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PARIS – A global registry to track the safety and efficacy of shows benefits comparable to those previously reported in randomized trials, according to 1-year results presented at the annual congress of the European Respiratory Society.
Bronchothermoplasty has been Food and Drug Administration approved since 2010, but joint 2014 guidelines from the ERS and the American Thoracic Society (ATS) recommended that this procedure be restricted to patients participating in a registry, making these findings an important part of an ongoing assessment, according to Alfons Torrego Fernández, MD, of the pulmonology service at Hospital de la Santa Creu i Sant Pau, Barcelona.
The BT Global Registry (BTGR), created at the end of 2014, involves 18 centers in Europe, South Africa, and Australia. Dr. Fernandez provided data on 123 of the 157 patients enrolled by the end of 2016. All had at least 1 year of follow-up.
Compared with the year prior to bronchial thermoplasty, the proportion of patients with severe exacerbations in the year following this procedure fell from 90.3% to 59.6%, a 34% reduction (P less than .001). The proportion of patients requiring oral corticosteroids fell from 47.8% to 23.5%, a reduction of more than 50%.
Relative to the year prior to bronchial thermoplasty, “there was also a reduction in emergency room visits [21.1% vs. 54.6%] and hospitalizations [20.2% vs. 43%] as well as a reduction in the need for asthma maintenance medications,” Dr. Fernandez reported.
On the Asthma Control Questionnaire (ACQ), quality of life (QOL) was improved on average by 1.2 points from the prior year (4.48 vs. 3.26; P less than .05), according to Dr. Fernandez. The proportion of patients who achieved at least a 0.5-point increase in the ACQ, a level that Dr. Fernandez said is considered clinically relevant, was 67.1%.
However, when lung function measures such as forced expiratory volume in one second and fractional exhaled nitric oxide taken 1 year after bronchothermoplasty were compared with the same measures taken prior to this treatment, there was no significant improvement, according to Dr. Fernandez.
Bronchial thermoplasty involves the use of thermal energy delivered through a bronchoscope to reduce airway smooth muscle mass, thereby eliminating a source of airway restriction. Although nearly 70% of severe asthma patients in this BTGR derived an improvement in quality of life, 30% did not. Asked if the registry has provided any insight about who does or does not respond, Dr. Fernandez acknowledged that this is “the key question,” but added that “no specific profile or biomarker” has yet been identified.
“These are early results, but a 2-year follow-up is planned,” he said.
Although the technical aspects of bronchial thermoplasty “are quite well standardized,” Dr. Fernandez acknowledged that there might be a learning curve that favors experienced operators. He reported that outcomes between high- and low-volume centers in BTGR have not yet been compared. However, he maintained that “these results in real-life patients confirm that severe asthma patients can benefit” from this therapy as shown previously in sham-controlled trials.
Dr. Fernandez reported having no conflicts of interest. The registry is funded by Boston Scientific.
PARIS – A global registry to track the safety and efficacy of shows benefits comparable to those previously reported in randomized trials, according to 1-year results presented at the annual congress of the European Respiratory Society.
Bronchothermoplasty has been Food and Drug Administration approved since 2010, but joint 2014 guidelines from the ERS and the American Thoracic Society (ATS) recommended that this procedure be restricted to patients participating in a registry, making these findings an important part of an ongoing assessment, according to Alfons Torrego Fernández, MD, of the pulmonology service at Hospital de la Santa Creu i Sant Pau, Barcelona.
The BT Global Registry (BTGR), created at the end of 2014, involves 18 centers in Europe, South Africa, and Australia. Dr. Fernandez provided data on 123 of the 157 patients enrolled by the end of 2016. All had at least 1 year of follow-up.
Compared with the year prior to bronchial thermoplasty, the proportion of patients with severe exacerbations in the year following this procedure fell from 90.3% to 59.6%, a 34% reduction (P less than .001). The proportion of patients requiring oral corticosteroids fell from 47.8% to 23.5%, a reduction of more than 50%.
Relative to the year prior to bronchial thermoplasty, “there was also a reduction in emergency room visits [21.1% vs. 54.6%] and hospitalizations [20.2% vs. 43%] as well as a reduction in the need for asthma maintenance medications,” Dr. Fernandez reported.
On the Asthma Control Questionnaire (ACQ), quality of life (QOL) was improved on average by 1.2 points from the prior year (4.48 vs. 3.26; P less than .05), according to Dr. Fernandez. The proportion of patients who achieved at least a 0.5-point increase in the ACQ, a level that Dr. Fernandez said is considered clinically relevant, was 67.1%.
