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Optimal management of GERD in IPF unknown
EXPERT ANALYSIS FROM CHEST 2016
LOS ANGELES – The optimal management of gastroesophageal reflux disease in patients with idiopathic pulmonary fibrosis has yet to be determined, according to Joyce S. Lee, MD.
“We need strong randomized clinical trial data to tell us whether or not medical or surgical treatment of GERD in IPF is indicated,” she said at the annual meeting of the American College of Chest Physicians.
Two proposed hypotheses explain the relationship between reflux and IPF. The first holds that reflux and microaspiration are involved in the pathogenesis of IPF. The second, favored by Dr. Lee, proposes that reflux and microaspiration impact the natural history, either through acute exacerbation, disease progression, or survival. Patients with IPF “have weakening of the lower esophageal sphincter, whether that’s due to the presence of a hiatal hernia, medications, or just aging of the tissue there,” she said. “We know how to diagnose reflux disease, but we don’t know how to diagnose microaspiration, which is defined as subclinical aspiration of small droplets of gastric contents. Reflux is a risk factor for the condition of microaspiration, but it is not a perfect surrogate. Not everybody with reflux will aspirate. There is a potential role for bronchoalveolar lavage pepsin and/or bile salt as a biomarker of microaspiration, but it is not validated or standardized in IPF yet.”
Reflux becomes pathologic when reflux of stomach contents causes troublesome symptoms and/or complications. “Troublesome” is defined as mild symptoms 2 or more days a week or moderate to severe symptoms more than 1 day a week. Dr. Lee said that chest physicians can diagnose GERD in their IPF patients the same way that gastroenterologists and primary care doctors do: with symptoms, barium swallow, 24-hour pH monitoring, impedance testing, and sometimes endoscopy. The 2015 IPF guidelines recommend that clinicians “use regular antacid treatment for patients with IPF (conditional recommendation, very low confidence in estimates of effect).” It does not extend to surgical treatment with fundoplication. (Am J Resp Crit Care Med. 2015 Jul 15;192[2]: e3-19).
In an effort to measure the relationship between antacid therapy and change in forced vital capacity, Dr. Lee and her associates evaluated IPF patients from placebo arms of the three Idiopathic Pulmonary Fibrosis Clinical Research Network randomized controlled trials. They found that, compared with patients who did not take antacid therapy at baseline, those who did experienced a slower decline in their forced vital capacity over time (Lancet Resp Med. 2013 Jul;1[5]:369-76). However, a more-recent analysis conducted by different investigators examined the placebo arms of three pirfenidone studies and found no significant effect of antacid therapy in IPF patients (Lancet Resp Med. 2016 May;4[5]:381-9). Dr. Lee said that both evaluations differed because they were secondary analyses of previously captured data. “There were also differences in the ways the trials obtained GERD history, medication indication, and dosing of the antacid therapy,” she said. “There were also differences in outcomes and different populations studied.”
Dr. Lee’s current approach to counseling IPF patients with GERD includes discussing lifestyle modifications and PPI therapy – either daily or twice a day dosing, depending on their symptoms. “Lifestyle modifications include weight loss, smoking cessation, raising the head of the bed 6-8 inches, and avoiding foods that cause acid reflux, including chocolate, alcohol, peppermint, and fatty or spicy foods, and avoiding large and late meals,” she said. “In terms of acid suppression therapy with H2 blockers and PPIs [proton pump inhibitors], symptom relief and healing of the esophagus occurs in 85%-90% of patients taking them correctly. This does not alter their risk of having microaspiration.” Laparoscopic antireflux therapy (fundoplication) is indicated only after the failure of medical therapy. “The goal is to correct any hernia and tighten the lower esophageal sphincter,” she said. “Efficacy and symptom relief is reported to be around 95%.”
An NIH-funded trial called Weighing Risks and Benefits of Laparoscopic Anti-Reflux Surgery in Patients with Idiopathic Fibrosis, is ongoing at six centers. Dr. Lee said that some results are expected within the next year. She reported having no financial disclosures.
EXPERT ANALYSIS FROM CHEST 2016
LOS ANGELES – The optimal management of gastroesophageal reflux disease in patients with idiopathic pulmonary fibrosis has yet to be determined, according to Joyce S. Lee, MD.
“We need strong randomized clinical trial data to tell us whether or not medical or surgical treatment of GERD in IPF is indicated,” she said at the annual meeting of the American College of Chest Physicians.
Two proposed hypotheses explain the relationship between reflux and IPF. The first holds that reflux and microaspiration are involved in the pathogenesis of IPF. The second, favored by Dr. Lee, proposes that reflux and microaspiration impact the natural history, either through acute exacerbation, disease progression, or survival. Patients with IPF “have weakening of the lower esophageal sphincter, whether that’s due to the presence of a hiatal hernia, medications, or just aging of the tissue there,” she said. “We know how to diagnose reflux disease, but we don’t know how to diagnose microaspiration, which is defined as subclinical aspiration of small droplets of gastric contents. Reflux is a risk factor for the condition of microaspiration, but it is not a perfect surrogate. Not everybody with reflux will aspirate. There is a potential role for bronchoalveolar lavage pepsin and/or bile salt as a biomarker of microaspiration, but it is not validated or standardized in IPF yet.”
Reflux becomes pathologic when reflux of stomach contents causes troublesome symptoms and/or complications. “Troublesome” is defined as mild symptoms 2 or more days a week or moderate to severe symptoms more than 1 day a week. Dr. Lee said that chest physicians can diagnose GERD in their IPF patients the same way that gastroenterologists and primary care doctors do: with symptoms, barium swallow, 24-hour pH monitoring, impedance testing, and sometimes endoscopy. The 2015 IPF guidelines recommend that clinicians “use regular antacid treatment for patients with IPF (conditional recommendation, very low confidence in estimates of effect).” It does not extend to surgical treatment with fundoplication. (Am J Resp Crit Care Med. 2015 Jul 15;192[2]: e3-19).
In an effort to measure the relationship between antacid therapy and change in forced vital capacity, Dr. Lee and her associates evaluated IPF patients from placebo arms of the three Idiopathic Pulmonary Fibrosis Clinical Research Network randomized controlled trials. They found that, compared with patients who did not take antacid therapy at baseline, those who did experienced a slower decline in their forced vital capacity over time (Lancet Resp Med. 2013 Jul;1[5]:369-76). However, a more-recent analysis conducted by different investigators examined the placebo arms of three pirfenidone studies and found no significant effect of antacid therapy in IPF patients (Lancet Resp Med. 2016 May;4[5]:381-9). Dr. Lee said that both evaluations differed because they were secondary analyses of previously captured data. “There were also differences in the ways the trials obtained GERD history, medication indication, and dosing of the antacid therapy,” she said. “There were also differences in outcomes and different populations studied.”
Dr. Lee’s current approach to counseling IPF patients with GERD includes discussing lifestyle modifications and PPI therapy – either daily or twice a day dosing, depending on their symptoms. “Lifestyle modifications include weight loss, smoking cessation, raising the head of the bed 6-8 inches, and avoiding foods that cause acid reflux, including chocolate, alcohol, peppermint, and fatty or spicy foods, and avoiding large and late meals,” she said. “In terms of acid suppression therapy with H2 blockers and PPIs [proton pump inhibitors], symptom relief and healing of the esophagus occurs in 85%-90% of patients taking them correctly. This does not alter their risk of having microaspiration.” Laparoscopic antireflux therapy (fundoplication) is indicated only after the failure of medical therapy. “The goal is to correct any hernia and tighten the lower esophageal sphincter,” she said. “Efficacy and symptom relief is reported to be around 95%.”
An NIH-funded trial called Weighing Risks and Benefits of Laparoscopic Anti-Reflux Surgery in Patients with Idiopathic Fibrosis, is ongoing at six centers. Dr. Lee said that some results are expected within the next year. She reported having no financial disclosures.
EXPERT ANALYSIS FROM CHEST 2016
LOS ANGELES – The optimal management of gastroesophageal reflux disease in patients with idiopathic pulmonary fibrosis has yet to be determined, according to Joyce S. Lee, MD.
“We need strong randomized clinical trial data to tell us whether or not medical or surgical treatment of GERD in IPF is indicated,” she said at the annual meeting of the American College of Chest Physicians.
Two proposed hypotheses explain the relationship between reflux and IPF. The first holds that reflux and microaspiration are involved in the pathogenesis of IPF. The second, favored by Dr. Lee, proposes that reflux and microaspiration impact the natural history, either through acute exacerbation, disease progression, or survival. Patients with IPF “have weakening of the lower esophageal sphincter, whether that’s due to the presence of a hiatal hernia, medications, or just aging of the tissue there,” she said. “We know how to diagnose reflux disease, but we don’t know how to diagnose microaspiration, which is defined as subclinical aspiration of small droplets of gastric contents. Reflux is a risk factor for the condition of microaspiration, but it is not a perfect surrogate. Not everybody with reflux will aspirate. There is a potential role for bronchoalveolar lavage pepsin and/or bile salt as a biomarker of microaspiration, but it is not validated or standardized in IPF yet.”
Reflux becomes pathologic when reflux of stomach contents causes troublesome symptoms and/or complications. “Troublesome” is defined as mild symptoms 2 or more days a week or moderate to severe symptoms more than 1 day a week. Dr. Lee said that chest physicians can diagnose GERD in their IPF patients the same way that gastroenterologists and primary care doctors do: with symptoms, barium swallow, 24-hour pH monitoring, impedance testing, and sometimes endoscopy. The 2015 IPF guidelines recommend that clinicians “use regular antacid treatment for patients with IPF (conditional recommendation, very low confidence in estimates of effect).” It does not extend to surgical treatment with fundoplication. (Am J Resp Crit Care Med. 2015 Jul 15;192[2]: e3-19).
In an effort to measure the relationship between antacid therapy and change in forced vital capacity, Dr. Lee and her associates evaluated IPF patients from placebo arms of the three Idiopathic Pulmonary Fibrosis Clinical Research Network randomized controlled trials. They found that, compared with patients who did not take antacid therapy at baseline, those who did experienced a slower decline in their forced vital capacity over time (Lancet Resp Med. 2013 Jul;1[5]:369-76). However, a more-recent analysis conducted by different investigators examined the placebo arms of three pirfenidone studies and found no significant effect of antacid therapy in IPF patients (Lancet Resp Med. 2016 May;4[5]:381-9). Dr. Lee said that both evaluations differed because they were secondary analyses of previously captured data. “There were also differences in the ways the trials obtained GERD history, medication indication, and dosing of the antacid therapy,” she said. “There were also differences in outcomes and different populations studied.”
