Transcript of NM-278608-AA_DEC2014 Long-Term Back Pain Relief with Precision Spectra SCS and 32-Contact...
- Slide 1
- NM-278608-AA_DEC2014 Long-Term Back Pain Relief with Precision
Spectra SCS and 32-Contact Anatomically-Based Programming Salim
Hayek MD PhD 1, Elias Veizi MD 1, James North MD 2, T. Brent Chafin
MD 3, Thomas Yearwood MD PhD 4, Louis Raso MD 5, Robert Frey MD 6,
Kevin Cairns MD 7, Anthony Berg MD 8, John Brendel MD 9, Nameer
Haider MD 10, Matthew McCarty MD 11, Henry Vucetic MD 12, Kasra
Amirdelfan MD 13, Lilly Chen MD 14, Jai Shetake PhD 14, Brad
Hershey MS 14, Nitzan Mekel-Bobrov PhD 14 1 University Hospitals
Case Medical Center, OH; 2 Carolinas Pain Institute, NC; 3
Roanoke-Chowan Hospital, NC; 4 Comprehensive Pain and
Rehabilitation, MS; 5 Jupiter Pain Clinic, FL; 6 Pacific Pain
Management, CA; 7 Florida Spine Specialists, FL; 8 Spine Team
Texas, TX; 9 Interventional Pain Specialists of Wisconsin, WI; 10
Comprehensive Pain Clinic, NY; 11 Balcones Pain Consultants, TX; 12
The Spine and Pain Institute, OH; 13 Integrated Pain Management
Medical Group, CA; 14 Boston Scientific Corporation, CA
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- Disclosures Dr. Salim Hayek has served as a paid consultant for
Boston Scientifics Medical Advisory Board.
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- Background Conventional SCS for low back pain has,
historically, been challenging compared to treatment of leg pain.
Modest clinical outcomes for low back pain relief in SCS RCT
(PROCESS 2008). Consistently lower relief of low back pain compared
to leg pain in SCS observational studies (Barolat et al. 2001,
North et al. 2005). The nature of the low back innervating fibers
is challenging for SCS: 1.More lateral: dorsal roots get recruited
first 2.Smaller: higher stimulation threshold 3.Deeper: higher
stimulation threshold (Kumar et al. 2008)
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- Background SCS advances have been developed to address these
challenges. Lead configurations New surgical leads Greater number
of electrodes New potential lead combinations Targeting specificity
Constant current Multiple independent current control
Anatomically-guided neural targeting algorithm Waveforms and Field
Shapes Anode intensification High frequency stimulation Burst
stimulation
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- Background Spectra SCS system introduced in 2013 a new SCS
paradigm using Anatomically-Guided Neural Targeting Algorithm with
32-contact multiple independent current control (MICC). Algorithmic
optimization of contacts and current to target a particular area of
the cord. Accounts for relative positions of contacts and leads
relative to each other. Adjustable resolution for search and
coverage around the stimulation target. Key design features :
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- Background Technological advancements do not always result in
better outcomes (Kumar et al., 2014) Study objective: characterize
the real-world clinical outcomes of the 32-contact MICC Neural
Targeting Algorithm to test whether high levels of low back pain
relief are being achieved.
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- Materials & Methods: Study Design Study Design
Multi-center, consecutive observational study (all patients meeting
inclusion criteria at participating sites were included without
bias) Study Device Precision Spectra SCS with 32-contact MICC
anatomically-guided neural targeting algorithm Sample Size 213 SCS
trialed patients Number of Sites 13 US sites Follow-up Duration 2
years planned currently at 1 year post-implant Key Inclusion
Criteria Real-world cohort only requirement is on label treatment
with the Precision Spectra SCS System for low back and leg pain.
