- Ghaly Neurosurgical Associates, Aurora, IL, USA
- Department of Anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, IL, USA
- Department of Anesthesiology, JHS Hospital of Cook County, Chicago, IL, USA
- Department of Anesthesiology, University of Illinois, Chicago, IL, USA
Ramsis F. Ghaly
Department of Anesthesiology, Advocate Illinois Masonic Medical Center, Chicago, IL, USA
Department of Anesthesiology, University of Illinois, Chicago, IL, USA
DOI:10.4103/2152-7806.179855Copyright: © Surgical Neurology International This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
How to cite this article: Ghaly RF, Lissounov A, Candido KD, Knezevic NN. Are there guidelines for implantable spinal cord stimulator therapy in patients using chronic anticoagulation therapy? - A review of decision-making in the high-risk patient. Surg Neurol Int 07-Apr-2016;7:33
How to cite this URL: Ghaly RF, Lissounov A, Candido KD, Knezevic NN. Are there guidelines for implantable spinal cord stimulator therapy in patients using chronic anticoagulation therapy? - A review of decision-making in the high-risk patient. Surg Neurol Int 07-Apr-2016;7:33. Available from: http://surgicalneurologyint.com/surgicalint_articles/are-there-a-guidelines-for-implantable-spinal-cord-stimulator-therapy-in-patients-using-chronic-anticoagulation-therapy-%e2%80%91-a-review-of-decision%e2%80%91making-in-the-high%e2%80%91risk-patient/
Background:Spinal cord stimulators (SCSs) are gaining increasing indications and utility in an expanding variety of clinical conditions. Complications and initial expenses have historically prevented the early use of SCS therapy despite ongoing efforts to educate and promote its utilization. At present, there exists no literature evidence of SCS implantation in a chronically anticoagulated patient, and neuromodulation manufacturers are conspicuously silent in providing warnings or recommendations in the face of anticoagulant use chronically. It would appear as through these issues demand scrutiny and industry as well as neuromodulation society advocacy and support in terms of the provision of coherent guidelines on how to proceed.
Case Description:A 79-year-old male returned to the neurosurgical clinic with persistent low back pain and leg heaviness due to adjacent level degenerative spondylosis and severe thoracic spinal stenosis. The patient had a notable history of multiple comorbidities along with atrial fibrillation requiring chronic anticoagulation. On initial presentation, he was educated with three choice of conservative medical therapy, intrathecal drug delivery system implantation, or additional lumbar decompression laminectomy with instrumented fusion of T10-L3 and a palliative surgical lead SCS implantation.
Description:A 79-year-old male returned to the neurosurgical clinic with persistent low back pain and leg heaviness due to adjacent level degenerative spondylosis and severe thoracic spinal stenosis. The patient had a notable history of multiple comorbidities along with atrial fibrillation requiring chronic anticoagulation. On initial presentation, he was educated with three choice of conservative medical therapy, intrathecal drug delivery system implantation, or additional lumbar decompression laminectomy with instrumented fusion of T10-L3 and a palliative surgical lead SCS implantation.
Conclusion:Our literature search did not reveal any evidence of SCS therapy among patients with chronic anticoagulation. This case illustrated a complicated clinical case scenario wherein a percutaneous SCS implantation would normally be contraindicated due to severe thoracic spinal stenosis and chronic anticoagulation which could lead to possible paralysis or even a lethal consequences associated with the possible formation of a thoracic epidural hematoma.
Keywords: Chronic anticoagulation, implantable device, neuromodulation, spinal cord stimulator, spinal epidural hematoma
The utility of spinal cord stimulator (SCS) has proven to be excellent when compared to conservative medical management (CMM) or reoperation for failed back surgery syndrome (FBSS) patients.[
Anticoagulation therapy has been a very common medical practice, especially among elderly patients for prevention of thromboembolic events. It is not hard to imagine that the number of these patients will be growing exponentially as the baby-boom population ages, and the instancy to address practical guidelines for a number of interventional procedures is expected to persist. The American Society of Regional Anesthesia and Pain Medicine (ASRA) developed separate guidelines for interventional pain procedures for patients on anticoagulation and antiplatelet medications in response to the interventional pain management community outcry for independent guidelines.[
We are presenting the case of an elderly patient with FBSS on chronic anticoagulation therapy for atrial fibrillation (AF), who was confronted with three options for managing his chronic, severe, and opioid-resistant pain; of either surgical decompression laminectomy and implantation of surgical lead SCS (if he presented in a stable surgical condition), implantation of an intrathecal drug delivery system (IDDS), or oral opioid therapy along with conservative medical management. This case addresses the needs for evaluation of continuous versus interrupted anticoagulation therapy for SCS implantation and long-term complication of chronic anticoagulation with implantable devices. A careful assessment for selecting between a percutaneous lead versus surgical paddle lead implantation.
