Evaluating Vagus Nerve Stimulation Treatment in Epilepsy Patients with Heart Monitoring Capacity Brandon
1 Santhumayor ,
Shefali Karkare
1Donald
Background
1 M.D. ,
Sanjeev Kothare
1 M.D. ,
1 Shaun Rodgers M.D.
and Barbara Zucker School of Medicine at Hofstra/Northwell
Conclusions
Results
• Auto-stimulation enabled VNS devices are safe and effective – 60% of patients reported greater than 50% seizure reduction and side effects did not differ between groups
Seizure subtype profiles for control (no auto-stim enabled VNS devices) and treatment (auto-stim enabled VNS devices) groups
• Daily auto-stimulation activations directly correlated with seizure frequency reduction
Afra P, Adamolekun B, Aydemir, S, Watson GDR. Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Front. Med. Technol. 2021 Aug. Doi: 10.3389/fmedt.2021.696543.
• Vagus Nerve Stimulators (VNS) were first approved in 1997 for adult patients with focal epilepsy, but have been shown to be an effective treatment modality for pediatric patients with generalized, intractable epilepsy1 • 80% of patients have significant increases in heart rate during an oncoming seizure, prompting VNS device companies to create an “auto-stimulation” feature that detects heart rate and submits electrical signals in a closed loop system2 • Further research is needed on the efficacy and safety of this auto-stimulation mode, which is present in newer VNS devices
Graph showing mean post-VNS percent decrease in seizure frequency based on presence of AutoStim enabled capacity at 12 months postoperative time point (p = 0.237)
Comparison of VNS treatment response and side effects between control (no auto-stimulation enabled VNS devices) and treatment (auto-stimulation enabled VNS devices) groups at 12 month follow up period post VNS insertion. Seizure freedom indicated if patients were without any seizures from 1-2 years follow up post-VNS insertion. Respiratory AE’s - Adverse effects including hoarseness, voice changes, coughing. Sleep Apnea AE’s - Adverse Effects including difficulty falling asleep, general lethargy. Post-Op AE’s - Adverse effects including post-operative infections at the incision site, discomfort following surgery
• SenTiva 1000 generator was most effective in decreasing seizure frequency – likely due to better programming options and detection of biomarkers predicting seizure onset
Hypothesis
Future Directions
Vagus Nerve Stimulators with auto-stimulation (AspireTM 106 and SenTivaTM 1000) have a greater seizure frequency reduction, seizure freedom rate, and anti-seizure medication decrease 1 year following VNS insertion for pediatric patients with intractable epilepsy
Methods
• Future work is needed to determine long-term effects of VNS therapy with autostimulation (>2 years) and if sudden death in patients with epilepsy (SUDEP) is reduced
Chart illustrating the breakdown of patients on either SenTiva or Aspire device models by McHugh seizure reduction classification at 12 months post-operative time point. McHugh classification is as follows: (0-50% seizure frequency reduction - Class III, 50-79% seizure frequency reduction - Class II, 80-100% seizure frequency reduction - Class I)
• Currently, a prospective review is being devised with a research questionnaire pertaining to impact of VNS therapy on patient seizure outcomes and quality of life for Aspire vs SenTiva models to further elucidate SenTiva’s impact as a first-line VNS option
Retrospective Chart Review Control Group: VNS models without auto-stimulation (DemipulseTM 103/104 and AspireTM 105) Treatment Group: VNS models with auto-stimulation (AspireTM 106 and SenTivaTM 1000)
Resources
Seizure Outcomes: Seizure Frequency Reduction, Seizure Freedom, Anti-Seizure Medication Load, Side Effects, Auto-Stim Parameters Statistical analysis done with IBM SPSS Figure 7: Independent CRISPR knockout of CDK4 or CDK6 does not cause dropout in most breast cancer cell lines studied.
Data recorded at 2 timepoints:
Scatter plot showing distribution between mean seizure frequency reduction 12 months post-VNS insertion and daily auto-stimulation activations at last VNS interrogation (p=0.025)
1Englot
DJ, Rolston JD, Wright CW, Hassnain KH, Chang EF. Rates and Predictors of Seizure Freedom With Vagus Nerve Stimulation for Intractable Epilepsy. Neurosurgery. 2016 Sep;79(3):345-53. 2Eggleston
KS, Olin BD, Fisher RS. Ictal tachycardia: the head-heart connection. Seizure. 2014 Aug;23(7):496-505. The authors would like to extend gratitude to the Donald and Barbara Zucker School of Medicine and the Office of Medical Student Research for extramural funding and for Long Island Neurological Associates for providing workspace for the research to be conducted The authors declare no conflicts of interest