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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