Latest Review Date: February 2024

Category:  Medical                                                                

POLICY:

Computerized Pulse Waveform Analysis (e.g. CV Profilor®, SphygmoCor®) is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

The CV Profilor®DO-2020 CardioVascular Profiling System and the SphygmoCor® Cardiovascular Management System are examples of non-invasive medical devices that provide an indication of arterial compliance (elasticity indices for both large and small arteries), which can be used to determine if patients have potential underlying vascular disease.  The devices also measure systolic, diastolic and mean arterial pressures and pulse rate, and calculates body surface area, body mass index and pulse pressure.

These devices obtain upper-arm blood pressure values and waveform data by non-invasive methods, via the use of an oscillometric blood pressure module and via the application of specially designed equipment.

The acquisition of calibrated radial artery blood pressure waveform data involves, the coordinated use of a blood pressure cuff placed on the left upper-arm and a piezoelectric-based, direct contact, acoustical transducer placed over the right radial artery adjacent to the styloid process of the radius (by the wrist).  The cuff systolic and diastolic pressures are utilized to calibrate the radial artery waveform data into units of pressure based on the median high and low value contained in a 30-second collection of blood pressure waveform data. 

An embedded computer performs a “pulse contour analysis” of the calibrated, digitized blood pressure waveform data, and generates a report.  The clinical data collected and analyzed are accurate and repeatable, and can be used in determining hemodynamic parameters relating to the structure, function and changes of a patient’s cardiovascular system.  

The report summarizes the pulse contour analysis performed on a 30-second collection of the radial artery blood pressure waveforms.  The results are based on the use of an electrical analog model which represents the vasculature as consisting of a capacitative compliance element (Large Artery Elasticity Index), an oscillatory or reflective compliance element (Small Artery Elasticity Index), an inductance and a resistance, during the diastolic decay portion of the cardiac cycle.

KEY POINTS:

A literature search was performed through February 6, 2024.

Summary

For individuals who receive computerized pulse waveform analysis for arterial elasticity measurement for cardiovascular disease, no studies found in the published literature validate the application of these devices. Relevant outcomes include cardiovascular mortality, coronary events, and surgical or percutaneous cardiac interventions. No evidence was found to show that evaluation of the status of the arterial elasticity is predictive and, thus, that type of evaluation cannot be used to alter the treatment of individuals. The evidence is insufficient to demonstrate that non-invasive measurements of arterial elasticity alters patient management or improves net health outcomes.

Practice Guidelines and Position Statements

American College of Cardiology (ACC)/ American Heart Association (AHA)

In 2010, the ACC/AHA made the following recommendation:

• Measures of arterial stiffness outside of research settings are not recommended for cardiovascular risk assessment in asymptomatic adults. (Level of Evidence: C)

U.S. Preventive Services Task Force

No recommendation found specific to computerized waveform analysis.

KEY WORDS:

Hypertension, Computerized Pulse Waveform Analysis, vascular compliance, CAPWA, blood pressure waveform, arterial elasticity, CVProfilor®, SphygmoCor® , SCOR-Px, MaxPulse

APPROVED BY GOVERNING BODIES:

CVProfilor® DO-2020 CardioVascular Profiling System (Hypertension Diagnostics, Inc.) was FDA approved November 1, 2000 (K001948).

SphygmoCor® Cardiovascular Management System (CvMS) (AtCor Medical Pty. Ltd) was FDA approved August 31, 2007 (K070795).

SphygmoCor® XCEL PWA (AtCor Medical) was FDA approved November 16, 2012.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts:  Special benefit consideration may apply.  Refer to the member’s benefit plan.

CURRENT CODING: 

CPT code:

 REFERENCES:

1. American College of Cardiology Foundation and American Heart Association. 2010 ACCF/AHA Guideline for assessment of cardiovascular risk in asymptomatic adults: Executive Summary.  https://www.ahajournals.org/doi/full/10.1161/CIR.0b013e3182051bab.
2. Benas D, Kornelakis M, Triantafyllidi H, et al. Pulse wave analysis using the Mobil0O-graph, Arteriograph and complior device: a comparative study.  Blood Press. 2019 Apr;28(2):107-113.
3. Borlaug BA, Olson TP, Mohamed SA, et al. A randomized pilot study of aortic waveform guided therapy in chronic heart failure. J Am Heart Assoc. April 2014; 3(2) e000745.
4. Chirinos JA, Kips JG, Jacobs DR, et al. Arterial wave reflections and incident cardiovascular events and heart failure: the multiethnic study of atherosclerosis. JACC. 2012; 60(21):2170-7.
5. Cohn J.N. Vascular wall function as a risk marker for cardiovascular disease, J of Hypertension 1999, S41-S44.
6. CVProfilor®DO-2020. Technical specifications, Hypertension Diagnostics Inc. 2000
7. Esposito C, Machado P, Cohen IS, etc. Comparing central aortic pressure obtained using a sphygmocor device to pressures obtained using a pressure catheter. Am J Hypertens. 2022 Jan25;hpac010. Doi:10.1093/ajh/hpac010.
8. FDA. SphygmoCor XCEL. https://www.accessdata.fda.gov/cdrh_docs/pdf12/K122129.pdf.
9. Hernandez JM, Fernandez GV, Brown J, et al. Validation study to determine the accuracy of central blood pressure measurement using
10. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
11. Kampus P, Serg M, Kals J, et al. Differential effects of nebivolol and metoprolol on central aortic pressure and left ventricular wall thickness. Hypertension. 2011; 57:1122-1128.
12. McVeigh G.E., et al. Age-related abnormalities in arterial compliance identified by pressure pulse contour analysis; aging and arterial compliance, Hypertension 1999; 33:1392-1398
13. McVeigh G.E. Arterial compliance in hypertension and diabetes mellitus, Am J Nephrol 1996; 16:217-272.
14. Prisant L.M., Resnick L.M., Hollenberg S.M., and Jupin D. Arterial elasticity among normotensive subjects and treated and untreated hypertensive subjects. Influence of race, ethnicity and disease. January 2002; 12(1):63-8
15. Prisant L.M., Resnick L.M., and Hollenberg S.M. Arterial elasticity among normotensive subjects and treated and untreated hypertensive subjects. Blood Pressure Monitoring. October 2001; 6(5):233-7.
16. Resnick LM, et al.  Pulse waveform analysis of arterial compliance: relation to other techniques, age, and metabolic variables, AJH 2000, 12:1243-1249.
17. Roman MJ, Devereux RB, Kizer JR, et al. High central pulse pressure is independently associated with adverse cardiovascular outcome: the strong heart study. J Am Coll Cardiol. 2009;54:1730-1734.
18. Sharman JE, Marwick TH, Gilroy D, et al. Randomized trial of guiding hypertension management using central aortic blood pressure compared with best-practice care. Hypertension, August 2015; 62:1138-1145.
19. U. S. Food and Drug Administration. (2000, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K001948. Retrieved June 21, 2011 from //www.accessdata.fda.gov/cdrh_docs/pdf/K001948.pdf.
20. U. S. Food and Drug Administration. (2007, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K070795. Retrieved June 21, 2011 from //www.accessdata.fda.gov/cdrh_docs/pdf7/K070795.pdf
21. U.S. Preventive Services Task Force. Recommendations.  https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results?topic_status=All&searchterm=cardiovascular+risk.
22. Woodman RJ, Kingwell BA, Beilin LJ et al. Assessment of central and peripheral arterial stiffness: studies indicating the need to use a combination of techniques. Am J Hypertens. 2005 Feb;18(2 Pt 1):249-60.
23. Zhu H, Gao Y, Cheng H, et al. Comparison of arterial stiffness indices measured by pulse wave velocity and pulse wave analysis. Blood Press. 2019 Jun;28(3):206-213.

POLICY HISTORY:

Medical Policy Group, September 2001

Medical Review Committee, September 2001

Medical Policy Administration Committee, October 2001

Medical Policy Group, February 2004

Medical Policy Group, February 2006 (1)

Medical Policy Group, February 2007 (1)

Medical Policy Group, February 2008 (1)

Medical Policy Group, February 2009 (1)

Medical Policy Group, February 2010 (1) No changes

Medical Policy Group, December 2010; 2011 Coding update

Medical Policy Group, June 2011, (1) Update to Description, Policy, Key Points, Key Words, Approved by Governing Bodies and References related to addition of SphygmoCor® device; also removed code 93922, as this is not an appropriate code for usage.

Medical Policy Administration Committee, July 2011

Medical Policy Group, September 2012 (3): Active Policy but no longer scheduled for regular literature reviews and updates.

Medical Policy Group, August 2015 (4): Updates to Key Points and References. No change to policy statement. Policy remains active, but not scheduled for regular literature reviews and updates.

Medical Policy Group, November 2015: 2016 Annual Coding Update.  Added new CPT code 93050 to the current coding section. Also added existing CPT code 93922 to policy.  Created Previous coding section and added deleted code 0311T.

Medical Policy Group, May 2016 (4): Updates to Key Points, Key Words, and References. No change to policy statement.

Medical Policy Group, May 2018 (4): Updates to Key Points and References.  No change to policy statement.

Medical Policy Group, February 2021 (4):  Updates to Key Points and References. Removed 0311T (deleted 2016) from previous coding section.

Medical Policy Group, February 2022 (4): Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, February 2023 (4): Reviewed by consensus.  Updates to Approved by Governing Bodies, Benefeit Application and References.  No changes to policy statement.

Medical Policy Group, February 2024 (4): Reviewed by consensus.  Updates to Key Points and References.  No change to policy statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent  therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.