say manipulative way, to gain the result they want. With a single batch study the selection of batch will absolutely determine the outcome of the study.”
In vitro bioequivalence studies are already required to use multiple batches, she noted.
This research was funded by Oriel Therapeutics, an indirect wholly-owned subsidiary of Novartis AG.
TORONTO – The Food and Drug Administration’s standards for demonstrating pharmacokinetic bioequivalence between two inhaled products, which allow for single batch comparisons of approved and generic candidate products, need to be revised to address batch to batch variability, suggested a presenter at the CHEST annual meeting.
Marketing approval of a new generic drug in the United States, including orally inhaled products, generally requires a demonstration of pharmacokinetic bioequivalence to a reference listed product. The standard criterion for statistical bioequivalence applied by the FDA requires the pharmacokinetics of the generic to be within about 10% of the branded product.
In early pharmacokinetic bioequivalence studies, Elise Burmeister Getz, PhD, and her colleagues compared single batches of their generic candidate OT329 Solis 100/50 to single batches of Advair Diskus 100/50 in five individual studies and single batches of Advair Diskus 100/50 to single batches of the same drug. They also found Advair Diskus 100/50 batches that were more than 30% different from each other.
“When patients differ from one another, we put many patients in the trial. And when batches differ from one another, we should be putting many batches in the trial,” Dr. Burmeister Getz, director of clinical pharmacology at Oriel Therapeutics, said at the CHEST meeting. “If we want a robust assessment of bioequivalence and not just a check the box exercise, we really need to have product sampling that’s aligned with product variability.”
When the researchers combined the data in a meta-analysis, bioequivalence was demonstrated, but the pooled analysis could not be used for FDA registration because of its retrospective nature.
They later conducted a prospective study with multiple batches of both the generic and branded drugs. This multiple-batch bioequivalence study involved 96 healthy subjects using 16 batches each of Advair Diskus and Oriel’s OT329 Solis 100/50. A single inhalation was administered to healthy adult subjects in a randomized crossover design and blood samples were collected pre dose and up to 48 hours after inhalation.
With the FDA’s definition of bioequivalence, the generic candidate fell within the bioequivalence goalposts, Dr. Burmeister Getz noted.
The issue of pharmacokinetic variance is not unique to Advair Diskus, but she and her colleagues don’t understand why different batches show such wide variability, Dr. Burmeister Getz noted.
“The advantage of this multibatch approach is that the results of the bioequivalence assessment aren’t dependent on the single batch that happened to be chosen for the study. They are generalizable to the product because the product has been robustly represented in the study,” Dr. Burmeister Getz told attendees.
Oriel makes OT329 Solis 100/50, a fully substitutable generic to Advair Diskus 100/50, which is indicated for treating asthma. Both are multidose dry powder oral inhalation products containing fluticasone propionate, to reduce inflammation in the lungs, and salmeterol, to relax muscles in the airways, for the maintenance treatment of asthma. Advair Diskus at higher doses is indicated for asthma and COPD.
An FDA response?
Asked what the FDA makes of the batch-to-batch variability data, Dr. Burmeister Getz answered simply, “We don’t know.” Before she and her colleagues ran the 16 batch per product study, they submitted their protocol to the FDA for review, but 1 year later, they still hadn’t heard any response.
“Sponsors are apparently allowed to simply pick their batch in a careful and, dare I say manipulative way, to gain the result they want. With a single batch study the selection of batch will absolutely determine the outcome of the study.”
In vitro bioequivalence studies are already required to use multiple batches, she noted.
This research was funded by Oriel Therapeutics, an indirect wholly-owned subsidiary of Novartis AG.
AT CHEST 2017
Key clinical point: The FDA’s standards for demonstrating pharmacokinetic bioequivalence between two inhaled products need to be revised to address batch to batch variability.
Major finding: Investigators found Advair Diskus 100/50 batches that were more than 30% different from each other.
Data source: Pharmacokinetic bioequivalence studies comparing batches of Advair Diskus 100/50 to each other, and to batches of the generic candidate OT329 Solis 100/50.
Disclosures: This research was funded by Oriel Therapeutics, an indirect wholly-owned subsidiary of Novartis AG. Dr. Burmeister Getz is director of clinical pharmacology at Oriel Therapeutics.
Comparing arterial ratios may aid risk assessment in IPF
An arterial ratio can help identify idiopathic pulmonary fibrosis (IPF) patients with a poor prognosis, suggests the findings of registry data from 50 adults.
The ratio of the main pulmonary artery diameter (PA) to the ascending aorta diameter (A) as seen on a chest CT correlates with pulmonary artery pressure, M. Faisal Siddiqui, MD, a pulmonologist in New York, and his colleagues wrote in an abstract from the agenda of the CHEST annual meeting. To determine whether higher PA:A ratios were associated with more biomarker abnormalities, the researchers reviewed 122 CT scans from 50 adults with IPF.
Overall, 48% of the patients had a PA:A ratio of at least 1, according to Dr. Siddiqui and his coauthors. These patients had significantly higher fibrosis scores (P = .0006), GAP index scores (P = .0144), brain natriuretic peptide scores (P = .0046), and pulmonary arterial systolic pressure (P = .0063) compared with patients who had PA:A ratios of less than 1, according to the Kruskal-Wallis test. This test also showed no significant differences on measures of coronary artery calcium, aortic value calcifications, mitral valve calcifications, bronchial wall thickening, emphysema, and spirometry data between the two patient groups, based on PA:A ratios.
Use of the Pearson correlation revealed a positive relationship between PA:A ratios greater than 1 and coronary artery calcium scores, fibrosis scores, and pulmonary arterial systolic pressure, but a negative relationship between a high PA:A ratio and both diffusing capacity and forced vital capacity.
Although the findings were limited by a small study population, the results suggest that clinicians can use the finding of an increased PA:A ratio to help identify IPF patients at greater risk for poor outcomes. Such patients might benefit from pharmacotherapy or transplants, the researchers noted.
Dr. Siddiqui and his coauthors had no financial conflicts to disclose.
An arterial ratio can help identify idiopathic pulmonary fibrosis (IPF) patients with a poor prognosis, suggests the findings of registry data from 50 adults.
The ratio of the main pulmonary artery diameter (PA) to the ascending aorta diameter (A) as seen on a chest CT correlates with pulmonary artery pressure, M. Faisal Siddiqui, MD, a pulmonologist in New York, and his colleagues wrote in an abstract from the agenda of the CHEST annual meeting. To determine whether higher PA:A ratios were associated with more biomarker abnormalities, the researchers reviewed 122 CT scans from 50 adults with IPF.
Overall, 48% of the patients had a PA:A ratio of at least 1, according to Dr. Siddiqui and his coauthors. These patients had significantly higher fibrosis scores (P = .0006), GAP index scores (P = .0144), brain natriuretic peptide scores (P = .0046), and pulmonary arterial systolic pressure (P = .0063) compared with patients who had PA:A ratios of less than 1, according to the Kruskal-Wallis test. This test also showed no significant differences on measures of coronary artery calcium, aortic value calcifications, mitral valve calcifications, bronchial wall thickening, emphysema, and spirometry data between the two patient groups, based on PA:A ratios.
Use of the Pearson correlation revealed a positive relationship between PA:A ratios greater than 1 and coronary artery calcium scores, fibrosis scores, and pulmonary arterial systolic pressure, but a negative relationship between a high PA:A ratio and both diffusing capacity and forced vital capacity.
Although the findings were limited by a small study population, the results suggest that clinicians can use the finding of an increased PA:A ratio to help identify IPF patients at greater risk for poor outcomes. Such patients might benefit from pharmacotherapy or transplants, the researchers noted.
Dr. Siddiqui and his coauthors had no financial conflicts to disclose.
