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Nebulized LABA safe for long-term use in COPD
TORONTO – No long-term safety signals were seen in a randomized trial that tested the formoterol fumarate inhalation solution (Perforomist, Mylan) against placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Safety was confirmed despite patients being permitted to remain on other background treatment for COPD, including inhaled corticosteroids and anticholinergics, in this study presented at the CHEST annual meeting. An additional benefit of the therapy was that it significantly improved lung function from baseline, according to some spirometry measures.
The Food and Drug Administration approved formoterol fumarate, a long-acting beta-2 agonist (LABA), as a nebulized maintenance treatment for bronchoconstriction in COPD. Because of a concern about long-term LABA safety in asthma patients, said Dr. Hanania, the FDA mandated this 1-year phase 4 study to evaluate the long-term safety of formoterol in patients with moderate to severe COPD.
This multicenter, double-blind, noninferiority study randomly assigned 1,071 patients with moderate to severe COPD (mean FEV1, 44.4% of predicted value, at least one exacerbation in the past 12 months) to receive either nebulized formoterol 20 mcg/2 mL twice daily or matching placebo for up to 12 months. Subjects were permitted to remain on stable COPD therapy, including inhaled corticosteroids and anticholinergics but excluding long-acting beta-agonists.
Formoterol was noninferior to placebo for the primary safety endpoint, defined as a first occurrence of respiratory-related death, COPD-related emergency department visit, or COPD-related hospitalization, with an estimated hazard ratio of 0.965.
Formoterol significantly improved trough forced expiratory volume in 1 second (FEV1), compared with placebo at 3 and 6 months of treatment, with (least squares) mean estimated differences of 42 mL (P = .007) and 41 mL (P = .025), respectively, but not at 9 or 12 months. Forced vital capacity was significantly improved with formoterol over placebo at all study visits (3, 6, 9, and 12 months), but improvements from baseline in inspiratory capacity did not significantly differ from placebo.
Mean age of study patients was 62.6 years and 48.5% were female. At baseline, about half of patients were still smokers, half were on inhaled corticosteroids, and about one-third were on concomitant long-acting muscarinic antagonists, mainly tiotropium, reported Dr. Hanania. The vast majority of patients had moderate or severe COPD, with less than 1% having very severe disease at baseline.
In response to a question on dosing, Dr. Hanania told attendees, “One thing we have to keep in mind is that formoterol is a full agonist, so there are dose-dependent adverse effects. So, even though you get better lung function as you go up on the dose, there’s no free lunch and always the potential for adverse effects.”
The safety data was previously presented at the American Thoracic Society meeting in May 2017 (Hanania N et al. Am J Respir Crit Care Med. 2017;195 A5473 [abstract]), while the lung function data are new, said Dr. Hanania.
Dr. Hanania reported being an adviser for several pharmaceutical companies, including Mylan. Four of the six authors of the study’s abstract are employees of Mylan.
TORONTO – No long-term safety signals were seen in a randomized trial that tested the formoterol fumarate inhalation solution (Perforomist, Mylan) against placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Safety was confirmed despite patients being permitted to remain on other background treatment for COPD, including inhaled corticosteroids and anticholinergics, in this study presented at the CHEST annual meeting. An additional benefit of the therapy was that it significantly improved lung function from baseline, according to some spirometry measures.
The Food and Drug Administration approved formoterol fumarate, a long-acting beta-2 agonist (LABA), as a nebulized maintenance treatment for bronchoconstriction in COPD. Because of a concern about long-term LABA safety in asthma patients, said Dr. Hanania, the FDA mandated this 1-year phase 4 study to evaluate the long-term safety of formoterol in patients with moderate to severe COPD.
This multicenter, double-blind, noninferiority study randomly assigned 1,071 patients with moderate to severe COPD (mean FEV1, 44.4% of predicted value, at least one exacerbation in the past 12 months) to receive either nebulized formoterol 20 mcg/2 mL twice daily or matching placebo for up to 12 months. Subjects were permitted to remain on stable COPD therapy, including inhaled corticosteroids and anticholinergics but excluding long-acting beta-agonists.
Formoterol was noninferior to placebo for the primary safety endpoint, defined as a first occurrence of respiratory-related death, COPD-related emergency department visit, or COPD-related hospitalization, with an estimated hazard ratio of 0.965.
Formoterol significantly improved trough forced expiratory volume in 1 second (FEV1), compared with placebo at 3 and 6 months of treatment, with (least squares) mean estimated differences of 42 mL (P = .007) and 41 mL (P = .025), respectively, but not at 9 or 12 months. Forced vital capacity was significantly improved with formoterol over placebo at all study visits (3, 6, 9, and 12 months), but improvements from baseline in inspiratory capacity did not significantly differ from placebo.
Mean age of study patients was 62.6 years and 48.5% were female. At baseline, about half of patients were still smokers, half were on inhaled corticosteroids, and about one-third were on concomitant long-acting muscarinic antagonists, mainly tiotropium, reported Dr. Hanania. The vast majority of patients had moderate or severe COPD, with less than 1% having very severe disease at baseline.
In response to a question on dosing, Dr. Hanania told attendees, “One thing we have to keep in mind is that formoterol is a full agonist, so there are dose-dependent adverse effects. So, even though you get better lung function as you go up on the dose, there’s no free lunch and always the potential for adverse effects.”
The safety data was previously presented at the American Thoracic Society meeting in May 2017 (Hanania N et al. Am J Respir Crit Care Med. 2017;195 A5473 [abstract]), while the lung function data are new, said Dr. Hanania.
Dr. Hanania reported being an adviser for several pharmaceutical companies, including Mylan. Four of the six authors of the study’s abstract are employees of Mylan.
TORONTO – No long-term safety signals were seen in a randomized trial that tested the formoterol fumarate inhalation solution (Perforomist, Mylan) against placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Safety was confirmed despite patients being permitted to remain on other background treatment for COPD, including inhaled corticosteroids and anticholinergics, in this study presented at the CHEST annual meeting. An additional benefit of the therapy was that it significantly improved lung function from baseline, according to some spirometry measures.
The Food and Drug Administration approved formoterol fumarate, a long-acting beta-2 agonist (LABA), as a nebulized maintenance treatment for bronchoconstriction in COPD. Because of a concern about long-term LABA safety in asthma patients, said Dr. Hanania, the FDA mandated this 1-year phase 4 study to evaluate the long-term safety of formoterol in patients with moderate to severe COPD.
This multicenter, double-blind, noninferiority study randomly assigned 1,071 patients with moderate to severe COPD (mean FEV1, 44.4% of predicted value, at least one exacerbation in the past 12 months) to receive either nebulized formoterol 20 mcg/2 mL twice daily or matching placebo for up to 12 months. Subjects were permitted to remain on stable COPD therapy, including inhaled corticosteroids and anticholinergics but excluding long-acting beta-agonists.
Formoterol was noninferior to placebo for the primary safety endpoint, defined as a first occurrence of respiratory-related death, COPD-related emergency department visit, or COPD-related hospitalization, with an estimated hazard ratio of 0.965.
Formoterol significantly improved trough forced expiratory volume in 1 second (FEV1), compared with placebo at 3 and 6 months of treatment, with (least squares) mean estimated differences of 42 mL (P = .007) and 41 mL (P = .025), respectively, but not at 9 or 12 months. Forced vital capacity was significantly improved with formoterol over placebo at all study visits (3, 6, 9, and 12 months), but improvements from baseline in inspiratory capacity did not significantly differ from placebo.
Mean age of study patients was 62.6 years and 48.5% were female. At baseline, about half of patients were still smokers, half were on inhaled corticosteroids, and about one-third were on concomitant long-acting muscarinic antagonists, mainly tiotropium, reported Dr. Hanania. The vast majority of patients had moderate or severe COPD, with less than 1% having very severe disease at baseline.
In response to a question on dosing, Dr. Hanania told attendees, “One thing we have to keep in mind is that formoterol is a full agonist, so there are dose-dependent adverse effects. So, even though you get better lung function as you go up on the dose, there’s no free lunch and always the potential for adverse effects.”
The safety data was previously presented at the American Thoracic Society meeting in May 2017 (Hanania N et al. Am J Respir Crit Care Med. 2017;195 A5473 [abstract]), while the lung function data are new, said Dr. Hanania.
Dr. Hanania reported being an adviser for several pharmaceutical companies, including Mylan. Four of the six authors of the study’s abstract are employees of Mylan.
AT CHEST 2017
Key clinical point: The long-term safety of formoterol fumarate inhaled solution was confirmed in an FDA-mandated randomized trial in patients with moderate to severe COPD.
Major finding: Formoterol fumarate was noninferior to placebo for the primary safety endpoint of respiratory-related death, COPD-related emergency department visit, or COPD-related hospitalization, with an estimated hazard ratio of 0.965.
Data source: Multicenter, randomized, double-blind, placebo-controlled trial including 1,071 patients with moderate or severe COPD, with at least one exacerbation recorded in the last year.
Disclosures: Dr. Hanania reported being an adviser for several pharmaceutical companies, including Mylan. Four of the six authors of the study’s abstract are employees of Mylan.
Nebulized glycopyrrolate improves lung function in COPD
TORONTO – Glycopyrrolate, a novel nebulized long-acting muscarinic antagonist (LAMA) in development, was well-tolerated and significantly improved lung function and health status in COPD patients regardless of baseline lung function or age, according to a subgroup analysis of pooled results from two randomized trials.*
There are currently no nebulized LAMAs approved for use in the U.S.
Jill Ohar, MD, from Wake Forest University School of Medicine (Winston-Salem, N.C.), presented this secondary analysis of the GOLDEN-3 and GOLDEN-4 trials at the CHEST annual meeting. She and her colleagues evaluated the efficacy and safety of glycopyrrolate in patients with a forced expiratory volume 1(FEV1) % predicted of less than 50 and an FEV1 % predicted of greater than or equal to 50, in age ranges of less than 65 years, greater than or equal to 65 years and at least 75 years, as measured by trough FEV1.
Similarly, both glycopyrrolate doses produced significant (P less than .05) and clinically meaningful lung function improvements vs. placebo in participants less than 65 years of age, at least 65 years, and greater than or equal to 75 years.
Glycopyrrolate use for 12 weeks led to greater improvements over placebo in St. George’s Respiratory Questionnaire (SGRQ) total score, in patients in both lung function classes. There were a higher percentage of SGRQ responders in the treatment arms compared to placebo arms.
The highest SGRQ improvement in SGRQ (−6.287) was seen in the 47 patients that comprised the at-least-75 years of age subgroup receiving glycopyrrolate 25 mcg BID. “It’s a small number of people, but I think it’s [valuable] to see if the very aged act in any way differently than the entire greater than or equal to 65-year-old group,” said Dr. Ohar.
Adverse event rates were similar for placebo and both glycopyrrolate doses, with no safety signals seen according to baseline lung function or age. Few cardiovascular events of special interest were seen.
“Looking at major adverse cardiovascular events, such as fatal MIs, other cardiovascular deaths, arrhythmias, etc., we see nothing that would suggest that the drug overall is associated with an undue number of these versus placebo,” reported Dr. Ohar.
