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Acute Peripheral Arterial Insufficiency

Acute Peripheral Arterial Insufficiency

Acute Peripheral Arterial Insufficiency

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 HBOT 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


Acute Peripheral Arterial Insufficiency

 Sample Physician Order   | $ ICD-10 Crosswalk |   Treatment Table 

 Emergent / Urgent Indication 

BackgroundAcute peripheral ischemias cover a spectrum of diseases that includes acute traumatic and non-traumatic events sharing the common feature of sudden occlusion of the arterial supply. The resultant tissue hypoxia and ischemia leads to increased local concentrations of cellular byproducts, compromised microcirculation, advancing hypoxia, decreased nutrient delivery to the end tissues, vascular membrane breakdown, and edema formation. These factors threaten wound healing and contribute to advancing infectious processes. The diagnosis of acute peripheral arterial insufficiency (APAI) is an accepted indication for use of HBOT. Any diagnosis of diabetes or venous insufficiency disease is to be excluded. Anything other than an acute arterial embolic event (including severe peripheral vascular disease at risk of extremity amputation) would not be an acceptable indication for HBOT.

Goals of HBOT

  • Serve as a bridge therapy until definitive vascular surgical intervention treats the thrombotic/embolic event by:
    • Increasing tissue oxygenation concentration to prevent cellular death
    • Reducing ischemia-reperfusion injury
    • Supporting host defense function of white blood cells
  • Enhance blood supply by:
    • Supporting neovascularization through stimulation of collagen secretion by fibroblasts and macrophages
    • Increasing tissue perfusion through reduction of capillary leakage and tissue swelling 

Diagnosis

  • Diagnosis of acute (i.e., sudden, unexpected) embolism:
    • Onset of signs/symptoms in the past 2 weeks [2] 
    • Six Ps of acute ischemia: pain, pallor, poikilothermia, pulselessness, paresthesia, and paralysis
    • History of:
      • Recent thrombectomy or peripheral arterial reconstruction (complications include embolic event, shower of thrombi in end arteries)
      • Cardiological conditions predisposing to embolism, such as atrial fibrillation, myocardial infarction, endocarditis, valvular disease)
      • Arterial conditions predisposing to embolism, such as aneurysm, atherosclerotic plaque
  • Diagnoses of venous, diabetic etiologies, and severe peripheral vascular disease with worsened symptoms should be ruled out

Hyperbaric Criteria

  • Ischemic limb or tissue, at risk of amputation due to acute embolic event 
  • Treatment or prevention of ischemia-reperfusion injury
  • Ideally, HBO would start within 24 hours of inciting event

Evaluation

  • History to include: specific time of symptom onset, duration, severity, and location; special attention should be paid to the evolution of symptoms. History of claudication 
  • Physical examination to include: external appearance and temperature of the skin of the patient’s affected extremity,  presence or absence of peripheral pulses, evaluation of sensation, limb may also appear mottled or marbled, 6 P's- Pain, pallor, paresthesia, paralysis, pulselessness, and poikilothermia
  • Vascular surgeon consulted for surgical revascularization/embolectomy
  • Labs to order or review:
    • Complete Blood Count (CBC)
    • Comprehensive Metabolic Panel (CMP)
    • Urinalysis; urinary myoglobin
    • Arterial Blood Gas (ABG)
    • Electrocardiogram (ECG)
    • Chest X-ray
  • Photograph extremity for signs of continued hypoxia or demarcation.
  • Transcutaneous oxymetry (TCOM) should be performed as close to the area at risk as possible at 1.0 ATA.

Treatment

  • Hyperbaric oxygen therapy at 2.0- 2.5 ATA oxygen for 90 minutes. (Table 1 or 3)
  • Treat three times within the first 24 hours
  • Treat twice daily after the first 24 hours until the tissue at risk stabilizes.
  • Daily HBOT may be required until tissue fully demarcates or begins to show evidence of healing. 
  • Repeat TCOM in the chamber as close to the area at risk as possible as this documents responsiveness to breathing oxygen under pressure. The TCOM in conjunction with the physical exam assists clinical management.
  • Heparin to prevent the formation of further emboli 
  • Photograph extremity for signs of continued hypoxia or demarcation.
  • Re-evaluate and document daily for normal tissue oximetry.

Follow-Up

  • Repeat photography of extremity
  • Repeat transcutaneous assessment

Treatment Threshold

3 – 9 treatments (Utilization review recommended after 9 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-HBOT. 
  • Avoid petroleum-based dressings and ointments whenever possible. If these are a necessary part of the surgical dressing, ensure that they are not exposed to air and are completely covered with 100% cotton during HBOT.
  • This protocol should not be used for patients with severe or end-stage peripheral vascular disease who now present with worsened disease and a digit or extremity as risk. These patients progress to amputation and would be unlikely to benefit from HBOT. 
Primary Sources: Whelan and Kindwall [3]Weaver [4]

DOCUMENTATION

History 

A sample history for an acute arterial insufficiency follows. (Please note that advancement of a chronic arterial process with sudden exacerbation is not an acceptable indication for hyperbaric oxygen therapy.)

