Anulex presentation to central florida case manager society 03.24.2011

Anular Repair: Decreasing Reherniations after Herniated Disc Surgery

Presentation Objectives
Overview of Spine Anatomy and Herniated Discs
Overview of Lumbar Discectomy Procedure & Outcomes
Overview of Anular Repair Procedure & Outcomes
Review Study Analyzing Costs of Poor Discectomy Outcomes

Spine Anatomy & Herniated Discs

Spine Anatomy

Intervertebral Lumbar Disc
Fibrocartilaginous joint of the motion segment
Present at levels L1-S1
Allows compressive, tensile, and rotational motion
Largest avascular structures in the body

Intervertebral Lumbar Disc
The Disc is Comprised of:
Nucleus Pulposus – soft, gel-like inner substance.
Anulus Fibrosus – tough, outer ring that contains the nucleus pulposus.

Nucleus Pulposus
Nucleus Pulposus
Inner structure
Gelatinous
High water content
Resists axial forces

Anulus Fibrosus
Anulus Fibrosus
Outer portion of the disc
Made up of lamellae
Layers of collagen fibers
Arranged obliquely 30°
Reversed contiguous layers
Great tensile strength
Lamellae

Herniated Disc
Herniated disc, or “ruptured disc” is one of the most frequently surgically treated pathologies of the spine.
Average patient age is approximately 40 yrs old.
Disc herniation is often referred to as HNP, or herniated nucleus pulposus.
Not all patients who develop a disc herniation experience pain.
Large disc herniation L5-S1

L3-4
L4-5
L5-S1
Herniated Disc
The most frequently involved sites are those with the greatest range of motion and/or axial loading forces.
L3-4, L4-5, and L5-S1 are most common levels for herniated discs.

Types of Herniated Discs
Disc protrusion
“Bulging disc” – ruptured nucleus distorts anulus. Synonymous with “prolapsed disc”.
Extrusion
-Split allows nuclear material to leak but remains attached to material remaining in disc.
Sequestered
-Nuclear substance not attached to material inside disc; fragment(s) may float in spinal canal.

Exiting nerve root
Lumbar Disc Herniation - Sciatic Pain
As the outer fibers of the disc become distorted, the disc may protrude, extrude or fragment into the spinal canal.
This puts the disc herniation a position to physically contact and exert pressure on the exiting nerve root.
The individual may begin experiencing sciatica, or pain down the back of the leg.

Lumbar Disc Herniation - Discogenic Pain
Some people experience discogenic back pain, or pain generated from tears in the anulus fibrosus.
Most initial tears in the inner anulus are asymptomatic.
As the anular split progresses to the outer layers, the individual may begin to experience low back pain, with or without pain in the buttocks and legs.
This pain is discogenic in nature and not due to the compression of, or tension on, a nerve root.

Treatment of Lumbar Disc Herniation
Conservative Treatment
Sciatica often resolves spontaneously.
Physicians cannot predict which individuals will have natural resolution.
Surgical Treatment
Surgery is typically considered only after 6 weeks of conservative treatment.
These patients often gain immediate relief of their sciatica.

Lumbar Discectomy Surgery

Lumbar Discectomy
Lumbar Discectomy:
Surgical procedure to remove a herniated disc.
Most frequently performed spinal surgery – over 800,000 procedures performed worldwide each year.
Performed in the inpatient and outpatient hospital as well as ASC settings.

Removal of herniated disc fragments & decompression of neural elements
Various techniques (aggressive vs. less aggressive) have been debated
Overall, a relatively successful operation
Lumbar Discectomy Procedure

Lumbar Discectomy Procedure
An Open Pathway or “Hole” is Left in the Anulus:
Until recently surgeons have not had a fast or effective way to repair the defect following lumbar discectomy surgery.
An open defect can lead to poor patient outcomes.

Lumbar Discectomy Outcomes

Lumbar Discectomy Outcomes
Clinical Literature
Post Discectomy
5 Year Outcome1-3
Post Op
30% have pain following Discectomy
Limited ability to predict the patients who will have poor outcomes
Back Pain
Improved 70 %
Same or worse 30 %
Leg Pain
Improved 71 %
Same or worse 29 %
Satisfied
Yes 63 %
No 37 %
1Atlas S., et al. Surgical and Nonsurgical Management of Sciatica Secondary to Lumbar Disc Herniation: Five-Year Outcomes from the Maine Lumbar Spine Study. Spine 2001;26:1179-1187.
2Atlas et. al. Long-Term Outcomes of Surgical and Nonsurgical Management of Sciatica to a Lumbar Herniation: 10 Year Results from the Maine Lumbar Spine Study. Spine 2005;30:927-935.
3Loupasis et al. Seven-to-20-Year Outcome of Lumbar Discectomy. Spine 1999;24: pp 2313-2317.