Dr. Lee’s current approach to counseling IPF patients with GERD includes discussing lifestyle modifications and PPI therapy – either daily or twice a day dosing, depending on their symptoms. “Lifestyle modifications include weight loss, smoking cessation, raising the head of the bed 6-8 inches, and avoiding foods that cause acid reflux, including chocolate, alcohol, peppermint, and fatty or spicy foods, and avoiding large and late meals,” she said. “In terms of acid suppression therapy with H2 blockers and PPIs [proton pump inhibitors], symptom relief and healing of the esophagus occurs in 85%-90% of patients taking them correctly. This does not alter their risk of having microaspiration.” Laparoscopic antireflux therapy (fundoplication) is indicated only after the failure of medical therapy. “The goal is to correct any hernia and tighten the lower esophageal sphincter,” she said. “Efficacy and symptom relief is reported to be around 95%.”
An NIH-funded trial called Weighing Risks and Benefits of Laparoscopic Anti-Reflux Surgery in Patients with Idiopathic Fibrosis, is ongoing at six centers. Dr. Lee said that some results are expected within the next year. She reported having no financial disclosures.
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.
New mechanical ventilation guidelines unveiled
LOS ANGELES – Acutely hospitalized patients who have been on mechanical ventilation for more than 24 hours, are at high risk for extubation failure, and have passed a spontaneous breathing trial should be extubated to noninvasive ventilation.
The recommendation comes from new clinical practice guidelines from the American College of Chest Physicians and the American Thoracic Society. Moderate-quality evidence suggests that early extubation and a switch to noninvasive ventilation reduces ventilator-related and ICU-related complications, including infections and injury to the lungs and other organs. Extubation also cuts costs by reducing ICU stays.
At the annual meeting of the American College of Chest Physicians, one of the six project cochairs, Daniel R. Ouellette, MD, said that the guidelines were intended to address “new territory” from the evidence-based guidelines for weaning and discontinuing ventilator support that were published in 2001. That effort, chaired by Neil R. MacIntyre, MD, “was a landmark article that helped us learn about the steps that we needed to take to liberate patients from mechanical ventilation,” said Dr. Ouellette of the Henry Ford Hospital Department of Pulmonary and Critical Care Medicine, Detroit. “We hope that this guideline lives up to the importance of that one. We wanted to look over new information and give new recommendations about things that haven’t been addressed in the past.”
Six recommendations from the guideline panel include:
We suggest that the initial spontaneous breathing trial be conducted with inspiratory pressure augmentation rather than T-piece or continuous positive airway pressure. The committee wrote that conducting the initial spontaneous breathing trial with pressure augmentation was more likely to be successful, produced a higher rate of extubation success, and was associated with a trend towards lower intensive care unit mortality.
We suggest protocols attempting to minimize sedation. The committee found that sedation protocols reduced ICU length of stay. However, the protocols did not appear to decrease time on the ventilator or reduce short-term mortality. The authors could not recommend one protocol over another but said the burden of providing sedation by any of the protocols was “very low.”
We suggest protocolized rehabilitation directed toward early mobilization. The committee wrote that patients receiving the intervention spent less time on the ventilator and were more likely to be able to walk when they left the hospital. However, their mortality rate appeared unchanged. The authors noted the exercises created additional work for ICU staff that might have come at the expense of other care priorities.
We suggest managing patients with a ventilator liberation protocol. The committee said that patients managed by protocol spent on average 25 fewer hours on mechanical ventilation and were discharged from the ICU a day early. However, their mortality rate appeared unchanged.
We suggest performing a cuff leak test in patients who meet extubation criteria and are deemed at high risk for postextubation stridor. The committee suggested that the test should be used only in patients with a high risk of stridor (abnormal breathing caused by blockage of windpipe) after extubation. Although patients passing the test had lower stridor and reintubation rates, the authors wrote that a high percentage of patients who failed the test could be successfully extubated.
For patients who failed the cuff leak test but are otherwise ready for extubation, we suggest administering systemic steroids at least 4 hours before extubation. The committee said that clinical judgment should take priority over test results, and systemic steroids should be administered to these patients at least 4 hours before extubation. The authors added that the short duration of the steroid therapy was likely to improve success rates without resulting in adverse events.
In a prepared statement, Timothy Girard, MD, of the department of medicine at the University of Pittsburgh and a lead author of the guidelines said the committee hoped the guidelines would help reduce variations in practice that do not benefit patients. “We are not prescribing a specific approach to care for every patient every time,” he said. “But we are trying to summarize the available evidence in as clear and succinct a way as possible so that clinicians know how it applies to most patients.”
Dr. Ouellette disclosed that he has received a research grant from Cardeas Pharma for health care–associated pneumonia.
Daniel R. Ouellette, MD, FCCP, comments: Liberation from mechanical ventilation is one of the most important goals in taking care of critically ill patients receiving mechanical ventilation in the ICU. Patients who have a prolonged ventilator course are at risk for many complications and so physicians who work in the intensive care unit must work carefully to liberate patients from the ventilator at the earliest possible moment. That has to be done in a safe fashion so criteria to ensure that this can be done safely are important as well.
Patients often have medical illness that requires sedation, and it is often necessary to sedate patients so that they can tolerate being on mechanical ventilation; however, we know that oversedation can lead to failure to liberate patients from mechanical ventilation expeditiously. Therefore, one of our recommendations’ suggestions is to design protocols for sedation that focus on minimizing sedation so that patients can be extubated expeditiously.
All of the recommendations ultimately focused on a team approach to liberation from mechanical ventilation, because involvement of team members is always important. However, there are a couple of our recommendations that are particularly important in terms of their implications for the team approach and those include recommendations about using protocols to liberate patients from ventilators, in general, and also to use sedation protocols to minimize sedations.
We began to look at developing this topic, because we had initially published guidelines on [liberation from mechanical ventilation] in 2001. We knew that there was much new information that had emerged since the 2001 guidelines. For that reason we began to think about an update. With the initial inception of this project, we reached out to the American Thoracic Society so as to develop a collaborative effort since this was a topic that interested both societies. This collaboration was at all levels at CHEST and it involved not only the guidelines organization, but also the leadership of both societies and, of course, the panel that was ultimately constructed to address these issues was made up of members from both societies. The entire process [of developing the new guideline] took nearly 3 years.
When one develops a guideline, one makes an effort to make a guideline as comprehensive and globally applicable as possible. I think the practices in Europe are very similar to practices in North America in terms of mechanical ventilation. Several of our panelists are European and some of the important work that we reviewed came from centers in Europe. It’s my opinion that our guideline will be broadly applicable in both North America and Europe, but there may be regional or local differences. Nevertheless, we recognize in different regions in the world, there are different resource allocations for medical treatment, there are different cultural precepts, and there are other factors that implicate medical problems.
Certainly the European Respiratory Society and other European organizations developed guidelines on related topics ... one of the important caveats when CHEST decides to develop a guideline is that we are not reproducing the work that has been done elsewhere and so this guideline represents a project that fills a gap that previously had not been filled.
All guidelines that CHEST develops are living guidelines … it’s hard to envision exactly how often a guideline will be updated. We know that there will be certain areas of our guideline that will stand the test of time, but there will be other areas that will need to be updated, some sooner than others.
The original CHEST guideline on liberation from mechanical ventilation was a very important document that appeared in 2001 and changed the practice of medicine and the practice of managing patients on mechanical ventilation. Nevertheless, the guideline was somewhat limited in scope, because there was only so much information available. … Our goal in developing this guideline was to address some of practitioners’ questions that had emerged in the last decade by looking at newly available data.
[In formulating these guidelines], we purposely chose six new questions that were not directly related to any of the questions [that has been answered] in the previous guideline.
Daniel R. Ouellette, MD, FCCP, comments: Liberation from mechanical ventilation is one of the most important goals in taking care of critically ill patients receiving mechanical ventilation in the ICU. Patients who have a prolonged ventilator course are at risk for many complications and so physicians who work in the intensive care unit must work carefully to liberate patients from the ventilator at the earliest possible moment. That has to be done in a safe fashion so criteria to ensure that this can be done safely are important as well.
Patients often have medical illness that requires sedation, and it is often necessary to sedate patients so that they can tolerate being on mechanical ventilation; however, we know that oversedation can lead to failure to liberate patients from mechanical ventilation expeditiously. Therefore, one of our recommendations’ suggestions is to design protocols for sedation that focus on minimizing sedation so that patients can be extubated expeditiously.
All of the recommendations ultimately focused on a team approach to liberation from mechanical ventilation, because involvement of team members is always important. However, there are a couple of our recommendations that are particularly important in terms of their implications for the team approach and those include recommendations about using protocols to liberate patients from ventilators, in general, and also to use sedation protocols to minimize sedations.
We began to look at developing this topic, because we had initially published guidelines on [liberation from mechanical ventilation] in 2001. We knew that there was much new information that had emerged since the 2001 guidelines. For that reason we began to think about an update. With the initial inception of this project, we reached out to the American Thoracic Society so as to develop a collaborative effort since this was a topic that interested both societies. This collaboration was at all levels at CHEST and it involved not only the guidelines organization, but also the leadership of both societies and, of course, the panel that was ultimately constructed to address these issues was made up of members from both societies. The entire process [of developing the new guideline] took nearly 3 years.
When one develops a guideline, one makes an effort to make a guideline as comprehensive and globally applicable as possible. I think the practices in Europe are very similar to practices in North America in terms of mechanical ventilation. Several of our panelists are European and some of the important work that we reviewed came from centers in Europe. It’s my opinion that our guideline will be broadly applicable in both North America and Europe, but there may be regional or local differences. Nevertheless, we recognize in different regions in the world, there are different resource allocations for medical treatment, there are different cultural precepts, and there are other factors that implicate medical problems.
Certainly the European Respiratory Society and other European organizations developed guidelines on related topics ... one of the important caveats when CHEST decides to develop a guideline is that we are not reproducing the work that has been done elsewhere and so this guideline represents a project that fills a gap that previously had not been filled.
All guidelines that CHEST develops are living guidelines … it’s hard to envision exactly how often a guideline will be updated. We know that there will be certain areas of our guideline that will stand the test of time, but there will be other areas that will need to be updated, some sooner than others.
The original CHEST guideline on liberation from mechanical ventilation was a very important document that appeared in 2001 and changed the practice of medicine and the practice of managing patients on mechanical ventilation. Nevertheless, the guideline was somewhat limited in scope, because there was only so much information available. … Our goal in developing this guideline was to address some of practitioners’ questions that had emerged in the last decade by looking at newly available data.
