Introduction Adult Spinal Deformity Surgical Complications and Surgical intervention can have a significant impact Classification Complications can be significant 9 th Annual UCSF Practical Course in Advanced Spinal Techniques Eric Klineberg, MD Professor and Vice Chair UC DA DAVIS Department of Orthopaedics UC DA DAVIS S PINE C ENTER University of California, Davis S PINE C ENTER Introduction Consulting: Depuy/Synthes, Stryker, Medicrea Speaking: AO Spine Deformity Surgery Fellowship Funding: AO Spine – Considered to have higher risks – Perioperative complications I have no financial interest are frequent (up to 40%) with any company regarding this subject UC DA DAVIS Eric Klineberg, MD S PINE C ENTER UC DA DAVIS Glassman et al. Spine 2007 S PINE C ENTER
INTRODUCTION What is a complication? Glassman et al com·pli·ca·tion – major and minor complications did not adversely noun \ ˌ käm-pl ə - ˈ k ā -sh ə n\ : something that makes something effect the improvement found in the HRQOL harder to understand, explain, or deal with measures medical : a disease or condition that happens in addition to – except for deterioration in the SF-12 for major another disease or condition : a problem that makes a disease complications. or condition more dangerous or harder to treat Theorized that outcome instruments were not sensitive enough to detect a difference Perioperative complications may not have a continued impact at one year. UC DA DAVIS UC DA DAVIS S PINE C ENTER S PINE C ENTER What is a complication? What is a complication? Physician and patient dependent Complication List Infection Major o Deep, Pneumonia, Sepsis Gastrointestinal Minor Major o Superficial, UTI, C Diff infection o Obstruction, Perforation, Bleed requiring surgery, Pancreatitis/Cholecystitis requiring surgery, Liver Implant Failure, SMA Syndrome Major Minor o Hook dislodgement, Interbody fracture/migration, Rod fracture/dislodgement, Screw fracture o Ileus, Bleed not requiring surgical intervention, Pancreatitis/Cholecystitis no surgery Minor o Painful/promininent, Screw malposition/loosening, Interbody subsidence/dislodgement Renal Major Radiographic o Acute Renal failure requiring dialysis Major Minor o DJK, PJK, Pseudoarthrosis o Acute Renal failure requiring medical intervention Minor Operative o Coronal/Sagittal imbalance, Curve decompensation, HO, Adjacent segment degeneration Major Neurologic o Retained sponge/instrument, Wrong surgical level, Unintended extension of fusion, Vascular injury, Major Visceral injury, EBL >4L Minor o Visual deficit/blindness, Brachial plexus injury, CVA/Stroke, Spinal cord injury, Nerve root injury with weakness, Retrograde ejaculation, Bowel/Bladder deficit o Dural tear, Fixation failure (hook/screw), Pedicle fracture, Posterior element fracture, Vertebral body Minor fracture o Neuropathy or sensory deficit, Pain (radiculopathy), Peripheral nerve palsy, Delirium Wound Problems Major Mortality All major o Dehiscence requiring surgery, Hematoma/seroma requiring surgery +/- neurological deficit, Cardiopulmonary Incisional hernia Major Minor o Cardiac arrest, PE, Respiratory arrest, DVT, MI, Reintubation, ARDS o Hematoma/seroma not requiring surgery, Hernia Minor o Coagulopathy, Arrhythmia, Pleural effusion, Hypotension, CHF Does it matter? UC DA DAVIS UC DA DAVIS S PINE C ENTER S PINE C ENTER
Prevention Prevention Medical Optimization Medical Optimization – Cardiac – Cardiac – Pulmonary – Pulmonary – Nutritional – Nutritional – Metabolic – Metabolic – Bone Quality – Bone Quality – What about consent? UC DA DAVIS UC DA DAVIS S PINE C ENTER S PINE C ENTER Surgical Strategy Informed Consent Despite ranking the consent process as important, patient recall was only 41% immediately after discussion and video re- enforcement. Recall subsequently declined to 20% at 6 months post-operatively. UC DA DAVIS UC DA DAVIS S PINE C ENTER S PINE C ENTER