Post-Discectomy Prognosis
Re-Operation
Conservative
Treatment
1/2
1/2
30% Post discectomy patients have continuing pain

Discectomy Re-operation Rates
1Hu R, et al. A Population Based Study of Reoperations After Back Surgery. Spine 1997;22:2265-2271.
2Malter A., et al. 5-Year Reoperation Rates After Different Types of Lumbar Surgery. Spine 1998;23:814-820.
3Atlas S., et al. Surgical and Nonsurgical Management of Sciatica Secondary to Lumbar Disc Herniation: Five-Year Outcomes from the Maine Lumbar Spine Study. Spine 2001;26:1179-1187.
4Osterman H., et al. Risk of Multiple Reoperations After Lumbar Disecectomy: A Population Based Study. Spine 2003;28:621-627.
5Atlas et. al. Long-Term Outcomes of Surgical and Nonsurgical Management of Sciatica to a Lumbar Herniation: 10 Year Results from the Maine Lumbar Spine Study. Spine 2005;30:927-935.

Discectomy Outcomes are Affected by Surgical Technique
How much nucleus should be removed?
30% pts have continuing pain after discectomy

How Much Nucleus Should be Removed?
Minimal Discectomy
Aggressive Discectomy
Pros: Maintenance of Disc Height2,3
Cons: Increased Reherniation1
Pros: Decreased Reherniation1
Cons: Disc Height Collapse2,3
Possible Tradeoffs
1Caragee, E. et al. A Prospective Controlled Study of Limited Vs. Subtotal Posterior Discectomy: Short-Term Outcomes in Patients With Herniated Lumbar Intervertebral Discs and Large Posterior Anular Defect. Spine 2006; 31:653-657.
2Brinckmann P, et al. Change of Disc Height, Radial Disc Bulge, and Intradiscal Pressure from Discectomy. Spine 1991;16(6):641-646.
3Kamaric E, et al. Restoration of Disc Competency by Increasing Disc Height Using an Anular Closure Device. Fifth Global Symposium on Motion Preservation Technology, Spine Arthroplasty Society (SAS) Meeting. New York, May 4-7 2005.

Why Perform a Minimal Discectomy?
A less aggressive discectomy results in better patient outcomes1,2
An aggressive discectomy results in low early reherniation rates3 but overall poorer patient outcomes1,2
Minimal Discectomy
Aggressive Discectomy
1Carragee, et al, March 2006, Spine.
2Barth, et al, February 2008, Spine.
3Wera, et al, February 2008, JBJS.

Clinical Evidence in Support of Minimal Techniques & Disc Preservation
Carragee Case Series Study
Barth Case Series Study

Carragee, et al.
Eugene Carragee, MD (Stanford); March 2006, Spine
2-Year prospective study comparing limited (46 pts) vs. aggressive (30 pts) technique
Conclusions:
Limited discectomy recommended (better outcomes), but patients should be warned of potential for reherniations
“…an effective barrier… may be clinically useful”

Barth et. al
Martin Barth, MD (Heidelberg, Germany); February 2008, Spine
2-Year prospective study comparing microdiscectomy (38 pts) vs. sequestrectomy (40 pts)
Conclusions:
“…outcome after microdiscectomy seems to worsen over time, whereas it remains stable after sequestrectomy…sequestrectomy alone may therefore represent an advantageous alternative…”

Improving Discectomy Outcomes

Repair of the Anulus Fibrosus
Reduce Reoperations and Improve Patient Outcomes by:
Restricting nucleus material from re-extruding1
Reducing inflammation and scar formation2,3
Enabling surgeons to perform a less extensive disc removal4
1Cauthen, JC. Chapter 11. pp 155-177 . In: Spinal Arthroplasty; A New Era in Spine Care, Guyer RD, editor. St. Louis MO: Quality Medical Publishing, 2005.
2Kawakami M, et al. The Role of Phospholipase A2 and Nitric Oxide in Pain-Related Behavior Produced by an Allograft of Intervertebral Disc Material to the Sciatic Nerve of the Rat. Spine 22(10):1074-1079, 1997.
3Omarker K, et al. Pathogenesis of Sciatic Pain: Role of Herniated Nucleus Pulposus and Deformation of Spinal Nerve Root and Dorsal Root Ganglion. Pain 78(2):99-105, 1998.
4Carragee et al. A Prospective Controlled Study of Limited Versus Subtotal Posterior Discectomy: Spine 2006: 31: pp653-657.

