Epidural Patching

Number: 0934

Policy

Aetna considers epidural blood patching (EBP) medically necessary for the treatment of post-dural puncture headache (PDPH) if member exhibited prolonged headaches (greater than 24 hours).

Aetna considers EBP for the treatment of spontaneous intracranial hypotension if any of the following selection criteria is met:

• An aggressive precipitating injury, a history of connective tissue disease, or joint hypermobility; or
• Headache unresponsive to a reasonable period of conservative treatment (e.g., bed rest and oral analgesics for 1 to 2 weeks); or
• Severe headache or other disabling symptoms, regardless of duration; or
• Symptomatic for 2 weeks or longer at the time of diagnosis.

Aetna considers the following experimental and investigational because the effectiveness of these approaches has not been established:

• Prophylactic EBP
• EBP for the treatment of post-dural puncture tinnitus
• Epidural fibrin glue patching for the treatment of PDPH
• Epidural autologous platelet-rich-plasma patching for the treatment of PDPH.

Background

Epidural Blood Patching (EBP) for the Treatment of Post-Dural Puncture Headache

Post-dural-puncture headache (PDPH) is a complication of puncture of the dura mater.  The headache can be severe and it entails the back and front of the head, and spreading to the neck and shoulders, sometimes involving neck stiffness.  It is exacerbated by movement, and sitting or standing, and relieved to some degree by lying down.  Nausea, vomiting, pain in arms and legs, hearing loss, tinnitus, vertigo, dizziness and paraesthesia of the scalp are common.  It is a common side-effect of spinal anesthesia and lumbar puncture and may occasionally accidentally occur in epidural anesthesia.  Leakage of cerebrospinal fluid (CSF) through the dura mater puncture causes reduced fluid levels in the brain and spinal cord, and may lead to the development of PDPH hours or days later.  Some individuals require no other treatment than pain medications and bed rest.  Persistent and severe PDPH may require an epidural blood patching (EBP), which entails injection of a small amount of autologous blood into the epidural space to stop certain types of spinal headaches.  This resulting blood clot patches the hole in the spine and treats the patient’s headache symptoms.  It is also believed that EBP causes compression and relieves the pressure state in the head, which causes the headache.  In a very small percentage of cases, the headache can recur, and EBP may need to be repeated.  Epidural blood patching is generally well-tolerated, and has a low incidence of complications, which include slight back pain, stiffness in the neck and low-grade fever.   Success rates of EBP varying from 60 to 95 % have been reported; this variability may be a consequence of a higher efficacy rate when EBP is used for small dural punctures.  Epidural blood patching usually takes approximately 15 minutes and is carried out in an out-patient setting (No authors listed, 2001; Turnbull and Shepherd, 2003).

In a Cochrane review, Boonmak and Boonmak (2010) examined the possible benefits and harms of EBP in both prevention and treatment of post-dural puncture headache (PDPH).  These investigators searched the Cochrane PaPaS Group Trials Register; CENTRAL; Medline and Embase in April 2009.  They sought all randomized controlled trials (RCTs) that compared EBP versus no EBP in the prevention or treatment of PDPH among all types of participants undergoing dural puncture for any reason.  One review author extracted details of trial methodology and outcome data from studies considered eligible for inclusion.  These researchers invited authors of all such studies to provide any details that were unavailable in the published reports.  They performed intention-to-treat (ITT) analyses using the Peto O-E method.  They also extracted information about adverse effects (AEs; post-dural puncture backache and epidural infection).  A total of 9 studies (379 participants) were eligible for inclusion.  Prophylactic EBP improved PDPH compared to no treatment (odds ratio [OR] 0.11, 95 % confidence interval [CI]: 0.02 to 0.64, 1 study), conservative treatment (OR 0.06, 95 % CI: 0.03 to 0.14, 2 studies) and epidural saline patch (OR 0.16, 95 % CI: 0.04 to 0.55, 1 study).  However, prophylactic EBP did not result in less PDPH than a sham procedure (1 study).  Therapeutic EBP resulted in less PDPH than conservative treatment (OR 0.18, 95 % CI: 0.04 to 0.76, 1 study) and a sham procedure (OR 0.04, 95 % CI: 0.00 to 0.39, 1 study).  Backache was more common with EBP.  However, these studies had very small numbers of participants and outcome events, as well as uncertainties about trial methodology, which precluded reliable assessments of the potential benefits and harms of the intervention.  The authors did not recommend prophylactic EBP over other treatments because there were too few trial participants to allow reliable conclusions to be drawn.  However, therapeutic EBP showed a benefit over conservative treatment, based on the limited available evidence.

