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Risks and Benefits of Ceasing or Continuing Anticoagulant Medication for Image-Guided Procedures for Spine Pain: A Systematic Review

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Objective: To determine the risks of continuing or ceasing anticoagulant or antiplatelet medications prior to image-guided procedures for spine pain. Design: Systematic review of the literature with comprehensive analysis of the published data. Interventions: Following a search of the literature for studies pertaining to spine pain interventions in patients on anticoagulant medication, seven reviewers appraised the studies identified and assessed the quality of evidence presented. Outcome measures: Evidence was sought regarding risks associated with either continuing or ceasing anticoagulant and antiplatelet medication in patients having image-guided interventional spine procedures. The evidence was evaluated in accordance with the Grades of Recommendation, Assessment, Development, and Evaluation system. Results: From a source of 120 potentially relevant articles, 14 provided applicable evidence. Procedures involving interlaminar access carry a nonzero risk of hemorrhagic complications, regardless of whether anticoagulants are ceased or continued. For other procedures, hemorrhagic complications have not been reported, and case series indicate that they are safe when performed in patients who continue anticoagulants. Three articles reported the adverse effects of ceasing anticoagulants, with serious consequences, including death. Conclusions: Other than for interlaminar procedures, the evidence does not support the view that anticoagulant and antiplatelet medication must be ceased before image-guided spine pain procedures. Meanwhile, the evidence shows that ceasing anticoagulants carries a risk of serious consequences, including death. Guidelines on the use of anticoagulants should reflect these opposing bodies of evidence.
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Review Article
Risks and Benefits of Ceasing or Continuing
Anticoagulant Medication for Image-Guided
Procedures for Spine Pain: A Systematic
Review
Clark C. Smith, MD, MPH,* Byron Schneider, MD,
Zachary L. McCormick, MD,
Jatinder Gill, MD,
§
Vivek Loomba, MD,
Andrew J. Engel, MD,
k
Belinda Duszynski,
kj
and Wade King, MMedSc
MMed(Pain),**; on behalf of the Standards Division
of the Spine Intervention Society
*Columbia University College of Physicians and
Surgeons, New York, New York;
Vanderbilt
University, Nashville, Tennessee;
University of
California at San Francisco, San Francisco, California;
§
Beth Israel Deaconess Medical Center, Boston,
Massachusetts;
Henry Ford Health System, Detroit,
Michigan;
k
Affordable Pain Management, Chicago,
Illinois;
kj
Spine Intervention Society, Hinsdale, Illinois,
USA; **Manning Pain Management, Mayo Private
Hospital, Taree, New South Wales, Australia
Correspondence to: Clark C. Smith, MD, MPH, 180
Fort Washington Ave. Ste 199, New York, NY, USA.
Tel: 212-305-3535; Fax: 212-342-8472; E-mail:
cs3028@columbia.edu.
Conflicts of interest: None of the authors has any fi-
nancial conflicts of interest to disclose.
Abstract
Objective. To determine the risks of continuing or
ceasing anticoagulant or antiplatelet medications
prior to image-guided procedures for spine pain.
Design. Systematic review of the literature with
comprehensive analysis of the published data.
Interventions. Following a search of the literature
for studies pertaining to spine pain interventions in
patients on anticoagulant medication, seven
reviewers appraised the studies identified and
assessed the quality of evidence presented.
Outcome Measures. Evidence was sought regard-
ing risks associated with either continuing or ceas-
ing anticoagulant and antiplatelet medication in
patients having image-guided interventional spine
procedures. The evidence was evaluated in accord-
ance with the Grades of Recommendation,
Assessment, Development, and Evaluation system.
Results. From a source of 120 potentially relevant
articles, 14 provided applicable evidence.
Procedures involving interlaminar access carry a
nonzero risk of hemorrhagic complications, regard-
less of whether anticoagulants are ceased or
continued. For other procedures, hemorrhagic
complications have not been reported, and case
series indicate that they are safe when performed
in patients who continue anticoagulants. Three
articles reported the adverse effects of ceasing anti-
coagulants, with serious consequences, including
death.
Conclusions. Other than for interlaminar procedures,
the evidence does not support the view that anti-
coagulant and antiplatelet medication must be ceased
before image-guided spine pain procedures.
Meanwhile, the evidence shows that ceasing anticoa-
gulants carries a risk of serious consequences, includ-
ing death. Guidelines on the use of anticoagulants
should reflect these opposing bodies of evidence.
Key Words. anticoagulant; spine; intervention;
epidural; antiplatelet; hematoma
Introduction
Image-guided interventional procedures are used to
diagnose or treat back, neck, and radicular pain.
Patients undergoing these procedures often have
V
C2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: jour nals.permissions@oup.com 1
Pain Medicine 2017; 0: 1–11
doi: 10.1093/pm/pnx152
comorbidities such as cerebrovascular or cardiovascular
disorders that require the use of antiplatelet or anti-
coagulant medications. For invasive, interventional pain
procedures, these medications may increase the risk of
hemorrhagic complications. The question that arises is
whether anticoagulant medications should be continued
or withheld when various pain procedures are
performed.
Possible hemorrhagic complications of interventional
spine procedures range from a potentially catastrophic
epidural hematoma to minor injection site oozing.
Theoretically, risks of different bleeding complications
should differ among various interventional spine proce-
dures. Although there is a risk of epidural hematoma in
procedures where the epidural space is accessed, there
is no mechanism by which a properly performed extra-
spinal injection such as a sacroiliac (SI) joint injection,
medial branch block, or intra-articular facet joint injec-
tion could cause an epidural hematoma. Other bleeding
complications such as paraspinal hematoma or injection
site oozing may occur in injections performed outside of
the spinal canal.
The 2015 guidelines of the American Society of
Regional Anesthesia (ASRA) explicitly recommend that
anticoagulants be stopped prior to many interventional
pain procedures [1]. While these guidelines provide an
excellent summary of relevant pharmacology, their rec-
ommendations related to interventional spine proce-
dures are not so clearly based on published evidence
related to adverse events.
