Outpatient Minimally Invasive

TLIFs with Stand-Alone

Expandable Interbody Devices

Richard N.W. Wohns, M.D., J.D., MBA

Richard N.W. Wohns, MD, JD, MBA

Education & Training • Seattle University, School of Law, J.D., May 2011

• University of Washington, School of Business, MBA, 1997

• University of Washington, Dept. of Neurological Surgery, Chief Resident &

Acting Instructor 1983

• National Hospital, Queen Square, London, England, Fellowship in

Neuroradiology, 1980

• Yale University, School of Medicine, M.D., 1977

• Harvard College, A.B., 1973

Professional Experience - Abbreviated • Founder, Managing Partner & Neurosurgeon, Neospine, 1983- Present

• Special Consultant for Spine Surgery, Symbion and Surgery Partners, 2008 -

Present

• Chief Medical Officer, angelMD, 2014 – present

• Aqueduct Technolgies, Board of Directors, 2013 - present

• Founder and Board Chairman, Neospine, LLC, 2001 – 2008

• U.S. Radiosurgery, Board of Directors, 2008 - 2012

• Ranier Technology Ltd., Scientific Advisory Board, 2006 - 2015

Disclosures

Consultant

o LDR, MIS Interspinous Fusion Device, Outpatient

Arthroplasties

o Medtronic, Streamlined Design Systems

o Nuvasive, Health Care Policy

o Synthes, Outpatient Spine Surgery Strategies

o Spineology

o Wenzel, MIS TLIF

o Stryker

Back Pain

• Back pain is the leading cause of disability in

Americans under 45 years old. More than 26 million

Americans between the ages of 20-64 experience

frequent back pain

• Nearly two-thirds of Americans experience low back

pain, but 37 percent do not seek professional help for

pain relief

• Back pain is the #1 cause of healthcare

expenditures in the U.S.

– Direct cost of over $80 billion for

diagnosis, treatment, and rehabilitation

National Center for Health Statistics Report

Cause of Back Pain

Improved Surgical Treatment

Transforaminal Lumbar Interbody Fusion (TLIF)

• Refinement of the PLIF procedure

• Generally less traumatic to the spine

• Safer for the nerves

• Allows for minimal access and endoscopic techniques

• Disc space repair with bone graft and cages, screws, rods

We currently use many state-of-the-art cage technologies including those made of bone, titanium, polymer, and even bioresorbable materials.

Outpatient TLIF & ASC Benefits

• Improved Clinical Outcomes o Less blood loss

o Lower infection rate

o Less reported patient pain

o Quicker ambulation and return to work

• Overall lower costs for minimally invasive

procedures

Source: Accelero Health Partners 2015

ASC & Spine Surgery

Medicare added new spine codes to its final 2015

Ambulatory Surgery Center (ASC) payment rules.

Those codes are:

• 22612 Lumbar spine fusion

• 22614 Spine fusion extra segment

• 63030 Low back disk surgery

• 63042 Laminotomy single lumbar

• 63044 Laminotomy, additional lumbar

• 63047 Removal of spinal lamina - lumbar

• 63056 Decompress spinal cord

Source: Centers for Medicare and Medicaid Services

Minimally Invasive Current Processes

• Tubular Retractors

Advantages Disadvantages

• Minimizes surgical dissection and exposure

• Allows for smaller incision, particularly among obese

• Hardware and fusion can be performed

• Increased length of surgery

• Sometimes less ability to thoroughly decompress spine

• Limited bone graft for spinal fusion

Minimally Invasive Current Processes

• Pedicle Screws

Advantages Disadvantages

• Rigidly stabilizes ventral and dorsal aspects of spine

• Allows for fewer normal motion segments to achieve stabilization of abnormal

level • ~60-90% fusion rate

• 1 in 1000 breakage rate • 1 in 1000 nerve root

damage

• 2-3 % infection risk

• Caudal or medial penetration can result

in dural or neural injury

• Requires extensive

tissue dissection • Rigid fixation

accelerates ASD • 5-10% require removal

due to pain

• Noted paraspinal muscle damage with

postoperative muscle fibrosis

• Increased muscle and

facet joint denervation

CAPLOX II Easyspine Nuvasive

Solera

Minimally Invasive Current Processes

• Mini Open Cortical Screws

Advantages Disadvantages

• Improved trajectory that avoids spinal canal

injury • Reduces overall stress

of the cortical bone

• Improved results in the sacral region (more

cancellous bone) • Use of K wires not

required

• Technically challenging • Screw misplacement

ranges from 6-40% Potential injury: • Spinal canal penetration

• Neural elements caused by medially misdirected

screws • Vascular injuries by

laterally misdirected

screws

Spineology Capture

Depuy Viper Medtronic Cortical

Screws

Minimally Invasive Current Processes

• Interspinous Process Clamps

Advantages Disadvantages

• Achieves rigid spinal fixation

• Reduces stress at adjacent levels

• Advantage with

Stenosis or Grade I Spondylolisthesis

• May require supplemental fixation

• Higher reoperation rates (short-term use vs long-term use)

Coflex

Aspen

Minimally Invasive Current Processes

• Interbody Implants

Advantages Disadvantages

• Direct neurological decompression

• Correction of coronal and sagittal plane deformity

• Restoration of foraminal height

• >90% fusion rate

• Requires Supplemental Fixation

Contraindicated for:

