A review of the complications of intrathecal baclofen in patients with cerebral palsy, K Kolaski, LR Logan

Tags: complications, cerebral palsy, intrathecal baclofen, report, CITB, adverse events, case reports, case series, Neurosurgery, withdrawal, intrathecal baclofen pump, pediatric patients, complication, spasticity, Pediatric Neurosurgery, Rehabilitation, Albright, K. Kolaski, surgical complication, reports, Wake Forest University School of Medicine, treatment effects, adult patients, withdrawal symptoms, ITB withdrawal syndrome, intrathecal baclofen therapy, Archives of Physical Medicine & Rehabilitation, continuous infusion, J.F. McLaughlin, Journal of Pediatric Rehabilitation Medicine 1, literature review, Pediatric Neurology, L.A. Koman, Developmental Medicine & Child Neurology 43, NR Mental status, mental status changes, Upstate Medical University, pts, ITB withdrawal, Retrospective studies, prospective studies, NR NR NR, baclofen pump, adverse event, studies report, Developmental Medicine & Child Neurology
Content: NeuroRehabilitation 22 (2007) 383­395
383
IOS Press
Review
A review of the complications of intrathecal baclofen in patients with cerebral palsy
Kat Kolaskia, and Lynne Romeiser Loganb aDepartment of Orthopaedic Surgery, Wake Forest University School of Medicine, Winston-Salem, NC, USA bTone Management and Mobility Program, Upstate Medical University, Syracuse, NY, USA
Abstract. Intrathecal baclofen (ITB) has become a standard treatment for spasticity in patients with cerebral palsy (CP) over the last ten years. This review summarizes and assesses the evidence for the safety of ITB in patients with CP. The literature was searched using electronic databases and reference lists from March 2000 through April 2007. There were 36 studies identified reporting on the complications of ITB in patients with CP in non-controlled case series or single case reports; about half of these report only on the issue of complications, while the other half report on treatment effects as well. The majority of the participants reported on in these studies are in the pediatric or adolescent age range, but many studies include some adult patients with CP as well as a minority of patients with diagnoses other than CP. Conclusions on the basis of these disparate studies are limited; however, the available literature suggests that a relatively high rate of complications is associated with ITB treatment and that certain complications are associated with significant morbidity. Children appear to be at higher risk for complications than adults. However, until we have consistent, reliable reports of complications, it will not be possible to perform specific risk/benefit analyses. Recommendations for improving investigation in this important area are discussed. Keywords: Cerebral palsy, intrathecal baclofen, spasticity, complications, outcomes
1. Introduction Use of intrathecal baclofen (ITB) has been increasing in patients with cerebral palsy (CP) over the last decade, and is generally acknowledged to be a relatively high gain/high risk way to manage spasticity in this patient population. This review considers all reports of complications and adverse events associated with ITB in patients with (CP) published since ITB was approved by the Food and Drug Administration (FDA) for use in patients with spasticity of cerebral origin in 1996. Since that time, reporting of adverse effects has been voluntary. In addition, there is no central registry to document the untoward events related to the intrathecal delivery of baclofen, the drug delivery system (DDS), Address for correspondence: Kat Kolaski, MD, Assistant Professor, Department of Orthopaedic Surgery, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, USA. E-mail: [email protected]
or surgical complication and human errors related to DDS-related procedures; thus the reports included in this review reflect the practice(s) of the author(s) and may only be generalized with caution. Moreover, each generation of the DDS components (pump, catheter, and programmer) provides technologic improvements intended to increase safety and reliability. Therefore, firm rates of risk are not available; however, comprehensive awareness of previous adverse events may allow their faster recognition and/or prevention in the future. 2. Methodology The systematic literature review of treatment outcomes of ITB in patients with CP by Butler and colleagues [15] summarized one study that reported exclusively on the issue of seizures and included information on complications from 6 of 14 other studies. The com-
ISSN 1053-8135/07/$17.00 2007 ­ IOS Press and the authors. All rights reserved
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K. Kolaski and L.R. Logan / A review of the complications of intrathecal baclofen in patients with cerebral palsy
Table 1 Results of literature review (March 2000­April 2007)
Report type
Number of studies References
Treatment Effects
Not reporting complications Reporting complications
12
[12,19,30,31,33,41,43,47,48,57,60,63]
17
[1,2,10,13,16,18,23,27,28,40,42,46,49,51,54,61,66]
Complications
Large case series
5
[3,14,26,70,75]
Small case series (N 5) or case reports
14
[8,17,20,21,25,33,44,50,58,59,62,65,76,77]
(see Table 1 for details)
Reviews
13
[5,11,24,35,53,55,64,67,69,71,72,73,74]
Survey of health care professionals
1
[68]
Technical
5
[6,34,39,45,56]
Other clinical observations
2
[4,29]
Total
69
Studies included < 50% participants with CP; these subgroups not separately analyzed. For systematic review of articles reporting treatment effects, refer to reference [38].
