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Spinal Cord Stimulator Implant


Spinal Cord Stimulator Implant

Article Author:
Alexander Dydyk
Article Editor:
Prasanna Tadi
Updated:
10/24/2020 5:53:59 PM
For CME on this topic:
Spinal Cord Stimulator Implant CME
PubMed Link:
Spinal Cord Stimulator Implant

Introduction

Spinal cord stimulators are designed to treat chronic pain. The implantable device offers a nonpharmacological approach to various pain conditions. Stimulators have been used for the treatment of both neuropathic and ischemic pain. Spinal cord stimulator implantation is usually reserved for patients who have failed various forms of conservative and pharmacological treatment options. After a percutaneous trial, a permanent stimulator is installed. Patients can have long-lasting pain relief following the procedure. There are various indications for implanting a stimulator, but it is most commonly done following failed back surgery. Although severe complications following the installation of a spinal cord stimulator are rare, they can be significant. Various types of stimulators and electrical impulses are used to provide pain relief.

Further research will determine if one type of stimulator is superior compared to another. Many insurance companies require psychological screening before the placement of the stimulator. Mental healthcare disorders are associated with worse outcomes after spinal cord stimulator implantation.[1][2] Chronic monitoring of the patient following implantation, including adjustment to the stimulator settings and battery replacement is often necessary. Revision of the stimulator implantation is very common secondary to lead migration and breakage.

Anatomy and Physiology

Spinal cord stimulator leads are placed within the epidural space. The dura mater lies anteriorly and the vertebral wall posteriorly to the epidural space. Blood vessels, lymph nodes, and fat also make up the posterior wall. The epidural space anatomically lies within the dural sac. Nerve roots are bathed with cerebrospinal fluid lie within the sac. The epidural space is at its fullest at the L2 vertebra; it starts superiorly with the base of the skull at the foramen magnum, then descends inferiorly until the sacrum at the sacral hiatus. Stimulator leads can be implanted within the level of cervical, thoracic, lumbar vertebra, and the sacrum. Electrical signals, either persistent our pulsatile, are applied to the epidural space once the spinal cord stimulator is installed.

Spinal cord stimulators function by neuromodulating the spinothalamic tract within the spinal cord. The spinothalamic tract regulates pain. When this pathway becomes disrupted as in the case of chronic pain, it is said to be dysregulated.[3] A spinal cord stimulator suppresses neurons within the dorsal horn of the spinal cord. These are known as dynamic range neurons.[4][5][6] The implant has been shown to be effective in reducing pain through the descending inhibitory pathways as well. Thus stimulators affect pain by both peripheral and central mechanisms.[7][8]

Indications

Ischemic back pain, such as symptomatic peripheral vascular disease and refractory angina, are possible indications for spinal cord stimulation implantation in inoperable cases. Spinal cord stimulators can improve New York Heart Association (NYHA) classification and enhance the quality of life.

Separately, failed back surgery syndrome is the most common indication for spinal cord stimulator implant. Spinal cord stimulation is an effective analgesic. Implantation is used for persistent radicular pain following surgery.[9][10][11]

Implantation of a stimulator is more effective than medical treatment for greater than fifty percent pain reduction for a multitude of chronic pain disorders, including diabetic neuropathy, chronic back pain, peripheral vascular pain (ischemic pain), failed back surgery syndrome, complex regional pain.[12] Stimulators have also been used for HIV-related polyneuropathy.[13]

Contraindications

Pacemakers and defibrillators are often compatible with spinal cord stimulator implants. However, a history of a prior pacemaker or cardiac defibrillator requires the approval of stimulator implantation by a cardiologist before the procedure. Having either a pacemaker or defibrillator remains a relative contraindication to the implant. Both devices require close follow up following stimulator implants.[14][15][16] Severe thrombocytopenia or uncontrolled coagulopathy are also contraindications to stimulator implant due to increased risk of a spinal epidural hematoma. Active infection is an absolute contraindication to implantation of a spinal cord. There is limited information regarding stimulator implantation in a pregnant patient.[17] Although, given the need for fluoroscopy to guide the procedure, the procedure is almost always postponed until birth.

Equipment

The equipment needed for spinal cord stimulator implantation includes stimulation leads, a cable to connect the leads to a generator, and an implantable pulse generator. The pulse generator’s electrical impulse can be modified to help provide pain relief. There are various types of generators. Paresthesia-based and paresthesia-free (high frequency or burst) stimulators are two types of generators.[18] Anesthetic (bupivacaine), spinal needed for local anesthetic as well. Patients elect to feel paresthesias in the area of pain (paresthesia-based), while others may not (paresthesia-free). Cylindrical leads are often used for percutaneous implantation of a spinal cord stimulator. The patient is also given a programmer for their spinal cord stimulator. Typically there are a few programmed settings following the procedure that can be adjusted on follow up.