Some physicians have expressed concerns that stop-
ping anticoagulant medication for interventional spine
procedures may lead to an increased rate of thrombo-
embolic events [2]. Prior studies in general medical
practice have shown that after cessation of therapeutic
anticoagulation, the risk of stroke may be two to three
times greater, and the risk for other major vascular
events is approximately five to six times greater [3,4].
Without evidence-based assessment of the risks and
benefits of ceasing or continuing anticoagulants prior to
image-guided spine procedures, decision-making be-
tween patients and physicians is based on incomplete
information. Therefore, the Spine Intervention Society
(SIS) assembled a task force to collect and assess the
evidence concerning the safety or lack thereof of image-
guided spine pain procedures in patients taking anti-
coagulant medications. This review reports the results of
that exercise.
Methods
A literature search was performed in both PubMed and
EMBASE for articles published January 1948 through
June 2016, using each of the following keyword search
strategies:
1. bleeding risk: (bleeding OR hematoma) AND (injec-
tion OR denervation OR ablation OR neurotomy)
AND spine;
2. spinal hematoma AND injection;
3. cardiovascular risks: (stroke OR myocardial infarction
OR cardiovascular event OR cerebrovascular event
OR thrombosis OR embolism OR blood clot) AND
(injection OR denervation OR ablation OR neurotomy)
AND spine.
When suitable papers were retrieved, their bibliogra-
phies were reviewed for relevant citations that had not
been identified by the database searches.
The titles and abstracts of articles generated by the lit-
erature search were screened by two of the authors (CS
and BD) for prima facie potential relevance or lack
thereof, using the following criteria. The same criteria
were subsequently applied by the investigators who
reviewed the articles selected.
To be accepted for review, articles needed to report a
complication attributable both to an image-guided spine
pain procedure and the use of anticoagulants; to report
the incidence or prevalence of such complications; to
report thrombo-embolic complications in patients who
ceased anticoagulants; or to report the absence of
complications in a series of patients undergoing a spine
pain procedure who were either taking, continuing, or
ceasing anticoagulants during the conduct of that
procedure.
Articles were excluded if they met one of the following
criteria; report of noncatastrophic complications, such
as local bleeding or paraspinal hematoma; report of
thrombo-embolic events not attributable to the use or
cessation of anticoagulants; lack of sufficient information
to allow conclusions to be drawn; lack of clarity regard-
ing whether anticoagulants were continued or ceased;
or lack of clarity regarding the cause of hemorrhagic or
thrombo-embolic complications.
Seven reviewers formally trained in evidence-based
medicine and specializing in spine care assessed the
articles selected for review. Each article was evaluated
to determine if it provided information on the occurrence
of a complication linked to the procedure performed
and if that complication could be attributed to the con-
tinuation or the cessation of anticoagulant or antiplatelet
agents.
Additionally, reviewers determined if articles provided
data to estimate the risk of a complication. Risk was
calculated as the prevalence of a complication in a con-
secutive series of patients, adjusted for sample size by
the 95% confidence interval of a proportion. For articles
reporting a zero prevalence of complications, the
reviewers adopted the upper 95% confidence limit of
that zero proportion as the highest likely risk of the
Smith et al.
2
complication. For this calculation, the method of Wilson
was used as it is deemed appropriate for small magni-
tudes of prevalence [5].
Thereafter, the resultant body of evidence was assessed
using the Grades of Recommendation, Assessment,
Development and Evaluation (GRADE) system to deter-
mine the quality of the evidence [6,7]. In essence, the
GRADE system asks reviewers to evaluate the body of
evidence transparently with consideration not only to
study design, but also to attributes that would
strengthen or weaken confidence in the estimate of ef-
fect. GRADE provides an initial rating of quality based
on the best available evidence that comprises the body
of knowledge, then further requires consideration of
weaknesses (e.g., risk of bias, indirectness) that merit
downgrading, as well as strengths (e.g., large magni-
tude of effect, dose-response gradient) that would justify
upgrading the rating of the quality of the body of evi-
dence. The published data on both the risks of continu-
ing and ceasing anticoagulation prior to interventional
spine procedures were taken into account, and overall
conclusions were drawn in accordance with the GRADE
system.
Results
A total of 2,657 articles were identified by electronic
search of the literature, of which 213 articles were dupli-
cates (identified by both the bleeding and cardiovascular
risk searches). Review of the titles and abstracts of these
2,444 articles identified 54 articles of potential relevance
to bleeding complications and 20 related to cardiovascu-
lar events. Review of the reference lists of the systematic
reviews and primary studies identified by the initial litera-
ture search identified an additional 46 potentially relevant
articles. All authors reviewed these studies.
Most articles failed to satisfy the inclusion criteria and
were subsequently excluded. Others, whose titles
appeared to promise relevance, were excluded for spe-
cific reasons. Three articles were excluded for lack
of sufficient evidence upon which to draw conclusions
[811]. Other articles were excluded because the
patients described were not taking any anticoagulants
[12,13]; insufficient information was reported to deter-
mine whether therapeutic anticoagulation was ceased
or continued [14,15]; the cause of the complication was
unclear [16]; the articles did not disclose whether the
patient was on anticoagulants; or the articles did not re-
port for how long medications had been stopped
[17,18]. Reports of bleeding due to clearly improper nee-
dle placement were excluded as well [19,20]. Reports of
thrombo-embolic complications due to the injection of
particulate steroids were also excluded [2124].
A large observational study that showed no major
bleeding in a cohort of patients undergoing medial
branch blocks was excluded because it was unclear
whether these patients were on therapeutic anticoagula-
tion [25]. Another large study showed no major bleeding
complications after facet joint injections but was likewise
excluded for lack of clarity as to whether patients were
taking therapeutic anticoagulant medications [26].
The remaining accepted literature provided information
in three domains: 1) reports of hemorrhagic complica-
tions in patients undergoing spine pain procedures and
either continuing or ceasing anticoagulants; 2) reports of
the purported safety of spine procedures in anticoagu-
lated patients; and 3) reports of adverse events in
patients who ceased anticoagulants.