An arterial ratio can help identify idiopathic pulmonary fibrosis (IPF) patients with a poor prognosis, suggests the findings of registry data from 50 adults.
The ratio of the main pulmonary artery diameter (PA) to the ascending aorta diameter (A) as seen on a chest CT correlates with pulmonary artery pressure, M. Faisal Siddiqui, MD, a pulmonologist in New York, and his colleagues wrote in an abstract from the agenda of the CHEST annual meeting. To determine whether higher PA:A ratios were associated with more biomarker abnormalities, the researchers reviewed 122 CT scans from 50 adults with IPF.
Overall, 48% of the patients had a PA:A ratio of at least 1, according to Dr. Siddiqui and his coauthors. These patients had significantly higher fibrosis scores (P = .0006), GAP index scores (P = .0144), brain natriuretic peptide scores (P = .0046), and pulmonary arterial systolic pressure (P = .0063) compared with patients who had PA:A ratios of less than 1, according to the Kruskal-Wallis test. This test also showed no significant differences on measures of coronary artery calcium, aortic value calcifications, mitral valve calcifications, bronchial wall thickening, emphysema, and spirometry data between the two patient groups, based on PA:A ratios.
Use of the Pearson correlation revealed a positive relationship between PA:A ratios greater than 1 and coronary artery calcium scores, fibrosis scores, and pulmonary arterial systolic pressure, but a negative relationship between a high PA:A ratio and both diffusing capacity and forced vital capacity.
Although the findings were limited by a small study population, the results suggest that clinicians can use the finding of an increased PA:A ratio to help identify IPF patients at greater risk for poor outcomes. Such patients might benefit from pharmacotherapy or transplants, the researchers noted.
Dr. Siddiqui and his coauthors had no financial conflicts to disclose.
FROM CHEST 2017
Shorter walk test predicts IPF outcomes
, based on data from 179 adults. The findings were presented at the CHEST annual meeting.
The 6-minute test is often used to evaluate functional capacity in IPF patients, but is not always practical in a busy clinic setting, according to Flavia S. Nunes, MD, of Inova Fairfax Hospital in Falls Church, VA, and colleagues.
“Among the clinical and physiologic predictors associated with survival in IPF, the 6MWT has been increasingly used over the past 5 years as a secondary endpoint in the efficacy analyses of potential therapies for IPF. Validation of shorter time of walking might make the test more feasible to be applied in routine clinical care,” she said.
To determine the predictive value of the first minute of the 6-minute test, the researchers reviewed data from 142 men and 37 women at a tertiary referral center between May 2010 and February 2017. The average age of the patients was 68 years, the average body mass index was 28.3 kg/m2, and 27% used oxygen supplementation during the walk test.
Overall, the mean distance for the 6-minute test was 372 m, and the average distance for the 1-minute test was 65 m. Study participants who achieved a 6-minute walk distance greater than 372 m were defined as high walkers, and those with a 6-minute walk distance less than 372 m were defined as low walkers. A strong correlation appeared between the 6-minute distance and 1-minute distance in terms of predicting survival, and 1-year transplant-free survival was significantly better in high walkers than in low walkers (27 months vs. 22 months; P = .015).
Dr. Nunes said she was not surprised by the results, in part because previous research has shown a strong correlation among 2-minute, 6-minute, and 12-minute walking tests.
Although more research is needed to validate the findings, the results suggest that the 1-minute test might be a practical substitute for the 6-minute test by providing similar prognostic information more quickly and easily than the 6-minute test, the researchers said.
“It is important for clinicians to know that the time chosen to assess exercise tolerance by walking tests might not be critical,” said Dr. Nunes. “Shorter walks are not only less time consuming, and easier for both patients and clinicians, but are also reproducible and discriminatory of survival.
“We need to validate the test performance characteristics and prognostic value of distance walked in a 1MWT compared to the standard 6MWT in an independent cohort of patients with IPF,” Dr. Nunes noted. “Additionally, the evaluation of alternate instruction, for example changing the wording from ‘walk as far’ to ‘walk as fast’ might facilitate a better effort, and a greater distance with improved reproducibility. Other novel parameters and modifications to the 6MWT or 1MWT might further improve the utility of these tests in the management of IPF and other patients,” she added.
The researchers had no financial conflicts to disclose.
, based on data from 179 adults. The findings were presented at the CHEST annual meeting.
The 6-minute test is often used to evaluate functional capacity in IPF patients, but is not always practical in a busy clinic setting, according to Flavia S. Nunes, MD, of Inova Fairfax Hospital in Falls Church, VA, and colleagues.
“Among the clinical and physiologic predictors associated with survival in IPF, the 6MWT has been increasingly used over the past 5 years as a secondary endpoint in the efficacy analyses of potential therapies for IPF. Validation of shorter time of walking might make the test more feasible to be applied in routine clinical care,” she said.
To determine the predictive value of the first minute of the 6-minute test, the researchers reviewed data from 142 men and 37 women at a tertiary referral center between May 2010 and February 2017. The average age of the patients was 68 years, the average body mass index was 28.3 kg/m2, and 27% used oxygen supplementation during the walk test.
Overall, the mean distance for the 6-minute test was 372 m, and the average distance for the 1-minute test was 65 m. Study participants who achieved a 6-minute walk distance greater than 372 m were defined as high walkers, and those with a 6-minute walk distance less than 372 m were defined as low walkers. A strong correlation appeared between the 6-minute distance and 1-minute distance in terms of predicting survival, and 1-year transplant-free survival was significantly better in high walkers than in low walkers (27 months vs. 22 months; P = .015).
Dr. Nunes said she was not surprised by the results, in part because previous research has shown a strong correlation among 2-minute, 6-minute, and 12-minute walking tests.
Although more research is needed to validate the findings, the results suggest that the 1-minute test might be a practical substitute for the 6-minute test by providing similar prognostic information more quickly and easily than the 6-minute test, the researchers said.
“It is important for clinicians to know that the time chosen to assess exercise tolerance by walking tests might not be critical,” said Dr. Nunes. “Shorter walks are not only less time consuming, and easier for both patients and clinicians, but are also reproducible and discriminatory of survival.
“We need to validate the test performance characteristics and prognostic value of distance walked in a 1MWT compared to the standard 6MWT in an independent cohort of patients with IPF,” Dr. Nunes noted. “Additionally, the evaluation of alternate instruction, for example changing the wording from ‘walk as far’ to ‘walk as fast’ might facilitate a better effort, and a greater distance with improved reproducibility. Other novel parameters and modifications to the 6MWT or 1MWT might further improve the utility of these tests in the management of IPF and other patients,” she added.
The researchers had no financial conflicts to disclose.
, based on data from 179 adults. The findings were presented at the CHEST annual meeting.
The 6-minute test is often used to evaluate functional capacity in IPF patients, but is not always practical in a busy clinic setting, according to Flavia S. Nunes, MD, of Inova Fairfax Hospital in Falls Church, VA, and colleagues.
“Among the clinical and physiologic predictors associated with survival in IPF, the 6MWT has been increasingly used over the past 5 years as a secondary endpoint in the efficacy analyses of potential therapies for IPF. Validation of shorter time of walking might make the test more feasible to be applied in routine clinical care,” she said.
To determine the predictive value of the first minute of the 6-minute test, the researchers reviewed data from 142 men and 37 women at a tertiary referral center between May 2010 and February 2017. The average age of the patients was 68 years, the average body mass index was 28.3 kg/m2, and 27% used oxygen supplementation during the walk test.
Overall, the mean distance for the 6-minute test was 372 m, and the average distance for the 1-minute test was 65 m. Study participants who achieved a 6-minute walk distance greater than 372 m were defined as high walkers, and those with a 6-minute walk distance less than 372 m were defined as low walkers. A strong correlation appeared between the 6-minute distance and 1-minute distance in terms of predicting survival, and 1-year transplant-free survival was significantly better in high walkers than in low walkers (27 months vs. 22 months; P = .015).
