You are on page 1of 49

Adjunct HBO2

Therapy:
Role Of Hyperbaric
Oxygen Therapy:
December 2, 2016
William Tettelbach, MD, FACP, FIDSA, FUHM
Update
ystem Medical Director of Wound & Hyperbaric
Medicine Services

Disclosures: National PI of Multi-Center DFU Trial,
MiMedx.

Refractory Osteomyelitis
___________________________________________________________

Classification of Osteomyelitis:

 Acute osteomyelitis1
 Is a suppurative infection of bone or bone marrow
 Typically accompanied by
 Surrounding edema
 Vascular congestion
 Small vessel thrombosis

1. Waldvogel FA, Medoff G, Swartz MN. Osteomyelitis—a review of clinical features, therapeutic considerations and unusual
aspects. 3: osteomyelitis associated with vascular insufficiency. N Engl J Med 1970;282:316–322

Refractory Osteomyelitis
___________________________________________________________

Classification of Osteomyelitis:

 Chronic Refractory Osteomyelitis
 Results when a nidus of infected dead bone remains
accompanied by a surrounding ischemic soft tissue
envelope and a chronic clinical course

 Acute osteomyelitis in a compromised host or location

Cierny G III. Penninck JJ. Clin Orthop Relat Res 2003. A clinical staging system for adult osteomyelitis. 414:7–24 . Refractory Osteomyelitis ___________________________________________________________ Classification of Osteomyelitis – Orthopedics View:  Cierny-Mader Staging System1  Anatomic Type  Stage 1: Medullary osteomyelitis  Stage 2: Superficial osteomyelitis  Stage 3: Localized osteomyelitis  Stage 4: Diffuse osteomyelitis 1. Mader JT.

Role Of Hyperbaric Oxygen Therapy Update ___________________________________________________________ .

time until wound closure. number of operative procedures. open-label. breakdown of closed wounds. time until definitive orthopedic fixation. clinical trial  Inclusion criteria:  Suffered trauma with an acute open fracture of the tibia  Severe soft tissue injury (Gustilo grade 3)  High risk of injury-related complications  Located at trauma hospital with hyperbaric facilities.  Within 48 h of injury starting 12 sessions of hyperbaric oxygen  Primary outcome measure is the incidence of acute complications of the open fracture wound at 14 days. randomized.  Short-term outcome measures include amputation. multicenter.Role Of Hyperbaric Oxygen Therapy Update ___________________________________________________________ Hyperbaric Oxygen in Lower Limb Trauma (HOLLT):  International. need for fasciotomy. .

high energy  adequate tissue for coverage  includes segmental / comminuted fractures even if wound <10cm  farm injuries are automatically Gustillo III  Type IIIB  extensive periosteal stripping and requires free soft tissue transfer  contamination  Type IIIC  vascular injury requiring vascular repair  contamination . Role Of Hyperbaric Oxygen Therapy Update ___________________________________________________________ Classification of Soft Tissue Injuries (derived from Gustillo):  Type I  wound < 1 cm  Type II  1-10cm  Type III A  > 10 cm.

Role Of Hyperbaric Oxygen Therapy Update ___________________________________________________________ Hyperbaric Oxygen in Lower Limb Trauma (HOLLT):  Pending Publication  High complication rates:  Non-union  Post-operative Infection (> 30%)  Amputations  Chronic pain  Preliminary data may suggest a reduction in amputations .

41(2):333-9. Role Of Hyperbaric Oxygen Therapy Update ___________________________________________________________ Hyperbaric Oxygen in Management of Crush Injuries:  Randomized double-blind placebo-controlled trial  36 patients with an acute open fracture of the tibia with severe soft tissue injury (Gustilo grade 3) and high risk of injury-related complications  Treated within 24 hours after surgery  100% O2 at 2. Cronier P. J Trauma. Alquier P.1 ATA for 90 min BID x 6 days (Placebo group n=18) Bouachour G. 1996 Aug. Toulemonde JL. . Hyperbaric oxygen therapy in the management of crush injuries: a randomized double-blind placebo-controlled clinical trial. Talha A.5 ATA for 90 min BID x 6 days (HBO2 group n=18)  21% O2 at 1. Gouello JP.

41(2):333-9. .05):  1 out of 18 in the HBO2 group  6 out of 18 in the placebo group Bouachour G. J Trauma. Alquier P. Toulemonde JL. 1996 Aug. Hyperbaric oxygen therapy in the management of crush injuries: a randomized double-blind placebo-controlled clinical trial.01):  17 out of 18 in the HBO2 group  10 out of 18 in the placebo group  New surgical procedure performed (p<0. Cronier P. Role Of Hyperbaric Oxygen Therapy Update ___________________________________________________________ Hyperbaric Oxygen in Management of Crush Injuries:  Complete healing observed (p < 0. Talha A. Gouello JP.