Hemorrhagic Complications
No reports of hemorrhagic complications were found at
any segmental level for transforaminal injections, medial
branch blocks, sacral lateral branch blocks, injections
into zygapophysial joints or the SI joint, or radiofre-
quency neurotomy. Hemorrhagic complications attribut-
able to a spine pain procedure were exclusively
reported for interlaminar procedures, being injections of
steroids performed at various segmental levels, and ei-
ther placement or removal of spinal cord stimulator
leads (Table 1).
Three case reports describe catastrophic bleeding as a
complication of cervical interlaminar injection of steroids
(Table 1). It was not clear whether the injection was
image-guided or not in the first case [27], but the injec-
tion was image-guided in the other two cases [28,29].
In the first case, an epidural hematoma caused lasting
paralysis in a patient who continued to take clopidogrel,
diclofenac, and aspirin during the epidural injection [27].
In the other two cases, anticoagulants were ceased in
accordance with guidelines. One patient had stopped
an aspirin-containing product (Fiorinal) seven days prior
to the procedure and developed a subdural hematoma
and lasting paralysis after the procedure [28]. The other
patient had stopped clopidogrel and developed an epi-
dural hematoma but did not suffer lasting neurologic im-
pairment [29].
One case report described an epidural hematoma
resulting in paraplegia after image-guided thoracic inter-
laminar corticosteroid injection [30]. The patient had
stopped warfarin for seven days and was bridged with
enoxaparin 1 mg/kg twice daily, which was discontinued
24 hours prior to the procedure. On the day of the pro-
cedure, the patient’s international normalized ratio (INR)
was 1.00. She remained on aspirin 81 mg/d for the pro-
cedure. The patient continued to have severe neurologic
deficit despite surgical decompression.
Three cases of epidural hematoma have been reported
following image-guided, lumbar interlaminar injection of
steroids (Table 1)[3133]. In all cases, patients were tak-
ing warfarin, which was stopped days prior to the pro-
cedure. In two of the cases, INR was checked prior to
the procedure and found to be 1.2 and 1.0, respectively
[31,33]. In one case, INR was not checked after warfarin
was held for six days [32]. In two cases, the patient was
Anticoagulants and Image-Guided Spine Pain Procedures
3
Table 1 Reports of hemorrhagic complications during spine pain procedures
Reference Procedure(s)
Bleeding
Complication(s)
Anticoagulation
Status Intervention/Outcome
Cervical
Benzon et al. [27] "Cervical epidural
steroid injection"
Image guidance not
specified
C2-7 epidural
hematoma
Presenting as incom-
plete quadriplegia
Continued on
“diclofenac, clopi-
dogrel, and possibly
aspirin”
Cervical decompres-
sion and hematoma
evacuation
Lower extremities
remained paralyzed
Reitman et al. [28] Image-guided C4-C5
interlaminar ESI
C2-6 subdural
hematoma
Presenting as incom-
plete quadriplegia
Fiorinal (containing
aspirin) stopped for
7d
Cervical
decompression
Partial motor recovery
initially
Postoperative course
complicated by
meningitis, patient
died from cardiopul-
monary arrest post-
operative day 8
Benyamin et al. [29] Image-guided C7-T1
interlaminar ESI
“C3 to upper thoracic”
epidural hematoma
Clopidogrel stopped
for 12 d
Cervical decompres-
sion resulting in
resolution of neuro-
logic symptoms
Thoracic:
Loomba et al. [30] Image-guided T9-10
interlaminar ESI
Thoracic epidural
hematoma
Presenting on postop
day 6 with numb-
ness and weakness
in bilateral lower
extremities
Coumadin stopped for
7 d, bridged with
enoxaparin until
24 h prior to injec-
tion; coagulation
profile normal prior
to procedure
Continued aspirin
81 mg
Thoracic
decompression
No significant reso-
lution of symptoms,
persistent complete
thoracic spinal cord
injury
Lumbar:
Ain et al. [31] Image-guided L4-5
interlaminar ESI
L1-5 epidural
hematoma
Presenting as pain,
urinary retention,
numbness/weak-
ness in lower
extremities
Coumadin held 6 d
prior, enoxaparin
bridge until 24 h be-
fore ESI
INR 1.2 on day of in-
jection, no other
labs reported
Lumbar
decompression
At 1 wk after decom-
pression, reported
to have “mild inter-
mittent low back
pain and numbness
in her toes on the
left”
Xu et al. [32] "Lumbar ESI with loss
of resistance
technique"
Image guidance not
specified
Lumbar epidural
hematoma
Presenting as pain
and bladder
retention
Warfarin stopped 6 d
preprocedure,
placed on enoxa-
parin bridge, with
last dose given 30 h
preprocedure
Peri-procedure co-
agulation labs,
including INR, not
reported
Aspirin stopped 6 d
preprocedure
Lumbar
decompression
Resolution of
symptoms
(continued)
Smith et al.
4
bridged with enoxaparin 1 mg/kg [31,32]. In the third
case, warfarin was held without low–molecular weight
heparin bridging. Two of the patients did not suffer per-
manent neurologic damage [31,32], but the third suffered
permanent bilateral foot drop [33].
