Despite continuing advances in our understanding of asthma and the development of new pharmacological agents, the prevalence of asthma continues to have a severe impact on the US population where over 480,000 patients are hospitalized and 5,000 die of this condition each year. Here, we test a new percutaneous medical treatment to induce bronchodilation in acute asthma through the application of electrical stimulation. This study was conducted under an FDA IDE with IRB approvals.
Adult patients (ages 26–58), seen in the Emergency Department with moderately severe asthma (FEV1 40%–70%) and who failed conventional pharmacologic therapy (inhaled bronchodilators ± oral steroids), were eligible for this multicenter study. Response failure was defined as a post-treatment FEV1 < 70%. Four patients met criteria and consented to the procedure. Following consent, patients were prepped and draped, and an electrode lead was placed percutaneously using ultrasound guidance in the vicinity of the carotid sheath. The minimally invasive procedure was conducted in fully conscious and responsive patients using local anesthesia at the insertion site. Treatment consisted of up to 180 minutes of continuous electrical stimulation at 25Hz and 200ms pulse width at amplitude ranging between 1–12 volts. The end points for voltage increase were symptomatic improvement, muscle twitching or discomfort. FEV1 measurements were obtained pre-stimulation, at 30min intervals during stimulation, and post stimulation with results compared using paired t-tests.
All patients were unresponsive to standard pharmacological therapy, including β2-adrenergic receptor agonists (4/4) and oral steroid treatment (3/4). During treatment, the percent predicted FEV1 increased from 59.5 ± 4.7 to 68.3 ± 5.2 (p = 0.014) at 30 min and reached a mean peak of 75.2 ± 5.5 (p = 0.004) during the study. After completing treatment, FEV1 remained elevated for 30 min (p = 0.035).
This study suggests that electrical stimulation can safely be used to reduce bronchoconstriction in certain patients with acute asthma.
This presents an exciting new opportunity to provide a non-pharmacological and non-airflow dependent bronchodilation treatment for use in critical care settings.
Pedro Sepulveda, Shareholder Giselle Mosnaim MD and Peter Staats MD are shareholders in ELectroCore LLC; Employee Thomas Hoffmann is an employee of ElectroCore LLC that sponsored this study; Consultant fee, speaker bureau, advisory committee, etc. Giselle Mosnaim MD receives a consultant fee; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Product is a new medical device under development for the acute treatment of asthma in critical care settings. This presentation includes the initial data obtained as part of the clinical safety testing that was conducted under an FPA IDE.