Clinical Benefits of Anular Repair:Historical Perspective
Cauthen J1
Extensive study with focus on reducing reoperations
254 patients series – suggested 21% recurrent herniation at 2 yrs with no suture, <10% with one suture, approx 5% with more than one suture
Yasargil MG2
Described placing 7-0 suture in anulus after nucleus removal
105 patients; reported no reherniations, impairment of neurological symptoms, or postoperative radiculopathy
Lehmann et al3
Included single 4-0 silk suture to close PLL flaps, peridural membrane and anulus outer fibers
152 patients; greater percentage of patients that were sutured had less post-op pain than patients not sutured; statistical significance not achieved & did not report recurrent herniation or reop rates
1 Cauthen, JC. Chapter 11. Microsurgical Annular Reconstruction (Annuloplasty) Following Lumbar Microdiscectomy: In: Spinal Arthroplasty; A New Era in Spine Care,Guyer RD, editor. St. Louis, MO: Quality Medical Publishing, 2005.
2Yasargil MG. Microsurgical operation of herniated lumbar disc. Advances in Neurosurgery 4:81, 1977.
3Lehmann TR, Titus MK. Refinements in technique for open lumbar discectomy. Proceedings of the International Society for the Study of the Lumbar Spine (ISSLS), June 1997.

Anular Repair- Cauthen Experience
Suture Repair Technique – 2 Year Follow-up1
%
Reop Rate Reduction of 68%
Percent Recurred
Surgical Group
Slit style anulotomy with anular repair results in favorable outcomes, but can be surgically challenging & time consuming (45 min OR time)
1 Cauthen, JC. Chapter 11. Microsurgical Annular Reconstruction (Annuloplasty) Following Lumbar Microdiscectomy: In: Spinal Arthroplasty; A New Era in Spine Care,Guyer RD, editor. St. Louis, MO: Quality Medical Publishing, 2005.

Shift in Type of Anulotomy Performed
Vertebra
Box
Slit
Disc
Vertebra
Discectomy often done through pre-existing anular tear
When anular tear is not evident (e.g., contained disc), anulotomy should be performed with minimally-adequate intention

System Components
Sterile, disposable delivery tools
Tension bands pre-loaded on delivery tools.
Sterile, disposable tension guide
Xclose™ Plus Tissue Repair System
Final Tension Band Construct
U.S. FDA 510(k) Clearance- Sep ’06
Over 10,000 procedures done in the U.S.
Soft tissue T-anchor assemblies
Tension lines
INDICATIONS: The Xclose™ Plus Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic procedures.

Xclose™ Plus Animation
Double Click

Xclose™ Plus Surgical TechniqueFive Primary Steps
1.
Insert/Deploy
1st Anchor
3.
Insert/Deploy
2nd Anchor
4.
Remove Slack to re-approximate
2.
Reposition Tool
5.
Trim White Line
Repeat steps 1 – 5 utilizing additional device(s)

Versaclose™ Tissue Repair System
Final Tension Band Construct
U.S. FDA 510(k) Clearance- March ’10
System Components
Tension lines
Sterile, disposable anchor delivery tool
Tension band delivery tool
Sterile, disposable tension guide with integrated blade
Soft tissue T-anchor assemblies
INDICATIONS: The Versaclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic procedures.

Versaclose™ Animation
Double Click

Versaclose™ Surgical TechniqueFive Primary Steps
1.
Insert/Deploy
Versaclose anchor
2.
Insert/Deploy 1st Xclose Plus Anchor
4.
Remove Slack to re-approximate Xclose Plus tension line
3.
Insert/Deploy 2nd Xclose Plus Anchor
5.
Remove Slack to re-approximate Versaclose tension line

Clinical Benefits of Anular Repair: Contemporary Perspective
Hartman L, et al (2009)1
Surgical Outcome of Lumbar Microdiscectomy with Emphasis on the Benefit of Anular Repair Techniques
Bailey A, et al (2010)2
Prospective, Randomized Controlled Study of Repairing the Anulus Fibrosus after Lumbar Discectomy: A Single Surgeon’s Experience
Araghi A, et al (2010)3
The Effect of Anular Repair on Sciatica Patients Receiving a Micro-Discectomy Procedure
11Hartman L, Griffith S., Melone B., Melone D. Surgical Outcome of Lumbar Microdiscectomy with Emphasis on the Benefit of Anular Repair Techniques. Proceeding of the Congress of Neurological Surgeons (CNS), October 2009, New Orleans, LA.
2Bailey A, et al Prospective, Randomized Controlled Study of Repairing the Anulus Fibrosus after Lumbar Discectomy: A Single Surgeon’s Experience.
3Araghi A, et al The Effect of Anular Repair on Sciatica Patients Receiving a Micro-Discectomy Procedure, Proceedings of the SAS, April, 2010, New Orleans, LA.