Dr. Nunes said she was not surprised by the results, in part because previous research has shown a strong correlation among 2-minute, 6-minute, and 12-minute walking tests.
Although more research is needed to validate the findings, the results suggest that the 1-minute test might be a practical substitute for the 6-minute test by providing similar prognostic information more quickly and easily than the 6-minute test, the researchers said.
“It is important for clinicians to know that the time chosen to assess exercise tolerance by walking tests might not be critical,” said Dr. Nunes. “Shorter walks are not only less time consuming, and easier for both patients and clinicians, but are also reproducible and discriminatory of survival.
“We need to validate the test performance characteristics and prognostic value of distance walked in a 1MWT compared to the standard 6MWT in an independent cohort of patients with IPF,” Dr. Nunes noted. “Additionally, the evaluation of alternate instruction, for example changing the wording from ‘walk as far’ to ‘walk as fast’ might facilitate a better effort, and a greater distance with improved reproducibility. Other novel parameters and modifications to the 6MWT or 1MWT might further improve the utility of these tests in the management of IPF and other patients,” she added.
The researchers had no financial conflicts to disclose.
FROM CHEST 2017
Tracheobronchial tree size changes may predict IPF outcomes
Changes in tracheobronchial tree size may serve as a practical and noninvasive method for predicting disease severity in patients diagnosed with idiopathic pulmonary fibrosis, according to data from 150 adults.
To determine the potential predictive value of tracheobronchial tree changes on mortality, Ankush Ratwani, MD, of Georgetown University, Washington, and colleagues reviewed data from adults with IPF seen at a single center between March 2012 and December 2016. The findings were presented at the CHEST annual meeting.
The researchers measured the tracheal diameters of the patients and used the GAP index, an established system for predicting mortality in IPF patients, to determine a relationship. Overall, they found a significant correlation between GAP index scores and increasing tracheobronchial tree size across eight measurements of different levels along the tracheobronchial tree “with an increase in GAP index stage for every level of increase in tracheal measurements (P less than .005),” they noted.
Measurements included the anterior-posterior diameter at the subglottic level, aortic arch, carina, right main stem bronchus, and left main stem bronchus, as well as transverse diameter assessment at the subglottis, aortic arch, and carina. The average anterior-posterior tracheal diameters were 21.77 mm for the subglottis, 21.84 mm for the aortic arch, 20.47 mm for the carina, 15.19 for the right main stem bronchus, and 14.21 mm for the left main stem bronchus.
No correlation appeared between tracheal size and lung volume, which suggests that enlargement of the trachea is likely caused by other factors beyond fibrosis, and next steps for research should determine whether tracheal size is an independent predictor of mortality in IPF patients, the investigators noted.
“With the field of treatment and management changing for IPF over the last few years, it has becoming increasingly important to prognose these patients in order to find where they fit in the spectrum for treatment or lung transplant,” Dr. Ratwani said in an interview. “Additionally, there needs to be a noninvasive measure to show disease progression, such as with using CT scans, and correlate with other prognostic indicators to hopefully create a regression formula that encompasses multiple parameters,” he explained.
“The results were surprising in that there was a correlation of a radiographic measure that has not been looked at previously with a validated measure of prognostication in IPF (GAP Index),” Dr. Ratwani said.
Although the findings do not imply more than a correlation, the results serve as “a good start to validate the theory that as the distal airways enlarge (traction bronchiectasis) in later stages of IPF, so may the proximal airways, which may be used to easily measure disease progression and guide the conversation for transplant or treatment,” Dr. Ratwani noted. His next steps for research include studying transplant-free survival in correlation with tracheal size, as well as serial changes between CT scans with correlations of lung volumes and survival.
Changes in tracheobronchial tree size may serve as a practical and noninvasive method for predicting disease severity in patients diagnosed with idiopathic pulmonary fibrosis, according to data from 150 adults.
To determine the potential predictive value of tracheobronchial tree changes on mortality, Ankush Ratwani, MD, of Georgetown University, Washington, and colleagues reviewed data from adults with IPF seen at a single center between March 2012 and December 2016. The findings were presented at the CHEST annual meeting.
The researchers measured the tracheal diameters of the patients and used the GAP index, an established system for predicting mortality in IPF patients, to determine a relationship. Overall, they found a significant correlation between GAP index scores and increasing tracheobronchial tree size across eight measurements of different levels along the tracheobronchial tree “with an increase in GAP index stage for every level of increase in tracheal measurements (P less than .005),” they noted.
Measurements included the anterior-posterior diameter at the subglottic level, aortic arch, carina, right main stem bronchus, and left main stem bronchus, as well as transverse diameter assessment at the subglottis, aortic arch, and carina. The average anterior-posterior tracheal diameters were 21.77 mm for the subglottis, 21.84 mm for the aortic arch, 20.47 mm for the carina, 15.19 for the right main stem bronchus, and 14.21 mm for the left main stem bronchus.
No correlation appeared between tracheal size and lung volume, which suggests that enlargement of the trachea is likely caused by other factors beyond fibrosis, and next steps for research should determine whether tracheal size is an independent predictor of mortality in IPF patients, the investigators noted.
“With the field of treatment and management changing for IPF over the last few years, it has becoming increasingly important to prognose these patients in order to find where they fit in the spectrum for treatment or lung transplant,” Dr. Ratwani said in an interview. “Additionally, there needs to be a noninvasive measure to show disease progression, such as with using CT scans, and correlate with other prognostic indicators to hopefully create a regression formula that encompasses multiple parameters,” he explained.
“The results were surprising in that there was a correlation of a radiographic measure that has not been looked at previously with a validated measure of prognostication in IPF (GAP Index),” Dr. Ratwani said.
Although the findings do not imply more than a correlation, the results serve as “a good start to validate the theory that as the distal airways enlarge (traction bronchiectasis) in later stages of IPF, so may the proximal airways, which may be used to easily measure disease progression and guide the conversation for transplant or treatment,” Dr. Ratwani noted. His next steps for research include studying transplant-free survival in correlation with tracheal size, as well as serial changes between CT scans with correlations of lung volumes and survival.
Changes in tracheobronchial tree size may serve as a practical and noninvasive method for predicting disease severity in patients diagnosed with idiopathic pulmonary fibrosis, according to data from 150 adults.
To determine the potential predictive value of tracheobronchial tree changes on mortality, Ankush Ratwani, MD, of Georgetown University, Washington, and colleagues reviewed data from adults with IPF seen at a single center between March 2012 and December 2016. The findings were presented at the CHEST annual meeting.
The researchers measured the tracheal diameters of the patients and used the GAP index, an established system for predicting mortality in IPF patients, to determine a relationship. Overall, they found a significant correlation between GAP index scores and increasing tracheobronchial tree size across eight measurements of different levels along the tracheobronchial tree “with an increase in GAP index stage for every level of increase in tracheal measurements (P less than .005),” they noted.
Measurements included the anterior-posterior diameter at the subglottic level, aortic arch, carina, right main stem bronchus, and left main stem bronchus, as well as transverse diameter assessment at the subglottis, aortic arch, and carina. The average anterior-posterior tracheal diameters were 21.77 mm for the subglottis, 21.84 mm for the aortic arch, 20.47 mm for the carina, 15.19 for the right main stem bronchus, and 14.21 mm for the left main stem bronchus.
No correlation appeared between tracheal size and lung volume, which suggests that enlargement of the trachea is likely caused by other factors beyond fibrosis, and next steps for research should determine whether tracheal size is an independent predictor of mortality in IPF patients, the investigators noted.
