Subcutaneous Stimulation: How to Assess Optimal Implantation Depth , Paul Verrills, MD
Transcription
Subcutaneous Stimulation: How to Assess Optimal Implantation Depth , Paul Verrills, MD
Neuromodulation: Technology at the Neural Interface Received: September 22, 2010 Revised: December 24, 2010 Accepted: February 19, 2011 (onlinelibrary.wiley.com) DOI: 10.1111/j.1525-1403.2011.00357.x Subcutaneous Stimulation: How to Assess Optimal Implantation Depth ner_357 343..348 David Abejón, MD*, Timothy Deer, MD†, Paul Verrills, MD‡ Introduction: Subcutaneous stimulation (peripheral nerve field stimulation) is a novel neuromodulation modality that has increased in its utilization during the last 10 years. It consists of introducing a lead in the subdermal level to stimulate the small nerve fibers in that layer. Unlike other neuromodulation techniques including direct peripheral nerve stimulation, spinal cord stimulation, or deep brain stimulation, the precise target is not identified. Materials and Methods: To date, there is no clear guideline on the appropriate depth or a method to achieve reproducibility of the appropriate depth to place these leads. From clinical experience, we have found that when electrodes are placed in a layer that is too superficial, stimulation is often painful or lacks efficacy. Further, if they are too deep, the patient may not feel adequate paresthesia or get uncomfortable stimulation including, in some circumstances, muscle contractions. Results: In this small series, we demonstrate a novel concept using a radiofrequency stimulation probe to identify the appropriate depth to place the lead. Reproducibility of results will add clarity to the accumulating data and hopefully increase the chances of adequate stimulation coverage and pain relief. Keywords: Chronic pain, electrode placement, implant, implantation, technical report Conflicts of Interest: Dr. David Abejón is a speaker for St. Jude Medical, Medtronic, and Boston Scientific. Dr. Timothy Deer is a consultant for Azur, Bioness, Medtronic, Spinal Modulation, St. Jude, Stryker, and Vertos. Dr. Paul Verrills reported no conflicts of interest. INTRODUCTION Subcutaneous stimulation, also called peripheral nerve field stimulation or peripheral subcutaneous field stimulation (1), is a relatively new neurostimulation modality. The first articles date from 2004, and since then, publications on this subject have grown exponentially. Studies have been carried out on the implantation of stimulation leads in the lumbar area, to manage low-back pain secondary to failed back surgery syndrome (2). The use of these systems has recently been utilized in situations in which it would be difficult to achieve paresthesia coverage with spinal cord stimulation systems (3) or in cases where epidural lead implantation is too complicated or risky (4–6). The number of publications and posters has increased exponentially since 2004, but some reasonable doubts about the development of this modality still linger. These doubts have arisen because of the lack of a prospective randomized study on the procedure and because of confusion regarding the indications for this technique. There also are unresolved issues in the area of the science of subcutaneous stimulation, including the mechanism of action, adequate lead depth of implant, and the most adequate parameters and stimulation modalities. This paper will provide an overview of indications, and then examine the proper depth of lead implantation in order to achieve activation of the subcutaneous nerve fibers. INTRODUCTION TO THE SURGICAL TECHNIQUE www.neuromodulationjournal.com Address corresponding to: David Abejón, MD, Hospital Universitario Puerta de Hierro Majadahonda, Madrid—Pain Unit, C/ Joaquin Rodrigo, 2.28222, Majadahonda, Madrid, Spain. Email: [email protected] * Hospital Universitario Puerta de Hierro Majadahonda, Madrid—Pain Unit, Madrid, Spain; † Center for Pain Relief, Charleston, WV, USA; and ‡ Metro Spinal Clinic—Research, South Caulfield, Vic., Australia For more information on author guidelines, an explanation of our peer review process, and conflict of interest informed consent policies, please go to http:// www.wiley.com/bw/submit.asp?ref=1094-7159&site=1 © 2011 International Neuromodulation Society Neuromodulation 2011; 14: 343–348 343 In order to stimulate the subcutaneous nervous system we must implant one or more leads into the subdermic layer of the skin. The depth of this implant has not been reported in the literature to date, and this can be problematic in achieving an optimal outcome. Leads that are implanted in the more superficial tissues such as the dermis can result in painful stimulation often described as “burning” and stabbing. Leads that are implanted in the deeper tissue layers can result in the inability to perceive stimulation or in muscle recruitment and uncomfortable stimulation. In both of these scenarios, the outcome will not be acceptable. It is important for the clinician to achieve the proper depth of stimulation, which is a conundrum based on current publications. Imaging techniques can be helpful in locating specific nerve fibers in both the upper and lower extremity (7–9). This type of guidance could be critical in subcutaneous stimulation and could result in the difference between a good outcome and a failure to achieve relief. To address these issues and in order to achieve proper depth for stimulation, the following technique has been developed in Spain. ABEJÓN ET AL. Figure 1. Marking of the implant area and location of the patient’s maximum pain spot. The photograph shows a bilateral pain, and the introduction point and target are marked on the left painful spot. 344 A needle is used to deliver current from a radiofrequency generator in the stimulation function to identify target fibers. This targeting also can be achieved by using a peripheral nerve stimulator in a manner used for peripheral nerve blocks, for regional anesthesia. After informed consent, the patient is taken to the operating theatre and prepped and draped in the proper fashion. The target area for stimulation is marked using a permanent marker before entering the operation room (Fig. 1). If the patient suffers from allodynia, the lead placement may have to be adapted to the areas just outside of the zone of allodynia. This may require lead cross-talk between two separate leads to achieve pain reduction (Fig. 2). The patients also are given intravenous antibiotics prior to incision. The needle is guided to the proper pain target of maximum discomfort by x-ray guidance and landmarks. Once the needle is in place we proceed to stimulate with the radiofrequency generator. This device allows for 2 Hz motor stimulation and 50 Hz sensory stimulation. The devices used are a RFG-3C Plus generator (Radionics, Burlington, MA, USA) and a 60-mm CXE cannula with a 4-mm active tip. Sensory stimulation is performed until a paresthesia is elicited in the painful area (Fig. 3), the goal is to achieve paresthesia at 0.5 v although it is accepted with the range of 0.5 to 1 v. The needle-generator connection is protected with a sterile tube cover to guarantee sterility. The proper depth of stimulation is located based on stimulation, and this depth is confirmed by lateral fluoroscopic guidance to identify the needle tip. Keeping the cannula in position, and with a continuous vision of fluoroscopy in lateral view, so that the display of the depth of radiofrequency cannula is appropriate, we introduce a Tuohy needle or a 14G angiocatheter through which the lead will be advanced and placed at the depth of sensory stimulation (Fig. 4). As in other stimulation modalities, a stimulation test is performed after positioning the lead, until the paresthesia perceived by the patient coincides with his/her painful area and this paresthesia is pleasant and comfortable. www.neuromodulationjournal.com Figure 2. Delimitation of the allodynic area, around which electrodes are implanted. Each line represents the introduction of one lead. Figure 3. Introduction of a 6-mm CXE needle with 4-mm active tip, used for sensitive stimulation and location of the implant depth. We use trial lead during the test phase that will be removed afterwards. Surgical technique in the test phase only consists of locating the stimulation depth and introducing the lead through a Tuohy needle or 14G angiocatheter, as explained; no incision is made on the skin. Leads are introduced through the needle and fixed directly to the skin with Steri-Strip (Fig. 5). Test duration may vary from 1 to 2 weeks. Following a positive trial we allow 2–4 weeks before performing the permanent implant. This waiting period is recommended to allow for skin healing to reduce the risk of infection (Fig. 6). During the permanent implantation we perform a 3–4 cm long incision to anchor the leads to the fascia, as in stimulation of the epidural space, and the leads are tunneled to the generator pocket. In some cases, especially with leads placed in the upper buttock or © 2011 International Neuromodulation Society Neuromodulation 2011; 14: 343–348 SUBCUTANEOUS DEPTH Figure 4. The lead is introduced and located at the depth where an adequate paresthesia was achieved with the RF needle. just above the beltline, IPG pocket can be used to introduce and anchor the leads, in order to avoid additional incisions. The use of widely spaced four contact or normal spaced eight contact leads depends on the area needed for paresthesia to achieve the stimulation goal, the complexity of the system based on other stimulation targets. Regardless of the system chosen, the most important outcome is to achieve adequate stimulation in the most painful area with an appropriate depth of lead placement. The experience to date with 21 leads in 10 patients has shown that the average target zone is at 10.5 mm (9.8–11.3 mm) below the surface of the skin (Tables 1 and 2). INDICATIONS Indications are not well established because therapeutic modalities have sometimes been confusing (2,10–13). One of the greatest confounding points is the use of the terms for stimulating a peripheral nerve directly and the fibers of a nerve as interchangeable. Taxonomy remains confusing, but the targets are very different. For example, in a recent publication a novel device was introduced to stimulate the median nerve. In that setting the depth is determined by a peripheral nerve stimulator to determine lead delivery (14). This is a different issue than we are addressing in this publication, which is to discuss a new method of determining proper depth of stimulation when targeting nerve fibers of a larger defined nerve. In our opinion, the main indications for the use of this therapy can by summarized in two specific items: • Hard-to-stimulate areas with other stimulation modalities • Well-defined areas of pain From this standpoint, this therapy can be proposed for patients with axial pain, from cervical to lumbar, which is hard to manage with spinal cord stimulation (15,16). Other hard-to-stimulate zones are the paravertebral and the scapular areas, and groin regions where spinal cord stimulation usually does not provide a consistent and constant paresthesia. Another indication that looks adequate is the management of painful scars with nerve entrapment (17), as it is often a well-delineated area. The physician can adapt these devices to treat other areas of concern and the identification of new targets are being evaluated in clinical studies. (18,19). DISCUSSION www.neuromodulationjournal.com management and can be performed with low risks and minimal insult during a trialing phase (6,20,21). The main problems that are faced when attempting a new therapeutic modality are common to all techniques: overuse, lack of randomized, prospective, and double-blinded studies, poor patient selection, adverse events, and lack of long-term cost-effectiveness data. In addition to those dilemmas, in this arena we are faced with some critical questions: • • • • • The mechanism of action The optimal surgical technique Proper indications and patient selection groups The optimal stimulation parameters and modes The long-term efficacy and cost-effectiveness Although we don’t have substantial replies to any of these issues or problems addressed above, based on the current knowledge in the field we can make some comment: The mechanism of action of spinal cord stimulation has been defined by the work of Linderoth, Foreman, and Meyerson (22,23). Direct stimulation of the peripheral nerve has been theorized to act by creating a change in nerve transmission or a balance of A delta and C fiber response compared with other nocioreceptors. Stimulation of the nerve fibers of the subcutaneous tissue has been theorized to act by changing the mechanism of tissue activation at the site of the pain generator and the responding nerve tissue. PNFS may theoretically operate in one of the following mechanisms: impact local blood flow, block cell membrane depolarization, change neurotransmitter levels, and change the message at the spinal cord level. Investigators are debating the mechanisms, but many think PNFS may change the levels of localized and systemic endogenous endorphins, thereby impacting the nociceptive threshold in the target zone. More basic research is needed in this area. Surgical technique and precise indications seem to be another obstacle for the development of this therapy. The surgical technique is relatively straightforward and has been described in the different articles referenced in this work. The concept idea of being able to stimulate before introduction of the leads is appealing and is pro- © 2011 International Neuromodulation Society Neuromodulation 2011; 14: 343–348 345 Peripheral subcutaneous stimulation is the newest area of neuromodulation that is providing an exciting new frontier in pain Figure 5. Trial phase: leads are not anchored to the patient’s skin. Some SteriStrip bands are enough to keep leads in place, don’t harm the area for the final implantation, and don’t cause discomfort for the patient. ABEJÓN ET AL. Figure 6. Permanent implant. Table 1. Patients’ Demographic Data. Name Diagnosis Leads Manufacturer IPG Depth (cm) AGM MGC JSM JSB CDV FA MLH LJF RAM SC Abdominal pain FBSS Abdominal pain FBSS Abdominal pain FBSS FBSS FBSS Cervicalgia FBSS 1 ¥ 8 sc 2 ¥ 4 sc (2 ¥ 4 epidural) 4 ¥ 4 sc 2 ¥ 8 sc 2 ¥ 8 sc 2 ¥ 4 sc (2 ¥ 4 epidural) 2 ¥ 8 sc 2 ¥ 4 sc (2 ¥ 4 epidural) 2 ¥ 4 sc (1 ¥ 8 epidural) 2 ¥ 4 sc (2 ¥ 4 epidural) Medtronic ANS Boston Boston Medtronic ANS Medtronic ANS ANS ANS Restore ultra Eon mini Precision Precision Restore ultra Eon mini Restore ultra Eon mini Eon mini Eon mini 11.3 10.5 9.9 10.4 10.5 10.6 9.8 11.0 10.7 10.3 FBSS, failed back surgery syndrome; SC, subcutaneous. Table 2. Patients’ Stimulation Parameters. Name pT Main T Discomfort T Fq (Hz) Pw (ms) Impedance (W) AGM MGC JSM JSB CDV FA MLH LJF RAM SC 1.5 3.6 2.0 10.5 3.5 8.0 3.0 6.0 2.5 5.5 2.0 4.2 2.4 11.0 4.5 9.0 3.5 9.0 3.5 6.5 10.5 4.8 2.8 12.8 10.5 13.0 10.0 12.0 4.5 8.0 60 70 40 50 60 60 60 50 50 50 330 300 300 300 390 300 300 200 287 300 533 687 1186 518 404 398 927 902 502 545 Fq, frequency; pT, perception threshold; Pw, pulse width; T, threshold. 346 posed as a reproducible way to assess the best implantation depth to obtain the most comfortable paresthesia. The use of imaging techniques alone does not currently solve this problem as it only indicates the radiological landmark in which the Touhy needle is residing at the time of lead deployment. To know the exact depth, it would possibly be necessary to devise some kind of mathematical model as the one developed by Manola and Holsheimer for spinal cord or cortex stimulation (24,25), which would help us to know what is really stimulated and what we should do to improve results (26). In our opinion, the best option to know the most precise positioning of the electrodes in this kind of stimulation www.neuromodulationjournal.com would be a combination of stimulation (to locate the targeted area) and echography (to define the exact depth of the electrodes). One of the doubts related to the therapy will be overcome if we can establish the depth to place the lead(s) exactly. The combination of these two techniques, together with the development of a suitable model, will strongly help the programing and stimulating techniques (27). Once we have an exact definition of how to perform the technique, which are the best indications and parameters, multicenter and randomized studies will be easy to perform in order to provide further scientific validation of the technique. © 2011 International Neuromodulation Society Neuromodulation 2011; 14: 343–348 SUBCUTANEOUS DEPTH CONCLUSIONS Here we provide for the first time a reproducible technique to establish ideal depth of stimulation in the subcutaneous area of patients suffering complex, difficult pain, and who have failed conservative management, and whose pain regions would not normally be treatable with spinal cord stimulation (28,29). Authorship Statements Dr. Abejón conceived the idea and prepared the manuscript draft. Dr. Deer provided important intellectual input on the mechanisms of action of peripheral nerve field stimulation and edited the manuscript for English. Dr. Verrills provided important intellectual input on peripheral nerve field stimulation and edited the manuscript for English. All authors approved the final version of the manuscript. How to Cite this Article: Abejón D., Deer T., Verrills P. 2011. Subcutaneous Stimulation: How to Assess Optimal Implantation Depth. Neuromodulation 2011; 14: 343–348 REFERENCES www.neuromodulationjournal.com COMMENTS In "Subcutaneous Stimulation: How to