"Mr. Simpson is a 65 y/o man who was in his usual state of health until this morning. He noted onset of sudden pain, coolness, and pallor of the left lower leg from the mid-calf down to the foot. He has never had significant arterial disease, but he has had atrial fibrillation which had been treated medically. He is also taking a daily anticoagulant and has blood levels monitored frequently. 

Emergency arteriogram in radiology shows an arterial clot at the trifurcation of the left knee. There are only scant spiderwebs of arteries supplying blood to the lower leg and foot. No identifiable arteries were noted. The interventional radiologist tried to remove the clot in the radiology suite. The report indicates success in restoring some blood flow, but this was incomplete. 

After the radiological procedure, the patient's left leg is swollen, purple, and mottled. There is no evidence of pulsatile blood flow by Doppler ultrasound in the recovery room. 

Our vascular surgeon has been called for an emergent femoral popliteal bypass and potential for further bypass as indicated in the operating room. He asked that we consider using the hyperbaric chamber to provide oxygen to the foot and potential limb salvage from this limb-threatening condition. The hyperbaric indication would be an acute peripheral arterial insufficiency with adjunctive hyperbaric oxygen therapy as a bridge to operative care. We have agreed to see the patient and will start hyperbaric therapy immediately."

Physical Exam

Physical examination to include:

  • External appearance and temperature of the skin of the patient’s affected extremity. Limb may also appear mottled or marbled,
  • Presence or absence of peripheral pulses,
  • Evaluation of sensation,
  • 6 P's- Pain, pallor, paresthesia, paralysis, pulselessness, and poikilothermia

Impression  

  • Acute Peripheral Arterial Insufficiency Refer to the ICD-10 Crosswalk 

Plan

"A typical hyperbaric regimen for a patient with acute peripheral arterial insufficiency consists of daily 2.0 to 2.5 ATA hyperbaric oxygen treatments with 90 minutes of oxygen breathing time. Treatment with hyperbaric oxygen is generally once daily. However, in the presence of advancing ischemia, twice daily treatments may be required."

Risk and Benefit of Hyperbaric Oxygen Therapy 

  • Please refer to topic "Documentation HBO: Risks and Benefits"

Indication for Hyperbaric Oxygen Therapy (HBOT)

"Acute peripheral arterial insufficiency covers a spectrum of diseases, which includes acute traumatic and non-traumatic events sharing the common feature of sudden occlusion of the arterial blood supply. The resultant tissue hypoxia and ischemia leads to CO2 retention with increased local concentrations of cellular byproducts, compromised microcirculation, advancing hypoxia and decreased nutrient delivery to the end tissues, vascular membrane breakdown, and edema formation. These factors threaten wound healing and contribute to advancing infectious processes. 

Hyperbaric oxygen can be beneficial in managing acute peripheral arterial insufficiency by several mechanisms: 1) Increasing tissue oxygen concentrations over 1000%, thus preventing cellular death, 2) stimulating fibroblasts and macrophages to secrete collagen and enhance neovascularization, 3) Reducing edema formation by reducing capillary leakage and tissue swelling, thus increasing tissue perfusion, and 4) maintaining the bacterial killing ability of leukocytes after phagocytosis."

Sample Order

  •  See Sample Physician Order

REVISION UPDATES

DateDescription
4/28/19Added section on Documentation
Official reprint from WoundReference® woundreference.com ©2018 Wound Reference, Inc. All Rights Reserved
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NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.

REFERENCES

  1. CMS. National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29) . 2017;.
  2. Gerhard-Herman, Marie D; Gornik, Heather L; Barrett, Coletta; Barshes, Neal R; Corriere, Matthew A; Drachman, Douglas E; Fleisher, Lee A; Fowkes, Francis Gerry R; Hamburg, Naomi M; Kinlay, S... et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: A report of the american college of cardiology/american heart association task force on clinical practice guidelines. Circulation. 2017;volume 135(12):e686-e725.
  3. Harry T. Whelan, Eric Kindwall et al. Hyperbaric Medicine Practice 4th Edition Best Publishing Company. 2017;volume fourth():.
  4. Eugene R. Worth MD, MEd, William H Tettelbach, MD, FACP, Harriet W. Hopf MD et al. Undersea and Hyperbaric Medical Society, Hyperbaric Oxygen Indications, 13th edition: Arterial Insufficiencies: Enhancement of Healing in Selected Problem Wounds . 2014;.
Topic 980 Version 4.0