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Osteoradionecrosis - Mandibular

Osteoradionecrosis - Mandibular

Osteoradionecrosis - Mandibular

INTRODUCTION

Treatment Protocol Guidelines

The following hyperbaric medicine treatment protocol is based upon the recommendations of the Hyperbaric Oxygen Committee of the Undersea and Hyperbaric Medical Society.  Clinical protocols and/or practice guidelines are systematically developed statements that help physicians, other practitioners, case managers and clients make decisions about appropriate health care for specific clinical circumstances.  

Protocols allow health providers to offer evidence-based, appropriate, standardized diagnostic treatment and care services to patients undergoing hyperbaric oxygen therapy (HBOT). Evidenced-based medicine offers clinicians a way to achieve improved quality, improved patient satisfaction, and reduced costs.  Utilization Review should be initiated when clinical decisions result in deviation from or modification of treatment protocols.  This includes any course of treatment at or above the recognized threshold limits.  

Medical Necessity

Medicare.gov defines “medically necessary” as “health-care services or supplies needed to prevent, diagnose, or treat an illness, injury, condition, disease, or its symptoms and that meet accepted standards of medicine.” 

The following condition meets coverage indications per the National Coverage Determination (NCD) 20.29.[1] Continued HBO therapy without documented evidence of effectiveness does not meet the Medicare definition of medically necessary treatment. Thorough re-evaluation should be made at least every 30 days for documentation of response to therapy. 


TREATMENT PROTOCOL


BackgroundDelayed effects of radiation are a complication of modern radiotherapy that can be treated with hyperbaric oxygen therapy. Some examples of delayed radiation effects include soft tissue radionecrosis, osteoradionecrosis (ORN), radiation cystitis, radiation proctitis, and laryngeal chondroradionecrosis. The basic pathophysiology of delayed radiation tissue damage is endarteritis with resultant tissue hypoxia and secondary fibrosis. ORN can be characterized according to Marx classification.[2] HBO is an effective adjunctive therapy for existing ORN Marx Stage I-III [1] 

Goals of HBO

  • Reduce tissue fibrosis and breakdown by inducing neovascularization and improving tissue oxygenation 
  • Prevent wound dehiscence following soft tissue reconstruction in previously irradiated areas

Diagnosis

  • Osteoradionecrosis is the result of avascular, aseptic necrosis in a previously irradiated field. Irradiated bone becomes exposed through a wound in the overlying skin or mucosa with no signs of healing in 3-6 months. [3]
  • Clinical findings include pain upon mastication, fibrotic skin, orocutaneous fistula, exposed mandible, trismus, infection, bad breath
  • Radiographic findings include moth-eaten appearance of the mandible, pathological fractures  

Hyperbaric Criteria

  • Referral documenting confirmed diagnosis of osteoradionecrosis
  • History and documentation of radiation treatment to the region of the documented injury, terminating at least 6 months prior to onset of signs or symptoms or planned surgical intervention at the site.
  • Histology consistent with late radiation tissue effect

Evaluation 

  • Comprehensive history, to include:
    1. Date cancer diagnosed
    2. Date radionecrosis diagnosed
    3. type, amount, number of treatments and location of the radiation
    4. Radiation date span
    5. Previous treatment or therapies
  • Obtain the radiation-oncology reports 
  • Physical examination
  • Labs to order or review:
    1. CBC
    2. Serum Albumin
    3. Pre-albumin
    4. Sedimentation Rate
    5. C-reactive protein
  • Wound photographs
  • Chest x-ray: order or review
  • ECG: order or review
  • Determine present oncological status
  • Evaluation of tympanic membranes pre and post-treatment as needed
  • Baseline visual acuity assessment
  • Smoking/nicotine cessation
  • Nutritional screening
  • Coordination of hyperbaric therapy and surgical procedures, in conjunction with referring physician/oral-maxillofacial surgeon.
    • Classify mandibular necrosis with the Marx scale to describe the severity of the ORN. [2][4] 
      • Stage I ORN: patients with exposed bone which has been chronically present or which developed rapidly.
      • Stage II ORN: patients who do not respond favorably to 30 pre-operative HBO treatments, or when a more major operative debridement is required.
      • Stage III ORN: Presence of orocutaneous fistulae, evidence of lytic involvement extending to the inferior mandibular border, full thickness bone damage or pathologic fracture. Usually requires complete resection and reconstruction with free tissue transfer. If mandibular resection is anticipated, patients are advanced to Stage III from outset. 
  • Rule out cancer re-occurrence or residual tumor. 