[In formulating these guidelines], we purposely chose six new questions that were not directly related to any of the questions [that has been answered] in the previous guideline.
Daniel R. Ouellette, MD, FCCP, comments: Liberation from mechanical ventilation is one of the most important goals in taking care of critically ill patients receiving mechanical ventilation in the ICU. Patients who have a prolonged ventilator course are at risk for many complications and so physicians who work in the intensive care unit must work carefully to liberate patients from the ventilator at the earliest possible moment. That has to be done in a safe fashion so criteria to ensure that this can be done safely are important as well.
Patients often have medical illness that requires sedation, and it is often necessary to sedate patients so that they can tolerate being on mechanical ventilation; however, we know that oversedation can lead to failure to liberate patients from mechanical ventilation expeditiously. Therefore, one of our recommendations’ suggestions is to design protocols for sedation that focus on minimizing sedation so that patients can be extubated expeditiously.
All of the recommendations ultimately focused on a team approach to liberation from mechanical ventilation, because involvement of team members is always important. However, there are a couple of our recommendations that are particularly important in terms of their implications for the team approach and those include recommendations about using protocols to liberate patients from ventilators, in general, and also to use sedation protocols to minimize sedations.
We began to look at developing this topic, because we had initially published guidelines on [liberation from mechanical ventilation] in 2001. We knew that there was much new information that had emerged since the 2001 guidelines. For that reason we began to think about an update. With the initial inception of this project, we reached out to the American Thoracic Society so as to develop a collaborative effort since this was a topic that interested both societies. This collaboration was at all levels at CHEST and it involved not only the guidelines organization, but also the leadership of both societies and, of course, the panel that was ultimately constructed to address these issues was made up of members from both societies. The entire process [of developing the new guideline] took nearly 3 years.
When one develops a guideline, one makes an effort to make a guideline as comprehensive and globally applicable as possible. I think the practices in Europe are very similar to practices in North America in terms of mechanical ventilation. Several of our panelists are European and some of the important work that we reviewed came from centers in Europe. It’s my opinion that our guideline will be broadly applicable in both North America and Europe, but there may be regional or local differences. Nevertheless, we recognize in different regions in the world, there are different resource allocations for medical treatment, there are different cultural precepts, and there are other factors that implicate medical problems.
Certainly the European Respiratory Society and other European organizations developed guidelines on related topics ... one of the important caveats when CHEST decides to develop a guideline is that we are not reproducing the work that has been done elsewhere and so this guideline represents a project that fills a gap that previously had not been filled.
All guidelines that CHEST develops are living guidelines … it’s hard to envision exactly how often a guideline will be updated. We know that there will be certain areas of our guideline that will stand the test of time, but there will be other areas that will need to be updated, some sooner than others.
The original CHEST guideline on liberation from mechanical ventilation was a very important document that appeared in 2001 and changed the practice of medicine and the practice of managing patients on mechanical ventilation. Nevertheless, the guideline was somewhat limited in scope, because there was only so much information available. … Our goal in developing this guideline was to address some of practitioners’ questions that had emerged in the last decade by looking at newly available data.
[In formulating these guidelines], we purposely chose six new questions that were not directly related to any of the questions [that has been answered] in the previous guideline.
LOS ANGELES – Acutely hospitalized patients who have been on mechanical ventilation for more than 24 hours, are at high risk for extubation failure, and have passed a spontaneous breathing trial should be extubated to noninvasive ventilation.
The recommendation comes from new clinical practice guidelines from the American College of Chest Physicians and the American Thoracic Society. Moderate-quality evidence suggests that early extubation and a switch to noninvasive ventilation reduces ventilator-related and ICU-related complications, including infections and injury to the lungs and other organs. Extubation also cuts costs by reducing ICU stays.
At the annual meeting of the American College of Chest Physicians, one of the six project cochairs, Daniel R. Ouellette, MD, said that the guidelines were intended to address “new territory” from the evidence-based guidelines for weaning and discontinuing ventilator support that were published in 2001. That effort, chaired by Neil R. MacIntyre, MD, “was a landmark article that helped us learn about the steps that we needed to take to liberate patients from mechanical ventilation,” said Dr. Ouellette of the Henry Ford Hospital Department of Pulmonary and Critical Care Medicine, Detroit. “We hope that this guideline lives up to the importance of that one. We wanted to look over new information and give new recommendations about things that haven’t been addressed in the past.”
Six recommendations from the guideline panel include:
We suggest that the initial spontaneous breathing trial be conducted with inspiratory pressure augmentation rather than T-piece or continuous positive airway pressure. The committee wrote that conducting the initial spontaneous breathing trial with pressure augmentation was more likely to be successful, produced a higher rate of extubation success, and was associated with a trend towards lower intensive care unit mortality.
We suggest protocols attempting to minimize sedation. The committee found that sedation protocols reduced ICU length of stay. However, the protocols did not appear to decrease time on the ventilator or reduce short-term mortality. The authors could not recommend one protocol over another but said the burden of providing sedation by any of the protocols was “very low.”
We suggest protocolized rehabilitation directed toward early mobilization. The committee wrote that patients receiving the intervention spent less time on the ventilator and were more likely to be able to walk when they left the hospital. However, their mortality rate appeared unchanged. The authors noted the exercises created additional work for ICU staff that might have come at the expense of other care priorities.
We suggest managing patients with a ventilator liberation protocol. The committee said that patients managed by protocol spent on average 25 fewer hours on mechanical ventilation and were discharged from the ICU a day early. However, their mortality rate appeared unchanged.
We suggest performing a cuff leak test in patients who meet extubation criteria and are deemed at high risk for postextubation stridor. The committee suggested that the test should be used only in patients with a high risk of stridor (abnormal breathing caused by blockage of windpipe) after extubation. Although patients passing the test had lower stridor and reintubation rates, the authors wrote that a high percentage of patients who failed the test could be successfully extubated.
For patients who failed the cuff leak test but are otherwise ready for extubation, we suggest administering systemic steroids at least 4 hours before extubation. The committee said that clinical judgment should take priority over test results, and systemic steroids should be administered to these patients at least 4 hours before extubation. The authors added that the short duration of the steroid therapy was likely to improve success rates without resulting in adverse events.
In a prepared statement, Timothy Girard, MD, of the department of medicine at the University of Pittsburgh and a lead author of the guidelines said the committee hoped the guidelines would help reduce variations in practice that do not benefit patients. “We are not prescribing a specific approach to care for every patient every time,” he said. “But we are trying to summarize the available evidence in as clear and succinct a way as possible so that clinicians know how it applies to most patients.”
Dr. Ouellette disclosed that he has received a research grant from Cardeas Pharma for health care–associated pneumonia.
LOS ANGELES – Acutely hospitalized patients who have been on mechanical ventilation for more than 24 hours, are at high risk for extubation failure, and have passed a spontaneous breathing trial should be extubated to noninvasive ventilation.
The recommendation comes from new clinical practice guidelines from the American College of Chest Physicians and the American Thoracic Society. Moderate-quality evidence suggests that early extubation and a switch to noninvasive ventilation reduces ventilator-related and ICU-related complications, including infections and injury to the lungs and other organs. Extubation also cuts costs by reducing ICU stays.
At the annual meeting of the American College of Chest Physicians, one of the six project cochairs, Daniel R. Ouellette, MD, said that the guidelines were intended to address “new territory” from the evidence-based guidelines for weaning and discontinuing ventilator support that were published in 2001. That effort, chaired by Neil R. MacIntyre, MD, “was a landmark article that helped us learn about the steps that we needed to take to liberate patients from mechanical ventilation,” said Dr. Ouellette of the Henry Ford Hospital Department of Pulmonary and Critical Care Medicine, Detroit. “We hope that this guideline lives up to the importance of that one. We wanted to look over new information and give new recommendations about things that haven’t been addressed in the past.”
Six recommendations from the guideline panel include:
We suggest that the initial spontaneous breathing trial be conducted with inspiratory pressure augmentation rather than T-piece or continuous positive airway pressure. The committee wrote that conducting the initial spontaneous breathing trial with pressure augmentation was more likely to be successful, produced a higher rate of extubation success, and was associated with a trend towards lower intensive care unit mortality.
We suggest protocols attempting to minimize sedation. The committee found that sedation protocols reduced ICU length of stay. However, the protocols did not appear to decrease time on the ventilator or reduce short-term mortality. The authors could not recommend one protocol over another but said the burden of providing sedation by any of the protocols was “very low.”
We suggest protocolized rehabilitation directed toward early mobilization. The committee wrote that patients receiving the intervention spent less time on the ventilator and were more likely to be able to walk when they left the hospital. However, their mortality rate appeared unchanged. The authors noted the exercises created additional work for ICU staff that might have come at the expense of other care priorities.
We suggest managing patients with a ventilator liberation protocol. The committee said that patients managed by protocol spent on average 25 fewer hours on mechanical ventilation and were discharged from the ICU a day early. However, their mortality rate appeared unchanged.
We suggest performing a cuff leak test in patients who meet extubation criteria and are deemed at high risk for postextubation stridor. The committee suggested that the test should be used only in patients with a high risk of stridor (abnormal breathing caused by blockage of windpipe) after extubation. Although patients passing the test had lower stridor and reintubation rates, the authors wrote that a high percentage of patients who failed the test could be successfully extubated.
For patients who failed the cuff leak test but are otherwise ready for extubation, we suggest administering systemic steroids at least 4 hours before extubation. The committee said that clinical judgment should take priority over test results, and systemic steroids should be administered to these patients at least 4 hours before extubation. The authors added that the short duration of the steroid therapy was likely to improve success rates without resulting in adverse events.
In a prepared statement, Timothy Girard, MD, of the department of medicine at the University of Pittsburgh and a lead author of the guidelines said the committee hoped the guidelines would help reduce variations in practice that do not benefit patients. “We are not prescribing a specific approach to care for every patient every time,” he said. “But we are trying to summarize the available evidence in as clear and succinct a way as possible so that clinicians know how it applies to most patients.”
Dr. Ouellette disclosed that he has received a research grant from Cardeas Pharma for health care–associated pneumonia.
AT CHEST 2016
Riociguat shows benefit in PAH with poor response to PDE inhibitors
LOS ANGELES – Pulmonary artery hypertension patients who have an insufficient response to phosphodiesterase inhibitors may benefit from a switch to riociguat (Adempas), based on results from a 24-week, open-label investigation from the drug’s maker, Bayer.