plications reported in these studies are summarized on the American Academy of Cerebral Palsy and Developmental Medicine (AACPDM) website [52] and thus are not included in this review. This review considers the many additional studies reporting on the complications of ITB in patients with CP that have been published since February 2000, the last month included in the review by Butler and colleagues [15]. The literature was searched independently by both authors through the MEDLINE and CINAHL databases (from March 2000 through April 2007) for full articles (not letters or abstracts) in English using various combinations of the following terms: intrathecal baclofen, spasticity, dystonia, and CP. Additional articles were identified by review of reference lists and consultation with experts in the field. Studies included in this review met three basic inclusion criteria: 1) treatment involved ITB administered into the cerebral spinal fluid (CSF) as either (i) a bolus test dose (TD) delivered by lumbar puncture (LP) or external catheter; or (ii) a continuous infusion of ITB (CITB) delivered by a surgically implanted pump or external catheter; 2) studies involved participants with a diagnosis of CP, with primarily spasticity or dystonia, or mixed movement disorders; and 3) studies provided data on complications experienced by participants with this diagnosis. The results of the literature search can be found in Table 1. A total of 69 articles were identified. Treatment effects are reported in 29 studies which are reviewed in a separate article [38]; of these, 17 include information about complications experienced by the patients who participated in the study and these details are included in this review. Description of complications is the main objective of another 19 studies; these include 5 large case series and 14 small series (with 5 of less participants) or single case reports. Short summaries
of the latter are contained in Table 2. In addition to the 36 articles documenting complications in case series or reports, some pertinent clinical impressions regarding complications are found in the other types of articles identified that include 13 review articles, 1 survey, 5 technical reports, and 2 reports of clinical observations. For comprehensiveness, a few studies that did not include patients with CP are cited because they contain information about complications relevant to patients with CP. The complications described in the studies reviewed are variable ­ in presentation, severity, and consequences. Variability also exists in the classification of reported complications. The primary causes of the complications described in the literature reviewed are those related: 1) to the drug itself; 2) to the surgical procedures involved in the implantation and/or revision of the DDS; and 3) to the presence, operation and/or functioning of the DDS. The latter two primary causes of complications may indirectly result in abnormally high or low levels of ITB, and thus, often present as drug-related adverse events characterized by overdose or withdrawal symptoms. This review summarizes information from recent reports on complications of ITB in patients with CP using this general classification system. Overall trends and patterns in the complications reported are discussed under a separate heading. 3. Drug adverse effects Five studies report on the effects of test doses of ITB performed prior to pump implantation [1,13,18, 19,33]. Adverse effects are reported in two of these; Dachy et al. [18] report one of six participants experienced drowsiness and hypotonia that was dose-related.
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Author(s) Samson-Fang et al. [58] Dickerman et al. [21] Murphy [50] Anderson et al. [8] Coffey et al. [17] Yeh et al. [76] Zuckerbraun et al. [77] Lew et al. [44] Darbari et al. [20] Segal et al. [62] Hoving et al. [32] Sansone et al. [59] Shirley et al. [65] Fulkerson et al. [25]
Table 2 Single case reports and small case series (N 5 ) reporting complications
Description of reported complication 9 year old with ITB withdrawal simulating neuroleptic malignant syndrome 4 year old who presented on repeated occasions with baclofen overdosage symptoms of variable severity 17 year old developed acute lower extremity hypotonia after catheter repair and post-operatively, developed lower extremity deep vein thrombosis Delayed post-operative coma in 5 of 9 patients who underwent DDS implantation Case series included one patient with CP who experienced severe ITB withdrawal due to an empty pump drug reservoir ITB overdose followed by withdrawal symptoms related to "dysfunctional catheter positioning" 4 cases of ITB withdrawal 15 year old with symptoms of baclofen overdose hypothesized to be related to catheter misplacement in the subdural space as seen on imaging with CT 12 year old with symptoms of overdose after a refill was treated and then developed withdrawal symptoms Case series of 5 patients who underwent spinal fusion after DDS implantation. Their complications included: 1) Positional headache and vomiting in 2 patients 2) Progression of curve after initiation of CITB was seen in 4 of 5 patients 16 year old who presented 3 weeks after DDS implantation with improved spasticity but "mediocre" general condition and a "fluctuating swelling" in the lumbar area. Retrospective chart review on 4 patients who showed accelerated progression of scoliosis after pump implant 12 year old presenting with significant symptoms of ITB overdose; after treatment, he developed withdrawal symptoms. 3 cases of children who experienced complications related to the interaction of a ventriculoperitoneal shunt and treatment with CITB.