Additional evidence pertaining to interlaminar proce-
dures was found in the literature on spinal cord stimula-
tors (Table 1). One patient who was taking aspirin
81 mg per day suffered an epidural hematoma after
placement of a spinal cord stimulator lead, although
with no lasting neurologic consequences [34]. A case
series reported two patients who developed epidural
hematomas after removal of stimulation leads [35]. One
patient continued to take aspirin, including on the morn-
ing of the procedure, whereas the other patient had
stopped aspirin for seven days. The patient who contin-
ued aspirin suffered permanent neurologic injury. A large
study of bleeding complications after percutaneous spi-
nal cord stimulator procedures included 101 procedures
Table 1 Continued
Reference Procedure(s)
Bleeding
Complication(s)
Anticoagulation
Status Intervention/Outcome
Page et al. [33] Image-guided L3-4
interlaminar ESI
Epidural hematoma at
L3-4 radiating to
L4-5
Presenting as foot
drop, urinary reten-
tion, and severe
radicular pain
Coumadin held for 7
d; INR 1.0 on day
of procedure
Lumbar decompres-
sion
2 y postoperation,
there was “little
change in the bilat-
eral foot drop,” but
bowel and bladder
function mostly
recovered
Spinal Cord Stimulator:
Buvanendran et al. [34] Percutaneous spinal
cord stimulator trial
and lead removal
T2-T10 epidural
hematoma
Severe pain in low
back and bilateral
lower extremities
during trial accom-
panied by cessation
of stimulation sen-
sation, prompting
immediate lead re-
moval, followed by
lower extremity
weakness
90 minutes
postremoval
Daily aspirin 81 mg
therapy continued
T5-T10 laminectomy
and hematoma
evacuation 7 h after
symptom onset
Complete resolution
of symptoms
Giberson et al. [35] Removal of percutan-
eous spinal cord
stimulator trial
leads
Patient 1: T5-L2 epi-
dural hematoma
Struggled to sit up
immediately after
lead removal, com-
plained of severe
back pain, followed
quickly by
paraparesis
Patient 2: T8-L3 epi-
dural hematoma
45 minutes after lead
removal, reported
acute lower thoracic
pain and lower ex-
tremity weakness
Patient 1: Excedrin
(containing aspirin)
taken on the morn-
ing of procedure
Patient 2: regular
81 mg aspirin, dis-
continued 11 d be-
fore lead removal
Patient 1: immediate
intravenous steroids,
“laminectomy and
hematoma evac-
uation” 2 d after
presentation
“Permanent weak-
ness in his left leg”
Patient 2: immediate
T8-L1 laminectomy
and hematoma
evacuation
Complete resolution
of symptoms
ESI ¼epidural steroid injection; INR ¼international normalized ratio.
Anticoagulants and Image-Guided Spine Pain Procedures
5
in patients in whom nonsteroidal anti-inflammatory
drugs and aspirin were continued with no bleeding
complications [36]. The 95% confidence interval of this
zero prevalence is 0% to 3.7% due to small sample
size, limiting a meaningful estimate of zero or low risk.
Estimates of Safety
Several large observational studies [3739] reported no
cases of major bleeding in various numbers of patients
who continued anticoagulants while undergoing various
spine pain procedures (Table 2).
For radiofrequency neurotomy and various cervical pro-
cedures, the numbers of patients monitored were too
small to provide a meaningful estimate of zero risk. For
other procedures, however, more substantial samples of
patients were monitored.
Studies have attempted to estimate the prevalence of
bleeding complications among patients who underwent
lumbar transforaminal injections while continuing anti-
coagulant and antiplatelet medications. One study found
no bleeding complications in 90 cases in which anti-
coagulant and antiplatelet drugs were continued [37].
Another larger study reported no complications in 955
patients who continued anticoagulants and none in 663
patients who continued antiplatelet medications (Table
2)[38]. These figures indicate that the 95% confidence
interval for hemorrhagic complications is 0.0% to 0.4%
when continuing anticoagulants and 0.0% to 0.6%
when continuing antiplatelet medications.
There are no reports of bleeding complications among
patients who continued therapeutic anticoagulation for
lumbar medial branch blocks. Endres et al. (2016) [38]
reported no complications in 1,142 patients who contin-
ued anticoagulants during lumbar medial branch blocks
or in 925 who continued antiplatelet medications. When
calculating 95% confidence intervals, these figures indi-
cate a risk of hemorrhagic complications of less than
0.3% for continuing anticoagulants and less than 0.4%
for continuing antiplatelet medications.
Among patients who underwent SI joint blocks, there
were no complications in 174 who continued anticoagu-
lants or in 85 who continued antiplatelet medications
[38]. The upper limits of the 95% confidence intervals
for the respective risks of hemorrhagic complications,
such as paraspinal hematoma, were 2.2% and 4.3%.
For lumbar facet intra-articular injections, one study
found no complications among 58 injections where
therapeutic anticoagulant and antiplatelet medications
were continued [37]. Another study encountered no
bleeding complications in 1,109 patients who continued
antiplatelet medications during intra-articular injections
of the lumbar zygapophysial joints (Table 2)[39]. This
constitutes a risk for epidural hematoma of less than
0.3%. Table 2 includes a list of all anticoagulants and
antiplatelet agents used in the above studies.
Medical Complications
The literature contains two case reports of medical
complications in patients who ceased anticoagulants
prior to a spine pain procedure (Table 3)[40,41]. One
patient developed a pulmonary embolism after stopping
warfarin in preparation for a spinal cord stimulator trial
[40]; the other patient suffered a middle cerebral artery
stroke after discontinuing warfarin for a lumbar epidural
injection of steroids [41].
One large retrospective study monitored 2,218 cases in
which anti-thrombotic therapy was stopped (Table 3)
[39]. No major cardiovascular complications were
encountered. In a large, prospective study, anticoagu-
lants were ceased in 1,626 patients [38]. Nine patients
suffered thrombo-embolic complications (Table 3). One
died from a stroke. Another died from a myocardial in-
farction. Five suffered nonfatal strokes, one suffered a
myocardial infarction, and one suffered a pulmonary
embolism. The prevalence of these complications was
nine in 1,626 (0.4%; 95% confidence interval [CI] ¼
0.2–0.7%). However, all events occurred in patients
who ceased warfarin. The same study demonstrated no
thromboembolic complications among 701 patients who
stopped antiplatelet therapy [38].
GRADE Evaluation
For procedures for which there is no evidence either for
risk or for safety, no conclusion about the quality of evi-
dence is applicable. For other procedures, the quality of
evidence differs according to the type of evidence
available.
The evidence concerning safety of interlaminar proce-
dures is low in quality according to the GRADE system
because it is based solely on case reports. This level
could be upgraded if future studies reported the preva-
lence of complications in prospective case series.