GOLDEN 3 and 4 were replicate, 12-week, phase 3, randomized, double-blind, placebo-controlled studies that evaluated glycopyrrolate solution administered by an investigational eFlow Close System (eFLOW CS) nebulizer in individuals with moderate-to-very severe COPD, including those with continued background use of a long-acting beta2-agonist (LABA), with or without an inhaled corticosteroid (ICS). In each of the trials, about 30% of patients were on LABA ICS, noted Dr. Ohar in her presentation. A total of 653 subjects were randomized in GOLDEN 3 and 641 in GOLDEN 4.
Its manufacturer, Sunovion Pharmaceuticals, resubmitted the product to the FDA in June 2017 in response to a Complete Response Letter received from the FDA in May 2017. The FDA is expected to act on the new submission on December 15, 2017. The novel agent is being considered for the long-term, maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema.
Dr. Ohar reported that she serves on the advisory boards of several pharmaceutical companies. The other three authors are employees of Sunovion Pharmaceuticals Inc.
*This article was updated on Nov. 6, 2017.
Eric Gartman, MD, FCCP, comments: If approved, this would represent the first nebulized LAMA available in the U.S. – so in the small population of patients that is unable to utilize standard delivery devices, this would provide an option. It is unclear if this medication must be administered via the proprietary nebulizer that was used in the study – but if so, this would certainly add to the already extremely high cost of respiratory medications and further limit access for many patients.
Eric Gartman, MD, FCCP, comments: If approved, this would represent the first nebulized LAMA available in the U.S. – so in the small population of patients that is unable to utilize standard delivery devices, this would provide an option. It is unclear if this medication must be administered via the proprietary nebulizer that was used in the study – but if so, this would certainly add to the already extremely high cost of respiratory medications and further limit access for many patients.
Eric Gartman, MD, FCCP, comments: If approved, this would represent the first nebulized LAMA available in the U.S. – so in the small population of patients that is unable to utilize standard delivery devices, this would provide an option. It is unclear if this medication must be administered via the proprietary nebulizer that was used in the study – but if so, this would certainly add to the already extremely high cost of respiratory medications and further limit access for many patients.
TORONTO – Glycopyrrolate, a novel nebulized long-acting muscarinic antagonist (LAMA) in development, was well-tolerated and significantly improved lung function and health status in COPD patients regardless of baseline lung function or age, according to a subgroup analysis of pooled results from two randomized trials.*
There are currently no nebulized LAMAs approved for use in the U.S.
Jill Ohar, MD, from Wake Forest University School of Medicine (Winston-Salem, N.C.), presented this secondary analysis of the GOLDEN-3 and GOLDEN-4 trials at the CHEST annual meeting. She and her colleagues evaluated the efficacy and safety of glycopyrrolate in patients with a forced expiratory volume 1(FEV1) % predicted of less than 50 and an FEV1 % predicted of greater than or equal to 50, in age ranges of less than 65 years, greater than or equal to 65 years and at least 75 years, as measured by trough FEV1.
Similarly, both glycopyrrolate doses produced significant (P less than .05) and clinically meaningful lung function improvements vs. placebo in participants less than 65 years of age, at least 65 years, and greater than or equal to 75 years.
Glycopyrrolate use for 12 weeks led to greater improvements over placebo in St. George’s Respiratory Questionnaire (SGRQ) total score, in patients in both lung function classes. There were a higher percentage of SGRQ responders in the treatment arms compared to placebo arms.
The highest SGRQ improvement in SGRQ (−6.287) was seen in the 47 patients that comprised the at-least-75 years of age subgroup receiving glycopyrrolate 25 mcg BID. “It’s a small number of people, but I think it’s [valuable] to see if the very aged act in any way differently than the entire greater than or equal to 65-year-old group,” said Dr. Ohar.
Adverse event rates were similar for placebo and both glycopyrrolate doses, with no safety signals seen according to baseline lung function or age. Few cardiovascular events of special interest were seen.
“Looking at major adverse cardiovascular events, such as fatal MIs, other cardiovascular deaths, arrhythmias, etc., we see nothing that would suggest that the drug overall is associated with an undue number of these versus placebo,” reported Dr. Ohar.
GOLDEN 3 and 4 were replicate, 12-week, phase 3, randomized, double-blind, placebo-controlled studies that evaluated glycopyrrolate solution administered by an investigational eFlow Close System (eFLOW CS) nebulizer in individuals with moderate-to-very severe COPD, including those with continued background use of a long-acting beta2-agonist (LABA), with or without an inhaled corticosteroid (ICS). In each of the trials, about 30% of patients were on LABA ICS, noted Dr. Ohar in her presentation. A total of 653 subjects were randomized in GOLDEN 3 and 641 in GOLDEN 4.
Its manufacturer, Sunovion Pharmaceuticals, resubmitted the product to the FDA in June 2017 in response to a Complete Response Letter received from the FDA in May 2017. The FDA is expected to act on the new submission on December 15, 2017. The novel agent is being considered for the long-term, maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema.
Dr. Ohar reported that she serves on the advisory boards of several pharmaceutical companies. The other three authors are employees of Sunovion Pharmaceuticals Inc.
*This article was updated on Nov. 6, 2017.
TORONTO – Glycopyrrolate, a novel nebulized long-acting muscarinic antagonist (LAMA) in development, was well-tolerated and significantly improved lung function and health status in COPD patients regardless of baseline lung function or age, according to a subgroup analysis of pooled results from two randomized trials.*
There are currently no nebulized LAMAs approved for use in the U.S.
Jill Ohar, MD, from Wake Forest University School of Medicine (Winston-Salem, N.C.), presented this secondary analysis of the GOLDEN-3 and GOLDEN-4 trials at the CHEST annual meeting. She and her colleagues evaluated the efficacy and safety of glycopyrrolate in patients with a forced expiratory volume 1(FEV1) % predicted of less than 50 and an FEV1 % predicted of greater than or equal to 50, in age ranges of less than 65 years, greater than or equal to 65 years and at least 75 years, as measured by trough FEV1.
Similarly, both glycopyrrolate doses produced significant (P less than .05) and clinically meaningful lung function improvements vs. placebo in participants less than 65 years of age, at least 65 years, and greater than or equal to 75 years.
Glycopyrrolate use for 12 weeks led to greater improvements over placebo in St. George’s Respiratory Questionnaire (SGRQ) total score, in patients in both lung function classes. There were a higher percentage of SGRQ responders in the treatment arms compared to placebo arms.
The highest SGRQ improvement in SGRQ (−6.287) was seen in the 47 patients that comprised the at-least-75 years of age subgroup receiving glycopyrrolate 25 mcg BID. “It’s a small number of people, but I think it’s [valuable] to see if the very aged act in any way differently than the entire greater than or equal to 65-year-old group,” said Dr. Ohar.
Adverse event rates were similar for placebo and both glycopyrrolate doses, with no safety signals seen according to baseline lung function or age. Few cardiovascular events of special interest were seen.
“Looking at major adverse cardiovascular events, such as fatal MIs, other cardiovascular deaths, arrhythmias, etc., we see nothing that would suggest that the drug overall is associated with an undue number of these versus placebo,” reported Dr. Ohar.
GOLDEN 3 and 4 were replicate, 12-week, phase 3, randomized, double-blind, placebo-controlled studies that evaluated glycopyrrolate solution administered by an investigational eFlow Close System (eFLOW CS) nebulizer in individuals with moderate-to-very severe COPD, including those with continued background use of a long-acting beta2-agonist (LABA), with or without an inhaled corticosteroid (ICS). In each of the trials, about 30% of patients were on LABA ICS, noted Dr. Ohar in her presentation. A total of 653 subjects were randomized in GOLDEN 3 and 641 in GOLDEN 4.
Its manufacturer, Sunovion Pharmaceuticals, resubmitted the product to the FDA in June 2017 in response to a Complete Response Letter received from the FDA in May 2017. The FDA is expected to act on the new submission on December 15, 2017. The novel agent is being considered for the long-term, maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema.
Dr. Ohar reported that she serves on the advisory boards of several pharmaceutical companies. The other three authors are employees of Sunovion Pharmaceuticals Inc.
*This article was updated on Nov. 6, 2017.
AT CHEST 2017
Key clinical point: Nebulized glycopyrrolate improved lung function and was well tolerated irrespective of baseline lung function or age.
Major finding: Statistically and clinically meaningful improvements in trough FEV1 at 12 weeks were seen in individuals, regardless of their baseline FEV1 % predicted.
Data source: Pooled findings from 2 RCTs, GOLDEN 3 and GOLDEN 4, that together included 1,294 moderate-to-very severe COPD patients.
Disclosures: Dr. Ohar reported that she serves on the advisory boards of several pharmaceutical companies. The other three authors are employees of Sunovion Pharmaceuticals Inc.
Remimazolam surpasses midazolam for bronchoscopy sedation
TORONTO – An investigational sedative, remimazolam, that’s similar to midazolam but with faster onset and offset, resulted in significantly better procedural success compared with midazolam in a multicenter, phase III trial with 431 patients.
The results also showed that remimazolam was as safe as midazolam (Versed), with a very similar adverse event profile, said Gerard A. Silvestri, MD, FCCP, at the CHEST annual meeting.
The bronchoscopy trial enrolled patients at any of 15 U.S. centers with an American Society of Anesthesiologists (ASA) physical status classification of I-III and scheduled for diagnostic or therapeutic bronchoscopy. The enrolled patients averaged 62 years of age, and 38% were in ASA class III.
All patients received initial sedation treatment with fentanyl, followed by a three-to-one randomization to blinded remimazolam, blinded placebo that included midazolam rescue, or open-label midazolam. The study’s primary efficacy endpoint was procedural success, defined as patients who underwent the complete procedure without need for an alternative sedative and without need for more than five doses of the patient’s assigned medication within any 15 minute period during the procedure or need for more than three midazolam doses within any 12-minute period in the patients randomized to receive midazolam.
This primary endpoint occurred in 83% of 303 patients in the remimazolam arm, 5% of 59 patients in the placebo arm, and 34% of 69 patients in the midazolam arm, a statistically significant difference between the remimazolam patients and each of the comparator groups, reported Dr. Silvestri, a professor of medicine and a lung cancer pulmonologist at the Medical University of South Carolina in Charleston.
The results also demonstrated the faster inset and offset of remimazolam. Treatment achieved adequate sedation to start the procedure after a median of 5 minutes with remimazolam, a median of 15.5 minutes with midazolam, and a median of 17 minutes among patients in the placebo group. Once sedation finished, patients returned to being fully alert after a median of 6 minutes with remimazolam, a median of 12 minutes with midazolam, and a median of 13.5 minutes for patients in the placebo arm.
“What’s nice about remimazolam is that the adverse event profile is exactly the same as with placebo and midazolam, and you have a reversal agent,” the same as what’s used for midazolam, he said.
Dr. Silvestri suggested several additional studies he would like to see run on remimazolam to better understand its clinical performance and role. These include studying the drug in the elderly, patients with an ASA classification of IV, obese patients, and those on high narcotic doses. He also suggested comparing remimazolam directly with propofol, testing remimazolam as a stand-alone agent without fentanyl co-administration, and trying the drug during other pulmonary procedures such as pleural-catheter placement and other invasive procedures, and in ICU patients.
The trial was funded by Paion, the company developing remimazolam. Dr. Silvestri and Dr. Stanbrook had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
TORONTO – An investigational sedative, remimazolam, that’s similar to midazolam but with faster onset and offset, resulted in significantly better procedural success compared with midazolam in a multicenter, phase III trial with 431 patients.