Assess Optimal Implantation Depth," Abejon et al. provide a concise technical introduction to a novel intra-operative mapping technique for the placement of peripheral nerve field stimulation (PNfS) percutaneous electrodes. Previous reports have discussed the use of ultrasound to determine depth of implantation, but as the authors point out, there is some ambiguity in the literature regarding PNfS as distinct from classical peripheral nerve stimulation (PNS) in which a specific named nerve is directly targeted. Ultrasound has generally been investigated primarily for PNS applications where direct visualization of the target nerve clarifies the desired implant depth. In PNfS, no such discrete target structure exists, and the functional nature of the target increases the uncertainty regarding optimal implant depth. The technique for subcutaneous electrode implantation requires the surgeon to choose a depth, and the placement of the electrode through the introducer only allows electrophysiologic testing along one dimension. The authors have creatively applied the principles of electrophysiologic mapping of pain generators with RF stimulation to the subcutaneous space to identify the optimum implant depth, and then used lateral fluoroscopy to maintain this depth along the implant trajectory. They report their results in a small series of patients. This is certain to be a useful technique for the many implanters who are using PNfS in cases that are difficult to obtain paresthesia coverage with more traditional techniques. Kenneth M. Alo’, M.D. Clinical Member The Methodist Hospital Research Institute The Texas Medical Center Houston, TX, USA Director, Section of Neuro-Cardiology Associate Professor, Institute of Cardiology and Vascular Medicine Monterrey Technical University, Monterrey Mexico (Instituto de Cardiologia y Medicina Vascular del TEC de Monterrey) © 2011 International Neuromodulation Society Erich O. Richter, M.D. Assistant Professor of Neurosurgery Department of Neurosurgery LSU Health Sciences Center, New Orleans New Orleans, LA, USA Neuromodulation 2011; 14: 343–348 347 1. Abejón D, Krames E. Peripheral nerve stimulation or is it peripheral subcutaneous field stimulation; what’s in a moniker? Neuromodulation 2009;12:1–4. 2. Verrills P, Mitchell B, Vivian D, Sinclair C. 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Pain Physician 2009;12:965–983. ABEJÓN ET AL. *** The field of peripheral subcutaneous stimulation (or peripheral field stimulation) is rapidly growing and is gaining a very important role in the management of intractable pain with neurostimulation techniques. Even though the technique seems to be simple, proper positioning of the leads can prove to be tricky. As the authors appropriately point out, there is no objective instrumental method to judge the exact depth of the electrode placement. Personal clinical experience has allowed the reviewer to successfully place subcutaneous leads in most circumstances without any additional tools. The technique described by the authors, however, can be useful in less experienced implanters and certainly could avoid repetitive leads passes before finding the proper depth. *** The authors have reported a novel technique to stimulate subcutaneous neural targets and ascertain the appropriate depth of these targets for optimal stimulation outcomes. Only further study will ultimately decide the merits of this approach. Currently, inaccuracies in our understanding of subcutaneous stimulation include uncertainty regarding the mechanisms of effect and a lack of uniformity in implantation techniques. Imaging of soft tissues or other localization techniques such as the described use of electrical verification of target depth via radiofrequency hardware may aid the field in achieving better standardization. The authors accurately point out the ongoing need for more basic research in the use of subcutaneous stimulation, to better understand exactly how this new and exciting technique works. Giancarlo Barolat, M.D. INS Founder & Director at Large Medical Director, Barolat Neuroscience Denver, CO, USA Marc Huntoon, M.D. Professor of Anesthesiology Consultant in Anesthesiology, Pain Medicine College of Medicine Mayo Clinic Rochester, MN, USA Comments not included in the Early View version of this paper. 348 www.neuromodulationjournal.com © 2011 International Neuromodulation Society Neuromodulation 2011; 14: 343–348