The 61 patients – mean age 54 years, 74% of whom were women – had World Health Organization functional class 3 disease, with 6-minute walking distances of 165-440 meters, and cardiac indices below 3 L/min/m2 despite being on a phosphodiesterase inhibitor (PDEi) for 90 days or more, 40 (66%) on sildenafil (Viagra) and 21 (34%) on tadalafil (Cialis).
After PDEi washout, the researchers swapped them for riociguat titrated to a maximum oral dose of 2.5 mg t.i.d. The 50 patients (82%) on concomitant endothelin receptor antagonists (ERA) were allowed to stay on them. At week 24, 16 patients (34% of the 47 evaluable patients) achieved the combined endpoint of no clinical worsening, functional class 1 or 2, and 30 meters or more improvement on their walk test.
“The key point is that it was safe to switch people from a [PDEi] to riociguat, and it seemed to have improved efficacy, but we hesitate on these conclusions because it was an open-label trial, and the results need to be confirmed,” lead investigator James Klinger, MD, professor of medicine at Brown University, Providence, R.I., said at the annual meeting of the American College of Chest Physicians. A randomized, controlled trial is underway, he added.
The usual approach to PAH is to start patients on a PDEi, often with an ERA. If that doesn’t work, a prostacyclin is added. The cost can exceed $200,000 a year.
“This is a study that says, wait a minute, before you add a third drug to the first two, maybe it would be worthwhile to” switch out the PDEi. “You would save the person the addition of a third drug,” and the cost would be comparable or less than a three-drug regimen, Dr. Klinger said.
The researchers also found that after 24 weeks on riociguat, mean plasma cyclic guanosine monophosphate (cGMP) increased by 4.6 pmol/mL, urinary cGMP by 1,005 pmol/mL, and asymmetric dimethylarginine (ADMA) by 0.004 micromol/L.
The biomarkers were important because the team is trying to find a way to identify patients who would benefit most from riociguat. “As a field, we still don’t understand the disease well enough to know” how to best match patients and drugs. “We are trying to find a biomarker that would identify patients who are more likely to respond to one medication versus another,” Dr. Klinger said.
ADMA inhibits the production of nitric oxide, and is a bad player in PAH. The study results were reassuring because riociguat didn’t have much of an effect on ADMA levels, although the “slight difference was not enough to identify people who might do better with” it, Dr. Klinger said.
As for cGMP, “when we raise [levels] with riociguat, patients get better, so we think riociguat is raising cGMP in the right place, which we think is the lungs. Unfortunately, we don’t’ have a biomarker that can distinguish lung cGMP from total body cGMP,” he said.
The work was funded by Bayer, maker of riociguat. Dr. Klinger is an unpaid consultant, and also receives research support from the company.
LOS ANGELES – Pulmonary artery hypertension patients who have an insufficient response to phosphodiesterase inhibitors may benefit from a switch to riociguat (Adempas), based on results from a 24-week, open-label investigation from the drug’s maker, Bayer.
The 61 patients – mean age 54 years, 74% of whom were women – had World Health Organization functional class 3 disease, with 6-minute walking distances of 165-440 meters, and cardiac indices below 3 L/min/m2 despite being on a phosphodiesterase inhibitor (PDEi) for 90 days or more, 40 (66%) on sildenafil (Viagra) and 21 (34%) on tadalafil (Cialis).
After PDEi washout, the researchers swapped them for riociguat titrated to a maximum oral dose of 2.5 mg t.i.d. The 50 patients (82%) on concomitant endothelin receptor antagonists (ERA) were allowed to stay on them. At week 24, 16 patients (34% of the 47 evaluable patients) achieved the combined endpoint of no clinical worsening, functional class 1 or 2, and 30 meters or more improvement on their walk test.
“The key point is that it was safe to switch people from a [PDEi] to riociguat, and it seemed to have improved efficacy, but we hesitate on these conclusions because it was an open-label trial, and the results need to be confirmed,” lead investigator James Klinger, MD, professor of medicine at Brown University, Providence, R.I., said at the annual meeting of the American College of Chest Physicians. A randomized, controlled trial is underway, he added.
The usual approach to PAH is to start patients on a PDEi, often with an ERA. If that doesn’t work, a prostacyclin is added. The cost can exceed $200,000 a year.
“This is a study that says, wait a minute, before you add a third drug to the first two, maybe it would be worthwhile to” switch out the PDEi. “You would save the person the addition of a third drug,” and the cost would be comparable or less than a three-drug regimen, Dr. Klinger said.
The researchers also found that after 24 weeks on riociguat, mean plasma cyclic guanosine monophosphate (cGMP) increased by 4.6 pmol/mL, urinary cGMP by 1,005 pmol/mL, and asymmetric dimethylarginine (ADMA) by 0.004 micromol/L.
The biomarkers were important because the team is trying to find a way to identify patients who would benefit most from riociguat. “As a field, we still don’t understand the disease well enough to know” how to best match patients and drugs. “We are trying to find a biomarker that would identify patients who are more likely to respond to one medication versus another,” Dr. Klinger said.
ADMA inhibits the production of nitric oxide, and is a bad player in PAH. The study results were reassuring because riociguat didn’t have much of an effect on ADMA levels, although the “slight difference was not enough to identify people who might do better with” it, Dr. Klinger said.
As for cGMP, “when we raise [levels] with riociguat, patients get better, so we think riociguat is raising cGMP in the right place, which we think is the lungs. Unfortunately, we don’t’ have a biomarker that can distinguish lung cGMP from total body cGMP,” he said.
The work was funded by Bayer, maker of riociguat. Dr. Klinger is an unpaid consultant, and also receives research support from the company.
LOS ANGELES – Pulmonary artery hypertension patients who have an insufficient response to phosphodiesterase inhibitors may benefit from a switch to riociguat (Adempas), based on results from a 24-week, open-label investigation from the drug’s maker, Bayer.
The 61 patients – mean age 54 years, 74% of whom were women – had World Health Organization functional class 3 disease, with 6-minute walking distances of 165-440 meters, and cardiac indices below 3 L/min/m2 despite being on a phosphodiesterase inhibitor (PDEi) for 90 days or more, 40 (66%) on sildenafil (Viagra) and 21 (34%) on tadalafil (Cialis).
After PDEi washout, the researchers swapped them for riociguat titrated to a maximum oral dose of 2.5 mg t.i.d. The 50 patients (82%) on concomitant endothelin receptor antagonists (ERA) were allowed to stay on them. At week 24, 16 patients (34% of the 47 evaluable patients) achieved the combined endpoint of no clinical worsening, functional class 1 or 2, and 30 meters or more improvement on their walk test.
“The key point is that it was safe to switch people from a [PDEi] to riociguat, and it seemed to have improved efficacy, but we hesitate on these conclusions because it was an open-label trial, and the results need to be confirmed,” lead investigator James Klinger, MD, professor of medicine at Brown University, Providence, R.I., said at the annual meeting of the American College of Chest Physicians. A randomized, controlled trial is underway, he added.
The usual approach to PAH is to start patients on a PDEi, often with an ERA. If that doesn’t work, a prostacyclin is added. The cost can exceed $200,000 a year.
“This is a study that says, wait a minute, before you add a third drug to the first two, maybe it would be worthwhile to” switch out the PDEi. “You would save the person the addition of a third drug,” and the cost would be comparable or less than a three-drug regimen, Dr. Klinger said.
The researchers also found that after 24 weeks on riociguat, mean plasma cyclic guanosine monophosphate (cGMP) increased by 4.6 pmol/mL, urinary cGMP by 1,005 pmol/mL, and asymmetric dimethylarginine (ADMA) by 0.004 micromol/L.
The biomarkers were important because the team is trying to find a way to identify patients who would benefit most from riociguat. “As a field, we still don’t understand the disease well enough to know” how to best match patients and drugs. “We are trying to find a biomarker that would identify patients who are more likely to respond to one medication versus another,” Dr. Klinger said.
ADMA inhibits the production of nitric oxide, and is a bad player in PAH. The study results were reassuring because riociguat didn’t have much of an effect on ADMA levels, although the “slight difference was not enough to identify people who might do better with” it, Dr. Klinger said.
As for cGMP, “when we raise [levels] with riociguat, patients get better, so we think riociguat is raising cGMP in the right place, which we think is the lungs. Unfortunately, we don’t’ have a biomarker that can distinguish lung cGMP from total body cGMP,” he said.
The work was funded by Bayer, maker of riociguat. Dr. Klinger is an unpaid consultant, and also receives research support from the company.
AT CHEST 2016
Key clinical point:
Major finding: At week 24, 34% of 47 evaluable patients (16%) achieved the combined endpoint of no clinical worsening, functional class 1 or 2, and a 30-meter or more improvement on their walk test.
Data source: Open-label, nonrandomized 24-week study of 61 patients
Disclosures: The work was funded by Bayer, maker of riociguat. The lead investigator is an unpaid consultant, and also receives research support from the company.
Inhaled antibiotic for bronchiectasis shows promise
AT CHEST 2016
LOS ANGELES – Long-term inhaled ciprofloxacin therapy appears to be a safe and effective treatment option in patients with bronchiectasis, results from an international phase III trial showed.
“This is really exciting; it’s the first large study of an inhaled antibiotic to show a benefit in this population,” study investigator Kevin Winthrop, MD, said in an interview prior to the annual meeting of the American College of Chest Physicians. “There’s a tremendous unmet need and a lot of these patients have daily struggles and their quality of life is low. To have something that would improve that would be a benefit for patients and physicians alike.”
Compared with patients in the placebo arm, those in the ciprofloxacin dry powder for inhalation (DPI) 14-day on/off arm experienced a significantly prolonged time to first exacerbation (a mean of 336 days versus 186 days, respectively; adjusted hazard ratio, 0.53; P = .0005) and a significantly reduced exacerbation frequency over 48 weeks (a mean of 0.78 vs. 1.42; adjusted incident rate of 0.61; P = .0061). A nonsignificant trend in favor of ciprofloxacin DPI was observed for both primary endpoints among patients in the 28-day on/off arm (time to first exacerbation: HR, 0.73; P = .065; frequency of exacerbations: adjusted incidence rate ratio, 0.98; P = .89).