The results also showed that remimazolam was as safe as midazolam (Versed), with a very similar adverse event profile, said Gerard A. Silvestri, MD, FCCP, at the CHEST annual meeting.
The bronchoscopy trial enrolled patients at any of 15 U.S. centers with an American Society of Anesthesiologists (ASA) physical status classification of I-III and scheduled for diagnostic or therapeutic bronchoscopy. The enrolled patients averaged 62 years of age, and 38% were in ASA class III.
All patients received initial sedation treatment with fentanyl, followed by a three-to-one randomization to blinded remimazolam, blinded placebo that included midazolam rescue, or open-label midazolam. The study’s primary efficacy endpoint was procedural success, defined as patients who underwent the complete procedure without need for an alternative sedative and without need for more than five doses of the patient’s assigned medication within any 15 minute period during the procedure or need for more than three midazolam doses within any 12-minute period in the patients randomized to receive midazolam.
This primary endpoint occurred in 83% of 303 patients in the remimazolam arm, 5% of 59 patients in the placebo arm, and 34% of 69 patients in the midazolam arm, a statistically significant difference between the remimazolam patients and each of the comparator groups, reported Dr. Silvestri, a professor of medicine and a lung cancer pulmonologist at the Medical University of South Carolina in Charleston.
The results also demonstrated the faster inset and offset of remimazolam. Treatment achieved adequate sedation to start the procedure after a median of 5 minutes with remimazolam, a median of 15.5 minutes with midazolam, and a median of 17 minutes among patients in the placebo group. Once sedation finished, patients returned to being fully alert after a median of 6 minutes with remimazolam, a median of 12 minutes with midazolam, and a median of 13.5 minutes for patients in the placebo arm.
“What’s nice about remimazolam is that the adverse event profile is exactly the same as with placebo and midazolam, and you have a reversal agent,” the same as what’s used for midazolam, he said.
Dr. Silvestri suggested several additional studies he would like to see run on remimazolam to better understand its clinical performance and role. These include studying the drug in the elderly, patients with an ASA classification of IV, obese patients, and those on high narcotic doses. He also suggested comparing remimazolam directly with propofol, testing remimazolam as a stand-alone agent without fentanyl co-administration, and trying the drug during other pulmonary procedures such as pleural-catheter placement and other invasive procedures, and in ICU patients.
The trial was funded by Paion, the company developing remimazolam. Dr. Silvestri and Dr. Stanbrook had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
TORONTO – An investigational sedative, remimazolam, that’s similar to midazolam but with faster onset and offset, resulted in significantly better procedural success compared with midazolam in a multicenter, phase III trial with 431 patients.
The results also showed that remimazolam was as safe as midazolam (Versed), with a very similar adverse event profile, said Gerard A. Silvestri, MD, FCCP, at the CHEST annual meeting.
The bronchoscopy trial enrolled patients at any of 15 U.S. centers with an American Society of Anesthesiologists (ASA) physical status classification of I-III and scheduled for diagnostic or therapeutic bronchoscopy. The enrolled patients averaged 62 years of age, and 38% were in ASA class III.
All patients received initial sedation treatment with fentanyl, followed by a three-to-one randomization to blinded remimazolam, blinded placebo that included midazolam rescue, or open-label midazolam. The study’s primary efficacy endpoint was procedural success, defined as patients who underwent the complete procedure without need for an alternative sedative and without need for more than five doses of the patient’s assigned medication within any 15 minute period during the procedure or need for more than three midazolam doses within any 12-minute period in the patients randomized to receive midazolam.
This primary endpoint occurred in 83% of 303 patients in the remimazolam arm, 5% of 59 patients in the placebo arm, and 34% of 69 patients in the midazolam arm, a statistically significant difference between the remimazolam patients and each of the comparator groups, reported Dr. Silvestri, a professor of medicine and a lung cancer pulmonologist at the Medical University of South Carolina in Charleston.
The results also demonstrated the faster inset and offset of remimazolam. Treatment achieved adequate sedation to start the procedure after a median of 5 minutes with remimazolam, a median of 15.5 minutes with midazolam, and a median of 17 minutes among patients in the placebo group. Once sedation finished, patients returned to being fully alert after a median of 6 minutes with remimazolam, a median of 12 minutes with midazolam, and a median of 13.5 minutes for patients in the placebo arm.
“What’s nice about remimazolam is that the adverse event profile is exactly the same as with placebo and midazolam, and you have a reversal agent,” the same as what’s used for midazolam, he said.
Dr. Silvestri suggested several additional studies he would like to see run on remimazolam to better understand its clinical performance and role. These include studying the drug in the elderly, patients with an ASA classification of IV, obese patients, and those on high narcotic doses. He also suggested comparing remimazolam directly with propofol, testing remimazolam as a stand-alone agent without fentanyl co-administration, and trying the drug during other pulmonary procedures such as pleural-catheter placement and other invasive procedures, and in ICU patients.
The trial was funded by Paion, the company developing remimazolam. Dr. Silvestri and Dr. Stanbrook had no relevant disclosures.
[email protected]
On Twitter @mitchelzoler
AT CHEST 2017
Key clinical point:
Major finding: The rate of successful bronchoscopies was 83% with remimazolam, 34% with midazolam, and 5% with placebo.
Data source: A multicenter, phase III trial with 431 patients.
Disclosures: The trial was funded by Paion, the company developing remimazolam. Dr. Silvestri and Dr. Stanbrook had no relevant disclosures.
IGRA preferred test for latent TB diagnosis
TORONTO – U.S.-based pulmonary and infectious disease specialists prefer interferon-gamma release assays (IGRA) over tuberculin skin tests (TST) for the diagnosis of latent TB infection, but may not fully understand how to use and interpret the test results, according to survey results presented at the CHEST annual meeting.
Adam G. Green, MD, conducted the research while he was a fellow in pulmonology/critical care at Montefiore Medical Center in New York. Dr. Green told attendees that about one-third of the world’s population are infected with TB and about 15 million of those live in the United States. Two-thirds of U.S. cases are seen in foreign-born individuals and are clustered in four states—New, York, California, Florida, and Texas.
Among 304 clinicians who responded to an invitation to an online questionnaire, 78% said they preferred to use IGRA over TST and 91% said they had a “good understanding” of how to use and interpret IGRA. However, when queried further on how to best use and interpret IGRAs according to current guidelines, their answers to 11 knowledge-based questions told a somewhat different story, said Dr. Green, who is an intensivist at Cooper University Health Care in Camden, N.J.
While 96% knew IGRAs are not helpful in monitoring response to TB treatment, 20% erroneously thought that a positive IGRA predicts latent TB infection reactivation in the future.
Most respondents correctly answered two “fundamental” questions on cross-reactivity of IGRAs with Mycobacterium avium complex and bacilli Calmette-Guérin (BCG) vaccination (84% and 96%, respectively). “While 80% sounds good, I think we’re talking about ID and pulmonary docs at the best institutions across the United States, so I would have expected much higher,” Dr. Green said.
Only one-third of respondents knew that the T-SPOT.TB test, an IGRA, had the highest sensitivity for identifying those with latent TB infection. And only about half were able to appropriately identify the need to initiate therapy for latent TB in a scenario in which the patient was at “high risk for latent tuberculosis with a positive tuberculin skin test and a negative interferon-gamma release assay.”
Fellows comprised 42.5% of respondents and the remainder were attendings of varying levels of seniority. About half of respondents were pulmonologists and the other half infectious disease specialists. The majority (91%) were practicing or training in university hospitals.
One major limitation of the study, said Dr. Green, is the low response rate. “I would have liked 3,000 responses,” he said, rather than just over 300.
To disseminate the questionnaire, he contacted pulmonary and infectious disease academic program directors and coordinators and asked them to forward the survey invitation to their full-time faculty and fellows. Dr. Green also acknowledged that his project missed those physicians not working in academic centers.
“I would like to think that the reason people didn’t do as well as I had hoped is because of the conflicting literature out there and using not necessarily the guidelines but rather their current knowledge on what was most recently published,” said Dr. Green. “But maybe there is a true misunderstanding.”
The authors reported there were no product or funding disclosures relevant to this study.
TORONTO – U.S.-based pulmonary and infectious disease specialists prefer interferon-gamma release assays (IGRA) over tuberculin skin tests (TST) for the diagnosis of latent TB infection, but may not fully understand how to use and interpret the test results, according to survey results presented at the CHEST annual meeting.
Adam G. Green, MD, conducted the research while he was a fellow in pulmonology/critical care at Montefiore Medical Center in New York. Dr. Green told attendees that about one-third of the world’s population are infected with TB and about 15 million of those live in the United States. Two-thirds of U.S. cases are seen in foreign-born individuals and are clustered in four states—New, York, California, Florida, and Texas.
Among 304 clinicians who responded to an invitation to an online questionnaire, 78% said they preferred to use IGRA over TST and 91% said they had a “good understanding” of how to use and interpret IGRA. However, when queried further on how to best use and interpret IGRAs according to current guidelines, their answers to 11 knowledge-based questions told a somewhat different story, said Dr. Green, who is an intensivist at Cooper University Health Care in Camden, N.J.
While 96% knew IGRAs are not helpful in monitoring response to TB treatment, 20% erroneously thought that a positive IGRA predicts latent TB infection reactivation in the future.
Most respondents correctly answered two “fundamental” questions on cross-reactivity of IGRAs with Mycobacterium avium complex and bacilli Calmette-Guérin (BCG) vaccination (84% and 96%, respectively). “While 80% sounds good, I think we’re talking about ID and pulmonary docs at the best institutions across the United States, so I would have expected much higher,” Dr. Green said.
Only one-third of respondents knew that the T-SPOT.TB test, an IGRA, had the highest sensitivity for identifying those with latent TB infection. And only about half were able to appropriately identify the need to initiate therapy for latent TB in a scenario in which the patient was at “high risk for latent tuberculosis with a positive tuberculin skin test and a negative interferon-gamma release assay.”
Fellows comprised 42.5% of respondents and the remainder were attendings of varying levels of seniority. About half of respondents were pulmonologists and the other half infectious disease specialists. The majority (91%) were practicing or training in university hospitals.
One major limitation of the study, said Dr. Green, is the low response rate. “I would have liked 3,000 responses,” he said, rather than just over 300.
To disseminate the questionnaire, he contacted pulmonary and infectious disease academic program directors and coordinators and asked them to forward the survey invitation to their full-time faculty and fellows. Dr. Green also acknowledged that his project missed those physicians not working in academic centers.
“I would like to think that the reason people didn’t do as well as I had hoped is because of the conflicting literature out there and using not necessarily the guidelines but rather their current knowledge on what was most recently published,” said Dr. Green. “But maybe there is a true misunderstanding.”
The authors reported there were no product or funding disclosures relevant to this study.
TORONTO – U.S.-based pulmonary and infectious disease specialists prefer interferon-gamma release assays (IGRA) over tuberculin skin tests (TST) for the diagnosis of latent TB infection, but may not fully understand how to use and interpret the test results, according to survey results presented at the CHEST annual meeting.
