Running head: NEURAXIAL MANAGEMENT IN PATURIENT WITH HELLP SYNDROME
Appropriate Neuraxial Management in Parturient Patients with HELLP Syndrome
Danielle Dillon, Amy Milewski, Dan Morrissey, Tom Ruzich, Enrique Ramirez, and Jessica
Willis
Barry University
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NEURAXIAL MANAGEMENT IN PATURIENT WITH HELLP SYNDROME
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Appropriate Neuraxial Management in Parturient Patients with HELLP Syndrome
HELLP syndrome, a variant of severe preeclampsia is named for is characteristic
development of hemolysis, elevated liver function enzymes, and low platelet levels. The
syndrome is associated with increased morbidities, maternal mortality rate of 1%, and a 70%
preterm delivery rate (Chestnut, Polley, Tsen, and Wong, 2009). While the incidence of HELLP
syndrome is difficult to establish due to it lack of universally accepted diagnostic criteria, it is
estimated that HELLP-syndrome effects 6 in 1000 pregnancies. As a consequence of the
syndromes associated morbidities and mortality, obstetricians have deemed the syndrome an
indicator for immediate delivery (Chestnut, Polley, Tsen, and Wong, 2009). In a study evaluating
24,677 parturient patients who either had hypertention, preeclampsia, or HELLP-syndrome,
100% of the term parturients delivered by elective or emergent cesarean section (Pacher,
Brix,and Lehner, 2014). Immediate delivery is frequently accomplished through cesarean section
delivery, and therefore necessitates the use of general or neuraxial anesthesia. While neuraxial
anesthesia is the preferred method of anesthesia delivery in the cesarean section patient (scite
source), bleeding risks associates with the syndrome poses increased risk for hematoma
formation and bleeding with the use of neuraxial anesthesia. This literature review seeks to
identify the most appropriate use and management of neuraxial anesthesia in the HELLP
syndrome patient undergoing cesarean section delivery.
Relevance to Nurse Anesthesia Practice
The benefits of anesthesia in the management of labor pain to minimize the adverse
effects of prolonged, sever pain of childbirth are widely accepted and jointly recommended by
both the American Society of Anesthesiologists and the American College of Obstetricians [1].
Neuraxial anesthesia precludes the general anesthesia risks associated with intubation related
NEURAXIAL MANAGEMENT IN PATURIENT WITH HELLP SYNDROME
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complications and is generally preferred in the hematologically stable patient. However, in the
patient with coagulopathy the potential risk of a debilitating spinal hematoma and lack of clear
and specific risks and guidelines presents a dilemma. While recommendations pertaining to the
administration of RA to patients with coagulopathy have been established in most developed
countries, the risks have not been defined and the guidelines are broad. Numerous reviews of the
problem have been published in recent years; yet little primary research has been conducted to
support data from earlier studies suggesting, but not defining the risk and precise factors
contributing to bleeding related complications from NA in HELLP patients. Specific data
defining the risk related to NB in patients with coagulopathy and the specific relationship
between the level of risk and degree of coagulopathy would be most beneficial to the practitioner
confronted with these patients. If an increased risk were shown to exist, to what extent might
other obvious factors, such as the equipment used in the procedure, be contributory, and thus
provide potentially mitigating solutions?
The purpose of this review is to attempt to identify any existing consensus among recent
reviews defining the risks for bleeding related complications in patients undergoing NA, explore
the foundational research upon which the perceived risk and current guidelines have been
established, and explore potential obstacles toward the establishment and acceptance of evidence
based criterion in the management of these patients.