Gottschalk (2015) stated that in most cerebro-spinal fluid (CSF) leaks are iatrogenic and caused by medical interventions (e.g., lumbar puncture, peri-dural anesthesia and surgical interventions on the spine).  However, spontaneous cerebral hypotension is currently detected more frequently due to improvements in diagnostic possibilities but often the cause cannot be clarified with certainty.  There are various diagnostic tools for confirming the diagnosis and searching for the site of CSF leakage, such as postmyelography computed tomography (postmyelo-CT), indium-111 radioisotope cisternography and (myelo) magnetic resonance imaging (MRI), which show different sensitivities.  In accordance with the authors’ experience, native MRI with fat-saturated T2-weighted sequences is often sufficient for diagnosing CSF leakage and the site.  For the remaining cases, an additional postmyelo-CT or alternatively myelo-MRI is recommended.  In some patients with spontaneous cranial hypotension multiple CSF leaks are found at different spinal levels.  The main symptom in most cases is an orthostatic headache.  While post-puncture syndrome is self-limiting in many cases, spontaneous CSF leakage usually requires EBP.  Lumbar EBP can be safely carried out under guidance by fluoroscopy.  In the case of a cervical or dorsal blood patch, CT guidance is recommended, which ensures epidural application of the blood patch and minimizes the risk of damaging the spinal cord.  Despite a high success rate at the 1st attempt with a blood patch of up to 85 %, some cases require repeating blood patching.  A targeted blood patch of a CSF leak should generally be favored over a blindly placed blood patch; nevertheless, if a CSF leak cannot be localized by CT or MRI a therapeutic attempt with a lumbar blood patch can be carried out.  After a successful blood patch, intracranial hygromas and pachymeningeal enhancement in the head showed fast regression; however, epidural hygromas of the spine could persist for a period of several months, even though patients are already symptoms-free.  The authors concluded that EBP is a safe and relatively simple method with a high success rate; thus; it represents the therapy of choice in patients with spontaneous CSF leakage as well as in cases of PDPH refractory to conservative therapy.

Kapoor and Ahmed (2015) stated that EBP is rarely performed at the cervical levels, primarily due to fear of neurological complications such as spinal cord compression.  These investigators reviewed the literature to provide an evidence-based review of performance of cervical EBPs, with a specific focus on indication, technique, safety, and efficacy.  They performed a comprehensive electronic literature search to include studies that reported on performance of cervical EBPs in patients with CSF leak at the cervical level.  Data regarding indication, level of CSF leak, level of cervical EBP, volume of blood used, efficacy, and complications were collected.  A total of 15 studies, reporting on 19 patients were included.  All patients presented with a headache that increased in the standing position, and improved in the supine position.  All patients were identified to have a CSF leak at the cervical level; 8 patients first underwent a lumbar EBP, without complete, long-term relief.  All these patients, along with 11 patients who did not undergo a lumbar EPB prior to cervical EBP, reported complete, long-term pain relief; EBPs were mostly done in the prone position, using imaging guidance.  An average of 5 to 8 ml of autologous blood was injected in the epidural space.  No major neurological complications were reported in any patient.  The authors concluded that the findings of this review suggested that cervical EBP can be performed for cervical CSF leaks associated with positional headache without a significant risk of serious AEs.  This review provided Class II level of evidence that cervical EBPs were safe and effective in reliving positional headache due to CSF leak.

Suescun and associates (2016) noted that PDPH due to accidental dural puncture during epidural catheter placement is a source of morbidity for new mothers.  It can interfere with maternal-newborn bonding and increase the length of hospitalization.  This evidence-based article examined the question: For obstetric patients experiencing an accidental dural puncture during epidural placement, which non-pharmacologic prophylactic neuraxial interventions safely and effectively decrease the incidence of PDPH?  A search of online databases revealed 4 systematic reviews with meta-analysis and a RCT meeting the inclusion criteria; 3 of the 4 systematic reviews used rigorous appraisal methods; 2  systematic reviews included non-obstetric populations and 3 included additional interventions.  Subgroup analyses allowed examination of the interventions of interest.  Non-pharmacologic prophylactic neuraxial interventions included prophylactic EBP, epidural saline administration, and intra-thecal catheter placement.  There was a lack of standardization of interventions.  The authors concluded that the evidence suggested there may be value in performing a prophylactic blood patch or placing an intra-thecal catheter.  The risk of the intervention must be carefully weighed with the benefits.   They stayed that further rigorous studies are needed to help determine the best methods to decrease the incidence of PDPH in obstetric patients experiencing an accidental dural puncture during epidural placement.

Furthermore, an UpToDate review on “Post-lumbar puncture headache” (Sun-Edelstein and Lay, 2018a) states that “Other agents that have been evaluated for the treatment of PLPHA in small controlled trials or case series include oral and intravenous caffeine, epidural saline, intramuscular adrenocorticotropic hormone (ACTH) and intravenous synthetic ACTH, oral gabapentin, intravenous hydrocortisone, oral theophylline, and subcutaneous sumatriptan, and sphenopalatine block … Of these, the limited available data suggest modest effectiveness for gabapentin, hydrocortisone, and theophylline.  For patients with moderate to severe PLPHA that is prolonged (greater than 24 hours) and refractory to conservative measures, we suggest treatment with epidural blood patch (Grade 1B)”.

EBP for the Treatment of Spontaneous Intracranial Hypotension

Girgis and co-workers (2015) noted that spontaneous intracranial hypotension (SIH) is caused by spinal CSF leakage.  Treatment is directed at sealing the site of leak, which is often difficult to localize.  These researchers presented a case of near fatal SIH that was treated with thoracic EBP.  A 47-year old man presented with orthostatic headache and bilateral cranial nerve VI palsies progressing over several weeks.  Brain MRI showed features typical of SIH and identified an epidural collection stretching from spinal levels C6 to T4, but further imaging with MR myelography and radionuclide cisternography failed to identify a precise site of leak.  The patient worsened in the hospital requiring craniotomy for evacuation of an evolving subdural hematoma (SDH).  Epidural blood patch was performed at the T1 to T2 level, the presumed location of the leak due to presence of a bone spur on CT and the large corresponding CSF collection.  This quickly led to resolution of the headache and cranial nerve palsies, and later to the complete resolution of his SDH.  Through this case and review of the literature, the authors demonstrated that directed cervical or thoracic EBP should be considered for SIH as an alternative to the conventional lumbar EBP.

Ansel and co-workers (2016) stated that patients with a spontaneous CSF leak, normally at a spinal level, typically present with low-pressure headache.  In refractory cases, EBP may be attempted.  These investigators evaluated the efficacy of lumbar EBP in spontaneous, low-pressure headaches.  They retrospectively analyzed notes of patients who had EBP performed for SIH in a single-center.  Information regarding demographics, radiology and clinic follow-up was extracted from an electronic patient record system.  Questionnaires regarding outcome were sent to patients a minimum of 6 months post-procedure.  All patients received EBP in the lumbar region irrespective of the site of CSF leak.  A total of 16 patients who underwent lumbar EBP were analyzed (11 women; mean age of 43 years).  The site of CSF leak was evident in only 3/16 patients; 13 patients attended clinic follow-up; 3 reported complete headache resolution, 4 reported improvement in intensity or frequency and 6 described no change; 5 of 8 questionnaire respondents reported reduction in pain, and in these responders, mean headache severity improved from 9/10 to 3/10; 5 of 8 patients returning follow-up questionnaires reported sustained improvement in headache symptoms.  The authors concluded that EBP can provide sustained improvement in headache symptoms in selected patients with SIH, but an untargeted approach had a lower success rate than reported in other case series.

Rettenmaier and co-workers (2017) noted that SIH is a more common than previously noted condition (1 to 2.5 per 50,000 persons) typically caused by CSF leakage.  Initial treatment involves conservative therapies, but the mainstay of treatment for patients who fail conservative management is EBP.  Subdural hematoma (SDH) is a common complication occurring with SIH, but its management remains controversial.  In this report, these researchers discussed a 62-year old woman who presented with a 5-week history of orthostatic headaches associated with nausea, emesis, and neck pain.  Despite initial imaging being negative, the patient later developed classic imaging evidence characteristic of SIH; MRI was unrevealing for the source of the CSF leak.  Radionuclide cisternography showed possible CSF leak at the right-sided C7 to T1 nerve root exit site.  After failing a blind lumbar EBP, subsequent targeted EBP at C7 to T1 improved the patient's symptoms.  Two days later she developed a new headache with imaging evidence of worsening SDH with mid-line shift requiring burr hole drainage.  This yielded sustained symptomatic relief and resolution of previously abnormal imaging findings at 2-month follow-up.  These investigators performed a literature review and revealed 174 cases of SIH complicated by SDH.  This revealed conflicting opinions concerning the management of this condition.  The authors concluded that although blind lumbar EBP was often successful, targeted EBP had a lower rate of patients requiring a 2nd EBP or other further treatment.  On the other hand, targeted EBP had a larger risk profile.  Depending on the clinic situation, treatment of the SDH via surgical evacuation may be necessary.

