Diaphragm pacing in amyotrophic lateral sclerosis ―A long–term analysis of safety and effectiveness―

Abstract

We evaluated 5 ALS patients without positive–pressure mechanical ventilation who utilized diaphragm pacing (DP) with NeuRx Diaphragm Pacing System (NeuRx DPS^®) with 24 months of follow–up. Several anticipated non–serious adverse events, such as discomfort and pain with pacing (5 patients), break of external cable (3 patients), and focal skin infection (2 patients) occurred, however, we observed no sequelae or interruption of pacing. During the follow–up period, 2 patients without bi–level positive airway pressure (BIPAP) died from aspiration pneumonia or chronic respiratory failure. 1 of 3 patients with BIPAP was introduced mechanical ventilation because of aspiration. However, other 2 patients needed neither tracheotomy nor positive–pressure mechanical ventilation during the observation period. Clinical efficacy of NeuRx DPS^® for ALS has not been elucidated yet. Further investigation for proper indication and pacing condition of NeuRx DPS^® is necessary.