Automatic Vagus Nerve Stimulation Triggered by Ictal Tachycardia: Clinical Outcomes and Device Performance--The U.S. E-37 Trial.

Fisher, Robert S

Afra, Pegah

Macken, Micheal

Minecan, Daniela N

Bagić, Anto

Benbadis, Selim R

Helmers, Sandra L

Sinha, Saurabh R

Slater, Jeremy

Treiman, David

Begnaud, Jason

Raman, Pradheep

Najimipour, Bita

2019-04-01T13:32:14Z

2019-04-01T13:32:14Z

2016-02

2019-04-01T13:32:13Z

The Automatic Stimulation Mode (AutoStim) feature of the Model 106 Vagus Nerve Stimulation (VNS) Therapy System stimulates the left vagus nerve on detecting tachycardia. This study evaluates performance, safety of the AutoStim feature during a 3-5-day Epilepsy Monitoring Unit (EMU) stay and long- term clinical outcomes of the device stimulating in all modes.The E-37 protocol (NCT01846741) was a prospective, unblinded, U.S. multisite study of the AspireSR(®) in subjects with drug-resistant partial onset seizures and history of ictal tachycardia. VNS Normal and Magnet Modes stimulation were present at all times except during the EMU stay. Outpatient visits at 3, 6, and 12 months tracked seizure frequency, severity, quality of life, and adverse events.Twenty implanted subjects (ages 21-69) experienced 89 seizures in the EMU. 28/38 (73.7%) of complex partial and secondarily generalized seizures exhibited ≥20% increase in heart rate change. 31/89 (34.8%) of seizures were treated by Automatic Stimulation on detection; 19/31 (61.3%) seizures ended during the stimulation with a median time from stimulation onset to seizure end of 35 sec. Mean duty cycle at six-months increased from 11% to 16%. At 12 months, quality of life and seizure severity scores improved, and responder rate was 50%. Common adverse events were dysphonia (n = 7), convulsion (n = 6), and oropharyngeal pain (n = 3).The Model 106 performed as intended in the study population, was well tolerated and associated with clinical improvement from baseline. The study design did not allow determination of which factors were responsible for improvements.

1094-7159

1525-1403

https://hdl.handle.net/10161/18189

eng

Wiley

Neuromodulation : journal of the International Neuromodulation Society

10.1111/ner.12376

Humans

Epilepsies, Partial

Tachycardia

Treatment Outcome

Adult

Aged

Middle Aged

Female

Male

Vagus Nerve Stimulation

Young Adult

Drug Resistant Epilepsy

Automatic Vagus Nerve Stimulation Triggered by Ictal Tachycardia: Clinical Outcomes and Device Performance--The U.S. E-37 Trial.

Journal article

Sinha, Saurabh R|0000-0003-0305-6731

188

195

2

School of Medicine

Duke

Neurology, Epilepsy and Sleep

Neurology

Clinical Science Departments

Published

19