“PRO” Argument AVASCULAR NECROSIS HBO Indications List NE Chapter Presentation Norma L. Cooney, MD, FACEP Presented to UHMS HBO Therapy Committee Sarah Parks, MD Heather Murphy-Lavoie, MD Tracy Leigh LeGros, MD, PhD DEFINITION OF AVN  Definition: temporaryy or permanent loss of blood supply to a bone resulting in the death of bone cellular p - marrow,, fat,, and mineralized tissue components  Joint Involvement: occurrence near a joint can collapse leading to collapse of the joint surface and disabling arthritis  Final Common Pathway: of several disease entities which impair blood supply to the bone PATHOPHYSIOLOGY Interruption of Blood Flow  Early Cell Death: hematopoetic cells, fat cells and osteocytes - painless  Compartment Syndrome: cytogenic edema and inflammation within enclosed space (pain with negative films) PATHOPHYSIOLOGY Interruption of Blood Flow  R Remodeling d li Phase: Ph I b l Imbalance d develops l * Osteocytes y have high g oxygen yg requirements q for normal function. In a hypoxic environment the rate of bone resorption exceeds the rate of repair. repair * Multipotential Mesenchymal Cells in the marrow fail  tto differentiate diff ti t into i t osteoblasts t bl t iin a hypoxic h i environment Fi l O Final Outcome: t new immature i t bone b iis weaker k than th mineralized (dead) bone; collapse of the femoral head occurs with repeated “body “ weight loading”” ETIOLOGIC GROUPINGS    Idiopathic: Idi thi usually ll ffemorall hhead; d occurs w/o underlying disease Post-Traumatic: fracture f off scaphoid, lunate, talus, or femur neckk (30% - 50% progress tto AVN) Secondary: environmental pressure (divers (di & caisson), i ) alcoholism, steroids, radiation, ESRD gout ESRD, gout, hemoglobinopathies hemoglobinopathies, SLE, arteriosclerosis, Cushings, pancreatitis etc pancreatitis, etc.       IDIOPATHIC AVN Involvement: any bone Bilateral: 30% - 80% Most Common: FH Numbers: 10 K – 20 K new FHN cases p per annum in the USA Gender: M : F = 8 : 1 Age: 30 – 60 years( 75%) 25% are < 25 yy/o WHY THE FEMORAL HEAD?    Most Vulnerable: the femoral head lies at the most remote area of the skeleton’s vascular tree N C No Collateral ll t l Back-Up: B k U th the subchondral b h d l bbone iis supplied li d by end arterioles that fan out as they approach the end of the bone Heavy Load: FH is subjected repeated body weight loading DIAGNOSIS OF AVN  Radiographs: mineralized changes on x-ray lag 2 - 4 months behind the insult; lose precious time to treat  Bone Scan: sensitive but not anatomically detailed   MRI = GOLD STANDARD S iti specific Sensitive, ifi and d reliable li bl b basis i ffor staging by anatomic details The basis of Steinberg Staging Bilateral MRI is Mandatory STEINBERG CLASSIFICATION FICAT CLASSIFICATION MRI Findings Natural History FICAT CLASS TREATMENT OF AVN    Preservation: sphericity of the femoral head  Marrow Pressure: to prevent further necrosis  Vascularity STAGE ONE DISEASE NATURAL HISTORY 70% - 80% of patients will progress to FH collapse without intervention HYPERBARIC OXYGEN THERAPY HBO is aimed at STAGE 1 & 2 disease. HBO cannot reverse subchondral fxs or FH collapse. TREATMENT OF AVN – NO CONSENSUS   Conservative  NWB / ROM NSAID NSAIDs Medical / Non-Invasive  Bisphosphonates  Electromagnetic g Shock Wave Electrical Stimulation Stem Cell Injections j  Core Decompression  Bone Graft Marrow Injection  Cement Electrical Stimulations  Free Vascularized Fibular Graft Shock Wave  Re-Alignment Osteotomy TOTAL HIP ARTHROPLASTY (THA)      THA Required: for > Stage 3 ((articular surface damaged) g ) AVN Survival Statistics: worse than for any other group; 67% failure at 16 years (men < 50 y/o - Cigna) THA Damage: greater than the original insult Revisions Required: younger patients have an almost absolute certainty they will need a revision THA Redo Surgery: fraught with complications and suboptimal outcome PSYCHOSOCIAL BURDEN OF AVN        Afflicts the Young: should be productive citizens Chronic Pain and Disability: interferes with work & socializing Lost Independence Multiple Major Orthopedic Surgeries: for many Financial Hardship Depression, Anxiety, and Stress Burden to Family BENEFITS OF HBO Reduces: marrow edema  Increases O2 Delivery: y to ischemic cells; thus relieving g the compartment syndrome and preventing further necrosis  Significant Pain Relief: from  marrow pressure (20 txs)  Stimulates Angiogenesis  Stimulates Oxygen Dependent Cells: osteoclast and osteoblast function for remodeling & repair  Stimulates Multi-Potential Fibroblasts: in the marrow to become osteogenic and form bone; when the O2 tension is low these cells produce cartilage. Reverses the Imbalance  HUMAN STUDIES (Strauss, et al.)     Meta Analysis (1998): Meta-Analysis 4,224 patients with St Stage 11, 2 or 3 di disease Natural History Group (no tx): 842 (20%) Long Term Success ( > 24 months) = 32% All Type Orthopedic Interventions: 3,193 (76%) Long Term Success = 66% H Hyperbaric b i Oxygen O Th Therapy: 189 (4%) Long Term Success = 81% Strauss M , Dvorak T. Femoral Head Necrosis & HBOT. In Kindwall EP, Whelan HT eds. Hyperbaric Medicine Practice 3rd Ed. Best Publishing Co. 2008. HUMAN STUDIES Reiss, et al.       Case Series C S i with ith M Matched t h dC Control t lG Group: 12 patients ti t Steinberg Stage 1 AVN (16 hips) Age Range: 19 – 54 years Treatment: all HBO patients received 100 Sessions 2 - 2.4 ATA 100% O2 (90 minutes) HBO P Patients: ti t 81% reverted t d to t a normall MRI HBO Failures: 1 p pt with SLE / Steroids & 1 ESRD p pt Matched Control Group: 17% reverted to normal MRI Reis et al. HBOT for Stage 1 Avascular Necrosis of the Femoral Head. Journal of Bone & Joint Surgery (Br) 2003 HUMAN STUDIES Montanari, et al.      Case Series: C S i 109 cases FHN FHN, Ficat Fi t St Staged d Imaging g g Studies: MRI’s before and after treatment HBO Patients: 20 - 60 sessions @ 2.2 ATA (90 min) Results: 94% HBO group (Ficat Stage < 2) recovered completely Conclusions: early diagnosis and HBO allows for nearly complete recovery of FN AVN; no reason to treat patients with Ficat Stage > 2 lesions Montanari M, Bronzini N. Clinica Ortopedica e Traumatoligica Universita Montanari M Bronzini N Clinica Ortopedica e Traumatoligica Universita degli Studi di Verona & Istituto Iperbarico, OTI Medicale, Vicenza, Italy (2003) HUMAN STUDIES Schwartz, et al.      Case Matched Series: 16 Stage 1 AVN hips treated with HBO & NWB HBOT Patients: 15 (idiopathic AVN); 1 SLE patient (on steroids) Control Group: 16 AVN matched hips Results: HBOT patients registered > 90% total resolution / reduction of subchondral lesion size Single Failure: the lupus case Schwartz O, Militianu D, Levin D, Norman D, Ramon Y, Shupak A, Melamed Y, Zinman C, Reis ND. Israel (2003) HUMAN STUDIES Camporesi, et al.     Double Blind, Randomized, Controlled, Prospective Study: 20 patients (no co-morbidities) co morbidities) Classification: Ficat Stage 2 disease Treatment Groups:  10 patients received HB Air (60 minutes)  10 patients received HB Oxygen (60 minutes) Evaluations: Pain & ROM at 10, 20, 30 treatments Camporesi EM, et al. Hyperbaric Oxygen therapy in Femoral head Necrosis Journal of Arthroplasty Vol. 25 No. 6 Suppl. 1 2010 HUMAN STUDIES Camporesi, et al.    Results: R lt HBO Patients P ti t had h d significantly i ifi tl  pain i and d  ROM after 30 treatments Study Suspended: all patients offered HBO  19 patients went on to receive 90 HBO treatments  17 patients reported for 7 year follow-up Outco es aall were Outcomes: e e pa pain free ee with t no o  in ADLss  None Received THA  None Developed Contralateral Disease  This is STAGE 2 100% Success! Camporesi EM, et al. Hyperbaric Oxygen therapy in Femoral head Necrosis Journal of Arthroplasty Vol. 25 No. 6 Suppl. 1 2010 ORTHOPEDIC SURGICAL DISADVANTAGES    Less Efficacious Bilateral Interventions: two surgeries  Bone Damage: to the femoral neck & trochanter beyond the AVN damage  Core Decompression: hip fracture rate up to 17%  FVFG: 17% complication rate (donor site, DVT, infection, microvascular)  Osteotomy: so much femur damage that there is great g eat d difficultly cu t y in pe performing o g a f/u /u THA THE HBO ADVANTAGE         High Efficacy Bilateral “Two-Fer”: approximately ½ the patients Durable “Preserves Bone Stock”: does not extend the injury Painless Financially Feasible: breadwinners might still keep working during treatment Non-Invasive: low risk of serious complications Improvement: starts with 1st day of treatment COST COMPARISONS  HBO Therapy: $18,000 $18 000 - 39,000 39 000 (60 sessions) $27,000 - 58,000 (90 sessions)  THA Surgery: $45,000 $45 000 - $65,000 $65 000 not considering g bilateral disease, likely revisions, & increased morbidity. bidit Costs based on 3rd Party Payors & negotiated fees. THERAPEUTIC LOGIC Stage 1 and 2 AVN = Physiologic Disease Ischemia Compartment Syndrome Hypoxia Dysfunctional Osteocytes HBO is a Physiologic Cure Stage g 3 or greater g AVN = Structural Problem Orthopedic Intervention Appropriate Please Consider Adding g Stage 1 & 2 AVN To the Indications List Questions?          REFERENCES Aiello MR, et al. Imaging in Avascular Necrosis emedicine.medscape.com/article/386808-overview di i d / ti l /386808 i 1-29 1 29 Bove and Davis Diving Medicine 4th Edition 2004 Chapter 21 Bejar J, et al. Vascular deprivation-induced osteonecrosis of the rat femoral head as a model for therapeutic trials Theoretical Biology & Medical Modeling 2005. 2:24 Boss JH et al. Experimentally gained insight – based proposal apropos the treatment of osteonecrosis of the femoral head Medical Hypothesis (2004) 62 62, 958-965 Banerjee A, et al. Avascular Necrosiswww.med.harvard.edu/JPNM/ BoneTF/Case13/Writeuo13.html Camporesi, et al. Hyperbaric Oxygen Therapy in Femoral Head Necrosis The Journal of Arthroplasty Vol 25 No. 6 2010 Jain K.K. Textbook of Hyperbaric yp Medicine 5th Edition 2009 Chapter p 30 Kindwall and Whelan Hyperbaric Medicine Practice 3rd Edition2008 Chapter 34 Montanari M, Bronzini N. Indication About Hyperbaric Treatment of Aseptic Necrosis Of the Femoral Head ((NATF)) Clinica Ortopedica e Traumatoligica g Universita degli Studi di Verona & Istituto Iperbarico, OTI Medicale , Vicenza Italy. REFERENCES     Reis, et al. Hyperbaric oxygen therapy as a treatment for Stage 1 avascular necrosis of the femoral head J Bone & Joint Surgery (BR) 2003;85-B:371-5 Schwartz O, et al. Research on Avascular Necrosis of Femoral Head Dept. Orthopaedics, Bnai Zion,Med> Center, Haifa; MRI Unit, Dept. Radiology, Rambam Med. Center; Dept. Ortopaedics B, Rambam Med Center; RambamElisha Hyperbaric Medical Unit, Haifa; Marine Medicine Institute, Zahal, Israel. Vezzani, et al. http://archive.rubicon-foundation.org/1641 Vande Berg et al. Idiopathic Bone Marrow Edema Lesions of the Femoral Head: Predictive Value of MR Imaging Findings Radiology August 1999Vol 212 No 2:527-535.