Staudt and colleagues (2018) noted that SIH is a progressive clinical syndrome characterized by orthostatic headaches, nausea, emesis, and occasionally focal neurological deficits.  Rarely, SIH is associated with neurocognitive changes.  An EBP is commonly used to treat SIH when conservative measures are inadequate, although some patients require multiple EBP procedures or do not respond at all.  Recently, the use of a large-volume (LV) EBP has been described to treat occult leak sites in treatment-refractory SIH.  These investigators described the management of a patient with profound neurocognitive decline associated with SIH, who was refractory to conservative management and multiple interventions.  The authors described the successful use of an ultra-LV-EBP of 120 ml across multiple levels, the largest volume reported in the literature, and described the technical aspects of the procedure.  This procedure has resulted in dramatic and sustained symptom resolution.

He and co-workers (2018) noted that EBP is the mainstay of treatment for refractory SIH.  These researchers evaluated the treatment efficacy of targeted EBP in refractory SIH.  All patients underwent brain MRI with contrast and heavily T2-weighted spine MRI.  Whole spine CT myelography with non-ionic contrast was performed in 46 patients, and whole spine MR myelography with intra-thecal gadolinium was performed in 119 patients.  Targeted EBPs were placed in the prone position 1 or 2 vertebral levels below the CSF leaks.  Repeat EBPs were offered at 1-week intervals to patients with persistent symptoms, continued CSF leakage, or with multiple leakage sites.  Brain MRIs showed pachymeningeal enhancement in 127 patients and subdural hematomas in 32 patients; 152 patients had CSF leakages on heavily T2-weighted spine MRIs; CSF leaks were also detected on CT and MR myelography in 43 and 111 patients, respectively.  Good recovery was achieved in all patients after targeted EBP.  No serious complications occurred in patients treated with targeted EBP during the 1 to 7 years of follow-up.  The authors concluded that targeted and repeat EBPs are rational choices for treatment of refractory SIH caused by CSF leakage.

Furthermore, an UpToDate review on “Spontaneous intracranial hypotension: Treatment and prognosis” (Sun-Edelstein and Lay, 2018b) states that “The most conservative treatment for spontaneous intracranial hypotension is avoidance of the upright position, with strict bed rest and the possible addition of analgesics … We suggest epidural blood patch (EBP) for patients with spontaneous intracranial hypotension who fulfill any of the following conditions (Grade 2C)”:

• An aggressive precipitating injury, a history of connective tissue disease, or joint hypermobility
• Headache unresponsive to a reasonable period of conservative treatment (e.g., bed rest and oral analgesics for 1 to 2 weeks)
• Severe headache or other disabling symptoms, regardless of duration
• Symptomatic for 2 weeks or longer at the time of diagnosis

EBP Treatment of Post-Dural Puncture Tinnitus

Jia and Fadhlillah (2018) stated that audiometric disturbances are recognized as potential complications after spinal or epidural anesthesia; however, incidences of tinnitus occur less frequently.  These researchers reported the case of a patient with severe bilateral tinnitus post-lumbar puncture who was treated with EBP.  Subject was a 40-yearold ASA I woman (a medically fit patient with no known medical problem) presented with ongoing bilateral severe tinnitus for 6 days after a lumbar puncture.  Venous blood (18 ml) was injected into the epidural space using a 16-G needle.  The patient completed the Tinnitus Handicap Inventory (THI) Questionnaire before EBP, 3 hours, 24 hours and 1-month post-procedure.  An audiogram was also conducted before and 1 month after EBP.  The patient scored 84 (grade 5) on the THI before EBP; 3 hours post-procedure, her score improved to 16 (grade 1), with complete resolution by 24 hours.  Audiogram revealed a low-frequency mild sensori-neural hearing loss in the left ear prior to the procedure.  By her 1-month follow-up, her hearing was back to normal.  The authors concluded that EBP is an effective treatment for post-dural puncture tinnitus.  Its effects are instantaneous and complete resolution is achieved by 24 hours.  These preliminary findings need to be validated by well-designed studies.