Literature Research Method
Searches of electronic databases including CINHAL, MEDLINE, PubMed, and Google
Scholar for articles published between June, 2010-June 2014 using variations of the expression “
‘HELLP’ AND ((‘Spinal Hematoma’ OR ‘Hematoma’) AND (‘Regional’ OR ‘Neuraxial’))”
identified 45 potentially eligible studies published within the past five years. Studies not
NEURAXIAL MANAGEMENT IN PATURIENT WITH HELLP SYNDROME
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including specific references to the bleeding related complications from NA in HELLP patients
were eliminated, leaving 17 eligible studies. Initially, primary research involving prospective
correlational analysis between procedure and incidence of spinal hematoma, coagulopathy and
risk, or equipment and risk were the goal. Unfortunately, no such studies could be found, and
very few primary studies could be identified even when expanding the search beyond the 20102014 time frame. After review of the published material revealed a lack of primary research,
further review was conducted among the eligible studies to identify common sources and
authoritative guidelines specific to risk and coagulopathy parameters. Due to the unexpected
lack of primary research supporting current guidelines, the literature review topic was expanded
to include exploration into potential reasons for the lack of primary studies on this topic.
Literature Review Discussion and Scarcity of Recent Primary Research
The lack of recent primary research defining the risks and contributing factors to bleeding
related complications from NA in HELLP patients became of specific interest in the review
considering the general lack of specific criteria and guidelines for the administration of RA in
HELLP patients. Investigation into the primary sources cited by more recent literature revealed
a number of potential gaps in the research from which the prevailing perceptions of risk came,
but the absence of prospective investigation into the correlation between the incidence of spinal
hematoma and obvious variables such as platelet count and equipment raised its own questions.
Discussion of Current Published Material
Almost universally, studies within the past five years claim that few studies have been
performed and little data exists defining the exact correlation between hematologic values and
incidence of bleeding related complications resulting from neuraxial technique or even the risk
of spinal hematoma for the general population. The majority of data cited representing the
NEURAXIAL MANAGEMENT IN PATURIENT WITH HELLP SYNDROME
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degree of known risk comes from a very small number of retrospective studies conducted with
very few controls and limited inclusion/exclusion criteria. Since the majority of published
material on the topic consisted of reviews intended to clarify the uncertainty surrounding the
specific risks and criteria for the administration of RA, and the majority of the studies in our
review cited similar primary studies and authoritative guidelines concerning the risks and criteria
for RA in HELLP patients, four of these studies and two of the most referenced authoritative
guidelines were selected for discussion. The primary sources relating to risk and criteria
referenced by these studies, although outside the desired time frame for the review, required
investigation to determine the strength of those findings based on study design and data analysis.
The earliest publication included in our investigation (V. Moen, 2009) was a 2009
analysis of the Royal College of Anaesthetists Third National Audit Project (The Royal College
of Anaesthetists Third National Audit Project, 2009), which is rarely referred to in most of the
current studies yet was cited as the largest prospective study pertaining to neuraxial anesthesia
complications. Interestingly, this review included contributions from members involved in the
most broadly cited source of primary research regarding spinal hematoma risk in HELLP
patients (Vibeke Moen, 2004). The authors of the review focused much of the criticism of the
study design and explanation on how the methods of stratifying the sample and nominal
categorization of the data likely resulted in a misrepresentation of the incidence and risk of
complications from RA. The actual study under review involved a large sample of 707,455 CNB
procedures performed over a year involving a rigorous and exhaustive review by expert panel.
Unfortunately, the results were abstracted into two large nominal categories ambiguously named
“Optimistic” and “Pessimistic” regarding the severity of complication. The data analysis
methods further altered the presentation of final results through inclusion of mixed-risk groups
NEURAXIAL MANAGEMENT IN PATURIENT WITH HELLP SYNDROME
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into the denominator and eliminating all complications not resulting in permanent damage or
death from the numerator. The final conclusion of the research was criticized as structured to
produce results reflecting favorably on the incidence of CNB complications within the UK
National Health Service. **This study, as is common with others in this review, compare the
incidence of risk with the four primary studies regarded as landmark studies discussed later in
this review. This particular publication did not offer any additional clarity toward the subject of
RA risk for spinal hematoma.
