The restore rechargeable, implantable neurostimulator: handling and clinical results of a multicenter study.
BACKGROUND
Spinal cord stimulation is an effective therapy for chronic, neuropathic pain refractory to medication. Use of a rechargeable neurostimulation system (Restore, Medtronic Inc) could provide greater longevity in the treatment of complex pain. However, patients' ability to successfully recharge a neurostimulation system has not yet been demonstrated.


OBJECTIVE
Ability of patients to recharge the neurostimulator.


OBJECTIVE
Patient and physician satisfaction with the system, pain relief, quality of life, functional status, adverse events.


METHODS
Prospective, open-label, multicenter, European study in patients with long-term refractory neuropathic pain. Recharging ability was assessed 1-month postimplant. Patient and physician satisfaction, pain relief, quality of life, and functional status were assessed at scheduled follow-up visits through 12 months. Adverse events were monitored throughout.


RESULTS
Primary end point: 100% of patients (n=41) successfully recharged the neurostimulator. Secondary end points at 1 month: 78.6% of patients found recharging easy. At 12 months: physicians were satisfied with the system for 92.7% of patients; pain intensity decreased significantly (P<0.001); mean self-reported pain relief was 62%; 80.5% of patients had more than 50% pain relief; quality of life and functional status improved significantly (P<0.001); 98% of patients would recommend spinal cord stimulation to others. Overall, 41 device-related complications (23 patients) were observed.


CONCLUSIONS
Twelve-month experience indicates that the rechargeable neurostimulation system (Restore) was easy to use, with 100% of patients able to recharge successfully. Patient and physician satisfaction was high, with significant improvements in pain, quality of life, and functional status. Complications were comparable to prior experience with this therapy.
Van Buyten
Jean-Pierre
JP
AZ Nikolaas-Campus SM, Sint-Niklaas, Belgium. jeanpierre.vanbuyten@mariamiddelares.be
Fowo
Sylvain
S
Spincemaille
Geert H
GH
Tronnier
Volker
V
Beute
Guus
G
Pallarés
Jorge J
JJ
Naous
Hussein
H
Zucco
Furio
F
Krauss
Joachim K
JK
De Andrés
José
J
Buchser
Eric
E
Costantini
Amedeo
A
Lazorthes
Yves
Y
D000328:Adult; D000368:Aged; D004185:Disability Evaluation; D004599:Electric Stimulation Therapy / Q000295:instrumentation* / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000503:physiopathology / Q000523:psychology; D059408:Pain Management; D010147:Pain Measurement; D017060:Patient Satisfaction; D019736:Prostheses and Implants; D011788:Quality of Life; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome