Coverage Guideline

This document addresses non-invasive measurement of left ventricular end diastolic pressure in the outpatient setting. Left ventricular end diastolic pressure (LVEDP) is elevated in the setting of congestive heart failure, and its measurement may be useful in the management of individuals with heart failure. The Vivio^® and VeriCor^® devices are examples of devices for the non-invasive measurement of LVEDP.

Note: for a high-level overview of this document, please see “Summary for Members and Families” below.

Investigational and Not Medically Necessary:

Non-invasive measurement of left ventricular end diastolic pressure in the outpatient setting is considered investigational and not medically necessary.

This document describes clinical studies and expert recommendations, and explains whether non-invasive measurement of left ventricular end diastolic pressure in the outpatient setting is appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Some devices can estimate blood pressure in the heart without inserting anything into the body. These are called non-invasive devices. The measurement of blood pressure in one part of the heart, the left ventricular, when it is in its resting phase is called end-diastolic pressure (LVEDP). LVEDP is often high in people with heart failure, so measuring it could help doctors manage this condition. Examples of these devices are the Vivio and VeriCor systems. These devices use things like blood pressure cuffs, heart monitors, and computer software to estimate if pressure is high or low. They are used in doctors' offices and don’t require a hospital stay. Some studies have tested these devices, but experts say more research is needed before they can be used to guide care.

What the Studies Show

Some research shows that non-invasive LVEDP devices can tell if heart pressure is high or not, but accuracy may be lower in people who are more likely to have heart problems. For example, one study found good results in healthy people, but not as good in people with known heart disease. Another small study showed the Vivio system could tell the difference between normal and abnormal heart pumping in children and young adults. However, this study did not test if the results actually helped with real-world care or decisions. The study was also small and did not include enough people to draw strong conclusions. One early study suggested that using non-invasive pressure monitoring might help reduce hospital stays in people with heart failure, but that study was very small and has not been repeated.

Is this clinically appropriate?

This test is not appropriate because it has not been proven to improve health. While some studies suggest the test may detect high pressure in the heart, the results are not reliable enough in people who are most likely to have heart disease. A study that showed fewer hospital visits used a very small group of people and has not been repeated. Other studies did not show whether using the test helped doctors make better decisions or helped people feel better. Also, real-world studies did not use other tests to confirm if the results were correct.

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Summary

This document reviews whether the available evidence for non-invasive measurement of left ventricular end-diastolic pressure (LVEDP) improves individual outcomes, and real-world implementation data evaluating feasibility in primary care settings. While published studies demonstrate moderate correlation between non-invasive and invasive left ventricular end-diastolic pressure measurements, significant limitations persist including reduced diagnostic accuracy in clinically relevant populations, absence of large, randomized trials demonstrating improved health outcomes, and lack of confirmatory testing in real-world screening programs.

Discussion

Case for Non-Invasive Measurement

Most individuals with suspected heart failure do not require invasive testing for confirmation of diagnosis, but no single noninvasive test is considered the gold standard for diagnosis. LVEDP is elevated in the setting of heart failure, and its measurement has been proposed to be useful in the management of heart failure. However, to date, measurement of LVEDP has required cardiac catheterization, either by direct measurement by placing a catheter in the left ventricle, or indirect measurement by placing a catheter in the pulmonary artery to measure the pulmonary capillary wedge pressure, the latter of which is the current clinical gold standard. Non-invasive measurements of left ventricular end-diastolic pressure have been developed based on the observation that the arterial pressure during the strain phase of the Valsalva maneuver may directly reflect the LVEDP (see the Definitions section for information about Valsalva maneuvers). The ability to perform measurements of LVEDP non-invasively permits the outpatient use of this technology and potentially broadens the selection criteria for LVEDP measurement, to possibly include its role in the ongoing monitoring and management of stable individuals with heart failure. The manufacturer of the VeriCor device suggests that the device may be used to determine the need for hospitalization or to monitor individuals with heart failure to maintain left ventricular end-diastolic pressure within a targeted range to prevent future hospitalizations.

Case for Diagnostic Accuracy

Two devices have received clearance from the United States Food and Drug Administration (FDA) for non-invasive estimation of left ventricular end-diastolic pressure. The VeriCor device received clearance in 2004 for non-invasive estimation of left ventricular end-diastolic pressure, with labeling noting the device was clinically validated in males only (FDA, 2004). Sharma and colleagues performed simultaneous measurements of LVEDP based on three techniques in 49 participants scheduled for elective cardiac catheterization: direct measurement of left ventricular end-diastolic pressure by left cardiac catheterization, indirect measurement using pulmonary capillary wedge pressure, and noninvasive measurement using VeriCor (Sharma, 2002). VeriCor measurements correlated well with direct measures of LVEDP  (R²=0.86) and outperformed the pulmonary capillary wedge pressure, which had a correlation coefficient of 0.81 compared to the gold standard. The Vivio System received clearance from the FDA on October 6, 2023 through the 510(k) approval process (FDA, 2023). A pivotal multicenter validation study enrolled 728 individuals across 8 United States medical centers referred for coronary angiography and left heart catheterization, plus 321 healthy controls assumed to have non-elevated left ventricular end-diastolic pressure (Shavelle, 2026). Using a training dataset of 262 participants and a validation dataset of 155 participants, the device demonstrated sensitivity of 0.80 (95% confidence interval [CI], 0.64-0.91) and specificity of 0.83 (95% CI, 0.75-0.90) in the validation cohort. However, when analysis was restricted to the invasive cohort alone and excluded healthy controls, specificity decreased substantially to 0.66 (95% I, 0.48-0.81). This finding suggests that diagnostic performance may be reduced in clinically relevant populations where elevated LVEDP would actually be suspected, as opposed to healthy individuals with presumed normal pressures. A separate study evaluated the Vivio system in 50 children and young adults using an intrinsic frequency-machine learning approach (Cheng, 2023). Normal versus abnormal left ventricular ejection fraction was identified with 92% accuracy (sensitivity=100%, specificity=89%). Although the device consistently detected abnormal left ventricular ejection fraction values defined as less than 50%, the single cohort design, limited sample size, and absence of clinically meaningful outcomes precluded conclusions about real-world utility.

Case for Clinical Outcomes

Evidence demonstrating that non-invasive left ventricular end-diastolic pressure monitoring improves clinical outcomes remains limited. Sharma conducted a small prospective randomized study examining whether non-invasive LVEDP monitoring would reduce re-hospitalization rates in individuals hospitalized for heart failure (Sharma, 2011). A total of 50 participants admitted for heart failure were randomized to management guided by daily non-invasive estimated left ventricular end-diastolic pressure monitoring to a target of less than 20 mm Hg or management based on clinical assessment alone without knowledge of the estimated LVEDP. Estimated left ventricular end-diastolic pressure was significantly reduced at discharge in the intervention group compared with the control group (mean 19.7 ± 1.3 mm Hg vs. 25.6 ± 1.5 mm Hg, p=0.01). Re-hospitalization rates for heart failure were significantly improved at 1 month (0% vs. 25%, p=0.05), 3 months (0% vs. 32%, p=0.01), 6 months (4% vs. 36%, p=0.01), and 1 year (16% vs. 48%, p=0.03). However, the authors acknowledged that the findings of this small study require validation in larger well-designed trials, and no such replication has been published.

Case for Real-World Implementation

The first real-world implementation study of the Vivio System in primary care evaluated screening feasibility in 2040 outpatients at elevated risk for heart failure but without an established diagnosis (Cantu-Martinez, 2025). Individuals with diabetes mellitus, chronic kidney disease stage 3 or higher, or clinical suspicion for heart failure were screened at three primary care practices. Elevated LVEDP (greater than 18 mmHg) was detected in 785 individuals (38.5%). Among those with elevated LVEDP who completed the Kansas City Cardiomyopathy Questionnaire, 205 (31.4%) were asymptomatic while 173 (26.5%) had scores consistent with New York Heart Association Class II-IV functional limitation. While this study demonstrates feasibility of deploying non-invasive LVEDP screening in primary care, critical limitations include the absence of confirmatory testing such as echocardiography, natriuretic peptides, or catheterization to determine true positive rates. Given the device’s known specificity limitations, an unknown proportion of positive screens may not represent true heart failure.

 Outstanding Evidence Questions

At the present time, there is inadequate data to permit scientific conclusions regarding the clinical utility of non-invasive LVEDP technology. While published studies demonstrate moderate diagnostic accuracy compared to invasive reference standards, specificity appears reduced in clinically relevant populations with cardiovascular comorbidities. The single randomized trial demonstrating reduced re-hospitalization was small and has not been replicated. Real-world implementation studies have not included confirmatory diagnostic testing to establish whether screening identifies true heart failure. To date, there are no large, well-designed, published studies demonstrating that routine measurement of LVEDP in the outpatient setting results in improved management of heart failure, as evidenced by improvement in clinical signs and symptoms or reduced need for hospitalization.

The heart is a muscle that acts as an automatic pump to circulate blood throughout the body. Congestive heart failure (CHF), or the more recently used term, heart failure (HF), is a condition in which the heart's function as a pump is inadequate to meet the body's needs. Approximately 2 out of every 100 people between the ages of 27 and 74 have HF. HF becomes more common with advancing age. A poor blood supply resulting from HF may cause the body's organ systems to fail. When the heart's pumping action is inadequate as a result of HF, the blood "backs up" (becomes congested) in the venous system that leads to the heart. This congestion can lead to fluid accumulation in the lungs and body tissues. HF is a grouping of clinical findings, rather than a specific diagnosis or a single disease, and can be considered a symptom of impairment of the pumping action of the heart that is caused by an underlying disease.

The VeriCor device (CVP Diagnostics, Inc., Boston MA) obtained clearance from the U.S. Food and Drug Administration (FDA) for the non-invasive measurement of LVEDP on June 7, 2004 through the 510(k) approval process. The FDA labeled indication is as follows:

The VeriCor System is indicated for use in estimating (noninvasively) left ventricular end-diastolic (LVEDP) pressure. This estimate, when used along with clinical signs and symptoms and other patient test results (including weights on a daily basis), can aid the clinician in the selection of further diagnostic tests to use in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of intravascular volume are suspected. The device has been clinically validated in males only. Use of the device in females has not been investigated (FDA, 2004).

The device consists of a digital expiratory manometer coupled with a continuous arterial pressure monitor and a medical grade computer. A tonometric sensor is attached to the individual’s wrist with a blood pressure cuff attached to the arm. After an 8-minute tonometric calibration period is completed, the VeriCor system is ready for use. For the test, the individual is prompted to perform a Valsalva maneuver by blowing into the mouthpiece of the digital manometer to produce an expiratory pressure of 20 to 30 mm Hg for a minimum of 8 seconds. The digital signals are collected and stored on a medical grade computer. The arterial pressure signals are then analyzed according to algorithms that were developed to most accurately predict PCWP.

The Vivio LVEDP System (Avicena, LLC, Pasadena, CA) received clearance from the FDA on October 6, 2023 through the 510(k) approval process (K223905). The FDA labeled indication is as follows:

The Vivio® System is indicated to non-invasively estimate whether left ventricular end-diastolic pressure (LVEDP) is above or below 18 mm Hg. This measurement can aid in the diagnosis of heart failure when used by qualified healthcare professionals as an adjunct alongside other clinically relevant information. For use in adults only.

The Vivio device consists of an arm cuff system, an EKG patch, and a software application that runs on a standard computer tablet. To use the system, the blood pressure arm cuff is attached to the individual’s upper arm, and two electrodes connected to the EKG Patch are placed on the left side of the chest. Data is collected non-invasively at both the brachial artery and via the single-lead EKG Patch. The collected data is processed by a proprietary algorithm based on a fixed parameter model. The result indicates whether the individual’s LVEDP is likely above or below 18 mmHg, providing a binary output. This information is intended to be interpreted in conjunction with other diagnostic tests and clinical observations to aid in the diagnosis of heart failure (FDA, 2023).

The American College of Cardiology (ACC)/American Heart Association (AHA) 2001 Guideline for the Evaluation and Management of Heart Failure stated that, “Invasive and noninvasive hemodynamic measurements in the management of heart failure remain uncertain” (Hunt, 2001). The 2005 ACC/AHA Guideline update for the Diagnosis and Management of Chronic Heart Failure in the Adult states that, “There has been no established role for periodic invasive or noninvasive hemodynamic measurements in the management of heart failure” (Hunt, 2005). This position was repeated in the 2009 focused update from the ACC/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults (Hunt, 2009) and in the American College of Cardiology Foundation (ACCF), American Heart Association (AHA) Guidelines for the Diagnosis and Management of Heart Failure in Adults (Jessup, 2009) with no change regarding hemodynamic measurements, and the above statement is considered current. Additional updated guidelines from the ACC/AHA (2022) do not address non-invasive measurements of LVEDP (Heidenreich, 2022).

The following is excerpted from the 2009 updated guidelines regarding the basis for their position:

Most drugs used for the treatment of heart failure (HF) are prescribed on the basis of their ability to improve symptoms or survival rather than their effect on hemodynamic variables. Moreover, the initial and target doses of these drugs are selected on the basis of experience in controlled trials and are not based on the changes they may produce in cardiac output or pulmonary wedge pressure …Nevertheless, invasive hemodynamic measurements may assist in the determination of volume status and in distinguishing HF from other disorders that may cause circulatory instability, such as pulmonary diseases and sepsis. Measurements of cardiac output and pulmonary wedge pressure through a pulmonary artery catheter have also been used in patients with refractory HF to assess pulmonary vascular resistance, a determinant of eligibility for heart transplantation. Cardiac output can also be measured by noninvasive methods (Hunt, 2009; Jessup, 2009).

