Clinical Updates in Hyperbaric Oxygen

Transcription

1 HBO Indications Lots of new research and updates recently Clinical Updates in Hyperbaric Oxygen Col Brian F. McCrary, DO, MPH Medical Representative USAF Physical Evaluation Board Randolph AFB, TX These are the disease processes you will be referring to the chamber This lecture will help you answer the questions you may have and will be asked about HBO therapy and when it is applied HBO Indications Overview History of HBO Air Gas Embolism Carbon Monoxide Poisoning Clostridial Myositis & Myonecrosis - Gas Gangrene Crush Injury/CRAO & Compartment Syndrome Decompression Sickness/Injury Problem/Non-Healing Wounds Exceptional Blood Loss Anemia Intracranial Abscess Necrotizing Soft Tissue Infections Refractory Osteomyelitis Delayed Radiation Injury Skin Grafts & Flaps Thermal Burns Sudden Idiopathic hearing loss EXPERIMENTAL USES Treatment with 100% O2 inhaled in a pressurized environment or chamber over 125 indications for HBO UMS Committee on HBO (q 3 yrs) approved indications UHMS- 1996: 13 approved indications Recently modified to 15 indications Approved Indications primary treatment modality DCS AGE Acute CO Poisoning CRAO and SIHL adjunctive treatment modality acute thermal burns compromised skin grafts/flaps crush injury/other acute ischemias Approved Indications (continued) adjunctive treatment modality (cont.) selected problem wounds vascular insufficiency diabetic ulcers clostridial gas gangrene necrotizing soft tissue infections osteoradionecrosis soft tissue radionecrosis refractory chronic osteomyelitis intracranial abscess exceptional blood loss anemia K-1

2 NEW INDICATIONS Central Retinal Artery Occlusions Especially those who present w/i 24 hours Treat BID until 3 consecutive days of no visual improvement Sudden Idiopathic Hearing Loss Defined: at least 30 db loss, within 3 days, over at least 3 consecutive frequencies Treat within 3 months of onset WHATS NEW? Traumatic Brain Injury Chronic Traumatic Encephalopathy Glioblastoma What else is new? HBOT for Traumatic Brain Injury 5.3 million Americans currently living with a TBIrelated disability 1.7 million will suffer a TBI incident this year (and any yr) according to the CDC 500,000 of those will be hospitalized 50,000 TBI victims will die 80,000 TBI survivors/yr (from various causes) will develop long term disabilities- 8 X more than people dx ed with breast CA Johns Hopkins Medicine, Fall 2010 CDC DoD Studies on TBI SSAMC- completion 12/2010 Utah Study- completed Phase II Utah Study- currently completing RCT, f/u symptoms and neuropsych testing Virginia and Florida Studies Ongoing, three arms to study MBIRR-1 Study- active More Studies LSU Pilot Trial HBOT and SPECT brain imaging- reporting soon Loma Linda Literature Review Published 9/11 HBOT in TBI neuroprotective in severe cases Efficacy unknown if mild-moderate cases Recent trials promising, multiple mechanisms offer neuroprotection Why are we doing this? Military TBI K-2

3 Military continues off-label drug use, despite concerns Typical tx of TBI/PTS by military and VA consists of FDA Black Boxed antipsychotics Risperidone and Seroquine augmentation in particular have recently come under fire Side effects include heart failure, increased risk of suicide Military now admits that on average, between vets of current wars commit suicide every day JAMA: 2011:306: (Sep 28 issue) Army Times Clear strategies for treating TBI are elusive (Wash Post, Oct 11, 2011) Conclusion of scientific review of cognitive rehab therapy performed by IOM at request of Defense Center of Excellence According to Pentagon, since 2009 the military health system has directly provided >71,000 hrs of cognitive rehab to service members and Tricare has reimbursed an additional 54,000 hrs in private sector No reimbursement have been made for HBOT Another High Profile Group TBI/CTE in Football players Study of 2 cases, published 2011, one former NFL player now in 50 s, hospitalized with TBI as youngster playing Pop Warner football as well as during 1 st yr in NFL and numerous smaller concussions in between. After 9 brain surgeries- mostly shunt repairs for hydrocephalus- has been on Aricept, Namenda and Lamictal among other meds Neurocognitive exam and SPECT scan done, then referral for HBOT- 40 tx at1.5 ATA, 60 minutes, then post-treatment SPECT Post-HBOT Treatment Information processing speed, reaction time, general cognitive function, memory, reasoning and spatial processing speed all greatly improved Young Football Players are Reconsidering TX Junior Safety Nolan Brewster once touted as rising college football star destined to play in the NFL is quitting football because of concussions and posttraumatic migraine headaches - ESPN Sep 26, 2011 NFL commenting on lawsuits from over 100 former players acknowledged the long term damage caused by recurrent TBI. Similar actions by two formers players against NCAA. Hockey leagues in US and Canada may be facing similar suits. NFL rule changes now filtering down to colleges and high schools More on Sports Medicine The Medical Director of the NFL is very interested in HBOT The Team Physician of the Dallas Mavericks believes in HBOT for sports injuries In process of opening three free standing centers to treat Mavs, Rangers and other athletes K-3

4 Glioblastoma Hyperbaric Hyperoxygenation with Radiotherapy and Temozolomide in Adults with Newly Diagnosed Glioblastoma Long Island, NY- results pending HBOT for Brain Tumors Patients who received radiation therapy immediately after HBOT with chemotherapy had longer survival rates and better long term results (Ogawa et al, 2006 and 2001 HBOT had a positive effect on neurophysiological performance in long term brain tumor survivors (Schellert et al, 2011) NY Phase II study, patients newly diagnosed with malignant Glioblastoma with recent surgery but no chemo or XRT received HBOT in addition to current standard of care This includes chemotherapy with Temodar, taken at home daily and radiation 5 days a week for first 6 wks with HBOT prior to each radiation session More Research on HBOT and Brain Tumors Cellular level research at USF with promising preliminary results Clinical research collaboration with Dept of Biology at Boston College combining HBOT and Ketogenic diet to eradicate blastomas Other Research Proposal to add HBOT indication for Femoral Head Necrosis at next ECHM Consensus Conference Phase II development of hyperbaric chamber with functional MRI which would allow visualization of real time effects of HBOT on cerebral function at Mass General Thoughts Oxygen is addictive and deadly, everyone who uses it will eventually die. RW Hamilton, PhD 1991 Modern Medicine Statistically speaking, at some point in the 1900s, an American patient entered a doctors office and for the first time- had more than a 50-50% chance of being helped by the encounter. The medical student is likely to be one son of the family too weak to labour on the farm, too indolent to do any exercise, too stupid for the bar and too immoral for the pulpit. Daniel Coit Gilman First President of Johns Hopkins K-4

5 Modern Medicine Past years has seen exponential growth in science & technology to benefit patients & care: but with certain tradeoffs Risks and Harms of Modern Medicine Unproven therapy Technologic blunders Allergic & idiosyncratic reactions Patient expectation Modern technology allows more aggressive interventions Overusing technology Profit motive drives therapeutics Background 39,000 sites for HBO and CP HBOT is a primary or adjunctive treatment for a specific list of conditions (the list differs somewhat from country to country) The public is increasingly interested in HBOT for off-label (not FDA approved in the U.S.) indications. Most of these off label conditions have no other effective medical treatment. Parent internet testimonies Scope of the problem My twin boys were born at 28 weeks. Peter was 1 pound 15 ounces and at 2 was diagnosed with Cerebral Palsy. He was unable to sit unsupported, not crawling and could only say the first syllable of words like uma' for mommy... A month after his first series of 40 hyperbaric oxygen treatments, Peter began talking much more. He began singing the "ABC" song and counting to 10. Watching Peter make improvements every day has brought much joy to me. I feel like I have finally found a therapy that, coupled with his other therapies, has begun to make a noticeable difference... I plan to continue to give Peter more treatments for as long as we can financially afford them. I would encourage anyone with a brain injury to try HBOT. Research is impeded by funding problems Information of questionable accuracy is quickly disseminated via the Internet Patients and their families are desperate In the U.S., regulation of facilities and advertising is limited and poorly enforced K-5

6 Scope of the problem What are the real questions? In the U.S., chambers have been installed in private homes and garages Many public facilities have no physician who assesses patients or supervises HBOT Patients are paying thousands of dollars upfront, and may not be told that HBOT is unproven for their condition Informed consent is rare Is it ethical to treat a patient for an unproven indication? What constitutes proof of efficacy anyway? Is it unethical to charge a patient for an unproven therapy? What sort of informed consent is needed for treating a patient with an unproven therapy? Ethical questions are not unique to HBO Bone marrow transplant for breast cancer (only recently considered proven in the U.S. -- patients paid cash prior to that). Using a drug approved by the FDA for an indication other than what it is approved for (ex: chemotherapy drugs for retained nonviable products of conception) Other cutting edge technologies (ECHMO) Guidelines for rational decisions Physician s individual clinical judgement Evaluation of what scientific information is available Analysis of the Risk Benefit Risk/Benefit Assessment: Elderly woman with COPD who wants HBO2T to improve her skin benefit Dangerous Applications: Asthmatic given HBOT for Memory loss I am an 84 year old man. I have had asthma and breathing problems for years but now also have balance problems and memory problems. Most of my prior care was directed toward the asthma using Prednisone, inhalers, allergy injections and other medications. I was given full explanations of the functions and possible effects of hyperbaric oxygenation treatment...i have improved breathing, but more importantly, improved balance and memory K-6

7 What is Research? Case by case decisions to treat are practicing medicine, but repeated offlabel use with the intention to apply info to other patients is RESEARCH (this requires an IRB) So, can I treat someone for a condition not on the list? There must be evidence (or a good rationale) that HBOT will be of some benefit The benefit must outweigh the risks The patient must understand that HBOT is unproven for their problem, how much it costs, the risks and side effects, and whether other medical treatments are available. Then, it is your medical decision The problem of getting patients to understand the data According to Dr. Marois " the results are really incredible! 23 of the 25 children have great results. Twenty-three have amelioration with their spasticity and may have amelioration with speech and cognitive function". Further, their published results reveal "the clinical observations do list numerous functional changes, definite improvements, a large amount in the level of arousal/response to communication." From statistical analysis of the objective estimations we confirm these changes, more particularly on the level of motor functioning like walking and the quality of sitting position, similarly on the level of spasticity. This is the way the results of a controlled trial were portrayed- There was no difference between the HBOT and the compressed air group and the interpretation was oxygen works. The Undersea & Hyperbaric Medical Society Oxygen Therapy Committee Report Since 1978, the UHMS Committee report has been recognized by the FDA as a guide in establishing the "indications of use" for hyperbaric chambers in a manufacturer's claim of substantial equivalency for the 510(k) Premarket Notification requirements Advertising and the FDA This means that all hyperbaric chambers are cleared for marketing ONLY for those conditions that are listed as approved in the UHMS Hyperbaric Oxygen Therapy Committee Report. A chamber can be approved to treat an indication not on this list, -requires that data to support the use of HBOT in that condition be submitted to the FDA for review. Although the Federal Food, Drug, and Cosmetic (FDC) Act does not authorize FDA to regulate the practice of medicine, it specifically directs FDA to regulate the promotion of drugs and devices. Promotional materials are unlawful if they promote an unapproved use for the product Lists of Indications Treated with HBOT = Problems with the FDA However, a free-standing center.. not restricted.. HBOT is beneficial in any condition that would improve with increased oxygen levels... K-7

8 Experimental Uses of HBO Davis Hyperbaric Laboratory Clinical Experimental Protocols Multiple Sclerosis MI Not a comprehensive list! Autism Sports injuries Stroke Femoral Head Necrosis Spinal Cord Injury Brain Injury/TBI/chronic traumatic encephalopathy Glioblastoma Frostbite Brown Recluse spider bite Bisphosphonate-induced osteonecrosis Chronic Refractory Lyme Disease Crohn s Disease/Ulcerative Colitis Long bone fractures Post-prostatectomy nerve healing Laser eye injury Retinal artery occlusion Blood loss TBI Laser cutaneous burns Nerve lacerations Carpal tunnel syndrome Chronic wound healing Guidelines for deciding how to handle an off-label request: Financial Requirements Insurance usually will not cover Some payors covering HBOT for some off-label indications? (correspond carefully, should state that it is unproven) Issue of finding a covered primary diagnosis -patients may pressure physicians Hospital vs physician charges References Hyperbaric oxygen therapy article list emedicine Davis Hyperbaric Medicine Laboratory K-8