Presentation on theme: "High-Frequency Spinal Cord Stimulation Therapy in Failed Back Surgery Syndrome Patients with Predominant Back Pain Adnan Al-Kaisy1, Jean-Pierre Van Buyten2,"— Presentation transcript:
1 High-Frequency Spinal Cord Stimulation Therapy in Failed Back Surgery Syndrome Patients with Predominant Back PainAdnan Al-Kaisy1, Jean-Pierre Van Buyten2, Stefano Palmisani1, Thomas Smith1, Iris Smet21St Thomas' hospital, London, United Kingdom, 2AZ Nikolaas, St Niklaas, Belgium
2 Disclosure Study supported by grant from Nevro Corp (Menlo Park, CA) CAUTION – Nevro’s Senza™ system is an investigational device limited by Federal (USA) law to investigational use. The device is approved for use in the European Union.
3 Most common locations of chronic pain 5%8%24%15%9%6%18%16%14%8%
4 IntroductionFBSS: Each year, more than 1 million spinal surgeries are performed in the US with 400,000 cases being instrumented. 1 Roughly half of these are in the lumbosacral area. 2 Despite surgery, approximately 30% of these patients fail to improve, as shown by persistent back pain. 2 SCS: Traditional SCS is a well-accepted option for Failed Back Surgery Syndrome (FBSS) patients with predominantly neuropathic leg pain. 1, 2 However, providing adequate and sustained back pain relief for patients with predominant back pain remains more challenging. 1, 21 Frey, Manchikanti, Benyamin, et al. Spinal Cord Stimulation for Patients with Back Surgery Syndrome: A Systematic Review. Pain Physician. 2009; 12:2 Van Buyten JP, Linderoth B. “The Failed Back Surgery Syndrome”: Definition and therapeutic algorithms: An Update. Eur J of Pain Suppl. 2010;4:
5 High-Frequency SCSSenza High-Frequency SCS system is a novel SCS system allows pulse rate up to 10 kHz.Surgical technique similar to traditional SCS, however, a useful difference:Traditional SCS requires intraoperative paresthesia mappingPotentially uncomfortable for patientCan lead to wide range in procedure timesHF-SCS lead positioning is more efficient:No paresthesia mapping neededAnatomically positionedOverlapping leads along midline Shorter, more predictable procedure times
6 High-Frequency SCS & FBSS Senza was evaluated for use in the treatment of chronic pain in a prospective, open label study. 3The study trialed 83 patients with or without prior surgeryThe study demonstrated the safety and efficacy of the novel therapyA subset analysis was conducted for the FBSS subsetThis subset includes 67 patientsThe patients were followed-up to 12 months3 Van Buyten et al, High-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back Pain Patients: Results of a Prospective Multicenter European Clinical Study. Neuromodulation. Accepted for publication
7 Baseline Demographics Mean age in years49.6 ± 9.5Gender54% FemaleMean years since back pain diagnosis10Predominant back pain91%Failed traditional SCS18%VAS Back (SD)8.4 ( 1.2)VAS Leg (SD)5.4 ( 3.2)Mean # of prior surgeries (range)2 (1-5)History of back surgery:spinal fusiondiscectomy laminectomydisc replacement52%42%40%13%mean number of back surgeries: 2 (range: 1-5)
8 Trial Results57/66 patients (86%) had successful trial (> 50% pain relief) and went to permanent implant.Notable results given significant number of difficult-to-treat patients:91% of FBSS cohort had predominant back pain, which doesn’t respond well to traditional SCS18 % of FBSS cohort previously failed traditional SCSNote: 1 patient did not complete the trial
9 Average Visual Analog Scale (VAS) for Pain Pain Relief at 12 MonthsAverage Visual Analog Scale (VAS) for Pain(mean + SEM)Significant and sustained back pain & leg pain relief despite difficult-to-treat population.70% of the patients had ≥ 50% backpain relief at 12 months.N=57N=57N=54p < 0.001p < 0.001Note: Subjects who have successfully passed the trial and received permanent implant
10 Improved Function at 12 Months Average Oswestry Disability Index(mean + SEM)Severe disabilitySustained reduction in disabilities.15 point decrease in ODI at 12 months.LowdisabilityN=56N=56N=53p < 0.001p < 0.001
11 Excellent Safety Profile Device related Serious Adverse Events were consistent with standard SCS practice:There were no therapy-related neurological findings.No device had to be explanted due to battery life issues.SAENumber of EventsPocket Pain4Wound Infection3Lead Migration2Loss of Pain Relief1Suboptimal Lead Placement
12 Summary & ConclusionsDespite advances in traditional SCS (i.e. transverse tripole, triangular stimulation, etc), providing relief to FBSS patients with predominant axial low back pain remains very difficult.This 67 patient analysis of High-Frequency SCS on FBSS patients shows:High trial success rate despite difficult to treat patients (91% of the cohort had predominant back pain)86% trial phase success rateSignificant and sustained relief for both back pain and leg pain70% responder rate at 12 monthsSizeable and durable improvement in function15 point reduction in ODI at 12 monthsHF-SCS should be considered as a leading therapeutic option for FBSS patients (even those with predominant back pain)The “Holy Grail” of SCS has been the relief of low back painAnatomical and technological issues have made consistent paresthesiae difficult.These issues have led to the development of newer techniques and technologies (e.g. peripheral field stimulation, transverse tripole stimulation, etc.CAUTION – Nevro’s Senza™ system is an investigational device limited by Federal (USA) law to investigational use. The device is approved for use in the European Union.