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

Robert S. Fisher*, Pegah Afra, Micheal P Macken, Daniela N. Minecan, Anto Bagic, Selim R. Benbadis, Sandra L. Helmers, Saurabh R. Sinha, Jeremy Slater, David Treiman, Jason Begnaud, Pradheep Raman, Bita Najimipour

*Corresponding author for this work

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

Objectives 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. Materials and Methods 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. Results 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). Conclusions 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.

Original languageEnglish (US)
Pages (from-to)188-195
Number of pages8
JournalNeuromodulation
Volume19
Issue number2
DOIs
StatePublished - Feb 1 2016

Fingerprint

Vagus Nerve Stimulation
Tachycardia
Seizures
Stroke
Equipment and Supplies
Epilepsy
Quality of Life
Dysphonia
Vagus Nerve
Magnets
Outpatients
Heart Rate
Safety
Pain

Keywords

  • AspireSR
  • VNS therapy system
  • ictal tachycardia
  • vagus nerve stimulation

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

Cite this

Fisher, Robert S. ; Afra, Pegah ; Macken, Micheal P ; Minecan, Daniela N. ; Bagic, Anto ; Benbadis, Selim R. ; Helmers, Sandra L. ; Sinha, Saurabh R. ; Slater, Jeremy ; Treiman, David ; Begnaud, Jason ; Raman, Pradheep ; Najimipour, Bita. / Automatic Vagus Nerve Stimulation Triggered by Ictal Tachycardia : Clinical Outcomes and Device Performance - The U.S. E-37 Trial. In: Neuromodulation. 2016 ; Vol. 19, No. 2. pp. 188-195.
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title = "Automatic Vagus Nerve Stimulation Triggered by Ictal Tachycardia: Clinical Outcomes and Device Performance - The U.S. E-37 Trial",
abstract = "Objectives 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. Materials and Methods The E-37 protocol (NCT01846741) was a prospective, unblinded, U.S. multisite study of the AspireSR{\circledR} 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. Results 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). Conclusions 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.",
keywords = "AspireSR, VNS therapy system, ictal tachycardia, vagus nerve stimulation",
author = "Fisher, {Robert S.} and Pegah Afra and Macken, {Micheal P} and Minecan, {Daniela N.} and Anto Bagic and Benbadis, {Selim R.} and Helmers, {Sandra L.} and Sinha, {Saurabh R.} and Jeremy Slater and David Treiman and Jason Begnaud and Pradheep Raman and Bita Najimipour",
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Fisher, RS, Afra, P, Macken, MP, Minecan, DN, Bagic, A, Benbadis, SR, Helmers, SL, Sinha, SR, Slater, J, Treiman, D, Begnaud, J, Raman, P & Najimipour, B 2016, 'Automatic Vagus Nerve Stimulation Triggered by Ictal Tachycardia: Clinical Outcomes and Device Performance - The U.S. E-37 Trial', Neuromodulation, vol. 19, no. 2, pp. 188-195. https://doi.org/10.1111/ner.12376

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 P; Minecan, Daniela N.; Bagic, Anto; Benbadis, Selim R.; Helmers, Sandra L.; Sinha, Saurabh R.; Slater, Jeremy; Treiman, David; Begnaud, Jason; Raman, Pradheep; Najimipour, Bita.

In: Neuromodulation, Vol. 19, No. 2, 01.02.2016, p. 188-195.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Automatic Vagus Nerve Stimulation Triggered by Ictal Tachycardia

T2 - Clinical Outcomes and Device Performance - The U.S. E-37 Trial

AU - Fisher, Robert S.

AU - Afra, Pegah

AU - Macken, Micheal P

AU - Minecan, Daniela N.

AU - Bagic, Anto

AU - Benbadis, Selim R.

AU - Helmers, Sandra L.

AU - Sinha, Saurabh R.

AU - Slater, Jeremy

AU - Treiman, David

AU - Begnaud, Jason

AU - Raman, Pradheep

AU - Najimipour, Bita

PY - 2016/2/1

Y1 - 2016/2/1

N2 - Objectives 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. Materials and Methods 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. Results 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). Conclusions 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.

AB - Objectives 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. Materials and Methods 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. Results 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). Conclusions 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.

KW - AspireSR

KW - VNS therapy system

KW - ictal tachycardia

KW - vagus nerve stimulation

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