Lora L. Brown
INTRODUCTION
Figure 38-1. Lumbar spinal stenosis treatment algorithm.
INDICATIONS
CONTRAINDICATIONS
There are no FDA contraindications for the mild procedure. However, relevant clinical contraindications are listed:
RELEVANT ANATOMY
PATHOPHYSIOLOGY OF SPINAL STENOSIS
Figure 38-2. Lumbar spine anatomy.
As the vertebral canal narrows, there is a transient pressure elevation at the level of stenosis that is provoked by weight bearing. Symptomatic lumbar spinal stenosis can be related to this pressure elevation. It is postulated that as the pressure rises, venous congestion and neural ischemia occur. Flexion of the lumbar spine expands the canal diameter to its maximum diameter, thus providing a decrease in canal pressure and symptomatic relief. Positions that decrease the force of gravity on the spinal canal also provide symptomatic relief in lumbar canal stenosis. When seated, the counter force provided by the chair counteracts that of gravity, providing an overall decrease in canal pressure. When supine, the effect of gravity on the spinal canal is eliminated totally, as the force of gravity is now perpendicular to the spine.
MECHANISM OF ACTION
LIGAMENTUM FLAVUM HYPERTROPHY
Figure 38-3. This is a photo of an axial cut MRI image of the lumbar spine demonstrating spinal stenosis with ligamentum flavum hypertrophy (black V-shaped tissue in posterior canal). (Used with permission Courtesy of Wade H.M. Wong, DO.)
Figure 38-4. The ligamentum flavum measurement is taken at the midpoint of the pedicle and is measured in a perpendicular direction from the pedicle as demonstrated in this photo. A measurement of 2.5 mm or greater is considered hypertrophic. (Used with permission from Charles Stevens, MD.)
It has been observed that mild is extremely effective in treating spinal stenosis associated with adjacent segmental disease, provided there is no preexisting spinal instability. The posterior anatomical position of this tissue makes it amenable to percutaneous decompression. The mild procedure utilizes a 12-gauge working port through which decompression instruments are placed. The optimum approach for effective decompression is in line with the inferior lamina. The working port is positioned in such a manner that it parallels the superior surface of the inferior lamina. Although minor adjustments may be indicated based upon individual patient anatomy, this approach provides the most consistent position for maximum tissue resection.
The ligamentum flavum tissue is accessed through the interlaminar window. The size and shape of this space varies by patient and spinal level. In addition, degenerative changes, including shingling of the lamina, as well as intraoperative positioning of the patient, may influence access through the interlaminar space. Preoperative imaging studies are extremely important to ensure optimum access and decompression.
EPIDUROGRAM
An important and key aspect of the mild procedure is the epidurogram. An epidurogram is utilized as a safety feature allowing the mild decompression to proceed while avoiding device contact with the dura, cauda equina/nerve roots and major blood vessels, thus preventing potential patient injury.
PREOPERATIVE CONSIDERATIONS
Mild is considered a minimally invasive outpatient procedure. It is performed in a sterile operating or procedure room with utilization of fluoroscopy. The patient’s imaging studies should be present and available for reference during the procedure.
The preoperative workup for the mild procedure is similar to that of other minimally invasive spine surgical interventions, ie, implantation of spinal cord stimulators or intrathecal pumps. Patients should have appropriate medical or cardiac clearance per treating facility’s anesthesia guidelines. Normal coagulation studies should be confirmed and anticoagulation medication use suspended.
Preoperative intravenous antibiotic administration is desirable. Most mild patients require light conscious sedation. In the rare case that conscious sedation is contraindicated, a general anesthetic may be used. Occasionally physicians have found their patients to be comfortable during the procedure using only local anesthetic.
INDICATIONS
Mild is cleared by FDA to perform lumbar decompressive procedures for the treatment of various spinal conditions. The mild devices are specifically designed to access the interlaminar space from a posterior approach, enabling removal of small portions of the lamina, then preferentially resecting and debulking the thickened ligamentum flavum, thus accomplishing a lumbar decompression.
FLUOROSCOPIC VIEWS
Although AP and lateral fluoroscopic views are appreciated, the bulk of this procedure is performed utilizing a contralateral oblique fluoroscopic view.
Figure 38-5. The “contralateral oblique” fluoroscopic approach is used during tissue resection. This view provides maximum visualization of the lamina and the epidurogram at the level of resection.
Figure 38-6. A typical scene of a physician performing the mild procedure. (Used with permission from Wade H.M. Wong DO.)
Depth of instrument placement during the mild procedure is observed in the contralateral oblique fluoroscopic view. All advancement of instruments, and the entire decompression procedure should be performed utilizing this view.
While all aspects of the procedure should be conducted in the contralateral oblique fluoroscopic view with constant visualization of the epidurogram, it is prudent to frequently stop and check the AP view. The AP view allows verification of the mild instruments’ medial to lateral position within the posterior spinal space.