Treatment-emergent adverse events and adverse events leading to discontinuation were similar across treatment groups (82% in the ciprofloxacin DPI 14-day on/off arm, 83% in the ciprofloxacin DPI 28-day on/off arm, and 83% in the pooled placebo arm. The rates of serious adverse events were also similar in the three treatment groups (17%, 20%, and 23%, respectively). “Tolerability markers like hoarseness, bronchospasm, shortness of breath, or increased cough were similar between the treatment arms,” said Dr. Winthrop, who is an infectious diseases specialist at Oregon Health and Science University, Portland.“The safety profile looks really good. There were no typical fluoroquinolone types of problems such as tendinopathy reported.”
A follow-up trial known as RESPIRE 2 is ongoing. RESPIRE 1 was funded by Bayer. Dr. Winthrop disclosed that he is a consultant for the company.
This article was updated on 10/25/2016 at 9:51 AM Est
AT CHEST 2016
LOS ANGELES – Long-term inhaled ciprofloxacin therapy appears to be a safe and effective treatment option in patients with bronchiectasis, results from an international phase III trial showed.
“This is really exciting; it’s the first large study of an inhaled antibiotic to show a benefit in this population,” study investigator Kevin Winthrop, MD, said in an interview prior to the annual meeting of the American College of Chest Physicians. “There’s a tremendous unmet need and a lot of these patients have daily struggles and their quality of life is low. To have something that would improve that would be a benefit for patients and physicians alike.”
Compared with patients in the placebo arm, those in the ciprofloxacin dry powder for inhalation (DPI) 14-day on/off arm experienced a significantly prolonged time to first exacerbation (a mean of 336 days versus 186 days, respectively; adjusted hazard ratio, 0.53; P = .0005) and a significantly reduced exacerbation frequency over 48 weeks (a mean of 0.78 vs. 1.42; adjusted incident rate of 0.61; P = .0061). A nonsignificant trend in favor of ciprofloxacin DPI was observed for both primary endpoints among patients in the 28-day on/off arm (time to first exacerbation: HR, 0.73; P = .065; frequency of exacerbations: adjusted incidence rate ratio, 0.98; P = .89).
Treatment-emergent adverse events and adverse events leading to discontinuation were similar across treatment groups (82% in the ciprofloxacin DPI 14-day on/off arm, 83% in the ciprofloxacin DPI 28-day on/off arm, and 83% in the pooled placebo arm. The rates of serious adverse events were also similar in the three treatment groups (17%, 20%, and 23%, respectively). “Tolerability markers like hoarseness, bronchospasm, shortness of breath, or increased cough were similar between the treatment arms,” said Dr. Winthrop, who is an infectious diseases specialist at Oregon Health and Science University, Portland.“The safety profile looks really good. There were no typical fluoroquinolone types of problems such as tendinopathy reported.”
A follow-up trial known as RESPIRE 2 is ongoing. RESPIRE 1 was funded by Bayer. Dr. Winthrop disclosed that he is a consultant for the company.
This article was updated on 10/25/2016 at 9:51 AM Est
AT CHEST 2016
LOS ANGELES – Long-term inhaled ciprofloxacin therapy appears to be a safe and effective treatment option in patients with bronchiectasis, results from an international phase III trial showed.
“This is really exciting; it’s the first large study of an inhaled antibiotic to show a benefit in this population,” study investigator Kevin Winthrop, MD, said in an interview prior to the annual meeting of the American College of Chest Physicians. “There’s a tremendous unmet need and a lot of these patients have daily struggles and their quality of life is low. To have something that would improve that would be a benefit for patients and physicians alike.”
Compared with patients in the placebo arm, those in the ciprofloxacin dry powder for inhalation (DPI) 14-day on/off arm experienced a significantly prolonged time to first exacerbation (a mean of 336 days versus 186 days, respectively; adjusted hazard ratio, 0.53; P = .0005) and a significantly reduced exacerbation frequency over 48 weeks (a mean of 0.78 vs. 1.42; adjusted incident rate of 0.61; P = .0061). A nonsignificant trend in favor of ciprofloxacin DPI was observed for both primary endpoints among patients in the 28-day on/off arm (time to first exacerbation: HR, 0.73; P = .065; frequency of exacerbations: adjusted incidence rate ratio, 0.98; P = .89).
Treatment-emergent adverse events and adverse events leading to discontinuation were similar across treatment groups (82% in the ciprofloxacin DPI 14-day on/off arm, 83% in the ciprofloxacin DPI 28-day on/off arm, and 83% in the pooled placebo arm. The rates of serious adverse events were also similar in the three treatment groups (17%, 20%, and 23%, respectively). “Tolerability markers like hoarseness, bronchospasm, shortness of breath, or increased cough were similar between the treatment arms,” said Dr. Winthrop, who is an infectious diseases specialist at Oregon Health and Science University, Portland.“The safety profile looks really good. There were no typical fluoroquinolone types of problems such as tendinopathy reported.”
A follow-up trial known as RESPIRE 2 is ongoing. RESPIRE 1 was funded by Bayer. Dr. Winthrop disclosed that he is a consultant for the company.
This article was updated on 10/25/2016 at 9:51 AM Est
Key clinical point:
Major finding: Compared with patients in the placebo arm, those in the ciprofloxacin 14-day on/off arm experienced a significantly prolonged time to first exacerbation (a mean of 336 days vs. 186 days, respectively; adjusted hazard ratio, 0.53; P = .0005).
Data source: A multicenter study of 416 patients who were randomized 2:1 to ciprofloxacin 32.5 mg or placebo administered twice per day using a pocket-sized inhaler as a cyclical regimen of either 14 days on/off drug or 28 days on/off drug, for 48 weeks.
Disclosures: RESPIRE 1 was funded by Bayer. Dr. Winthrop disclosed that he is a consultant for the company.
Lung cancer screening found effective in a community hospital
LOS ANGELES – Lung cancer screening with low-dose CT scans in a community hospital setting replicates results from international and multicenter trials when it comes to diagnosing early-stage lung cancer, findings from a single-center study showed.
“It’s too early in our experience to say that we’re saving lives, but the fact that we’re detecting early lung cancers in the predicted percentages is good for community hospitals that are wondering, ‘Is it worth it to screen for lung cancer? Can we do it?’ ” Richard P. Salzano Jr., MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians.
In July 2013, the 130-bed Griffin Hospital launched a lung cancer screening program codirected by a pulmonologist and a cardiothoracic surgeon. All low-dose CT scans were read by two designated radiologists. Dr. Salzano reported results from 514 patients enrolled in the program between July 2013 and December 2015. A total of nine lung cancers were detected. Seven (78%) were stage I or II lung cancers, and the remaining two (22%) were stage II or IV, results that are in line with data from the I-ELCAP and NLST trials.
In another component of the study, the researchers randomly selected 101 patients from the lung cancer screening program to answer questions by telephone intended to quantify their anxiety about lung cancer before and after participating in the program, attitudes about smoking behaviors, and general impressions of the screening process. On a scale of 0-10, with 10 being “very anxious,” Dr. Salzano reported that the mean anxiety level about lung cancer fell from a level of 4.69 before screening to 3.87 afterward, a difference that reached statistical significance, with a P value of .014. “None of the patients reported negative impacts of the program,” he added. “They reported a general improvement in their well-being as a result of participating in the program.” In addition, of the 53 respondents who were current smokers upon enrolling in the screening program, five quit after intake, and the remaining 48 indicated that they were “more likely to quit” as a result of being enrolled.
“Community hospitals need to embrace lung screening,” Dr. Salzano concluded. “The findings from the large studies are transferable. It’s helping your patients in terms of their attitudes about lung cancer, about smoking cessation, and about improving their wellness.”
He reported having no relevant financial disclosures.
LOS ANGELES – Lung cancer screening with low-dose CT scans in a community hospital setting replicates results from international and multicenter trials when it comes to diagnosing early-stage lung cancer, findings from a single-center study showed.
“It’s too early in our experience to say that we’re saving lives, but the fact that we’re detecting early lung cancers in the predicted percentages is good for community hospitals that are wondering, ‘Is it worth it to screen for lung cancer? Can we do it?’ ” Richard P. Salzano Jr., MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians.
In July 2013, the 130-bed Griffin Hospital launched a lung cancer screening program codirected by a pulmonologist and a cardiothoracic surgeon. All low-dose CT scans were read by two designated radiologists. Dr. Salzano reported results from 514 patients enrolled in the program between July 2013 and December 2015. A total of nine lung cancers were detected. Seven (78%) were stage I or II lung cancers, and the remaining two (22%) were stage II or IV, results that are in line with data from the I-ELCAP and NLST trials.
In another component of the study, the researchers randomly selected 101 patients from the lung cancer screening program to answer questions by telephone intended to quantify their anxiety about lung cancer before and after participating in the program, attitudes about smoking behaviors, and general impressions of the screening process. On a scale of 0-10, with 10 being “very anxious,” Dr. Salzano reported that the mean anxiety level about lung cancer fell from a level of 4.69 before screening to 3.87 afterward, a difference that reached statistical significance, with a P value of .014. “None of the patients reported negative impacts of the program,” he added. “They reported a general improvement in their well-being as a result of participating in the program.” In addition, of the 53 respondents who were current smokers upon enrolling in the screening program, five quit after intake, and the remaining 48 indicated that they were “more likely to quit” as a result of being enrolled.
“Community hospitals need to embrace lung screening,” Dr. Salzano concluded. “The findings from the large studies are transferable. It’s helping your patients in terms of their attitudes about lung cancer, about smoking cessation, and about improving their wellness.”
He reported having no relevant financial disclosures.
LOS ANGELES – Lung cancer screening with low-dose CT scans in a community hospital setting replicates results from international and multicenter trials when it comes to diagnosing early-stage lung cancer, findings from a single-center study showed.
“It’s too early in our experience to say that we’re saving lives, but the fact that we’re detecting early lung cancers in the predicted percentages is good for community hospitals that are wondering, ‘Is it worth it to screen for lung cancer? Can we do it?’ ” Richard P. Salzano Jr., MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians.
In July 2013, the 130-bed Griffin Hospital launched a lung cancer screening program codirected by a pulmonologist and a cardiothoracic surgeon. All low-dose CT scans were read by two designated radiologists. Dr. Salzano reported results from 514 patients enrolled in the program between July 2013 and December 2015. A total of nine lung cancers were detected. Seven (78%) were stage I or II lung cancers, and the remaining two (22%) were stage II or IV, results that are in line with data from the I-ELCAP and NLST trials.