Treatment

Stage I:
  • Consists of HBO sessions followed by minor bony debridement, then additional HBO sessions
  • HBO:
    • 2.5 ATA for 90 minutes of oxygen breathing with two ten-minute air breaks at the 30 and 60-minute portions of oxygen breathing (Table 3)
    • HBOT once daily for 30 treatments
  • Surgery:
    • Minor bony debridement
    • If adequate response, continue with 10 additional daily HBOT and follow patient to complete clinical resolution
    • If little or no improvement after 30 treatments, the patient is advanced to stage II.  

Stage II:

  • Consists of HBOT followed by more radical surgical debridement, then additional HBOT
  • If stage I patients have not progressed appropriately at 30 daily treatments or if a more major debridement is needed, they are advanced to stage II
  • Surgery:
    • Stage II patients receive a more radical surgical debridement immediately followed by 10 postoperative daily HBOT. 
    • Surgery for stage II patients must maintain mandibular continuity.
    • If mandibular segmental resection is required, patients are advanced to stage III 

Stage III:

  • Consists of HBOT followed by transoral mandibular resection then additional HBOT
  • Patients originally classified as stage I or II who fail the initial 30 treatments, or patients who present initially with serious signs of pathologic fracture, orocutaneous fistulae or evidence of lytic involvement extending to the inferior mandibular border, are treated as stage III.
  • Surgery:
    • Mandibular segmental resection and eradication of all necrotic bone are planned as part of the treatment.  If present, orocutaneous fistula or large tissue loss are also surgically addressed in this phase. Surgery is followed immediately by 10 postoperative daily HBOT 
  • After surgical resection and HBO post-resection, the patient is advanced to stage III-R  (reconstructive protocol)   

Stage III-R

  • Consists of mandibular reconstruction and additional HBO 
  • After a period of several weeks following completion of stage III, definite mandibular bony reconstruction with techniques such as free flaps or myocutaneous flaps is conducted
  • 10 immediate treatments are to follow reconstruction to support initial metabolic demands.

For all patients

  • Wound photography post-reconstruction
  • Evaluation of tympanic membranes pre HBO and as needed
  • Smoking Cessation

Follow-Up

  • Visual acuity assessment for progressive myopia
  • Wound assessment and photography as indicated
  • Transcutaneous oximetry to determine tissue oxygenation

Treatment Threshold

30 – 60 treatments (Utilization review should be requested after 60 treatments)

Coding

Refer to the ICD-10 Guideline for the appropriate ICD-10 code

Comments

  • If diabetic, blood sugar should be checked 1 hour prior to treatment and post HBO by unit personnel. 
  • Avoid petroleum based dressings and ointments whenever possible. If these are a necessary part of the surgical dressing, ensure that they are not exposed and are completely covered with 100% cotton.
Primary Sources: Whelan and Kindwall [5]Weaver [6]National Baromedical Services [7]

DOCUMENTATION 

Radiation doses in excess of 40 Gray (4,000 cGy) are more commonly associated with compromised/delayed healing and persistent soft tissue/ integumentary breakdown within a previously irradiated field that has failed conservative and/or surgical management. The role of hyperbaric oxygen is one of overcoming hypovascular - hypocellular - hypoxic tissue bed and the late-radiation effects. Acute inflammatory responses to ongoing or recently completed radiation therapy need to be differentiated. Relieve the radiotherapy-induced hypoxic/ischemic state by stimulating angiogenesis, thereby overcoming radiation-induced obliterative endarteritis. Below we explain in detail what needs to be documented. See also:

History and Physical

  • An initial assessment including a history and physical that clearly substantiates the condition for which HBO is recommended.
  • Prior medical, surgical and/or hyperbaric treatments.
  • Past medical records must support history of radiation therapy at the site identified by anatomical location and laterality.