The second earliest study selected for review (A.J. Butwick, 2010) sought to establish
safer hemostatic conditions for NB placement through advancement of hematologic testing prior
to performing neuraxial blockade in patients with preeclampsia and identify possible correlation
between blood pressure, thrombocytopenia, and risk of DIC. The study involved a retrospective
analysis of medical records among a convenience sample of preeclamptic patients in a university
hospital using Pearson and Spearman correlation coefficients between hematologic indices
having clinical and biochemical parameters. The conclusion arrived at by the researchers of this
study were to suggest the need for additional research to determine a correlation between the
timing of hematologic testing and bleeding related complication. Like the majority of studies on
the topic from recent years, this study offered little in the form of greater clarification of risk or
specific guidelines. This review also relied upon earlier research (Vibeke Moen, 2004) and
authoritative guidelines ( American Society of Anesthesiologists Task Force on Obstetric
Anesthesia, 2007) as an established premise of the known risk of bleeding related complications
in the patient with low platelets and offered little in the way of clarification on those results.
**In a systematic review of the literature, Veen et all (2009) attempted to decipher at
what level of platelets one may safely administer a neuraxial anesthetic without hemorrhagic
NEURAXIAL MANAGEMENT IN PATURIENT WITH HELLP SYNDROME
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complications. They reviewed 9 specific case series, all of which were retrospective in nature
excluding one, which focused on neuraxial anesthesia administered to thrombocytopenic
patients. All patients who received neuraxial anesthesia during these series had a platelet count
below 100 x 10^9/l at the time of insertion Of the 345 patients included in the case series that
received either an epidural or spinal anesthesia, no complications of spinal hematoma were noted
(Veen et al, 2009). Among the case series many of the exclusion criteria for their sample
populations were not expounded upon, and therefore the results cannot be generalized to larger
populations. Twenty-one case reports were also scrutinized by Veen et al (2009) and their
findings included 5 patients who incurred a spinal hematoma. Of these 5 patients, 3 of them
presented with HELLP syndrome, but all of them had further risk factors noted for bleeding that
were not documented in the study.
The agreed upon platelet count for the safe administration of neuraxial anesthesia
according to their research was 80 x 10^9/L. However, this guideline comes with the stipulation
that platelets still be monitored closely and must be stable at time of administration. With
careful scrutiny one can start to notice extraneous variables come into play with these studies.
One variable that anesthesiologists can try to control but is not always possible is the number of
attempts for insertion of the epidural or spinal anesthetic. The greater the number of attempts
made the greater the risk for spinal hematoma. The authors also make note that some patients
had received a platelet transfusion prior to insertion of the needle. Further research should be
done on this practice to see if transfusing platelets at a certain level prior to epidural or spinal
administration would decrease the risk of bleeding. Another challenge that presents with
retrospective studies is that there is not always additional information on a study when required.
Take for example coagulation studies, this information may not always be readily available to
NEURAXIAL MANAGEMENT IN PATURIENT WITH HELLP SYNDROME
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assist the researcher in answering further questions they may have that led to an undesirable
outcome.
Among the recent published studies included in our review, four studies were commonly
cited as the primary sources of accepted risk of spinal hematoma in hematologically
compromised patients. Two of those studies did not involve primary research and simply cited
another one of the four as the authority on established risk, reducing the number of primary
sources to only two studies. In addition to the two primary studies, three authoritative
publications were cited as sources for guidelines on the practice of managing NA in HELLP
patients.
Discussion of Primary Research
As pointed out earlier in this review, most of the current material published on the topic
of RA in HELLP patients references one of four primary research sources and two authoritative
advisory bodies regarding the risk of bleeding related complications from NB in HELLP paieints
and the criteria defining the safe range for platelet count. Among the four primary sources of
risk data, only two involve research and are also referenced by the other two. There are two
pieces of data that are of questionable origin, the actual of risk of spinal hematoma related to
platelet count, and the source of the commonly adhered to standard for safe platelet count when
considering NA.
