The Prospective Evaluation of Safety and Success of a New Method of Introducing Percutaneous Paddle Leads and Complex Arrays With an Epidural Access System
ABSTRACT Spinal cord stimulation (SCS) has become a mainstay in the continuum of care for patients suffering from chronic neuropathic pain of the trunk and limbs. Options for placing these devices have included a percutaneous method of using an epidural needle to place a cylindrical (percutaneous) lead to stimulate the spinal cord, or an open laminotomy method for placing a paddle lead at the location of the surgical decompression of the laminae. Both of these methods have been successful in a high percentage of patients, but neither have been ideal. Limitations of the percutaneous leads have been inefficiency of power delivery, inability to achieve desired depth of stimulation in the spinal cord, occasional lead migration and difficulty covering complex pain patterns. Limitations of the paddle lead have been the need for surgical laminotomy, inability to steer the lead once placed, limits on placement in the vicinity of the surgical decompression, and a perceived risk of increased bleeding and trauma to the tissue. These factors have led many minimally invasive spine specialists to seek new options for SCS. This paper presents the initial US experience with a newly approved device to place both paddle leads, and multi-lead arrays into the epidural space via a percutaneous Seldinger-guided approach through a single needle placement. We will both describe the technique and review the outcomes of some of the early cases.
After Investigational Review Board clearance, patients consented to data collection in a prospective fashion regarding the use of a new percutaneous epidural introducer (Epiducer, St. Jude Neurological, Minneapolis, MN, USA) to place paddle leads and complex lead arrays. The patients underwent education regarding expectations and risks of the procedure consistent with our normal preoperative period. Patients underwent preoperative anesthesia screening and proper testing as outlined by the Joint Commission on Hospital Accreditation, and were given the opportunity to ask questions concerning the procedure. Once the patient wished to move forward, they were consented using the approved case reporting form and followed during the course of their care. The initial cases were performed in West Virginia with subsequent cases following at the other centers involved in this analysis. The outcomes of this analysis focused on three areas: 1. The technical success in placing the percutaneous sheath. This included the ability to successfully complete: • epidural access with a 14-gauge Tuohy needle • ability to place a styleted guidewire • ability to introduce the introduction system over the wire into the epidural space • ability to remove the guidewire and introduction tip leaving the 10-gauge sheath intact. 2. The ability to place the desired lead or leads into the epidural space via the percutaneous introduction sheath. 3. The presence of any major adverse event which were defined as: • nerve injury • paraplegia • worsening of baseline pain • epidural hematoma • epidural infection • dural tear • dural rent • retained device that could not be removed. This information was carefully recorded for each implant, and summarized in this communication.
During the initial 30 days of the evaluation period, 43 epidural introduction systems were attempted in 38 patients. In patients in whom more than one paddle lead was placed, the system required the reinsertion of the guidewire through the Epiducer, removal of the Epiducer, and rewiring over the guidewire. This is necessary because the diameter of a paddle lead does not allow two or three leads to be placed without rewiring the system. The success of placement was 42/43, with inability to access the epidural space in one patient in whom ligamentum flavum hypertrophy was present on the preoperative imaging study. In all patients, the system was placed at the L1-L2 level, or lower, based on the Food and Drug Administration labeling. The total numbers of leads placed were 75, with both paddle and percutaneous arrays implanted successfully. There were no adverse events during this prospective surveillance evaluation. Ten patients complained of soreness at the entry site and post-procedure stiffness. These complaints were treated with ice, rest, and analgesics and resolved without incident.
This paper describes the initial US cases of the placement of a paddle lead via a minimally invasive percutaneous method, as well as complex cylindrical arrays with a single needle entry to the epidural space. The device functioned successfully and presented a safe option for placing paddle leads and complex arrays.
- Neuromodulation 01/2012; 15(1):1-4. DOI:10.1111/j.1525-1403.2011.00425.x · 2.70 Impact Factor
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ABSTRACT: Durable pain remission using radiofrequency thermal neurotomy (RTN) requires thoughtful patient selection and a lesion of optimal size and position. Success necessitates complete ablation of approximately 8-10 mm of the targeted neural pathway. Technical failure may result if anatomical variations in the targeted pathway are not incorporated into the lesion and if the electrode is not positioned optimally relative to the target nerve. This paper presents an improvement in RF electrode design intended to improve RTN outcomes. Keywords: radiofrequency thermal neurotomy, pain managementMinimally Invasive Surgery for Pain, Las Vegas, NV; 05/2012
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ABSTRACT: Spinal cord stimulation (SCS) has been used to treat neuropathic pain since 1967. Following that, technological progress, among other advances, helped SCS become an effective tool to reduce pain. This article is a non-systematic review of the mechanism of action, indications, results, programming parameters, complications, and cost-effectiveness of SCS. In spite of the existence of several studies that try to prove the mechanism of action of SCS, it still remains unknown. The mechanism of action of SCS would be based on the antidromic activation of the dorsal column fibers, which activate the inhibitory interneurons within the dorsal horn. At present, the indications of SCS are being revised constantly, while new applications are being proposed and researched worldwide. Failed back surgery syndrome (FBSS) is the most common indication for SCS, whereas, the complex regional pain syndrome (CRPS) is the second one. Also, this technique is useful in patients with refractory angina and critical limb ischemia, in whom surgical or endovascular treatment cannot be performed. Further indications may be phantom limb pain, chronic intractable pain located in the head, face, neck, or upper extremities, spinal lumbar stenosis in patients who are not surgical candidates, and others. Spinal cord stimulation is a useful tool for neuromodulation, if an accurate patient selection is carried out prior, which should include a trial period. Undoubtedly, this proper selection and a better knowledge of its underlying mechanisms of action, will allow this cutting edge technique to be more acceptable among pain physicians.Surgical Neurology International 10/2012; 3(Suppl 4):S275-89. DOI:10.4103/2152-7806.103019 · 1.18 Impact Factor