Outcome Recovery, catheter disconnection required revision. Catheter breakdown (tear) due to catheter overlying iliac crest; required replacement of the catheter twice as well as pump repositioning at the second revision. Treated with anticoagulation therapy and decreased ITB dose. Recovery; symptoms related to inadvertent boluses given during purge bolus procedure. Recovery. Recovery, required catheter replacement. All recovered. One needed refill; 3 with catheter problems required revisions (multiple in 1 patient) Recovery, required catheter revision. Recovery. Investigation of DDS found catheter disconnection requiring revision. 1) Headache resolved within 2­3 months with fluid hydration and observation; 2) 4 patients with progression of scoliosis underwent spinal stabilization surgery. DDS-related problem was ruled out by Indium flow study. CITB was continued. No treatment was pursued for lumbar swelling and patient's general condition improved. All patients treated underwent successful spinal stabilization surgery. Recovery. Cause of overdosage hypothesized as partial injection of pump pocket during a refill; during investigation of DDS function, radionuclide study revealed a cathether disconnection requiring revision. Two of three cases did well after shunt malfunctions addressed; one patient who had a shunt disconnection repaired developed infection resulting in DDS explantation.
Bleyeneuft et al. [13] report one of seven patients who received 72 hours of CITB via an external pump developed chemical meningitis and required removal of the test material and antibiotics. In patients with CP who undergo DDS implantation for long term treatment with CITB, reports of drug adverse effects are inconsistent both in terms of their nature and frequency. Table 3 summarizes the information about common adverse effects reported in studies of patients with CP treated with CITB for at least six months. Central nervous system (CNS) side effects often limit use of oral anti-spasticity medications, and the decreased incidence of such effects is a theoretical advantage of continuous ITB infusion. CNS side effects (e.g.,
sedation, lethargy, mental status changes, hypotonia, cognitive status changes) occurred at rates of 2­43% [1, 3,10,16,27]. Another case series did not find CNS side effects in any of the 25 patients treated [51]. Fitzgerald et al. [23] report one patient with drug adverse effects of headaches and gastrointestinal upset that responded to dose reduction. Authors of two studies reporting higher rates of CNS side effects suggest that these side effects are dose-related; however, the patients affected were considered to be in the maintenance phase of ITB therapy [2,16]. McCall and McDonald [46] report aspiration pneumonia in one patient of a series of those with cervical level catheter placements. The authors relate this complication to over-sedation from the si-
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K. Kolaski and L.R. Logan / A review of the complications of intrathecal baclofen in patients with cerebral palsy
Table 3 Drug adverse effects
Author(s), N (%CP) Albright et al. [1] N = 77 (71) Meythaler et al. [49] N = 13 (100) Murphy et al. [51] N = 23 (100) Campbell et al. [16]b N = 21 (86)c Albright et al. [2]f N = 68 (78) Gooch et al. [26] N = 100 (76) Awaad et al. [10] N = 29 (100) Gooch et al. [27] N = 80 (78) Fitzgerald et al. [23] N = 52 (92) McCall and McDonald [46] N = 48 (15)
Sedation, Hypotonia Headache Nausea, Constipation New Seizure frequency
drowsiness,
vomiting
onset in those with
lethargy
seizure prior history
6%
8%a
NR
NR
19%
1
Increased = 1
NR
NR
NR
NR
2
2
NR
NR
NR
3
3
NR
NR No change
9 events NR in 7 pts
NRd
NR
8 events in 6 pts
None Increased = 4 events/2 patients
13
17
1
0
NR
NR
NR
NR
NR
NR
1
No change = 8
NR NR
2
NR
NR
4
NR
NR
NR
NR
NR
NR
NR
NR
1 (see NR
NR
Other)
NR
NR
NR
NR
NR
2
Increased = 2
NR NR
None NR
Increased frequency in "small number"g NR
Other Personality change = 1 Psychosis = 2 No change in urinary voiding patterns No change in bowel/bladder, drooling, dysphagia, or cognitive processes; LE DVT = 1 Behavior problems = 5 events/5 pts; Drooling = 5 events /5 pts; Decubitus ulcers = 10 events/7 pts; more othere NR Mental status decline = 2 Bradycardia = 1 Severe spasm = 1 Overdose = 1 Urinary retention = 1 Increased oral secretions = 1 Cognitive status change = 2; Severe spasm = 1 Overdose = 1; Bradycardia = 1 Gastrointestinal upset and headache in 1 patient responded to dose reduction Aspiration pneumonia = 1
Information presented in table reflects how data was provided in study unless otherwise specified. NR ­ Not reported. LE DVT-Lower extremity deep vein thrombosis. aSpecifically reported as decreased head/neck control. bResults reported here include those from first review period (after 5 years of CITB). cInformation obtained from corresponding author. dListed as one of a list of 8 symptoms that occurred as 14 events in 9 patients. eEdema = 3 events/2 pts; Decreased function = 19 events/12 pts; Increased tone 12 events/10 pts; None reported in the following categories: gastrointestinal, swallowing difficulties, urinary, pneumonia, pain. f Symptoms occurring during maintenance phase of therapy. gRelated to weight gain.
multaneous use of CITB and oral baclofen based on the improvement in symptoms observed after the oral baclofen was discontinued. Variable rates of nausea and vomiting (11­14%) [3, 10,51], headache (11­12%) [3,51], and constipation (19­38%) [1,10,16] have also been reported. Other notable, but less commonly reported, adverse effects associated with ITB therapy in pediatric patients with spasticity of cerebral origin include personality changes and psychosis [1], urinary retention and increased oral secretions [10], cardio-respiratory depression [26], lower extremity deep vein thrombosis [50], and decubitus ulcers [16].