The most recent of the primary sources spinal hematoma risk in patients with
coagulopathy is a Swedish retrospective study conducted in 2004 (Vibeke Moen, 2004). The
study design was a retrospective medical record review and postal survey consisting of
1,260,000 spinal blocks and 450,000 epidural blocks between 1990 and 1999 which did not
include hematologic criteria. Of the combined 1,710,000 procedures, the researchers identified
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33 spinal hematomas. Spinal hematomas represented 25% of the complications found to result
from NA, and according to the raw data in their study; the incidence of spinal hematoma was
1:80,000-120,000 for spinal blockade and 1:100,000 for epidural. These numbers were referred
to in several studies found in our review as the accepted level of risk for spinal hematoma among
HELLP patients receiving NA. Only two of the 33 spinal hematomas occurring among the
nearly two million cases were found to involve patients with HELLP syndrome. No other data
representing potentially influential variables was analyzed, and no data regarding the total
number of patients with HELLP syndrome or low platelet count among the sample population
was provided. Extrapolation upon the accepted incidence of HELLP syndrome of 0.2 to 0.6
percent (Kjell Haram, 2009) would suggest roughly twice the incidence of spinal hematoma
among patients with HELLP syndrome from the general population; however, this would be
largely speculative. The absence of data reflecting the incidence of HELLP criteria in the sample
as well as lack of other controls limits the strength and validity of these projections onto the
general population.
Regarding the source of the current standard of safe platelet count when considering NA,
most of the published material point making reference to the 100,000 platelet count cite a book
(Cousins, 1988) from 26 years ago which appears to attribute that value solely to expert opinion
and relative normal biological parameters. We were not able to trace any studies that specifically
attempt correlational analysis between platelet count and incidence of spinal hematoma.
Presumably, the lack of such effort is likely due in part to the existing limited research indicating
the extremely low incidence of spinal hematoma among hematologically compromised patients
relative to the general population. As practitioners exercise prudence and careful consideration
NEURAXIAL MANAGEMENT IN PATURIENT WITH HELLP SYNDROME
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with these cases, it might be assumed that the incidence of spinal hematoma even with patients
having coagulopathy might drop to the point where a prospective study is simply not feasible.
Discussion of Authoritative Guidelines
Three of the most commonly cited authoritative sources for guidelines relating to
neuraxial anesthesia in HELLP patients were the 2010 ASRA Practice Advisory, (Terese T.
Horlocker, 2010) the ASA Practice Guidelines for Obstetric Anesthesia ( American Society of
Anesthesiologists Task Force on Obstetric Anesthesia, 2007), and the recommendations
published from the ASA 2010 Annual Meeting (American Society of Anesthesiologists, 2010).
While none of these publications involve primary research, to varying degrees, they all
acknowledge the difficulty in achieving definitive data regarding risk due to the rarity of spinal
hematoma, and rely predominantly upon expert opinion and synthesis of case reports, clinical
series and subject matter expertise. [Need more content on this]
[Need discussion of gaps in research]
Prospective & retrospective correlational studies between platelet count and incidence of
spinal hematoma.
Research into potential mitigating effect of reducing needle/catheter by a single gauge
[Need discussion of obstacles toward reliance upon research data over expert opinion]
Defensive medicine/perception of liability
Role authoritative guidelines play in limiting EBP when research is contrary to liability
related “standard of care” established by authoritative guidelines.
Blood Pressure Guidelines for Preventing Complications in HELLP Syndrome
Evidenced based practice for blood pressure management in HELLP syndrome patients
involves stabilization of preeclampsia, pre-neuraxial fluid preloading, hypotension secondary to
NEURAXIAL MANAGEMENT IN PATURIENT WITH HELLP SYNDROME
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anesthesia, and the use of antihypertensive agents. In HELLP syndrome, maintaining a systolic
blood pressure less than 160 mm Hg and a diastolic blood pressure less than 105 mm Hg is
recommended for prevention of complications including cerebral hemorrhage and pulmonary
edema. Arterial blood pressure monitoring is often indicated due to the rapidly changing blood
pressure and varying degrees of intravascular volume depletion. Pulmonary artery catheters
have not been shown to improve outcomes and the usefulness of central venous catheters has
also been controversial (Chestnut, et al., 2009).
