title: Comparison between an Ascenda and a silicone catheter in intrathecal baclofen therapy in pediatric patients: analysis of complications.
abstract: OBJECTIVE In this single-center study the authors investigated the complications occurring before and after the introduction of the new Ascenda intrathecal catheter (Medtronic Inc.) in pediatric patients treated with intrathecal baclofen therapy (ITB) for spasticity and/or dystonia. METHODS This was a retrospective review of 508 children who had received ITB, 416 with silicone catheters in the 13 years between September 1998 and September 2011 and 92 with Ascenda catheters in the 3 years between September 2011 and August 2014. The authors evaluated major complications such as infections, CSF leaks treated, and problems related to the catheter or pump, and they compared the 2 groups of patients who had received either a silicone catheter or an Ascenda catheter implant. RESULTS One hundred twenty patients in the silicone group (29%) and 1 patient in the Ascenda group (1.1%; p < 0.001) had a major complication. In the silicone group 23 patients (5.5%) were affected by CSF leakage and 75 patients (18%) experienced 82 catheter-related events, such as occlusion, dislodgment, disconnection, or breakage, which required catheter replacement. In the Ascenda group, only 1 patient (1.1%) was affected by CSF leakage. CONCLUSIONS To the authors' knowledge, this study is the first in the literature to compare the performance of the new Ascenda catheter, introduced in 2011, with the traditional silicone catheter for intrathecal drug infusion. In their analysis, the authors found that the Ascenda catheter can reduce major complications related to the catheter after ITB pump implantation. Further investigation is necessary to expand on and confirm their results.
authors.affiliation: Department of Paediatric Orthopaedics, "V. Buzzi" Children's Hospital, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Motta
authors.affiliation: Department of Paediatric Orthopaedics, "V. Buzzi" Children's Hospital, Milan, Italy.
authors.forename: Clara Eleonora
authors.initials: CE
authors.lastname: Antonello
mesh_terms: D000293:Adolescent; D001418:Baclofen / Q000008:administration & dosage*; D002408:Catheters, Indwelling / Q000009:adverse effects; D065634:Cerebrospinal Fluid Leak / Q000209:etiology; D002648:Child; D002675:Child, Preschool; D004421:Dystonia / Q000150:complications / Q000188:drug therapy; D004868:Equipment Failure; D005260:Female; D006801:Humans; D007223:Infant; D015918:Infusion Pumps, Implantable / Q000009:adverse effects*; D007278:Injections, Spinal / Q000009:adverse effects / Q000295:instrumentation*; D008297:Male; D009125:Muscle Relaxants, Central / Q000008:administration & dosage*; D009128:Muscle Spasticity / Q000150:complications / Q000188:drug therapy; D012189:Retrospective Studies; D012828:Silicones
chemical_list: D009125:Muscle Relaxants, Central; D012828:Silicones; D001418:Baclofen
keywords: Ascenda catheter; CP = cerebral palsy; CSF = cerebrospinal fluid; GMFCS = Gross Motor Function Classification System; ITB = intrathecal baclofen therapy; PET = polyethylene terephthalate; complications; functional neurosurgery; intrathecal baclofen; pediatric patient