Transcript Establishing a Structured and More Patient

Nestor D. Tomycz M.D., Raj Nangunoori B.S.,
Joseph Hobbs M.D., Donald M. Whiting M.D.,
Michael Y. Oh M.D.
Department of Neurosurgery, Allegheny General Hospital,
Pittsburgh, PA, U.S.A.

Baclofen: an analogue of γ-aminobutyric acid (GABA)

Oral baclofen

In 1984, Penn and Kroin demonstrated the effectiveness of
intrathecal baclofen

Intrathecal baclofen (ITB) has become routine in the
management of spasticity and dystonia arising from either
spinal or cerebral origin

Dearth of literature which effectively characterizes
complications related to ITB therapy

No coherent system for reporting ITB complications

To better characterize complications related to ITB therapy
and to devise a simple, comprehensive, and more patientcentered scheme for complication reporting

MEDLINE search: January 1985 to May 2010

N≥10 and if complications were reported

Articles were excluded if N<10 and if there were multiple
articles by the same author with an overlap in patient
populations

310 articles found, 28 met criteria

Reclassified complications into 4 categories:
technique, device, drug, and infection

Technique: due to the operative procedure itself
◦ CSF-related complications (CSF wound leaks, pseudomeningoceles),
hematoma/seroma, and wound dehiscence

Drug: subjective complaints and symptoms related to baclofen
◦ Nausea, vomiting, somnolence, hypotonia, hypertonia, gastrointestinal
disturbances, respiratory depression, and coma, overdose and withdrawal

Device: problems with the hardware itself
◦ pump (flipping, failure), catheter (kinks, breaks, tears, and migration)

Infections: related to the pump or catheter incision
◦ Wound infection/dehiscence was categorized here due the cause and effect
relationship to the two, “wound dehiscence” was otherwise categorized as a
complication of surgical technique.

28 papers met criteria for systematic review and
included prospective trials, retrospective studies, and
case series

2,623 unique patients, 1,637 complications

Combined complication incidence: 62.4%

Range in total complication incidence: 10-570%

Device complications (n=587, 35.5%) were the most
frequent followed by drug (n=544, 33.2%) followed by
technique (n=293, 17.8%), and infection (n=213,
13.4%)

Among technique complications, CSF-related complications (n =
113, 6.9%) were the most common followed by hematoma/seroma
(n = 14, 0.9%)

Among drug complications, non-postural headache, nausea,
vomiting, dizziness, and drowsiness were the most commonly
reported (n = 212, 13.0%)

Baclofen overdose/withdrawal: n = 28, 1.7%

Among device complications, catheter-related problems were the
most common (n = 193, 11.8%)

