Patient Safety in Spine Procedures: Dr. Babaria's Research
Dr. Vivek Babaria, DO, served as co-first author on a 2023 patient safety review published in Interventional Pain Medicine, written with colleagues on the Spine Intervention Society's Patient Safety Committee. The review summarizes the published evidence on two potential procedure-related complications: vasovagal reactions during interventional pain procedures, and lead migration during spinal cord stimulator trials.
Part 1: Vasovagal reactions during spine and pain procedures
What is a vasovagal reaction?
A vasovagal reaction (VVR) is a sudden drop in heart rate and blood pressure, often triggered by stress or a painful stimulus. Common signs include dizziness, a feeling of warmth or flushing, sweating, nausea and blurred vision. In its most extreme form, a person may briefly lose consciousness, which is called vasovagal syncope.
How common is it?
Across the studies reviewed, vasovagal reactions occurred in roughly 1% to 8% of interventional procedures for spine pain. One study reported a higher rate with cervical (neck) injections than with lumbar (low back) injections, 8% compared with 1%.
Who may be at higher risk?
The review identified several factors associated with a greater likelihood of a vasovagal reaction:
- Younger age. A study of more than 8,000 patients found higher risk in patients ages 18 to 35.
- Male sex. Men were more likely to experience a reaction in that same study.
- A prior reaction. Patients who had a vasovagal reaction during a previous spine procedure had a 23% chance of another one at a later procedure, compared with 3% for patients without that history.
Can moderate sedation help?
For patients with a history of vasovagal reactions, the evidence suggests moderate sedation may play a role in prevention. In one study of 134 procedures in patients with a prior reaction, 21 of 90 procedures done without moderate sedation (23.3%) led to a repeat reaction. None of the 44 procedures done with moderate sedation did.
The review also notes that monitoring pulse, oxygen levels and blood pressure before, during and after a procedure can help the care team spot early signs. It also recommends steps to reduce anxiety, including telling patients what to expect and assigning a care team member to stay with them during the procedure.
Part 2: Spinal cord stimulator trial lead migration
What is a spinal cord stimulator trial?
Spinal cord stimulation (SCS) is FDA-approved for conditions such as failed back surgery syndrome, complex regional pain syndrome and painful neuropathy. Before a permanent device is considered, patients typically complete a trial. Thin wires called leads are placed temporarily, and a permanent implant is generally considered if the patient reports at least 50% relief of their main pain.
What is lead migration?
During a trial, the leads can shift from where they were placed. Published rates of lead migration during trials range widely, from as low as 0.7% to as high as 23%.
Myth vs. fact
Myth: Proper anchoring techniques will mitigate safety concerns related to lead migration during spinal cord stimulator trials.
Fact: Suturing (stitching) percutaneous trial leads does not appear to reduce the risk of migration compared with taping alone. Most lead migration does not pose a safety concern during the trial period.
What the evidence shows
In one study of three-day trials, leads that were sutured and taped moved an average of 24.5 mm. Leads that were taped only moved an average of 8.7 mm. The researchers suggested the extra tension from the sutures may cause an "inch worm" effect when patients bend forward.
The review also notes that downward (caudal) migration is more common than upward migration. Rare case reports describe leads moving much farther, causing new symptoms that resolved once the leads were removed.
What this means for patients
Based on the evidence, the review's recommendations include:
- Following post-procedure guidance during an SCS trial, including avoiding bending or twisting and leaving the procedure site alone
- Telling your care team about less pain relief, new pain, tingling in new areas or any changes in strength or sensation, which may prompt an x-ray
- An x-ray at the end of the trial to confirm lead position if moving forward with an implant
Talk with our team
If you're considering an interventional spine procedure or a spinal cord stimulator trial, Dr. Babaria and the team at Orange County Spine & Sports Medicine can walk you through what to expect. We see patients in Newport Beach, Huntington Beach and Carlsbad. Call (949) 216-5277 or visit ocspineandsports.com to schedule a consultation.
This article is for educational purposes and is not a substitute for medical advice. Talk with your physician about your individual situation.
Source: Babaria V, Patel J, Schneider BJ, Mattie R, McCormick ZL; Spine Intervention Society's Patient Safety Committee. FactFinders for patient safety: Preventing potential procedure-related complications: Vasovagal reactions and spinal cord stimulator lead migration. Interventional Pain Medicine. 2023;2(3):100268.
FAQ
How common are vasovagal reactions during spine injections? Published studies report vasovagal reactions in roughly 1% to 8% of interventional procedures for spine pain. One study found a higher rate with cervical (neck) injections than lumbar (low back) injections, 8% compared with 1%.
Who is more likely to feel faint during a spine procedure? Younger patients (ages 18 to 35), men, and people who have had a vasovagal reaction during a previous procedure may be at higher risk. Patients with a prior reaction had a 23% chance of another one at a later procedure, compared with 3% for those without that history.
Can sedation help prevent fainting during a spine procedure? For patients with a history of vasovagal reactions, moderate sedation may help. In one study, 23.3% of procedures done without moderate sedation in these patients led to a repeat reaction, compared with none of the procedures done with moderate sedation.
Does stitching spinal cord stimulator trial leads keep them from moving? The evidence suggests it does not. In one study of three-day trials, sutured and taped leads moved an average of 24.5 mm, while taped-only leads moved an average of 8.7 mm.
Is lead migration during a spinal cord stimulator trial dangerous? Most lead migration during a trial does not pose a safety concern or lead to long-term problems. It may cause new pain, reduce how well the trial works, or require a repeat procedure, so patients should report any changes in pain or sensation to their care team.
Who wrote this research? Dr. Vivek Babaria, DO, of Orange County Spine & Sports Medicine served as co-first author with Dr. Jaymin Patel, alongside Dr. Byron J. Schneider, Dr. Ryan Mattie and Dr. Zachary L. McCormick, on behalf of the Spine Intervention Society's Patient Safety Committee. It was published in Interventional Pain Medicine in 2023.
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