In another component of the study, the researchers randomly selected 101 patients from the lung cancer screening program to answer questions by telephone intended to quantify their anxiety about lung cancer before and after participating in the program, attitudes about smoking behaviors, and general impressions of the screening process. On a scale of 0-10, with 10 being “very anxious,” Dr. Salzano reported that the mean anxiety level about lung cancer fell from a level of 4.69 before screening to 3.87 afterward, a difference that reached statistical significance, with a P value of .014. “None of the patients reported negative impacts of the program,” he added. “They reported a general improvement in their well-being as a result of participating in the program.” In addition, of the 53 respondents who were current smokers upon enrolling in the screening program, five quit after intake, and the remaining 48 indicated that they were “more likely to quit” as a result of being enrolled.
“Community hospitals need to embrace lung screening,” Dr. Salzano concluded. “The findings from the large studies are transferable. It’s helping your patients in terms of their attitudes about lung cancer, about smoking cessation, and about improving their wellness.”
He reported having no relevant financial disclosures.
AT CHEST 2016
Key clinical point:
Major finding: Of nine lung cancers detected, seven (78%) were stage I or II lung cancers and the remaining two (22%) were stage II or IV.
Data source: Results from 514 patients enrolled in a community hospital–based lung cancer screening program between July 2013 and December 2015.
Disclosures: Dr. Salzano reported having no relevant financial disclosures.
Sepsis mortality linked to concentration of critical care fellowships
LOS ANGELES – Compared with other parts of the United States, survival rates for sepsis were highest in the Northeast and in metropolitan areas in the Western regions of the United States, which mirrors the concentration of critical care fellowship programs, results from a descriptive analysis found.
“There must be consideration to redistribute the critical care work force based on the spread of the malady that they are trained to deal with,” lead study author Aditya Shah, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “This could be linked to better reimbursements in the underserved areas.”
Dr. Shah has conducted similar projects in patient populations with HIV and hepatitis, but to his knowledge, this is the first such analysis using NCHS data. “What is unique about this is that we can make real time presentations to see how the work force and the pathology is evolving with regards to an epidemiological stand point with real time data, which can be easily accessed,” he explained. “Depending on what we see, interventions and redistributions could be made with regards to better distributing providers based on where they are needed the most.”
Of 150 critical care fellowship programs identified in the analysis, the majority were concentrated in the Northeast and metropolitan areas in the Western regions of the United States, which parallel similar patterns noted in other specialties. Survival rates for sepsis were also higher in these locations. Dr. Shah said that the findings support previous studies, which indicated that physicians often tend to practice in geographic areas close to their training sites. However, the fact that such variation existed in mortality from sepsis – one of the most common diagnoses in the medical and surgical intensive care units – surprised him. “You would have thought that there would be a work force to deal with this malady,” he said.
He acknowledged certain limitations of the study, including the fact that the NCHS data do not enable researchers to break down mortality from particular causes of sepsis. “Also, the most current data will always lag behind as it is entered retrospectively and needs time to be uploaded online,” he said. “I am still in search of a more real-time database. However, that would require much more intensive time, money, and resources.”
Dr. Shah reported having no financial disclosures.
LOS ANGELES – Compared with other parts of the United States, survival rates for sepsis were highest in the Northeast and in metropolitan areas in the Western regions of the United States, which mirrors the concentration of critical care fellowship programs, results from a descriptive analysis found.
“There must be consideration to redistribute the critical care work force based on the spread of the malady that they are trained to deal with,” lead study author Aditya Shah, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “This could be linked to better reimbursements in the underserved areas.”
Dr. Shah has conducted similar projects in patient populations with HIV and hepatitis, but to his knowledge, this is the first such analysis using NCHS data. “What is unique about this is that we can make real time presentations to see how the work force and the pathology is evolving with regards to an epidemiological stand point with real time data, which can be easily accessed,” he explained. “Depending on what we see, interventions and redistributions could be made with regards to better distributing providers based on where they are needed the most.”
Of 150 critical care fellowship programs identified in the analysis, the majority were concentrated in the Northeast and metropolitan areas in the Western regions of the United States, which parallel similar patterns noted in other specialties. Survival rates for sepsis were also higher in these locations. Dr. Shah said that the findings support previous studies, which indicated that physicians often tend to practice in geographic areas close to their training sites. However, the fact that such variation existed in mortality from sepsis – one of the most common diagnoses in the medical and surgical intensive care units – surprised him. “You would have thought that there would be a work force to deal with this malady,” he said.
He acknowledged certain limitations of the study, including the fact that the NCHS data do not enable researchers to break down mortality from particular causes of sepsis. “Also, the most current data will always lag behind as it is entered retrospectively and needs time to be uploaded online,” he said. “I am still in search of a more real-time database. However, that would require much more intensive time, money, and resources.”
Dr. Shah reported having no financial disclosures.
LOS ANGELES – Compared with other parts of the United States, survival rates for sepsis were highest in the Northeast and in metropolitan areas in the Western regions of the United States, which mirrors the concentration of critical care fellowship programs, results from a descriptive analysis found.
“There must be consideration to redistribute the critical care work force based on the spread of the malady that they are trained to deal with,” lead study author Aditya Shah, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “This could be linked to better reimbursements in the underserved areas.”
Dr. Shah has conducted similar projects in patient populations with HIV and hepatitis, but to his knowledge, this is the first such analysis using NCHS data. “What is unique about this is that we can make real time presentations to see how the work force and the pathology is evolving with regards to an epidemiological stand point with real time data, which can be easily accessed,” he explained. “Depending on what we see, interventions and redistributions could be made with regards to better distributing providers based on where they are needed the most.”
Of 150 critical care fellowship programs identified in the analysis, the majority were concentrated in the Northeast and metropolitan areas in the Western regions of the United States, which parallel similar patterns noted in other specialties. Survival rates for sepsis were also higher in these locations. Dr. Shah said that the findings support previous studies, which indicated that physicians often tend to practice in geographic areas close to their training sites. However, the fact that such variation existed in mortality from sepsis – one of the most common diagnoses in the medical and surgical intensive care units – surprised him. “You would have thought that there would be a work force to deal with this malady,” he said.
He acknowledged certain limitations of the study, including the fact that the NCHS data do not enable researchers to break down mortality from particular causes of sepsis. “Also, the most current data will always lag behind as it is entered retrospectively and needs time to be uploaded online,” he said. “I am still in search of a more real-time database. However, that would require much more intensive time, money, and resources.”
Dr. Shah reported having no financial disclosures.
AT CHEST 2016
Key clinical point:
Major finding: Higher survival rates for sepsis were more concentrated in the Northeast and metropolitan areas in the Western regions of the United States, compared with other areas of the country.
Data source: A descriptive analysis that evaluated sepsis mortality data linked to 150 critical care fellowship programs in the United States.
Disclosures: Dr. Shah reported having no financial disclosures.
Smokers’ hand grip strength predicts risk for respiratory events
LOS ANGELES – Hand grip strength is independently predictive of risk for respiratory events in smokers who have or are at risk for chronic obstructive pulmonary disease, results from a single-center study showed.
“Measures of lung function, including spirometry, are used as the main descriptors of COPD severity and prognosis,” Carlos H. Martinez, MD, MPH, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “These measurements, as important as they are, need to be improved, in order to develop better risk and prognostic models of the disease, to identify subgroups at higher risk of poor outcomes ... With our work, we have proved that simple physical tests could be part of future prognostic models.”
Interest has grown in developing multidimensional models to predict respiratory prognosis. Such models include BODE (body mass index, airflow obstruction, dyspnea and exercise capacity), ADO (age, dyspnea and airflow obstruction), and DOSE (dyspnea, airflow obstruction, smoking status, and exacerbation frequency).
In patients with or at risk for COPD, Dr. Martinez, of the University of Michigan Health System, Ann Arbor, and his colleagues tested the associations of hand grip strength with measures of body composition such as pectoralis muscle area and extent of subcutaneous fat, imaging phenotypes, and lung function.
The researchers obtained demographic, clinical, lung function, hand grip strength, and imaging data from 441 smokers with and without COPD participating in the Genetic Epidemiology of COPD Study (COPDGene) at the National Jewish Health in Denver. Imaging methods used in the study were developed by George R. Washko, MD, and his associates at Brigham and Women’s Hospital, Boston, to evaluate patients’ body composition, including chest CTs to obtain measures of airway thickness, emphysema percentage, pectoralis muscle area, and subcutaneous adipose tissue area.
Correlations between measures of lung function, imaging phenotypes, body composition, and hand grip strength were analyzed in univariate analysis and in multivariate linear models. The association between hand grip strength and exacerbations was analyzed at enrollment and during an average follow-up of 2.6 years.
Hand grip strength was similar across groups categorized by spirometry severity and was not associated with emphysema severity.
After adjustment for demographics, smoking history, smoking intensity, comorbidities and lung imaging phenotypes, however, grip strength was associated with pectoralis muscle area (increase of 3.9 kg per one standard deviation of pectoral muscle area) and subcutaneous adipose tissue (a decrement of 5.1 kg per one standard deviation of subcutaneous adipose tissue). These associations were independent of body mass index and the presence of emphysema.
During follow-up, hand grip strength was associated with exacerbations (risk ratio 0.94 per one kg increment on grip strength) and incident exacerbations (incident risk ratio 0.92 per one kg increment on grip strength) in models adjusted for other factors known to be associated with exacerbations.
Research in body composition has mostly relied on dual absorptiometry and bioelectrical impedance, tools not routinely used in clinical practice, Dr. Martinez said. “We were surprised by the ability to show similar results using imaging data that are available from regular chest CTs.”
“We have confirmed prior hypotheses that it is not just weight or BMI that matters (to risk of exacerbations), but how much muscle and how much fat are contributing to our patient’s high or low BMI,” Dr. Martinez said.
Hand grip testing can be challenging in this patient population, he said. Still, “asking relevant questions about (patients’) physical fitness will help us to understand better our patients’ needs. We can also give more attention to the extrapulmonary structures included in the numerous chest CT scans that we order for our patients. These imaging studies, besides the information that they provide about parenchymal and mediastinal structures, include important and easy to discover clues to identify patients at higher risk of exacerbations – those with low muscle and low hand grip could benefit from close follow-up.”
Dr. Martinez acknowledged certain limitations of the study, including the selection of the measures of body composition. “We used analysis of chest CTs, instead of the gold standard of dual absorptiometry (DXA) or other methods such as bioelectrical impedance,” he said. “A final limitation is that we tested a selected group of participants in a cohort study, not a representative sample of the population, [with a] low burden of emphysema and fewer African American participants.”
Dr. Martinez disclosed that his work is supported by the National Institutes of Health and that COPDGene also receives NIH funding. He acknowledged the support and effort of all COPDGene investigators and participants.