Personnel

  • Primary care provider
  • Pain medicine specialist
  • First assistant for the spinal cord implantation.
  • Nursing team
  • Anesthesiologist

Preparation

The management of antiplatelet and anticoagulant medications should be discussed with the primary medical team prior to implantation. Patients taking anticoagulants may be at increased risk of developing spinal epidural hematomas.[19] A successful trial of the spinal cord stimulator is required before permanent implantation. The trial determines the efficacy and patient tolerance before permanent placement. Trials are done as an outpatient procedure under fluoroscopy to determine proper lead placement. Furthermore, percutaneous trials are done with a local anesthetic. Permanent implantation typically requires operative anesthesia care. The goal is often to limit the patient's pain without completing masking it for correct lead placement during implantation. The consensus on appropriate trial length, on average, lasts three to seven days.

Technique

Stimulators that are paraesthesia based or paraesthesia free are the two main types of stimulators. There are persistently activated stimulators, high frequency, and burst stimulators. Electrical impulse control determines either persistent or tonic delivery.[20][21] Closed-loop evoked action potential stimulation is a type of stimulator that uses an algorithm to determine the frequency and pulse amplitude. This type of stimulator is persistently adjusting settings based on neural input. Spinal cord stimulators can be either chargeable or non-rechargeable. There are also stimulators being developed that are wireless. However, more studies need to be determined by their efficacy.[22] Chargeable stimulators charge through the patient's skin. Non-rechargeable batteries have a shorter battery life compared to rechargeable, four to seven years, and ten years respectively. Most of the current spinal cord stimulator generators are MRI compatible. Alternatively, older model safety should be reviewed before getting an MRI.

The technique of installation is relatively comparable from one type of stimulator to another. When surgical leads are placed, it is typically done with spinal anesthesia using bupivacaine. Paresthesia testing can still be complete despite the anesthesia.[23] If necessary, general anesthesia can be used. Yet, general anesthesia increases the risk of catastrophic injury during stimulator implantation. Paresthesia free stimulators do not require patient feedback during the procedure. The frequencies of stimulation can be changed on the generator during the procedure. Both low frequency and high-frequency stimulation has been studied.[24][25][26][27] High-frequency stimulators are less energy-efficient and may require battery replacement more frequently compared to other settings. 

Stimulator implantation requires fluoroscopy to determine proper lead placement. Lead placement depends on the location of the patient's back pain. A small cut is made to insert an epidural needle and to insert the leads. For example, in the case of chronic low back pain, the leads would be placed at the levels of T8 to L1. For neck pain, the leads are positioned above C3 in the epidural space.[28][14][29] In a trial, the temporary percutaneous leads are connected to an external generator for three to seven days. If successful, a permanent stimulator is installed. Permanent implantation is typically complete one to two weeks following the trial run.[14][30][31][32][33] The leads are anchored after their insertion and confirmed correct placement via fluoroscopy. The topography of the patient's pain correlates with lead placement. Thus the goal of successful implantation is at least 80 percent overlap with the area of the patient's pain and lead coverage. A tunnel track, created during the permanent procedure, connects the generator to the leads. The stimulator leads are tunneled to the generator via an extension cable. A second cut is made for the generator to reside.

Complications

The complication rate following spinal cord stimulator implantation is relatively high, between 5.3 to 40 percent of cases. The majority are due to the hardware malfunction, such as lead migration, requiring revisions.[34][14] Lead migration is the sudden loss of pain coverage, due to the change of location of one or both of the leads. When this occurs, the leads are often anchored.[30][35] Anchoring devices have been developed to minimize lead migration.[36][37] Lead migration occurs more often in the cervical vertebra rather than more inferior secondary to the increased range of motion of the neck.[29][38] Lead fractures can occur in above nine percent of cases.[14][39][40] Strenuous physical activity can cause a lead fracture.[41] Seromas can occur postoperatively, many resolves spontaneously but can require incision and drainage.[30][42] Infections range between two to twelve percent of cases one year following implantation.[43][44][45] Dural puncture causing as a cerebrospinal fluid leak can occur, but it is rare. The puncture of the dura can occur during lead placement, with headaches occurring in up to 70 percent of cases. Refractory cases require a blood patch for treatment.[46][47] Spinal epidural hematoma is a medical emergency requiring urgent neurosurgical intervention. The hematoma must be decompressed. Luckily, spinal epidural hematomas and spinal cord trauma are extremely rare following stimulator implantation. In 20 to 40 percent of patients with a spinal cord stimulator, tolerance develops. The effectiveness of the stimulator to provide adequate pain relief decreases over time.[48] An estimated eight percent of stimulators are explanted, the majority due to inadequate pain relief.[49][46][30]

