Download Patients in this cohort showed highly significant

Long-Term Back Pain Relief with
Precision Spectra SCS and 32-Contact
Anatomically-Based Programming
Salim Hayek MD PhD1, Elias Veizi MD1, James North MD2, T. Brent Chafin MD3, Thomas Yearwood
MD PhD4, Louis Raso MD5, Robert Frey MD6, Kevin Cairns MD7, Anthony Berg MD8, John Brendel
MD9, Nameer Haider MD10, Matthew McCarty MD11, Henry Vucetic MD12, Kasra Amirdelfan MD13,
Lilly Chen MD14, Jai Shetake PhD14, Brad Hershey MS14, Nitzan Mekel-Bobrov PhD14
1University
Hospitals Case Medical Center, OH;
4Comprehensive
7Florida
Pain
and
Rehabilitation,
Spine Specialists, FL;
10Comprehensive
13Integrated
8Spine
Pain Clinic, NY;
MS;
5Jupiter
Team Texas, TX;
11Balcones
Pain Management Medical Group, CA;
NM-278608-AA_DEC2014
2Carolinas
Pain Institute, NC;
Pain
Clinic, FL;
9Interventional
Pain Consultants, TX;
14Boston
3Roanoke-Chowan
6Pacific
Pain
Hospital, NC;
Management, CA;
Pain Specialists of Wisconsin, WI;
12The
Scientific Corporation, CA
Spine and Pain Institute, OH;
Disclosures
Dr. Salim Hayek has served as a paid consultant for Boston Scientific’s Medical Advisory Board.
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).
(Kumar et al. 2008)
• 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
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
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).
Key design features:
• 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.
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.
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)
Materials & Methods: Patient Cohort (N=213)
50%
50%
44%
40%
36%
40%
30%
30%
20%
20%
25%
18%
20%
16%
13%
10%
10%
8%
4%
6%
4
5
11%
0%
0%
Low Back
Only
Legs
Only
Pain Locations
Low Back
and Legs
1-3
Mild
6
Moderate
7
8
9
10
Severe
Baseline Distribution of Pain Intensity (0-10 NRS)
• 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.
Materials & Methods: Procedure Information
1 Lead
3%
8
contacts
1%
50%
42%
4 Leads
12%
40%
30%
30%
3 Leads
14%
2 Leads
71%
32
contacts
50%
16
contacts
37%
20%
10%
10%
24
contacts
12%
Number of Contacts Implanted
8%
T9
T10 - T12
0%
T1 - T5
Number of Leads Implanted
7%
3%
T6
T7
T8
Vertebral Position of Implanted Leads (top of lead)
•
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.
Results: SCS trial outcomes
Trial-to-perm ratio was 86% in this cohort, with highly significant
pain reduction.
Patient Reported Trial Outcomes
Responders
Sleep Improvement (N=56)
18%
Medications Reduced (N=56)
31%
ADLs Increased (N=36)
28%
Physical Function Increased (N=36)
40%
• 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).
Results: Overall Pain Outcomes
Patients in this cohort showed highly significant overall pain relief maintained
out to 12 months post-implant.
• 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).
Results: Low Back Pain Outcomes
Patients in this cohort showed highly significant low back pain relief maintained
out to 12 months post-implant, equivalent to overall pain relief.
• 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).
Results: Responder Rate Outcomes
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.
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.
Conclusions
• 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 previouslyunattained clinical outcomes for low back pain.
• Further study is currently underway in both an RCT and a large-scale registry study.
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.
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