Impact of Vagus Nerve Stimulation on Quality of Life, Seizure Control, and Cost of Care for Patients with Developmental Disabilities Living in a Long Term Care Setting (ICF-DD): Early Postoperative Results.
Abstract number :
2.329
Submission category :
Year :
2001
Submission ID :
221
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
K. Kneedy-Cayem, MA, LPT, Epilepsy and Brain Mapping Program, Huntington Memorial Hospital, Pasadena, CA; A.N. Mamelak, MD, Epilepsy and Brain Mapping Program, Huntington Memorial Hospital, Pasadena, CA; R.L. Huf, MD, Epilepsy and Brain Mapping Program, H
RATIONALE: To determine the impact of Vagus Nerve Stimulation (VNS) on quality of life, seizure frequency and duration, and cost of care in patients with severe developmental disabilities living in a long term care (ICF-DD) setting.
METHODS: This is a prospective non-randomized trial of 40 subjects. Eligible patients are developmentally disabled adults ([gt]18 years) who live in ICFDD facilities and have medically refractory seizures. Patient eligibility is determined by the principle investigators after referral from the ICF. Once enrolled, pre-surgical baseline evaluations are performed by chart review, discussion with direct care staff and consultant professionals. This assessment includes seizure frequency, anticonvulsant requirements, and a CDER-based index of quality of life. A VNS is subsequently implanted with programming parameters adjusted according to standard criteria for seizure control. Subjects are then assessed for response to VNS with respect to quality of life, seizure control and medication reduction at three-month intervals for two years using a CDER-based questionnaire, chart review, and interview with care givers. Cost of care is also measured, based on medical bills and institutional costs.
RESULTS: To date 36 subjects have undergone a VNS implant, with no surgical complications or inability to tolerate the device. Initial 3-month follow-up was available in 19 patients. No anticonvulsant reductions have occurred. Across all patients the overall seizure frequency has been reduced by 36%, with 31% of patients exhibiting a decrease in seizure duration. A reduction in seizure frequency and duration has been reported in all patients that had previously been hospitalized for status epilepticus. A shortened post-ictal period was reported in 2 patients. Increased alertness has been reported in 52% (n=10) and improved speech production has been reported in 31% (n=6). No changes have been noted in 26% of the patients, and a worsening of seizure frequency or duration has been noted in 10% of the patients.
CONCLUSIONS: Preliminary results indicate that VNS may be an effective treatment option in this population with respect to seizure control and cognitive functioning. Longer-term follow-up is needed to determine if this therapy is cost-effective in this patient population. A detailed analysis of results to date will be presented.
Support: Cyberonics, Inc., Houston TX.
Disclosure: Grant - Cyberonics, Inc., Houston TX.