“With the field of treatment and management changing for IPF over the last few years, it has becoming increasingly important to prognose these patients in order to find where they fit in the spectrum for treatment or lung transplant,” Dr. Ratwani said in an interview. “Additionally, there needs to be a noninvasive measure to show disease progression, such as with using CT scans, and correlate with other prognostic indicators to hopefully create a regression formula that encompasses multiple parameters,” he explained.
“The results were surprising in that there was a correlation of a radiographic measure that has not been looked at previously with a validated measure of prognostication in IPF (GAP Index),” Dr. Ratwani said.
Although the findings do not imply more than a correlation, the results serve as “a good start to validate the theory that as the distal airways enlarge (traction bronchiectasis) in later stages of IPF, so may the proximal airways, which may be used to easily measure disease progression and guide the conversation for transplant or treatment,” Dr. Ratwani noted. His next steps for research include studying transplant-free survival in correlation with tracheal size, as well as serial changes between CT scans with correlations of lung volumes and survival.
FROM CHEST 2017
Live Streaming at CHEST 2017
In April 2016, Facebook launched Facebook Live, a tool for live streaming to a Facebook page to share live video with their followers on Facebook. At CHEST 2016, the CHEST New Media team began to experiment with live video with some early success. The CHEST 2017 team made the decision, based on the organization’s goal to help educate clinicians to improve patient care, to live stream complete sessions from CHEST 2017. With the help of the CHEST 2017 Education Committee and the Social Media Work Group, more than 25 sessions were selected and live streamed.
CHEST’s efforts on Facebook Live resulted in the following:
- Total people reached: 133,737
- Total video views: 34,449
- Total minutes watched: 30,786 (or 513 hours, or 21 days)
- Total interactions: 1,050 (eg, likes, loves, hahas, etc)
- Total shares: 302
The content concept was well received, and comments ranged from followers chiming in with their location, appreciation for live streaming, and even comments from patients.
- “Thank you for sharing this live presentation.”
- “Here from Mexico !!”
- “Here from Natal/RN, Brazil”
- “Here from Milan, Italy.”
- “Appreciate this live streaming on important sessions, big service for those who couldn’t attend!!”
- “My brother survived after six days on ECMO. I am so glad to have him.”
- “It’s a great chance for physicians working in pulmonology and general practice to get the pearls of guidelines from American College to improve clinical practice. Now distance doesn’t matter”
Plans are underway for live streaming from CHEST 2018 in San Antonio. To view the CHEST 2017 live stream videos, visit CHEST’s Facebook page, facebook.com/accpchest.
In April 2016, Facebook launched Facebook Live, a tool for live streaming to a Facebook page to share live video with their followers on Facebook. At CHEST 2016, the CHEST New Media team began to experiment with live video with some early success. The CHEST 2017 team made the decision, based on the organization’s goal to help educate clinicians to improve patient care, to live stream complete sessions from CHEST 2017. With the help of the CHEST 2017 Education Committee and the Social Media Work Group, more than 25 sessions were selected and live streamed.
CHEST’s efforts on Facebook Live resulted in the following:
- Total people reached: 133,737
- Total video views: 34,449
- Total minutes watched: 30,786 (or 513 hours, or 21 days)
- Total interactions: 1,050 (eg, likes, loves, hahas, etc)
- Total shares: 302
The content concept was well received, and comments ranged from followers chiming in with their location, appreciation for live streaming, and even comments from patients.
- “Thank you for sharing this live presentation.”
- “Here from Mexico !!”
- “Here from Natal/RN, Brazil”
- “Here from Milan, Italy.”
- “Appreciate this live streaming on important sessions, big service for those who couldn’t attend!!”
- “My brother survived after six days on ECMO. I am so glad to have him.”
- “It’s a great chance for physicians working in pulmonology and general practice to get the pearls of guidelines from American College to improve clinical practice. Now distance doesn’t matter”
Plans are underway for live streaming from CHEST 2018 in San Antonio. To view the CHEST 2017 live stream videos, visit CHEST’s Facebook page, facebook.com/accpchest.
In April 2016, Facebook launched Facebook Live, a tool for live streaming to a Facebook page to share live video with their followers on Facebook. At CHEST 2016, the CHEST New Media team began to experiment with live video with some early success. The CHEST 2017 team made the decision, based on the organization’s goal to help educate clinicians to improve patient care, to live stream complete sessions from CHEST 2017. With the help of the CHEST 2017 Education Committee and the Social Media Work Group, more than 25 sessions were selected and live streamed.
CHEST’s efforts on Facebook Live resulted in the following:
- Total people reached: 133,737
- Total video views: 34,449
- Total minutes watched: 30,786 (or 513 hours, or 21 days)
- Total interactions: 1,050 (eg, likes, loves, hahas, etc)
- Total shares: 302
The content concept was well received, and comments ranged from followers chiming in with their location, appreciation for live streaming, and even comments from patients.
- “Thank you for sharing this live presentation.”
- “Here from Mexico !!”
- “Here from Natal/RN, Brazil”
- “Here from Milan, Italy.”
- “Appreciate this live streaming on important sessions, big service for those who couldn’t attend!!”
- “My brother survived after six days on ECMO. I am so glad to have him.”
- “It’s a great chance for physicians working in pulmonology and general practice to get the pearls of guidelines from American College to improve clinical practice. Now distance doesn’t matter”
Plans are underway for live streaming from CHEST 2018 in San Antonio. To view the CHEST 2017 live stream videos, visit CHEST’s Facebook page, facebook.com/accpchest.
Acute kidney injury linked with doubled inpatient VTEs
TORONTO – Hospitalized patients with acute kidney injury had more than double the inpatient rate of venous thromboembolism as had patients without acute kidney injury in a prospective, observational study of more than 6,000 hospitalized U.S. soldiers.
He offered four possible mechanisms to explain a link between AKI and VTE:
- Patients with AKI are in a hypercoagulable state.
- AKI alters the pharmacodynamics or pharmacokinetics of VTE prophylactic treatments.
- AKI is a marker of an illness that causes VTE.
- VTE leads to an increased rate of AKI rather than the other way around.
Dr. McMahon’s analysis also revealed that two other clinical conditions that are generally believed to raise VTE risk – obesity and impaired overall renal function identified with stagnant measures – did not correspond with a significantly elevated VTE rate in this study.
The data came from 6,552 adults hospitalized for at least 2 days at Walter Reed between September 2009 and March 2011. The study excluded patients with VTE at the time of admission and also those who had been treated with an anticoagulant at the time of admission. The patients averaged 55 years of age and were hospitalized for a median of 4 days. About 22% of patients received VTE prophylaxis with unfractionated heparin, about 41% received prophylaxis with low-molecular-weight heparin, and about 39% received no VTE prophylaxis (percentages total 102% because of rounding).
About 16% of the patients had been diagnosed with AKI at the time of admission, and an additional 8% developed AKI while hospitalized, defined as an increase in serum creatinine during hospitalization of at least 50% above baseline levels or an increase of more than 0.3 mg/dL above the level at time of admission. During hospitalization, 160 patients (2%) developed a new onset VTE.
In an analysis that adjusted for baseline differences in type of surgery, body mass index, sex, age, and prior hospitalizations during the prior 90 days, the results showed that patients with preexisting or new onset AKI had a 2.2-fold higher rate of VTE, compared with patients without AKI, and this difference was statistically significant, Dr. McMahon reported.
The analysis also showed a significant 62% relatively higher rate of VTE among soldiers hospitalized for a deployment-related event, as well as a significant 63% relatively lower VTE rate among patients not receiving medical prophylaxis, compared with patients receiving an anticoagulant. Dr. McMahon suggested that this lower rate of VTEs among patients not on prophylaxis reflected success in identifying which patients had an increased risk for VTE and hence received prophylaxis.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
TORONTO – Hospitalized patients with acute kidney injury had more than double the inpatient rate of venous thromboembolism as had patients without acute kidney injury in a prospective, observational study of more than 6,000 hospitalized U.S. soldiers.
