TBD Meeting (3036-23)

WASHINGTON – Patients with emphysema treated with one-way endobronchial values showed consistent improvement in lung function after 5 years compared with controls, based on data from 174 individuals.

One-way endobronchial valves demonstrated benefits for patients with severe emphysema over a 12-month period in the EMPROVE trial, according to Gerard J. Criner, MD, of Temple University, Philadelphia, and colleagues.

Five-year results from the EMPROVE study were presented in a poster session at the American Thoracic Society’s international conference.

The initial EMPROVE trial demonstrated safety and efficacy of the Spiration Valve System (SVS) over 12 months. However, data on the long-term benefits of one-way endobronchial values are limited, the researchers wrote.

The valve was designed for use in selected areas of the bronchial airways and features a flexible umbrella that allows air and mucus to clear from treated airways while blocking inspired air flow to areas of the lungs affected by disease, the researchers explained in the poster.

Dr. Criner and colleagues assessed 172 patients who were randomly assigned to treatment with a one-way valve system (113 patients) or a control group (59 patients).

Participants were evaluated at 1, 3, 6, and 12 months, then annually for 5 years.

The primary efficacy outcome was lung function, measured by forced expiratory volume per second (FEV₁). At five years, the FEV₁ values improved by 0.1098 liters in the treatment group (P < .001). Treated patients and controls experienced decreased FEV₁ at a rate of 0.0440 liters per year from baseline, a significant difference (P < .001). Assuming a steady rate of disease progression, “the treatment group gained approximately 2.5 years of FEV₁ improvement immediately following SVS treatment, which was maintained, compared to controls,” the researchers noted in their abstract.

Serious adverse events were assessed from 6 months to 5 years (352.7 patient-years) for treated patients and from 6 months to 2 years (72.9 patient-years) for controls.

Overall, 210 SAEs occurred in the treatment group and 35 occurred in controls, for rates of 0.60 and 0.48, respectively (P = .201). The most common SAEs in the treatment and control groups were COPD exacerbations, pneumothorax, and death.

The results suggest that the FEV₁ improvements seen in patients with severe emphysema after one-way endobronchial value placement compared with usual care are enduring after 5 years, with no significant changes in safety, the researchers concluded.

The original EMPROVE study was supported by Olympus Respiratory America, a part of Olympus Corporation and the developer of the Spiration Valve System. Results of the original study were published in the American Journal of Respiratory and Critical Care Medicine. Dr. Criner is associate editor of the American Journal of Respiratory and Critical Care Medicine. His participation complies with American Thoracic Society requirements for recusal from review and decisions for authored works.
 

A version of this article first appeared on Medscape.com.

WASHINGTON – Patients with emphysema treated with one-way endobronchial values showed consistent improvement in lung function after 5 years compared with controls, based on data from 174 individuals.

One-way endobronchial valves demonstrated benefits for patients with severe emphysema over a 12-month period in the EMPROVE trial, according to Gerard J. Criner, MD, of Temple University, Philadelphia, and colleagues.

Five-year results from the EMPROVE study were presented in a poster session at the American Thoracic Society’s international conference.

The initial EMPROVE trial demonstrated safety and efficacy of the Spiration Valve System (SVS) over 12 months. However, data on the long-term benefits of one-way endobronchial values are limited, the researchers wrote.

The valve was designed for use in selected areas of the bronchial airways and features a flexible umbrella that allows air and mucus to clear from treated airways while blocking inspired air flow to areas of the lungs affected by disease, the researchers explained in the poster.

Dr. Criner and colleagues assessed 172 patients who were randomly assigned to treatment with a one-way valve system (113 patients) or a control group (59 patients).

Participants were evaluated at 1, 3, 6, and 12 months, then annually for 5 years.

The primary efficacy outcome was lung function, measured by forced expiratory volume per second (FEV₁). At five years, the FEV₁ values improved by 0.1098 liters in the treatment group (P < .001). Treated patients and controls experienced decreased FEV₁ at a rate of 0.0440 liters per year from baseline, a significant difference (P < .001). Assuming a steady rate of disease progression, “the treatment group gained approximately 2.5 years of FEV₁ improvement immediately following SVS treatment, which was maintained, compared to controls,” the researchers noted in their abstract.

