1. THE POTENTIAL ROLE OF INTRADISCAL BIACUPLASTY IN REDUCING SPINE DISABILITY AND PROVIDING VALUE
Mehul J. Desai, MD, MPH
President, International Spine, Pain & Performance Center
George Washington University
Legislative Fellow 2016, North American Neuromodulation Society
Leadership Fellow , American Academy of Physical Medicine & Rehabilitation
10 x 25 Spine Summit: Technology Update
July 15, 2016

2. DISCLOSURES Advisory Board – Halyard Health Advisory Board – Medtronic
Stock Options – dorsaVi, Inc.

3. Objectives
To elucidate the role of intradiscal procedures such as biacuplasty in treatment pain of discogenic origin in the lumbar spine.
To understand the potential cost-benefits of this procedure as a part of the continuum of spine care.

4. Costs Approximately 800,000 spinal surgeries in the U.S. annually.
From approximately 3.6 million fusions in the U.S.. Total cost of > $ 287 billion.
Average national cost of $14,000 ($11-25K) for a single-level ACDF and $26,000 ($20-37K) for single- level PLIF (direct costs; professional and technical).
Indirect costs much higher.
Goz V. 2015

5. Cost-Effectiveness
Laminectomy calculated to cost $77,000 per QALY gained.
Lumbar fusion calculated to cost $114,000 per QALY gained.
In the United States, $100,000 is the maximum at which procedures are considered cost-effective.
Tosteson AN et al. 2008

6. Unsatisfactory Outcomes
Rates of development in the literature range from 4- 50%.
Frequency of cases in the general population from % ( U.S. 72,000-7,200,000).
Conservative estimates that we are adding 80, ,000 new patients to those already suffering from this issue.
Cost associated with Post Spine Surgery Syndrome.
Taylor RS 2012

7. Background
Internal disc disruption resulting in lumbar discogenic pain is a common cause of chronic low back.
Implicated in approximately 40% of younger patients.
Schwarzer AC 1995

8. Discogenic Pain Self-care Analgesic and anti-inflammatory medications
Conventional Medical Management (CMM) is the primary treatment option for discogenic LBP
Self-care
Analgesic and anti-inflammatory medications
Physical and cognitive therapies
These CMM choices tend to be moderately effective
Surgical Interventions
Artificial disc replacement
Lumbar discectomy
Instrumented lumbar fusion

9. Biacuplasty

10. Bipolar Cooled RF Lesion
42 mm
Describe the image on the left- 18G electrode, 6mm active tip, 22mm spacing. After lesioning for 25 minutes at 80C there are two independent lesions which are 14 mm apart.
Describe the image on the right- …. After lesioning for 25 minutes at 55C set temp, the lesion is confluent and measures 42mm across.
Testing performed in chicken (37°C) for 25:00 at a set temperature of 55 °C.

11. Intradiscal Biacuplasty (IDB)
Ease of Use
Direct percutaneous application of the electrodes into the targeted spinal disc
-enables better targeting
-reduces complications
Large Lesion
Cooled probes
Bipolar heating configuration
High probability to ablate culprit nociceptive nerves
Structures nearby (collagen in the posterior annulus, vertebral end plates, nerve roots) are not damaged
42 mm

12. N = 67 enrolled, 63 treated
Biacuplasty (IDB) (n = 29)
Conservative Medical Management (CMM) (n = 34)
Single level disease confirmed by positive pain reproduction on discography
1, 3, & 6 month follow up
Outcomes include measures of:
Pain (VAS)
Function (SF-36)
Disability (ODI)
Quality of Life (EQ-5D, PGIC)
CMM subjects could elect to cross-over to IDB + CMM at 6-months, or to continue CMM-alone to 12-months
IDB + CMM:
One ablation procedure/patient
CMM continued as prescribed by physician
CMM for both groups defined as:
Physical Therapy
Pharmacological Management
Minimally invasion interventions permitted as needed
Lumbar-epidural injections
Sacro-iliac joint injections
Facet-joint or nerve interventions
Behavioral Therapy
Weight Loss
Acupuncture

13. Methods: Comparative effectiveness RCT comparing Biacuplasty (n = 29) against Conventional Medical Management (n = 34)
1, 3, & 6 month follow up
Outcomes include SF-36, VAS, ODI
Results:
Statistically significant improvement in 1, 3, & 6 months
Trends indicating functional improvement
50% vs 18% Responder rate (2 point/30% decrease in VAS)
42% reported >50% decrease in pain
Conclusion: Superior performance of IDB with respect to all study outcomes suggests that it is a more effective treatment for discogenic pain than CMM-alone.