The Valsalva maneuver may be contraindicated in a variety of cardiovascular conditions, for example, hypertrophic obstructive cardiomyopathy, significant aortic valvular disease and recent myocardial infarction (FDA, 2004).

Congestive heart failure (CHF) also known as heart failure (HF): A condition in which the heart cannot pump enough blood to supply the body's tissues with sufficient nutrients that results in a back-up of blood in the vessels and lungs and causes the build-up of fluid in the tissues.

Left ventricular end diastolic pressure (LVEDP): The pressure at the end of the filling phase of the heartbeat contraction, which is the clinical definition of preload.

Valsalva maneuver: The act of attempting to forcibly exhale while keeping the mouth and nose closed. It is used as a diagnostic tool to evaluate the condition of the heart and is sometimes done as a treatment to correct abnormal heart rhythms or to relieve chest pain.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Cantu-Martinez O, Girard AA, Jin W, et al. Noninvasive screening for elevated left ventricular end-diastolic pressure and health status in outpatients at risk for heart failure. JACC Adv. 2025; 4:102002.
2. Cheng AL, Liu J, Bravo S, et al. Screening left ventricular systolic dysfunction in children using intrinsic frequencies of carotid pressure waveforms measured by a novel smartphone-based device. Physiol Meas. 2023; 44(3):10.1088/1361-6579/acba7b.
3. Felker GM, Cuculich PS, Gheorghiade M. The Valsalva maneuver: a bedside "biomarker" for heart failure. Am J Med. 2006; 119(2):117-122.
4. Lancellotti P, Galderisi M, Edvardsen T, et al. Echo-Doppler estimation of left ventricular filling pressure: results of the multicenter EACVI Euro-Filling study. Eur Heart J Cardiovasc Imaging. 2017; 18(9):961-968.
5. McIntyre KM, Vita JA, Lambrew CT, et al. A noninvasive method of predicting pulmonary-capillary wedge pressure. N Engl J Med. 1992; 327(24):1715-1720.
6. Rinderknecht D, De Balasy JM, Pahlevan NM. A wireless optical handheld device for carotid waveform measurement and its validation in a clinical study. Physiol Meas. 2020; 41(5):055008.
7. Sharma GV, Woods PA, Lambrew CT, et al. Evaluation of a noninvasive system for determining left ventricular filling pressure. Arch. Intern. Med. 2002; 162(18):2084-2088.
8. Sharma GV, Woods PA, Lindsey N, et al. Noninvasive monitoring of left ventricular end-diastolic pressure reduces re-hospitalization rates in patients hospitalized for heart failure: a randomized controlled trial. J Card Fail. 2011; 17(9):718-725.
9. Shavelle D, Rinderknecht D, Jin W, et al. Screening patients for elevated left ventricular end-diastolic pressure using a novel noninvasive brachial cuff-ECG system: a multicenter validation study. J Am Heart Assoc. 2026; 15:e040879.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: a Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022; 79(17): e263-e421.
2. Hunt SA, Abraham WT, Chin MH, et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). Circulation. 2005; 112(12):e154-e235.
3. Jessup M, Abraham WT, Casey DE, et al.; Writing on behalf of the 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult Writing Committee. 2009 Focused update: ACCF/AHA guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2009; 119(14):1977-2016.
4. McMurray JJ, Adamopoulos S, Anker SD, et al.; ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2012; 14(8):803-869.
5. U.S. Food and Drug Administration (FDA) Center for Devices and Radiologic Health. VeriCor^® (CVP Diagnostics, Inc., Boston MA). 510(k) Approval. Summary of Safety and Effectiveness No. K031327. Rockville, MD: FDA. June 7, 2004. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/K031327.pdf. Accessed on January 23, 2026.
6. U.S. FDA Center for Devices and Radiologic Health. Vivio® LVEDP System^® (Avicena, LLC, Pasadena, CA 510(k) Approval. Summary of Safety and Effectiveness No. K223905. Rockville, : FDA. January 11, 2023. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223905.pdf. Accessed on January 23, 2026.

1. American Heart Association: Congestive Heart Failure. Available at: https://www.heart.org/en/health-topics/heart-failure. Accessed on January 23, 2026.

Congestive Heart Failure
Left Ventricular End Diastolic Pressure, Noninvasive Measurement
LVEDP, Noninvasive Measurement
VeriCor, Left Ventricular End Diastolic Pressure
Vivio® LVEDP System

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