Adam G. Green, MD, conducted the research while he was a fellow in pulmonology/critical care at Montefiore Medical Center in New York. Dr. Green told attendees that about one-third of the world’s population are infected with TB and about 15 million of those live in the United States. Two-thirds of U.S. cases are seen in foreign-born individuals and are clustered in four states—New, York, California, Florida, and Texas.
Among 304 clinicians who responded to an invitation to an online questionnaire, 78% said they preferred to use IGRA over TST and 91% said they had a “good understanding” of how to use and interpret IGRA. However, when queried further on how to best use and interpret IGRAs according to current guidelines, their answers to 11 knowledge-based questions told a somewhat different story, said Dr. Green, who is an intensivist at Cooper University Health Care in Camden, N.J.
While 96% knew IGRAs are not helpful in monitoring response to TB treatment, 20% erroneously thought that a positive IGRA predicts latent TB infection reactivation in the future.
Most respondents correctly answered two “fundamental” questions on cross-reactivity of IGRAs with Mycobacterium avium complex and bacilli Calmette-Guérin (BCG) vaccination (84% and 96%, respectively). “While 80% sounds good, I think we’re talking about ID and pulmonary docs at the best institutions across the United States, so I would have expected much higher,” Dr. Green said.
Only one-third of respondents knew that the T-SPOT.TB test, an IGRA, had the highest sensitivity for identifying those with latent TB infection. And only about half were able to appropriately identify the need to initiate therapy for latent TB in a scenario in which the patient was at “high risk for latent tuberculosis with a positive tuberculin skin test and a negative interferon-gamma release assay.”
Fellows comprised 42.5% of respondents and the remainder were attendings of varying levels of seniority. About half of respondents were pulmonologists and the other half infectious disease specialists. The majority (91%) were practicing or training in university hospitals.
One major limitation of the study, said Dr. Green, is the low response rate. “I would have liked 3,000 responses,” he said, rather than just over 300.
To disseminate the questionnaire, he contacted pulmonary and infectious disease academic program directors and coordinators and asked them to forward the survey invitation to their full-time faculty and fellows. Dr. Green also acknowledged that his project missed those physicians not working in academic centers.
“I would like to think that the reason people didn’t do as well as I had hoped is because of the conflicting literature out there and using not necessarily the guidelines but rather their current knowledge on what was most recently published,” said Dr. Green. “But maybe there is a true misunderstanding.”
The authors reported there were no product or funding disclosures relevant to this study.
AT CHEST 2017
Key clinical point: Most physicians queried preferred IGRAs over TST for the detection of latent TB infection.
Major finding: Of the 304 respondents to a survey, 78% said they preferred IGRAs over TST for TB testing and 91% reported having a good understanding of how to use and interpret IGRAs.
Data source: Online survey of 304 pulmonary and infectious disease attending physicians and fellows from U.S.-based academic programs.
Disclosures: The authors reported there were no product or funding disclosures relevant to this study.
VIDEO: Balanced crystalloids protect kidney better than saline
TORONTO – Treatment with balanced crystalloid IV fluids cut adverse renal events modestly but with statistical significance, compared with 0.9% saline in hospitalized patients in a pair of single-center randomized trials with more than 29,000 total patients.
Despite showing a number needed to treat with balanced crystalloids of roughly 100 to prevent one major renal event, compared with saline, the scope of IV fluid use makes even this relatively small improvement potentially important to tens of thousands of patients annually.
“It’s a small but clinically important difference,” Wesley H. Self, MD, said at the CHEST annual meeting.
“These fluids are used every day and in millions of patients annually in the United States and worldwide. There is no functional cost difference between them, and now we have the data to show that [balanced crystalloid fluids] produce a better patient outcome. It’s reasonable to consider changing practice,” based on the results, said Matthew W. Semler, MD, a pulmonologist at Vanderbilt University Medical Center in Nashville, Tenn., who led one of the two trials.
At Vanderbilt, where the two studies ran, “we’ve changed our practice and are transitioning from primarily using saline to primarily balanced crystalloid,” Dr. Semler said in a video interview. The main limitation to changing practice now because of the results is that the two trials both ran at a single center.
The findings Dr. Semler reported came from the Isotonic Solutions and Major Adverse Renal Events Trial (SMART), which randomized 7,860 ICU patients to treatment with 0.9% saline fluid and 7,942 ICU patients to treatment with balanced crystalloid fluid, either lactated Ringer’s or Plasma-Lyte A. The study’s primary endpoint was the combined 30-day rate of in-hospital death, incident need for renal replacement therapy, or at least a doubling of the patient’s baseline creatinine level, a marker of persistent renal dysfunction.
This outcome occurred in 14.3% of patients on balanced crystalloid fluid and 15.4% on saline, a 1.1% statistically significant absolute difference. The endpoint components showed that patients treated with balanced crystalloid had 0.8% less in-hospital death and 0.4% less incident renal replacement therapy; both of these between-group differences were close to having statistical significance. The two treatment groups showed less difference in the rate of persistent renal dysfunction.
The second trial had an identical design but ran instead in the emergency department. The Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SALT-ED) trial randomized 6,708 to receive balanced crystalloid and 6,639 to receive saline. The combined primary renal endpoint was 0.9% less frequent with balanced crystalloid fluid, a statistically significant difference, Dr. Self, an emergency medicine physician at Vanderbilt, reported at the meeting. In this study the between-group differences for both incident renal replacement therapy and persistent renal dysfunction were statistically significant in favor of balanced crystalloid, but the between-group mortality difference was not significantly different.
The reason why balanced crystalloid fluid produced better renal outcomes than saline remains unclear. Both Dr. Semler and Dr. Self noted that the two balanced crystalloid fluids used in the study have chloride levels that closely match normal plasma levels, but the chloride concentration in 0.9% saline is about 50% higher than plasma. Some researchers have hypothesized, based on animal findings, that this difference may influence inflammation, blood pressure, acute kidney injury, and renal vasoconstriction.
The SMART and SALT-ED trials received no commercial funding. Dr. Semler had no disclosures. Dr. Self has been a consultant to Abbott Point of Care, BioTest, Cempra, Ferring, Gilead, and Pfizer.
[email protected]
On Twitter @mitchelzoler
Bennett P. deBoisblanc, MD , is professor of medicine at Louisiana State University Health and director of Critical Care Services at the Medical Center of Louisiana in New Orleans. He had no disclosures. He made these comments from the floor during discussion of the two reports.
Bennett P. deBoisblanc, MD , is professor of medicine at Louisiana State University Health and director of Critical Care Services at the Medical Center of Louisiana in New Orleans. He had no disclosures. He made these comments from the floor during discussion of the two reports.
Bennett P. deBoisblanc, MD , is professor of medicine at Louisiana State University Health and director of Critical Care Services at the Medical Center of Louisiana in New Orleans. He had no disclosures. He made these comments from the floor during discussion of the two reports.
TORONTO – Treatment with balanced crystalloid IV fluids cut adverse renal events modestly but with statistical significance, compared with 0.9% saline in hospitalized patients in a pair of single-center randomized trials with more than 29,000 total patients.
Despite showing a number needed to treat with balanced crystalloids of roughly 100 to prevent one major renal event, compared with saline, the scope of IV fluid use makes even this relatively small improvement potentially important to tens of thousands of patients annually.
“It’s a small but clinically important difference,” Wesley H. Self, MD, said at the CHEST annual meeting.
“These fluids are used every day and in millions of patients annually in the United States and worldwide. There is no functional cost difference between them, and now we have the data to show that [balanced crystalloid fluids] produce a better patient outcome. It’s reasonable to consider changing practice,” based on the results, said Matthew W. Semler, MD, a pulmonologist at Vanderbilt University Medical Center in Nashville, Tenn., who led one of the two trials.
At Vanderbilt, where the two studies ran, “we’ve changed our practice and are transitioning from primarily using saline to primarily balanced crystalloid,” Dr. Semler said in a video interview. The main limitation to changing practice now because of the results is that the two trials both ran at a single center.
The findings Dr. Semler reported came from the Isotonic Solutions and Major Adverse Renal Events Trial (SMART), which randomized 7,860 ICU patients to treatment with 0.9% saline fluid and 7,942 ICU patients to treatment with balanced crystalloid fluid, either lactated Ringer’s or Plasma-Lyte A. The study’s primary endpoint was the combined 30-day rate of in-hospital death, incident need for renal replacement therapy, or at least a doubling of the patient’s baseline creatinine level, a marker of persistent renal dysfunction.
This outcome occurred in 14.3% of patients on balanced crystalloid fluid and 15.4% on saline, a 1.1% statistically significant absolute difference. The endpoint components showed that patients treated with balanced crystalloid had 0.8% less in-hospital death and 0.4% less incident renal replacement therapy; both of these between-group differences were close to having statistical significance. The two treatment groups showed less difference in the rate of persistent renal dysfunction.
The second trial had an identical design but ran instead in the emergency department. The Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SALT-ED) trial randomized 6,708 to receive balanced crystalloid and 6,639 to receive saline. The combined primary renal endpoint was 0.9% less frequent with balanced crystalloid fluid, a statistically significant difference, Dr. Self, an emergency medicine physician at Vanderbilt, reported at the meeting. In this study the between-group differences for both incident renal replacement therapy and persistent renal dysfunction were statistically significant in favor of balanced crystalloid, but the between-group mortality difference was not significantly different.
The reason why balanced crystalloid fluid produced better renal outcomes than saline remains unclear. Both Dr. Semler and Dr. Self noted that the two balanced crystalloid fluids used in the study have chloride levels that closely match normal plasma levels, but the chloride concentration in 0.9% saline is about 50% higher than plasma. Some researchers have hypothesized, based on animal findings, that this difference may influence inflammation, blood pressure, acute kidney injury, and renal vasoconstriction.
The SMART and SALT-ED trials received no commercial funding. Dr. Semler had no disclosures. Dr. Self has been a consultant to Abbott Point of Care, BioTest, Cempra, Ferring, Gilead, and Pfizer.
[email protected]
On Twitter @mitchelzoler
TORONTO – Treatment with balanced crystalloid IV fluids cut adverse renal events modestly but with statistical significance, compared with 0.9% saline in hospitalized patients in a pair of single-center randomized trials with more than 29,000 total patients.
Despite showing a number needed to treat with balanced crystalloids of roughly 100 to prevent one major renal event, compared with saline, the scope of IV fluid use makes even this relatively small improvement potentially important to tens of thousands of patients annually.
“It’s a small but clinically important difference,” Wesley H. Self, MD, said at the CHEST annual meeting.
“These fluids are used every day and in millions of patients annually in the United States and worldwide. There is no functional cost difference between them, and now we have the data to show that [balanced crystalloid fluids] produce a better patient outcome. It’s reasonable to consider changing practice,” based on the results, said Matthew W. Semler, MD, a pulmonologist at Vanderbilt University Medical Center in Nashville, Tenn., who led one of the two trials.
At Vanderbilt, where the two studies ran, “we’ve changed our practice and are transitioning from primarily using saline to primarily balanced crystalloid,” Dr. Semler said in a video interview. The main limitation to changing practice now because of the results is that the two trials both ran at a single center.
The findings Dr. Semler reported came from the Isotonic Solutions and Major Adverse Renal Events Trial (SMART), which randomized 7,860 ICU patients to treatment with 0.9% saline fluid and 7,942 ICU patients to treatment with balanced crystalloid fluid, either lactated Ringer’s or Plasma-Lyte A. The study’s primary endpoint was the combined 30-day rate of in-hospital death, incident need for renal replacement therapy, or at least a doubling of the patient’s baseline creatinine level, a marker of persistent renal dysfunction.