• Severe osteoporosis Anomalous neural

anatomy; i.e. conjoined nerve root

• Severe fixed kyphosis

• Irreducible high-grade spondylolisthesis

BENVENUE Luna

Medtronic Capstone

Globus Caliber Nuvasive

XLIF

Minimally Invasive Current Processes

• Expandable Stand-Alone Interbody Implants

Advantages Disadvantages

• Direct neurological decompression

• Correction of coronal and sagittal plane deformity

• Restoration of foraminal height

• >90% fusion rate • Typical incision length

2”

• No supplemental fixation needed

Contraindicated for: • Severe osteoporosis

Anomalous neural anatomy; i.e. conjoined nerve root

• Severe fixed kyphosis • Irreducible high-grade

spondylolisthesis

ASC Adequate Patient Selection

for Stand-Alone Interbody Fusion

• First Surgery at the Index Level

• Eligible Diagnosis: o Degenerative disc disease (DDD)

o Grade I spondylolisthesis

o Unilateral, bilateral, or central disc herniation

• Chronically-ill patients: o Is not immunologically suppressed or receiving steroid for chronic

conditions

o Has a stable HbA1C <7.0 for diagnosis of diabetes or insulin-dependent

diabetes

Case Study Summary: XLIF

45-year-old, Caucasian female, who presented with iatrogenic facet

disruption at L3-L4, disc degeneration at L3-L4, and iatrogenic pars defect at L3–left. The patient underwent an XLIF at L3-L4 with

percutaneous pedicle screw instrumentation left side L3-L4.

Case Study Summary: ALIF

This is a 32-year-old female who presents with a 13-year history of

progressive low back pain. Lumbar radiculitis; severe DDD at L5-S1; failure to respond to conservative measures. L5-S1 ALIF with PEEK

cage and anterior plate. Posterior L5-S1 fusion L5-S1 with Aspen

interspinous posterior instrumentation.

Case Study Summary: OLIF

A 68-year-old woman showing spondylolytic spondylolisthesis at L4-5.

MRI (A and B) and myelography (C) showing spondylolisthesis and stenosis at L4-5. Surgery performed was OLIF and percutaneous pedicle

screws without posterior decompression

Case Study Summary: VariLift

9 Current Stand-Alone Cases

0123456789

10

Preop 6 mo Post Op

Average VAS Pain Score

Average Patient Age: 54

(4 Male/5 Female)

Initial Diagnosis:

Degenerative Disc Disease

Spondylosis w/Radiculopathy

Recurrent Disc Herniation

Surgical Intervention: TLIF AVG Surgical Time: 123 minutes

AVG EBL: <50ml (minimal)

LOS: <23 hours

At 6 months: Fusion almost

complete or In progress

Supplemental Fixation

vs Stand-Alone Grade I spondylolisthesis and severe disc space narrowing at L4-5

6 month follow-up with solid fusion

Grade I Spondylolisthesis at L4-L5

2 week follow-up

VariLift-LX Video

References Benjamin J, Shin MD, Innocent U, Njoku BS, Tsiouris J, Hartl R. Navigated guide tube for the placement of mini-open pedicle screws using stereotactic 3D navigation without the use of K-Wires Technical Note. J Neurosurg Spine 2013 Feb; 18(2): 178-183. DOI: . 10.3171/2012.10.SPINE12569

Davis R, Auerbach JD, Bae H, Errico TJ. Can low-grade spondylolisthesis be effectively treated by either coflex interlaminar stabilization or laminectomy and posterior spinal fusion? Two-year clinical and radiographic results from the randomized, prospective, multicenter US investigational device exemption trial: clinical article. J Neurosurg Spine. 2013 Aug;19(2):174-84. doi: 10.3171/2013.4.SPINE12636. Epub 2013 May 31.

Epstein N. More nerve root injuries occur with minimally invasive lumbar surgery, especially extreme lateral interbody fusion. A Review. Surg Neurol Int 2016 Jan. 7(3): S83-S95. doi 10.4103/2152-7806.174895

Gazzeri R, Galarza M, Alfieri A. Controversies about Interspinous Process Devices in the Treatment of Degenerative Lumbar Spine Diseases: Past, Present, Future. 2014 Apr; BioMed Research International Epub. doi 10.1155/2014/975052

Lo WL, Lin CM, Yeh YS, Su Yk, Tseng YY, Shun-Tai Y, Lin JW. Comparing Miniopen and Minimally Invasive Transforaminal Interbody Fusion in Single-Level Lumbar Degeneration. Biomed Res Int. 2015 Jan. Epub doi 10.1155/2015/168384

Perez-Orribo L, Kalb S, Reyes P, Chang S, Crawford N. Biomechanics of Lumbar Cortical Screw-Rod Fixation vs Pedicle Screw-Rd Fixation with and without Interbody Fusion. SPINE 2013 Apr; 38(8): 635-641. doi: 10.1097/BRS.0b013e318279a95e

Polikeit A, Ferguson S, Nolte L, Orr T. The importance of the endplate for interbody cages in the lumbar spine. Eur Spine J 2003 May; 12(6):556-561. doi: 10.1007/s00586-003-0556-5

Wong AP, Smith ZA, Nixon AT, Lawton CD, Dahdaleh NS, Wong RH, Auffinger B, Lam S, Song JK, Liu JC, Koski TR, Fessler RG. Interoperative and perioperative complications in minimally invasive transforaminal lumbar interbody fusion: a review of 513 patients. J Neurosurg Spine. 2015 May; 22(5): 487-495. doi 10.3171/2014.10.SPINE14129