IHMA & IHMF: Sister Organizations Translating Science into Medical Practice and Public Policy to Create Healthcare Solutions for the 21st CenturyUsing Aerospace Medicine in 21st Century Medical Practice Presentation to:Independent Football Veterans Conference Las Vegas, Nevada April 21, 2012 Practical Hyperbaric Medicine for Athletes & Recovering Athletes Using the Principles of Translational Medicine William A. Duncan, Ph.D. Vice President for Government Affairs, IHMA Vice President of Development, IHMF
Football is Dangerous!“We MightHave to DoAway with Football” Statement from a U.S. Congress member
Fact: Many Sports are Prone to Head Injury Do we do away with all of them?• Soccer• Cheerleading• Snow Boarding• Skiing• Rugby• Horse Sports• Prize Fighting• Rodeo
America’s Heroes Answered Our Nations CallMilitary Medicine Reports 40% have been exposed to blast and RAND reports Over 1/3rd have Suffered Traumatic Brain Injury and/or PTSD• Brian Schiefer is an American Hero• Joint Terminal Attack Controller (JTAC)• 3.5 years to train• One in 1,000 USAF Personnel Qualify• Worth $5 million• After 3 Deployments of over 20 months to Iraq and Afghanistan, Brian was injured during a pre-deployment training exercise at Fort Irwin, CA that left him paralyzed.• He was not evaluated for a brain injury until almost a year and a half after his accident even though incurring a skull fracture to his temporal lobe which resulted in a loss of consciousness.• He was treated with the NBIRR-01 protocol, 80 treatments, and his recovery has permitted him to regain his life and be productive again.• Brian joins many active duty war veterans who were able to continue their careers in the military, and those who Brian Schiefer, USAF. have returned to civilian life with great improvements in Many millions of tax dollars have their quality of life and restored productivity. been saved because of• See Brian’s Story at www.HyperbaricMedicalFoundation.org hyperbaric oxygen therapy!
Marine: Battle of Fallujah Never Unconscious Prior to 40 HBOT TreatmentsSource: Patient’s Family
Football Player’s Brain: Avg 200 Concussions Before NFL PlayNFL Player & Combat InjuriesSimilar Images of NFL Player Before & After• The Damage from Multiple Concussions in Sports is very similar Before to the Marine from Fallujah HBOT• Published Reports Estimate the Average NFL Player has sustained 200 concussions before starting to play professional football!• This indicates a tremendous biological reserve capacity in these professional athletes brains!• These athletes likely have “Genius After Level” Reserve Capacity! HBOT• (Discussion on Reserve Capacity: The Oxygen Revolution-Harch-2010)
All of These Situations Can Lead to an Untreated Brain Insult• Plus Falls A 9 Mile Per Hour Motor Vehicle• Motor Vehicle Accidents Collision Can Leave• Victims of Crime a Residual Brain• Injury Domestic Violence (UCLA Research)
Results of Untreated Brain Insults• 50% Future Lifetime • Incarceration Loss of Income • Anger Issues (including• 45% Unemployed two Road Rage) (2) years post injury • Sleep Disorders• Early Retirement • Depression• Early Onset Dementia • Compulsive Gambling• Homelessness • Dysfunctional Family• Substance Abuse Life• Costs Society $60,000 • Suicide Per Year! One [Brain Injured Person] effects 40 others around them! Alcoholics Anonymous Big Book
“Recovery” does not mean“healed without residual effect”
Acute Injury? Minutes Matter 71.3 m 12.8 min 5.2 min
Current Reimbursed Largely Ineffective Drug Treatments (Symptom Management) Suicides now exceed losses from combat casualties! There is no drug currently approved by the • • Psychiatry (Con’t) Antidepressents (All Black Label Warning Suicide) FDA to treat TBI. The only drugs approved for • Celexa PTSD are Zoloft and Paxil. All other treatment • Lexapro with drugs for these conditions is off-label and • Prozac All in Red carry a black label intended to treat symptoms. In fact, a significant • Luvox warning for suicidality in percentage of psychiatric medications are • *Paxil those under age 25! prescribed off-label. Further, the use of • *Zoloft • Cymbalta antipsychotics in these patients is often as a • The Veteran Suicide Rate is Effexor chemical restraint. • Wellbutrin • Remeron 120 per week! (CDC Numbers) The following list of drugs are FDA approved for • Desyrel psychiatric and neurologic disorders. The great All in Red Fail to beat majority of these drugs have been and are • Antimanic Placebo yet Millions Spent! currently prescribed by DoD Medicine off-label for • Tegretol TBI/PTSD in the service members Dr. Harch has • Lamictal (Journal of Clinical Psychiatry, Nov 29, 2011) treated with HBOT 1.5 in New Orleans. • Eskalith • Topamax Neurology: Psychiatry • Depakote Alzheimers Anti-anxiety •• Ebixa Lectopam • Antipsychotics August 2, 2011: $717 million• Klonopin Tranxene • Clozaril spent by VA on Drug that does not • Zyprexa• Neurontin Valium • Seroquel work!!!