POSITIONING THE PATIENT
Patients undergoing the mild decompression procedure are placed in a prone position with the abdomen bolstered to reduce lordosis. Reduction of lumbar lordosis opens the interlaminar window facilitating access to the posterior spinal space. It is important to appreciate the degree of laminar shelving that may exist. In some elderly patients with significant degenerative changes to the spine, the lamina can overlap or “kiss,” making interlaminar entry difficult. Increased lumbar flexion can aid in these cases (Figure 38-7).
Figure 38-7. A properly positioned patient for the mild procedure is demonstrated. The patient is prone with reduction of the lumbar lordosis. (Used with permission from Wade H.M. Wong DO.)
Conversely, it is also important not to over-flex the lumbar spine. Hyperflexion of the lumbar spine extends the epidural space as well as the posterior spinal tissue. Too much extension of these tissues can increase the difficulty of decompression. In addition, once the epidural space is extended, the epidurogram will lose its scalloped shape associated with ligamentum flavum hypertrophy making it more difficult to identify the procedure endpoint (a straighter, thicker epidurogram).
Abdominal bolstering can be accomplished utilizing multiple techniques. Pillows can be used under the abdomen. Sometimes with this technique, the pillows become too compressed and the patient can sink, thus reducing the intended lumbar flexion. Another technique utilizes rolling of sheets or blankets into logs 8 to 12 in in height, depending on patient’s body. These logs are then placed under the patient’s iliac crests and under the clavicles. Finally, radiolucent devices such as Wilson and Camden frames may be utilized.
EQUIPMENT
Figure 38-8. The mild kit contains the Tissue Sculptor, the Bone Sculptor Rongeur, the mild portal, the mild trocar and handle, the mild portal stabilizer, the mild depth guide, and the mild surgical clamp.
INTRAOPERATIVE TECHNICAL STEPS
Position patient prone with reduction of lumbar lordosis (see patient positioning above). Check pressure points prior to implementation of anesthesia.
Using fluoroscopy, identify and superficially mark the midline as well as the medial pedicular borders bilaterally at the intended treatment level(s).
These markings will prove useful later in the case as they can serve as a reminder of instrument distal tip orientation.
For example, if the proximal end of the portal is positioned extremely lateral, outside of the skin markings, it is likely the distal tip has crossed midline, thus requiring repositioning (Figure 38-9).
Figure 38-9. Superficial skin markings are made to identify the midline and the medial pedicular borders.
Align the inferior end plate of the level to be treated with the fluoroscope. This will open the superior aspect of the intervertebral space.
The goal is to place the epidural needle as high in the apex of the intervertebral space and as close to midline as possible while remaining ipsilateral to the treatment side.
This will provide the best epidurogram with the needle as far out of the working zone as possible.
Utilize a “loss of resistance” technique with a continuous pressure placed on the hub of the syringe. A bounce loss of resistance technique will more often than not result in a wet tap in these patients.
Once loss of resistance is confirmed, inject a small quantity on contrast (1 cc or less) to confirm epidural spread in the contralateral oblique fluoroscopic view. Injection of contrast is facilitated with the use of a high-pressure IV extension tube.
With severe stenosis, it may be necessary to place the epidural needle at the level above or below the level of the stenosis.
The skin entry site is usually one and one half levels below the treatment site on the ipsilateral side. This typically falls at the level of the pedicle, one level down.
The best approach is usually about 15 degrees off of midline, but may need to be adjusted based on the patient’s spinal anatomy.
Create a skin wheel with local anesthetic. Use a 5-in 22-gauge spinal needle to advance toward the inferior lamina.
Utilize an AP fluoroscopic view to direct the needle approximately half way to determine the medial to lateral trajectory needed at this level on this side. (Imaging studies should be reviewed preoperatively for trajectory planning and available throughout the case for reference.)
This access device is advanced along the same track until the distal end is positioned on the superior surface of the inferior lamina, within the posterior half of the lamina (Figures 38-10 and 38-11).
Figure 38-10. The mild portal is loaded with a trocar and is positioned parallel to the superior surface of the inferior lamina.
Figure 38-11. A photograph of a contralateral oblique fluoroscopic image demonstrating the epidural needle positioned high in the L4-5 intralaminar space with visible epidurogram. The trocar is positioned parallel to the superior surface of the inferior lamina. The tip of the trocar is seen here at the posterior edge of the inferior lamina.
Release and remove the trocar by gently turning the locking screw on the handle.
Next slide the portal stabilizer over to the portal and snap into place.
The stabilizer has a roller ball mechanism that allows pivoting of the cannula, which may facilitate tissue removal.
The portal stabilizer simultaneously provides some stability as it serves to control the angle of the mild portal against the skin surface.
Next, attach the depth guide to the distal end of the portal.
This device provides a stop that limits the depth (forward motion) of any instrument inserted into the portal.
It has a dial mechanism that allows instruments to extend in 5 mm increments from 0 to 25 mm beyond the tip of the port and into the interlaminar space (Figure 38-12).
Figure 38-12. The mild Portal Stabilizer serves to control the angle of the mild portal against the surface of the skin. The mild depth guide serves to adjust the depth of the Bone Sculpter Rongeur and the Tissue Sculpter within the intralaminar space in 5 mm increments.