However, when lung function measures such as forced expiratory volume in one second and fractional exhaled nitric oxide taken 1 year after bronchothermoplasty were compared with the same measures taken prior to this treatment, there was no significant improvement, according to Dr. Fernandez.
Bronchial thermoplasty involves the use of thermal energy delivered through a bronchoscope to reduce airway smooth muscle mass, thereby eliminating a source of airway restriction. Although nearly 70% of severe asthma patients in this BTGR derived an improvement in quality of life, 30% did not. Asked if the registry has provided any insight about who does or does not respond, Dr. Fernandez acknowledged that this is “the key question,” but added that “no specific profile or biomarker” has yet been identified.
“These are early results, but a 2-year follow-up is planned,” he said.
Although the technical aspects of bronchial thermoplasty “are quite well standardized,” Dr. Fernandez acknowledged that there might be a learning curve that favors experienced operators. He reported that outcomes between high- and low-volume centers in BTGR have not yet been compared. However, he maintained that “these results in real-life patients confirm that severe asthma patients can benefit” from this therapy as shown previously in sham-controlled trials.
Dr. Fernandez reported having no conflicts of interest. The registry is funded by Boston Scientific.
PARIS – A global registry to track the safety and efficacy of shows benefits comparable to those previously reported in randomized trials, according to 1-year results presented at the annual congress of the European Respiratory Society.
Bronchothermoplasty has been Food and Drug Administration approved since 2010, but joint 2014 guidelines from the ERS and the American Thoracic Society (ATS) recommended that this procedure be restricted to patients participating in a registry, making these findings an important part of an ongoing assessment, according to Alfons Torrego Fernández, MD, of the pulmonology service at Hospital de la Santa Creu i Sant Pau, Barcelona.
The BT Global Registry (BTGR), created at the end of 2014, involves 18 centers in Europe, South Africa, and Australia. Dr. Fernandez provided data on 123 of the 157 patients enrolled by the end of 2016. All had at least 1 year of follow-up.
Compared with the year prior to bronchial thermoplasty, the proportion of patients with severe exacerbations in the year following this procedure fell from 90.3% to 59.6%, a 34% reduction (P less than .001). The proportion of patients requiring oral corticosteroids fell from 47.8% to 23.5%, a reduction of more than 50%.
Relative to the year prior to bronchial thermoplasty, “there was also a reduction in emergency room visits [21.1% vs. 54.6%] and hospitalizations [20.2% vs. 43%] as well as a reduction in the need for asthma maintenance medications,” Dr. Fernandez reported.
On the Asthma Control Questionnaire (ACQ), quality of life (QOL) was improved on average by 1.2 points from the prior year (4.48 vs. 3.26; P less than .05), according to Dr. Fernandez. The proportion of patients who achieved at least a 0.5-point increase in the ACQ, a level that Dr. Fernandez said is considered clinically relevant, was 67.1%.
However, when lung function measures such as forced expiratory volume in one second and fractional exhaled nitric oxide taken 1 year after bronchothermoplasty were compared with the same measures taken prior to this treatment, there was no significant improvement, according to Dr. Fernandez.
Bronchial thermoplasty involves the use of thermal energy delivered through a bronchoscope to reduce airway smooth muscle mass, thereby eliminating a source of airway restriction. Although nearly 70% of severe asthma patients in this BTGR derived an improvement in quality of life, 30% did not. Asked if the registry has provided any insight about who does or does not respond, Dr. Fernandez acknowledged that this is “the key question,” but added that “no specific profile or biomarker” has yet been identified.
“These are early results, but a 2-year follow-up is planned,” he said.
Although the technical aspects of bronchial thermoplasty “are quite well standardized,” Dr. Fernandez acknowledged that there might be a learning curve that favors experienced operators. He reported that outcomes between high- and low-volume centers in BTGR have not yet been compared. However, he maintained that “these results in real-life patients confirm that severe asthma patients can benefit” from this therapy as shown previously in sham-controlled trials.
Dr. Fernandez reported having no conflicts of interest. The registry is funded by Boston Scientific.
REPORTING FROM THE ERS CONGRESS 2018
Key clinical point: In a global registry, bronchothermoplasty provided improvement in real-world severe asthma consistent with clinical trials.
Major finding: At 1 year, severe asthma exacerbations were reduced 34% (P less than .001) relative to the year before treatment.
Study details: Open-label observational study.
Disclosures: Dr. Fernandez reported having no conflicts of interest. The registry is funded by Boston Scientific.