LOS ANGELES – Hand grip strength is independently predictive of risk for respiratory events in smokers who have or are at risk for chronic obstructive pulmonary disease, results from a single-center study showed.
“Measures of lung function, including spirometry, are used as the main descriptors of COPD severity and prognosis,” Carlos H. Martinez, MD, MPH, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “These measurements, as important as they are, need to be improved, in order to develop better risk and prognostic models of the disease, to identify subgroups at higher risk of poor outcomes ... With our work, we have proved that simple physical tests could be part of future prognostic models.”
Interest has grown in developing multidimensional models to predict respiratory prognosis. Such models include BODE (body mass index, airflow obstruction, dyspnea and exercise capacity), ADO (age, dyspnea and airflow obstruction), and DOSE (dyspnea, airflow obstruction, smoking status, and exacerbation frequency).
In patients with or at risk for COPD, Dr. Martinez, of the University of Michigan Health System, Ann Arbor, and his colleagues tested the associations of hand grip strength with measures of body composition such as pectoralis muscle area and extent of subcutaneous fat, imaging phenotypes, and lung function.
The researchers obtained demographic, clinical, lung function, hand grip strength, and imaging data from 441 smokers with and without COPD participating in the Genetic Epidemiology of COPD Study (COPDGene) at the National Jewish Health in Denver. Imaging methods used in the study were developed by George R. Washko, MD, and his associates at Brigham and Women’s Hospital, Boston, to evaluate patients’ body composition, including chest CTs to obtain measures of airway thickness, emphysema percentage, pectoralis muscle area, and subcutaneous adipose tissue area.
Correlations between measures of lung function, imaging phenotypes, body composition, and hand grip strength were analyzed in univariate analysis and in multivariate linear models. The association between hand grip strength and exacerbations was analyzed at enrollment and during an average follow-up of 2.6 years.
Hand grip strength was similar across groups categorized by spirometry severity and was not associated with emphysema severity.
After adjustment for demographics, smoking history, smoking intensity, comorbidities and lung imaging phenotypes, however, grip strength was associated with pectoralis muscle area (increase of 3.9 kg per one standard deviation of pectoral muscle area) and subcutaneous adipose tissue (a decrement of 5.1 kg per one standard deviation of subcutaneous adipose tissue). These associations were independent of body mass index and the presence of emphysema.
During follow-up, hand grip strength was associated with exacerbations (risk ratio 0.94 per one kg increment on grip strength) and incident exacerbations (incident risk ratio 0.92 per one kg increment on grip strength) in models adjusted for other factors known to be associated with exacerbations.
Research in body composition has mostly relied on dual absorptiometry and bioelectrical impedance, tools not routinely used in clinical practice, Dr. Martinez said. “We were surprised by the ability to show similar results using imaging data that are available from regular chest CTs.”
“We have confirmed prior hypotheses that it is not just weight or BMI that matters (to risk of exacerbations), but how much muscle and how much fat are contributing to our patient’s high or low BMI,” Dr. Martinez said.
Hand grip testing can be challenging in this patient population, he said. Still, “asking relevant questions about (patients’) physical fitness will help us to understand better our patients’ needs. We can also give more attention to the extrapulmonary structures included in the numerous chest CT scans that we order for our patients. These imaging studies, besides the information that they provide about parenchymal and mediastinal structures, include important and easy to discover clues to identify patients at higher risk of exacerbations – those with low muscle and low hand grip could benefit from close follow-up.”
Dr. Martinez acknowledged certain limitations of the study, including the selection of the measures of body composition. “We used analysis of chest CTs, instead of the gold standard of dual absorptiometry (DXA) or other methods such as bioelectrical impedance,” he said. “A final limitation is that we tested a selected group of participants in a cohort study, not a representative sample of the population, [with a] low burden of emphysema and fewer African American participants.”
Dr. Martinez disclosed that his work is supported by the National Institutes of Health and that COPDGene also receives NIH funding. He acknowledged the support and effort of all COPDGene investigators and participants.
LOS ANGELES – Hand grip strength is independently predictive of risk for respiratory events in smokers who have or are at risk for chronic obstructive pulmonary disease, results from a single-center study showed.
“Measures of lung function, including spirometry, are used as the main descriptors of COPD severity and prognosis,” Carlos H. Martinez, MD, MPH, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “These measurements, as important as they are, need to be improved, in order to develop better risk and prognostic models of the disease, to identify subgroups at higher risk of poor outcomes ... With our work, we have proved that simple physical tests could be part of future prognostic models.”
Interest has grown in developing multidimensional models to predict respiratory prognosis. Such models include BODE (body mass index, airflow obstruction, dyspnea and exercise capacity), ADO (age, dyspnea and airflow obstruction), and DOSE (dyspnea, airflow obstruction, smoking status, and exacerbation frequency).
In patients with or at risk for COPD, Dr. Martinez, of the University of Michigan Health System, Ann Arbor, and his colleagues tested the associations of hand grip strength with measures of body composition such as pectoralis muscle area and extent of subcutaneous fat, imaging phenotypes, and lung function.
The researchers obtained demographic, clinical, lung function, hand grip strength, and imaging data from 441 smokers with and without COPD participating in the Genetic Epidemiology of COPD Study (COPDGene) at the National Jewish Health in Denver. Imaging methods used in the study were developed by George R. Washko, MD, and his associates at Brigham and Women’s Hospital, Boston, to evaluate patients’ body composition, including chest CTs to obtain measures of airway thickness, emphysema percentage, pectoralis muscle area, and subcutaneous adipose tissue area.
Correlations between measures of lung function, imaging phenotypes, body composition, and hand grip strength were analyzed in univariate analysis and in multivariate linear models. The association between hand grip strength and exacerbations was analyzed at enrollment and during an average follow-up of 2.6 years.
Hand grip strength was similar across groups categorized by spirometry severity and was not associated with emphysema severity.
After adjustment for demographics, smoking history, smoking intensity, comorbidities and lung imaging phenotypes, however, grip strength was associated with pectoralis muscle area (increase of 3.9 kg per one standard deviation of pectoral muscle area) and subcutaneous adipose tissue (a decrement of 5.1 kg per one standard deviation of subcutaneous adipose tissue). These associations were independent of body mass index and the presence of emphysema.
During follow-up, hand grip strength was associated with exacerbations (risk ratio 0.94 per one kg increment on grip strength) and incident exacerbations (incident risk ratio 0.92 per one kg increment on grip strength) in models adjusted for other factors known to be associated with exacerbations.
Research in body composition has mostly relied on dual absorptiometry and bioelectrical impedance, tools not routinely used in clinical practice, Dr. Martinez said. “We were surprised by the ability to show similar results using imaging data that are available from regular chest CTs.”
“We have confirmed prior hypotheses that it is not just weight or BMI that matters (to risk of exacerbations), but how much muscle and how much fat are contributing to our patient’s high or low BMI,” Dr. Martinez said.
Hand grip testing can be challenging in this patient population, he said. Still, “asking relevant questions about (patients’) physical fitness will help us to understand better our patients’ needs. We can also give more attention to the extrapulmonary structures included in the numerous chest CT scans that we order for our patients. These imaging studies, besides the information that they provide about parenchymal and mediastinal structures, include important and easy to discover clues to identify patients at higher risk of exacerbations – those with low muscle and low hand grip could benefit from close follow-up.”
Dr. Martinez acknowledged certain limitations of the study, including the selection of the measures of body composition. “We used analysis of chest CTs, instead of the gold standard of dual absorptiometry (DXA) or other methods such as bioelectrical impedance,” he said. “A final limitation is that we tested a selected group of participants in a cohort study, not a representative sample of the population, [with a] low burden of emphysema and fewer African American participants.”
Dr. Martinez disclosed that his work is supported by the National Institutes of Health and that COPDGene also receives NIH funding. He acknowledged the support and effort of all COPDGene investigators and participants.
AT CHEST 2016
Key clinical point:
Major finding: During an average follow-up of 2.6 years, hand grip strength was associated with cross-sectional exacerbations (risk ratio 0.94 per one kg increment on grip strength) and incident exacerbations (incident risk ratio 0.92 per one kg increment on grip strength).
Data source: Data from 441 smokers with and without COPD participating in the Genetic Epidemiology of COPD Study (COPDGene) at National Jewish Health in Denver.
Disclosures: Dr. Martinez disclosed that his work is supported by the National Institutes of Health and that COPDGene also receives NIH funding.
Chest physician perceptions of e-cigarettes mixed
AT CHEST 2016
LOS ANGELES – Chest physicians in the United States are likely to encounter electronic cigarette users in clinical practice, yet there is no consensus regarding how to advise them, results from a survey suggest.
“There is controversy in the community of physicians we surveyed on whether e-cigarettes would be useful for smoking cessation and whether they can reduce harm from tobacco smoking,” lead study author Stephen R. Baldassarri, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “Our results suggest that we need more high quality scientific data regarding potential harms and benefits of e-cigarettes in order to inform both health professionals and the general public.”
When asked if ECs promote tobacco cessation, respondents were split (33% agreed or strongly agreed while 32% disagreed or strongly disagreed); only 13% believed that ECs were at least as effective as Food and Drug Administration–approved treatments to promote smoking cessation, and 11% reported that ECs should be used in an initial quit attempt. Dr. Baldassarri also reported that 6% of respondents thought ECs are more harmful than smoking, 21% thought switching from daily tobacco smoking to EC use would improve a patient’s health, and 55% reported feeling comfortable discussing health effects of ECs with their patients.
“In light of the fact that the long-term health risks of ECs remain unknown, we were surprised to find that more than half of the survey respondents reported feeling comfortable discussing health effects of ECs,” Dr. Baldassarri commented. “This proportion was higher than we expected given the current state of the scientific evidence.”
He acknowledged certain limitations of the survey, including its low response rate, “which limits the degree to which we can generalize our findings to account for the perceptions of all chest physicians,” he said. “We surveyed providers only within CHEST, and opinions and experiences of physicians outside of the organization and in other specialties may vary. And finally, since knowledge regarding e-cigarettes is rapidly evolving, the perceptions and opinions here are likely subject to change over the next few years as more becomes known.”
Dr. Baldassarri reported having no financial disclosures.
AT CHEST 2016
LOS ANGELES – Chest physicians in the United States are likely to encounter electronic cigarette users in clinical practice, yet there is no consensus regarding how to advise them, results from a survey suggest.
“There is controversy in the community of physicians we surveyed on whether e-cigarettes would be useful for smoking cessation and whether they can reduce harm from tobacco smoking,” lead study author Stephen R. Baldassarri, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “Our results suggest that we need more high quality scientific data regarding potential harms and benefits of e-cigarettes in order to inform both health professionals and the general public.”
