CAM 60122

Scintigraphy of Acute Deep Venous Thrombus

Category:Radiology   Last Reviewed:February 2020
Department(s):Medical Affairs   Next Review:February 2999
Original Date:February 2000    

Description:
Deep vein thrombosis (DVT) is a common occurrence. It is estimated that in the United States, approximately 5 million patients experience one or more episodes of DVT each year, resulting in more than 500,000 cases of pulmonary embolism and 100,000 deaths. Prompt treatment of acute thrombus is considered essential to initiate anticoagulation or thrombolytic therapy to prevent the serious consequences of pulmonary embolus. Radiographic evaluation of deep venous thrombus is performed both in symptomatic patients and in asymptomatic patients at high risk of venous thrombus (i.e., after orthopedic surgery). Contrast venography is considered the gold standard of diagnosis, but this invasive procedure is not routinely used. Duplex ultrasonography is probably the most common noninvasive technique used, followed by impedance plethysmography. Ultrasonography is thought to have excellent sensitivity and specificity in the thigh, but poor diagnostic accuracy below the knee. Both of the above techniques provide indirect evidence of thrombus by imaging an alteration in blood flow and, thus, cannot distinguish between acute and chronic thrombus.

Direct detection of acute venous thrombus has been investigated using intravenously injected radio-labeled synthetic peptides that bind with high affinity to receptors expressed on activated platelets. In 1999, the FDA approved the radiopharmaceutical peptide apcitide (AcuTectTM) for use in the scintigraphic imaging of acute venous thrombosis in the lower extremities in patients who have signs and symptoms of acute thrombophlebitis. Apcitide binds to glycoprotein llb/lla fibrinogen receptors, which are expressed on the surface of activated platelets, thus making the radiopharmaceutical specific for acute, not chronic thrombus.

Policy:
Scintigraphic imaging of acute venous thrombus in the lower extremities may be considered MEDICALLY NECESSARY in patients with signs and symptoms of acute thrombus.

Scintigraphic imaging of acute venous thrombus in the lower extremities is considered INVESTIGATIONAL in asymptomatic patients at risk of acute venous thrombus
.

Rationale:
The following data are based on the package insert of AcuTect. (1) 

Two multicenter clinical studies included 243 patients with signs and symptoms of acute thrombus who underwent evaluation with scintigraphic imaging compared with contrast venography, considered the gold standard. The primary outcome of the studies was agreement between the interpretations of the blindly read scintigraphic and contrast venography studies. The criterion for efficacy end point was pre-set at 75 percent agreement, with the lower limit of the 95 percent confidence interval being 60 percent. This agreement rate took into account the blind read variability of venography due to the adverse impact of the reader being blinded to the clinical information on the patient. The agreement rate between the results of scintigraphy vs. venography met this criterion.

It should be noted that the FDA-labeled indications are limited to symptomatic patients, and the data presented to the FDA focused on symptomatic patients. There are no data regarding the use of scintigraphic imaging in asymptomatic patients. Asymptomatic patients may represent a large percentage of patients undergoing imaging for DVT as a "rule-out" test. For example, prior to hospital discharge after orthopedic procedures such as arthroplasties, many asymptomatic patients may undergo Doppler ultrasonography to rule out the presence of a thrombus. Data regarding this application of the scintigraphic imaging have not been published. The FDA labeling also states: "How negative AcuTect images should be used in the diagnostic evaluation or therapeutic management of patients with suspected acute venous thrombosis has not been studied."