Pre-neuraxial fluids remain important but additional factors to prevent pulmonary edema
must be considered. For labor epidurals, clinical practice has switched to much lower
concentrations of local anesthetic (0.0625% to 0.125% bupivacaine) which reduces the clinical
need for fluid preload. Spinal anesthesia has a greater hypotension risk so fluid administration
with careful monitoring of infusion rate is required but should be balanced against the patients
other clinical risks. Hypotension incidence after neuraxial administration should involve
judicious, small doses of ephedrine (2.5 mg) or phenylephrine (25-50 mcg) due to concern there
may be an excessive response to vasopressors in severe preeclamptic patients (Chestnut, et al.,
2009). While studies have not confirmed the concern, smaller and more incremental dosing is
regarded as safe and best practice when compared to giving larger doses of vasopressors.
Antihypertensive medications are a mainstay of blood pressure management for HELLP
patients and the primary recommended agents include labetalol, hydralazine, and nitroglycerin
due to their effectiveness and safety profiles (Chestnut, et al., 2009). Further blood pressure
management will be required in the case of a failed block when a rapid sequence intubation will
be required but those considerations are outside of the scope of this paper.
Differential Diagnosis
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Due to the variable clinical presentations with HELLP syndrome, it may be easily
misdiagnosed. Some of the common differential diagnosis include acute fatty liver of pregnancy
(AFLP), hemolytic uremic syndrome (HUS), thrombotic thrombocytopenic purpura (TTP), and
systemic lupus erythematosus (SLE) (Ankichetty SP, Chin KJ, Chan VW, Sahajanandan R, Tan
H, Grewal A, Perlas A., 2013). The wide variable onset of HELLP syndrome can take place
antepartum 70% of cases to post-partum in 30% of cases, making a diagnostic timeframe
difficult when making comparisons (Chestnut, Polley, Tsen and Wong, 2009, p. 988-989).
Clinical symptoms of AFLP vary and there is significant overlay in features with HELLP
syndrome. AFLP generally occurs after the 30th week of gestation with a 1 to 2 week history of
headache, right upper abdominal pain, malaise, anorexia, and nausea vomiting (Haram, 2009).
Hypertension and proteinuria may or may not be present. Additional symptoms include
metabolic acidosis, acute liver failure, mild disseminated intravascular coagulation (DIC) and a
prolonged prothrombin time (PT) and partial thromboplastin time (PTT) (Haram, 2009).
Ammonia level are increased while glucose and fibrinogen levels are decreased compared to
HELLP (Ankichetty SP, Chin KJ, Chan VW, Sahajanandan R, Tan H, Grewal A, Perlas, 2013).
HUS and TTP are thrombotic diseases which include some of the same characteristics in
HELLP syndrome including vascular injury, platelet aggregation, microthrombi, anemia and
thrombocytopenia (Haram, 2009). A significantly elevated lactate dehydrogenase and increased
creatinene levels with a blood smear may help differentiate HUS and TTP from HELLP
syndrome (Ankichetty SP, Chin KJ, Chan VW, Sahajanandan R, Tan H, Grewal A, Perlas,
2013). The microvascular injury in HUS affecting the kidneys occurs mainly in the post-partum
period where signs and symptoms of renal failure may manifest (Haram, 2009). TTP, although a
rare condition during pregnancy, is demonstrated by neurological manifestations, bleeding,
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abdominal pain and fever (Haram, 2009). Neurological symptoms presenting include headaches,
confusion, aphasia, transient paresis, weakness and seizures (Haram, 2009).