Serious adverse events were assessed from 6 months to 5 years (352.7 patient-years) for treated patients and from 6 months to 2 years (72.9 patient-years) for controls.

Overall, 210 SAEs occurred in the treatment group and 35 occurred in controls, for rates of 0.60 and 0.48, respectively (P = .201). The most common SAEs in the treatment and control groups were COPD exacerbations, pneumothorax, and death.

The results suggest that the FEV₁ improvements seen in patients with severe emphysema after one-way endobronchial value placement compared with usual care are enduring after 5 years, with no significant changes in safety, the researchers concluded.

The original EMPROVE study was supported by Olympus Respiratory America, a part of Olympus Corporation and the developer of the Spiration Valve System. Results of the original study were published in the American Journal of Respiratory and Critical Care Medicine. Dr. Criner is associate editor of the American Journal of Respiratory and Critical Care Medicine. His participation complies with American Thoracic Society requirements for recusal from review and decisions for authored works.
 

A version of this article first appeared on Medscape.com.

WASHINGTON – Patients with emphysema treated with one-way endobronchial values showed consistent improvement in lung function after 5 years compared with controls, based on data from 174 individuals.

One-way endobronchial valves demonstrated benefits for patients with severe emphysema over a 12-month period in the EMPROVE trial, according to Gerard J. Criner, MD, of Temple University, Philadelphia, and colleagues.

Five-year results from the EMPROVE study were presented in a poster session at the American Thoracic Society’s international conference.

The initial EMPROVE trial demonstrated safety and efficacy of the Spiration Valve System (SVS) over 12 months. However, data on the long-term benefits of one-way endobronchial values are limited, the researchers wrote.

The valve was designed for use in selected areas of the bronchial airways and features a flexible umbrella that allows air and mucus to clear from treated airways while blocking inspired air flow to areas of the lungs affected by disease, the researchers explained in the poster.

Dr. Criner and colleagues assessed 172 patients who were randomly assigned to treatment with a one-way valve system (113 patients) or a control group (59 patients).

Participants were evaluated at 1, 3, 6, and 12 months, then annually for 5 years.

The primary efficacy outcome was lung function, measured by forced expiratory volume per second (FEV₁). At five years, the FEV₁ values improved by 0.1098 liters in the treatment group (P < .001). Treated patients and controls experienced decreased FEV₁ at a rate of 0.0440 liters per year from baseline, a significant difference (P < .001). Assuming a steady rate of disease progression, “the treatment group gained approximately 2.5 years of FEV₁ improvement immediately following SVS treatment, which was maintained, compared to controls,” the researchers noted in their abstract.

Serious adverse events were assessed from 6 months to 5 years (352.7 patient-years) for treated patients and from 6 months to 2 years (72.9 patient-years) for controls.

Overall, 210 SAEs occurred in the treatment group and 35 occurred in controls, for rates of 0.60 and 0.48, respectively (P = .201). The most common SAEs in the treatment and control groups were COPD exacerbations, pneumothorax, and death.

The results suggest that the FEV₁ improvements seen in patients with severe emphysema after one-way endobronchial value placement compared with usual care are enduring after 5 years, with no significant changes in safety, the researchers concluded.

The original EMPROVE study was supported by Olympus Respiratory America, a part of Olympus Corporation and the developer of the Spiration Valve System. Results of the original study were published in the American Journal of Respiratory and Critical Care Medicine. Dr. Criner is associate editor of the American Journal of Respiratory and Critical Care Medicine. His participation complies with American Thoracic Society requirements for recusal from review and decisions for authored works.
 

A version of this article first appeared on Medscape.com.

Measurement error may be the culprit in underdiagnosing obstructive sleep apnea in Black patients, compared with White patients, based on data from nearly 2,000 individuals.