Refractory Osteomyelitis ___________________________________________________________ Classification of Osteomyelitis:  Chronic Refractory Osteomyelitis  CMS  Chronic osteomyelitis is classified as refractory when it has failed to respond to a combination of definitive surgical debridement and a period of 4 weeks of appropriate antibiotic therapy .

IV (PICC) for outpatient management 7/10  Aggressive Surgical Debridement  Remove infected/dead bone. Vitamin C. diabetes. as well as involved hardware if possible  Educate on dietary needs  e.Osteomyelitis Treatment Protocol: ___________________________________________________________  “Appropriate therapy” includes:  Aggressive Antibiotics  Typically 42 days (6 weeks)  Antibiotics should be culture-directed  Oral vs. renal/liver failure  Vascular evaluation/intervention if indicated . venous insufficiency... Zinc  Address comorbidities  e.g.g. smoking cessation. vitamin D. Vitamin A. malnutrition (protein).

0 to 2.4 ATA once or twice daily  Oxygen administered 90 to 120 minutes per session 9/16  Treatment range: 30 to 40  May require up to 60 treatments “within a 12 month period” to achieve sustained therapeutic benefit .Osteomyelitis Treatment Protocol: ___________________________________________________________  HBO2 as adjunctive therapy  Treat at 2.

and it was in a distinctly African American population. Maximum of 60 treatments/12 months. but New Jersey increased by 50% under the same trial conditions.Osteomyelitis Treatment Protocol: CMS Proposed Changes ___________________________________________________________  HBO2 therapy restrictions:  DFU Wagner Grade 3 or greater will be allowed no more than 40 treatments (90-120 minutes daily) without documentation of improvement. .  Wound volume or surface area is expected to measurably diminish over 30 days of wound care with adjunctive HBO2 therapy.  Prior Authorization trial between 3 regions recently revealed racial bias:  Michigan and Illinois increased their denial rates by about 15%.

Osteomyelitis Treatment Protocol: CMS Proposed Changes ___________________________________________________________  HBO2 therapy is not considered medically necessary for:  Treatment of osteomyelitis of small. solid exposed bones of the forefoot and fingers  Metatarsal head  Phalanges  Sesamoid  Effectively treated with debridement and receive minimal benefit from HBO2 therapy due to limited perfusion. .

Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation: a cohort study. et al.. Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective.. et al. 2013.Role Of Hyperbaric Oxygen Therapy: Further Controversy ___________________________________________________________ Fedorko.. 36(7): p. D. 1961-6. Randomized Controlled Clinical Trial. Diabetes Care. . Margolis. L. Double-Blind. Diabetes Care.J. 2016..

Diabetes Care.3% of the HBO2 group that also showed no benefit of HBO2. Randomized Controlled Clinical Trial. 1961-6. L. et al... D. et al..J. Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective.. 1. . Diabetes Care. Margolis. conclusion toward the absence of benefit from HBO2 therapy. 36(7): p. 2. adjudication.  Including a substantial cohort of patients with Wagner grade 2 DFUs  Including a substantial cohort of patients with Wagner grade 2 DFUs that do not even meet the indications set by both the Undersea & that do not even meet the indications set by both the Undersea & Hyperbaric Medical Society or CMS unavoidably biases the study’s Hyperbaric Medical Society or CMS unavoidably biases the study’s conclusion toward the absence of benefit from HBO2 therapy. Double-Blind. Fedorko. 2016. Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation: a cohort study.3% of the HBO2  Margolis cohort study included Wagner 2 DFUs in 54.1 1  Margolis cohort study22 included Wagner 2 DFUs in 54. 2013. Role Of Hyperbaric Oxygen Therapy: Further Controversy ___________________________________________________________ Both these studies have significant shortcomings:  Inclusion Inclusion of of Wagner Wagner grade grade 22 DFUs DFUs inin 46 46 out out of of 103 103 (45%) (45%) subjects subjects available available for for end end point point adjudication. group that also showed no benefit of HBO2.