He offered four possible mechanisms to explain a link between AKI and VTE:
- Patients with AKI are in a hypercoagulable state.
- AKI alters the pharmacodynamics or pharmacokinetics of VTE prophylactic treatments.
- AKI is a marker of an illness that causes VTE.
- VTE leads to an increased rate of AKI rather than the other way around.
Dr. McMahon’s analysis also revealed that two other clinical conditions that are generally believed to raise VTE risk – obesity and impaired overall renal function identified with stagnant measures – did not correspond with a significantly elevated VTE rate in this study.
The data came from 6,552 adults hospitalized for at least 2 days at Walter Reed between September 2009 and March 2011. The study excluded patients with VTE at the time of admission and also those who had been treated with an anticoagulant at the time of admission. The patients averaged 55 years of age and were hospitalized for a median of 4 days. About 22% of patients received VTE prophylaxis with unfractionated heparin, about 41% received prophylaxis with low-molecular-weight heparin, and about 39% received no VTE prophylaxis (percentages total 102% because of rounding).
About 16% of the patients had been diagnosed with AKI at the time of admission, and an additional 8% developed AKI while hospitalized, defined as an increase in serum creatinine during hospitalization of at least 50% above baseline levels or an increase of more than 0.3 mg/dL above the level at time of admission. During hospitalization, 160 patients (2%) developed a new onset VTE.
In an analysis that adjusted for baseline differences in type of surgery, body mass index, sex, age, and prior hospitalizations during the prior 90 days, the results showed that patients with preexisting or new onset AKI had a 2.2-fold higher rate of VTE, compared with patients without AKI, and this difference was statistically significant, Dr. McMahon reported.
The analysis also showed a significant 62% relatively higher rate of VTE among soldiers hospitalized for a deployment-related event, as well as a significant 63% relatively lower VTE rate among patients not receiving medical prophylaxis, compared with patients receiving an anticoagulant. Dr. McMahon suggested that this lower rate of VTEs among patients not on prophylaxis reflected success in identifying which patients had an increased risk for VTE and hence received prophylaxis.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
TORONTO – Hospitalized patients with acute kidney injury had more than double the inpatient rate of venous thromboembolism as had patients without acute kidney injury in a prospective, observational study of more than 6,000 hospitalized U.S. soldiers.
He offered four possible mechanisms to explain a link between AKI and VTE:
- Patients with AKI are in a hypercoagulable state.
- AKI alters the pharmacodynamics or pharmacokinetics of VTE prophylactic treatments.
- AKI is a marker of an illness that causes VTE.
- VTE leads to an increased rate of AKI rather than the other way around.
Dr. McMahon’s analysis also revealed that two other clinical conditions that are generally believed to raise VTE risk – obesity and impaired overall renal function identified with stagnant measures – did not correspond with a significantly elevated VTE rate in this study.
The data came from 6,552 adults hospitalized for at least 2 days at Walter Reed between September 2009 and March 2011. The study excluded patients with VTE at the time of admission and also those who had been treated with an anticoagulant at the time of admission. The patients averaged 55 years of age and were hospitalized for a median of 4 days. About 22% of patients received VTE prophylaxis with unfractionated heparin, about 41% received prophylaxis with low-molecular-weight heparin, and about 39% received no VTE prophylaxis (percentages total 102% because of rounding).
About 16% of the patients had been diagnosed with AKI at the time of admission, and an additional 8% developed AKI while hospitalized, defined as an increase in serum creatinine during hospitalization of at least 50% above baseline levels or an increase of more than 0.3 mg/dL above the level at time of admission. During hospitalization, 160 patients (2%) developed a new onset VTE.
In an analysis that adjusted for baseline differences in type of surgery, body mass index, sex, age, and prior hospitalizations during the prior 90 days, the results showed that patients with preexisting or new onset AKI had a 2.2-fold higher rate of VTE, compared with patients without AKI, and this difference was statistically significant, Dr. McMahon reported.
The analysis also showed a significant 62% relatively higher rate of VTE among soldiers hospitalized for a deployment-related event, as well as a significant 63% relatively lower VTE rate among patients not receiving medical prophylaxis, compared with patients receiving an anticoagulant. Dr. McMahon suggested that this lower rate of VTEs among patients not on prophylaxis reflected success in identifying which patients had an increased risk for VTE and hence received prophylaxis.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT CHEST 2017
Key clinical point:
Major finding: Inpatients with AKI had an adjusted 2.2-fold higher rate of VTE, compared with other inpatients.
Data source: Prospective, observational data from 6,552 inpatients at a single U.S. military hospital.
Disclosures: Dr. McMahon had no disclosures.
Alarm reductions don’t improve ICU response times
TORONTO – It will take more than a reduction in alarms to address the issue of alarm fatigue in the ICU; a change in the ICU staff culture is needed, suggests new research.
“It may take years to recondition clinicians [to realize] that alarms are actionable and must get a response,” Afua Kunadu, MD, said during her presentation on the study at the CHEST annual meeting. Results from prior studies had suggested that as many as 99% of clinical alarms do not result in clinical intervention, noted Dr. Kunadu, an internal medicine physician at Harlem Hospital Center in New York.
She described the program, which started in the 20-bed adult ICU of Harlem Hospital Center, following a 2014 National Patient Safety Goal issued by The Joint Commission to improve the safety of clinical alarm systems by reducing unneeded alarms and alarm fatigue. The Harlem Hospital task force that ran the program began with an audit of alarms that went off in the ICU and used the results to identify the three most common alarms: bedside cardiac monitors, infusion pumps, and mechanical ventilators. The task force arranged to reset the default settings on these devices to decrease alarm frequency and boost the clinical importance of each alarm that still sounded. Concurrently, they ran educational sessions about the new alarm thresholds, the anticipated drop in alarm number, and the increased urgency to respond to the remaining alarms very quickly for the ICU staff.
The raised thresholds effectively cut the number of alarms. The average number of alarms per patient per hour fell from 4.5 at baseline during September 2016 to about 2 after 1 month, during December 2016. Then the rate further declined to reach a steady nadir that stayed at about 1.3 alarms per patient per hour 4 months into the program.
But timely responses, measured as the percentage of alarm responses occurring within 60 seconds after the alarm went off, fell from 60% at 1 month into the program down to 12% after 4 months, Dr. Kunadu reported.
She had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
TORONTO – It will take more than a reduction in alarms to address the issue of alarm fatigue in the ICU; a change in the ICU staff culture is needed, suggests new research.
“It may take years to recondition clinicians [to realize] that alarms are actionable and must get a response,” Afua Kunadu, MD, said during her presentation on the study at the CHEST annual meeting. Results from prior studies had suggested that as many as 99% of clinical alarms do not result in clinical intervention, noted Dr. Kunadu, an internal medicine physician at Harlem Hospital Center in New York.
She described the program, which started in the 20-bed adult ICU of Harlem Hospital Center, following a 2014 National Patient Safety Goal issued by The Joint Commission to improve the safety of clinical alarm systems by reducing unneeded alarms and alarm fatigue. The Harlem Hospital task force that ran the program began with an audit of alarms that went off in the ICU and used the results to identify the three most common alarms: bedside cardiac monitors, infusion pumps, and mechanical ventilators. The task force arranged to reset the default settings on these devices to decrease alarm frequency and boost the clinical importance of each alarm that still sounded. Concurrently, they ran educational sessions about the new alarm thresholds, the anticipated drop in alarm number, and the increased urgency to respond to the remaining alarms very quickly for the ICU staff.
The raised thresholds effectively cut the number of alarms. The average number of alarms per patient per hour fell from 4.5 at baseline during September 2016 to about 2 after 1 month, during December 2016. Then the rate further declined to reach a steady nadir that stayed at about 1.3 alarms per patient per hour 4 months into the program.