Epidural Fibrin Glue Patching for the Treatment of Post-Dural Puncture Headache

Wong and Monroe (2017) stated that EBP is the gold standard for the treatment of PDPH when conservative treatments have failed to provide any relief.  However, alternative therapies are lacking when EBP persistently fails to improve symptoms.  This case described a woman who developed PDPH secondary to accidental dural puncture during a spinal cord stimulator trial.  She was successfully treated with epidural fibrin glue patch after multiple trials of EBP.  The authors concluded that percutaneous injection of fibrin glue to seal the dural defect demonstrated promising outcomes for both immediate and long-lasting resolution of persistent PDPH in this patient.  They stated that in the event of EBP failure, epidural fibrin glue patching may be a reasonable alternative for the treatment of persistent PDPH.  These preliminary findings need to be validated by well-designed studies.

Furthermore, an UpToDate review on “Post-lumbar puncture headache” (Sun-Edelstein and Lay, 2018a) states that “Epidural patching with fibrin glue at the site of the CSF leak has been used successfully in small numbers of patients.  Anecdotal evidence suggests that this method is effective, and thereby avoids surgery, in about 1/3 of patients who have failed epidural blood patch treatment.  Further evidence of benefit in larger studies is needed before this technique can be routinely recommended”.

Epidural Autologous Platelet-Rich-Plasma Patching for the Treatment of Post-Dural Puncture Headache

Gunaydin and colleagues (2017) performed epidural patching using platelet-rich-plasma (PRP), which has the potential to regenerate and heal tissues via degranulation of platelets, in a 34-year old parturient suffering from persistent PDPH after failed EBP.  After her admission to the authors’ unit, these researchers re-confirmed the clinical and radiologic diagnosis of PDPH.  Cranial MRI with contrast showed diffuse pachymeningeal thickening and contrast enhancement with enlarged pituitary consistent with intracranial hypotension.  Clinical and radiological improvements were observed 1 week after epidural patching using autologous PRP.  The authors recommended using autologous PRP for epidural patching in patients with incomplete recovery after standard EBP as a novel successful approach.  These preliminary findings need to be validated by well-designed studies.

Table: CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+" :
CPT codes covered if selection criteria are met:
62273	Injection, epidural, of blood or clot patch
CPT codes not covered for indications listed in the CPB:
0232T	Injection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed [epidural autologous platelet-rich-plasma patching]
Other CPT codes related to the CPB:
62320 - 62323	Injection(s), of diagnostic or therapeutic substance(s) (eg, anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic or lumbar or sacral (caudal) [not covered for epidural fibrin glue patching]
76942	Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation
77003	Fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures (epidural or subarachnoid) (List separately in addition to code for primary procedure)
77012	Computed tomography guidance for needle placement (eg, biopsy, aspiration, injection, localization device), radiological supervision and interpretation
HCPCS codes not covered for indications listed in the CPB:
P9020	Platelet rich plasma, each unit [epidural autologous platelet-rich-plasma patching]
Other HCPCS codes related to the CPB:
J1720	Injection, hydrocortisone sodium succinate, up to 100 mg
ICD-10 codes covered if selection criteria are met:
G96.0	Cerebrospinal fluid leak [spontaneous intracranial hypotension]
G97.1	Other reaction to spinal and lumbar puncture [covered for post-dural puncture headache (PDPH)] [not covered for post-dural puncture tinnitus]
G97.2	Intracranial hypotension following ventricular shunting [spontaneous intracranial hypotension]
O29.40 - O29.43	Spinal and epidural anesthesia induced headache during pregnancy
O89.4	Spinal and epidural anesthesia-induced headache during the puerperium
T88.59xA - T88.59xS	Other complications of anesthesia [covered for post-dural puncture headache (PDPH)] [not covered for post-dural puncture tinnitus]
ICD-10 codes not covered for indications listed in the CPB:
H93.11 - H93.19	Tinnitus [post-dural puncture tinnitus]

The above policy is based on the following references: