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Salim Hayek, MD, PhD Division of Pain Medicine Department of Anesthesiology Case Western Reserve University SCS Complications.

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Presentation on theme: "Salim Hayek, MD, PhD Division of Pain Medicine Department of Anesthesiology Case Western Reserve University SCS Complications."— Presentation transcript:

1 Salim Hayek, MD, PhD Division of Pain Medicine Department of Anesthesiology Case Western Reserve University SCS Complications

2 Learning Objectives Be aware of common SCS Complications Understand the reasons for complications Strategies to minimize complications

3 Turner JA et al., Pain Mar;108(1-2): Complications AN UNAVOIDABLE PROBLEM 34% of patients who received a stimulator had an adverse occurrence PROPORTIONATE TO NUMBERS MUST BE ADDRESSED EARLY AN IMPLANT COORDINATOR IS ESSENTIAL CAN BE REDUCED

4 Minimizing Complications PreoperativePatient selection IntraoperativeTechnique PostoperativeVigilance Pain relief

5 3 tracks NANS, as a specialty society, neither accredits training programs nor certifies individuals to perform SCS Understanding and being able to manage complications: Crucial

6 Complications of SCS Technical Biologic Other

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8 Kumar K etal., J Neurosurg Spine 5:191–203, 2006 Total = 31.9%; in 42/160 patients 162 paddle leads; 28 percutaneous leads

9 Kumar K. et al., Pain 132 (2007) 179–188 PROCESS Study

10 Kumar K etal., J Neurosurg Spine 5:191–203, 2006 Lead Migration 18 cases 13 in axial plane 5 in transverse plane Cervical leads 2x > thoracolumbar Multipolar/multichannel leads Gluteal placement Flexion-Extension: Up to 9 cm displacement

11 Henderson JM et al., Neuromodulation, Volume 9, Number 3, –191

12 Kumar K etal., J Neurosurg Spine 5:191–203, 2006 IPG in Anterior Abdominal Wall Minimal excursion Walking: 0.2cm Twisting: 1.7 cm Scoliosis: lateral displacement Paddle leads

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14 Rosenow J et al., J Neurosurg Spine 5:183–190, 2006

15 Kumar K etal., J Neurosurg Spine 5:191–203, 2006 Percutaneous Lead Breakage just cephalad to anchoring point risk when >1cm between anchor tip and lead entry point into fascia

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17 Kumar K etal., J Neurosurg Spine 5:191–203, cm displacement between epidural space and the TL fascia Strain relief loop Paddle Lead Breakage

18 Henderson JM et al., Neuromodulation, Volume 9, Number 3, –191 Strain: Fascia--Epidural

19 Rosenow J et al., J Neurosurg Spine 5:183–190, 2006

20 Twist-Lock Anchor Pressure Forces of flexion- extension

21 Henderson JM et al., Neuromodulation, Volume 9, Number 3, –191 Simulated/sheep model Use of a soft silastic anchor pushed through the fascia to provide a larger bend radius for the lead was associated with a time to failure 65 times longer than an anchored but unsupported lead Failures of surgical paddle leads occurred when used with an anchor, whereas without an anchor, no failures occurred to 1 million cycles

22 Henderson JM et al., Neuromodulation, Volume 9, Number 3, –191 The panel recommended a paramedian approach Keeping the lead midlineprevent lateral maximizing bend radius by pushing the anchor through the fascia anchoring of the extension connector near the lead anchor Strain relief loop

23 Henderson JM et al., Neuromodulation, Volume 9, Number 3, –191 Generator Placement The anchor should be placed as near as possible to the spinous process to avoid lead movement generated by muscle contractions Placement of the IPG in the buttock region may produce up to a fivefold increase in tensile loading compared with placement in the abdomen or midaxillary line. The panel therefore recommended that buttock IPG placement be reserved for special clinical situations and should not be routinely performed

24 Kumar K et al., Neuromodulation 10 (1):24–33, black braided nylon Strain relief loop

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26 Avoid Anchoring Paddle Lead

