Evaluation of a wearable medical device for ambulatory screening of obstructive sleep apnea in atrial fibrillation patients after ablation

Several studies have identified obstructive sleep apnea (OSA) as a risk factor for atrial fibrillation (AF) recurrence after catheter ablation, on top of other cardiovascular complications. While polysomnography (PSG) remains the gold standard for OSA diagnosis, to perform it can be both expensive and challenging because of patient acceptance and healthcare resources availability. In Europe, the use of PSG has experienced significant growth over the past decade. However, access to conventional PSG remains limited in some areas, with delays that can exceed 200 days in public healthcare centers which may impact the ability to diagnose and treat OSA in a timely manner. To overcome some of the challenges and limitations, alternative diagnostic methods and devices have emerged.

To evaluate the diagnostic accuracy and real-world, unattended usability of a wearable medical device for OSA screening in AF patients after ablation.

In patients referred for AF ablation, OSA was assessed using the Berlin and the STOP-BANG screening questionnaires, a wearable medical device validated for automated diagnosis of OSA and ambulatory PSG. The wearable device attaches to the neck and works with an accompanying self-explanatory application running on a smartphone. Diagnostic reliability across the different methods, as well as patient acceptance, were evaluated.

32 AF patients were enrolled (age 56±8 years). Baseline characteristics of the study population described in the Table. Berlin and STOP-BANG questionnaires showed sensitivity 64% and 93%, specificity 89% and 61%, positive-predictive value 82% and 65%, and negative-predictive value 76% and 92%, respectively. The wearable medical device showed sensitivity 93%, specificity 83%, positive-predictive value 81% and negative-predictive value 94%. Figure. All the patients reported a strong preference for the wearable medical device over PSG. Perceived satisfaction was also high, with an overall score of 9,3 out of 10 in the patient feedback survey.

This wearable medical device for ambulatory screening of OSA is a reliable tool that can optimize the management of AF patients, providing an early diagnosis and a more rational use of healthcare resources.

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