• Lyrica • Risperdal DoD Could have repaired 176,000 • Geodon themselves w/ O2!• Topamax • Abilify “Antipsychotic Doesn’t Ease Veterans’• Dalmane *FDA Approved for PTSD Post-Traumatic Stress, JAMA Published• Symmetrel Study Finds” - NYTimes.com
Non-Healing Wound of the Foot Diabetic Foot Ulcer: This Wagner Grade III was present for one year and unresponsive to conventional therapy.1 Day Prior to Scheduled Amputation 26 HBOT Treatments Hyperbaric Oxygenation prevents 75% of amputations in diabetic patients. Therapy approved by CMS for Medicare upon application by IHMA to CMS for coverage, 2003. These photographs are the property of Kenneth P. Stoller, MD, FAAP Permission given by Dr. Stoller to the IHMA to publish on this CD (2004) Copyright retained: Kenneth Stoller, M.D., 50 HBOT Treatments 2010 & IHMA
Solution?Biologically Repair the Brain Case Published in: Cases Report June 2009 http://casesjournal.com/casesjournal/rt/suppFiles/6538/31370
Brain Insults often Result in a 50% Decrease In Brain Metabolism HBOT Restores Brain MetabolismCase Published in: Cases Report June 2009 http://casesjournal.com/casesjournal/rt/suppFiles/6538/31370
Solution: It’s Just Oxygen! Oxygen is being used to repair an injury caused by a lack of oxygen!• O2 used in 5,769+ cellular processes Pressure causes• HBOT activates 8,101 Genes! oxygen to – Down Regulates Inflammation Processes – Up Regulates Growth & Repair Processes saturate tissues – Normobaric O2 does not! at 7x to 12x• Simple: Lack of oxygen is bad normal breathing.• We know how it works – Acutely stops swelling/reperfusion injury – Restarts stunned cellular metabolism – Regrows Blood Vessels – Activates Stem Cells 8x Normal• No wound can heal without oxygen – Wounds that have not healed do – Wounds heal 50% faster with less scar tissue – Broken bones 30% faster & 30% stronger• Placebos have to have the potential of HBOT is FDA-approved & available & being inert. Saturating injured tissue with oxygen On-Label for neurological conditions & has never been shown to have a placebo effect! non-healing wounds!
Results Speak for Themselves• NBIRR-01 Begins Enrolling Patients March 2010. Preliminary Results from multi-site study support Harch’s Findings.• LSU Pilot Published in the Journal of Neurotrauma, J Neurotrauma. 2011 Oct 25. A Phase I Study of Low Pressure Hyperbaric Oxygen Therapy for Blast-Induced Post Concussion Syndrome and Post Traumatic Stress Disorder PMID: 22026588 – Subjects as a group showed significant improvements on most measures of intelligence, function and quality of life – All subjects received 1/2 the clinically recommended protocol being used in NBIRR-01 ( NCT01105962) – Nearly 15 point IQ Increase (average) (Difference between a high school dropout & a college graduate)(14.8 P<.001 ) – Post-Concussion Syndrome (PCS): 39% Reduction in PCS symptoms (p=0.0002); 87% substantial headache reduction – 30% Improvement in PTSD (20 points of a 62 point scale; a patient must score 50 on to have PTSD “diagnosis”) – 51% Reduction in Depression Indices with Large Reduction in Suicide Ideation(p=0.0002) – 64% had a reduced need for psychoactive or narcotic prescription medications – 92% reported sustained improvement 6 months post treatment – Functional Improvements: Cognitive 39% (p=0.002); Physical 45% (p<0.001); Emotional 96% (p<0.001) • Significant Reduction in Anger Issues! – Placebo Effect Ruled Out! Results too great to be placebo effect and neurological imaging is inconsistent with a placebo effect
HOPS: Translating Known Science into Medical Practice• Athletes (Professional & Amateur) have four basic problems – Acute Untreated Brain Insults – Chronic Untreated Brain Insults (prior injuries) – Blunt Trauma Injury & pulled Tendons – Need for Recovery After Strenuous Training – Injuries that may require surgical intervention• IHMF’s Hospital Outcomes & Profit System (HOPS), creates a system that enables acute delivery of consistent HBOT protocols for all indications. Hyperbaric Medical Protocols Currently Exist for ALL of these Challenges
As A Professional Football Player Step 1• Step 1: Reset the Brain’s Reserve Capacity & Function – 80 HBOT 1.5 NBIRR-01 Protocol Treatments & Evaluate – Reserve Capacity Detailed in Harch’s Oxygen Revolution, 2nd Edition, pages 120-128 – NFL Players have Genius Level Reserve Capacity • Reportedly NFL players have sustained, on average 200 concussions BEFORE they start playing pro ball. • Top 1% of High School to College Ball, to 1% of College Ball to NFL • Olympic Level Athletes• Recover Reaction Time, IQ, Executive Function, Memory & Processing Speed
As A Professional Football Player Step 2• Receive Acute HBOT Treatment for any NEW Concussions Using the IHMF’s Acute Brain Insult Protocol (NBIRR-11)• Receive Acute “Sports Injury or Falls” HBOT Treatment for Concussions (NBIRR-11), Blunt Trauma (ACTS-08) or Spinal Cord (Acts-11) or Fracture Protocol (ACTS-09) (Combined as ACTS-05 & ACTS-01 Respectively)• Have Pre-Post Surgery (ACTS-06) for any surgical interventions or repairs
Returning Athletes to Competition • U.S. Olympic Team – Treated at San Diego IHMF-NBIRR Site – Sports Injuries – Concussions – Summer & Winter Sports • U.S. Navy SEALs & SOCOM Members – Treated for Fractures – Treated for Knee Replacement – Treated for TBI and PTSD
Fractures • Air Force Research Demonstrated that Fractures heal 30% faster and 30% stronger when Hyperbaric Oxygen is used. • Shorter back to work time • Stronger Fusion • Cost Effective through reduced down time The effect of hyperbaric oxygen on fracture healing in rabbits, completed 2003. J Wright
Is Hyperbaric Medicine Safe?Source: “HBOT for TBI” Consensus Conference, December 2008• Treatment involves • The DoD White Paper simply breathing pure stated: “side effects are oxygen under pressure uncommon and severe or permanent complications (often while sleeping or are rare…” (White Paper for watching TV). the HBOT in TBI Consensus Paper,• Ten thousand plus 12/08) • The DoD After Action similar treatments are Report stated: “safety of given every day at the treatment is not an 1,200+ locations issue.” (After Action Report HBOT in TBI nationwide for other Consensus Conference, Defense Centers of Excellence, 16 Dec 2008) indications.
Examples: HBOT is Synergistic with Other Treatments• Drug Protocols • Cognitive Rehabilitation – Patients in the LSU Study – Treatment Cannot Begin were on no medication or until a Patient can Sleep less medication Through the Night – Medication was now more – HBOT Repairs Sleep Cycles effective at controlling and most Patients can begin symptoms sleeping at 10 HBOT• Nutritional Programs Treatments – NBIRR Nutritional Program – When Brain Tissue is reduced Aberrant Violent Recovered, it is somewhat Behavior in Felons in 30 RCT disorganized! Studies by 39-41% • Acupuncture – Harch did not use NBIRR • Bio-Feedback supplement in his study • Counseling & Coping Skills
Retired NFL Player: Age 58 Pre-Post HBOT 1.5 4+ NFL Players now treated with similar resultsSource: MicroCog Assessment-- Independent Evaluation by Amen Clinic. NBIRR Subject Courtesy of Dr. Stoller
Example of TBI impact assessment in NFL Player Enlarged Fiber Tract showing • NFL football player with fibers from concussive event concussion • Loss of about 2% of the fiber tracts in the region of the corpus callosum. Courtesy Dr. Walter Schneider, U Pittsburgh [fMRI photo]Area of Tissue change Fibers passing through areas
Severe TBI Patient: Whole Brain CT Perfusion Pre & Post HBOT Pre HBOT – 10/16/09 Post HBOT – 10/28/09Images Courtesy of Dr. Germin, Las Vegas
IHMF’s National Brain Injury Rescue and Rehabilitation Project NBIRR-01: Mild-Moderate TBI Ages 18-65• 1,000 patients with mTBI • All participants have and/or PTSD ANY CAUSE improved• 17+ centers • Most improved in every• All receive HBOT measure• Early results encouraging • Most improved• 35 participants in treatment substantially (Mar 2011) • No participants worsened • Results are durableMany are U.S. War Veterans who have had to be treated “for free” by the clinics as charity cases! NBIRR Study, see: http://www.clinicaltrials.gov/ct2/show/NCT01105962
