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Soft Tissue Radionecrosis

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 is initiated in accordance with the policy on quality assurance.

Medical Necessity

The listing of treatment indications for hyperbaric oxygen therapy represent the commonly accepted uses. It is important to note, however, that there are minor “medically necessary” differences between the various providers of health insurance. The approved uses and indications are standardized across the country and can be found 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

(SKIN, PELVIC, BLADDER, RECTUM, COLON, CNS, LARYNX)


 HBO Request Requirements Checklist   Sample Physician Order   |   $ ICD-10 Crosswalk  | Treatment Table


Objectives

  1. Relieve the radiotherapy-induced hypoxic/ischemic state by stimulating angiogenesis, thereby overcoming radiation-induced obliterative endarteritis.
  2. Prepare lesions for definitive wound coverage

Diagnosis

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 the late-radiation effects. Acute inflammatory responses to ongoing or recently completed radiation therapy need to be differentiated.

Criteria for hbo therapy

(one or more of the following should exist)

  1. History of radiation therapy at the site in question, completed at least two months prior to wound development.
  2. Non-responding lesion, within the previously irradiated field.
  3. Preparation for definitive coverage. Failure of definitive coverage attempts

Work-Up
Considerations 

  1. Comprehensive history, to include type and amount of radiation, and oncologic status. Obtain the radiation portal photographs, where possible
  2. Physical examination
  3. Labs to order or review
    • CBC 
    • Serum Albumin 
    • Sedimentation Rate
  4. Wound photographs, where possible (after signed consent)
  5. Generate a wound schematic
  6. Chest x-ray: order or review, where indicated
  7. ECG: order or review, where indicated .
  8. Ideally, the patient should have been pronounced cancer free for at least six weeks. 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 research, and other published reports.
  9. Wound biopsy, to rule out tumor, as indicated
  10. Baseline visual acuity assessment
  11. Nutritional assessment, as indicated
  12. No (limit) use of nicotine products during the hyperbaric treatment course.

Treatment

  1. After signed informed consent:
  2. 2.0 ATA oxygen for 90 minutes, on a QD basis. (Table 1 or 2).
  3. Reassessment after 20 treatments. Essentially, there should be evidence of wound healing response at this point, as well as improved/normalized tissue oximetry (40mmHg greater). If the lesion is well on the way to resolution, discontinue HBO at this time and schedule patient for 7 day follow-ups.
  4. After 20 treatments, if the lesion has improved but remains significant, provide 10 additional treatments. Pending clinical response, continue to 40 treatments.
  5. Where no evidence of response is apparent after the initial series of 20 treatments, consider and evaluate for: a. Incorrect diagnosis b. Persistent/recurrent tumor; biopsy lesion c. Persistent smoking d. Non-responder to hyperbaric oxygen therapy .
  6. Follow-up wound photography at 10 treatments and 20 treatments .
  7. Re-evaluate and document weekly for wound status (appearance and dimensions) and wound evolution.

Follow-Up

  1. Visual acuity assessment
  2. Wound photography

Treatment Threshold

20 – 40 treatments; 60 treatments in rare cases. Do not exceed 60 without external peer review

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. 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.

Plan

Example Statement supporting the role of hyperbaric oxygen therapy:

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

  1. Enhanced fibroblast proliferation – cell proliferation responds to increased tissue levels of oxygen in a dose-dependent fashion.
  2. 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.
  3. Angiogenesis – increased oxygen gradients result in enhanced angiogenesis.

Sample Order

CLINICAL EVIDENCE AND RECOMMENDATIONS  

  • 1A
     For patients with refractory radiation proctitis with a history of radiation treatment terminating at least 6 months prior to onset of signs and symptoms, we recommend HBO as an adjunctive therapy to improve healing responses (as demonstrated by SOMA-Lent scores) (Grade 1A)
  • 1B
    For patients who need reconstructive soft tissue surgery or flaps into a previously irradiated area in the head or neck, we recommend HBO therapy to prevent postoperative wound dehiscence (Grade 1B)
  • 2C
    For patients with hemorrhagic radiation cystitis with a history of radiation treatment terminating at least 6 months prior to onset of signs and symptoms, we suggest HBO as an adjunctive therapy to resolve bleeding (Grade 2C) 
  • 2C
    For patients with radio-induced lesions of the larynx with a history of radiation treatment terminating at least 6 months prior to onset of signs and symptoms, we suggest HBO as an adjunctive therapy to promote healing of the radio-induced lesions (Grade 2C). 
    • Rationale: The impact of HBO in terms of its beneficial effects is likely to involve all three of these mechanisms in irradiated tissues: HBO stimulates angiogenesis and secondarily improves tissue oxygenation; reduces fibrosis; and mobilizes and induces an increase of stem cells within irradiated tissues [2] [3]Quality of evidence varies according to the type of irradiated soft tissue being treated. Of note, high-certainty evidence derived from a well-designed randomized clinical trial supports the use of HBO to treat radiation proctitis [4] ; and moderate-certainty evidence supports the use of HBO pre and postoperatively to prevent wound dehiscence following head and neck soft tissue reconstruction in previously irradiated areas [5] . Evidence supporting use of HBO to treat hemorrhagic cystitis and radio-induced lesions of the larynx is of low-certainty, mainly supported by observational studies. [3]
    • Despite benefits, a frequent concern is the fear that HBO will somehow accelerate malignant growth or cause a dormant malignancy to be reactivated. However, an overwhelming majority of both clinical reports and animal studies showed no enhancement of cancer growth. [3] 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 preoperative and postoperative use of HBO as an adjunctive therapy for existing soft tissue radionecrosis. 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. Numerous forms of soft tissue radiation necrosis and treatment with HBO have been documented with beneficial effect. Tissues previously irradiated with subsequent planned surgery appear to benefit from HBO surrounding the surgery with decreased morbidity from large vessel necrosis. For this reason patients manifesting signs and symptoms of radiation injury will be approved for coincidental HBO, without the histologic diagnosis of ongoing osteoradionecrosis or soft tissue radionecrosis. [6] Utilization review should be accomplished after 60 treatments when HBO is applied to the treatment of radiation injury. Characteristically, most treatment courses for radiation injury will be in the range of 30-60 treatments when the course of treatment is carried out with daily treatments at 2-2.5 ATA of 100% oxygen for 90-120 minutes. [3] 

CODING

See ICD-10 Coding for STRN

APPENDIX

Summary of Evidence

We reviewed the guidelines and studies published since guidelines were last updated. Applying the GRADE framework to the combined body of evidence, we found that the use of HBO to:

  • Treat patients with hemorrhagic radiation cystitis is supported by low-certainty evidence (evidence level C) derived from observational studies and case series [3]
  • Prevent postoperative wound dehiscence in patients who undergo soft tissue reconstruction in the head and neck area post irradiation, is supported by moderate-certainty evidence derived from a 2016 Cochrane meta-analysis [5]
  • Treat patients with refractory radiation proctitis (as demonstrated by improvement in SOMA-Lent scores) is supported by high-certainty evidence derived from a large RCT at low risk of bias conducted by Clarke et al.  [4]
  • Treat patients with radio-induced lesions of the larynx is supported by low-certainty evidence derived from observational studies and case series  [3]

Systematic reviews:     

  • A 2016 systematic review [7] included 8 studies (1 uncontrolled observational cohort, 5 case series, and 2 case reports) including 720 participants who received HBOT for radiation induced skin necrosis.  [8] [9] [10] [11] [12] [13] [14] [15] Sites of skin necrosis included lower extremity, buttocks , scrotum, abdomen, chest wall, upper extremity, and head and neck. Majority of studies were at high risk of bias. Six studies provided the primary outcome measure of interest: complete wound healing after HBOT (98 patients). Pooled together the rate of complete wound healing was 79.6% (78/98). Two studies provided the secondary outcome measures of interest, symptomatic improvement of skin necrosis after HBOT (622 patients). Pooled together the rate of symptomatic improvement was 86% (535/622). Further analysis revealed the rate of complete resolution of pain symptoms was 30% (187/6 22), wound healing symptoms 30% (187/622), and wound drainage symptoms 39%(243/ 622). Evidence level is considered as low certainty (evidence level C) as currently no randomized control trial has tested the efficacy of HBOT in the treatment of skin necrosis due to late radiation tissue injury. Authors concluded that HBO is a safe intervention with promising outcomes, however additional evidence is needed to endorse its application as a relevant therapy in the treatment of radiation induced skin necrosis. 
  • A 2016 Cochrane systematic review [5] included 14 trials (753 participants) that assessed the effect of HBO on complete mucosal cover in people with osteoradionecrosis and on wound healing of dehiscence following complex head and neck surgery and irradiation. 2 RCTs (264 participants) assessed soft tissue radiation injuries and showed that HBO is effective in promoting healing of dehiscence following complex head and neck surgery and irradiation (moderate quality evidence, RR 4.23 95% CI, (1.06 to 16.83) of from single studies there was a significantly increased chance of improvement or cure following HBO for radiation proctitis (RR 1.72; 95% CI 1.0 to 2.9, P value = 0.04, NNTB 5). Authors concluded that these small trials suggest that for people with LRTI affecting tissues of the head, neck, anus and rectum, HBOT is associated with improved outcome.