Decompression is initiated with the use of the mild Bone Sculpter Rongeur.
This instrument is inserted through the port and used to resect and excise superior and inferior laminar tissue.
It is a single bite instrument that must be withdrawn from the port and emptied after each pass.
It is recommended that a systematic technique be utilized starting at the medial surface of the inferior lamina and working toward the lateral end.
Then, beginning at the medial surface of the superior lamina, work toward the lateral end to include the lateral intervertebral border (Figure 38-13).
Figure 38-13. The mild Bone Sculpter Rongeur is being used along the inferior edge of the superior lamina.
Once an adequate amount of bone has been resected, the mild Tissue Sculpter is placed within the port and utilized to resect remaining soft ligamentum flavum tissue.
This device may be used for multiple bites, but must be withdrawn from the port regularly and tissue sufficiently discharged to avoid overfilling, which could affect normal action of the trigger mechanism.
The instrument design requires a scooping upward motion from inferior to superior direction combined with activation of the trigger, which implements the cutting action.
Repositioning of the tissue sculpter with each cut ensures additional tissue resection. It is suggested that a thoughtful plan of resection be utilized beginning at the medial aspect of the interlaminar space and working laterally.
Continual visualization of the epidurogram is required throughout the procedure. Care is taken to avoid passage of instruments beyond the epidurogram.
Maintaining a position posterior to the epidurogram with all instrumentation throughout the procedure ensures that neural structures are protected (Figure 38-14).
Figure 38-14. The mild Tissue Sculpter is being used to remove ligamentum flavum tissue from the posterior intralaminar space.
With adequate ligamentum flavum tissue resection, a change in the epidurogram is observed.
Typically, the epidurogram is visualized as straighter and/or thicker.
This finding is considered the end-point of the procedure and all instruments are withdrawn (Figures 38-15 and 38-16).
Figure 38-15. (A, B) Per-mild. Note the shape of the epidurogram before the mild procedure as a thin scalloped shape.
Figure 38-16. (A, B) Post-mild. Note the shape of the epidurogram after the mild procedure as thicker and straighter indicating improved flow of contrast after debulking the hypertrophied ligamentum flavum.
The wounds are then cleaned and closed using a sterile adhesive-strip and a sterile dressing. The patient is taken to PACU (Figure 38-17).
Figure 38-17. Small 5.1 mm incisions are covered with a small dressing post procedure.
POSTPROCEDURE CONSIDERATIONS
CLINICAL PEARLS AND PITFALLS
Pearls
Pitfalls
SUGGESTED READING
Abbas J, Hamoud K, Masharawi YM, May H, Hay O, Medlej B, Peled N, Hershkovitz I. Ligamentum flavum thickness in normal and stenotic lumbar spines. Spine. 2010;35(12):1225-1230.
Basu S. mild ® procedure: single-site experience with prospective IRB approved clinical outcomes research. Clin J Pain. 2011.
Castro-Menéndez M, Bravo-Ricoy JA, Casal-Moro R, Hernández-Blanco M, Jorge-Barreiro FJ. Midterm outcome after microendoscopic decompressive laminotomy for lumbar spinal stenosis: 4-year prospective study. Neurosurgery. 2009;65:100-110.
Chopko B. A novel method for treatment of lumbar spinal stenosis in high-risk surgical candidates: pilot study experience with percutaneous remodeling of ligamentum flavum and lamina. J Neurosurg Spine. 2011 Jan;14:46-50.
Chopko B, Caraway D. MiDAS I (mild ® Decompression Alternative to Open Surgery): a preliminary report of a prospective, multi-center clinical study. Pain Physician. 2010;13:369-378. ISSN 1533-3159.
Deer T, Kapural L. New image-guided ultra-minimally invasive lumbar decompression method: the mild ® procedure. Pain Physician. 2010;13:35-41. ISSN 1533-3159.
Deer T, Mekhail N, Lopez G, Amirdelfan K. The evolving use of minimally invasive surgery for the treatment of pain—minimally invasive lumbar decompression for spinal stenosis. J Neurosurg Spine. 2011.
Lingreen R, Grider J. Retrospective review of patient self-reported improvement and post-procedure findings for mild ® (Minimally Invasive Lumbar Decompression). Pain Physician. 2010;13:555-560. ISSN 1533-3159.
Mekhail N, Benyamin R. Long-term results of percutaneous lumbar decompression mild ® for spinal stenosis. Pain Practice. 2011 Jun 16. Online ISSN 1533-2500.
Sairyo K, Biyani A, Goel V, et al. Pathomechanism of ligamentum flavum hypertrophy: a multidisciplinary investigation based on clinical, biomechanical, histologic, and biologic assessments. Spine. 2005;30:2649-2656.
Schomer D, Solsberg D, Wong, Chopko B. mild ® lumbar decompression for the treatment of lumbar spinal stenosis. Neuroradiol J. 2011 Aug15.
Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008;358:794-810.