But timely responses, measured as the percentage of alarm responses occurring within 60 seconds after the alarm went off, fell from 60% at 1 month into the program down to 12% after 4 months, Dr. Kunadu reported.
She had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
TORONTO – It will take more than a reduction in alarms to address the issue of alarm fatigue in the ICU; a change in the ICU staff culture is needed, suggests new research.
“It may take years to recondition clinicians [to realize] that alarms are actionable and must get a response,” Afua Kunadu, MD, said during her presentation on the study at the CHEST annual meeting. Results from prior studies had suggested that as many as 99% of clinical alarms do not result in clinical intervention, noted Dr. Kunadu, an internal medicine physician at Harlem Hospital Center in New York.
She described the program, which started in the 20-bed adult ICU of Harlem Hospital Center, following a 2014 National Patient Safety Goal issued by The Joint Commission to improve the safety of clinical alarm systems by reducing unneeded alarms and alarm fatigue. The Harlem Hospital task force that ran the program began with an audit of alarms that went off in the ICU and used the results to identify the three most common alarms: bedside cardiac monitors, infusion pumps, and mechanical ventilators. The task force arranged to reset the default settings on these devices to decrease alarm frequency and boost the clinical importance of each alarm that still sounded. Concurrently, they ran educational sessions about the new alarm thresholds, the anticipated drop in alarm number, and the increased urgency to respond to the remaining alarms very quickly for the ICU staff.
The raised thresholds effectively cut the number of alarms. The average number of alarms per patient per hour fell from 4.5 at baseline during September 2016 to about 2 after 1 month, during December 2016. Then the rate further declined to reach a steady nadir that stayed at about 1.3 alarms per patient per hour 4 months into the program.
But timely responses, measured as the percentage of alarm responses occurring within 60 seconds after the alarm went off, fell from 60% at 1 month into the program down to 12% after 4 months, Dr. Kunadu reported.
She had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT CHEST 2017
Key clinical point:
Major finding: Average alarms/patient/hour fell from 4.5 to 1.3, but the percentage of responses in less than 60 seconds fell from 60% to 12%.
Data source: An observational study at a single adult ICU in the United States.
Disclosures: Dr. Kunadu had no disclosures.
Ultrathin bronchoscopy plus radial EBUS unreliable at making diagnoses
TORONTO – Ultrathin bronchoscopy plus radial endobronchial ultrasound is not a great method for determining whether a suspicious lesion is cancerous or benign, suggests new research.
In this study of patients with CT-detected solid lung lesions, the researchers were able to make a diagnosis for only 49% of those whose nodules were evaluated using ultrathin bronchoscopy plus radial endobronchial ultrasound (EBUS).
“When you do CT-guided biopsies of lung lesions, the [diagnostic] yield is about 94%. So do the math” by comparing it to the roughly 50% yield from ultrathin bronchoscopy plus radial EBUS to decide whether the latter procedure is worth doing, she noted.
The study Dr. Tanner and her associates designed compared the diagnostic yield of ultrathin bronchoscopy plus radial EBUS with standard bronchoscopy and fluoroscopy in patients with CT-detected solid lung lesions 1.5-5.0 cm in size. It ran at five U.S. centers and randomized 221 patients: 85 evaluable patients were tested using the standard methods, and 112 evaluable patients were tested using ultrathin bronchoscopy plus radial EBUS. Patients averaged 65-68 years of age and were divided evenly between women and men. Their lesions averaged slightly more than 3 cm. The ultrathin device had a 4 mm wide diameter and had a 2 mm working channel.
The diagnostic yield was 38% among patients who underwent standard bronchoscopy and fluoroscopy, and 49% among those biopsied using ultrathin bronchoscopy and radial EBUS, Dr. Tanner reported. The between-group difference in yield fell short of being statistically significant.
Forty-six of the 53 patients who were not diagnosable using standard bronchoscopy and fluoroscopy crossed over to the investigational method, which produced a diagnosis for an additional seven patients (15% of the biopsied crossover patients).
The results showed that standard bronchoscopy plus fluoroscopy is “very poor” for distinguishing cancerous and benign pulmonary lesions, Dr. Tanner concluded. The yield from ultrathin bronchoscopy plus radial EBUS in her study was similar to the diagnostic yields reported in prior studies of guided bronchoscopy, even when also using radial EBUS, she added.
Given the limitations of ultrathin bronchoscopy plus radial EBUS, Dr. Tanner suggested that the best scenario for using this diagnostic method would be in patients who need a linear EBUS procedure for mediastinal lymph node staging. Such staging often requires a biopsy of the primary tumor to make a cancer diagnosis, and in such cases, “while you’re in the neighborhood, you could do bronchoscopy with an ultrathin scope,” she suggested.
The potential also exists to augment the diagnostic yield of ultrathin bronchoscopy by applying a navigational software platform and needle biopsy, two methods not included in the study, Dr. Tanner noted. “More studies should be done using this combination,” she said.
The study was funded by Olympus. Dr. Tanner has been a consultant to and has received research funding from Olympus. She has also been a consultant to Cook Medical, Integrated Diagnostics, Oncocyte, Veracyte, and Veran Medical Technologies, and she has also received research funding from Cook, Integrated Diagnostics, Oncocyte, Oncimmune, and Veracyte.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
Although bronchoscopic tools are safe and accurate to evaluate both central and peripheral lung lesions, the diagnostic yield of the different available techniques is variable. In this study, a diagnostic yield of only 49% was achieved when ultrathin bronchoscopy with radial EBUS was performed for diagnosis of solid nodules. This yield is not much better than that obtained from conventional bronchoscopy with fluoroscopic guidance and much lower than the diagnostic yield from transthoracic needle biopsy. While there is no doubt that the advances in minimally invasive technologies for diagnosing lung nodules and diagnosing and staging lung cancer have revolutionized clinical practice, pulmonologists and thoracic surgeons need to recognize not only the utility but also the limitations of the available diagnostic procedures (as well as the cost). These technologies are complimentary and multidisciplinary discussions should facilitate selection of the best procedure for each individual case.
Although bronchoscopic tools are safe and accurate to evaluate both central and peripheral lung lesions, the diagnostic yield of the different available techniques is variable. In this study, a diagnostic yield of only 49% was achieved when ultrathin bronchoscopy with radial EBUS was performed for diagnosis of solid nodules. This yield is not much better than that obtained from conventional bronchoscopy with fluoroscopic guidance and much lower than the diagnostic yield from transthoracic needle biopsy. While there is no doubt that the advances in minimally invasive technologies for diagnosing lung nodules and diagnosing and staging lung cancer have revolutionized clinical practice, pulmonologists and thoracic surgeons need to recognize not only the utility but also the limitations of the available diagnostic procedures (as well as the cost). These technologies are complimentary and multidisciplinary discussions should facilitate selection of the best procedure for each individual case.
Although bronchoscopic tools are safe and accurate to evaluate both central and peripheral lung lesions, the diagnostic yield of the different available techniques is variable. In this study, a diagnostic yield of only 49% was achieved when ultrathin bronchoscopy with radial EBUS was performed for diagnosis of solid nodules. This yield is not much better than that obtained from conventional bronchoscopy with fluoroscopic guidance and much lower than the diagnostic yield from transthoracic needle biopsy. While there is no doubt that the advances in minimally invasive technologies for diagnosing lung nodules and diagnosing and staging lung cancer have revolutionized clinical practice, pulmonologists and thoracic surgeons need to recognize not only the utility but also the limitations of the available diagnostic procedures (as well as the cost). These technologies are complimentary and multidisciplinary discussions should facilitate selection of the best procedure for each individual case.
TORONTO – Ultrathin bronchoscopy plus radial endobronchial ultrasound is not a great method for determining whether a suspicious lesion is cancerous or benign, suggests new research.