Guidelines:

  • The 2014 UHMS HBO Therapy Indications Book (Guidelines) and the 2017 European Committee for Hyperbaric Medicine Guidelines support the use of HBOT as therapy to treat Soft Tissue Radiation Necrosis, and although the guidelines use different evidence grading methodologies, they are in agreement regarding strength of recommendation.  [3]  [16] See table below:

HBO therapy for Soft Tissue Injury

UHMS, 2014

ECHMG, 2017

Treatment of soft tissue injury

AHA Level Ib 

n/a

Treatment of hemorrhagic radiation cystitis 

n/a

Grade 1B

Treatment of radiation proctitis

n/a

Grade 1A

The treatment of soft-tissue radionecrosis (other than cystitis and proctitis), in particular in the head and neck area

n/a

Grade 2C

Treating or preventing radio-induced lesions of the larynx 

n/a

Grade 3C

Randomized Clinical Trials                       

  • In 2008, Clarke et al conducted an RCT with 120 evaluated participants that compared the effects of HBO on the late effects normal tissue-subjective, objective, management, analytic (SOMA-LENT) score and standardized clinical assessment in patients with chronic refractory radiation proctitis [4]. In the experimental group, the mean was lower (p = 0.0150) and the amount of improvement nearly twice as great (5.00 vs. 2.61, p = 0.0019). Similarly, Group 1 had a greater portion of responders per clinical assessment than did Group 2 (88.9% vs. 62.5%, respectively; p = 0.0009). Significance improved when the data were analyzed from an intention to treat perspective (p = 0.0006). Authors concluded that hyperbaric oxygen therapy significantly improved the healing responses in patients with refractory radiation proctitis, generating an absolute risk reduction of 32% (number needed to treat of 3) between the groups after the initial allocation. The study is considered by the 2016 Cochrane systematic review [5] as at low risk of bias (evidence level A). 
Observational Studies
  • Case series support use of HBO to resolve hemorrhagic radiation cystitis  [3] (level C)


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REFERENCES

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  2. Undersea and Hyperbaric Medical Society Hyperbaric Oxygen Committee,, et al. Hyperbaric Oxygen Therapy Indications . Date of publication 2014 Oct 7;volume ():.
  3. Clarke RE, Tenorio LM, Hussey JR, Toklu AS, Cone DL, Hinojosa JG, Desai SP, Dominguez Parra L, Rodrigues SD, Long RJ, Walker MB et al. Hyperbaric oxygen treatment of chronic refractory radiation proctitis: a randomized and controlled double-blind crossover trial with long-term follow-up. International journal of radiation oncology, biology, physics. Date of publication 2008 Sep 1;volume 72(1):134-143.
  4. 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.
  5. . Local Coverage Determination for Hyperbaric Oxygen (HBO) Therapy (L35021) . Date of publication 2017 Oct 7;volume ():.
  6. Borab Z, Mirmanesh MD, Gantz M, Cusano A, Pu LL et al. Systematic review of hyperbaric oxygen therapy for the treatment of radiation-induced skin necrosis. Journal of plastic, reconstructive & aesthetic surgery : JPRAS. Date of publication 2017 Apr 1;volume 70(4):529-538.
  7. Bui QC, Lieber M, Withers HR, Corson K, van Rijnsoever M, Elsaleh H et al. The efficacy of hyperbaric oxygen therapy in the treatment of radiation-induced late side effects. International journal of radiation oncology, biology, physics. Date of publication 2004 Nov 1;volume 60(3):871-8.
  8. Feldmeier JJ, Heimbach RD, Davolt DA, Court WS, Stegmann BJ, Sheffield PJ et al. Hyperbaric oxygen as an adjunctive treatment for delayed radiation injury of the chest wall: a retrospective review of twenty-three cases. Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, In.... Date of publication 1995 Dec 1;volume 22(4):383-93.
  9. Feldmeier JJ, Heimbach RD, Davolt DA, Court WS, Stegmann BJ, Sheffield PJ et al. Hyperbaric oxygen an adjunctive treatment for delayed radiation injuries of the abdomen and pelvis. Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, In.... Date of publication 1996 Dec 1;volume 23(4):205-13.
  10. Feldmeier JJ, Heimbach RD, Davolt DA, McDonough MJ, Stegmann BJ, Sheffield PJ et al. Hyperbaric oxygen in the treatment of delayed radiation injuries of the extremities. Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, In.... Date of publication 2000 Apr 1;volume 27(1):15-9.
  11. Hampson NB, Holm JR, Wreford-Brown CE, Feldmeier J et al. Prospective assessment of outcomes in 411 patients treated with hyperbaric oxygen for chronic radiation tissue injury. Cancer. Date of publication 2012 Aug 1;volume 118(15):3860-8.
  12. Korpinar S, Cimsit M, Cimsit B, Bugra D, Buyukbabani N et al. Adjunctive hyperbaric oxygen therapy in radiation-induced non-healing wound. The Journal of dermatology. Date of publication 2006 Jul 1;volume 33(7):496-7.
  13. 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.
  14. Uzun G, Candas F, Mutluoglu M, Ay H et al. Successful treatment of soft tissue radionecrosis injury with hyperbaric oxygen therapy. BMJ case reports. Date of publication 2013 Jul 10;volume 2013():.
  15. 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.