Physical Exam

  • An initial assessment including a history and physical that clearly substantiates the condition for which HBO is recommended.
  • History of radiation therapy at the site identified by anatomical location and laterality.
  • Non-responding lesion, within the previously irradiated field.
  • Preparation for definitive coverage, flap or graft.
  • Failure of definitive coverage attempts, flap or graft.
  • Documentation of total radiation dose
  • Documentation of standard wound care in patients with diabetic wounds
  • Documentation of optimization of nutritional status

Risk Assessment

  • Risk benefit ratio in favor of offering hyperbaric oxygen therapy, example statement:

 "The patient was informed of the possible risks and complications of hyperbaric oxygen therapy. These include, but are not limited to, fire, barotrauma of the ears, sinuses, and lungs to include air embolism, central nervous system oxygen toxicity resulting in seizure, cataracts, myopia, and exacerbation of congestive heart failure.  Having no absolute contraindication to hyperbaric oxygen therapy the patient will be offered treatment at 2.5 ATA for 90 minutes with two inter-current ten minute air breaks (used in the case of mandibular osteoradionecrosis) OR 2.0 ATA for 90 minutes in cases of soft tissue injury. Thirty treatments will initially be provided on a once daily basis Monday through Friday. Thereafter, a re-evaluation of the patient’s clinical progress will be in order to determine if additional treatments may be required."

Impression

Plan

Example Statement supporting the role of hyperbaric oxygen therapy:

Mechanisms by which HBO has been shown to be beneficial include the following:

  • Enhanced fibroblast proliferation – cell proliferation responds to increased tissue levels of oxygen in a dose-dependent fashion.
  • Collagen maturation – adequate oxygen is provided as a substrate for hydroxylative processes resulting in collagen fibril cross-linking. This collagen scaffolding supports the fragile advancing capillary buds.
  • Angiogenesis – increased oxygen gradients result in enhanced angiogenesis.

Sample Order

CLINICAL EVIDENCE AND RECOMMENDATIONS  

  • 1BFor patients with ORN Stage I, II and III, we recommend HBO as an adjunctive therapy (Grade 1B)
  • Stage I: HBO followed by minor debridement, then additional HBO; 
  • Stage II: HBO followed by more radical surgical debridement, then additional HBO;
  • Stage III: HBO followed by mandibular resection, additional HBO, then mandibular reconstruction and additional HBO 
    • Rationale: A small percentage of patients treated with radiation for head and neck cancers will develop osteoradionecrosis (ORN) of the jaw. Patients treated with more than 6000 centigray (cGy) of radiation have an approximately 9% incidence of developing mandibular ORN. [2] Radiation doses in excess of 40 Gray (4,000 cGy) are more commonly associated with compromised/delayed healing and persistent soft tissue/ integumentary breakdown within a previously irradiated field that has failed conservative and/or surgical management. 
    • The Marx scale classifies mandibular necrosis and is used to describe the severity of the ORN. [2] Stage I ORN: patients with exposed bone which has been chronically present or which developed rapidly. Stage II ORN: patients who do not respond favorably to 30 pre-operative HBO treatments, or when a more major operative debridement is required. Stage III ORN: presence of orocutaneous fistulae, evidence of lytic involvement extending to the inferior mandibular border, full thickness bone damage or pathologic fracture. Usually requires complete resection and reconstruction with free tissue transfer. [4] If mandibular resection is anticipated, patients are advanced to Stage III from outset. 
    • Use of HBO for management as an adjunctive therapy to treat ORN is supported by moderate certainty evidence (evidence level B). [8][9][10] The role of hyperbaric oxygen is one of overcoming hypovascular - hypocellular - hypoxic tissue bed and the late-radiation effects. Acute inflammatory responses to ongoing or recently completed radiation therapy need to be differentiated. 
    • A frequently expressed concern by those considering hyperbaric oxygen for a patient with radiation injury is the fear that hyperbaric oxygen will somehow accelerate malignant growth or cause a dormant malignancy to be reactivated. An overwhelming majority of both clinical reports and animal studies reviewed showed no enhancement of cancer growth. [9] The patient should be informed of the possible risks and complications of hyperbaric oxygen therapy. These include, but are not limited to, fire, barotrauma of the ears, sinuses, and lungs to include air embolism, central nervous system oxygen toxicity resulting in seizure, cataracts, myopia, and exacerbation of congestive heart failure.
    • Medicare covers perioperative use of HBO as an adjunctive therapy for existing ORN Marx Stage I-III. Prerequisite for treatment includes history of radiation treatment to the region of the documented injury, terminating at least 6 months prior to onset of signs or symptoms or planned surgical intervention at the site. The recommended daily treatments are designed around the stages of radionecrosis and typically last 90-120 minutes at 2.0 to 2.5 ATA. The duration of HBO therapy for these patients is highly individualized but is not expected to exceed 4-8 weeks therapy. The Marx mandibular osteoradionecrosis protocol extends from 30-60 treatments based on stage I-III, adhering to the established principle that all necrotic bone must be debrided. No demonstrable evidence of improvement post two 30 day periods of HBOT (2.0-2.5 ATA, for 90 to 120 minutes, 5 days per week) suggests lack of benefit and subsequent treatments will be denied as not medically reasonable and necessary. [11]
    • Medicare non-covered conditions: Data to justify HBOT prophylaxis for osteoradionecrosis in a previously irradiated mandible undergoing tooth extraction is lacking at this time; subsequently this is a non-covered service. HBO is not covered to prepare the patient for dental extraction when radiation therapy has not been done at least 6 months prior, in order to prevent the development of osteoradionecrosis. [11]

