0414 AcuTect Scintigraphic Imaging for Detection of Lower ...
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AcuTect Scintigraphic Imaging forDetection of Lower Limb Deep VeinThrombosis
Clinical Policy Bulletins Medical Clinical Policy Bulletins
Policy History Last
Review
08/22/2018
Effective: 05/04/2000
Next Review:
04/25/2019
Review History
Definitions
Additional
Number: 0414
Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB.
Aetna considers AcuTect scintigraphic imaging for detection and localization of
deep vein thrombosis (DVT) in the lower extremity experimental and investigational
because the clinical value of this test in the management of persons with suspected
DVT has not been clearly established by the peer-reviewed medical literature.
Background
Contrast venography (also known as contrast phlebography) is the gold standard
for the diagnosis of DVT, although it is rarely used anymore because it is
invasive, painful, time-consuming, and entails exposure to significant amounts of
radiation. For patients with symptoms suggestive of DVT, compression
ultrasonography is the most frequently used test. Pooled analyses showed that
ultrasonography has a sensitivity of 96 % and a specificity of 98 % for proximal vein
thrombosis. It has been reported that venous thromboembolic complications occur
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in less than 1 % of untreated patients in whom the presence of DVT is rejected on
the basis of serial ultrasonography or ultrasonography plus either an assay for
D-dimer (a fragment that is specific for the degradation of fibrin) or clinical score.
AcuTect (Diatide, Inc., Londenderry, NH) is a complex of a small-molecule synthetic
peptide, apcitide, and the radionuclide, technetium (Tc) 99m (a gamma ray emitter).
Apcitide binds preferentially to glycoprotein IIb/IIIa receptors, which are expressed
on the surface of activated platelets, a major component of active thrombus
formation. Thus, it may localize at sites where blood clots are present or forming.
AcuTect is approved for use in the scintigraphic imaging of acute (not chronic)
venous thrombosis in the lower extremities of patients who have signs and
symptoms of acute venous thrombosis. It allows for early (10 to 60 minutes post-
injection, administered by injection into the antecubital vein) imaging of DVT of the
entire lower extremities, including the calf.
Information provided in the product labeling of AcuTect stated that the agreement
rates between AcuTect and contrast venography are between 56 and 73 %.
Furthermore, clinical follow-up studies of patients with negative AcuTect scans
have not been carried out to determine if negative image findings represent the
absence of acute venous thrombosis, and the rate of venous thromboembolic
complications in untreated patients after a negative AcuTect scan has not been
determined. Thus, the value of AcuTect in the management of patients with
suspected DVT has not been clearly established.
Dunzinger et al (2008) studied the detection of acute DVT in patients presenting
with clinical symptoms suggesting DVT and pulmonary embolism (PE) with (99m) Tc
apcitide. A total of 19 patients (11 males, 8 females) received within 24 hrs after
admission to the hospital a mean of 841 MBq (range of 667 to 1,080) (99m)Tc
apcitide i.v. followed by planar recordings 10, 60, and 120 mins after injection.
Images were compared to the results of compression ultrasonography and/or
phlebography. Patients with clinically suspected PE underwent spiral computed
tomography or lung perfusion scans. (99m)Tc-apcitide scintigraphy showed acute
clot formation in 14 out of 16 patients where the other imaging modalities
suggested DVT. Positive scintigraphic results were seen up to 17 days after the
onset of clinical symptoms. In 3 out of 3 patients without any proof of DVT, (99m) Tc
apcitide scintigraphy was truly negative. Glycoprotein receptor imaging showed only
one segmental PE in 6 patients with imaging-proven sub-segmental (n = 3) or
segmental PE (n = 3). The authors concluded that (99m)Tc-apcitide scintigraphy
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may be an easy and promising tool for the detection of acute clot formation in
patients with DVT up to 17 days after the onset of clinical symptoms with a
sensitivity of 87 % and a specificity of 100 %. However, it failed to demonstrate PE
in 83 % of examined patients with proven PE.
