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 o o o Less blood loss Lower infection rate Less reported patient pain 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 Minimizes surgical dissection and exposure Allows for smaller incision, particularly among obese Hardware and fusion can be performed Disadvantages 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 Solera CAPLOX II Nuvasive Easyspine
Minimally Invasive Current Processes Mini Open Cortical Screws Advantages 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 Disadvantages 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 Medtronic Cortical Screws Depuy Viper
Minimally Invasive Current Processes Interspinous Process Clamps Advantages Achieves rigid spinal fixation Reduces stress at adjacent levels Advantage with Stenosis or Grade I Spondylolisthesis Disadvantages May require supplemental fixation Higher reoperation rates (short-term use vs long-term use) Coflex Aspen
Minimally Invasive Current Processes Interbody Implants Advantages Direct neurological decompression Correction of coronal and sagittal plane deformity Restoration of foraminal height >90% fusion rate Disadvantages Requires Supplemental Fixation Contraindicated for: Severe osteoporosis Anomalous neural anatomy; i.e. conjoined nerve root Severe fixed kyphosis Irreducible high-grade spondylolisthesis Globus Caliber BENVENUE Luna Nuvasive XLIF Medtronic Capstone
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 o o Degenerative disc disease (DDD) Grade I spondylolisthesis Unilateral, bilateral, or central disc herniation Chronically-ill patients: o o Is not immunologically suppressed or receiving steroid for chronic conditions 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 10 9 8 7 6 5 4 3 2 1 0 Average VAS Pain Score Preop 6 mo Post Op 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 at L4-L5 Grade I spondylolisthesis and severe disc space narrowing at L4-5 6 month follow-up with solid fusion 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