Data collected from ICU patients during the COVID-19 pandemic suggested that pulse oximetry devices used to measure oxygen saturation may be less accurate for patients with darker skin, according to Ali Azarbarzin, PhD, of Harvard Medical School, Boston.

“We wanted to examine the implications for obstructive sleep apnea,” which is often caused by a reduction in air flow, Dr. Azarbarzin said in an interview.

In a study presented at the American Thoracic Society’s international conference, Dr. Azarbarzin and colleagues examined data from 1,955 adults who were enrolled in the Multi-Ethnic Study of Atherosclerosis (MESA) Exam 5. The study participants underwent unattended 15-channel polysomnography that included a finger pulse oximeter. The mean age of the participants was 68.3 years, and 53.7% were women. A total of 12.1%, 23.7%, 27.7%, and 36.5% of the participants were Asian, Hispanic, Black, and White, respectively.

Apnea hypopnea index (AHI3P) was similar between Black and White patients, at approximately 19 events per hour. Black participants had higher wake SpO2, higher current smoking rates, and higher body mass index, compared with White participants, but these differences were not significant.

Severity of obstructive sleep apnea (OSA) was based on the hypoxic burden, which was defined as the total area under the respiratory curve. The total ventilatory burden was defined as the event-specific area under the ventilation signal and identified by amplitude changes in the nasal pressure signal. The researchers then calculated desaturation sensitivity (the primary outcome) as hypoxic burden divided by ventilatory burden.

In an unadjusted analysis, desaturation sensitivity was significantly lower in Black patients and Asian patients, compared with White patients (P < .001 and P < .02, respectively). After adjusting for age, sex, body mass index, and time spent in a supine position, desaturation sensitivity was lower only in Black patients, compared with White patients, and this difference persisted in both men and women.

The difference in desaturation sensitivity by race could be caused by differences in physiology or in measurement error, Dr. Azarbarzin told this news organization. If measurement error is the culprit, “we may be underestimating OSA severity in [Black people],” especially in Black women, he said.

However, more research is needed to understand the potential impact of both physiology and device accuracy on differences in oxygen saturation across ethnicities and to effectively identify and treat OSA in all patients, Dr. Azarbarzin said.

The MESA Study was supported by the National Institutes of Health and the National Institute on Aging. Data from MESA were obtained through support from the National Heart, Lung, and Blood Institute and the National Center for Advancing Translational Sciences. Dr. Azarbarzin disclosed funding from the National Institutes of Health, the American Health Association, and the American Academy of Sleep Medicine.

A version of this article first appeared on Medscape.com.

Measurement error may be the culprit in underdiagnosing obstructive sleep apnea in Black patients, compared with White patients, based on data from nearly 2,000 individuals.

Data collected from ICU patients during the COVID-19 pandemic suggested that pulse oximetry devices used to measure oxygen saturation may be less accurate for patients with darker skin, according to Ali Azarbarzin, PhD, of Harvard Medical School, Boston.

“We wanted to examine the implications for obstructive sleep apnea,” which is often caused by a reduction in air flow, Dr. Azarbarzin said in an interview.

In a study presented at the American Thoracic Society’s international conference, Dr. Azarbarzin and colleagues examined data from 1,955 adults who were enrolled in the Multi-Ethnic Study of Atherosclerosis (MESA) Exam 5. The study participants underwent unattended 15-channel polysomnography that included a finger pulse oximeter. The mean age of the participants was 68.3 years, and 53.7% were women. A total of 12.1%, 23.7%, 27.7%, and 36.5% of the participants were Asian, Hispanic, Black, and White, respectively.

Apnea hypopnea index (AHI3P) was similar between Black and White patients, at approximately 19 events per hour. Black participants had higher wake SpO2, higher current smoking rates, and higher body mass index, compared with White participants, but these differences were not significant.

Severity of obstructive sleep apnea (OSA) was based on the hypoxic burden, which was defined as the total area under the respiratory curve. The total ventilatory burden was defined as the event-specific area under the ventilation signal and identified by amplitude changes in the nasal pressure signal. The researchers then calculated desaturation sensitivity (the primary outcome) as hypoxic burden divided by ventilatory burden.