Tan et al (2009) noted that currently the combination of a clinical decision rule,
D-dimer testing and compression ultrasonography has proved to be safe and
effective for the diagnosis of DVT in the lower extremities. Computed tomography
(CT) and magnetic resonance imaging (MRI) can be useful as additional or
secondary imaging modalities. Somarouthu and colleagues (2010) discussed the
approach for diagnosing DVT in different patient populations. Clinical features and
probability assessment guide further diagnostic tests. D-dimer testing is used as
screening test; however, duplex ultrasound remains the primary confirmatory test.
Furthermore, CT and MRI are used only in select patient populations (e.g., when
ultrasound results are equivocal, in patients suspected of central venous DVT, or as
a part of combined protocol for diagnosis of PE). The authors stated that contrast
phlebography and plethysmography do not have much of a role during routine
diagnosis of DVT.
Contrast venography (phlebography) is the "gold-standard" examination (Polak et
al, 2005) for suspected deep venous thromboses of the lower extremity. An iodine-
containing contrast agent is injected into a foot vein. DVT is present if a distinct
filling defect is present in a deep vein of the calf or thigh. Other findings, such as
an abrupt cutoff, absence of filling or presence of collaterals, are less specific and
may be related to technical factors or to chronic venous thrombosis. American
College of Radiology Appropriateness Criteria (Polak et al, 2005) on suspected
lower extremity deep venous thrombosis state that invasive contrast
phlebography may be necessary where other studies are equivocal or an
intervention is planned. Contrast phlebography is assigned an appropriateness
rating of 5 of 10. The authors note that, although this examination serves as the
"gold standard", it may not give reliable results in 5 to 10 % of patients. It also
carries some risks: contrast reaction, local irritation or skin loss due to
extravasation, renal failure, and chemically induced thrombophlebitis.
Guidelines on venous thromboembolism from the University of Michigan (2009)
state that phlebography "is seldom indicated any longer". The guidelines state that
phlebography carries appreciable local morbidity, the risk of contrast administration,
and is technically inadequate in 7 to 20 % of studies.
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Ultrasound is recommended for patients with intermediate to high pretest probability
of DVT in the lower extremities. Use of ultrasound in diagnosing symptomatic
thrombosis in the proximal veins of the lower limb is recommended for patients
whose pretest probability of disease falls in the category of intermediate to high risk
of DVT under the Wells prediction rule. Ultrasound is less sensitive in patients who
have DVT limited to the calf; therefore, a negative ultrasound does not rule out DVT
in these patients. Repeat ultrasound or venography may be required for patients
who have suspected calf-vein DVT and a negative ultrasound and for patients who
have suspected proximal DVT and an ultrasound that is technically inadequate or
equivocal. Contrast venography is still considered the definitive test to rule out the
diagnosis of DVT.
CPT Codes / HCPCS Codes / ICD-10 Codes
Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":
CPT codes not covered for indications listed in the CPB:
Other CPT codes related to the CPB:
75820 Venography, extremity, unilateral, radiological supervision and
interpretation
75822 Venography, extremity, bilateral, radiological supervision and
interpretation
78457 Venous thrombosis imaging, venogram; unilateral
78458 bilateral
ICD-10 codes not covered for indications listed in the CPB:
I80.10 - I80.13
I80.201 - I80.9
I82.0 - I82.91
Other HCPCS code related to the CPB:
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A9504
The above policy is based on the following references:
1. Birdwell B. Recent clinical trials in the diagnosis of deep-vein thrombosis.
Curr Opin Hematol. 1999;6(5):275-279.
2. Kraaijenhagen RA, Lensing AW, Wallis JW, et al. Diagnostic management of
venous thromboembolism. Baillieres Clin Hematol. 1998;11(3):541-586.
3. Lensing AW, Prandoni P, Prins MH, Buller HR. Deep-vein thrombosis.
Lancet. 1999;353(9151):479-485.
4. Kearon C, Julian JA, Newman TE, Ginsberg JS. Noninvasive diagnosis of
deep vein thrombosis. McMaster Diagnostic Imaging Practice Guidelines
Initiative. Ann Intern Med. 1998;128(8):663-677.