SLE is an autoimmune disease evident by antigen-antibody complexes in capillaries, with
mild to severe clinical findings. SLE may affect multiple organ systems in the body including
kidneys, lungs, heart, liver and brain (Haram, 2009). The clinical and laboratory findings in
women with SLE are similar to those with HELLP syndrome. According to Haram:
“Antiphospholipid antibodies are present in 30–40% of the cases, while thrombocytopenia
occurs in 40–50% and hemolytic anemia in 14–23% of the women with SLE. Cerebral lesions
and symptoms may develop because of vasculitis and/or cerebro-vascular occlusion that might
lead to seizures.” In antiphospholipid syndrome (APS), the antiphospholipid antibodies that
occur are associated with recurrent arterial and venous thrombosis which can result in a
spontaneous abortion (Haram, 2009). APS may also occur as a primary solely and unrelated to
SLE. This research helps explain HELLP syndrome occurring in women with an existing APS
syndrome may be more common than was thought (Haram, 2009). Abnormalities that are
indicative of a SLE disease flare include a C3 (complement component) and C4 decrease, high
titer of anti-double stranded DNA antibodies, active urine sediment and the coexistence of active
SLE manifestations in other organs (Doria A., Lockshin M., Tincani, A., 2008). These tests
should be done promptly to help differentiate the disease processes even though they are time
consuming and expensive (Doria A., Lockshin M., Tincani, A., 2008).
Which type of anesthetic technique is the most advantageous?
Epidural, Spinal and CSE techniques can all be used providing certain criteria are met.
Traditionally, epidural anesthesia has been considered the gold standard in regional anesthesia in
women with HELLP, while spinal anesthesia was contraindicated due to the marked hypotension
NEURAXIAL MANAGEMENT IN PATURIENT WITH HELLP SYNDROME
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from the rapid onset of spinal sympathetic blockade (Chestnut, Polley, Tsen and Wong, 2009, p.
994). Advantages of epidural use include stability of maternal blood pressure, uteroplacental
perfusion and the ability to titrate fluids and local anesthetics slowly to avoid significant drops in
blood pressure. A recent study by Wallace randomly assigned 80 women with HELLP requiring
a cesarian delivery to receive epidural, CSE or general anesthesia. The study showed no
significant decrease in maternal mean arterial pressure when using a CSE and an epidural
(Chestnut, Polley, Tsen and Wong, 2009, p. 993). Another study by Hood and Curry noted that
with 138 women having Cesarian deliveries, there were no significant differences comparing the
lowest mean arterial pressures in women receiving an epidural vs a spinal anesthetic (Chestnut,
Polley, Tsen and Wong, 2009, p. 994). Researchers’ concluded that the known greater
sensitivity to vasoconstrictors in pregnancy may explain the incidence of post spinal anesthesia
hypotension that was occurring (Chestnut, Polley, Tsen and Wong, 2009, p. 994).
Is there a best practice? Safety in neuraxial anesthesia and alternative techniques.
Regardless of the technique, some additional best practice recommendations according to
Chestnut involve proper hydration status before neruaxial anesthesia, avoiding epinephrine
containing locals (including the test dose), and having the most skilled provider preforming the
neuraxial technique (Chestnut, Polley, Tsen and Wong, 2009, p. 992). Providers must consider
safety techniques such as using a spinal technique when appropriate (due to the smaller needle),
use of a flexible wire embedded epidural catheter to reduce epidural venous trauma and
rechecking platelet counts prior to catheter pulls (Chestnut, Polley, Tsen and Wong, 2009, p.
992). Alternative techniques can also be used including a paracervical block, lumbar sympathetic
block, pudendal nerve block and a perineal infiltration if regional anesthesia cannot be used
(Chestnut, Polley, Tsen and Wong, 2009, p. 493-498). Although uncommon, complications such
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as parametrial hematoma, abscess and vasovagal syncope can occur from paracervical or lumbar
blocks. The patient should be continuously monitored post-delivery for neurologic signs of
bleeding, abscess and infiltration (Chestnut, Polley, Tsen and Wong, 2009, p. 495).
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