CODING

ICD-10 Coding 

APPENDIX

Summary of Evidence

Systematic reviews

  • A 2016 Cochrane systematic review [8] included 14 trials (753 participants). A meta-analysis of three RCTs showed that there was some moderate quality evidence that HBO was more likely to achieve mucosal coverage with osteoradionecrosis (ORN) (risk ratio (RR) 1.3; 95% confidence interval (CI) 1.1 to 1.6, P value = 0.003, 246 participants, 3 studies). There was also moderate quality evidence of a significantly improved chance of wound breakdown without HBO following operative treatment for ORN (RR 4.2; 95% CI 1.1 to 16.8, P value = 0.04, 264 participants, 2 studies). As for bony continuity, 1 RCT (104 participants) showed that the experimental group (HBO) had statistically significant higher chance of establishment of bony continuity compared to the control group (P value = 0.002). 1 RCT (74 participants) contributed results to healing of tooth sockets following extraction in irradiated field at six months [8]. There was an increased chance of successful healing with HBO compared to the control group (P value = 0.02)
  • A 2016 systematic review [12] included 7 studies (RCTs and observational studies) that analyzed HBO in ORN management. Authors concluded that HNO‐DF/BWCC does not recommend the routine use of HBO for the prevention or management of ORN. Adjunctive HBO may be considered for use on a case‐by‐case basis in patients considered to be at exceptionally high risk who have failed conservative therapy and subsequent surgical resection. The highest level of evidence available to date on the management of ORN using HBO comes from the Annane et al. 2004 multicenter trial. The trial was terminated early due to worse outcomes in the HBO arm (19% resolution with HBO versus 32% resolution with placebo). This study did not include the same RCTs evaluated by Bennett et al [8] and thus generated different conclusions

Guidelines:

  • The 2014 UHMS HBO Therapy Indications Book (Guidelines) [9] and the 2017 European Committee for Hyperbaric Medicine Guidelines [10] support the use of HBOT as an adjunctive therapy to treat ORN, and although the guidelines use different evidence grading methodologies, they are in agreement regarding strength of recommendation.  See table below:

HBO therapy for Mandibular Osteoradionecrosis (ORN)

UHMS, 2014 ECHMG, 2017

HBO followed by debridement and additional HBO for Stage I Mandibular ORN

AHA Class Ib  Grade 1B

HBO followed by a more radical surgical debridement for Stage II Mandibular ORN

AHA Class Ib  Grade 1B
Mandibular resection followed by HBO, then mandibular reconstruction and HBO in the treatment of Stage III Mandibular ORN AHA Class Ib  Grade 1B

