Stimulation of the anterior nucleus of the thalamus for epilepsy (SANTE) does not appear to

promote adverse ventilatory changes during sleep

Christopher T. Anderson1 , R. Mani1, M. Rizk2, M. Callanan3, J. Pollard1 and Robert S. Fisher3
(1)Penn Epilepsy Center, University of Pennsylvania, Philadelphia, PA, Nihon Kohden America, (3) Stanford University, Stanford, CA
RATIONALE: Stimulating Electrode, 4 contacts
Results of chronic cyclic AN thalamic stimulation thalamus was recently reported in Epilepsia Other studies have shown that thalamic
(the SANTE study); overall results were positive. The device is now approved in 26 countries. injury can disrupt sleep and sleep related
The thalamus is a critical structure in sleep, exploring changes in sleep-related physiological ventilation:
parameters (including breathing) is important in evaluating device safety. Sleep apnea can
exacerbate epilepsy. Patients with apnea will be candidates for AN-stim. Our study evaluated Heumann et al. Obstructive sleep apnea is related to
potential sleep-related ventilatory changes in the SANTE cohort. a thalamic cholinergic deficit in MSA, Neurology
Our goals were: 2003;61;35-39
(1) to determine if those receiving AN-stim had more hypopneas or apneas
than matched controls, & Electrical stimulation of the posteromedial thalamus,
modulates breathing in unanesthetized fetal sheep.
(2) to determine if hypopneas or apneas appeared central or obstructive.
Koos BJ et al. , J Appl Physiol 96: 115–123, 2004
METHODS:
AN-Stim Group Longest events (s) Type SaO2 (%) for the Lowest SaO2 (%) Length and event
4 patients receiving AN-stim and 4 matched controls with epilepsy were studied with standard
longest event type for lowest
PSG (and a full EEG montage) for 2 nights. Although the total number of days of recording was SaO2
16, only 8 nights of recording generated reliable data for measurement of ventilatory changes
and determination of cause (central v. obstructive). All underwent ambulatory PSG EEG. All 78 obstructive 97% 90 78 sec obstructive
wore a nasal thermistor, an SaO2 pulse-ox, and effort sensor belts at the chest and abdomen. hypopnea hypopnea
PSG scoring was performed using Nihon-Kohden, Polysmith ™ software. 98 Average SaO2 Nadirs Per Group
78 obstructive 96% 81 10 sec obstructive 96.25
hypopnea hypopnea 96
RESULTS: Among the AN-stim patients, the longest events for each of the 4 nights, were a 78
s (sec) obstructive hypopnea (OH) with a minimum SaO2 of 97%, a 78 s OH with a min SaO2 47 obstructive 96% 95 12 sec central apnea 94 92.75
of 96%, a 47 s mixed apnea with a min SaO2 of 96%, and a 78 s OH with a min SaO2 of 96%. hypopnea
The lowest SaO2 values were a 90% associated with a 78 s OH, an SaO2 of 81% associated 92
78 obstructive 96% 87 77 sec mixed
with a 10 s OH, an SaO2 of 95% associated with a 12 s central apnea, and an SaO2 of 87% 90
hypopnea hypopnea 89.25
associated with a 77 s mixed hypopnea. For comparison, among the non-stimulated, the
longest events for each of the 4 nights of recording were as follows: a 17 s OH with a min Matched Controls Longest events (s) Type SaO2 (%) for the Lowest SaO2 (%) Length and event 88 88.25
SaO2 of 90%, a 76 s OH with a min SaO2 of 95%, a 77 s OH with a minimum SaO2 of 93%, longest event type for lowest
SaO2 86
and a 78 s OH with a min SaO2 of 93%. The lowest SaO2 values were a 90% associated with
a 17 s OH, an SaO2 of 93% associated with a 71 s OH, an SaO2 of 85% associated with a 57 84
s obstructive apnea, and an SaO2 of 89% associated with a 35 s OH. 17 obstructive 90 90 17 sec obstructive
hypopnea hypopnea AN Stim Group
CONCLUSIONS: Patients receiving AN-stim do not appear to have an increased incidence of 76 obstructive 95 93 71 sec obstructive Lowest
sleep-related ventilatory disruption. During the long events, the lowest SaO2s were found in Lowest
hypopnea hypopnea SaO2% for
controls. AN-stim patients had a slighter higher incidence of central apnea (n=1) although the SaO2%
longest central apnea was only 12 sec. (SaO2 fell only to 95%). The small (n) precludes 77 obstructive 93 85 57 sec obstructive longest event
hypopnea apnea overall
statistical analysis. The events were longer than expected; the event times are likely
overestimates due to the detection software which is extremely sensitive to minor ventilatory 78 obstructive 93 89 35 sec obstructive
changes. Nevertheless, the Medtronic SANTE device does not appear to provoke adverse hypopnea hypopnea
ventilatory changes in sleep.