Dynamic laryngotracheal closure for aspiration: A preliminary report

Objectives/Hypothesis: An estimated 500,000 patients per year in the United States. are affected by stroke-related dysphagia. Approximately half exper ience aspiration, which can lead to pneumonia or death. Aspiration may resu lt from many factors, including delayed transport of the bolus, faulty lary ngeal elevation, and poor coordination or inappropriate timing of vocal cor d closure. Interventions carried out to protect the lungs are usually irrev ersible, destructive to the upper airway, and rarely prevent the need for e nteral tube feeding. Study Design: We present a report of the first implant ations of a new device in an FDA-approved study to restore dynamic laryngot racheal separation. Two stroke patients needing tracheostomy were selected based on chronic aspiration verified by clinical and radiologic criteria (m odified barium swallow [MBS]). Methods: The left recurrent laryngeal nerve was exposed and electrically stimulated to verify vocal fold adduction. Hun tington Medical Research Institute Bipolar Helical Electrodes were then imp lanted around the nerve. The leads were tunneled and linked to a NeuroContr ol(TM) Implantable Receiver-Stimulator placed subcutaneously on the chest w all. Activation of the stimulator was performed through an external transmi tter linked by induction. Results. The device was successfully triggered in tra- and postoperatively. Serial flexible fiberoptic endoscopies and MBS de monstrate that aspiration is systematically arrested using low levels of el ectrical stimulation (42 Hz, 48-100 mu sec, 1 mA). Discussion: This pioneer ing work has shown that aspiration can be controlled without airway damage for a wide population of neurologically impaired patients because it appear s more physiological than standard therapies. Conclusion: Based on the firs t two patients, paced laryngotracheal separation is clinically effective in controlling aspiration.