Spine surgery experience at the Loveland Surgery Center Loveland, Colorado

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Spine surgery experience at the Loveland Surgery Center Loveland, Colorado Kenneth A. Pettine, M.D., M.S. Loveland Surgery Center I.D.E. Site for Twelve F.D.A. Spinal Implant Studies Joint Commission Accredited 1

Loveland Surgery Center A.S.C.-Three O.R. s 6,550 Square Feet Convalescent Center-Four Patient Rooms 1,950 Square Feet Convalescent Center License Similar license as a nursing home No limit on length of stay 2

Options with only A.S.C 23 hour license with home health care Loveland Surgery Center Spine Surgeons 2 (2) E.N.T. Surgeons 2 Orthopedic Surgeons 2 Pain Specialists 2 (1) Spine Surgery Data from Two Surgeons Spine Surgery at Loveland Surgery Center Spring 2003 to Spring 2010 Total Spine Cases: 2,932 Instrumented 1,242 Non-instrumented 1,690 3

Spine Surgery at Loveland Surgery Center Spring 2003 to 2008 Every spine surgery prospectively evaluated Instrumented spine cases: 653 patients Non-instrumented spine cases: 377 patients Total: 1,030 Spine surgery cases Instrumented Spine Surgery Every Instrumented Spine Surgery Prospectively Analyzed, From Spring 2003 Through 2008 (653 patients) Instrumented Spine Surgery 653 Patients Anterior Cervical Fusion 1 Level : 108 Patients 2 Level : 82 Patients 3 Level : 3 Patients Posterior Cervical Fusion: 7 Patients Cervical Artificial Disc: 57 Patients Anterior Lumbar Interbody Fusion: 9 Patients Posterior Lumbar Fusion 1 Level : 166 Patients 2 Level : 102 Patients 3 Level : 30 Patients Lumbar Artificial Disc : 83 Patients SI Joint Fusions: 6 Patients 4

Cervical Spine Surgery Arm and/or Neck Pain Anterior Cervical Fusion Posterior Cervical Surgery is rare Results of Anterior Cervical Fusions (ACF) (193 Patients) Time In OR 1 Level : 81.72 Min. (108 Patients) 2 Level : 84.43 Min. (82 Patients) Time In PACU 1 Level : 92.54 Min. 2 Level : 80.80 Min. Convalescent Care 1 Level : 20.68 Hours 2 Level : 20.33 Hours Results of A.C.F. / 1 and 2 Levels Peri-Operative Complications = None Unplanned Transfers = None 5

Patient Satisfaction Rates for Anterior Cervical Fusion Convalescent care room: 95% Pain control: 98% Food in the convalescent care unit: 93% Nursing care: 97% Overall experience: 95% Conclusion of Anterior Cervical Fusion Data Anterior Cervical Fusion Can Be Safely Performed With Efficacy At An A.S.C. Cervical Artificial Disc (one and two level) 57 patients O.R. Time: 84 minutes P.A.C.U: 81 minutes Convalescent Center: 20 hours Complications: No Infections, Nerve Injuries, Re-operations, or Unplanned Transfer 6

Conclusion of Cervical Artificial Disc Data Cervical Artificial Disc Surgery can safely be performed at an A.S.C. Lumbar Fusion 298 Patients Time In O.R. 1 Level : 157.51 Min. (166 Patients) 2 ½ hours 2 Level : 186.09 Min. (102 Patients) 3 hours 3 Level : 213 Min. (30 Patients) 3 ½ hours Time In P.A.C.U. 1 Level : 77.59 Min. 2 Level : 85.79 Min. 3 Level : 91.07 Min. Time In Convalescent Unit (2 days) 1 Level : 42.10 Hours 2 Level : 50.07 Hours 3 Level : 55.11 Hours Patient Satisfaction Rates After Posterior Lumbar Fusion Convalescent care room: 99% Pain control: 93% Food in the convalescent care unit: 89% Nursing care: 99% Overall experience: 97% 7

