VAGUS NERVE STIMULATION FOR PATIENTS IN RESIDENTIAL TREATMENT FACILITIES

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1 VAGUS NERVE STIMULATION FOR PATIENTS IN RESIDENTIAL TREATMENT FACILITIES Michael Frost, MD Roger Huf, MD John Gates, MD This paper has been prepared specifically for: American Epilepsy Society Annual Meeting Philadelphia, PA November 30 December 5, 2001 Please consider this information to be preliminary findings. Minnesota Epilepsy Group, P.A. 225 Smith Avenue N., Suite 201 St. Paul, MN Phone: (651) Fax: (651)

2 REVISED ABSTRACT This analysis compared the effectiveness of VNS therapy among patients with intractable seizures: a group living in residential treatment facilities (RTFs) with a group not living in RTFs (non-rtf). Among a constant cohort of patients with baseline, 3-month, and 12-month data, the RTF group had significantly (P<0.05) larger numbers of patients with generalized seizures, previous callosotomy, psychiatric disorders, behavioral problems, and Rett s syndrome. Median seizure reductions after 3 months were 33% in the RTF group and 49% in the non-rtf group (P<0.001); after 12 months, 50% (RTF) and 56% (non-rtf). After both 3 and 12 months, alertness, mood, postictal recovery, and cluster seizures improved in more than a third of patients in both groups. Because VNS therapy does not interact with medications and is delivered automatically, it should be seriously considered for patients with intractable epilepsy and who reside in RTFs. Epilepsia 42 Suppl. 7 :203 (Abst ), 2001 Page 1 of 6

3 RATIONALE Patients who live in residential treatment facilities (RTFs) often have complex behavioral, emotional, physical, and cognitive challenges that are exacerbated by medically refractory seizures. This analysis compared the effectiveness of vagus nerve stimulation (VNS) among patients who had intractable seizures and lived in (RTFs) with similar patients who did not live in RTFs (non-rtf). METHODS Data Source: VNS Patient Outcome Registry Patient Selection Criteria: Patients who lived in RTFs Patients who did not live in RTFs Constant cohort of patients with baseline, 3-month, and 12-month data Comparisons: Baseline demographics Median reductions in seizure frequency, and quality of life at 3- and 12-month follow-up Statistical Analyses Changes over time and differences between treatments were compared with non-parametric methods for ordinal data including the two-sample test and Wilcoxon two-sample test. The signed rank test was used to measure changes within groups. Statistical significance was assumed when p < Page 2 of 6

4 RESULTS Demographics: Constant cohort of 776 patients 86 patients in the RTF group 690 patients in the non-rtf group RTF group had a significantly (p<0.05) larger number of patients generalized seizures previous callosotomy psychiatric disorders behavioral problems neurological defects cognitive challenges Rett s syndrome Median seizure reductions after 3 months (p<0.001) 33% in the RTF group 49% in the non-rtf group Median seizure reductions after 12 months (similar) 50% in the RTF group 56% in the non-rtf group Quality of life improved in more than a third of patients in both groups after both 3 and 12 months of VNS therapy alertness mood postictal recovery cluster seizures CONCLUSIONS: Reductions in Seizure Frequency: 3-month follow-up: statistically significant difference (greater reduction among non-rtf patients) 12-month follow-up: reductions were similar in both groups Because VNS therapy does not interact with medications and is delivered automatically, it should be seriously considered for patients who live in RTFs and have medically intractable epilepsy Page 3 of 6

5 Quality of Life: Percentage of Patients Reported as better or much better Cluster Post-ictal Mood Achievements *Memory Verbal Alertness RTF Group Non-RTF Group *Statistically significant differences (P<=0.05) Page 4 of 6

6 Figure 2 Medical History: Percentage Reported as YES RTF Non-RTF Etiology Known Abnormal MRI Localized Syndrome *Generalized Lennox-Gastaut Syndrome JME Congenital Brain Malformation Meningitis Encephalitis Vascular Brain Malformation Evaluated for Epilepsy Surgery *Previous Callosotomy Previous Lobectomy Previous Any Other Intracranial Surgery Brain Tumor Head Injury *Psychiatric Disorder Depression *Behavior Problems Cerebral Palsy Autism *Rett's Syndrome Tuberous Sclerosis *Statistically significant differences (P<=0.05) Page 5 of 6

7 Figure 3 Change in Seizure Frequency: Percent of Respondents >=50% Reduction >=50% Reduction 30 >=75% Reduction >=90% Reduction No Seizures 30 >=75% Reduction >=90% Reduction No Seizures RTF Non-RTF 0 RTF Non-RTF At 3 Months At 12 Months Page 6 of 6

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