Clinical Benefits of Anular Repair:Hartman et. al.
Retrospective, Single Surgeon Case Series comparing reoperations with anular repair (59 cases) vs. no anular repair (133 cases)
March 05 – Feb 07
March 07 – Feb 08
Conclusions:
Repairing the anulus fibrosus during lumbar microdiscectomy reduced the rate of reoperation for reherniation by 47% within one year of first discectomy. (12.9% re-op rate in non anular repair group and 6.8% in anular repair group).

Clinical Benefits of Anular Repair:Bailey et. al.
Prospective, Single Surgeon Case Series comparing reoperations with anular repair (44 cases) vs. no anular repair (16 cases)
Conclusions:
Repairing the anulus fibrosus during lumbar microdiscectomy resulted in a 64% decrease in reoperation for recurrent herniation with a 28% reduction in the overall need for additional surgery.
Anular repair can be successfully accomplished in greater than 90% of cases if the discectomy is performed with the ultimate goal of repair being appreciated.

Clinical Benefits of Anular Repair:Araghi et. al.
Prospective, Multi-Center Case Series comparing reoperations with anular repair (146 cases) vs. no anular repair (75 cases)
Conclusions:
Repairing the anulus fibrosus during lumbar microdiscectomy has the potential to decrease the reoperation rate by 48.8% when comparing patients with anular repair to those without repair.
There were no negative effects as a result of the repair (specifically the perceived irritation potential from the knot of the repair device on the nerve root) as the repair study group did not have an increased incidence of leg pain as reported by VAS.

Clinical Benefits of Anular Repair:Post-Market Study (Anulex Technologies, Sponsor)
Purpose – Further define the benefits of anular repair following a standard discectomy procedure
Study Design: Randomized, single-blind, parallel control design:
2:1 Randomization (Repair with Xclose vs. No-repair)
Enrolled 750 patients (58 surgeons at 34 centers)
Patients are followed and evaluated pre-op, 2 wks, 6 mo, 12 mo, 18 mo, and 24 mo following their procedure

Clinical Benefits of Anular Repair:Post-Market Study Endpoints
Primary Endpoint:
- Reoperation rates; specifically those for reherniation
Secondary Endpoints:
- Oswestry Disability Index Score - Visual Analog Scale
- Quality of Life (SF-12) - Health Care Utilization
- Pain medications - Return to work
- Disc height collapse - All cause adverse events
Study Enrollment was completed as of August ’09
- Patient outcomes are currently being tracked

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Studies Analyzing Costs of Poor Discectomy Outcomes

Recurrent Lumbar Disc Herniation After Single-Level Lumbar Discectomy: Incidence and Health Care Cost Analysis
Study purpose:
Identify the incidence and health care costs of same-level recurrent disc herniation after primary lumbar discectomy
Costs are defined as billed charges
Article included in Neurosurgery: Sept. 2009, Volume 65, No. 3, pp 574-578

Recurrent Lumbar Disc Hernation After Single-Level Lumbar Discectomy: Incidence and Health Care Cost Analysis
A retrospective study performed by Ambrossi, et. al. at Johns Hopkins Hospital.
Study identified the incidence and health care costs of same-level recurrent disc herniation after primary lumbar discectomy. Costs included
Epidural steroid injections (ESI)
Imaging studies (MRI, CT, Myelograms, plain films)
Repeat surgery including hospitalization costs
Inpatient and outpatient physical therapy
156 patients were reviewed and 141 were available for 1 year follow-up.
17 patients (12%) developed a same-level recurrent disc herniation.
Of these 17 patients, 11 (7.8%) required revision surgery, and 6 patients (4.2% responded to conservative therapy).

Incidence and Health Care Cost Analysis - Costs of a Recurrent Disc Hernation
Substantial Health Care Costs:
Of the 17 patients with a recurrent disc herniation, the cost was $26,593 billed charges per patient.
Of the 11 that had revision surgery, the cost was $39,836 per patient.
Of the 6 that had conservative treatment, the cost was $2,315 per patient.

Lumbar Disc Herniation- An Old Problem
Patient outcomes after microdiscectomy, are generally satisfying, but not without challenges
Improvements to the discectomy procedure can be made
Reherniation and reoperation rates should be decreased to minimize healthcare costs

Lumbar Disc Herniation- A New Solution
Disc preservation with anular repair of is a valuable shift in lumbar discectomy treatment
The ability to repair the anulus quickly and efficiently offers confidence to preserve and contain disc material and potentially improve patient outcomes
Anular repair is a proactive prevention of additional expensive health care costs

Thank You!

Anulex presentation to central florida case manager society 03.24.2011

by buddhaben on Apr 10, 2011

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Anulex presentation to central florida case manager society 03.24.2011 — Presentation Transcript