Lumbar Fusion Surgery 298 Patients: Complications: 13 Patients (4.3%) Return to O.R. 3 Patients (1%) Drain Hematoma: 1 Patient Dural Tear Repair: 1 Patient Re-do Nerve Decompression: 1 Patient Unplanned Transfer to Hospital 5 Patients (1.7%) For Pulmonary Care and Arterial Thrombosis Unplanned Transfer to Rehab. Unit 2 Patients (.7%) Operative Complications 3 Patients (1%) D.V.T: 2 Patients Nerve Injury: 1 Patient Conclusions Fusion At One, Two, And Three Levels Can Be Safely Performed With Efficacy At An A.S.C./Convalescent Center. Lumbar Artificial Disc 83 Patients Time In O.R. 100 Min. Time In P.A.C.U. 83 Min. Time In Convalescent (Less Than 1 Day) 21 Hours 8

Lumbar Artificial Disc Peri-Operative Complications One Intra-Op 2mm Vein Laceration = Intra-Operative Repair One Arterial Thrombosis = Transfer to Hospital for Immediate Thrombectomy Return To O.R. (2 Patients) Reposition Implant (1 Patient) Convert to A.L.I.F. (1 Patient) Conclusion Lumbar Artificial Disc Surgery Can Be Safely Performed With Efficacy At An Outpatient A.S.C. Non-Instrumented Spine Surgery Microdiscectomies/Nerve Decompressions 377 Patients 9

Microdiscectomies/ Nerve Decompressions 377 Patients OR Time : 74 Minutes PACU Time : 78 Minutes Convalescent Time : 19 Hours Microdiscectomies/ Nerve Decompressions Complications: 1 patient One Patient Returned to O.R. to Drain Fluid Conclusions Lumbar Microdiscetomies/Nerve Decompressions Can Be Performed at an A.S.C. With Safety and Efficacy 10

Outside Insurance Cost Analysis 60% Savings Over Hospital Costs Facility Fee Case Rate For ACF- $6,500.00 PLIF- $8,500.00 Implant Costs ACF 1 Level - $4,500.00 2 Level - $8,000.00 PLIF 1 Level - $21,000.00 2 Level - $32,000.00 3 Level - $44,200.00 Spine Implant Costs Spine Surgery Equipment Costs Cloward (Medium and Large): $2,000.00 each Dural Tear Product: $210.00 Cell Saver: $4,800.00 refurbished Spine Specific Instruments: $15,000.00 Micro-retractors: $2,300.00 each Estimated Total: $25,000-30,000 11

Headlight- Mandatory O ptical N avigation E ngine Cordless Battery Powered LED Technology www.litsurgical.com Spine Surgery at an A.S.C. Instrumented Spine Surgery Anterior Cervical Fusions (one, two and possible three level) Anterior Lumbar Fusions (one, possible two and three level) Lumbar and Cervical Artificial Disc Replacements Lumbar Interspinous Devices (X-stop, Coflex) Spine Surgeries at an A.S.C. with Convalescent Center Midline Approach Posterior Lumbar Fusions 12

Spine Surgery at only an A.S.C. Lumbar Fusions with XLIF or M.I.S. approach Spineology - OptiMesh OptiMesh Graft containment implant Discectomy and implantation performed through 7mm port Device deploys to large size Implantable using perc methods similar to perc decompression (scope disc) FDA labeling Labeled for placement in vertebral body defects Interbody application currently regarded as off-label IDE study to expand labeling to include interbody fusion in progress A.S.C. (2005-2010) 1 st ASC case performed in 2005 To date 401 cases and 601 levels treated in ASC ASC centers procedure performed with less than 23 hour stay Procedures augmented with mixture of facet screws, spinous process plates and MIS pedicular fixation Stand-alone not recommended 13

Overall Conclusions Outpatient Spine Surgery Can Be Performed with Safety and Efficacy A.S.C. Spine Surgery is Cost Effective: 60% Below Hospital Costs A.S.C. Spine Surgery Includes: Cervical Fusions, Lumbar Discectomies, Nerve Decompressions, Cervical and Lumbar Artificial Disc Replacements, Verterbralplasty, A.L.I.F., and Inter Spinous Fixation A.S.C. Posterior Lumbar Fusion Currently Requires Convalescent/Rehab Unit, But Even This May Change with M.I.S., X-LIF, and Trans-One Approaches A.S.C. Spine Surgery Fits Perfectly the Obama Vision of Cost Effective Quality Care Become an Obama Flagship and Embrace the Future 14

THANK YOU! 15