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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.

The protocol is designed to standardize therapeutic regimens, whenever possible, in order to optimize clinical outcomes and cost-effectiveness, and provide the basis for prospective analysis of data. Care plans may need to be individualized according to a particular patient’s general medical condition and relevant medical history. Where the clinical decision is to deviate from the protocols, including the upper treatment threshold, a case audit should be initiated.

Medical Necessity

The listing of treatment indications for hyperbaric oxygen therapy represent the commonly accepted uses. The approved uses and indications are standardized across the country and can be found within the National Coverage Determination (NCD) 20.29. [1]

It is recommended, therefore, that contact is made (pre-authorization) with each patient’s insurance company in order to clarify benefits. Each health insurance company’s decision-making process for inclusion or exclusion of a particular indication for hyperbaric oxygen therapy is based upon several factors. Literature-specific reviews by panels of experts, technology assessments, resourcing of evidence-based repositories and historical precedent are tools used for “medically necessary‟ determination. 


TREATMENT PROTOCOL


 HBO request requirements checklist |   Sample Physician Order | $ ICD-10 Crosswalk   |  Treatment Table


Objectives

  1. Re-establish wound tissue oxygen gradients, thereby stimulating angiogenesis within areas of radiation – induced obliterative endarteritis.
  2. Provide a competent vascular foundation in order to support reconstructive procedures.
  3. Surgical specialty involvement in the case.

Diagnosis

Breakdown of mandible, or pathological/traumatic fracture; exposed mandible; non-healing socket(s), or other bony lesions within a previously irradiated field. Soft tissue fistula. Radiographic evidence of mandibular changes consistent with late radiation injury.

Criteria for hbo therapy

(one or more of the following should exist)

  1. Documentation of confirmed diagnosis.
  2. Documentation of radiation therapy to the affected site.
  3. Histology consistent with late radiation tissue effect.

Work-Up
Considerations 

  1. Comprehensive history, to include type and amount of radiation. Obtain the radiation portal photographs, where possible 
  2. Physical examination
  3. Labs to consider, order or review
    • CBC
    • Serum albumin
    • Sedimentation rate 
  4. Wound photographs (after signed consent), where appropriate
  5. Chest x-ray: order or review, as indicated
  6. Ideally, the patient should be pronounced cancer free. This requirement is based upon historic concerns regarding the potential tumor enhancing and/or carcinogenic effect of hyperbaric oxygen. These concerns have not been supported by recent, controlled, research, and other published reports.
  7. Baseline visual acuity assessment
  8. No (limit) use of nicotine products during the hyperbaric treatment course.
  9. Nutritional assessment
  10. Coordination of hyperbaric therapy and surgical procedures, in conjunction with referring physician/oral-maxillofacial surgeon.
  11. Rule out cancer re-occurrence or residual tumor. 

Treatment

  • After signed informed consent:
  • Stage I: 30 treatments at 2.5 ATA oxygen for 90 minutes each, with two 10 minute air breaks QD (Table 3). Discontinue all antibiotics; wound care – saline rinses or self-irrigation only. No bone is removed during Stage I.  a. Wound examined after 30 treatments. HBO is halted if spontaneous sequestration occurs and full mucosal cover is achieved. b. With definite clinical improvement, the patient continues to a total of 40 treatments, in order to achieve full mucosal cover. c. If little/no improvement is evident after 30 treatments, patient is classed as a Stage I non-responder and advanced to Stage II.
  • Stage II: Following the initial (Stage 1) 30 treatments, the patient undergoes local surgical debridement. a. 10 immediate additional hyperbaric treatments. (providing the wound is seen to progress without complications) b. If wound dehisces, leaving exposed non-healing bone, the patient is identified as a non-responder to Stage II, and advanced to Stage III.
  • Stage III: Following the initial 30 treatments (if advanced from Stage I and Stage II) or after 30 treatments when entered directly as Stage III, the patient undergoes a transoral partial jaw resection. Where orocutaneous fistula or large soft tissue loss exists, primary closure or a soft tissue reconstruction is accomplished at this time. a. 10 immediate additional hyperbaric treatments follow the above procedure(s), then the patient is advanced into Stage III-R.
  • Stage III-R: Approximately 10 weeks after resection the soft tissues are expected to be healed and the potential graft recipient bed free of infection and contamination. Definitive bony reconstruction is undertaken at this time, followed by 10 immediate additional hyperbaric treatments.
  • Repeat wound photography, where possible
  • Re-evaluate and document weekly for wound status (appearance and dimensions)

Follow-Up

  1. Visual acuity assessment
  2. Wound photography
  3. Transcutaneous oximetry

Treatment Threshold

30 – 60 treatments

ICD-9 to ICD-10 Crosswalk

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

Notes

  1. In diabetic patients, obtain finger stick for blood glucose prior to each treatment.
  2. Avoid petroleum based dressings and ointments.
  3. Where a patient suffers an oxygen-induced seizure, or appears to experience premonitory signs or symptoms of oxygen intolerance, consider reducing subsequent treatment pressure to 2.0 ATA.
  4. It is important to confirm that this indication meets the “medically necessary” reimbursement standard of the patient’s health insurance plan.

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: debridement followed by HBO; 
  • Stage II: More radical surgical debridement followed by HBO;
  • Stage III: Mandibular resection followed by HBO, then mandibular reconstruction and 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 treatments, or when a more major operative debridement is required. Stage III ORN: Full thickness bone damage or pathologic fracture, usually requires complete resection and reconstruction with free tissue. [3] If mandibular resection is anticipated, patients are advanced to Stage III. 
    • Use of HBO for management as an adjunctive therapy to treat ORN is supported by moderate certainty evidence (evidence level B). [4] [5] [6] 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. [5] 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. [7]
    • 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. [7]

CODING

ICD-10 Coding 

APPENDIX

Summary of Evidence

Systematic reviews

  • A 2016 Cochrane systematic review [4] 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 [4]. There was an increased chance of successful healing with HBO compared to the control group (P value = 0.02)
  • A 2016 systematic review [8] 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 [4] and thus generated different conclusions

Guidelines:

  • The 2014 UHMS HBO Therapy Indications Book (Guidelines) [5] and the 2017 European Committee for Hyperbaric Medicine Guidelines [6] 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, 2014ECHMG, 2017

Debridement followed by HBO in the treatment of

Stage I Mandibular ORN

AHA Class Ib Grade 1B

A more radical surgical debridement followed by HBO in the treatment of

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 ORNAHA Class Ib Grade 1B

Observational

  • A 2017 observational study by Dieleman et al [9] evaluated the success of hyperbaric oxygen therapy (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 [10] 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. Hanley, Mary; Cooper, Jeffrey et al. StatPearls . Date of publication 2017 Jan 1;volume ():.
  2. 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 Dec 1;volume 46(8):653-60.
  3. 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 Apr 28;volume 4():CD005005.
  4. Undersea and Hyperbaric Medical Society Hyperbaric Oxygen Committee,, et al. Hyperbaric Oxygen Therapy Indications . Date of publication 2014 Oct 7;volume ():.
  5. 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 Mar 1;volume 47(1):24-32.
  6. . Local Coverage Determination for Hyperbaric Oxygen (HBO) Therapy (L35021) . Date of publication 2017 Oct 7;volume ():.
  7. 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 Apr 1;volume 46(4):428-433.
  8. 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 Jan 1;volume 29(1):12-19.
  9. 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 Mar 1;volume 22(3):343-350.
  10. . National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29) . Date of publication 2017 Oct 7;volume ():.