For lumbar transforaminal injections, lumbar medial
branch blocks, and lumbar intra-articular injections, the
GRADE quality of evidence is moderate as it is based
on large observational studies. For SI joint injections, the
quality of evidence is perhaps best regarded as low be-
cause although provided by an observational study, the
sample size is small. Larger sample sizes could upgrade
the quality of evidence to moderate.
Discussion
The published literature clearly shows that interlaminar
procedures carry a risk of hemorrhagic complications.
The magnitude of that risk is not known because no
case series has provided a prevalence estimate, but it is
manifestly nonzero. Indeed, the majority of case reports
of hemorrhagic complications occurred in patients who
ceased anticoagulant and antiplatelet medications
according to the 2015 ASRA guidelines. This predomin-
ance may reflect the fact that during routine practice
Smith et al.
6
Table 2 Case series of interventional spine procedures performed without ceasing anticoagulation
Reference Procedure(s) Bleeding Complications Anticoagulation Status
Moeschler et al. [36] 421 patients, 642 percu-
taneous SCS proce-
dures (SCS trial,
revision, or
implantation)
No major bleeding
complications
101 procedures on patients who had
taken aspirin or NSAIDs within 7 d of
procedure
Goodman et al. [37] 197/4,253 procedures
were performed on
patients taking thera-
peutic anticoagulant
and antiplatelet
medications
One patient not taking
therapeutic or antipla-
telet medication suf-
fered spinal epidural
hematoma, which
resolved with nonsurgi-
cal conservative care
Anticoagulant* and antiplatelet
medica-
tions were continued:
90 LTFESI
11 lumbar intradiscal injection
4 CMBB
58 lumbar facet injection
3 sympathetic paravertebral injection
3 cervical RFN
23 lumbar RFN
5 SIJ injection
*Warfarin, dabigatran, apixaban,
rivaroxaban
Clopidogrel, cilostazol, prasugrel,
ticagrelor
Endres et al. [38] 1,383 patients, 7,062
pain procedures
No major bleeding
complications
On anticoagulants* at time of procedure:
955 LTFESI
1,142 LMBB
174 SIJ injection
35 RFN
26 ILESI
On antiplatelets
at time of procedure:
633 LTFESI
925 LMBB
85 SIJ injection
22 RFN
15 ILESI
*Warfarin, rivaroxaban, dabigatran, apix-
aban, enoxaparin
Aspirin/dypyridanole, clopidogrel, cilos-
tazol, ticagrelor, prasugrel
Subtherapeutic only
Manchikanti et al. [39] ESI: 2,664/10,261
patients on antithrom-
bosis medication
Facet: 2,068/7,482 on
antithrombosis
medication
Other injections: 183/546
on antithrombosis
medications
No major bleeding com-
plications that resulted
in neurologic injury
On warfarin at time of procedure:
10 ESI
7 facet procedures
2 “other”
On antiplatelet* at time of procedure:
1,455 ESI
1,109 facet procedures
78 “other”
*Aspirin, clopidogrel, aspirin
CMBB ¼cervical medial branch block; cont ¼continued; dc ¼discontinued; ESI ¼epidural steroid injection; facet ¼facet joint in-
jection; ILESI ¼interlaminar epidural steroid injection; LMBB ¼lumbar medial branch block; LTFESI ¼lumbar transforaminal epi-
dural steroid injections; RFN¼radiofrequency neurotomy; SIJ ¼sacroiliac joint injection.
Anticoagulants and Image-Guided Spine Pain Procedures
7
anticoagulants are held in the vast majority of patients
undergoing procedures. The occurrence of bleeding
complications was not limited to any particular antiplate-
let or anticoagulant. While different antiplatelet agents
are associated with varying degrees of platelet inhibition,
there is insufficient evidence to distinguish the risk of
bleeding complications among these agents. Although
the risk of hemorrhagic complications following interlam-
inar procedures might be small, some reported compli-
cations are severe or catastrophic. Therefore, the
published evidence supports safety concerns during
interlaminar procedures, regardless of whether anti-
coagulant and antiplatelet agents are continued or
ceased.
For several other procedures, published evidence is ei-
ther lacking or minimal in magnitude. There were no
case reports that met inclusion criteria of hemorrhagic
complications for cervical transforaminal injections, cer-
vical medial branch blocks, or radiofrequency
Table 3 Cardiovascular and thrombo-embolic complications attributable to discontinuing
anticoagulation or antiplatelet therapy for pain procedures
Reference Technique
Cardiovascular
Complication(s) Anticoagulation Status
Endres et al. [38] 1,383 patients, 7,062 pain
procedures
9/1,626 complications when
anticoagulants stopped
0/701 complications when
antiplatelet stopped
Complications: 2 patients
died, 5 suffered strokes, 1
pulmonary embolism, 1
myocardial infarction
Anticoagulants held* at time of
procedure:
505 LTFESI
458 LMBB
41 SIJ injection
309 RFN
180 ILESI
Antiplatelets
held at time of
procedure:
250 LTFESI
178 LMBB
6 SIJ injection
195 RFN
72 ILESI
*Warfarin, rivaroxaban, dabiga-
tran, apixaban, enoxaparin
Aspirin/dypyridanole, clopidog-
rel, cilostazol, ticagrelor,
prasugrel
Manchikanti et al. [39] ESI: 2,664/10,261 patients
on antithrombosis
medication
Facet injection: 2,068/7,482
on antithrombosis
medication
Other injections: 183/546 on
antithrombosis
medications
No major cardiovascular
complications reported in
2,218 cases in which
antithrombosis was
stopped
48-hour follow-up
Warfarin held for procedure:
182 ESI
238 facet procedures
22 “other”
Antiplatelet* held procedure:
981 ESI
714 facet procedures
81 “other”
*Aspirin, clopidogrel, aspirin,
and others
Kumar et al. [40] Dorsal Column Stimulator
Trial
Pulmonary embolism
No lasting complications
Warfarin discontinued
Linn et al. [41] L5-S1 epidural steroid
injection
Right middle cerebral artery
infarction; persistent left
hemiparesis, neglect, and
dysarthria
Warfarin discontinued for 9 d
preprocedure
cont ¼continued; dc ¼discontinued; ESI ¼epidural steroid injection; ILESI ¼interlaminar epidural steroid injection; inj ¼injection;
MBB ¼medial branch block; RFN ¼radiofrequency neurotomy; SIJ ¼sacroiliac joint injection; TFESI ¼transforaminal epidural
steroid injections.