Although both increased seizure frequency and new onset of seizures have occurred during treatment with ITB, authors of several studies imply that seizure activity was not significantly influenced by ITB [2,16, 26,49,51]. Fitzgerald et al. [23] theorize that in some cases, increased seizure frequency in epileptic patients treated with CITB may relate to inadequate levels of antiepileptic medications that occur when dosages are not adjusted for increases in body weight experienced after treatment with CITB. Buonaguro et al. [14] reviewed a series of 150 patients treated with CITB compared to a control group of 100 patients with CP and report that 40% of those treated had seizures prior to
K. Kolaski and L.R. Logan / A review of the complications of intrathecal baclofen in patients with cerebral palsy
387
treatment. Of these, seizures experienced by 2 children worsened and 8 improved while only one child developed new onset seizures. The authors conclude that ITB does not aggravate or induce seizure activity in children with spasticity of cerebral origin. There are also concerns about complications occurring in patients with ventriculoperitoneal shunts who undergo DDS implantation for CITB. Fulkerson et al [25] describe three cases of children with CP and shunted hydrocephalus that experienced complications arising from the interaction of these devices, and recommend investigation of shunt function prior to pump implantation [25]. Albright et al. [4] suggest that an increased rate of hydrocephalus in CP may be related to high rate of CSF leaks in CP patients treated with CITB, although this correlation was not directly studied. These authors recommend evaluation of baseline intracranial pressure. 4. Surgical complications Overall, surgical complication rates are relatively high, affecting 25­40% of patients based on frequencies reported or calculated from information in the studies reviewed as shown on Table 4. Because types of surgical complications are classified differently in each study, complication rates, even when specified, are difficult to compare: Albright et al. [1] report a surgical complication rate of 38% in dystonic patients. Vender et al. [70] report that 40 surgical complications occurred in a series of 116 pediatric patients. In this series, wound-related complications were more prevalent in the pediatric than adult groups (46% versus 25%, respectively). Two changes in the original surgical procedure have been advocated for smaller patients in order to maximize soft tissue coverage, reduce potential for skin breakdown, and decrease the risk of peri-operative infection. The first is use of a smaller sized or pediatric pump; the other is implantation of the pump in the abdominal wall in the sub-fascial as opposed to subcutaneous plane. Both of these technique changes have been studied in a non-controlled case series with a majority of CP patients: Based on a multi-center study of the pediatric size pump, Albright et al. [3] report 25 serious procedure-related adverse events occurred in 24 of 100 patients. Kopell et al. [39] report no infection or skin breakdown occurred at an average follow-up of 13.7 months in a series of 18 undernourished pediatric patients who underwent sub-fascial placement of the
pump. In recent reviews on surgical technique, two authors recommend both use of the pediatric sized pump as well as sub-fascial pump placement for smaller patients [6,70]. However, in a series of 571 DDS implantations performed in a pediatric facility, Wunderlich and Krach [75] report 45 infections and note that these pumps were routinely implanted subcutaneously. Choice of pump size and depth of placement are still not well standardized among the surgeons who implant pumps in pediatric patients with CP. Of the surgical complications reported, infections appear to be associated with a higher level of morbidity. Infections may involve the wound and/or pump pocket, can result in meningitis, and frequently require pump explantation. In a review article, Albright and Ferson [5] report an overall infection rate of 10% and state most are caused by Staphylococcus aureus and occur within 6 weeks after DDS implantation. Wunderlich and Krach [75] report that gram negative infections are associated with higher morbidity as compared to gram positive infections, and that those patients who experience this complication are less likely to pursue re-implantation. These authors also report an association of incontinence in patients with gram negative infections and recommend that these organisms be included in the peri-operative antibiotic coverage for ITB-related surgeries. Other relatively common surgical complications such as CSF leaks or collections and wound dehiscence are generally associated with less morbidity. Pump inversions or "flips" are categorized by some authors as a surgical complication and by others as a DDS-related complication. We have classified this relatively uncommon problem as a surgical complication because it is not directly attributable to the device and more likely relates to the surgical technique used to secure the device and/or the patient's manual manipulation of the pump. 5. Drug delivery system-related complications As shown on Table 5, overall rates of DDS-related complications associated with CITB in CP are not often specifically reported or readily extrapolated from the literature. In many cases, DDS-related complications require further surgical interventions. For DDSrelated adverse events reported by Campbell et al. [16], the incidence per patient year of follow-up was 0.48. Vender et al. [70] report 43 DDS-related complications occurred in a series of 116 pediatric patients.