27 Alo KM et al., Neuromodulation 1:30–45, 1998 The Good News Improved education/techniques Newer extensionless systems have resulted in a marked decrease in revision rates (e.g. 3.8%) Advancements in anchoring technology

28 Anchor Options Enhanced Silicon suture sleeves Mechanical Anchors Silicone suture sleeves

29 Types of Mechanical Anchors Swift-Lock TM Clik TM TwistLock TM Audible and tactile Clik confirms lock using hex wrench Radio-opaque Bi-directional

30 Anchor Design

31 Infections

32 Cameron T. Safety and Efficacy of Spinal Cord Stimulation for the Treatment of Chronic Pain: a 20-year Review. J Neurosurg 2004; 100: Infections 12%

33 Gaynes RP et al., Clin Infect Dis 2001;33(S2):S69-77 Haridas M, Malangoni MA. Surgery 2008;144: Surgical Site Infection--SSI Increased risk of SSI ASA classification prolonged operative time – defined as 75 th % hypoalbuminemia ( 3.4 mg/dL) anemia (Hgb 10 g/dL) excessive alcohol use (not defined) history of COPD history of CHF infection at remote site current operation through a previous incision perioperative hyperglycemia

34 Nery PB et al., J Cardiovasc Electrophysiol 2010 Jan 22 Cesar de Oliveira J et al., Circ Arrhythmia Electrophysiol 2009;2:29-34 Lessons from the Heart Historic infection rates for implanted cardiac devices (ICDs - pacemakers and defibrillators) 0.5-6% More recently as low as 1% A PRDBPCT evaluated infection risk: prophylactic cefazolin vs. placebo Trial was interrupted early by the safety committee because of the dramatically higher rate of infection in those that did not receive antibiotics vs. those that did (3.28% vs. 0.63%)

35 Infection Prevention: Antibiotic Prophylaxis RECOMMENDATION Category IA cefazolin 1-2 g iv 30 minutes prior to incision clindamycin 600 mg iv 30 minutes prior to incision [ß-lactam allergy] vancomycin 1 g iv over 60 minutes prior to incision [MRSA carriers] Gyssens. Drugs 57:175-85; 1999

36 SCS Infection Prevention Chlorhexidine more effective than Povidone Iodine skin prep Minimize OR traffic Preoperative antibiotics Meticulous hemostasis Gentle tissue handling Maki DG et al.,: Prospective randomised trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters. Lancet 338: , 1991 Kinirons B et al: Chlorhexidine versus povidone iodine in preventing colonization of continuous epidural catheters in children: a randomized, controlled trial. Anesthesiology 94: , 2001

37 Infection Recommendations?

38 How to manage an Infected SCS? The gold standard in treating deep SCS infections is a 2-stage procedure: the initial stage involves removal of implanted material, wound debridement, and antibiotic treatment ID consult After wound healing has occurred and no infection imminent, re-implantation can be performed

39 Can an Infected SCS be Salvaged? SCS Leads epidural space IPG is by far the most expensive SCS component No case reports of keeping generator in an open incision after I&D Distinguish superficial vs. deep SSI Attempts at salvaging SCS in the setting of SSI should be made only in the setting of: Complete patient understanding of potential risks Close follow up by implanter and ID specialist Careful serial monitoring of patient Clinically Laboratory values such as CRP

40 Rare Surgical Complications CSF fluid leak/headache Post-op bleeding/hematoma Pocket Seroma Wound dehiscence Epidural abscess/meningitis Headache CSF Leak Pain in the incision site Allergic response to the system Programmer or telemetry problems Residual pain phenomenon Postural Changes

41 Technical Complications Too deep an insertion Too superficial an insertion IPG flip Rib/iliac crest friction Anchor/lead erosion Anchor protrusion Uncomfortable position sitting Standing: protrusion laying down

42 CONCLUSION Overall SCS represents a low risk effective therapy to control chronic pain Complications do occur and range in severity from minor to fatal Recognizing a complication early and understanding how to intervene appropriately is your responsibility Surgical backup and extreme vigilance are highly desirable

43 Thank You!!

44 Do It Yourself

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51 The EGL Scan (Electronically Generated Lead scan)


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