title: Rate of complications among the recipients of intrathecal baclofen pump in Japan: a multicenter study.
abstract: OBJECTIVE
  To evaluate the incidence of complications of intrathecal baclofen (ITB) therapy for spasticity in Japan, where a unique training course and nationwide registration are required.
  
  
  METHODS
  An analysis of complications was performed in all patients who underwent ITB in Japan from 2005 to 2011. Prior to surgery, all the doctors involved took a one-day training course, which included hands-on training. Surgical techniques that avoided complications were emphasized.
  
  
  RESULTS
  A total of 406 pumps were implanted in 400 patients (277 men, 123 women) having severe spasticity. Because this study is currently in progress, among the 400 patients, 78.3% (313/400) had finished a one-year observation follow-up. There were 369 adult and 31 juvenile (under 17 years old) patients, including 12 patients under nine years old. All-cause adverse events were seen in 148 patients (37%), and 93 (23.3%) of these were regarded as severe. Catheter problems were observed in 34 (8.5%) patients: catheter migration in 25 (6.3%), breakage in 6 (1.5%), obstruction in 2 (0.5%), kinking in 1 (0.3%), and dislodgement in 1 (0.3%). Pump trouble was observed in seven (1.8%) patients: alarm abnormality in one (0.3%), memory error in one (0.3%), delayed recovery in one (0.3%), rotation in one (0.3%), malfunction in one (0.3%), and abnormal infusion rate in two (0.6%). Device-related and surgical wound infection occurred in 12 patients (3%), and nine were regarded as severe. Leakage or subcutaneous accumulation of the cerebrospinal fluid was seen in 13 patients (3.3%).
  
  
  CONCLUSIONS
  The requirement of taking of a training course before starting ITB seemed to reduce complications. Although there were surgery-related complications, the rate of complications in Japan appeared to be lower than those reported in larger series of ITB. However, whether the reported rates can be primarily ascribed to a mandatory training course requires further investigations.
authors.affiliation: Department of Neurosurgery, Tokyo Women's Medical University, Tokyo, Japan. ttaira@nij.twmu.ac.jp
authors.forename: Takaomi
authors.initials: T
authors.lastname: Taira
authors.forename: Takayoshi
authors.initials: T
authors.lastname: Ueta
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Katayama
authors.forename: Mamori
authors.initials: M
authors.lastname: Kimizuka
authors.forename: Akinobu
authors.initials: A
authors.lastname: Nemoto
authors.forename: Hidehiro
authors.initials: H
authors.lastname: Mizusawa
authors.forename: Meigen
authors.initials: M
authors.lastname: Liu
authors.forename: Motonao
authors.initials: M
authors.lastname: Koito
authors.forename: Yuko
authors.initials: Y
authors.lastname: Hiro
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Tanabe
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001418:Baclofen / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D016503:Drug Delivery Systems / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007278:Injections, Spinal / Q000009:adverse effects* / Q000295:instrumentation; D007564:Japan; D008297:Male; D008875:Middle Aged; D009125:Muscle Relaxants, Central / Q000008:administration & dosage / Q000009:adverse effects*; D009128:Muscle Spasticity / Q000188:drug therapy*; D012042:Registries; D013530:Surgical Wound Infection / Q000209:etiology; D055815:Young Adult
chemical_list: D009125:Muscle Relaxants, Central; D001418:Baclofen