A 79-year-old male returned to our neurosurgical clinic with weakness and increasing leg pain, due to extensive spinal stenosis (T11-L3), adjacent level degenerative spondylosis [Figures
Lumbar magnetic resonance imaging of adjacent level disease with severe spinal stenosis at L1-L2 and L3. (a) Transverse plane view at L1-L2 intradiscal space, (b) sagittal plane view, (c) transverse plane view at L2-L3 intradiscal space, and (d) sagittal plane view with evidence of instrumental fusion at L3-S1
Patient's main concerns were leg heaviness and neurogenic claudication pain, which had affected his quality of life. Our intention was to improve his pain control without resorting to oral opioid medications, which were considered a relatively poor choice due to his advanced age and multiple comorbidities, which included obesity, chronic obstructive pulmonary disease, multiple malignancies, coronary artery disease, PVD, Type II diabetes mellitus, hypertension (HTN), and AF. Pain management options included CMM with physical therapy, IDDS, surgical decompression and fusion with surgical lead SCS implantation, or percutaneous SCS therapy at the thoracic level.
This high-risk patient with multiple comorbidities was confronted with the following choices. Standard conservative medical management with analgesic medications and physical therapy were largely unsuccessful in treating adjacent level degenerative spondylosis. Surgical options might include considerations of a decompression laminectomy of L1-L3 with an extended instrumental lumbar fusion of T10-L3 that would also include palliative intervention by implanting surgical paddle leads at T10-T12 for SCS therapy. These procedures would be performed by withholding warfarin and restarting it postoperatively, as for the previously performed neuraxial surgical procedures. Decompression laminectomy would address his leg heaviness as a result of the compressive nature of symptoms and associated neurogenic claudication. SCS therapy should provide coverage for the leg pain, due to inoperable PVD. The choice of a surgical paddle lead was preferred due to severe low-level thoracic spinal stenosis on magnetic resonance imaging (MRI) [
The main concerns for this patient were presented to him during the educational process regarding his use of chronic anticoagulation, choice of intervention, and its potential for catastrophic risks. A surgical paddle lead was recommended over a percutaneous lead to decrease the chances of him developing a catastrophic thoracic spinal-epidural hematoma upon lead migration, repeated epidural needle insertions, multiple lead advancements in the epidural space, and/or micromotion trauma. An elderly patient should be presumed to have a greater chance of traumatic and spontaneous bleeding risk due to poor international normalized ratio control on warfarin, fragile venous vessels, and a high risk for accidental trauma due to expected poor balance and limited mobility. One-time discontinuation of anticoagulation medications might carry less risk in this patient rather than repeated abstinence of warfarin for the several procedures required with percutaneous lead placement for trial and permanent implantation and any revision or re-implantation unless a “perm-trial” type of procedure was selected for use. All these considerations may lead to a potentially catastrophic intraspinal thoracic hematoma, which may carry with it severe morbidity and mortality among elderly patients, and the proximity to the spinal cord water shadow zone has a potential for a high risk of permanent paralysis.
Despite neurosurgical recommendations of fusion and a surgical paddle lead, the patient elected to receive percutaneous lead SCS therapy with another group of pain specialists without consulting us as to his decision and choice. We believe the complexity of this case deserves a multispecialty approach of consulting and including a trained and experienced neurosurgeon and/or pain specialist in the area of surgical and percutaneous leads placement for patients on chronic anticoagulation therapy.