John Eisenberg Treatment Registry (JETR) Provides Structure for the NBIRR-01 HBOT 1.5 TBI/PTSD Study & Is a Clinical Research Platform for Translational Medicine Powered by CareVector®• Platform Follows FDA-Devices Methodology for Medical Evidence – IRB Workflow Supports Multi-Site World-Wide Studies – Online Data Entry Forms – Security Roles protect patient privacy• Site Records all DoD ANAM Test Scores Identify & all Other Diagnostics Patient• Screening & Web-based Reporting & Analysis Capture Demographics – 3rd Party Payer/Policy Auditing as Requested – Analysis Tools Available to Auditors Pre-Rx Exam – Permits CMS “Coverage with Evidence” Rules & Testing• All Patients get Real Treatment No Placebo!• NO BARRIER To 3rd Party Reimbursement Treatments – (40 HBOT) Normally “Study” treatments are not reimbursable because of placebo (no) Post-Rx Exam treatment provided. This study design permits & Testing 3rd party payers to pay for treatment and have it tracked for analysis and rapid proofing. Analysis & – Willing to only be paid when the treatment Reporting works under the rules of HR 396, TBI Treatment Act Patient• Evidence-based Medicine Rules & Bayesian Follow-up Analysis Permits – Rapid Publication & Potential FDA Marketing JETR is a Tool Permitting Practitioners to Proof Approval Off-Label Uses for FDA-approved or cleared – Rapid 3rd Party Payment for New Indications Drugs & Devices & Build Treatment Protocols
AK Nationwide Location of Clinics participating in N-BIRR HBOT 1.5 Study Sponsor: International Hyperbaric Medical Foundation See: http://www.clinicaltrials.gov/ct2/show/NCT01105962 This is a Multi-Center Study Locations of Clinics participating in N-BIRR HBOT 1.5 Study Sponsor: InternationalHI Hyperbaric Medical Foundation WIRB-Approved Active Clinics See: http://www.clinicalt Clinics available to join rials.gov/ct2/show/ WIRB-Approved Clinics on standby NCT01105962 Warrior Transition Units in US PR
Figure 1: The passenger side of the M915 truck showing the damage caused by the IED. Conclusion by article authors:Several aspects of these two cases demonstrate the efficacy of HBO for the airmen treated.Although both airmen had stable symptoms of mTBI/post-concussive syndrome, which had notimproved for seven months; substantive improvement was achieved within ten days of HBOtreatment. The headaches and sleep disturbances improved rapidly while the irritability,cognitive defects, and memory difficulties improved more slowly.Fortunately both airman had taken the ANAM and presented objective demonstration of theirdeficits from TBI and their improvements after HBO treatment. Both airmen, who were injured bythe same blast sitting side by side, had similar symptom complexes of TBI and improved at similarrates after initiation of HBO treatment. Neither airman had any other form of treatment for TBI.It seems unlikely to the authors that any explanation other than the HBO treatments can beoffered for their improvements.“Case report: Treatment of Mild Traumatic Brain Injury with Hyperbaric Oxygen:Colonel James K. Wright, USAF, MC, SFS; Eddie Zant, MD; Kevin Groom, PhD;Robert E. Schlegel, PhD, PE; Kirby Gilliland, PhD”
ANAM Scores - pre-injury, post-injury, after HBOT Budget Savings from Restoring 4 Military Personnel to Duty: $11.2 million Long Term Additional Savings: $4 million ($15.2 million) Cost? $100,000100%50% 0
ANAM – CNSVS Comparison Consistency Between Two Neuropsych Tests Executive Function is a Measure of the Person’s Ability to Function, and Manage Their Daily Affairs Change in ANAM Percentiles Improvement in Percentile CNSVS Scores 45.0 30.0 40.0 25.0 35.0 Percent Change 30.0 20.0 Percent Change 25.0 20.0 15.0 15.0 10.0 10.0 5.0 5.0 0.0 Δ Simple Substitution - reaction Time Mathematical Δ Matching to Substitution - Δ Simple Reaction Δ Procedural Reaction 0.0 Time ® Processing Time Learning Delayed Δ Code Δ Code Sample Neurocognitive Composite Verbal Memory Visual memory Psychmotor Reaction Time Attention Flexibility Processing Funtioning Cognitive Complex Executive Memory Speed Speed Δ Index ANAM Test N=26 All Patients completed at least 40 HBOT 1.5 treatmentsConfidentiality Statement applies.
Physical Symptoms Questionnaire Eliminated or Reduced Need For Pain or Sleep Medication: Government Cost Savings as well as Quality of Life Improvement: 55% no drugs in Harch Pilot study. 45% reduced need for drugs!Confidentiality Statement applies.