Smith et al.
8
neurotomy at any segmental level; conversely, no case
series has provided compelling data that show that
these procedures are safe in patients who continue anti-
coagulants. Such case series are needed before these
procedures might be regarded as safe.
In contrast, the published evidence indicates that lum-
bar transforaminal injections, lumbar intra-articular injec-
tions, and lumbar medial branch blocks are safe and
that SI joint injections might be safe, regardless of con-
tinuation of therapeutic anticoagulation or antiplatelet
medication. For these procedures, there are no case
reports of hemorrhagic complications. Large case series
allow for the calculation of the 95% confidence interval for
the true prevalence of bleeding complications. For lumbar
medial branch blocks, the risk is less than 0.3% in patients
continuing anticoagulants and less than 0.4% in patients
continuing antiplatelet medications. For lumbar transforami-
nal injections, the respective risks are less than 0.4% and
less than 0.6%. For lumbar intra-articular injections, the
risk is less than 0.2% in patients taking antiplatelet medi-
cations. For SI injections, the risks are less than 2.2% for
patients taking anticoagulants and less than 4.3% for
patients taking antiplatelet medications.
Antecedent studies have established a definition of
safety for spine procedures. A study concluded that
lumbar epidural steroid injections are safe in patients
taking anti-inflammatory drugs, on the grounds that zero
hemorrhagic complications were encountered in 383
consecutive patients, for a risk of less than 0.96% [42].
One large study conducted by eminent anesthesiolo-
gists found no bleeding complications in 386 patients
for a risk of 1.1%. The resulting risks of bleeding com-
plications of 0.96% and 1.1% were considered safe by
the authors [42,43].
According to these standards, lumbar medial branch
blocks with a risk of 0.3% or 0.4% and lumbar intra-
articular injections with a risk of 0.3% are clearly safe.
So too are lumbar transforaminal injections, with a risk
of either 0.4% in patients continuing anticoagulants or
0.6% in patients taking antiplatelet agents. The risk of
hemorrhagic complications for SI injections (2.2–4.3%)
falls short of the threshold for safety (1.0%) but might
be demonstrated in a larger case series in the future.
In contrast to the safety of the aforementioned proce-
dures, the literature records complications from ceasing
anticoagulants for spine pain procedures, as currently
recommended by guidelines [1]. Although small (0.4%;
0.2–0.7%), the risk of vascular and cerebrovascular
complications is not negligible, and the nature of the
complications is severe and potentially life-threatening.
Moreover, in patients taking warfarin, the risk of vascular
and cerebrovascular medical complications (0.6%;
0.32–1.15%) is almost significantly greater statistically
than the risk of hemorrhagic complications in like
patients undergoing lumbar medial branch blocks (0.00–
0.34%), lumbar intra-articular injections (0.00–0.35%), or
lumbar transforaminal injections (0.00–0.38%). These
figures warn that guidelines concerning the cessation of
anticoagulants need to balance the risk of hemorrhagic
complications against a potentially greater risk of med-
ical complications.
With respect to vascular and cerebrovascular complica-
tions, this focused review found no vascular or cerebro-
vascular complications pertaining to holding antiplatelet
medications. However, there is a large body of literature
that points to the real and high risk of interrupting antipla-
telet therapy, especially for stent thrombosis [44,45]. This
review only found vascular and cerebrovascular compli-
cations in patients who discontinued warfarin. This finding
may indicate that stopping warfarin may constitute a par-
ticular risk of vascular and cerebrovascular complications.
This may be due to factors relating to the agent itself or
the conditions for which it is prescribed.
This review was undertaken expressly to identify the lit-
erature pertinent to anticoagulation and spine pain pro-
cedures. It was not designed to formulate guidelines or
to discuss conjectures about the risks of complications
in procedures about which there is no evidence.
However, the evidence gathered serves to inform the
directions that future guidelines might take.
For many procedures, there is no published evidence ei-
ther of risk or of safety. Recommendations for these
procedures would be theoretical until evidence becomes
available. Interlaminar procedures carry a risk of hemor-
rhagic complications. In contrast, the evidence does not
warrant attributing any significant risk to lumbar transfor-
aminal injections, lumbar intra-articular injections, or
lumbar medial branch blocks in anticoagulated patients.
Meanwhile, ever present is the risk of serious medical
complications if anticoagulant and antiplatelet medica-
tions are ceased for any spine pain procedure.
In conclusion, the evidence does not support the view
that anticoagulant and antiplatelet medications must be
ceased before image-guided spine pain procedures that
do not involve interlaminar access. Meanwhile, the evi-
dence shows that ceasing anticoagulants carries a risk
of serious consequences, including death. Guidelines
on the use of anticoagulants should reflect these oppos-
ing bodies of evidence.
Acknowledgments
The authors wish to thank the other members of the Spine
Intervention Society’s Standards Division: Professor
Nikolai Bogduk and Drs Anil Sharma, Milan Stojanovic,
and Yakov Vorobeychik, who read and offered comments
on the final draft.
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Anticoagulants and Image-Guided Spine Pain Procedures
11
... Multiple studies have reported no hemorrhagic complications associated with CMBB in patients maintained or not maintained on therapeutic AC/AP agents [4,8,9,[14][15][16][17]. Indeed, in a systematic review examining the risks of continuing or ceasing AC/AP agents prior to image-guided spine procedures performed according to clinical practice guidelines [13], there were no reports of hemorrhagic complications associated with CMBB, although the authors note that there were no compelling data specifically addressing the safety of this procedure in patients who continue AC agents [18]. ...