In this study of patients with CT-detected solid lung lesions, the researchers were able to make a diagnosis for only 49% of those whose nodules were evaluated using ultrathin bronchoscopy plus radial endobronchial ultrasound (EBUS).
“When you do CT-guided biopsies of lung lesions, the [diagnostic] yield is about 94%. So do the math” by comparing it to the roughly 50% yield from ultrathin bronchoscopy plus radial EBUS to decide whether the latter procedure is worth doing, she noted.
The study Dr. Tanner and her associates designed compared the diagnostic yield of ultrathin bronchoscopy plus radial EBUS with standard bronchoscopy and fluoroscopy in patients with CT-detected solid lung lesions 1.5-5.0 cm in size. It ran at five U.S. centers and randomized 221 patients: 85 evaluable patients were tested using the standard methods, and 112 evaluable patients were tested using ultrathin bronchoscopy plus radial EBUS. Patients averaged 65-68 years of age and were divided evenly between women and men. Their lesions averaged slightly more than 3 cm. The ultrathin device had a 4 mm wide diameter and had a 2 mm working channel.
The diagnostic yield was 38% among patients who underwent standard bronchoscopy and fluoroscopy, and 49% among those biopsied using ultrathin bronchoscopy and radial EBUS, Dr. Tanner reported. The between-group difference in yield fell short of being statistically significant.
Forty-six of the 53 patients who were not diagnosable using standard bronchoscopy and fluoroscopy crossed over to the investigational method, which produced a diagnosis for an additional seven patients (15% of the biopsied crossover patients).
The results showed that standard bronchoscopy plus fluoroscopy is “very poor” for distinguishing cancerous and benign pulmonary lesions, Dr. Tanner concluded. The yield from ultrathin bronchoscopy plus radial EBUS in her study was similar to the diagnostic yields reported in prior studies of guided bronchoscopy, even when also using radial EBUS, she added.
Given the limitations of ultrathin bronchoscopy plus radial EBUS, Dr. Tanner suggested that the best scenario for using this diagnostic method would be in patients who need a linear EBUS procedure for mediastinal lymph node staging. Such staging often requires a biopsy of the primary tumor to make a cancer diagnosis, and in such cases, “while you’re in the neighborhood, you could do bronchoscopy with an ultrathin scope,” she suggested.
The potential also exists to augment the diagnostic yield of ultrathin bronchoscopy by applying a navigational software platform and needle biopsy, two methods not included in the study, Dr. Tanner noted. “More studies should be done using this combination,” she said.
The study was funded by Olympus. Dr. Tanner has been a consultant to and has received research funding from Olympus. She has also been a consultant to Cook Medical, Integrated Diagnostics, Oncocyte, Veracyte, and Veran Medical Technologies, and she has also received research funding from Cook, Integrated Diagnostics, Oncocyte, Oncimmune, and Veracyte.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
TORONTO – Ultrathin bronchoscopy plus radial endobronchial ultrasound is not a great method for determining whether a suspicious lesion is cancerous or benign, suggests new research.
In this study of patients with CT-detected solid lung lesions, the researchers were able to make a diagnosis for only 49% of those whose nodules were evaluated using ultrathin bronchoscopy plus radial endobronchial ultrasound (EBUS).
“When you do CT-guided biopsies of lung lesions, the [diagnostic] yield is about 94%. So do the math” by comparing it to the roughly 50% yield from ultrathin bronchoscopy plus radial EBUS to decide whether the latter procedure is worth doing, she noted.
The study Dr. Tanner and her associates designed compared the diagnostic yield of ultrathin bronchoscopy plus radial EBUS with standard bronchoscopy and fluoroscopy in patients with CT-detected solid lung lesions 1.5-5.0 cm in size. It ran at five U.S. centers and randomized 221 patients: 85 evaluable patients were tested using the standard methods, and 112 evaluable patients were tested using ultrathin bronchoscopy plus radial EBUS. Patients averaged 65-68 years of age and were divided evenly between women and men. Their lesions averaged slightly more than 3 cm. The ultrathin device had a 4 mm wide diameter and had a 2 mm working channel.
The diagnostic yield was 38% among patients who underwent standard bronchoscopy and fluoroscopy, and 49% among those biopsied using ultrathin bronchoscopy and radial EBUS, Dr. Tanner reported. The between-group difference in yield fell short of being statistically significant.
Forty-six of the 53 patients who were not diagnosable using standard bronchoscopy and fluoroscopy crossed over to the investigational method, which produced a diagnosis for an additional seven patients (15% of the biopsied crossover patients).
The results showed that standard bronchoscopy plus fluoroscopy is “very poor” for distinguishing cancerous and benign pulmonary lesions, Dr. Tanner concluded. The yield from ultrathin bronchoscopy plus radial EBUS in her study was similar to the diagnostic yields reported in prior studies of guided bronchoscopy, even when also using radial EBUS, she added.
Given the limitations of ultrathin bronchoscopy plus radial EBUS, Dr. Tanner suggested that the best scenario for using this diagnostic method would be in patients who need a linear EBUS procedure for mediastinal lymph node staging. Such staging often requires a biopsy of the primary tumor to make a cancer diagnosis, and in such cases, “while you’re in the neighborhood, you could do bronchoscopy with an ultrathin scope,” she suggested.
The potential also exists to augment the diagnostic yield of ultrathin bronchoscopy by applying a navigational software platform and needle biopsy, two methods not included in the study, Dr. Tanner noted. “More studies should be done using this combination,” she said.
The study was funded by Olympus. Dr. Tanner has been a consultant to and has received research funding from Olympus. She has also been a consultant to Cook Medical, Integrated Diagnostics, Oncocyte, Veracyte, and Veran Medical Technologies, and she has also received research funding from Cook, Integrated Diagnostics, Oncocyte, Oncimmune, and Veracyte.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT CHEST 2017
Key clinical point:
Major finding: The diagnostic yield using ultrathin bronchoscopy with radial EBUS was 49%, while standard bronchoscopy had a 38% yield.
Data source: Multicenter, randomized study with 221 total patients and 197 evaluable patients.
Disclosures: The study was funded by Olympus. Dr. Tanner has been a consultant to and has received research funding from Olympus. She has also been a consultant to Cook Medical, Integrated Diagnostics, Oncocyte, Veracyte, and Veran Medical Technologies, and she has also received research funding from Cook, Integrated Diagnostics, Oncocyte, Oncimmune, and Veracyte.
Phrenic-nerve stimulator maintains benefits for 18 months
TORONTO – The implanted phrenic-nerve stimulation device that received Food and Drug Administration marketing approval in October 2017 for treating central sleep apnea has now shown safety and efficacy out to 18 months of continuous use in 102 patients.
After 18 months of treatment with the Remede System, patients’ outcomes remained stable and patients continued to see the improvements they had experienced after 6 and 12 months of treatment. These improvements included significant average reductions from baseline in apnea-hypopnea index and central apnea index and significant increases in oxygenation and sleep quality, Andrew C. Kao, MD, said at the CHEST annual meeting.
“We were concerned that there would be a degradation of the benefit [over time]. We are very happy that the benefit was sustained,” said Dr. Kao, a heart failure cardiologist at Saint Luke’s Health System in Kansas City, Mo.
Dr. Kao did not report an 18-month follow-up for the study’s primary endpoint, the percentage of patients after 6 months on treatment who had at least a 50% reduction from baseline in their apnea-hypopnea index. His report focused on the 6-, 12-, and 18-month changes relative to baseline for five secondary outcomes: central sleep apnea index, apnea-hypopnea index, arousal index, oxygen desaturation index, and time spent in REM sleep. For all five of these outcomes, the 102 patients showed an average, statistically significant improvement compared with baseline after 6 months on treatment that persisted virtually unchanged at 12 and 18 months.