PHQ-9 Components 7-9 worse Suicidal PHQ 9 (7-9) thoughts Reduced! 1.6 1.2Score 0.8 0.4 better 0 7. Pre HBOT 7. Post HBOT 8. Pre HBOT 8. Post HBOT 9. Pre HBOT 9. Post HBOT Trouble Trouble Moving or Moving or Thoughts that Thoughts that concentrating concentrating speaking so speaking so you would be you would be on things on things slowly that slowly that better off dead better off dead other people other people or hurting or hurting could have could have yourself yourselfPre HBOT “If ANY drug reduced or eliminated suicidal thoughts, it should be fast-track researchedPost HBOT and adopted immediately!”Confidentiality Statement applies. James Wright, M.D. (COL, MC, USAF, Ret.)
FDA Cleared HBOT Indications HBOT as used by the team is currently in use for 13 FDA-cleared indications (which means the manufacturer or practitioner can advertize those indications) by hundreds of physicians at nearly 1,000 locations across the nation, delivering approximately 10,000 treatments per day. The thirteen accepted indications for HBOT treatment include:1. Air or gas embolism.2. CO poisoning, CO poisoning complicated by cyanide poisoning (Neurological)3. Clostridial myositis and myonecrosis (gas gangrene)4. Crush injury, compartment syndrome, and other acute traumatic ischemias5. Decompression sickness (Neurological)• Arterial Insufficiency: (Non-Healing Wound) Enhancement of healing in selected problem wounds (includes uses like Diabetic Foot Wounds, Hypoxic Wounds, and other non-healing wounds, etc.)7. Exceptional blood loss anemia8. Intracranial abscess (Neurological)9. Necrotizing soft tissue infections10. Osteomyelitis (refractory)11. Radiation tissue damage (soft tissue and bony necrosis) (Non-Healing Wound)12. Skin grafts and flaps (compromised) (Non-Healing Wound)13. Thermal burns  Hyperbaric Oxygen Therapy: 1999 Committee Report. Editor, N.B. Hampson. Undersea and Hyperbaric Medical Society, Kensington, MD. See also: Harch PG. Application of HBOT to acute neurological conditions. Hyperbaric Medicine 1999, The 7th Annual Advanced Symposium. The Adams Mark Hotel, Columbia, South Carolina, April 9-10, 1999; and Mitton C, Hailey D. Health technology assessment and policy decisions on hyperbaric oxygen treatment. Int J of Tech Assess in Health Care, 1999;15(4):661-70.
HBOT: MECHANISMS OF ACTION HBOT’s mechanisms of action are well known and wellcharacterized both in scientific literature and in clinical practice. Translational Medicine Methods are Necessary to make these treatments for these conditions ROUTINE!
HBOT: It’s About Oxygen Saturation The body’s liquids are saturated with more oxygen, helping areas with compromised circulation. Before HBOT After HBOTImage Courtesy of Dr.
HBOT: Its about the MitochondriaImage Courtesy of Dr.
HBOT: It’s About Your Own Stem Cells In humans, HBOT at 2.0 atm and 100% oxygen for 2 hours per treatment for 20 treatments increased the number of circulating stem cells in the blood by 8-fold Thom et al., 2006 Am J Physiol Heart Circ Physiol 290:1378-86Image Courtesy of Dr.
HBOT works at the DNA level • Decreases hypoxia- inducible factor-1α (hip-1α) & multiple genes related to apoptosis • Inhibition of apoptosis (programmed cell death) by HBOTZhang, JH et al. Neuroscience and Critical Care Yin, W Brain Res 926: 165-171 translates into brainBadr et al 2001 brain Res 916: 85-90 Atochin, DN 2000 UHMS 27: 185-190 tissue preservation Image Courtesy of Dr.
Micro Air Embolism Contribution to Blast-Induced Mild Traumatic Brain Injury Reimers, SD1; Harch, PG2; Wright, JK3; Slade, JB4; Sonnenrein, R1; Doering, ND1 1 Reimers Systems, Inc., Lorton VA; 2 Clinical Associate Professor and Director; Wound Care and Hyperbaric Medicine Department, LSU School of Medicine, New Orleans, LA; 3Col., USAF MC (ret.), Butte MT; 4Baromedical Associates, Doctors Medical Center, San Pablo CA INTRODUCTION Fig. 1: Blast Waves Are More Than Simple Shock Waves, Duration Makes a Difference RESULTS (CON’D) Massive air embolism (AE) from lung disruption is the accepted principal etiology of mortality in • In hemodialysis, CNS abnormalities attributed to microbubbles have been correlated with the blast injury (White et al., 1971; Sharpnack, Johnson & Phillips, 1990). For sub-lethal blast injury, duration of dialysis treatment. Barak & Katz (2008) attributed the abnormalities to air embolism has been ignored, considered innocuous or believed to have not occurred. The microbubbles and stated “a small quantity of microbubbles may be clinically silent, while high incidence of post-concussion syndrome (PCS), neurocognitive deficits, and mental health recurrent exposure has a slow, smoldering, chronic effect” (p. 2921) issues resulting from sub-lethal blast injuries in U.S. Iraq and Afghanistan War veterans has Recent Combat Medical Literature vexed military authorities and medical specialists. We propose that micro air embolism is a • Bauman et al. (2009) provides a summary of the test conditions and initial results from the heretofore unappreciated etiologic factor. PREVENT (Preventing Violent Explosive Neurotrauma) research program being conducted by DARPA. In the tests reported (swine model), the thorax and upper abdomen were protected to minimize the possibility of brain injury by indirect pathways. Some neurological MATERIALS AND METHODS damage was observed, and its significance is still being determined. However, the test conditions are of interest as they are also ones where lung injury can readily occur. Point C Materials and Methods: Using PubMed, PsychInfo, Google Scholar, Sci.gov, and PubCrawler, a on Fig. 1 represents a typical Friedlander wave reported for the blast tube. Test set-ups were systematic review of the literature was conducted identifying published papers in the following built to simulate exposures in the crew compartment of a Humvee with a blast under its floor domains: biodynamics and physics of blast overpressure; primary blast injury; microbubbles in and an open gunner port and in semi-confined space (open top room with dimensions as systemic circulation from diving and iatrogenic causes; neurological problems and microbubbles. shown in Fig 1). In both cases the overpressure durations from a moderate sized charge When necessary, key documents were obtained from U.S. Government archives. Reference were reported to be about 4 ms. The overpressure data was reported in general form only lists of articles were also scanned. Papers with both significant and null findings were included. without numerical values. However, at 4 ms duration, the pressures required to produce lung injury are not large. In situations where the Humvee or building were to be fully closed, both RESULTS the magnitude and duration of blast overpressures can be expected to be greater. (Note 7) • Buamoul (2009) reports results from a computer model developed by Defence R & D Blast-induced AE Canada (CRDC) for estimating the blast damage to the lungs of sheep and humans. He • For mammals that die promptly from either air or underwater blast, air embolism has long reports the intra-thoracic pressure range currently accepted as the “threshold” for lung been recognized as the primary cause of death (Desaga,1950; Shapnack, Johnson & Phillips, damage is 70 kPa (695 cmH20) to 110 kPa (1,091 cmH20), which corresponds roughly to 1990; Richmond & Damon, 1991). Lung disruption is proportional to both magnitude and the intra-thoracic pressures predicted by the model at exposures near the lung damage length of blast overpressurization (Buamoul, 2009) with disruption beginning to occur at threshold line on the Bowen charts. The intra-thoracic pressures produced by even moderate Notes to Fig. 1 modest overpressures easily within the range of pressures experienced by U.S. combat 2.Figure is based on the survival curves for a 70 kg man where the thorax is near a surface against which a blast wave reflects at normal size blasts can be very substantial (Fig. 3). They also vary widely with both time and location troops from improvised explosive devices (IED) (Fig 1 & 3). incidence (Bowen, Fletcher, & Richmond,1968). data shown is for a single reflection where the total overpressure is ~2x incident in the lung, suggesting that opportunities for localized AE may be plentiful. The model also • The disruption threshold is lowered by exposures near reflective surfaces, exposures inside pressure. Total pressures can be up to 8x incident pressure if circumstances are right (Richmond & Damon,1991). In free field exposures indicates that complex (multi-peak) blast waves can produce higher lung pressures, and (no reflections) the damage thresholds are approx. 2x those shown. When used, free field pressure data values are plotted at 50% of structures that impede dispersion of the blast gases, and by longer exposure times. It is therefore greater risk of lung damage than do single peak, classic Friedlander waves of the actual. further lowered by repeat exposures in less than 24 hours (Stuhmiller, Phillips & Richmond, 3. “Short” and “Long” refer to the ratio of the length of the overpressure region to thorax dimensions. Long blast waves produce much same impulse value. 1990). greater chest compression (White et al., 1971). • Recent work by Yang et al.,1996 (sheep model) suggests the lung damage threshold • Benzinger (1950) concluded that because symptoms were only present when a blast hit the 4. Repeat exposures in less than 24 hours, lower the lung damage threshold (Stuhmiller, Phillips & Richmond 1990). pressure may be as much as 75% lower than the Bowen charts (Fig 1) indicate when 5.The lung damage threshold curve is based on an estimated damage threshold of 20% of the 50% mortality level (White et al., 1971). thorax, air embolism must originate in the thorax and becomes effective when it travels to the the threshold pressure is taken as the lowest pressure at which lung tissue damage Recent data (Yang et al., 1996) suggests the threshold pressures for lung damage may be lower (circa 50%) than those shown. brain. Benzinger also found that small amounts of air in arterial circulation could readily 6.Blast waveform is also important. However, that is beyond what can be addressed in this poster. is observable by light and/or electron microscopy. reproduce neurologic symptoms seen in blast injury to dogs and humans. Only 1 cc of air 7.A = shock wave period, B= period where expanding blast gases maintain compartment pressure a wave speed of Mach 1. Most blast 1. Based on • It is well established that AE is a possible/probable sequelae of exposure to air blast. injected into the pulmonary veins of a dog was sufficient to reproduce the waves are faster (up to Mach 2+) increasing the wave length for the same time.. • It is also well established that microbubbles are harmful to brains, and that symptoms may electrocardiographic changes seen in blast-injured dogs (Phillips & Richmond, 1990). not manifest immediately. • Maison (1971) outfitted a dog with a Doppler bubble detector on the carotid artery, exposed Fig. 2 Blood Velocity & Embolus Indications Following Canine Exposure to LD50 Air • Blast overpressure exposures typical of the current wars in Iraq and Afghanistan, the dog to an LD50 air blast, and subsequently observed bursts of Doppler deflections going Blast particularly blast exposures in confined spaces, are sufficient to create risk of lung damage. up the carotid correlating with respirations for approximately 30 minutes post-blast. The dog’s Quickly repeated exposures increase the risk. carotid blood flow was observed to temporarily drop to near zero following each group of • It is reasonable to expect that the degree of blast-related AE is a continuum ranging from no echoes, possibly indicating reduced blood velocity due to temporary distal occlusions (Fig. 2). bubbles, to a few microbubbles to massive amounts depending on the exposure. The dog initially showed severe respiratory distress, but recovered. Postmortem exam • The blast-related intra-thoracic pressures can be very substantial (Fig 3). The range showed evidence of residual lung hemorrhage, but no other damage. Maison concluded that customarily accepted as the threshold for lung injury is 7 to 11 times higher than the 80 the bubbles were “clinically silent”. mmHg (10.7 kPa) differential known to produce disruption of aveolar-capilary boundary • A conceptual model of how AE sequelae to blast exposure occurs, confirmed with rabbit tissues in slowly varying pressure environments such as diving (Neuman, 1997). model data, can be found in White (1971). Any fast-rising blast pressure wave long enough • Work by Yang, et. al (1996) suggests that lung tissue damage, and the concurrent to produce significant chest compression is likely to produce some AE. possibility of transient microbubble release, can occur at lung damage levels insufficient to • Goh (2009) and Mayo & Kleger (2006) in separate articles regarding civilian blast casualty produce clinical blast lung and at overpressures substantially lower than indicated by the management advise that AE is a possible complication of exposure to air blast. However, widely-used Bowen charts. neither author addresses the possibility of neurocognitive sequelae from AE. • The CRDC model confirms suggestions from prior efforts that complex blast waves typical • Protective vests reduced mortality & neural fiber degeneration in rats exposed to air blast of confined space exposures are more likely to be damaging to lungs than are the simpler (Long, et.al., 2009) waveforms typical of free-field blasts. Evidence that microbubbles are NOT harmless • Blast related bubble production, when it does occur, has been shown to be transient, lasting • Microbubbles were first recognized as a medical hazard in open-heart surgery decades ago only 15 minutes to 3 hours for significant AE (Mayo & Kluger, 1996). The duration of (Barak & Katz 2005). Air emboli from various sources in the extracorporeal circulation (ECC) microbubble production can be expected to be shorter still making them hard to detect. set and tubes can drift into the aorta and systemic circulation, carrying microbubbles to the • All recent publications that we found, including a recent review article (Cernak & Noble, brain. Clinical results of this unwanted