14. SF 36 PF mean improvement 18 points ODI mean improvement 11 points
VAS mean improvement 2.4
SF 36 PF mean improvement 18 points
ODI mean improvement 11 points

15. Main Inclusion Criteria
Completion of the 6-month follow up of the original effectiveness study
Consent to continue follow up for additional 6-month following either IDB after crossing over or remaining in CMM group
Main Exclusion Criteria
Major deviations from protocol criteria
22 active treatment patients reported 12-month data.
25/28 available chose to crossover
22/25 Crossovers reported 6-month data
Manuscript Accepted, Pain Medicine

16. 41% of IDB group maintained >50% decrease in pain at 12 months
IDB: 55% Responder Rate (>2 points VAS or 30% decrease) vs. CMM: 18% at 12 months
41% of IDB group maintained >50% decrease in pain at 12 months
Crossover group responded the same to treatment as originally treated group

17. Crossover subjects responded similarly to originally treated subjects

18. Clinically relevant improvements in Pain, Function and Quality of Life maintained through 12 month time point
All metrics reflect similar, consistent message. The outcomes of this study suggest:
IDB + CMM more effectively reduces discogenic LBP than CMM, and can rescue individuals who continue suffering from discogenic pain despite of CMM
IDB + CMM enables better physical functioning, less disability, and a greater positive impact on patients’ health when compared to CMM-alone
The positive effects of IDB + CMM are durable, lasting up to 12-months after a single IDB treatment
The superior performance of the IDB + CMM treatment with respect to all study outcomes suggests that IDB + CMM is a more effective treatment for discogenic LBP than CMM-alone for carefully selected patients

19. N = 64 enrolled, 59 treated in 1:1 randomization scheme
Pain Med Mar;14(3):362-73
N = 64 enrolled, 59 treated in 1:1 randomization scheme
Biacuplasty (n = 29)
Sham Procedure (n = 30)
One and two level disease included
All patients had positive pain reproduction on discography
1, 3, & 6 month follow up
Outcomes include SF-36, NRS, ODI
6 month follow up for all patients
Study unblinded at 6 months & sham patients allowed to cross over to treatment
Dr. Kapural and team were previously at Cleveland Clinic and now practices at Wake Forest University. Study was conducted at both centers.
First ever double-blind randomized study of TransDiscal vs. placebo.
16 patients were single level, 11 were two level
25/30 sham patients chose to have TransDiscal biacuplasty at 6 month follow up.

20. Pain Med Mar;14(3):362-73
Results:
No procedure-related complications
Statistically significant improvements in pain and 6 mths
16 mg reduction in daily opioid use
Authors conclude that TransDiscal biacuplasty should be recommended to select patients with discogenic low back pain
All p < 0.05

21. all observed time points.
Pain Med Mar;16(3):425-31
Long term follow up
22 active tx (12 mth)
20 “cross-over” (6 mth)
Sustained improvements in pain and function
Slight reduction in opioid use
No adverse events
Halyard Multicenter trial is in final data collection stages and should be published later this year. It is a multicenter trial (9 centers across US) including 67 patients that compares TransDiscal to conservative medical management (what is being done today that doesn’t involve surgery). At the 6 month time point, we are seeing very similar results as shown here (consistency of procedure).
So between the two RCTS/studies, one indicates this procedure is better than nothing. The other will show that it is better than what you are doing now for these patients.
Conclusions: Clinically significant improvements after IDB initially reported at 6 months were maintained at 9 and 12 months. The cross-over subjects had similar improvement in all outcome measures at
all observed time points.

22. Conclusions Where is the appropriate place to position this procedure?
Demonstrated effectiveness and reduction in disability? Questions about durability?
Cost-effectiveness?
$ per procedure.
Should this be a treatment for patient under the age of 50 with discogenic low back pain prior to and earlier in the continuum of care than surgery?