Results: 246 patients with 2 Surgical Strategy year f/u Peri-op (<6wks) Delayed (>6wks) Total Complication Category minor/major minor/major minor/major (%) (%) (%) Implant 3/8 (3.8) 11/59 (24.1) 14/67 (27.8) Radiographic 4/10 (4.8) 25/42 (23.0) 29/52 (27.8) Neurologic 21/24 (15.5) 16/20 (12.4) 37/44 (27.8) Operative 41/32 (25.1) 0/1 (0.3) 41/33 (25.4) Cardiopulmonary 31/20 (17.5) 1/3 (1.4) 32/23 (18.9) Infection 11/20 (10.7) 5/7 (4.1) 16/27 (14.8) Gastrointestinal 24/1 (8.6) 0/0 (0) 24/1 (8.6) Wound (excluding infection) 3/7 (3.4) 0/5 (1.7) 3/12 (5.2) Vascular 4/0 (1.4) 1/0 (0.3) 5/0 (1.7) Musculoskeletal 0/0 (0) 3/0 (1.0) 3/0 (1.0) Renal 1/2 (1.0) 0/0 (0) 1/2 (1.0) Other 2/1 (1.0) 0/0 (0) 2/1 (1.0) Total (minor/major) 270 (145/125) 199 (62/137) 469 (207/262) Mean # complications/patient 0.93 (0.50/0.43) 0.68 (0.21/0.47) 1.61 (0.71/0/90) (minor/major) Number of patients affected (%) 150 (51.5) 124 (42.6) 203 (69.8) UC DA DAVIS UC DA DAVIS S PINE C ENTER S PINE C ENTER Surgical Strategy Peri-op (<6wks) Delayed (>6wks) Total Complication Category minor/major minor/major minor/major (%) (%) (%) Implant 3/8 (3.8) 11/59 (24.1) 14/67 (27.8) Radiographic 4/10 (4.8) 25/42 (23.0) 29/52 (27.8) Neurologic 21/24 (15.5) 16/20 (12.4) 37/44 (27.8) Operative 41/32 (25.1) 0/1 (0.3) 41/33 (25.4) Cardiopulmonary 31/20 (17.5) 1/3 (1.4) 32/23 (18.9) Infection 11/20 (10.7) 5/7 (4.1) 16/27 (14.8) Gastrointestinal 24/1 (8.6) 0/0 (0) 24/1 (8.6) Wound (excluding infection) 3/7 (3.4) 0/5 (1.7) 3/12 (5.2) Vascular 4/0 (1.4) 1/0 (0.3) 5/0 (1.7) Musculoskeletal 0/0 (0) 3/0 (1.0) 3/0 (1.0) Renal 1/2 (1.0) 0/0 (0) 1/2 (1.0) Other 2/1 (1.0) 0/0 (0) 2/1 (1.0) Total (minor/major) 270 (145/125) 199 (62/137) 469 (207/262) Mean # complications/patient (minor/major) 0.93 (0.50/0.43) 0.68 (0.21/0.47) 1.61 (0.71/0/90) Number of patients affected (%) 150 (51.5) 124 (42.6) 203 (69.8) UC DA DAVIS UC DA DAVIS S PINE C ENTER S PINE C ENTER
Can We Develop A Better Complication Score? Canadian (SAVES) We rely on AE/Minor/Major determination Have led the way with the development of a intervention severity score – No consensus – Severity of complication may be biased – Use a scale from I-IV to determine severity (or grades 1-6) Can a less biased score better predict HRQoL outcomes? – Also assign a Length Of Stay modifier – Do not have specific score for neurology, readmission or reoperation – How we obtain the information is critical UC DA DAVIS UC DA DAVIS S PINE C ENTER S PINE C ENTER CMS AO Spine/Scoli-Risk-1 Increased interest in complications and when they occur Gathers info for non-neurologic complications All complications that occur within 30 days from the operation All readmission/reoperations that occur within 90 days Granular information regarding neurologic injury Defines the neurologic injury May have significant impact with bundling of payments – (cord, motor, sensory, incontinence etc…) – Level of injury Describes timing, intervention, and outcome UC DA DAVIS UC DA DAVIS S PINE C ENTER S PINE C ENTER
Baseline Pre-OP Demographics No Complications Minor Major Both p ‐ value Age 55.2 57.7 61.1 58.8 0.072 BMI 26.9 27.3 28.1 28.4 0.487 ASA 2.2 2.4 2.4 2.4 0.06 Charlson 1.2 1.9 2.0 1.9 0.015* Factor that predicted 2-year SF-36PCS Smoker (%) 6 11 8 11 0.693 SVA (mm) 45.6 53.9 68.6 68.5 0.217 – Age (p < .001), ASA grade (p < .001) Max Cobb (Degrees) 41.5 45.0 41.9 44.2 0.689 – Maximum preoperative Cobb angle (p = .007) Prior Spine Fusion 75.0 73.0 80.6 70.6 0.853 Surgery (%) – Number of three-column osteotomies (p = .049) – Type of neurologic complication (p = .068) Similar distribution for Age, BMI, and ASA, as well as Pre-OP spinopelvic parameters. Factors predictive of 2-year SRS-22R Total scores Sig lower Charlson Comorbidity Index for the Maximum preoperative Cobb angle (p = .001) no complication group. Number of serious adverse events (p = .071) UC DA DAVIS UC DA DAVIS S PINE C ENTER S PINE C ENTER Do Complications Effect HRQoL? Operative Summary 355 pts prospectively enrolled in the ISSG No Complications Minor Major Both p ‐ value Levels Fused 12.0 11.9 12.3 12.4 0.825 multicenter study Osteotomy (%) 71.1 55.6 71.4 73.0 0.997 PSO/PVCR (%) 22.9 21.1 31.7 29.7 0.413 BMP (%) 51.8% 86.7% 86.5% 69.8% 0.0001 Anterior (%) 14.5 30.0 30.2 40.5 0.013 202 met the inclusion criteria EBL (cc) 1783 2061 2698 2704 0.005* OR Time (min) 412 494 517 533 0.0001** Mean age 57.4, levels fused 12 Length of Stay (Days) 8.0 8.9 10.5 9.9 0.073 Four groups identified: – No Complications N=84 Trend towards > PSO for Major and Both complication groups – Minor Complications N=87 No complication group also had the lowest percent of BMP, – Major Complications N=65 anterior approach, EBL and Time in the OR. – Both Major and Minor N=35 May be a surrogate for surgical complexity. – UC DA DAVIS UC DA DAVIS S PINE C ENTER S PINE C ENTER
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