8/28 studies (28.6%) reported no drug complications
Articles (Author)
Albright et al.
Albright et al.
Smail et al.
Follett et al.
Gilmartin et al.
Gooch et al.
Guillaume et al.
Ivanhoe et al.
McCall et al.
Murphy et al
Nielsen et al.
Plassat et al.
Rawlins et al.
Sadiq et al.
Vender et al.
Wunderlinch et al.
Zahavi et al.
Hoving et al
Motta et al.
Armstrong et. al.
Borowski et. al.
Heetla et. al.
Rawicki et. al.
Ford et. al.
Penn et. al.
Coffey et. al.
Teddy et. al.
Penn et. al.
Year
2003
2004
2006
2000
2000
2004
2005
2006
2006
2002
2002
2004
2004
2006
2006
2006
2004
2008
2007
1997
2010
2009
1999
1996
1995
1993
1992
1989
# of patients
68
100
64
209
51
152
129
74
48
23
79
40
50
36
195
571
21
17
200
12
174
37
18
12
102
75
46
20
2623 patients
Table 1. Complications by Author
Technique (%)
Drug (%)
System (%)
11.6
14.9
3.9
14.7
0.0
1.0
0.3
0.0
1.5
1.7
0.2
4.8
10.2
23.0
4.1
4.1
0.7
9.9
3.4
0.2
1.5
3.4
11.2
1.4
0.7
0.0
1.7
1.4
1.1
1.0
2.7
0.6
2.9
0.0
6.1
5.3
5.1
2.6
6.0
1.0
0.0
3.9
5.8
1.5
9.4
0.0
0.0
0.0
5.5
12.9
5.3
8.5
9.4
0.5
11.6
0.0
3.6
0.3
2.2
1.7
1.4
5.3
8.2
0.0
2.9
1.9
0.7
0.6
0.3
1.0
1.7
0.2
0.0
0.0
11.2
1.7
2.2
4.3
2.7
0.9
4.1
0.3
0.00
0.51
293 technique
544 drug
587 device
complications
complications
complications
Infection (%)
1.4
2.3
1.4
7.0
2.3
3.8
1.9
2.3
1.4
5.2
3.3
3.8
0.5
0.0
11.3
21.1
0.9
0.5
9.4
1.4
14.6
0.9
0.5
0.0
0.0
0.5
2.3
0.00
213 infections
# of complic
141
54
13
49
184
82
24
84
15
27
35
72
65
26
104
45
119
80
75
26
112
29
8
13
66
43
42
4
1637 total
complications
Defined Complication
Table 1. Technique Complications
# of Total Events
% of Total
CSF leak (and other CSF-related)
wound hematoma/seroma
other
non-serious
pain/discomfort/swelling
wound dehiscence
spinal headache
surgery related
wound pruritus
wound leakage
moving pump
skin necrosis/breakdown
suture site inflammation
incontinence
pocket erosion
catheter dislodgement during surgery
debridement of granuloma
incomplete operation
pressure ulcer
femoral vessel occlusion
skin erosion req. pump removal
113
51
23
22
16
14
14
14
4
4
3
3
2
2
2
1
1
1
1
1
1
6.9
3.1
1.4
1.3
1.0
0.9
0.9
0.9
0.2
0.2
0.2
0.2
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
% of Surgical
Complications
38.6
17.4
7.8
7.5
5.5
4.8
4.8
4.8
1.4
1.4
1.0
1.0
0.7
0.7
0.7
0.3
0.3
0.3
0.3
0.3
0.3
Table 2. Drug Complications
Defined Complication
# of Total
% of Total
Events
headache/nausea/vomiting/dizziness/d
212
13.0
rowsiness
hypotonia/hypertonia/muscle
99
6.0
weakness/spasms
epileptic
61
3.7
seizures/convulsions/psychiatric
changes/alteration in consciousness
constipation/urinary or fecal
40
2.4
incontinence/drooling or salivation
drug overdose/withdrawal and drug
28
1.7
overinfusion/underinfusion§
cardiovascular/respiratory system
20
1.2
related
dysarthria/dysphagia/appetite
13
0.8
changes/difficulty swallowing
other
14
0.9
accidental injury
12
0.7
pain
11
0.7
loss of efficacy/lack of response
8
0.5
pressure sore
4
0.2
sweating
3
0.2
% of Drug
Complications
39.0
18.2
11.2
7.4
5.1
3.7
2.4
2.6
2.2
2.0
1.5
0.7
0.6
Table 3. Device Complications
Defined Complication
# of Total
# of Total
Events
catheter
193
11.8
kink/break/tear/hole/occlusion
catheter
137
8.4
disconnection/dislodgement/
migration*
unspecified catheter
107
6.5
problems/catheter dysfunction
pump problems
86
5.3
(flip/failure/others)
catheter problems (drawing out,
21
1.3
disconnection, breakage)§
other
14
0.9
catheter fibrosis
11
0.7
catheter cut, break, or
6
0.4
disconnection§
malfunction of unidentified
4
0.2
cause
underinfusion
3
0.2
back pain at catheter site
2
0.1
inversion
2
0.1
malfunction of side port
1
0.1
% of Device
Complications
32.9
23.3
18.2
14.7
3.6
2.4
1.9
1.0
0.7
0.5
0.3
0.3
0.2
Table 4. Infection Complications
Defined Complication
# of Total Events
% of Total
% of Infections
Infection (unspecified)
80
4.9
37.6
pump explantation due to infection
50
3.1
23.5
pump/pump pocket infection
46
2.8
21.6
wound infection/dehiscence
10
0.6
4.7
septic/aseptic meningitis
10
0.6
4.7
infection in the back
7
0.4
3.3
urinary tract infection
5
0.3
2.3
lumbar infection
1
0.1
0.5
aspiration pneumonia
1
0.1
0.5
infected hematoma
1
0.1
0.5
infection w/pump salvage after antibiotic
therapy
cystitis
1
0.1
0.5
1
0.1
0.5

Our primary objective: report the combined incidence of complications
related to ITB therapy and to devise a classification scheme that is more
patient-centered

We selected the 4 categories for classification for their simplicity and
comprehensiveness

We found a combined complication incidence of 62.4%

The incidence of complications related to ITB remains high

Much of the reporting on ITB complications has neglected patientcentered complaints (especially drug complications)

Although ITB has been touted as having a lower side effect profile than
oral baclofen, drug complications from ITB are not rare

Improvements in ITB may be prompted by better complication reporting

The 4-tiered complication scheme for ITB will help patients better
appreciate the risks of ITB