1  The fact that there may be patients who “met the criteria for major amputation” but who went on to heal undermines the conclusions of this study. L. D. et al. 2013.... 2016..J. Diabetes Care. Fedorko. . 1961-6. 36(7): p. et al. Margolis. Randomized Controlled Clinical Trial. 1. Diabetes Care. 2. Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation: a cohort study. Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective. Double-Blind. Role Of Hyperbaric Oxygen Therapy: Further Controversy ___________________________________________________________ Other significant shortcomings:  Study’s use of photographic adjudication whether a limb “met the criteria for amputation” rather than the use of actual amputation rates as an outcome measure.

g.J. 2  Patients whose ambulation was preserved with a partial foot or toe amputation were still considered hyperbaric failures.. Diabetes Care. Randomized Controlled Clinical Trial. Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation: a cohort study. et al. 1.. D. Diabetes Care... et al. Fedorko. 1961-6. 2. . 2013. Margolis.g. toe or partial foot). Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective. Double-Blind. L... Role Of Hyperbaric Oxygen Therapy: Further Controversy ___________________________________________________________ Other significant shortcomings:  Dataset also did not distinguish “major” amputations (e. 36(7): p. 2016. below or above the knee) from “minor” amputations (e.

.

Clinical Practice Guideline HBO2 Therapy Treatment of DFUs ___________________________________________________________  Exhaustive HBO2 therapy systematic review to develop the UHMS clinical practice guidelines for the diabetic foot:  Analyzing 9 RCTs  > 20 observational studies  Using GRADE criteria .

Elements of GRADE ___________________________________________________________  Clear separation between quality of evidence and strength of recommendations  Explicit evaluation of the importance of outcomes  Explicit and comprehensive criteria for downgrading and upgrading the quality of evidence rating  Transparent system of moving from evidence to recommendations .

Elements of GRADE ___________________________________________________________  The GRADE approach specifically assesses:  Methodological flaws within the component studies  Consistency of results across different studies  Generalizability of research results to the wider patient base  How effective the treatments have been shown to be .

Organizations that use GRADE ___________________________________________________________ .

.

.

.

1987 Jan. UHMS CPG Oversight Committee.Diabetic Foot Infections: Treatment ___________________________________________________________ 1 Algorithm for the use of HBO2 2 Wagner Grading System: A. Grade 5: Extensive gangrene of foot 1. Huang ET et al. .42(3):205-47. tendon. joint capsule or fascia • no active infection (abscess or osteomyelitis) C. tendon. Grade 3: Ulcer with deep structures involved: • ligament.10(1):163-72. A clinical practice guideline for the use of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers. The diabetic foot. Wagner FW. Grade 2: Ulcer with deep structures involved: • ligament. Undersea Hyperb Med. 2015 May-Jun. Grade 1: Superficial Diabetic Ulcer B. Grade 4: Gangrene to portion of forefoot E. 2. joint capsule or fascia • + evidence of infection (abscess or osteomyelitis) D. Orthopedics.

.

Osteomyelitis ___________________________________________________________ Infected bone is hypoxic*  Normal Oxygen Tension (21% O2 at sea level)  Healthy Bone = 45 mmHg  Infected Bone = 21 mmHg  Hyperbaic Oxygen Tension (100% O2 at 2 ATA)  Healthy Bone = 321 mmHg  Infected Bone = 104 mmHg * Rabbit animal model .

1999 . HBO 2 & Antibiotics with Osteomyelitis in ___________________________________________________________ 10 Rats 7 CFU x g-1 of Tibial Bone Control 106 HBO Cefazolin 105 Cefazolin + HBO 104 103 2 wk 4 wk Mendel et al Undersea Hyperb Med 26:169.

tobramycin. decreases the degree of inflammation which may accompany the surgical treatment of refractory osteomyelitis  Can reduce treatment costs of complicated refractory osteomyelitis by approximately 5x (9) . required by Neutrophils to destroy bacteria by oxidative killing mechanisms (1. amikacin) across bacterial cell walls does not occur if tissue oxygen tensions are below 20 to 30 mmHg(5)  Enhances osteogenesis(6)  Reduces tissue edema(7)  Promotes capillary angiogenesis(8)  Prevents polymorphonuclear leukocytes from adhering to damaged blood vessel linings . active transport of antibiotics (e.4)  Augments transport of certain antibiotics across bacterial cell walls .g. gentamicin.2)  Direct suppressive effect on anaerobic pathogens(3. Benefits of HBO 2 ___________________________________________________________  Tissue oxygen tension restored to > 30 mmHg .