This outcome occurred in 14.3% of patients on balanced crystalloid fluid and 15.4% on saline, a 1.1% statistically significant absolute difference. The endpoint components showed that patients treated with balanced crystalloid had 0.8% less in-hospital death and 0.4% less incident renal replacement therapy; both of these between-group differences were close to having statistical significance. The two treatment groups showed less difference in the rate of persistent renal dysfunction.
The second trial had an identical design but ran instead in the emergency department. The Saline Against Lactated Ringers or Plasmalyte in the Emergency Department (SALT-ED) trial randomized 6,708 to receive balanced crystalloid and 6,639 to receive saline. The combined primary renal endpoint was 0.9% less frequent with balanced crystalloid fluid, a statistically significant difference, Dr. Self, an emergency medicine physician at Vanderbilt, reported at the meeting. In this study the between-group differences for both incident renal replacement therapy and persistent renal dysfunction were statistically significant in favor of balanced crystalloid, but the between-group mortality difference was not significantly different.
The reason why balanced crystalloid fluid produced better renal outcomes than saline remains unclear. Both Dr. Semler and Dr. Self noted that the two balanced crystalloid fluids used in the study have chloride levels that closely match normal plasma levels, but the chloride concentration in 0.9% saline is about 50% higher than plasma. Some researchers have hypothesized, based on animal findings, that this difference may influence inflammation, blood pressure, acute kidney injury, and renal vasoconstriction.
The SMART and SALT-ED trials received no commercial funding. Dr. Semler had no disclosures. Dr. Self has been a consultant to Abbott Point of Care, BioTest, Cempra, Ferring, Gilead, and Pfizer.
[email protected]
On Twitter @mitchelzoler
AT CHEST 2017
Key clinical point:
Major finding: Balanced crystalloids reduced combined adverse renal events by 1.1% in ICU patients and 0.9% in ED patients.
Data source: The SMART and SALT-ED trials, both single-center studies with a total of 29,149 patients.
Disclosures: The SMART and SALT-ED trials received no commercial funding. Dr. Semler had no disclosures. Dr. Self has been a consultant to Abbott Point of Care, BioTest, Cempra, Ferring, Gilead, and Pfizer.
Cardiogenic shock boosts PAH readmissions 10-fold
TORONTO – Cardiogenic shock, acute kidney injury, and chronic obstructive pulmonary disease were the top drivers of 30-day rehospitalizations in U.S. patients after an index hospitalization for pulmonary artery hypertension, based on an analysis of U.S. national data from 2013.
An episode of cardiogenic shock boosted 30-day rehospitalizations nearly 10-fold in recently discharged pulmonary artery hypertension (PAH) patients. A history of chronic obstructive pulmonary disease (COPD) linked with a threefold higher rehospitalization rate, and acute kidney injury linked with a doubled number of 30-day rehospitalizations, Kshitij Chatterjee, MD, said at the CHEST annual meeting.
The powerful impact of cardiogenic shock in particular suggests that interventions that improve patient compliance with stabilizing treatments following an index PAH hospitalization might be effective at preventing a patient’s quick return to the hospital. Contacting PAH patients a week after their index hospitalization discharge to make sure they are compliant with their diuretic regimen, for example, might help prevent a decompensation that then leads to cardiogenic shock and a return trip to the hospital, Dr. Chatterjee suggested.
Follow-up of PAH patients after an index hospitalization “is probably the single most important thing, because it can help with compliance,” he said in an interview.
The rehospitalizations he studied could be for any cause. His analysis showed that the most common cause of rehospitalization was heart failure, which caused 23% of the rehospitalizations, followed by pulmonary hypertension that caused 20%, and acute kidney injury, responsible for 11% of the 30-day rehospitalizations.
Dr. Chatterjee’s study used data collected during 2013 in the National Readmissions Database, run by the federal Agency for Healthcare Quality and Research. During that period, 776 patients entered a U.S. hospital with a primary diagnosis of PAH. During the 30 days following discharge, 114 (15%) returned to the hospital. During the second hospitalization 8% died, and the median length of stay for those who remained alive was 7 days.
Dr. Chatterjee highlighted that the modest number of index hospitalizations for PAH, as well as 30-day rehospitalizations he found in 2013, make it highly unlikely that PAH rehospitalizations will become a target for Medicare penalties as has been done for heart failure, pneumonia, COPD, and a few other disorders. But he stressed that patients with PAH who need rehospitalization generally have a highly compromised quality of life that potentially could be avoided by better management, which could prevent the need for rehospitalization.
Dr. Chatterjee had no disclosures.
[email protected]
On Twitter @mitchelzoler
TORONTO – Cardiogenic shock, acute kidney injury, and chronic obstructive pulmonary disease were the top drivers of 30-day rehospitalizations in U.S. patients after an index hospitalization for pulmonary artery hypertension, based on an analysis of U.S. national data from 2013.
An episode of cardiogenic shock boosted 30-day rehospitalizations nearly 10-fold in recently discharged pulmonary artery hypertension (PAH) patients. A history of chronic obstructive pulmonary disease (COPD) linked with a threefold higher rehospitalization rate, and acute kidney injury linked with a doubled number of 30-day rehospitalizations, Kshitij Chatterjee, MD, said at the CHEST annual meeting.
The powerful impact of cardiogenic shock in particular suggests that interventions that improve patient compliance with stabilizing treatments following an index PAH hospitalization might be effective at preventing a patient’s quick return to the hospital. Contacting PAH patients a week after their index hospitalization discharge to make sure they are compliant with their diuretic regimen, for example, might help prevent a decompensation that then leads to cardiogenic shock and a return trip to the hospital, Dr. Chatterjee suggested.
Follow-up of PAH patients after an index hospitalization “is probably the single most important thing, because it can help with compliance,” he said in an interview.
The rehospitalizations he studied could be for any cause. His analysis showed that the most common cause of rehospitalization was heart failure, which caused 23% of the rehospitalizations, followed by pulmonary hypertension that caused 20%, and acute kidney injury, responsible for 11% of the 30-day rehospitalizations.
Dr. Chatterjee’s study used data collected during 2013 in the National Readmissions Database, run by the federal Agency for Healthcare Quality and Research. During that period, 776 patients entered a U.S. hospital with a primary diagnosis of PAH. During the 30 days following discharge, 114 (15%) returned to the hospital. During the second hospitalization 8% died, and the median length of stay for those who remained alive was 7 days.
Dr. Chatterjee highlighted that the modest number of index hospitalizations for PAH, as well as 30-day rehospitalizations he found in 2013, make it highly unlikely that PAH rehospitalizations will become a target for Medicare penalties as has been done for heart failure, pneumonia, COPD, and a few other disorders. But he stressed that patients with PAH who need rehospitalization generally have a highly compromised quality of life that potentially could be avoided by better management, which could prevent the need for rehospitalization.
Dr. Chatterjee had no disclosures.
[email protected]
On Twitter @mitchelzoler
TORONTO – Cardiogenic shock, acute kidney injury, and chronic obstructive pulmonary disease were the top drivers of 30-day rehospitalizations in U.S. patients after an index hospitalization for pulmonary artery hypertension, based on an analysis of U.S. national data from 2013.
An episode of cardiogenic shock boosted 30-day rehospitalizations nearly 10-fold in recently discharged pulmonary artery hypertension (PAH) patients. A history of chronic obstructive pulmonary disease (COPD) linked with a threefold higher rehospitalization rate, and acute kidney injury linked with a doubled number of 30-day rehospitalizations, Kshitij Chatterjee, MD, said at the CHEST annual meeting.
The powerful impact of cardiogenic shock in particular suggests that interventions that improve patient compliance with stabilizing treatments following an index PAH hospitalization might be effective at preventing a patient’s quick return to the hospital. Contacting PAH patients a week after their index hospitalization discharge to make sure they are compliant with their diuretic regimen, for example, might help prevent a decompensation that then leads to cardiogenic shock and a return trip to the hospital, Dr. Chatterjee suggested.
Follow-up of PAH patients after an index hospitalization “is probably the single most important thing, because it can help with compliance,” he said in an interview.
The rehospitalizations he studied could be for any cause. His analysis showed that the most common cause of rehospitalization was heart failure, which caused 23% of the rehospitalizations, followed by pulmonary hypertension that caused 20%, and acute kidney injury, responsible for 11% of the 30-day rehospitalizations.
Dr. Chatterjee’s study used data collected during 2013 in the National Readmissions Database, run by the federal Agency for Healthcare Quality and Research. During that period, 776 patients entered a U.S. hospital with a primary diagnosis of PAH. During the 30 days following discharge, 114 (15%) returned to the hospital. During the second hospitalization 8% died, and the median length of stay for those who remained alive was 7 days.
Dr. Chatterjee highlighted that the modest number of index hospitalizations for PAH, as well as 30-day rehospitalizations he found in 2013, make it highly unlikely that PAH rehospitalizations will become a target for Medicare penalties as has been done for heart failure, pneumonia, COPD, and a few other disorders. But he stressed that patients with PAH who need rehospitalization generally have a highly compromised quality of life that potentially could be avoided by better management, which could prevent the need for rehospitalization.
Dr. Chatterjee had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT CHEST 2017
Key clinical point:
Major finding: Patients with cardiogenic shock following PAH hospitalization had a 9.7-fold increased rate of 30-day rehospitalization, compared with patients without shock.
Data source: The National Readmissions Database, which included 776 index U.S. hospitalizations for pulmonary arterial hospitalization during 2013.
Disclosures: Dr. Chatterjee had no disclosures.
Lung recovery high after ECMO in near-fatal pediatric asthma
TORONTO – Extracorporeal membrane oxygenation (ECMO) is associated with lung recovery rates as high as 90% in pediatric patients with near-fatal asthma, but the risk of complications was also high and the cannulation technique employed made a significant difference to outcomes, according to a study presented at the CHEST annual meeting.
“ECMO for near-fatal asthma is a potentially life-saving intervention, however, clinicians should be aware of the potentially severe complications, particularly with veno-arterial cannulation in this population,” said Rebecca Kohlberg-Davis, MD, a pediatric resident at Connecticut Children’s Medical Center, Hartford.
ECMO is being used increasingly in the setting of near-fatal pediatric asthma but there are limited data on outcomes in this population. Dr. Kohlberg-Davis and her colleagues conducted a retrospective analysis of all children with asthma who were treated with ECMO using the Extracorporeal Life Support Organization (ELSO) registry.
Between 1988 and 2016, 371 children with status asthmaticus underwent ECMO cannulation using one of two methods. Sixty-five percent were treated with ECMO using veno-venous (VV) cannulation and 33% were treated using veno-arterial (VA) cannulation. Both VV and VA require insertion of a cannula to take deoxygenated blood from a central vein or the right atrium. VA ECMO returns the oxygenated blood, under pressure, to the arterial side of the circulation (typically to the aorta), supporting cardiac output, while VV ECMO returns oxygenated blood back to a large vein and does not support circulation.
The median age of the study participants was 7.5 years and 56% were male. The median ECMO run duration was 123 hours.
Overall, lung recovery was seen in 83% of patients, and 77% were discharged from the hospital. Of the children who received VV cannulation, 90% experienced lung recovery, while VA cannulation was associated with only a 69% rate of lung recovery and significantly more complications. Among those who experienced lung recovery, those who received VV cannulation had a 3.6-fold higher likelihood of survival (P = .006), Dr. Kohlberg-Davis reported.
At presentation, 88% of patients had hypercarbic respiratory failure, 34% had hypoxemic respiratory failure, and 27% had mixed respiratory failure. Children with hypercarbic respiratory failure were more likely to receive VV cannulation (P = .003), while children with hypoxemic or combined respiratory failure were more likely to receive VA cannulation. Those with hypoxemic respiratory failure had a significantly lower likelihood of lung recovery (odds ratio, 4.9; P less than .0001), she said.
Eighty percent of runs were associated with one or more complications and 20% had three or more complications. Of that 80%, most involved cardiovascular complications (53%), while 36% were hemorrhagic and 35% were mechanical. The most common cardiovascular complications included the need for inotropic support (in 39% of patients) and hypertension requiring vasodilators (in 18% of patients). The most common hemorrhagic complications were cannula-site bleeding (23%) and surgical-site bleeding (8%), while mechanical complications were mostly clots (19%) and cannulation problems (12%).
Children who received VA cannulation had a significantly higher rate of neurologic complications, compared with those who received VV cannulation (22% vs. 5%), and these included cerebral hemorrhage or infarct in 6% and clinical brain death in 5%.
“If early cannulation with VV ECMO could prevent the need for VA ECMO, this might lead to lower neurological complication and increased survival,” said Dr. Kohlberg-Davis. Current guidelines recommend considering cannulation at an oxygenation index – used to measure the fraction of inspired oxygen and its usage within the body – between 40 and 60. This study suggests that initiating cannulation at a lower OI is associated with better outcomes and fewer complications, she said.
The authors reported having nothing to disclose.
This is a large study looking at the use of extracorporeal membrane oxygenation (ECMO) patients dying of status asthmaticus. It is interesting that the pCO2 seemed to predict the type of ECMO used and outcomes. Of course, an ounce of prevention (i.e., appropriate asthma management) is the most important thing to say about any pediatric intensive care unit asthma study! Having said all of this, we have known that venovenous ECMO is preferred for a long time.
This is a large study looking at the use of extracorporeal membrane oxygenation (ECMO) patients dying of status asthmaticus. It is interesting that the pCO2 seemed to predict the type of ECMO used and outcomes. Of course, an ounce of prevention (i.e., appropriate asthma management) is the most important thing to say about any pediatric intensive care unit asthma study! Having said all of this, we have known that venovenous ECMO is preferred for a long time.
This is a large study looking at the use of extracorporeal membrane oxygenation (ECMO) patients dying of status asthmaticus. It is interesting that the pCO2 seemed to predict the type of ECMO used and outcomes. Of course, an ounce of prevention (i.e., appropriate asthma management) is the most important thing to say about any pediatric intensive care unit asthma study! Having said all of this, we have known that venovenous ECMO is preferred for a long time.
TORONTO – Extracorporeal membrane oxygenation (ECMO) is associated with lung recovery rates as high as 90% in pediatric patients with near-fatal asthma, but the risk of complications was also high and the cannulation technique employed made a significant difference to outcomes, according to a study presented at the CHEST annual meeting.
“ECMO for near-fatal asthma is a potentially life-saving intervention, however, clinicians should be aware of the potentially severe complications, particularly with veno-arterial cannulation in this population,” said Rebecca Kohlberg-Davis, MD, a pediatric resident at Connecticut Children’s Medical Center, Hartford.
ECMO is being used increasingly in the setting of near-fatal pediatric asthma but there are limited data on outcomes in this population. Dr. Kohlberg-Davis and her colleagues conducted a retrospective analysis of all children with asthma who were treated with ECMO using the Extracorporeal Life Support Organization (ELSO) registry.
Between 1988 and 2016, 371 children with status asthmaticus underwent ECMO cannulation using one of two methods. Sixty-five percent were treated with ECMO using veno-venous (VV) cannulation and 33% were treated using veno-arterial (VA) cannulation. Both VV and VA require insertion of a cannula to take deoxygenated blood from a central vein or the right atrium. VA ECMO returns the oxygenated blood, under pressure, to the arterial side of the circulation (typically to the aorta), supporting cardiac output, while VV ECMO returns oxygenated blood back to a large vein and does not support circulation.
The median age of the study participants was 7.5 years and 56% were male. The median ECMO run duration was 123 hours.
Overall, lung recovery was seen in 83% of patients, and 77% were discharged from the hospital. Of the children who received VV cannulation, 90% experienced lung recovery, while VA cannulation was associated with only a 69% rate of lung recovery and significantly more complications. Among those who experienced lung recovery, those who received VV cannulation had a 3.6-fold higher likelihood of survival (P = .006), Dr. Kohlberg-Davis reported.
At presentation, 88% of patients had hypercarbic respiratory failure, 34% had hypoxemic respiratory failure, and 27% had mixed respiratory failure. Children with hypercarbic respiratory failure were more likely to receive VV cannulation (P = .003), while children with hypoxemic or combined respiratory failure were more likely to receive VA cannulation. Those with hypoxemic respiratory failure had a significantly lower likelihood of lung recovery (odds ratio, 4.9; P less than .0001), she said.
Eighty percent of runs were associated with one or more complications and 20% had three or more complications. Of that 80%, most involved cardiovascular complications (53%), while 36% were hemorrhagic and 35% were mechanical. The most common cardiovascular complications included the need for inotropic support (in 39% of patients) and hypertension requiring vasodilators (in 18% of patients). The most common hemorrhagic complications were cannula-site bleeding (23%) and surgical-site bleeding (8%), while mechanical complications were mostly clots (19%) and cannulation problems (12%).
Children who received VA cannulation had a significantly higher rate of neurologic complications, compared with those who received VV cannulation (22% vs. 5%), and these included cerebral hemorrhage or infarct in 6% and clinical brain death in 5%.
“If early cannulation with VV ECMO could prevent the need for VA ECMO, this might lead to lower neurological complication and increased survival,” said Dr. Kohlberg-Davis. Current guidelines recommend considering cannulation at an oxygenation index – used to measure the fraction of inspired oxygen and its usage within the body – between 40 and 60. This study suggests that initiating cannulation at a lower OI is associated with better outcomes and fewer complications, she said.
The authors reported having nothing to disclose.
TORONTO – Extracorporeal membrane oxygenation (ECMO) is associated with lung recovery rates as high as 90% in pediatric patients with near-fatal asthma, but the risk of complications was also high and the cannulation technique employed made a significant difference to outcomes, according to a study presented at the CHEST annual meeting.
“ECMO for near-fatal asthma is a potentially life-saving intervention, however, clinicians should be aware of the potentially severe complications, particularly with veno-arterial cannulation in this population,” said Rebecca Kohlberg-Davis, MD, a pediatric resident at Connecticut Children’s Medical Center, Hartford.
ECMO is being used increasingly in the setting of near-fatal pediatric asthma but there are limited data on outcomes in this population. Dr. Kohlberg-Davis and her colleagues conducted a retrospective analysis of all children with asthma who were treated with ECMO using the Extracorporeal Life Support Organization (ELSO) registry.
Between 1988 and 2016, 371 children with status asthmaticus underwent ECMO cannulation using one of two methods. Sixty-five percent were treated with ECMO using veno-venous (VV) cannulation and 33% were treated using veno-arterial (VA) cannulation. Both VV and VA require insertion of a cannula to take deoxygenated blood from a central vein or the right atrium. VA ECMO returns the oxygenated blood, under pressure, to the arterial side of the circulation (typically to the aorta), supporting cardiac output, while VV ECMO returns oxygenated blood back to a large vein and does not support circulation.
The median age of the study participants was 7.5 years and 56% were male. The median ECMO run duration was 123 hours.
Overall, lung recovery was seen in 83% of patients, and 77% were discharged from the hospital. Of the children who received VV cannulation, 90% experienced lung recovery, while VA cannulation was associated with only a 69% rate of lung recovery and significantly more complications. Among those who experienced lung recovery, those who received VV cannulation had a 3.6-fold higher likelihood of survival (P = .006), Dr. Kohlberg-Davis reported.
At presentation, 88% of patients had hypercarbic respiratory failure, 34% had hypoxemic respiratory failure, and 27% had mixed respiratory failure. Children with hypercarbic respiratory failure were more likely to receive VV cannulation (P = .003), while children with hypoxemic or combined respiratory failure were more likely to receive VA cannulation. Those with hypoxemic respiratory failure had a significantly lower likelihood of lung recovery (odds ratio, 4.9; P less than .0001), she said.
Eighty percent of runs were associated with one or more complications and 20% had three or more complications. Of that 80%, most involved cardiovascular complications (53%), while 36% were hemorrhagic and 35% were mechanical. The most common cardiovascular complications included the need for inotropic support (in 39% of patients) and hypertension requiring vasodilators (in 18% of patients). The most common hemorrhagic complications were cannula-site bleeding (23%) and surgical-site bleeding (8%), while mechanical complications were mostly clots (19%) and cannulation problems (12%).
Children who received VA cannulation had a significantly higher rate of neurologic complications, compared with those who received VV cannulation (22% vs. 5%), and these included cerebral hemorrhage or infarct in 6% and clinical brain death in 5%.
“If early cannulation with VV ECMO could prevent the need for VA ECMO, this might lead to lower neurological complication and increased survival,” said Dr. Kohlberg-Davis. Current guidelines recommend considering cannulation at an oxygenation index – used to measure the fraction of inspired oxygen and its usage within the body – between 40 and 60. This study suggests that initiating cannulation at a lower OI is associated with better outcomes and fewer complications, she said.
The authors reported having nothing to disclose.
AT CHEST 2017
Key clinical point: ECMO is a life-saving option in children with asthma, but it is associated with significant complications.
Major finding: The use of ECMO resulted in lung recovery in 83% of pediatric patients with near-fatal asthma; 77% were discharged from the hospital.
Data source: Retrospective analysis of children with asthma treated with ECMO in the Extracorporeal Life Support Organization (ELSO) registry (n = 371).
Disclosures: The authors reported having nothing to disclose.
VIDEO: Rapid influenza test obviates empiric antivirals
TORONTO – A test that only requires a maximum 2-hour wait for results was highly accurate at detecting influenza and respiratory syncytial virus infection in lung transplant patients, according to research presented at the CHEST annual meeting on Oct. 30.
This rapid and highly accurate test for detecting three common respiratory viruses has dramatically cut the need for empiric treatments and the risk for causing nosocomial infections in lung transplant patients who develop severe upper respiratory infections, Macé M. Schuurmans, MD, noted during the presentation.
This study involved 100 consecutive lung transplant patients who presented at Zurich University Hospital with signs of severe upper respiratory infection. The researchers ran the rapid and standard diagnostic tests for each patient and found that, relative to the standard test, the rapid test had positive and negative predictive values of 95%.
The number of empiric treatments with oseltamivir (Tamiflu) and ribavirin to treat a suspected influenza or respiratory syncytial virus infection (RSV) has “strongly diminished” by about two-thirds, noted Dr. Schuurmans, who is a pulmonologist at the hospital.