Study Assessments Baseline information: demographics, diagnosis,
pain location Procedural information: lead configuration,
programming parameters Clinical outcomes: - SCS trial outcomes
success rate - Trial QoLs: sleep improvement, physical function,
activities of daily living (ADLs), percent pain relief (PPR). -
Pain intensity (0-10 numerical rating scale - NRS)
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- Pain Locations Age (mean SD): 57 15 Gender: 63% F, 37% M The
most common location of pain was low back only (44%), followed by
low back and legs (36%). The baseline distribution of pain
intensities was skewed towards the severe category, as expected for
SCS patients, with a median of 8.0 points. Baseline Distribution of
Pain Intensity (0-10 NRS) Materials & Methods: Patient Cohort
(N=213)
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- A wide range of lead configurations was used, consistent with
intended flexibility. The predominant mode of implant for this
system was two 1x16 percutaneous leads (40% of patients). 62% of
patients were treated with lead configurations using 24-32
contacts. Lead placement for permanent implant procedures, based on
location of the lead tip, was predominantly in the T6-T8 vertebral
levels, capturing 88% of cases. Number of Leads ImplantedNumber of
Contacts Implanted Materials & Methods: Procedure Information
Vertebral Position of Implanted Leads (top of lead)
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- All patients: Highly significant difference of 4.00 points
between baseline overall pain (7.17) and overall pain at end of
trial (3.17). Severe patients (baseline NRS = 8-10): Highly
significant difference of 5.30 points between baseline pain (8.74)
and pain at end of trial (3.44). Trial-to-perm ratio was 86% in
this cohort, with highly significant pain reduction. Results: SCS
trial outcomes Patient Reported Trial OutcomesResponders Sleep
Improvement (N=56)18% Medications Reduced (N=56)31% ADLs Increased
(N=36)28% Physical Function Increased (N=36)40%
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- All patients: Highly significant difference of 4.21 points
between baseline pain (7.17) and pain at 12 months post-implant
(2.96). Severe patients (baseline NRS = 8-10): Highly significant
difference of 5.73 points between baseline pain (8.75) and pain at
12 months post-implant (3.02). Patients in this cohort showed
highly significant overall pain relief maintained out to 12 months
post-implant. Results: Overall Pain Outcomes
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- All patients: Highly significant difference of 4.04 points
between baseline pain (7.21) and pain at 12 months post-implant
(3.17). Severe patients (baseline NRS = 8-10): Highly significant
difference of 5.73 points between baseline pain (8.60) and pain at
12 months post-implant (2.87). Patients in this cohort showed
highly significant low back pain relief maintained out to 12 months
post-implant, equivalent to overall pain relief. Results: Low Back
Pain Outcomes
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- 71% of patients in this cohort showed 50% low back pain NRS
reduction at 12 months post-implant, equivalent to the responder
rate for overall pain. Results: Responder Rate Outcomes Responder
Rate (50% NRS reduction) Responder rates for overall pain and low
back pain converge by 6 months post-implant and remain stable out
to 12 months post-implant at an equivalently high level.
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- In a cohort of 213 patients treated with the Precision Spectra
system, based on an anatomically-guided neural targeting algorithm,
and followed out to 12 months post-implant, we found: High
trial-to-perm ratio Highly significant low back pain reduction,
equivalent to reduction in overall pain High low back pain
responder rate, equivalent to responder rate of overall pain These
results suggest that the novel anatomically-guided neural targeting
algorithm, with the 32-contact MICC Precision Spectra system, may
provide previously- unattained clinical outcomes for low back pain.
Further study is currently underway in both an RCT and a
large-scale registry study. Conclusions
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- Indications for Use Indications for Use. The Precision Spectra
Spinal Cord Stimulator System (Precision Spectra System) is
indicated as an aid in the management of chronic intractable pain
of the trunk and/or limbs, including unilateral or bilateral pain
associated with the following: failed back surgery syndrome,
intractable low back pain, and leg pain. Contraindications,
warnings, precautions, side effects. The Precision Spectra System
is contraindicated for patients who: are unable to operate the
Precision Spectra System, have failed trial stimulation by failing
to receive effective pain relief, are poor surgical risks, or are
pregnant. Refer to the Instructions for Use provided with the
Precision Spectra System or ControlYourPain.com for potential
adverse effects, warnings, and precautions prior to using this
product. Caution: Federal (U.S.) law restricts this device to sale
by or on the order of a physician. Results from clinical studies
are not predictive of results in other studies. Results in other
studies may vary. 2014 Boston Scientific Corporation or its
affiliates. All rights reserved. All trademarks are the property of
their respective owners.