Alternatives to FibroScan®: Ultrasound-Based Elastography (pSWE & 2D-SWE)

1. Introduction

Transient elastography (TE), commercialized as FibroScan®, is the most widely used non-invasive tool for assessing liver stiffness and quantifying steatosis through Controlled Attenuation Parameter (CAP). However, TE is only one member of a larger family of elastographic techniques. Modern ultrasound manufacturers have developed their own shear-wave elastography (SWE) technologies—point Shear Wave Elastography (pSWE) and two-dimensional Shear Wave Elastography (2D-SWE)—that can rival or even surpass TE in specific clinical scenarios.

The development of these alternative techniques addresses several practical limitations of FibroScan®. While VCTE has been validated in over 5,000 peer-reviewed publications (Echosens, 2022), it provides no B-mode imaging, cannot visualize focal lesions, and may have reduced reliability in obese patients even with the XL probe. In contrast, pSWE and 2D-SWE are integrated into conventional ultrasound machines, allowing clinicians to perform elastography during routine abdominal examinations with the advantage of real-time anatomical guidance.

Current clinical practice guidelines from EASL (2021), AASLD (2023), and the SRU Consensus (Barr et al., 2015; Barr et al., 2020) recognize pSWE and 2D-SWE as validated techniques for liver fibrosis assessment. Both are acceptable alternatives to TE, with expanding evidence supporting their use in obesity, narrow intercostal windows, and in settings where B-mode guidance improves reliability.

Understanding when to choose each modality—and critically, understanding that their results are not interchangeable—is essential for accurate clinical interpretation.

2. Overview of Elastography Modalities

All elastography techniques share a fundamental principle: they measure how shear waves propagate through liver tissue. Stiffer tissues (those with more fibrosis) cause shear waves to travel faster than softer, healthier tissues. This velocity is then converted to a stiffness value expressed in kilopascals (kPa) or meters per second (m/s) (Bamber et al., 2013).

Think of it like dropping a pebble into two different pools—one filled with jelly and one with water. In jelly (which is stiffer), the ripples move faster and differently than in water. By measuring how quickly these “ripples” travel through your liver, doctors can estimate how much scarring exists without ever making an incision.

2.1 Vibration Controlled Transient Elastography (VCTE / FibroScan®)

VCTE was the first elastography technique developed specifically for liver stiffness assessment. Introduced in 2003, it employs a mechanical vibrator to generate low-frequency shear waves (50 Hz) that propagate through the liver. An ultrasound transducer then tracks the shear wave and calculates its velocity (Sandrin et al., 2003).

Key characteristics:

Uses an external actuator to generate a mechanical vibration
Measures shear-wave speed (1D) in a fixed cylindrical volume (1 cm × 4 cm)
No real-time B-mode imaging—functions as a dedicated stiffness measurement device
Includes CAP for simultaneous steatosis quantification
Large global evidence base (Castera et al., 2005; Tapper & Lok, 2017)

2.2 Acoustic Radiation Force Impulse Imaging (ARFI) / pSWE

Point shear wave elastography (pSWE), also known as Acoustic Radiation Force Impulse (ARFI) quantification, represents a different approach. Rather than using an external mechanical vibrator, pSWE uses focused acoustic radiation force—essentially a “push pulse” from the ultrasound transducer itself—to generate shear waves at a specific location within the liver (Nightingale et al., 2002).

Key characteristics:

A short, focused acoustic “push pulse” induces shear waves
Measurement occurs at a single point within a small region of interest
Integrated into conventional ultrasound machines with B-mode imaging
Present in Siemens, Samsung, Canon, Hitachi platforms
First validated in early ARFI studies (Friedrich-Rust et al., 2009; Nightingale et al., 2002)

2.3 Two-Dimensional Shear-Wave Elastography (2D-SWE)

2D-SWE represents an evolution of pSWE technology, creating shear waves across a larger field of view rather than at a single point. This technique uses supersonic shear imaging, generating shear waves from multiple focal points in rapid succession to produce a real-time, color-coded elasticity map (Herrmann et al., 2018).

Key characteristics:

Rapid focused push pulses create shear-wave cones across a field of view
Offers a color elastography map with adjustable region of interest (ROI)
Provides visual confirmation of measurement quality through “quality boxes”
Commercialized first by Supersonic Imagine (Aixplorer)
Also available on GE Healthcare, Canon Medical, Philips, and other platforms
Highly reproducible (Ferraioli et al., 2018; Dietrich et al., 2017)

3. Technical Principles

All elastographic systems measure shear-wave speed, which correlates with stiffness via Young’s modulus:

E = 3ρc²

where c is shear-wave speed and ρ is liver density (assumed constant at approximately 1000 kg/m³).

