Pharyngeal electrical stimulation for neurogenic dysphagia following stroke, traumatic brain injury or other causes: Main results from the PHADER cohort study

Bath, Philip M.; Woodhouse, Lisa J.; Suntrup-Krueger, Sonja; Likar, Rudolf; Koestenberger, Markus; Warusevitane, Anushka; Herzog, Juergen; Schuttler, Michael; Ragab, Suzanne; Everton, Lisa; Ledl, Christian; Walther, Ernst; Saltuari, Leopold; Pucks-Faes, Elke; Bocksrucker, Christof; Vosko, Milan; de Broux, Johanna; Haase, Claus G.; Raginis-Zborowska, Alicja; Mistry, Satish; Hamdy, Shaheen; Dziewas, Rainer

Abstract

Background: Neurogenic dysphagia is common and has no definitive treatment. We assessed whether pharyngeal electrical stimulation (PES) is associated with reduced dysphagia. Methods: The PHAryngeal electrical stimulation for treatment of neurogenic Dysphagia European Registry (PHADER) was a prospective single-arm observational cohort study. Participants were recruited with neurogenic dysphagia (comprising five groups – stroke not needing ventilation; stroke needing ventilation; ventilation acquired; traumatic brain injury; other neurological causes). PES was administered once daily for three days. The primary outcome was the validated dysphagia severity rating scale (DSRS, score best-worst 0–12) at 3 months. Findings: Of 255 enrolled patients from 14 centres in Austria, Germany and UK, 10 failed screening. At baseline, mean (standard deviation) or median [interquartile range]: age 68 (14) years, male 71%, DSRS 11·4 (1·7), time from onset to treatment 32 [44] days; age, time and DSRS differed between diagnostic groups. Insertion of PES catheters was successfully inserted in 239/245 (98%) participants, and was typically easy taking 11·8 min. 9 participants withdrew before the end of treatment. DSRS improved significantly in all dysphagia groups, difference in means (95% confidence intervals, CI) from 0 to 3 months: stroke (n = 79) –6·7 (–7·8, –5·5), ventilated stroke (n = 98) –6·5 (–7·6, –5·5); ventilation acquired (n = 35) –6·6 (–8·4, –4·8); traumatic brain injury (n = 24) -4·5 (–6·6, –2·4). The results for DSRS were mirrored for instrumentally assessed penetration aspiration scale scores. DSRS improved in both supratentorial and infratentorial stroke, with no difference between them (p = 0·32). In previously ventilated participants with tracheotomy, DSRS improved more in participants who could be decannulated (n = 66) –7·5 (–8·6, –6·5) versus not decannulated (n = 33) –2·1 (–3·2, –1·0) (p<0·001). 74 serious adverse events (SAE) occurred in 60 participants with pneumonia (9·2%) the most frequent SAE. Interpretation: In patients with neurogenic dysphagia, PES was safe and associated with reduced measures of dysphagia and penetration/aspiration. Funding: Phagenesis Ltd.

Citation

Bath, P. M., Woodhouse, L. J., Suntrup-Krueger, S., Likar, R., Koestenberger, M., Warusevitane, A., Herzog, J., Schuttler, M., Ragab, S., Everton, L., Ledl, C., Walther, E., Saltuari, L., Pucks-Faes, E., Bocksrucker, C., Vosko, M., de Broux, J., Haase, C. G., Raginis-Zborowska, A., Mistry, S., …Dziewas, R. (2020). Pharyngeal electrical stimulation for neurogenic dysphagia following stroke, traumatic brain injury or other causes: Main results from the PHADER cohort study. eClinicalMedicine, 28, Article 100608. https://doi.org/10.1016/j.eclinm.2020.100608

• Journal Article Type: Article
• Acceptance Date: Oct 8, 2020
• Online Publication Date: Nov 10, 2020
• Publication Date: Nov 1, 2020
• Deposit Date: Nov 11, 2020
• Publicly Available Date: Nov 11, 2020
• Journal: EClinicalMedicine
• Electronic ISSN: 2589-5370
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 28
• Article Number: 100608
• DOI: https://doi.org/10.1016/j.eclinm.2020.100608
• Keywords: Decannulation; Dysphagia; Pharyngeal electrical stimulation; Stroke; Traumatic brain injury; Ventilation
• Public URL: https://nottingham-repository.worktribe.com/output/5034944
• Publisher URL: https://www.sciencedirect.com/science/article/pii/S2589537020303527