Until the rapid test became available, Dr. Shuurmans and his associates used a standard polymerase chain reaction test that takes 36-48 hours to yield a result. Using this test made treating patients empirically with oseltamivir and oral antibiotics for a couple of days a necessity, he said in a video interview. The older test also required isolating patients to avoid the potential spread of influenza or RSV in the hospital.
The rapid test, which became available for U.S. use in early 2017, covers influenza A and B and RSV in a single test with a single mouth-swab specimen.
“We now routinely use the rapid test and don’t prescribe empiric antivirals or antibiotics as often,” Dr. Schuurmans said. “There is much less drug cost and fewer potential adverse effects from empiric treatment.” Specimens still also undergo conventional testing, however, because that can identify eight additional viruses that the rapid test doesn’t cover.
Dr. Schuurmans acknowledged that further study needs to assess the cost-benefit of the rapid test to confirm that its added expense is offset by reduced expenses for empiric treatment and hospital isolation.
He had no disclosures. The study received no commercial support.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
TORONTO – A test that only requires a maximum 2-hour wait for results was highly accurate at detecting influenza and respiratory syncytial virus infection in lung transplant patients, according to research presented at the CHEST annual meeting on Oct. 30.
This rapid and highly accurate test for detecting three common respiratory viruses has dramatically cut the need for empiric treatments and the risk for causing nosocomial infections in lung transplant patients who develop severe upper respiratory infections, Macé M. Schuurmans, MD, noted during the presentation.
This study involved 100 consecutive lung transplant patients who presented at Zurich University Hospital with signs of severe upper respiratory infection. The researchers ran the rapid and standard diagnostic tests for each patient and found that, relative to the standard test, the rapid test had positive and negative predictive values of 95%.
The number of empiric treatments with oseltamivir (Tamiflu) and ribavirin to treat a suspected influenza or respiratory syncytial virus infection (RSV) has “strongly diminished” by about two-thirds, noted Dr. Schuurmans, who is a pulmonologist at the hospital.
Until the rapid test became available, Dr. Shuurmans and his associates used a standard polymerase chain reaction test that takes 36-48 hours to yield a result. Using this test made treating patients empirically with oseltamivir and oral antibiotics for a couple of days a necessity, he said in a video interview. The older test also required isolating patients to avoid the potential spread of influenza or RSV in the hospital.
The rapid test, which became available for U.S. use in early 2017, covers influenza A and B and RSV in a single test with a single mouth-swab specimen.
“We now routinely use the rapid test and don’t prescribe empiric antivirals or antibiotics as often,” Dr. Schuurmans said. “There is much less drug cost and fewer potential adverse effects from empiric treatment.” Specimens still also undergo conventional testing, however, because that can identify eight additional viruses that the rapid test doesn’t cover.
Dr. Schuurmans acknowledged that further study needs to assess the cost-benefit of the rapid test to confirm that its added expense is offset by reduced expenses for empiric treatment and hospital isolation.
He had no disclosures. The study received no commercial support.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
TORONTO – A test that only requires a maximum 2-hour wait for results was highly accurate at detecting influenza and respiratory syncytial virus infection in lung transplant patients, according to research presented at the CHEST annual meeting on Oct. 30.
This rapid and highly accurate test for detecting three common respiratory viruses has dramatically cut the need for empiric treatments and the risk for causing nosocomial infections in lung transplant patients who develop severe upper respiratory infections, Macé M. Schuurmans, MD, noted during the presentation.
This study involved 100 consecutive lung transplant patients who presented at Zurich University Hospital with signs of severe upper respiratory infection. The researchers ran the rapid and standard diagnostic tests for each patient and found that, relative to the standard test, the rapid test had positive and negative predictive values of 95%.
The number of empiric treatments with oseltamivir (Tamiflu) and ribavirin to treat a suspected influenza or respiratory syncytial virus infection (RSV) has “strongly diminished” by about two-thirds, noted Dr. Schuurmans, who is a pulmonologist at the hospital.
Until the rapid test became available, Dr. Shuurmans and his associates used a standard polymerase chain reaction test that takes 36-48 hours to yield a result. Using this test made treating patients empirically with oseltamivir and oral antibiotics for a couple of days a necessity, he said in a video interview. The older test also required isolating patients to avoid the potential spread of influenza or RSV in the hospital.
The rapid test, which became available for U.S. use in early 2017, covers influenza A and B and RSV in a single test with a single mouth-swab specimen.
“We now routinely use the rapid test and don’t prescribe empiric antivirals or antibiotics as often,” Dr. Schuurmans said. “There is much less drug cost and fewer potential adverse effects from empiric treatment.” Specimens still also undergo conventional testing, however, because that can identify eight additional viruses that the rapid test doesn’t cover.
Dr. Schuurmans acknowledged that further study needs to assess the cost-benefit of the rapid test to confirm that its added expense is offset by reduced expenses for empiric treatment and hospital isolation.
He had no disclosures. The study received no commercial support.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
AT CHEST 2017
Key clinical point:
Major finding: The rapid test had positive and negative predictive values of 95%.
Data source: A single-center observational study of 100 consecutive lung transplant recipients who presented with severe, acute respiratory infection.
Disclosures: Dr. Schuurmans had no disclosures. The study received no commercial support.
Bag-mask ventilation for CPR deflates in large RCT
BARCELONA – Bag-mask ventilation for airway management during resuscitation of patients with out-of-hospital cardiac arrest was considerably less safe and yet no more effective than endotracheal intubation in a large randomized trial, Frederic Adnet, MD, reported at the annual congress of the European Society of Cardiology.
This was an unexpected result.
Several large, well-respected observational registry studies had strongly suggested that bag-mask ventilation is associated with a superior survival rate with good neurologic outcome. As a result, many in the resuscitation science field have been moving closer to replacing endotracheal intubation as the standard of care in favor of bag-mask ventilation. But this first-of-its-kind, large, randomized trial to formally address the issue showed virtually identical rates of day-28 survival with good neurologic outcome in the two study arms. Plus, bag-mask ventilation had a significantly higher complication rate.
“So, at this time, we will not yet change our technique,” according to coinvestigator Eric Vicaut, MD, of Fernand Widal Hospital in Paris.
This major prospective randomized trial included 2,043 patients with out-of-hospital cardiac arrest at 20 centers in France and Belgium. The primary endpoint – day-28 survival with good neurologic status as defined by a Glasgow-Pittsburgh Cerebral Performance Scale score of 2 or less – occurred in 4.2% of the bag-mask ventilation group and 4.1% of the endotracheal intubation group.
However, the rate of aspiration or regurgitation of gastric contents was significantly higher in the bag-mask ventilation group by a margin of 14.9% to 7.7%. Moreover, the bag-mask ventilation technique failed in 6.3% of patients, compared with a 2.5% endotracheal intubation failure rate.
Discussant Susanna Price, MD, praised the study as a high-quality, well-conducted randomized trial, adding that it’s just the sort of study that the field of resuscitation science had needed for a long time. Indeed, most guidelines in the field are based on faint supporting evidence. That may be one reason why good outcomes of out-of-hospital cardiac arrest are so disappointingly low: The worldwide average is roughly 7%, with huge differences between countries.
“It is really very depressing sometimes when one looks at the percentage of patients who actually return to normal life and normal functional neurologic status and, indeed, whose relatives get back to work,” commented Dr. Price, a cardiologist and intensivist at Royal Brompton Hospital in London.
“This is a huge study for resuscitation science,” she continued. “Prehospital airway management is currently a very hot topic. Bear in mind that in the United States, roughly 88% of cardiac arrests happen in the home.”
“This trial does challenge the current feeling that bag-mask ventilation is definitely superior to advanced airway interventions,” Dr. Price added.
For her, the study contained three surprises, she continued. One was the high bag-mask failure rate in the hands of very experienced operators. Another was the high complication rate associated with the device, again even in expert hands. Also, contrary to numerous published reports, the chest compression rate in this RCT was not better with bag mask ventilation.
“The study did not demonstrate that endotracheal intubation interrupts chest compressions. In fact, chest compression pauses were actually significantly more frequent in the bag-mask ventilation group than with endotracheal intubation,” she observed.
It’s worth noting that in the French EMS system, a physician experienced in cardiopulmonary resuscitation is typically on board for ambulance runs. This creates an element of uncertainty as to the generalizability of the study findings to EMS systems where paramedics who may be less proficient in endotracheal intubation are the first responders. Indeed, whether endotracheal intubation will stack up as favorably as it did against bag-mask ventilation in this randomized trial when tested in other settings where airway management is left in the hands of paramedics is an open question that’s the topic of ongoing studies, Dr. Price noted.
Dr. Adnet and Dr. Vicaut reported having no financial conflicts regarding their study, which was funded by the French Ministry of Health.
[email protected]
BARCELONA – Bag-mask ventilation for airway management during resuscitation of patients with out-of-hospital cardiac arrest was considerably less safe and yet no more effective than endotracheal intubation in a large randomized trial, Frederic Adnet, MD, reported at the annual congress of the European Society of Cardiology.
This was an unexpected result.
Several large, well-respected observational registry studies had strongly suggested that bag-mask ventilation is associated with a superior survival rate with good neurologic outcome. As a result, many in the resuscitation science field have been moving closer to replacing endotracheal intubation as the standard of care in favor of bag-mask ventilation. But this first-of-its-kind, large, randomized trial to formally address the issue showed virtually identical rates of day-28 survival with good neurologic outcome in the two study arms. Plus, bag-mask ventilation had a significantly higher complication rate.
“So, at this time, we will not yet change our technique,” according to coinvestigator Eric Vicaut, MD, of Fernand Widal Hospital in Paris.
This major prospective randomized trial included 2,043 patients with out-of-hospital cardiac arrest at 20 centers in France and Belgium. The primary endpoint – day-28 survival with good neurologic status as defined by a Glasgow-Pittsburgh Cerebral Performance Scale score of 2 or less – occurred in 4.2% of the bag-mask ventilation group and 4.1% of the endotracheal intubation group.
However, the rate of aspiration or regurgitation of gastric contents was significantly higher in the bag-mask ventilation group by a margin of 14.9% to 7.7%. Moreover, the bag-mask ventilation technique failed in 6.3% of patients, compared with a 2.5% endotracheal intubation failure rate.
Discussant Susanna Price, MD, praised the study as a high-quality, well-conducted randomized trial, adding that it’s just the sort of study that the field of resuscitation science had needed for a long time. Indeed, most guidelines in the field are based on faint supporting evidence. That may be one reason why good outcomes of out-of-hospital cardiac arrest are so disappointingly low: The worldwide average is roughly 7%, with huge differences between countries.
“It is really very depressing sometimes when one looks at the percentage of patients who actually return to normal life and normal functional neurologic status and, indeed, whose relatives get back to work,” commented Dr. Price, a cardiologist and intensivist at Royal Brompton Hospital in London.
“This is a huge study for resuscitation science,” she continued. “Prehospital airway management is currently a very hot topic. Bear in mind that in the United States, roughly 88% of cardiac arrests happen in the home.”
“This trial does challenge the current feeling that bag-mask ventilation is definitely superior to advanced airway interventions,” Dr. Price added.
For her, the study contained three surprises, she continued. One was the high bag-mask failure rate in the hands of very experienced operators. Another was the high complication rate associated with the device, again even in expert hands. Also, contrary to numerous published reports, the chest compression rate in this RCT was not better with bag mask ventilation.