Clinical Significance

Pain relief can continue for even weeks after a stimulator has been turned off.[50][51] Pain thresholds reduction has both been seen in EEG finds, as well as somatosensory evoked potentials following stimulator implantation.[52][3] Interestingly, not every type of stimulator works on both the peripheral nervous system and supraspinal mechanisms. For example, high-frequency spinal cord stimulation does not work via a central mechanism.[4] For patients who received a stimulator secondary to ischemic pain, stimulators have been shown to improve oxygen supply and demand, by improving blood flow to help improve pain.[50][51] Stimulators also work as vasodilators to improve ischemic pain via sympathetic nervous system activation.[53] High frequency, as well as burst spinal cord stimulation, have been efficacy in pain reduction compared to traditional stimulation [12]. Although not traditionally used for axial skeleton pain, stimulators are being studied in their use.[54][25][26][55] Small studies have assessed the use of a stimulator for painful diabetic neuropathy and persistent perineal pain.[56][57] Spinal cord stimulators are up to 85 percent effective if placed within two years after the onset of the patient’s pain. Patients with at least a 15-year history of chronic pain were found to find stimulators helpful to provide pain relief in only nine percent of cases.[36] Paresthesia free stimulators have also been shown to improve back pain.[20] High-frequency spinal cord stimulators have been used for various types of back pain. They are more than than 70 percent effective for greater than 50 percent pain relief on six months followup.[26] A burst stimulator (paresthesia free) is more effective in the treatment of neuropathic pain than standard paresthesia inducing stimulators. Paresthesia free stimulators were shown to be preferred to conventional stimulators by over 70 percent of patients at one year follow up.[18] Over 80 percent of patients will likely need an MRI within five years of implantation of their spinal cord stimulator, often due to lead migration.[58] Migration is widespread in the early post-procedure period.

Enhancing Healthcare Team Outcomes

Spinal cord stimulator implantation is an outpatient procedure and can provide pain relief to patients with various chronic pain syndrome. The procedure has minimal serious complications, but lead migration and breakage are common. It is imperative to identify the risk factors to the procedure and perform a thorough mental health assessment of the patient before any surgery. A team approach is an ideal way to limit the complications of this procedure. Before and following surgery, the patient should have the following done:

  • Evaluation of the patient's back pain and symptoms of peripheral neuropathy by the primary care provider. Conservative management options should be exhausted before stimulator implantation.

  • Workup and treatment of the primary pain complaint often include the need for further evaluation by a neurologist, orthopedic surgeon, or neurosurgeon.
  • Following unsuccessful back surgery, the surgeon should address the possible need for a spinal cord stimulator for pain further pain relief.
  • A pain medicine specialist should be consulted for spinal cord stimulator implantation.

  • An interprofessional team should address comorbid mental health disorders before implantation of the stimulator.
  • Before implantation, anticoagulation is typically held. The duration of holding anticoagulation should be coordinated with the primary care team, and for high-risk patients, the patient's cardiologist.

  • Patients with pacemakers and cardiac defibrillators require approval by cardiology before stimulator implantation.

  • Postoperative complications should be monitored closely, including postoperative infection and spinal epidural hematoma formation.
  • Following implantation, stimulator settings should be adjusted to provide optimal pain relief.

Nursing, Allied Health, and Interprofessional Team Interventions

Mental health disorders must be optimized before spinal cord stimulator implantation. Comorbid major depressive disorder and generalized anxiety disorder are prevalent comorbidities associated with chronic pain. The treatment of underlying anxiety and depression can have a lasting impact on the efficacy of a spinal cord stimulator and the treatment of the primary pain disorder. A primary care provider, cognitive-behavioral therapist, and psychiatrist are often needed to address the patient's mental healthcare. Both pharmacological and nonpharmacological treatment options are often necessary. 

Many patients who are candidates for a spinal cord stimulator suffer from failed back surgery syndrome. Coordination of care between the primary care provider, orthopedic or neurosurgeon, and the pain medicine physician is needed.

Nursing, Allied Health, and Interprofessional Team Monitoring

  • Following implantation of the spinal cord stimulator, the healthcare team must be cognitive of lead migration over time, as well as the possible need for further adjustments of the settings of the stimulator to maximize pain relief.
  • Complications following the procedure should be monitored closely, especially in the first few weeks postoperatively. 
  • For patients with a cardiac defibrillator or pacemaker, they should be monitored by cardiology following spinal cord stimulator implantation, in case of malfunction of the devices. 
  • If there is a concern for lead migration, such as a sudden reduction in pain relief following stimulator implantation. X-rays should be obtained to determine the stimulator lead location (AP and lateral views).
  • Postoperative follow up after implantation usually occurs one week after the procedure. Close monitoring and adjustments of the stimulator settings following the procedure are routine.

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