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K. Kolaski and L.R. Logan / A review of the complications of intrathecal baclofen in patients with cerebral palsy
Table 4 Surgical complications
Author(s), N (% CP) Albright et al. [1] N = 77 (71) Meythaler et al. [49] N = 13 (100) Murphy et al. [51] N = 23 (100) Campbell et al. [16]d N = 21 (86)e Albright et al. [2] N = 68 (78) Gooch et al. [26] N = 100 (76) Gooch et al. [27] N = 80 (78) Awaad et al. [10] N = 29 (100) Albright et al. [3] N = 100 (NR) Fitzgerald et al. [23] N = 52 (92) Vender et al. [70] N = 116 pediatric (NR) Wunderlich and Krach [75] N = 571 pumps (NR) Krach et al. [40] N = 100 (88) McCall and McDonald [46] N = 48 (15) Bleyenheuft et al. [13] N = 7 (100)
Overall 38%
Infection 14%a
CSF leak, fistula, accumulation 8%b
Hematoma, seroma NR
Wound dehiscence NR
Meningitis NR
Other
NR
NR
NR
NR
NR
NR
Post-operative
headache and nau-
sea = 2
NR
9c
4
NR
9c
2
NR
1 event in 1 pt 5 events in 4 NR
NR
NR
Transection of
pts
catheter = 1
Suture site inflam-
mation = 1
Retained catheter
fragment = 1
NR
NR
13
15
NR
NR
NR
5 (involving 5 (one with NR
NR
NR
Pump flip = 2
pump)
infection)
70 events in 8 events in 7 5 events in 5 NR
4 events in 4 NR
Pump flip = 4 events
63 pts relat- pts
pts, 1 required
pts
in 4 pts;
ed to DDS or
surgical repair
Femoral vein occlu-
surgery
sion = 1event/1pt;
Suture site inflam-
mation = 2 events in
2 pts
NR
3
NR
7
NR
2
Pump flip/rotated
=3
26 events in 4 events in 4 10 events in 9 7 events in 7 3 events in 3 1 event in 1 pt Spinal headache =
25 pts (25%) pts
pts
pts
pts
1event in 1 pt
Pump inversion = 2 events in 2 ptse
NR
3
5
(reported as NR
NR
Pressure sore over-
CSF leak)
lying pump = 1
40 events in 21 events 14 events
NR
45 pts (39%)
1 event
1 event
Debridement of granuloma = 1;
Drug overdose = 2
NR
45 events NR
NR
NR
2 of 12 who
had gram
negative in-
fections; to-
tal NR
32 events in 6
NR
NR
NR
NR
22 pts relat-
ed to DDS or
surgery
NR
1 (of pump) Pseudomenin- 1
NR
NR
Pump flip = 2
gocele = 1
NR
NR
2
NR
NR
NR
Information presented in table reflect how data was reported in study unless otherwise specified. Frequency calculated for this table based on reported total N and N of affected patients. NR ­ Not reported. aInvolved wound, CSF, or both. bRequired minor surgical procedures. cInvolved combined wound infection and dehiscence. dData included only from first review period (first 5 years after implant). eNot included in overall statistics because authors classify pump flip as DDS complication.
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Table 5 Device delivery system and human error-related complications
Author(s), N (% CP)
Overall
Catheter related Pump related
Human-error Other related
Albright et al. [1] N = 77 (71) Murphy et al. [51] N = 23 (100) Campbell et al. [16]a N = 21 (86)b Albright et al. [2] N = 68 (78) Gooch et al. [26] N = 100 (76) Gooch et al. [27] N = 80 (78) Awaad et al. [10] N = 29 (100) Fitzgerald et al. [23] N = 52 (92) Schmit et al. [61] N = 6 (100) Albright et al. [3] N = 100 (NR) Vender et al. [70] N = 116 (NR) Krach et al. [42] N = 100 (88) McCall and McDonald [46] N = 48 (15)
NR
21
NR
NR
NR
6
0
NR
NR
3 events in 3 pts 6 events in 6 ptsc Mis-injection of
pump = 1
NR
23
NR
NR
NR
28 cases
Catheter access port Overdose = 1
defect = 2
Pump failure = 1
70 events in 63 52 events in 45 pts 2 events in 1 pt
NR
patients related to
DDS or surgery
NR
3
NR
NR
NR
7
NR
NR
NR
3 events in 2 pts NR
NR
NR
4 events in 4 pts NR
NR
43 events in 45 pts 38 events
5 events
NR
32 events in 22 pts 19
NR
NR
related to DDS or
surgery
NR
8
NR
NR
Back pain at site = 2 events in 2 pts Pocket seromad=6 Overdose = 1 Decubitus overlying pump = 1 Catheter tip repositioning = 1 Low battery replacements = 6
Information presented in table reflects how data was reported in study unless otherwise specified. Frequencies calculated from information provided in study. NR ­ Not reported as DDS-related complication. aData included only from first review period (first 5 years after implant). bInformatiion obtained from author. cIncludes pump malfunction (N = 1) and "empty or erratic pump" (N = 5). dOccurred greater than 60 days after implant and, per authors, was related to device.
Complications related to the DDS much more often involve the catheter as compared to the pump. In a review article, Albright and Ferson [5] state that catheter problems occur in 5­15% of cases and require minor corrective surgical procedures. Vender et al. [70] report that catheter-related problems were the most common indication for corrective surgeries in both pediatric and adult patients, but that these complications occurred more often in adults than in children. Two studies note a decrease in catheter problems over the period of the study which is attributed to improvements in catheter technology [1,54]. Gooch et al. [26] report no differences in complication rates between one and two piece catheters. In this same report [26], pumps equipped with a catheter access port are associated with a higher incidence of complications than those without one, but this relationship is not observed in a larger, multicenter report by Albright and colleagues [2]. McCall et
al. [46] did not find any differences in complications or technical difficulties in patients who had thoracic level versus cervical level catheter placements. In a case report, Ross et al. [56] describe an ambulatory adult with CP who experienced repeated episodes of catheter migration which the authors relate to differential motion occurring within the spine and between the abdomen and spine. After multiple revisions, the patient underwent thoracic paraspinal muscle pump placement and adjacent catheter placement in the spine with good results. 6. ITB overdose and withdrawal There is a FDA drug label warning for the acute ITB withdrawal syndrome [22], a life-threatening symptom cascade that evolves in certain patients over one to three
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K. Kolaski and L.R. Logan / A review of the complications of intrathecal baclofen in patients with cerebral palsy
Table 6 Explantations
Author(s) Murphy et al. [51] Albright et al. [2] Gooch et al. [26] Gooch et al. [27] Awaad et al. [10] Fitzgerald et al. [23] Vender et al. [70] Krach et al [40] Wunderlich and Krach [75]
N (% CP) 25 pumps in 23 patients (100) 68 (78) 100 (76) 80 (78) 29 (100) 52 (92) 116 (NR) 100 (88) 12 patients with gram negative infections in a series of 451 DDS implantations (NR)
Number explanted (frequency) 11(44% ) 3 (4%) 4 events in 3 patients (4%) 11 events in 10 pts (12.5%) 4 (14%) 7 (13%) 17% 6 (6%) All 12 pts
Reasons ­ Removed within first 2 months due to wound dehiscence and infection = 8; ­ Removed within first 2 months due to persistent CSF leak = 2 events/1 pt; ­ Catheter repair complicated by meningitis =1 Infection Infection Infection Meningitis = 1; infection = 2; no clinical improvement = 1 Infection = 3; by request = 3; From infection due to decubitus overlying pump = 1 Infection Infection Gram negative infection
Information presented in table reflects how data was reported in study unless otherwise specified. Frequency calculated for this table based on reported total N and N of affected patients. NR ­ Not reported.
days after abrupt cessation of CITB infusion. To date, occurrences of such cases have resulted in death in six adults [17], none of whom had CP. In a general review of these and other cases of serious ITB withdrawal, Coffey and colleagues [17] hypothesize that patients with spinal cord injury levels above T6 who are at risk for episodic autonomic dysreflexia may also have a higher risk of the development of the severe form of ITB withdrawal. These authors and others [58] note that the recognition of the acute ITB withdrawal syndrome may be more difficult in patients with spasticity of cerebral origin treated with CITB. Additional difficulties are associated with recognizing ITB withdrawal in pediatric patients, who may initially present to clinicians unfamiliar with ITB therapy with non-specific symptoms such as fever, fussiness, or itching without rash [7,58]. The authors of one case report recommend confirmation of proper DDS function in any pediatric patient treated with CITB who presents with fever and unexplained systemic illness [7]. In the literature reviewed, there are 4 cases of ITB withdrawal described in patients with CP, all of whom recovered [17,58,77]. Of these, one case report [58] details the symptoms of the acute ITB withdrawal syndrome in a pediatric patient. The symptoms included increased spasticity, fever greater than 40C, mental status change, seizures, tachycardia, hypertension, rhabdomyolysis, and disseminated intravascular coagulopathy. Similar symptoms are described in another
case report of serious ITB withdrawal in a pediatric patient with adrenoleukodystrophy [7]. Medical management of withdrawal symptoms are necessary until CITB infusion can be re-instituted as soon as possible after a human error-related problem is identified and addressed or the system-related problem is corrected [36]. Oral baclofen is used initially for mild withdrawal symptoms. A variety of pharmacologic agents have been described for the alleviation of more significant withdrawal symptoms. In a consensus statement based on a review of patients of various ages and diagnoses, Coffey and colleagues recommend use of high-dose benzodiazepine infusion along with supportive measures [17]. However, there is currently no standardized treatment protocol for the management of the fulminant ITB withdrawal syndrome in patients with CP. Three studies included in this review provide details about the dosages and types of pharmacologic agents used for the management of the acute ITB withdrawal syndrome in pediatric patients and patients with CP [26,58,77]. The specific causes of ITB withdrawal and the process of the trouble-shooting evaluation are discussed in detail elsewhere [5,36]. When a DDS problem is identified as the primary cause of withdrawal, it is more far more likely related to a problem with the catheter as opposed to the pump. While examples of these DDSrelated problems are reported in the literature relatively consistently, it is not known how frequently withdraw-
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al symptoms are related to human errors that occur in daily clinical practice. However, withdrawal related to failures to refill the pump or errors in programming are usually recognized before more serious complications develop. In addition, compared to DDS-related problems, human errors are readily diagnosed with interrogation of the pump and comparison to the documentation of events related to programming. In this review, cases of serious overdosage are described more frequently than cases of withdrawal [8, 20,21,25,44,65,76]. In these reports, the patients described experienced severe symptoms and most required hospitalization and/or emergency room visitation; however, all recovered (Table 2). In several of these cases, patients developed withdrawal symptoms after being treated for overdose [20,65,76]. In two studies, overdose symptoms were related to errors in programming [8,26]. Anderson et al. [8] report five pediatric cases with reversible post-operative coma related to an inadvertent administration of an ITB bolus at the time of implantation surgery, possibly combined with the influence of anesthesia and narcotics. Another report relates overdosage symptoms to a malfunctioning ventriculoperitoneal shunt that caused decreased CSF clearance of baclofen [25]. Several reports implicate various catheter positioning problems as the cause of overdose [21,44,76]. Lew et al. [44] relate overdosage to catheter misplacement in the subdural space at the time of DDS implantation causing sequestration and subsequent release of an excessive amount of ITB. Dickerman et al. [21] relate overdosage to catheter tears from contact with underlying iliac crest and leakage of ITB into the pump pocket. Two studies report discovery of a catheter disconnection in the process of DDS trouble-shooting, but are unclear as to how this finding relates to the patients' initial presentations with overdosage [20,65]. Details regarding the specific causes and evaluation of ITB overdosage are discussed elsewhere [36]. The literature reviewed suggests that cases of ITB overdosage are more likely related to human errors that occur around the time of surgery, refills, or programming than to a primary DDS problem. Human errors responsible for overdosage are usually found by careful review of documentation, and probably are under-reported in the literature. Similar to withdrawal, treatment of ITB overdosage involves both medical and DDS management [36]; several case reports reviewed provide additional details [20,21,44,65,76].
7. Complication trends Krach et al. [40] report that 19 of 33 subjects experienced 29 DDS or surgical related complications within the year after implantation, and 5 subjects experienced two or more such complications. Albright et al. [2] report that approximately 50% of patients experience some adverse event within the first 2 months after implantation, and 50% experience some adverse event during long term follow-up. The incidence of surgical corrections per patient year of follow-up was 0.19 as reported by Gooch et al. [27]; in other words, the chances of requiring repeat DDS-related surgery in this series was 19%. Vender et al. [70] report that 116 pediatric patients required 80 procedures to correct surgical and DDS related complications, as compared to 12 of 55 adult patients requiring 16 procedures. In a multi-center review of complications associated with the pediatric sized pump device, Albright et al. [3] also find that younger patients (< 8 years) experienced more adverse events than their older ( 8 years) counterparts. In a review article, Albright and Ferson [5] state that the three most common complications of treatment with CITB are infections, catheter problems, and CSF leaks. Information about explantation surgeries are specifically reported in 8 of the case series reviewed (Table 6). Rates vary from 4­44%, with infection clearly the leading cause. Based on a series of 25 patients, Murphy et al. [51] report a correlation of explantation with mixed type CP and non-ambulatory status. In two studies, no definite correlations could be made between nutritional status and complication rates or rates of infection [3, 51]. Campbell et al. [16] comment that "regardless of CITB therapy," patients with more severe levels of functional impairment "will experience high rates of adverse events, including death" because of their "underlying severity of neurological impairment". 8. Discussion This review highlights several issues that limit the ability to make meaningful conclusions about complications of ITB in patients with CP. Most studies include patients of different ages and diagnoses, so it is not possible to know the exact frequency and nature of complications exclusively in CP or in pediatric patients. In addition, there is a considerable degree of overlap among participants included in these studies.