For example, average central sleep apnea index fell from 27 events/hour at baseline to 5 per hour at 6, 12, and 18 months. Average apnea-hypopnea index fell from 46 events/hour at baseline to about 25 per hour at 6, 12, and 18 months. The average percentage of sleep spent in REM sleep improved from 12% at baseline to about 15% at 6, 12, and 18 months.
During 18 months of treatment following device implantation, four of the 102 patients had a serious adverse event. One patient required lead repositioning to relieve discomfort and three had an interaction with an implanted cardiac device. The effects resolved in all four patients without long-term impact. An additional 16 patients had discomfort that required an unscheduled medical visit, but these were not classified as serious episodes, and in 14 of these patients the discomfort resolved.
The Remede System phrenic-nerve stimulator received FDA marketing approval for moderate to severe central sleep apnea based on 6-month efficacy and 12-month safety data (Lancet. 2016 Sept 3;388[10048]:974-82). The Pivotal Trial of the Remede System enrolled 151 patients with an apnea-hypopnea index of at least 20 events/hour, about half of whom had heart failure. All patients received a device implant: In the initial intervention group of 73 patients, researchers turned on the device 1 month after implantation, and in the 78 patients randomized to the initial control arm, the device remained off for the first 7 months and then went active. The researchers followed up with 46 patients drawn from both the original treatment arm and 56 patients from the original control arm, at which point the patients had been receiving 18 months of treatment.
The Remede System pivotal trial was sponsored by Respicardia, which markets the phrenic-verse stimulator. Dr. Kao’s institution, Saint Luke’s Health System, received grant support from Respicardia.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
TORONTO – The implanted phrenic-nerve stimulation device that received Food and Drug Administration marketing approval in October 2017 for treating central sleep apnea has now shown safety and efficacy out to 18 months of continuous use in 102 patients.
After 18 months of treatment with the Remede System, patients’ outcomes remained stable and patients continued to see the improvements they had experienced after 6 and 12 months of treatment. These improvements included significant average reductions from baseline in apnea-hypopnea index and central apnea index and significant increases in oxygenation and sleep quality, Andrew C. Kao, MD, said at the CHEST annual meeting.
“We were concerned that there would be a degradation of the benefit [over time]. We are very happy that the benefit was sustained,” said Dr. Kao, a heart failure cardiologist at Saint Luke’s Health System in Kansas City, Mo.
Dr. Kao did not report an 18-month follow-up for the study’s primary endpoint, the percentage of patients after 6 months on treatment who had at least a 50% reduction from baseline in their apnea-hypopnea index. His report focused on the 6-, 12-, and 18-month changes relative to baseline for five secondary outcomes: central sleep apnea index, apnea-hypopnea index, arousal index, oxygen desaturation index, and time spent in REM sleep. For all five of these outcomes, the 102 patients showed an average, statistically significant improvement compared with baseline after 6 months on treatment that persisted virtually unchanged at 12 and 18 months.
For example, average central sleep apnea index fell from 27 events/hour at baseline to 5 per hour at 6, 12, and 18 months. Average apnea-hypopnea index fell from 46 events/hour at baseline to about 25 per hour at 6, 12, and 18 months. The average percentage of sleep spent in REM sleep improved from 12% at baseline to about 15% at 6, 12, and 18 months.
During 18 months of treatment following device implantation, four of the 102 patients had a serious adverse event. One patient required lead repositioning to relieve discomfort and three had an interaction with an implanted cardiac device. The effects resolved in all four patients without long-term impact. An additional 16 patients had discomfort that required an unscheduled medical visit, but these were not classified as serious episodes, and in 14 of these patients the discomfort resolved.
The Remede System phrenic-nerve stimulator received FDA marketing approval for moderate to severe central sleep apnea based on 6-month efficacy and 12-month safety data (Lancet. 2016 Sept 3;388[10048]:974-82). The Pivotal Trial of the Remede System enrolled 151 patients with an apnea-hypopnea index of at least 20 events/hour, about half of whom had heart failure. All patients received a device implant: In the initial intervention group of 73 patients, researchers turned on the device 1 month after implantation, and in the 78 patients randomized to the initial control arm, the device remained off for the first 7 months and then went active. The researchers followed up with 46 patients drawn from both the original treatment arm and 56 patients from the original control arm, at which point the patients had been receiving 18 months of treatment.
The Remede System pivotal trial was sponsored by Respicardia, which markets the phrenic-verse stimulator. Dr. Kao’s institution, Saint Luke’s Health System, received grant support from Respicardia.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
TORONTO – The implanted phrenic-nerve stimulation device that received Food and Drug Administration marketing approval in October 2017 for treating central sleep apnea has now shown safety and efficacy out to 18 months of continuous use in 102 patients.
After 18 months of treatment with the Remede System, patients’ outcomes remained stable and patients continued to see the improvements they had experienced after 6 and 12 months of treatment. These improvements included significant average reductions from baseline in apnea-hypopnea index and central apnea index and significant increases in oxygenation and sleep quality, Andrew C. Kao, MD, said at the CHEST annual meeting.
“We were concerned that there would be a degradation of the benefit [over time]. We are very happy that the benefit was sustained,” said Dr. Kao, a heart failure cardiologist at Saint Luke’s Health System in Kansas City, Mo.
Dr. Kao did not report an 18-month follow-up for the study’s primary endpoint, the percentage of patients after 6 months on treatment who had at least a 50% reduction from baseline in their apnea-hypopnea index. His report focused on the 6-, 12-, and 18-month changes relative to baseline for five secondary outcomes: central sleep apnea index, apnea-hypopnea index, arousal index, oxygen desaturation index, and time spent in REM sleep. For all five of these outcomes, the 102 patients showed an average, statistically significant improvement compared with baseline after 6 months on treatment that persisted virtually unchanged at 12 and 18 months.
For example, average central sleep apnea index fell from 27 events/hour at baseline to 5 per hour at 6, 12, and 18 months. Average apnea-hypopnea index fell from 46 events/hour at baseline to about 25 per hour at 6, 12, and 18 months. The average percentage of sleep spent in REM sleep improved from 12% at baseline to about 15% at 6, 12, and 18 months.
During 18 months of treatment following device implantation, four of the 102 patients had a serious adverse event. One patient required lead repositioning to relieve discomfort and three had an interaction with an implanted cardiac device. The effects resolved in all four patients without long-term impact. An additional 16 patients had discomfort that required an unscheduled medical visit, but these were not classified as serious episodes, and in 14 of these patients the discomfort resolved.
The Remede System phrenic-nerve stimulator received FDA marketing approval for moderate to severe central sleep apnea based on 6-month efficacy and 12-month safety data (Lancet. 2016 Sept 3;388[10048]:974-82). The Pivotal Trial of the Remede System enrolled 151 patients with an apnea-hypopnea index of at least 20 events/hour, about half of whom had heart failure. All patients received a device implant: In the initial intervention group of 73 patients, researchers turned on the device 1 month after implantation, and in the 78 patients randomized to the initial control arm, the device remained off for the first 7 months and then went active. The researchers followed up with 46 patients drawn from both the original treatment arm and 56 patients from the original control arm, at which point the patients had been receiving 18 months of treatment.
The Remede System pivotal trial was sponsored by Respicardia, which markets the phrenic-verse stimulator. Dr. Kao’s institution, Saint Luke’s Health System, received grant support from Respicardia.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT CHEST 2017
Key clinical point:
Major finding: Average central apnea index improved from 27 events/hour at baseline to 5 events/hour after 6, 12, and 18 months of treatment.
Data source: 102 patients enrolled in the Pivotal Trial of the remede System were followed for 18 months of treatment.
Disclosures: The remede System pivotal trial was sponsored by Respicardia, which markets the phrenic-verse stimulator. Dr. Kao’s institution, Saint Luke’s Health System, received grant support from Respicardia.