Observational

  • A 2017 observational study by Dieleman et al [13] evaluated the success of HBOT and surgery in the treatment of mandibular osteoradionecrosis (ORN) in relation to the extent of the ORN. Twenty-seven patients with ORN with a history of primary oral or base of the tongue cancer who had been treated with radiation therapy with curative intent between 1992 and 2006, with a radiation dose to the mandible of ≥50Gy. The ORN was staged according to the classification of Notani et al. The time from completion of radiation therapy to the development of ORN varied (median 3 years). Forty HBOT sessions were offered. After HBOT alone, 3 of 11 stage I lesions, 0 of 8 stage II lesions, and 0 of 8 stage III lesions had healed (P=0.0018). An absolute incidence of 5.3% ORN was found in this population. Of all sites irradiated in this study, the floor of the mouth was most associated with ORN (8.6%), whereas the cheek was least associated (0%). Based on the results of this study, HBOT can be recommended for stage I and II ORN and for selected cases of stage III ORN (evidence level C)
  • A 2016 observational study by Niezgoda et al [14] analyzed the effect of HBO on a cohort of patients (588 participants) with ORN and found that 92% presented with improved scores 
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REFERENCES

  1. CMS. National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29) . Date of publication 2017;.
  2. Hanley, Mary; Cooper, Jeffrey et al. Hyperbaric, Chronic Refractory Osteomyelitis StatPearls. Date of publication 2017;.
  3. Lambade PN, Lambade D, Goel M et al. Osteoradionecrosis of the mandible: a review. Oral and maxillofacial surgery. Date of publication 2013;volume 17(4):243-9.
  4. Lyons A, Ghazali N et al. Osteoradionecrosis of the jaws: current understanding of its pathophysiology and treatment. The British journal of oral & maxillofacial surgery. Date of publication 2008;volume 46(8):653-60.
  5. Harry T. Whelan, Eric Kindwall et al. Hyperbaric Medicine Practice 4th Edition Best Publishing Company. Date of publication 2017;volume fourth():.
  6. Weaver L . "Hyperbaric Oxygen Therapy Indications” Best Publishing Company, North Palm Beach, FL . Date of publication 2014;volume 469(13th Edition,):.
  7. National Baromedical Services. Introduction to Hyperbaric Medicine Primary Training Manual .;.
  8. Bennett MH, Feldmeier J, Hampson NB, Smee R, Milross C et al. Hyperbaric oxygen therapy for late radiation tissue injury. The Cochrane database of systematic reviews. Date of publication 2016;volume 4():CD005005.
  9. Undersea and Hyperbaric Medical Society Hyperbaric Oxygen Committee,, et al. Hyperbaric Oxygen Therapy Indications . Date of publication 2014;.
  10. Mathieu, Daniel; Marroni, Alessandro; Kot, Jacek et al. Tenth European Consensus Conference on Hyperbaric Medicine: recommendations for accepted and non-accepted clinical indications and practice of hyperbaric oxygen treatment. Diving and hyperbaric medicine. Date of publication 2017;volume 47(1):24-32.
  11. Novitas Solutions, Inc et al. Local Coverage Determination for Hyperbaric Oxygen (HBO) Therapy (L35021) . Date of publication 2015;.
  12. Sultan A, Hanna GJ, Margalit DN, Chau N, Goguen LA, Marty FM, Rabinowits G, Schoenfeld JD, Sonis ST, Thomas T, Tishler RB, Treister NS, Villa A, Woo SB, Haddad R, Mawardi H et al. The Use of Hyperbaric Oxygen for the Prevention and Management of Osteoradionecrosis of the Jaw: A Dana-Farber/Brigham and Women's Cancer Center Multidisciplinary Guideline. The oncologist. Date of publication 2017;volume 22(3):343-350.
  13. Dieleman FJ, Phan TTT, van den Hoogen FJA, Kaanders JHAM, Merkx MAW et al. The efficacy of hyperbaric oxygen therapy related to the clinical stage of osteoradionecrosis of the mandible. International journal of oral and maxillofacial surgery. Date of publication 2017;volume 46(4):428-433.
  14. Niezgoda JA, Serena TE, Carter MJ et al. Outcomes of Radiation Injuries Using Hyperbaric Oxygen Therapy: An Observational Cohort Study. Advances in skin & wound care. Date of publication 2016;volume 29(1):12-19.
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