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

• 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

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 Inner structure

GelatinousHigh water contentResists axial forces

Nucleus Pulposus

Lamellae

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

Herniated Disc

Large disc herniation L5-S1

• 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.

Herniated Disc

L5-S1

L4-5

L3-4

• 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.

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.

Types of Herniated Discs

Lumbar Disc Herniation - Sciatic Pain

Exiting nerve root• 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

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.

Back Pain Improved

70

% Same or worse

30

%

Leg Pain Improved

71

% Same or worse

29

%

Satisfied Yes

63

% No

37

%

30% have pain

following Discectomy

Clinical LiteraturePost Discectomy

5 Year Outcome1-3 Post Op

Limited ability to predict the patients who will have poor outcomes

30% Post discectomy patients have

continuing pain

1/2

1/2

Conservative Treatment

Re-Operation

Post-Discectomy Prognosis

Discectomy Re-operation Rates

Author Follow-Up Re-Op Rate # Patients Population

1Hu 4 years 9.4% 2,287 Ontario, Canada

2Malter 5 years 15% 3,787 Washington State

3Atlas 5 years 19.4% 273 State of Maine

4Osterman 10 years 14% 35,309 Finland

5Atlas 10 years 25% 217 State of Maine

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.

30% pts have continuing pain after discectomy

How much nucleus should be removed?

Discectomy Outcomes are Affected by Surgical Technique

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

1Carragee, et al, March 2006, Spine.2Barth, et al, February 2008, Spine.3Wera, et al, February 2008, JBJS.

Minimal Discectomy Aggressive Discectomy

Clinical Evidence in Support of Minimal Techniques & Disc Preservation

Carragee Case Series Study

Barth Case Series Study

Carragee, et al.

Discectomy Limited Aggressive

Reherniation Rate 18% 9%

Mean Back Pain (VAS at 1 Year) 1.8 3.0

Oswestry (1 Year) 17.4 24.6

Daily Narcotic Usage (1 Year) 2.2% 10%

Mean Time Return to Work (Days) 12 28

Patient Satisfaction (6 months) 91% 71%

Conclusions: • Limited discectomy recommended (better outcomes), but

patients should be warned of potential for reherniations• “…an effective barrier… may be clinically useful”

• Eugene Carragee, MD (Stanford); March 2006, Spine• 2-Year prospective study comparing limited (46 pts)

vs. aggressive (30 pts) technique

Lumbar Discectomy Outcomes – (Randomized, 2 Year Study)

Standard Microdisc(More Aggressive)

Sequestrectomy (Less Aggressive)

Reherniation 10.5% 12.5%

Loss of Disc Height 63% 38% (P=<0.05)

Modic Type Endplate Degeneration

47% 14% (P=<0.05)

Drug Usage Significantly Less (P=<0.05)

Quality of Life (SF-36) Significantly Better (P=<0.05)

Overall Outcomes Significantly Better (P=<0.05)

• 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…”

Barth et. al

Improving Discectomy Outcomes

• 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

Repair of the Anulus Fibrosus

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

0

5

10

15

20

25

Control(n=166)

One Suture(n=32)

Two Sutures(n=37)

Fascial Patch(n=19)

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.

Suture Repair Technique – 2 Year Follow-up1

Per

cen

t R

ecu

rred

%

Surgical Group

Reop Rate Reduction of 68%

Slit style anulotomy with anular repair results in favorable outcomes, but can be surgically challenging & time consuming (45 min OR time)

Shift in Type of Anulotomy Performed

Vertebra

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

Box Slit

Xclose™ Plus Tissue Repair System

Final Tension Band Construct

Soft tissue T-anchor assemblies

Tension lines

U.S. FDA 510(k) Clearance- Sep ’06Over 10,000 procedures done in the U.S.

INDICATIONS: The Xclose™ Plus Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic procedures.

Tension bands pre-loaded on delivery tools.

Sterile, disposable tension guide

Sterile, disposable delivery tools

System Components

Xclose™ Plus Animation

Double Click

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)

Xclose™ Plus Surgical TechniqueFive Primary Steps

Tension band delivery tool

Versaclose™ Tissue Repair System

Final Tension Band Construct

Soft tissue T-anchor assemblies

Tension lines

U.S. FDA 510(k) Clearance- March ’10

INDICATIONS: The Versaclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic procedures.

Sterile, disposable tension guide with integrated blade

Sterile, disposable anchor delivery tool

System Components

Versaclose™ Animation

Double Click

1.Insert/Deploy

Versaclose anchor

4.Remove

Slack to re-approximate Xclose Plus tension line

2.Insert/Deploy

1st Xclose Plus Anchor

Versaclose™ Surgical TechniqueFive Primary Steps

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.

• Retrospective, Single Surgeon Case Series comparing reoperations with anular repair (59 cases) vs. no anular repair (133 cases)

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).

Discectomy procedure group

No anular repair (n=124)

No anular repair (n=9)

Anular repair (n=59)

Post-discectomy (months)

Post-discectomy (months)

Post-discectomy (months)

# of cases requiring 2nd discectomy within 1 yr of 1st discectomy

16 of 124 (12.9%)

range: 0.7 to 11.2

0 (0%)

NA 4 of 59 (6.8 %)

range: 1.2 to 3.7

March 05 – Feb 07 March 07 – Feb 08

Clinical Benefits of Anular Repair:Hartman 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:Bailey 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:Araghi et. al.

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 (Anulex Technologies, Sponsor)

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

Study Site Locations

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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

Q & A

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