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Health Risks Related to Polyurethan Foam Degradation in CPAP Devices Used for Sleep Apnea Treatment - Long-Term-Outcome Analysis in the Population-Based DISCOVERY Study
32 Pages Posted: 25 Nov 2021
More...Abstract
Background: A recent medical device recall notification reported on the risk for degradation of polyurethane foam (PUF) in continuous positive airway pressure (CPAP) devices used for obstructive sleep apnea (OSA) treatment. The current study analyzed adverse health outcomes associated with PUF-CPAP use.
Methods: National, longitudinal cohort study over an 8-year observation period in OSA patients in Sweden with health data collected from national registries (DISCOVERY study). Outcomes related to anti-obstructive drug use, hospitalizations, cancer incidence, and mortality were compared between OSA patients using CPAP devices with (N=18,561) or without PUF (N=29,830). Statistical methods included propensity score matching and multivariable regression models clustered by county and adjusted for anthropometric data and comorbidities.
Findings: During a total 139,056 person-years of follow-up, PUF-CPAP use was associated with more frequent use of short-acting beta2-agonists (adjusted odds ratio (aOR) 1·24; [95% CI] 1·10-1·39) and oral corticosteroids (aOR 1·10; 1·00-1·23) during the first year after CPAP initiation. Mortality and overall cancer incidence were similar between groups. Incident lung cancer risk was increased in the PUF-CPAP group (aHR1·91; 1·33-2·73), but this finding was not robust in sensitivity analyses.
Interpretation: In patients with OSA, use of PUF-CPAP is associated with mild deterioration of obstructive lung disease control suggesting increased airway inflammation, while overall cancer and mortality risks were unchanged. Signals of increased lung cancer incidence were inconclusive and warrant further study. Our findings may guide health care professionals and patients on risk-benefit assessment of PUF-CPAP use and replacement policies.
Funding: Uppsala-Örebro Regional Research Council, Swedish Heart and Lung Foundation, Swedish Research Council.
Declaration of Interest: None to declare.
Ethical Approval: The study was approved by the Ethics Committee at Medical Faculty, Lund
University, Log Nos. 2018/51, amendments 2020-02721 and 2021-04984.
Keywords: Sleep apnea, CPAP, Polyurethan foam, PUF, cancer, Airway obstruction
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