In addition, no data are available regarding the diagnostic performance of scintigraphic imaging compared with Duplex ultrasonography, a more commonly used diagnostic technique than contrast venography. Therefore, it is not known whether the evaluation of DVT is improved by routinely performing both ultrasonography and scintigraphic imaging. Some imaging protocols suggest the use of scintigraphic imaging in the setting of indeterminate or nondiagnostic ultrasonography in symptomatic patients. (2) 

References:

  1. AcuTect package insert. Diatide, Inc. Londonderry, New Hampshire.
  2. Kyrle PA, Eichinger S. Deep vein thrombosis. Lancet. 2005;365(9465):1163-1174.
  3. Ilahi OA, Reddy J, Ahmad I. Deep venous thrombosis after knee arthroscopy: A meta-analysis. Arthroscopy. 2005;21(6):727-730.
  4. Kearon C, Ginsberg JS, Douketis J, et al. A randomized trial of diagnostic strategies after normal proximal vein ultrasonography for suspected deep venous thrombosis: D-dimer testing compared with repeated ultrasonography. Ann Intern Med. 2005;142(7):490-496.
  5. Miyazaki M, Hong SW, Yoon SH et al. Kinematic analysis of the relationship between the grad of disc degeneration and motion unit of the cervical spine. Spine 2008; 33(2):187-93.
  6. Carretta RF, Vande Streek P, Weiland FL. Nuclear exam rivals venography for clots. Diagn Imaging 1998; 20(6):83-6.

Coding Section

Codes Number Description
CPT 78456 Acute venous thrombosis imaging, peptide
ICD-9 Procedure 92.19 Other radioisotope scan; other sites
ICD-9 Diagnosis 451.1 Phlebitis and thrombophlebitis of deep vessels of lower extremity
HCPCS    
ICD-10-CM (effective 10/01/15)  I8000 Phlebitis and thrombophlebitis of superficial vessels of unspecified lower extremity
  I8010 Phlebitis and thrombophlebitis of unspecified femoral vein
  I80209 Phlebitis and thrombophlebitis of unspecified deep vessels of unspecified lower extremity
  I803 Phlebitis and thrombophlebitis of lower extremities, unspecified
  I80219 Phlebitis and thrombophlebitis of unspecified iliac vein
  I808 Phlebitis and thrombophlebitis of other sites
  I809 Phlebitis and thrombophlebitis of unspecified site
ICD-10-PCS (effective (10/01/15)  CF1C1ZZ Planar Nuclear Medicine Imaging of Hepatobiliary System, All using Technetium 99m (Tc-99m)
  CF1CYZZ Planar Nuclear Medicine Imaging of Hepatobiliary System, All using Other Radionuclide
  CF1YYZZ Planar Nuclear Medicine Imaging of Hepatobiliary System and Pancreas using Other Radionuclide
  CG1YYZZ Planar Nuclear Medicine Imaging of Endocrine System using Other Radionuclide
  CG2YYZZ Tomographic (Tomo) Nuclear Medicine Imaging of Endocrine System using Other Radionuclide
  CH1YYZZ Planar Nuclear Medicine Imaging of Skin, Subcutaneous Tissue and Breast using Other Radionuclide
  CH2YYZZ Tomographic (Tomo) Nuclear Medicine Imaging of Skin, Subcutaneous Tissue and Breast using Other Radionuclide
  CT1YYZZ Planar Nuclear Medicine Imaging of Urinary System using Other Radionuclide
  CT2YYZZ Tomographic (Tomo) Nuclear Medicine Imaging of Urinary System using Other Radionuclide
  CV1YYZZ Planar Nuclear Medicine Imaging of Male Reproductive System using Other Radionuclide
  CW1YYZZ Planar Nuclear Medicine Imaging of Multiple Anatomical Regions using Other Radionuclide
  CW1ZZZZ Planar Nuclear Medicine Imaging of Other Anatomical Region
  CW2YYZZ Tomographic (Tomo) Nuclear Medicine Imaging of Multiple Anatomical Regions using Other Radionuclide
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Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

02/19/2020 

Annual review. No change to policy intent. 

02/01/2019 

Annual review. No change to policy intent. 

02/28/2018 

Annual review. No change to policy intent. 

02/09/2017 

Annual review. No change to policy intent. 

02/02/2016

Annual review. No changes made. 

09/23/2015 

Added ICD-10 codes to policy. 

03/05/2015

Removed disclaimer per mgmt.

02/10/2015 

Annual review, no change to policy intent. Policy to remain active, but will not undergo scheduled review after 2015. 

02/3/2014

Annual review. No changes made.


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