In an unadjusted analysis, desaturation sensitivity was significantly lower in Black patients and Asian patients, compared with White patients (P < .001 and P < .02, respectively). After adjusting for age, sex, body mass index, and time spent in a supine position, desaturation sensitivity was lower only in Black patients, compared with White patients, and this difference persisted in both men and women.

The difference in desaturation sensitivity by race could be caused by differences in physiology or in measurement error, Dr. Azarbarzin told this news organization. If measurement error is the culprit, “we may be underestimating OSA severity in [Black people],” especially in Black women, he said.

However, more research is needed to understand the potential impact of both physiology and device accuracy on differences in oxygen saturation across ethnicities and to effectively identify and treat OSA in all patients, Dr. Azarbarzin said.

The MESA Study was supported by the National Institutes of Health and the National Institute on Aging. Data from MESA were obtained through support from the National Heart, Lung, and Blood Institute and the National Center for Advancing Translational Sciences. Dr. Azarbarzin disclosed funding from the National Institutes of Health, the American Health Association, and the American Academy of Sleep Medicine.

A version of this article first appeared on Medscape.com.

Measurement error may be the culprit in underdiagnosing obstructive sleep apnea in Black patients, compared with White patients, based on data from nearly 2,000 individuals.

Data collected from ICU patients during the COVID-19 pandemic suggested that pulse oximetry devices used to measure oxygen saturation may be less accurate for patients with darker skin, according to Ali Azarbarzin, PhD, of Harvard Medical School, Boston.

“We wanted to examine the implications for obstructive sleep apnea,” which is often caused by a reduction in air flow, Dr. Azarbarzin said in an interview.

In a study presented at the American Thoracic Society’s international conference, Dr. Azarbarzin and colleagues examined data from 1,955 adults who were enrolled in the Multi-Ethnic Study of Atherosclerosis (MESA) Exam 5. The study participants underwent unattended 15-channel polysomnography that included a finger pulse oximeter. The mean age of the participants was 68.3 years, and 53.7% were women. A total of 12.1%, 23.7%, 27.7%, and 36.5% of the participants were Asian, Hispanic, Black, and White, respectively.

Apnea hypopnea index (AHI3P) was similar between Black and White patients, at approximately 19 events per hour. Black participants had higher wake SpO2, higher current smoking rates, and higher body mass index, compared with White participants, but these differences were not significant.

Severity of obstructive sleep apnea (OSA) was based on the hypoxic burden, which was defined as the total area under the respiratory curve. The total ventilatory burden was defined as the event-specific area under the ventilation signal and identified by amplitude changes in the nasal pressure signal. The researchers then calculated desaturation sensitivity (the primary outcome) as hypoxic burden divided by ventilatory burden.

In an unadjusted analysis, desaturation sensitivity was significantly lower in Black patients and Asian patients, compared with White patients (P < .001 and P < .02, respectively). After adjusting for age, sex, body mass index, and time spent in a supine position, desaturation sensitivity was lower only in Black patients, compared with White patients, and this difference persisted in both men and women.

The difference in desaturation sensitivity by race could be caused by differences in physiology or in measurement error, Dr. Azarbarzin told this news organization. If measurement error is the culprit, “we may be underestimating OSA severity in [Black people],” especially in Black women, he said.

However, more research is needed to understand the potential impact of both physiology and device accuracy on differences in oxygen saturation across ethnicities and to effectively identify and treat OSA in all patients, Dr. Azarbarzin said.

The MESA Study was supported by the National Institutes of Health and the National Institute on Aging. Data from MESA were obtained through support from the National Heart, Lung, and Blood Institute and the National Center for Advancing Translational Sciences. Dr. Azarbarzin disclosed funding from the National Institutes of Health, the American Health Association, and the American Academy of Sleep Medicine.

A version of this article first appeared on Medscape.com.