1. Response to case report; cephalad migration of externally powered spinal cord stimulator.

    Sirs, As a neuromodulator and instructor with extensive (30 year) experience with both "wired " and "wireless " systems, I feel compelled to repond to the conclusions of the cited case report.

    While the authors mention lead migration as an known complication of spinal cord stimulation, it is useful to consider that Cameron (1) cited 361 lead migration events in 2753 patients , a 13.2% incidence. Anderson (2) , in his report of spinal cord stimulation for angina pectoris, found lead migration to be the most frequent complication requiring reoperation (23%), an incidence verified by North. This is not the first case report of cephalad lead migration, although less common than caudal migration. McGreevy and colleagues (3) at Johns Hopkins reported a case of cephalad lead migration from T9 vertebral segment to T1 two weeks postoperatively. The Titan (Medtronic) anchor was sutured to lumbosacral fascia with a strain relief loop (SRL). An additional SRL was placed beneath the implanted IPG. This issue is not confined to percutaneous cylindrical leads, as significant cephalad paddle -lead migration has also been reported (4).

    A multitude of published research has confirmed that spinal cord stimulation is indeed a safe procedure (5). The author performing the procedure (MF) states that "this was the implanters first experience with this (wireless) device". I can personally attest that implanting the StimWave system is distinctly different in many respects, than competing "wired " systems. When teaching physicians , I continually stress these differences. The manufacturer recommends anchoring either with traditional sleeve anchors, or their proprietary Sandshark anchor. In addition, a knot is to be tied in the lead distal to the last mark . A separate subcutaneous incision (0.5cm) is made to secure the distal lead tip to the subcutaneous fascia. There is no indication that the author followed these recommended techniques. The authors also relate " challenges with connectivity and aberrant programming". I was informed personally that the StimWave engineer was able to obtain connectivity and paresthesia mapping at the non-migrated lead, hoever the patient expressed a preference for the "wired " system rather than the "wireless" external system. I concur with the authors recommendations for locking anchors and silicone elastomer adhesives. . I strongly disagree with the assertions made that this case "demands more research into the safety of externally powered devices". I have successfully implanted this system for three years ,without any lead migration, as have countless physicians worldwide. ]The proper conclusion of this report should be that this new wireless spinal cord stimulator system is distinctly different than previous wired systems, requiring proper triaining, strict adherence to recommended operative techniques and implanter experience. It is unfortunate that the authors first case utilizing this system was unsuccessful, however , their contention that these systems are unsafe is completely unfounded.

    Sincerely, George J.Arcos D.O.,FAOCA

    1) Safety and efficacy of spinal cord stimulation for the treatment of chronic pain; A 20-year review. Cameron,T J Neurosurg (Spine3) 100:254-267 2004 2) Anderson C Complications in spinal cord stimulation for the treatment of angina pectoris. Acta Cardiologica 52:35-39 1995 3)McGreevy K, WilliamsKA,Christo PJ Cephalad lead migration following spinal cord stimulator implantation Pain Physician 2012 Jan-Feb; 15(1): E 79-87 4) DiSanto S, Ravera E Significant cephalad laddle lead migration after lumbar spinal cord stimulator implant. Neuromodulation 2014 Jun ;17 (4): 385 5) Bendersky D, Yampolsky C Is Spinal cord stimulation safe? World Neurosurg 2014 Dec; 82(6): 1359-68.

    Conflict of Interest:

    No stock or investment ownership. Senior Consultant for BSC and StimWave.

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