The elderly population is often ideal candidates for SCS therapy while being vulnerable to polypharmacy and the unwanted side-effects due to narcotic analgesics. SCS is a safe, relatively minimal invasive procedure that is reversible when it is ineffective or leads to complications. A good safety rating of SCS compared to opioid analgesics was evident from comparing safety profiles of both therapies among chronic pain patients.[
In the past two decades, the discipline of spine surgery has expanded the number of invasive procedures that has led to well-recognized complications, including the entities of chronic pain and disability. Lad et al. noted that 16,060 (97.6%) patients required repeated operation after undergoing initial surgery.[
Commonly defined neuroanatomical coverage with SCS therapy targeting lower extremity pain (radiculopathy or neuropathy), and chronic axial low back pain (LBP) continue to have poor coverage with SCS.[
SCS complications can be characterized as mechanical (27–30%), biologic (3–5%), and other (3–4%). Most common mechanical complications of SCS are lead migration (13%), fracture (9%), and hardware malfunction.[
The epidural space has a rich network of valveless veins (Batson's plexus), which covers anterior and lateral portions of the epidural space. Epidural veins anastomose freely with the veins connecting the head and pelvis. Venous return from the pelvis passes through the extradural venous plexus to the azygous veins, which drains into the inferior vena cava. The epidural space also contains lymphatics and segmental arteries. The dura mater is a spinal meninges that is at the floor (anterior) to the epidural space. The dura is acellular, but the inner edge is highly vascular, which is important in drug delivery from the epidural space.[
Serrano et al. summarized of ASIPP guidelines which reconfirm a generally conservative approach for neuraxial interventional procedures in anticoagulated patients.[
However, a risk of epidural hematoma has not been formally assessed for SCS implantation among chronically anticoagulated patients on VKA or new oral anticoagulants. Neuromodulation device companies continue to promote their product in accordance with an increasing need for this invaluable therapy. Even so, there are no general manufacturer guidelines or warnings regarding the use of SCS and anticoagulation therapy. Subsequently, NACC recommendations were based on conservative recommendations promoted by ASRA, which has advised an interruption of anticoagulation therapy before procedures in accordance with the family practitioner or cardiologist.[
The United States has identified more than 2.3 million persons with AF.[
Technological improvements of SCS devices and improvement of specialists’ techniques in SCS implantation contributes to a reduced rate of complications. However, a choice of percutaneous lead or surgical paddle lead implantation must be strongly calculated with regards to previous spine surgery with the development of epidural fibrosis and the location of epidural lead placement in consideration of catastrophic complications (e.g., death or permanent paralysis due to thoracic epidural hematoma).[
Percutaneous implantation, while being fluoroscopically guided, is essentially a blinded advancement (vis-à-vis the vessels) of leads along the epidural space into a superior position to the site of pain. Percutaneous leads proved to have a relatively easy access to the epidural space at any level except for areas of previous posterior lumbar fusion, severe spinal stenosis, or laminectomy, due to obstructive or narrower spaces to advance leads along the epidural space. Bosscher and Heavner examined 78 FBSS patients with epiduroscopy, which revealed severe epidural fibrosis in 83.3% of all patients and significant fibrosis in 91.0% of patients.[
Surgical paddle leads have advanced in their size, which allows for directly visualized placement through a small laminotomy during paddle implantations. Surgical paddle leads placement allows the interventionist to control the critical time: Stopping and restarting anticoagulants, visualizing level of bleeding, and controlling the amount of trauma. Leads are inserted superiorly from the surgical site after minimal decompression and laminectomy which are performed under direct visualization of the epidural space.[
Even so, surgical paddle leads have shown to be an excellent alternative to percutaneous leads. Specialists must be versed in both procedures (percutaneous and surgical implantation) prior to initiating SCS trial in carefully selected patients where an adequate risk-to-benefit ratio must be determined with proposed interventions, ongoing therapies, and comorbidities. It should also be imperative that these considerations should not delay an SCS trial. The ProCESS study evaluated more than 50% of patients with more than one low back surgery, and a delay of SCS implantation averaged 4.7 years.[
Elderly patients on chronic anticoagulation therapy present with a series of risks: Spontaneous and induced bleeding, clot formation upon discontinuation of anticoagulation therapy or poor compliance, adverse events due to polypharmacy, and impending consequences of interventions or multiple comorbidities. An experienced and closely involved specialists would help the SCS or IDDS candidate patient make an appropriate decision for the most optimal therapeutic choice. More so, this clinician will anticipate possible complications either as a collaborative or individual effort for the best outcome in patient's well-being with close monitoring and appropriate patient education for complications. Although there presently exist no “gold standard” guidelines which are evident from literature evidence, such guidelines would be useful if forthcoming. Clinicians have a duty not abandon their patients during periods of intense suffering. Therefore, we call on all clinicians invested in the process of providing invasive pain-relieving modalities to agree on further collaboration with manufacturers involved with SCS therapy to develop guidelines that will address the real concerns associated with the use of these devices in chronically anticoagulated patients.
To the best of our literature review, we could not identify an actual number of SCS implantation for patients using chronic anticoagulation. Thus, we remain unaware of the true incidence of complications that can arise in a pain population on chronic anticoagulation with neuraxially implanted devices. We have highlighted concerns with chronic anticoagulation and spinal implantable devices in our patient so that manufacturers and the clinical pain management community continue to assess risks and create appropriate guidelines and warnings in long-term use of implantable neuromodulators with chronic anticoagulants. These guidelines and warning should differ from current evidence supported guidelines regarding neuraxial injections and minor procedures. Furthermore, we would like to advocate for different considerations among anticoagulated patients referred to the interventional pain specialist, who should base a therapeutic decision on most recently proposed guidelines and weighing on the risk-to-benefit factors when implanting spinal devices.[
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Conflicts of Interest
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