When asked if ECs promote tobacco cessation, respondents were split (33% agreed or strongly agreed while 32% disagreed or strongly disagreed); only 13% believed that ECs were at least as effective as Food and Drug Administration–approved treatments to promote smoking cessation, and 11% reported that ECs should be used in an initial quit attempt. Dr. Baldassarri also reported that 6% of respondents thought ECs are more harmful than smoking, 21% thought switching from daily tobacco smoking to EC use would improve a patient’s health, and 55% reported feeling comfortable discussing health effects of ECs with their patients.
“In light of the fact that the long-term health risks of ECs remain unknown, we were surprised to find that more than half of the survey respondents reported feeling comfortable discussing health effects of ECs,” Dr. Baldassarri commented. “This proportion was higher than we expected given the current state of the scientific evidence.”
He acknowledged certain limitations of the survey, including its low response rate, “which limits the degree to which we can generalize our findings to account for the perceptions of all chest physicians,” he said. “We surveyed providers only within CHEST, and opinions and experiences of physicians outside of the organization and in other specialties may vary. And finally, since knowledge regarding e-cigarettes is rapidly evolving, the perceptions and opinions here are likely subject to change over the next few years as more becomes known.”
Dr. Baldassarri reported having no financial disclosures.
AT CHEST 2016
LOS ANGELES – Chest physicians in the United States are likely to encounter electronic cigarette users in clinical practice, yet there is no consensus regarding how to advise them, results from a survey suggest.
“There is controversy in the community of physicians we surveyed on whether e-cigarettes would be useful for smoking cessation and whether they can reduce harm from tobacco smoking,” lead study author Stephen R. Baldassarri, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “Our results suggest that we need more high quality scientific data regarding potential harms and benefits of e-cigarettes in order to inform both health professionals and the general public.”
When asked if ECs promote tobacco cessation, respondents were split (33% agreed or strongly agreed while 32% disagreed or strongly disagreed); only 13% believed that ECs were at least as effective as Food and Drug Administration–approved treatments to promote smoking cessation, and 11% reported that ECs should be used in an initial quit attempt. Dr. Baldassarri also reported that 6% of respondents thought ECs are more harmful than smoking, 21% thought switching from daily tobacco smoking to EC use would improve a patient’s health, and 55% reported feeling comfortable discussing health effects of ECs with their patients.
“In light of the fact that the long-term health risks of ECs remain unknown, we were surprised to find that more than half of the survey respondents reported feeling comfortable discussing health effects of ECs,” Dr. Baldassarri commented. “This proportion was higher than we expected given the current state of the scientific evidence.”
He acknowledged certain limitations of the survey, including its low response rate, “which limits the degree to which we can generalize our findings to account for the perceptions of all chest physicians,” he said. “We surveyed providers only within CHEST, and opinions and experiences of physicians outside of the organization and in other specialties may vary. And finally, since knowledge regarding e-cigarettes is rapidly evolving, the perceptions and opinions here are likely subject to change over the next few years as more becomes known.”
Dr. Baldassarri reported having no financial disclosures.
Key clinical point:
Major finding: When asked if electronic cigarettes (ECs) promote tobacco cessation, respondents were split (33% agreed or strongly agreed, while 32% disagreed or strongly disagreed).
Data source: Responses from 994 members of the American College of Chest Physicians who completed a brief online questionnaire about practice patterns and perceptions regarding EC use and tobacco smoking among their patients.
Disclosures: Dr. Baldassarri reported having no financial disclosures.
High resting heart rate may signal exacerbation risk in COPD patients
LOS ANGELES – Higher resting heart rate may predict future risk of exacerbation in patients with recent chronic obstructive pulmonary disease (COPD) exacerbation, results from a multicenter study suggest.
“Resting heart [rate] is often a readily available clinical data,” lead study author Ahmad Ismail, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “Its significance is often overlooked in daily clinical practice until tachycardia or bradycardia happens. In COPD patients, it has been shown that the resting heart rate can predict mortality. However, there is a lack of data showing its association with the rates of exacerbations, the major player in determining overall outcome in patients with COPD.”
The mean age of the study population was 67 years, and 77% of them had higher resting heart rates, defined as one that exceeded 80 beats per minute (BPM). The mean resting heart rate in the higher resting heart rate group was 92, compared with a mean of 70 BPM in the lower resting heart rate group. Dr. Ismail reported that at month 3, patients with higher resting heart rates had significantly higher proportion of exacerbations, compared with those who had a lower resting heart rates (54% vs. 27%; P = .013). The trend was followed through until month 9. There was also a statistically significant moderate strength linear correlation between resting heart rate and exacerbation frequency at 3, 6, and 9 months (r = 0.400; P less than .001: r = 0.440; P less than .001: and r = 0.416; P = .004, respectively). The mean exacerbation frequency was also significantly higher in the higher resting heart rate group at month 3 and month 6 (2.00 vs. 0.48; P less than .001: and 3.42 vs. 1.14; P = .004).
“Higher resting heart rate may predict future risk of exacerbation in patients with recent COPD exacerbation,” Dr. Ismail concluded. “Further study however is required to determine the effect of lowering resting heart rate on the future risk of exacerbation.” He acknowledged certain limitations of the study, including the fact that it excluded patients who were on beta-blockers or any rate-modifying drugs, and those with history of cardiac failure and ischemic heart disease, and that there was no baseline echocardiogram performed to ensure the absence of ischemic heart disease and other possible causes of the higher resting heart rates. “We also had slightly higher than expected dropouts giving a nonsignificant result at 12 months follow-up, though the trend follows the overall results of the study,” he said.
The study was funded by a grant from the Malaysian Thoracic Society. Dr. Ismail reported having no financial disclosures.
LOS ANGELES – Higher resting heart rate may predict future risk of exacerbation in patients with recent chronic obstructive pulmonary disease (COPD) exacerbation, results from a multicenter study suggest.
“Resting heart [rate] is often a readily available clinical data,” lead study author Ahmad Ismail, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “Its significance is often overlooked in daily clinical practice until tachycardia or bradycardia happens. In COPD patients, it has been shown that the resting heart rate can predict mortality. However, there is a lack of data showing its association with the rates of exacerbations, the major player in determining overall outcome in patients with COPD.”
The mean age of the study population was 67 years, and 77% of them had higher resting heart rates, defined as one that exceeded 80 beats per minute (BPM). The mean resting heart rate in the higher resting heart rate group was 92, compared with a mean of 70 BPM in the lower resting heart rate group. Dr. Ismail reported that at month 3, patients with higher resting heart rates had significantly higher proportion of exacerbations, compared with those who had a lower resting heart rates (54% vs. 27%; P = .013). The trend was followed through until month 9. There was also a statistically significant moderate strength linear correlation between resting heart rate and exacerbation frequency at 3, 6, and 9 months (r = 0.400; P less than .001: r = 0.440; P less than .001: and r = 0.416; P = .004, respectively). The mean exacerbation frequency was also significantly higher in the higher resting heart rate group at month 3 and month 6 (2.00 vs. 0.48; P less than .001: and 3.42 vs. 1.14; P = .004).
“Higher resting heart rate may predict future risk of exacerbation in patients with recent COPD exacerbation,” Dr. Ismail concluded. “Further study however is required to determine the effect of lowering resting heart rate on the future risk of exacerbation.” He acknowledged certain limitations of the study, including the fact that it excluded patients who were on beta-blockers or any rate-modifying drugs, and those with history of cardiac failure and ischemic heart disease, and that there was no baseline echocardiogram performed to ensure the absence of ischemic heart disease and other possible causes of the higher resting heart rates. “We also had slightly higher than expected dropouts giving a nonsignificant result at 12 months follow-up, though the trend follows the overall results of the study,” he said.
The study was funded by a grant from the Malaysian Thoracic Society. Dr. Ismail reported having no financial disclosures.
LOS ANGELES – Higher resting heart rate may predict future risk of exacerbation in patients with recent chronic obstructive pulmonary disease (COPD) exacerbation, results from a multicenter study suggest.
“Resting heart [rate] is often a readily available clinical data,” lead study author Ahmad Ismail, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians. “Its significance is often overlooked in daily clinical practice until tachycardia or bradycardia happens. In COPD patients, it has been shown that the resting heart rate can predict mortality. However, there is a lack of data showing its association with the rates of exacerbations, the major player in determining overall outcome in patients with COPD.”
The mean age of the study population was 67 years, and 77% of them had higher resting heart rates, defined as one that exceeded 80 beats per minute (BPM). The mean resting heart rate in the higher resting heart rate group was 92, compared with a mean of 70 BPM in the lower resting heart rate group. Dr. Ismail reported that at month 3, patients with higher resting heart rates had significantly higher proportion of exacerbations, compared with those who had a lower resting heart rates (54% vs. 27%; P = .013). The trend was followed through until month 9. There was also a statistically significant moderate strength linear correlation between resting heart rate and exacerbation frequency at 3, 6, and 9 months (r = 0.400; P less than .001: r = 0.440; P less than .001: and r = 0.416; P = .004, respectively). The mean exacerbation frequency was also significantly higher in the higher resting heart rate group at month 3 and month 6 (2.00 vs. 0.48; P less than .001: and 3.42 vs. 1.14; P = .004).
“Higher resting heart rate may predict future risk of exacerbation in patients with recent COPD exacerbation,” Dr. Ismail concluded. “Further study however is required to determine the effect of lowering resting heart rate on the future risk of exacerbation.” He acknowledged certain limitations of the study, including the fact that it excluded patients who were on beta-blockers or any rate-modifying drugs, and those with history of cardiac failure and ischemic heart disease, and that there was no baseline echocardiogram performed to ensure the absence of ischemic heart disease and other possible causes of the higher resting heart rates. “We also had slightly higher than expected dropouts giving a nonsignificant result at 12 months follow-up, though the trend follows the overall results of the study,” he said.
The study was funded by a grant from the Malaysian Thoracic Society. Dr. Ismail reported having no financial disclosures.
AT CHEST 2016
Key clinical point:
Major finding: At month 3, patients with higher resting heart rates had significantly higher proportion of exacerbations, compared with those who had a lower resting heart rates (54% vs. 27%; P = .013).
Data source: An evaluation of 147 COPD patients at 10 centers who were hospitalized for acute exacerbation of COPD between April 2012 and September 2015.
Disclosures: The study was funded by a grant from the Malaysian Thoracic Society. Dr. Ismail reported having no financial disclosures.