event include major and minor neurologic injury, Fig. 3 . Lung Injury Prediction from CRDC Model 2009), were silent on the possible role of microbubbles as a mechanism for blast-related neurocognitive deterioration and an overall general decline in patient health (Barak, Nakhoul brain injury. & Katz, 2008; Shaw et al., 1987). The degree of decline in cognitive performance has been • When all the factors that may favor microbubble production are considered, it is difficult to correlated to the amount of air emboli delivered during the ECC (Deklunder et al., 19981,2). expect they do not occur. Patients with neuropsychological deficits 5 to 7 days after coronary bypass graft surgery • Undetected arterial microbubbles have the potential to significantly confound research into averaged nearly twice the number of emboli compared to those without deficits (Stump, et al., other mechanisms of blast-related brain injury. In research studies where there is a 1996). possibility of microbubble production, monitoring for their occurrence is • In mechanical heart valve carriers, bubbles are chronically delivered into the arterial system at recommended. variable rates, which can rise as high as 800 per hour in the cerebral circulation. Patients with The contribution of micro air embolism to blast-related brain injury may these devices have been found to have impairment in episodic memory and deficits in working memory (Deklunder et al., 19981,2). Notes to Fig 3. be significantly greater than has been previously believed. • Multiple brain lesions in divers with no reported history of neurological DCS have been found 2.Data shown are peak intro-thoracic pressures and lung damage estimates for a complex (2-peak) wave with a Available literature suggests that transient AE from primary blast exposure is possible, perhaps to be strongly correlated with patent foramen ovale of high haemodynamic relevance. This probable, at sub-lethal overpressures similar to the overpressures experienced by U.S. combat total impulse considered “threshold” for lung damage in a finding lead the authors to a hypothesis that the brain lesions were the consequence of free field (Point D in Fig. 1) Veterans. Arterial microbubbles have been shown to be neurologically harmful and may subclinical cerebral gas embolism (Knauth et al., 1997). 3.Data from Yang, et.al (1996) suggests the threshold for contribute to the high incidence of post-concussion syndrome in blast injured veterans. Current • A review of 140 cases of delayed DCS treatment (avg. delay 93.5 hrs) reported findings of “Trace” damage may be significantly lower that assumed research efforts are almost exclusively focused on the direct cerebral effects of blast waves. The neurocognitive symptoms including severely reduced executive function, apathy and by the CRDC model. AE pathway deserves prompt and thorough investigation. antisocial behavior in 49% of the patients. 100% of the neurocognitive symptoms resolvedCopyright: Reimers Systems, Inc. 2011, All rights with hyperbaric oxygen therapy. (HBOT) (Cianci & Slade, 2006).reserved.
HR 396: TBI Treatment Act• Subject must have TBI or PTSD and be a Veteran under 66• Voluntarily Treated by Civilian Physician• ANY FDA-approved or Cleared Treatment (Any Purpose)• Must Improve to be Paid – Neuropsych Testing (IQ, ANAM, CNS Vital Signs, etc.) – Standardized Instruments (PCS, PTSD, Depression Scales) – Neurological Imaging (Functional MRI, SPECT, QEEG) – Clinical Examination (Coma State, Gate & Balance)• Must be Enrolled in IRB-approved Study• No Discrimination Against Practitioner for Any Reason• Paid 30 days after presentation of valid bill to MM or VA• Other necessary protections for the treated veteran
HR396: TBI Treatment Act (Con’t)• Changes Focus from “Bureaucratic Decision” on Health Care Coverage to: – “What Actually Worked for the Patient?” – ALL TREATMENT MODALITIES INCLUDED• Outlines a “Rational” Way of Determining What Works and What Doesn’t• HC Provider is ONLY paid if the treatment works (True Pay for Performance)• All data is collected under OHRP Rules for Patient Protection• Provides Valid Evidence-based Medicine data very inexpensively! (10% of the cost of Standard NIH-funded Study!)• As a Principle of Federal Law, the Bill Radically Alters the Ability of Patients to get Effective Treatment!
Case Presentation Traumatic Brain Injury from Child AbuseIt is NEVER 48 y. male 45 Years After Too Late! Injury! Scan #1 Scan #2 Image Courtesy of Patient & Dr. Harch: 2002 IHMA Congressional Testimony
Own Your Own Future: Act Now!• If you or a loved one have a history of TBI or PTSD, and are between ages 18-65, enroll in NBIRR and get treated NOW! – $350 million treats all 14,000 living retired players – Insist HBOT be covered by workers compensation – Insist HBOT be covered by the “88” Plan – Provide funds to a charity of your choice who will pay for HBOT for retired football players & others – The IHMF: Fund for Veterans and Football Players• Write Congress about HR 396, the TBI Treatment Act, at the IHMA website: www.HyperbaricMedicalAssociation.org
THERE IS NO “I” IN TEAM!• Unite and Change Treatment of Brain Injury Forever!• Save Football, Soccer, Sports for our Youth, and help Athletes Recover from their Injuries• Donate to the Independent Football Veterans to help sustain those you enjoyed watching in your youth.• IHMF to get real treatment for Athletes with Brain Injury!