.1987. Perrins D. J Lab Clin Med. Park MK. 6. T.89(1):65-71. Halliday. Refractory osteomyelitis. R. 7. Bethesda. Journal of Bone andJoint Surgery 1986. Praeger: New York. Cleve Clin J Med 1992. 1977:101-110. Undersea Med.1:1093- 1094. Enhancement of osteogenesis with hyperbaric oxygen therapy. In Soft and Hard Tissue Repair. Hunt TL (eds. Hyperbaric Oxygen Therapy. 1984. 14: 720-740. Marzella L. Clin Infect Dis 1992. Soc. 1965.B. activity of antimicrobial agents. Myers RAM.6IA:288. Jr. Hunt. A clinical study. 2.:Hyperbaric oxygen reduces edema and necrosis of skeletal muscle in compartment syndromes associated with hemorrhagic hypotension. 1977 Jan.59: 517-28. 4. T.R. Oxygen and leukocyte microbial killing. Pines. Oxygen tensions and infections: Modulation of microbial growth. Benefits of HBO 2 : References ___________________________________________________________ 1. 8. Impairment of microbicidal function in wounds: Correction with oxygenation. SkyharMJetal.). Hohn DC. Editors. Thomas DA. . 455-68. 9. Journal of Hyperbaric Medicine 2: 147-159. Hyperbaric oxygenation in chronic osteomyelitis..K Hunt. and E. 5. Uses of hyperbaric oxygen therapy in the 1990s.k. 3. p. Kindwall EP.68A:1218- 1224. and D. Davis JC. Knighton. Strauss M. Slack WK. Alteration of effectiveness of antibiotics by anaerobiosis. Verklin RM. Mandell GL. and immunologic responses. Steed DL.B. Heppenstall. J Dent Res 1982. Lancet.

Role Of Hyperbaric Oxygen Therapy ___________________________________________________________ .

Role Of Hyperbaric Oxygen Therapy ___________________________________________________________ .

 7-24-2016 S/P partial 5th ray amputation left foot. (patient refused).  8-24-2016 referred to HBO2/Wound Care by treating DPM.  During course plastic surgery recommended split thickness skin graft for closure.  7-22-2016 ABI with no evidence of significant arterial insufficiency.  Treatment included:  Sharp debridement  Placental derived skin substitute  Mechanical NPWT  IV Antibiotics via PICC  Total Contact Cast  HBO2 Therapy (3x/week) .65___________________________________________________________ y/o Male DFU With Osteomyelitis  7-20-2016 MRI showed evidence of osteomyelitis.

65___________________________________________________________ y/o Male DFU With Osteomyelitis 9-2-2016 .

65___________________________________________________________ y/o Male DFU With Osteomyelitis 10-3-2016 .

65___________________________________________________________ y/o Male DFU With Osteomyelitis 11-21-2016 .

”  HBO2 therapy is not covered to prepare the patient for dental extraction. in order to prevent the development of osteoradionecrosis.Osteoradionecrosis: CMS Proposed Changes ___________________________________________________________  HBO2 therapy is not considered medically necessary for:  Osteoradionecrosis of the jaw unless there is evidence of overt fracture or bony resorption. when radiation therapy has not been done at least 6 months prior. consequently this is a non-covered service. .  “Data to justify HBO2 prophylaxis for osteoradionecrosis in a previously irradiated mandible undergoing tooth extraction is lacking at this time.

Mild Traumatic Brain Injury (mTBI): Update ___________________________________________________________  Effects of HBO2 on symptoms and quality of life among service members with persistent post-concussion symptoms (PPCS)1  Prospective. JAMA Intern Med 2015 Jan. Miller RS. Effects of hyperbaric oxygen on symptoms and quality of life among service members with persistent post-concussion symptoms: a randomized clinical trial. Bahraini N. . Weaver LK.2 ATA breathing room air)  Better characterized as dose varying  No supplemental chamber procedures 1.175(1): 43-52. et al.5 ATA breathing 100% oxygen)  Sham pressure (1. double-blind. sham-controlled conducted as part of the DoD HBO2 research program  72 military service members with ongoing symptoms at least 4 months after mild traumatic brain injury  Participants were randomized 1:1:1 to 40 HBO2 sessions  Intervention pressure (1.

Mild Traumatic Brain Injury (mTBI) Update ___________________________________________________________  Effects of HBO2 on symptoms and quality of life among service members with persistent post-concussion symptoms (PPCS)1  Studies suggest no conclusive differences in outcomes between sham and active intervention groups. Miller RS. 1. Effects of hyperbaric oxygen on symptoms and quality of life among service members with persistent post-concussion symptoms: a randomized clinical trial.  However. Bahraini N. et al. JAMA Intern Med 2015 Jan.175(1): 43-52. compared with the no intervention group both groups undergoing supplemental chamber procedures showed improvement in symptoms. . Weaver LK.