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Methods of ascertainment of adverse events vary widely. Some prospective studies use a specific reporting form and method (e.g., patient interview) but these are not standardized across studies. Retrospective studies are typically based on chart review, and thereby, only reflect documentation of adverse events present in the medical record. Documentation of adverse events is performed at various time intervals post-DDS implantation. In one study [16], adverse events are reported for some patients after 5 years post-implantation and for others during a period 5 to 8 years post-implantation. Adverse events are variably reported by simple frequencies, frequencies by treatment years, or by numbers of occurrences/events and/or patients affected. Several studies document the need for additional ITBrelated surgeries after initial DDS implantation; however, these rates often include surgeries for elective procedures, such as catheter tip repositioning, as well as pump device replacement at the end of battery life which is an anticipated surgical event. Unfortunately, adverse events are not categorized using any standardized system. Thus, considerable overlap exists between the different categories of complications; for example, development of a decubitus ulcer overlying the pump resulting in infection may be directly attributable to the DDS but also may reflect any or all of the following: poor patient selection in terms of body habitus, inappropriate surgical selection of the depth of device placement, and/or lack of attention to shear forces by an overlying pelvic positioning device on a wheelchair. Several studies report combined surgical and DDS- related complication rates. In one multicenter report [2], complications are designated as either surgical or DDS-related depending on the time postDDS implantation that had elapsed when the adverse events occurred; however, this same convention was not used in another study which involved many of the same investigators [3]. DDS explantation rates and rates of additional surgeries needed to correct complications are not consistently included in studies. Less than half of the case series reviewed included this information. This is despite the fact that such information is relatively easy to access and is especially relevant to patients and their healthcare providers. Similarly, information about reasons for decisions not to pursue re-implantation at end of battery life or after explantation due to complications is available in only a few studies. There is also little information reported about the long-term outcomes of patients who are treated with CITB and explanted but not re-implanted.
A few studies suggest various factors that may influence patients' and their families' decisions to electively explant, or not to pursue DDS re-implantation at the end of battery life or after explantation due to complications; however, no definite trends have been identified. Based on a telephone interview, Krach et al. [42] report no difference in the percentage of participants experiencing complications among those who would choose to pursue CITB "knowing what they know now" versus those who indicated they would not or were uncertain. Indeed, the subjective report of high levels of patient/caregiver satisfaction is reported frequently in several studies that investigate treatment outcomes [16, 27,54]. In comparison, Wunderlich and Krach [75] report that patients who experience complications from gram negative infections resulting in explantation are less likely to pursue DDS re-implantation. Unfortunately, there are no other studies that provide detailed information about how specific complications of CITB impact patients and their families. Moreover, no available studies evaluate the complications of CITB treatment in patients with CP in terms of a cost/benefit. Given the wide variability encountered in the studies reviewed, there is nevertheless consistency in terms of the association of CITB with a relatively high rate of complications, both in the acute post-implantation period and during the chronic phases of treatment. Because most reported complications are associated with a surgical or DDS complication, many result in the need for additional corrective surgical procedures. Certain types of complications are associated with significant morbidity as well; however, after management of complications, in general, outcomes for patients with CP were generally good. No deaths or significant longterm morbidity were directly related to any of ITBrelated complications reported. However, children do appear to have a higher complication and adverse event rate than adults. This may reflect their body habitus, underlying neurological status, medical co-morbidities, nutritional compromise, and/or other factors which we do not yet completely understand. 9. Conclusion The large number of recent publications reporting on complications of ITB in patients with CP reflects the increased experience with treatment modality in this population. It also provides further documentation of the previously suspected association of CITB treatment with a relatively high rate of complications [9]. Given
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the frequency of complications as well as the challenges involved in their appropriate evaluation and treatment, several authors recommend ­ and we strongly concur­ that in order to optimize treatment effects and minimize complications, patients treated with CITB should be managed in a coordinated system of care by a dedicated team of individuals [2,37,54,55]. Standardized training and experience requirements for all those involved with direct ITB practices­both surgical and nonsurgical­ as well as adequate systems support should be employed to minimize the risks of surgical and humanerror related complications. Detailed and accurate ITBrelated record-keeping must be maintained and accessible to those who are involved in the management of patients with CITB, including those who may be involved in the management of complications. Moreover, the value of patient and Family Education in the prevention and recognition of adverse events cannot be over-emphasized. Several studies [1,54,75] suggest that changes in surgical techniques and/or technological advances have resulted in lower rates of complications within series; to date, these observations have not been the subject of more rigorous investigation. Consistent and complete reporting of adverse events in this population will involve coordinated and collaborative efforts­e.g., with a national registry. Such methods will be necessary in order to provide an accurate understanding of the risks involved with ITB treatment and for identification of those patients who may be at higher risk of developing complications. Acknowledgement The authors would like to acknowledge Beth P. Smith, PhD, Department of Orthopedics, Wake Forest University, for her valuable review and comments. References [1] A.L. Albright, M.J. Barry, D.H. Shafton and S.S. Ferson, Intrathecal baclofen for generalized dystonia, Developmental Medicine & Child Neurology 43 (2001), 652­657. [2] A.L. Albright, R. GilMartin, D. Swift, L.E. Krach, C.B. Ivanhoe and J.F. McLaughlin, Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin, Journal of Neurosurgery 98 (2003), 291­295. [3] A.L. Albright, Y. Awaad, M. Muhonen, W.R. Boydston, R. Gilmartin, L.E. Krach, M. Turner, K.A. Zidek, E. Wright, D. Swift and K. Bloom, Performance and complications associated with the synchromed 10-ml infusion pump for intrathecal baclofen administration in children, Journal of Neurosurgery 101 (2004), 64­68.
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