5. Diatide Inc. AcuTect product insert. Londonderry, NH: Diatide; September
1998.
6. U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and
Research. Summary minutes for the Medical Imaging Drug Advisory
Committee Meeting. Silver Spring, MD, February 9, 1998.
7. Taillefer R. Radiolabeled peptides in the detection of deep venous
thrombosis. Semin Nucl Med. 2001;31(2):102-123.
8. Institute for Clinical Systems Improvement (ICSI). Venous
Thromboembolism. ICSI Health Care Guidelines. Bloomington, MN: ICSI;
January 2002.
9. Bates SM, Lister-James J, Julian JA, et al. Imaging characteristics of a novel
technetium Tc 99m-labeled platelet glycoprotein IIb/IIIa receptor
antagonist in patients with acute deep vein thrombosis or a history of
deep vein thrombosis. Arch Intern Med. 2003;163(4):452-456.
10. Bernarducci MP. 'Pathophysiologic mapping' of venous
thromboembolism: Opportunities for radiolabeled peptides. Q J Nucl Med.
2003;47(4):292-320.
11. McRae SJ, Ginsberg JS. The diagnostic evaluation of deep vein thrombosis.
Am Heart Hosp J. 2004;2(4):205-210.
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12. Kyrle PA, Eichinger S. Deep vein thrombosis. Lancet. 2005;365(9465):1163-
1174.
13. Ilahi OA, Reddy J, Ahmad I. Deep venous thrombosis after knee
arthroscopy: A meta-analysis. Arthroscopy. 2005;21(6):727-730.
14. 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.
15. Polak JF, Yucel EK, Bettmann MA, et al.; Expert Panel on Cardiovascular
Imaging. Suspected lower extremity deep vein thrombosis. ACR
Appropriateness Criteria. Reston, VA: American College of Radiology (ACR);
2005.
16. Dunzinger A, Hafner F, Schaffler G, et al. 99mTc-apcitide scintigraphy in
patients with clinically suspected deep venous thrombosis and pulmonary
embolism. Eur J Nucl Med Mol Imaging. 2008;35(11):2082-2087.
17. Qaseem A, Snow V, Barry P, Hornbake ER, Rodnick JE, Tobolic T, Ireland B,
Segal J, Bass E, Weiss KB, Green L, Owens DK, Joint American Academy of
Family Physicians/American College of Physicians. Current diagnosis of
venous thromboembolism in primary care: A clinical practice guideline
from the American Academy of Family Physicians and the American
College of Physicians. Ann Fam Med 2007 Jan-Feb;5(1):57-62.
18. University of Michigan Health System. Venous thromboembolism (VTE).
Guidelines for Clinical Care. Ann Arbor, MI: University of Michigan Health
System; February 2009.
19. Tan M, van Rooden CJ, Westerbeek RE, Huisman MV. Diagnostic
management of clinically suspected acute deep vein thrombosis. Br J
Haematol. 2009;146(4):347-360.
20. Somarouthu B, Abbara S, Kalva SP. Diagnosing deep vein thrombosis.
Postgrad Med. 2010;122(2):66-73.
21. Grant B. Diagnosis of suspected deep venous thrombosis of the lower
extremity. UpToDate [online serial]. Waltham, MA: UpToDate; updated
February 8, 2010.
22. Institute for Clinical Systems Improvement (ICSI). Venous
thromboembolism diagnosis and treatment. Bloomington, MN: Institute
for Clinical Systems Improvement (ICSI); February 2009.
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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan
benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,
general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care
services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in
private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible
for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to
change.
Copyright © 2001-2019 Aetna Inc.
http://www.aetna.com/cpb/medical/data/400_499/0414.html 08/28/2019
AETNA BETTER HEALTH® OF PENNSYLVANIA
Amendment to Aetna Clinical Policy Bulletin Number: 0414 AcuTect
Scintigraphic Imaging for Detection of Lower Limb Deep Vein Thrombosis
There are no amendments for Medicaid.
www.aetnabetterhealth.com/pennsylvania annual 09/01/2019