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Background: Perioperative management of patients on anticoagulant therapy prior to interventional pain procedures creates a challenge when balancing the risk of bleeding against thromboembolic events. Case report: We report a case of epidural hematoma formation in the cervical spine following interlaminar epidural steroid injection in an elderly woman with chronic neck and arm pain, who was on clopidogrel therapy. Conclusions: This is the first reported case of hematoma formation immediately following an epidural steroid injection possibly associated with clopidogrel, even though established guidelines on the timing of the discontinuation of clopidogrel prior to the procedure were exceeded. Severe pain appears to be the first symptom of hematoma formation, and therefore immediate diagnostic workup and evacuation of hematoma are essential in preventing neurological damage. It may be advisable to carry out a test specific for clopidogrel such as the P2Y12 to ensure that there is no residual action on platelet aggregation function, particularly in patients who may be slow metabolizers of clopidogrel. Caution is advised prior to administering analgesics with antiplatelet effects such as ketorolac.
Article
Background: The role of antithrombotic therapy is well known for primary and secondary prevention of cardiovascular disease to decrease the incidence of acute cerebral and cardiovascular events. Data shows that the risk of coronary thrombosis after antiplatelet drug withdrawal is much higher than that of surgical bleeding if the antiplatelet drug therapy were continued. However, it has been a common practice to discontinue antiplatelet therapy prior to performing interventional techniques, which may potentially increase the risk of acute cerebral and cardiovascular events. Study Design: A prospective study of 3,179 patients undergoing interventional techniques with 12,000 encounters and 18,472 procedures from May 2008 to December 2009. Study Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Objective: To assess the rates of adverse events in patients undergoing interventional techniques on antithrombotic therapy with cessation or without cessation and compare them to a group of patients without antithrombotic therapy. Methods: Measurable outcomes employed were intravascular entry of the needle, bruising, local bleeding, profuse bleeding, local hematoma, oozing, and postoperative soreness. The prospective evaluation was performed utilizing the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement which was developed with recommendations to improve the quality of reporting observational studies. Results: The results of this study illustrated that in one-quarter (3,087) of patient encounters utilizing interventional pain management techniques, antithrombotic therapy was included. Among these, for approximately 55%, or 1,711 encounters, antithrombotic therapy was continued during the interventional techniques, whereas, for 45%, or 1376 encounters, antithrombotic therapy was discontinued. Overall, these results illustrate that while intravascular penetration and oozing were higher in patients with continued antithrombotic therapy, bruising and local bleeding were higher in patients with discontinued antithrombotic therapy without any difference either statistical or clinical in any of the other aspects, either intraoperative, post procedure in the recovery room, or postoperative period. Limitations: Limitations include the nonrandomized observational nature of the study and that antiplatelet therapy was limited to aspirin and clopidogrel (Plavix). Conclusion: No significant prevalence of adverse events was observed in those who continued with or ceased antithrombotic therapy. Key words: Interventional pain management, interventional techniques, bleeding disorders, hemorrhagic complications, aspirin, nonsteroidal anti-inflammatory agents, clopidogrel (Plavix), warfarin (Coumadin), regional anesthesia, hemostasis, anticoagulants, antithrombotic agents
Article
Setting. Epidural hematoma rarely complicates interventional spine procedures. While anticoagulant and antiplatelet drugs increase bleeding risk, cessation may precipitate serious thromboembolic events. The Spine Intervention Society (SIS) and American Society of Regional Anesthesia and Pain Medicine (ASRA) put forth guidelines that dissent with regard to management of hemostatically active agents during commonly performed spinal injections. Objective. To validate an antiplatelet/anticoagulant management table based on modifications of the SIS 2013 and ASRA 2015 guidelines. Design. Prospective descriptive study. Subjects. Patients undergoing interventional spine injections from a interventional physiatrist’s practice. Methods. A Modified SIS 2013—ASRA 2015 Antiplatelet & Anticoagulant (MSAAA) guideline table was devised and adopted. Patients undergoing interventional spine procedures were monitored for bleeding events. Results. Of 4,253 injection sites, 197 (4.6%) were performed in 74 patients on antiplatelet/anticoagulants. No clinically evident bleeding events were observed in patients on antiplatelet/anticoagulant medications for lumbar transforaminal epidural (N = 90), posterior-approach facet joint (N = 62), lumbar intradiscal (N = 11), lumbar sympathetic (N = 3), and sacroiliac (N = 5) injections or in 26 radiofrequency neurotomy procedures. One in 2,026 (0.05%, 95% confidence interval = 0.00–0.31%) interlaminar epidural injections (cervical, thoracic, lumbar, and caudal) suffered epidural hematoma. This patient was not on an antiplatelet/anticoagulant drug. No patient in 191 cervicothoracic and 723 lumbar transforaminal injections experienced bleeding complications. Conclusions. Continuing antiplatelet and anticoagulant medications for intermediate- to low-risk interventional spine procedures may be advisable. The MSAAA table may be a reasonable guideline reference for managing antiplatelet and anticoagulant drugs.
Article
Epidural steroid injections are a common procedure performed by pain physicians. The American Society of Regional Anesthesia along with several other groups recently provided guidelines for performing epidural injections in the setting of anticoagulants. We present a case of a patient who developed an epidural hematoma and subsequent paraplegia despite strict adherence to these guidelines. Although new guidelines serve to direct practice, risks of devastating neurologic complications remain as evidenced by our case.