Neurology.  Doses of O2 applied:  100% O2 at pressures ≥ 1. Hyperbaric oxygen: B-level evidence in mild traumatic brain injury clinical trials. peer-reviewed articles of HBO2 therapy prospective and controlled trials of mTBI/PPCS symptoms. .87(13):1400-6.5% O2 at 2. Wright JK2.2 ATA  Control: non-chamber standard of care or 10.5 ATA  ≥ 21% O2 at pressures > 1.0 ATA 1. Figueroa XA1. Mild to Moderate Traumatic Brain Injury: Update ___________________________________________________________  B-level evidence in mild to moderate traumatic brain injury/persistent post-concussion syndrome (mTBI/PPCS)1  Review of published. 2016 Sep 27.

0 ATA) values1  Error bars are SD  ImPACT 5 Immediate Post-Concussion Assessment and Cognitive Testing  PCL-M 5 PTSD Check. 2016 Sep 27.87(13):1400-6. Wright JK2.5% oxygen at 2. Figueroa XA1. . Neurology.2–2. Mild to Moderate Traumatic Brain Injury: Update ___________________________________________________________  Hyperbaric oxygen (HBO) and hyperbaric air (HBA) at 1.list–Military  RPQ 5 Rivermead Post-Concussion Questionnaire 1.4 ATA produce improvements that are superior to the combined standard of care (SoC) or the 21% oxygen equivalent concentration control (10. Hyperbaric oxygen: B-level evidence in mild traumatic brain injury clinical trials.

 The current use of pressurized air (1. Wright JK2. Mild to Moderate Traumatic Brain Injury: Update ___________________________________________________________  B-level evidence in mild to moderate traumatic brain injury/persistent post-concussion syndrome (mTBI/PPCS)1  Hyperbaric oxygen and hyperbaric air have demonstrated therapeutic effects on mTBI/PPCS symptoms and can alleviate posttraumatic stress disorder symptoms secondary to a brain injury in 5 out of 5 peer-reviewed clinical trials. Figueroa XA1.2–1. 2016 Sep 27. Neurology.87(13):1400-6. .3 ATA) as a placebo or sham in clinical trials biases the results due to biological activity that favors healing. Hyperbaric oxygen: B-level evidence in mild traumatic brain injury clinical trials. 1.

Limb Preservation Treatment Network Hyperbaric TeleHealth .

limb. Crush injuries and suturing of severed limbs . limb.adjunctive treatment to be used in combination with accepted standard therapeutic measures when loss of function. only as an adjunct to conventional therapy when the disease process is refractory to antibiotics and surgical treatment 15. or life is threatened 6. Progressive necrotizing infections (necrotizing fasciitis) 8. Gas embolism 4. Osteoradionecrosis as an adjunct to conventional treatment 12.adjunctive treatment when loss of function.Role Of Hyperbaric Oxygen Therapy – Covered By CMS ___________________________________________________________ 1. 7. Patient has type I or type II diabetes and has a lower extremity wound that is due to diabetes b. Gas gangrene 5. Soft tissue radionecrosis as an adjunct to conventional treatment 13. Decompression illness 3. Cyanide poisoning 14. Actinomycosis. unresponsive to conventional medical and surgical management 11. Preparation and preservation of compromised skin grafts (not for primary management of wounds) 10. Chronic refractory osteomyelitis. Diabetic wounds of the lower extremities in patients who meet the following three criteria a. or life is threatened. Acute traumatic peripheral ischemia . Acute peripheral arterial insufficiency 9. Patient has failed an adequate course of standard wound therapy . Acute carbon monoxide intoxication 2. Patient has a wound classified as Wagner grade III or higher c.

Acute cerebral edema. smoke inhalation with pulmonary insufficiency. Acute or chronic cerebral vascular insufficiency. 20. 14. and stasis ulcers. 15. 3. 5. Myocardial infarction. Senility. 12. 8. Exceptional blood loss anemia. 2. Idiopathic sudden sensorineural hearing loss (SSNHL) 24. 21. Systemic aerobic infection. Sickle cell anemia. 4. 17. Nonvascular causes of chronic brain syndrome (Pick’s disease. Korsakoff’s disease). Hepatic necrosis. Pulmonary emphysema. Aerobic septicemia.Role Of Hyperbaric Oxygen Therapy – Not covered By CMS ___________________________________________________________ 1. Chronic peripheral vascular insufficiency. Arthritic Diseases. i. Skin burns (thermal). Acute thermal and chemical pulmonary damage. Anaerobic septicemia and infection other than clostridial. 9. 6. Cutaneous. decubitus. Alzheimer’s disease.. 13. 11. Acute retinal artery occlusion .e. Organ storage. 16. 23. 7. Tetanus. 10. 22. Multiple Sclerosis. 19. Organ transplantation. 18. Cardiogenic shock.