“The study did not demonstrate that endotracheal intubation interrupts chest compressions. In fact, chest compression pauses were actually significantly more frequent in the bag-mask ventilation group than with endotracheal intubation,” she observed.
It’s worth noting that in the French EMS system, a physician experienced in cardiopulmonary resuscitation is typically on board for ambulance runs. This creates an element of uncertainty as to the generalizability of the study findings to EMS systems where paramedics who may be less proficient in endotracheal intubation are the first responders. Indeed, whether endotracheal intubation will stack up as favorably as it did against bag-mask ventilation in this randomized trial when tested in other settings where airway management is left in the hands of paramedics is an open question that’s the topic of ongoing studies, Dr. Price noted.
Dr. Adnet and Dr. Vicaut reported having no financial conflicts regarding their study, which was funded by the French Ministry of Health.
[email protected]
BARCELONA – Bag-mask ventilation for airway management during resuscitation of patients with out-of-hospital cardiac arrest was considerably less safe and yet no more effective than endotracheal intubation in a large randomized trial, Frederic Adnet, MD, reported at the annual congress of the European Society of Cardiology.
This was an unexpected result.
Several large, well-respected observational registry studies had strongly suggested that bag-mask ventilation is associated with a superior survival rate with good neurologic outcome. As a result, many in the resuscitation science field have been moving closer to replacing endotracheal intubation as the standard of care in favor of bag-mask ventilation. But this first-of-its-kind, large, randomized trial to formally address the issue showed virtually identical rates of day-28 survival with good neurologic outcome in the two study arms. Plus, bag-mask ventilation had a significantly higher complication rate.
“So, at this time, we will not yet change our technique,” according to coinvestigator Eric Vicaut, MD, of Fernand Widal Hospital in Paris.
This major prospective randomized trial included 2,043 patients with out-of-hospital cardiac arrest at 20 centers in France and Belgium. The primary endpoint – day-28 survival with good neurologic status as defined by a Glasgow-Pittsburgh Cerebral Performance Scale score of 2 or less – occurred in 4.2% of the bag-mask ventilation group and 4.1% of the endotracheal intubation group.
However, the rate of aspiration or regurgitation of gastric contents was significantly higher in the bag-mask ventilation group by a margin of 14.9% to 7.7%. Moreover, the bag-mask ventilation technique failed in 6.3% of patients, compared with a 2.5% endotracheal intubation failure rate.
Discussant Susanna Price, MD, praised the study as a high-quality, well-conducted randomized trial, adding that it’s just the sort of study that the field of resuscitation science had needed for a long time. Indeed, most guidelines in the field are based on faint supporting evidence. That may be one reason why good outcomes of out-of-hospital cardiac arrest are so disappointingly low: The worldwide average is roughly 7%, with huge differences between countries.
“It is really very depressing sometimes when one looks at the percentage of patients who actually return to normal life and normal functional neurologic status and, indeed, whose relatives get back to work,” commented Dr. Price, a cardiologist and intensivist at Royal Brompton Hospital in London.
“This is a huge study for resuscitation science,” she continued. “Prehospital airway management is currently a very hot topic. Bear in mind that in the United States, roughly 88% of cardiac arrests happen in the home.”
“This trial does challenge the current feeling that bag-mask ventilation is definitely superior to advanced airway interventions,” Dr. Price added.
For her, the study contained three surprises, she continued. One was the high bag-mask failure rate in the hands of very experienced operators. Another was the high complication rate associated with the device, again even in expert hands. Also, contrary to numerous published reports, the chest compression rate in this RCT was not better with bag mask ventilation.
“The study did not demonstrate that endotracheal intubation interrupts chest compressions. In fact, chest compression pauses were actually significantly more frequent in the bag-mask ventilation group than with endotracheal intubation,” she observed.
It’s worth noting that in the French EMS system, a physician experienced in cardiopulmonary resuscitation is typically on board for ambulance runs. This creates an element of uncertainty as to the generalizability of the study findings to EMS systems where paramedics who may be less proficient in endotracheal intubation are the first responders. Indeed, whether endotracheal intubation will stack up as favorably as it did against bag-mask ventilation in this randomized trial when tested in other settings where airway management is left in the hands of paramedics is an open question that’s the topic of ongoing studies, Dr. Price noted.
Dr. Adnet and Dr. Vicaut reported having no financial conflicts regarding their study, which was funded by the French Ministry of Health.
[email protected]
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: Rates of survival with good neurologic outcome 28 days after out-of-hospital cardiac arrest were similarly low whether airway management during CPR relied upon endotracheal intubation or bag-mask ventilation, but the latter strategy had a significantly higher complication rate.
Data source: This prospective randomized trial included 2,043 patients with out-of-hospital cardiac arrest at 20 centers in France and Belgium.
Disclosures: The study was funded by the French Ministry of Health. The presenter reported having no financial conflicts.
Aspirin responsiveness improved in some with OSA
Obstructive sleep apnea patients with endothelial dysfunction gained aspirin responsiveness after using continuous positive airway pressure (CPAP) therapy, according to the findings from a small study scheduled to be presented at CHEST 2017.
“Endothelial dysfunction is an important phenomenon implicated in cardiovascular morbidity in obstructive sleep apnea (OSA) patients. While it has been demonstrated that CPAP improves endothelial function, our understanding of the pathophysiologic links between CPAP therapy and cardiovascular outcomes remain limited,” researchers wrote in the study’s abstract.
The researchers examined 18 patients’ endothelial function before and after using CPAP therapy for a median of 37 days, along with the relationship between endothelial function and aspirin responsiveness in these same patients. All study participants had been recently diagnosed with moderate to severe OSA and underwent modified peripheral artery tonometry and platelet aggregometry before and after beginning CPAP therapy. Most of the patients (14) demonstrated aspirin resistance at baseline.
Endothelial dysfunction was defined as having a reactive hyperemia index (RHI) of less than or equal to 1.67, while aspirin resistance was defined as having a reading of at least 550 aspirin reaction units (ARU).
At baseline, the average RHI of patients was 1.79 (standard deviation = 0.3), with 8 of the patients having had endothelial dysfunction. Following CPAP use, patients’ mean RHI increased to 1.94 (SD = 0.36), and endothelial dysfunction was present in just 5 of the study participants.*
After using CPAP, those patients with endothelial dysfunction at baseline were responsive to aspirin, with their average ARU reading at 520 following therapy. In contrast, those patients with normal endothelial function at baseline remained resistant to aspirin following CPAP use, based on mean ARU values before and after therapy.
Lirim Krveshi, DO, of Danbury (Conn.) Hospital, is scheduled to present this study, “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients,” on Sunday, Oct. 29, at 1:45 p.m. in Convention Center, room 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session, running from 1:30 p.m. to 3:00 p.m.
The study’s authors reported no conflicts of interest.
*This article was updated Oct. 27, 2017.
Obstructive sleep apnea patients with endothelial dysfunction gained aspirin responsiveness after using continuous positive airway pressure (CPAP) therapy, according to the findings from a small study scheduled to be presented at CHEST 2017.
“Endothelial dysfunction is an important phenomenon implicated in cardiovascular morbidity in obstructive sleep apnea (OSA) patients. While it has been demonstrated that CPAP improves endothelial function, our understanding of the pathophysiologic links between CPAP therapy and cardiovascular outcomes remain limited,” researchers wrote in the study’s abstract.
The researchers examined 18 patients’ endothelial function before and after using CPAP therapy for a median of 37 days, along with the relationship between endothelial function and aspirin responsiveness in these same patients. All study participants had been recently diagnosed with moderate to severe OSA and underwent modified peripheral artery tonometry and platelet aggregometry before and after beginning CPAP therapy. Most of the patients (14) demonstrated aspirin resistance at baseline.
Endothelial dysfunction was defined as having a reactive hyperemia index (RHI) of less than or equal to 1.67, while aspirin resistance was defined as having a reading of at least 550 aspirin reaction units (ARU).
At baseline, the average RHI of patients was 1.79 (standard deviation = 0.3), with 8 of the patients having had endothelial dysfunction. Following CPAP use, patients’ mean RHI increased to 1.94 (SD = 0.36), and endothelial dysfunction was present in just 5 of the study participants.*
After using CPAP, those patients with endothelial dysfunction at baseline were responsive to aspirin, with their average ARU reading at 520 following therapy. In contrast, those patients with normal endothelial function at baseline remained resistant to aspirin following CPAP use, based on mean ARU values before and after therapy.
Lirim Krveshi, DO, of Danbury (Conn.) Hospital, is scheduled to present this study, “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients,” on Sunday, Oct. 29, at 1:45 p.m. in Convention Center, room 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session, running from 1:30 p.m. to 3:00 p.m.
The study’s authors reported no conflicts of interest.
*This article was updated Oct. 27, 2017.
Obstructive sleep apnea patients with endothelial dysfunction gained aspirin responsiveness after using continuous positive airway pressure (CPAP) therapy, according to the findings from a small study scheduled to be presented at CHEST 2017.
“Endothelial dysfunction is an important phenomenon implicated in cardiovascular morbidity in obstructive sleep apnea (OSA) patients. While it has been demonstrated that CPAP improves endothelial function, our understanding of the pathophysiologic links between CPAP therapy and cardiovascular outcomes remain limited,” researchers wrote in the study’s abstract.
The researchers examined 18 patients’ endothelial function before and after using CPAP therapy for a median of 37 days, along with the relationship between endothelial function and aspirin responsiveness in these same patients. All study participants had been recently diagnosed with moderate to severe OSA and underwent modified peripheral artery tonometry and platelet aggregometry before and after beginning CPAP therapy. Most of the patients (14) demonstrated aspirin resistance at baseline.
Endothelial dysfunction was defined as having a reactive hyperemia index (RHI) of less than or equal to 1.67, while aspirin resistance was defined as having a reading of at least 550 aspirin reaction units (ARU).
At baseline, the average RHI of patients was 1.79 (standard deviation = 0.3), with 8 of the patients having had endothelial dysfunction. Following CPAP use, patients’ mean RHI increased to 1.94 (SD = 0.36), and endothelial dysfunction was present in just 5 of the study participants.*
After using CPAP, those patients with endothelial dysfunction at baseline were responsive to aspirin, with their average ARU reading at 520 following therapy. In contrast, those patients with normal endothelial function at baseline remained resistant to aspirin following CPAP use, based on mean ARU values before and after therapy.
Lirim Krveshi, DO, of Danbury (Conn.) Hospital, is scheduled to present this study, “A Prospective Cohort Study of Endothelial Function and its Relationship to Aspirin Responsiveness in OSA Patients,” on Sunday, Oct. 29, at 1:45 p.m. in Convention Center, room 601A. This presentation is part of the Obstructive Sleep Apnea: Insights & Management session, running from 1:30 p.m. to 3:00 p.m.
The study’s authors reported no conflicts of interest.
*This article was updated Oct. 27, 2017.
FROM CHEST 2017
Key clinical point:
Major finding: The average aspirin reaction units reading for patients who had endothelial dysfunction at baseline was 520 following therapy.
Data source: A prospective cohort study of 18 patients with newly diagnosed moderate to severe OSA.
Disclosures: The study’s authors reported no conflicts of interest.