Article
Introduction: Spinal cord stimulators (SCS) are indicated for the management of multiple pain states with strong evidence. Recent guidelines recommend discontinuing aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) for the described procedures. The goal of this investigation is to assess the rate of bleeding and neurologic sequelae in patients undergoing SCS trials and implantation. Methods: This is a retrospective review from 2005 through 2014 of all patients 18 years or older undergoing the following procedures: Percutaneous SCS implantations, SCS revisions, and SCS trials. Baseline characteristics, antiplatelet and anticoagulation medications, coagulation parameters, and procedural details were extracted. The primary outcome was the presence of a bleeding complication within 31 days of the procedure requiring emergency medicine, neurology, or neurosurgical evaluation. The neurological complication was independently categorized for its potential relationship to procedural bleeding, and periprocedural red blood cell transfusion requirements were analyzed as a secondary outcome. Results: A total of 642 percutaneous SCS procedures were performed on 421 unique patients, including 346 SCS trials, 255 SCS implantations, and 41 revision surgeries. Patients had received aspirin or NSAIDs within 7 days of needle placement for 101 procedures (15.7%). There were no bleeding or neurological complications identified in this cohort. Conclusion: Although the incidence of epidural hematoma is low, the development of bleeding complications following SCS lead placement can be devastating. In the present investigation, we identified no cases of epidural hematoma following percutaneous SCS lead placement, including more than 100 patients receiving aspirin or NSAIDs. Future investigations with larger numbers are needed to better define the relationships between periprocedural aspirin and NSAID utilization and bleeding complications.
Article
Background. Guidelines have been published that recommend discontinuing anticoagulants in patients undergoing interventional pain procedures. The safety and effectiveness of these guidelines have not been tested. Objectives. The present study was performed to determine if continuing or discontinuing anticoagulants for pain procedures is associated with a detectable risk of complications. Methods. An observational study was conducted in a private practice in which some partners continued anticoagulants while other partners routinely discontinued anticoagulants. Results. No complications attributable to anticoagulants were encountered in 4,766 procedures in which anticoagulants were continued. In 2,296 procedures in which anticoagulants were discontinued according to the guidelines, nine patients suffered serious morbidity, including two deaths. Conclusions. Lumbar transforaminal injections, lumbar medial branch blocks, trigger point injections, and sacroiliac joint blocks appear to be safe in patients who continue anticoagulants. In patients who discontinue anticoagulants, although low (0.2%) the risk of serious complications is not zero, and must be considered when deciding between continuing and discontinuing anticoagulants.
Article
Objective: Spinal epidural steroid injections are generally considered a safe, effective treatment for radicular pain in a variety of spinal conditions. Complications secondary to these injections, although rare, can result in devastating neurologic symptoms. Patients with preexisting moderate-to-severe spinal stenosis and recent use of chronic anticoagulation pose a challenging dilemma when making treatment decisions, as a history of both can increase the risk of complications. Case report: The following case study provides a description of a patient with spinal stenosis who discontinued anticoagulation therapy according to the recommended guidelines but who experienced a subsequent acute epidural hematoma and significant neurologic injury. Conclusions: This case report describes the potential risk factors present in this patient. Presence of spinal stenosis and the interlaminar approach seem to be significant risk factors in this case. Presence of an intrinsic coagulopathy was not determined.
Article
Introduction Epidural steroid injection is an efficacious treatment for acute and chronic back pain. However, patients undergoing epidural steroid injection frequently receive antiplatelet medications for the treatment of their musculoskeletal pain or underlying inflammatory condition. Unfortunately, antiplatelet therapy, including such medications as aspirin, ibuprofen, naproxen, and ketorolac has been considered a contraindication to epidural steroid injection by some anesthesiologists due to the associated prolongation of the bleeding time and theoretical risk of spinal hematoma formation. Although previous investigations involving surgical or obstetrical patients have demonstrated the safety of neuraxial blockade in patients receiving antiplatelet therapy (1,2), the results have not routinely been applied to the outpatient pain clinic population. This study prospectively evaluated the risk of spinal hematoma in outpatients receiving antiplatelet medications who undergo epidural steroid injection. Methods After 1KB approval, 1000 patients undergoing outpatient epidural steroid injection were prospectively studied. Indication for epidural steroid injection and history of bruising or bleeding was recorded. Ingestion of antiplatelet medications within one week of epidural steroid injection, total daily dose, and timing of last dose of medication were noted. Level of needle placement (cervical, thoracic, lumbar, caudal), needle approach (midline, paramedian), volume of injectate, and dose of local anesthetic/steroid was evaluated. Needle gauge and number of needle passes by pain clinic personnel was recorded. Evidence of minor spinal bleeding such as blood aspirated through the epidural needle, or major spinal bleeding such as spinal hematoma resulting in transient or permanent neurologic deficits was noted. The presence and duration of neurologic symptoms following treatment was recorded. Patients on antiplatelet medications were compared to those not on antiplatelet medications to determine if antiplatelet therapy increased the risk of minor and major spinal bleeding. P<0.05 was considered significant. Results Preliminary results are presented for 141 patients undergoing 131 procedures. There were 97 (69%) females and 45 (31%) males. Mean age was 61±18 years (range 22-94 years). A history of bruising/bleeding was present in 20 (14%) patients. Antiplatelet medications were reported by 72 (51%) of patients; aspirin and ibuprofen were the most commonly reported drugs. Platelet count was assessed in only 2 patients prior to epidural steroid injection; both were normal values. A 17/18 gauge needle was used in 126 (89%) patients; a 20-22 gauge needle was used in the remaining 15 (11%) patients. Needle placement occurred at the lumbar or caudal level in 124 (88%), thoracic level in 2 (1%), and cervical level in 16 (11%) patients. A midline approach was utilized in 120 (85%) patients. Needle placement was achieved with a single pass in 114 (81%), 2-3 passes in 24 (17%), and >3 passes in 3 (2%) patients. Blood was noted during needle placement in 19 (13%) patients. Five (4%) patients reported bruising at the site. Preinjection antiplatelet therapy or history of bruising was not associated with blood during needle placement or post-injection bruising at the site. No patient exhibited signs of spinal hematoma. However, worsening of back pain or radicular symptoms occurred in 15 (11%) patients. In addition, 10 (7%) patients complained of transient tingling or numbness following epidural injection. Conclusions Our study does not implicate antiplatelet medications as a risk factor for traumatic needle placement in patients undergoing epidural steroid injection. While the finding of zero events (spinal hematoma) does not imply the risk is zero (the 95% confidence interval places the incidence between 0-2.6%), our results are similar to those previously reported and suggest that antiplatelet therapy is not a significant risk factor for the development of spinal hematoma (3).