In healthy liver tissue, the shear wave velocity is relatively low (approximately 1.0–1.5 m/s, corresponding to 3–7 kPa), reflecting the soft, compliant nature of normal hepatic parenchyma. As fibrosis develops, collagen deposition increases tissue stiffness, accelerating shear wave propagation. Advanced cirrhosis may demonstrate stiffness values exceeding 20–25 kPa (Barr et al., 2020).

How Each Technique Generates Shear Waves

FibroScan (VCTE): A 50 Hz mechanical vibration from an external actuator generates a shear wave, which is tracked using M-mode ultrasound.
pSWE (ARFI): A focused acoustic pulse creates localized tissue displacement at a specific point. Tracking beams measure the resulting shear wave speed at that location.
2D-SWE: Multiple rapid ARFI pushes create a propagation map across a larger region, producing a real-time 2D elastogram that can be overlaid on B-mode imaging.

Because 2D-SWE samples a larger region, it is theoretically less susceptible to regional heterogeneity within the liver. However, this advantage must be weighed against other factors including operator experience and device-specific validation (Bamber et al., 2013; Ferraioli et al., 2015).

4. Diagnostic Performance: FibroScan vs pSWE vs 2D-SWE

4.1 Meta-analytic Performance

Studies consistently show comparable AUROC (Area Under the Receiver Operating Characteristic curve) values across elastography modalities. The following data are compiled from multiple meta-analyses:

Modality	F≥2 AUROC	F≥3 AUROC	F=4 AUROC	Key Literature
FibroScan (VCTE)	0.80–0.88	0.86–0.92	0.90–0.95	Castera 2005; Friedrich-Rust 2008; EASL 2021
pSWE (ARFI)	0.82–0.88	0.86–0.91	0.90–0.93	Friedrich-Rust 2009; Bota 2013 meta-analysis
2D-SWE	0.85–0.91	0.89–0.93	0.92–0.96	Ferraioli 2015; Dietrich 2017; Barr 2020

The systematic review by Selvaraj et al. (2021), which compared multiple modalities specifically in NAFLD patients, found summary AUROCs of 0.83 (VCTE), 0.86 (pSWE), and 0.75–0.88 (2D-SWE) for significant fibrosis (F≥2). All techniques performed well for cirrhosis detection, with AUROCs exceeding 0.88.

A key finding across etiologies (MASLD, viral hepatitis, mixed cohorts) is that 2D-SWE frequently demonstrates the highest technical success rate and lowest variability, especially in obesity. The meta-analysis by Bota et al. (2013) found that ARFI had a failure rate of only 2.1% compared to 6.6% for VCTE, though both achieved similar diagnostic performance for significant fibrosis and cirrhosis.

4.2 MASLD-Specific Evidence

SWE validation in MASLD is robust and continues to grow:

Imajo et al. (2016) directly compared MRE, VCTE, and 2D-SWE in 231 NAFLD patients. While MRE demonstrated the highest diagnostic accuracy for stage 4 fibrosis, 2D-SWE showed accuracy comparable to VCTE for ≥F2 fibrosis, with excellent performance across all modalities.
Yoneda et al. (2010) demonstrated that ARFI correlates strongly with biopsy-proven fibrosis in NAFLD patients, establishing early validation for pSWE in this population.
Wong et al. (2018) reviewed noninvasive biomarkers in NAFLD/NASH, confirming the validity of SWE techniques with high reproducibility in large MASLD cohorts.

The 2020 SRU consensus (Barr et al., 2020) proposed a simplified “rule of four” for ARFI-based techniques to standardize interpretation across vendors:

<5 kPa (1.3 m/s): Normal stiffness
<9 kPa (1.7 m/s): Excludes cACLD in absence of other clinical signs
9–13 kPa (1.7–2.1 m/s): Suggestive of cACLD; additional testing may be needed
>13 kPa (2.1 m/s): Highly suggestive of cACLD

5. Advantages and Limitations

5.1 Advantages of pSWE

Better technical success rates in obesity compared to FibroScan M-probe. The meta-analysis by Bota et al. (2013) reported ARFI failure rates of only 2.1% versus 6.6% for TE.
B-mode guidance allows operators to visualize the liver and avoid vessels, ribs, and other structures that could affect measurements.
Integration with conventional ultrasound means one exam can serve multiple purposes—elastography can be performed during routine abdominal imaging without requiring a separate device.
Lower capital cost if an elastography-capable ultrasound machine is already available in the facility.

5.2 Limitations of pSWE

Single measurement point means greater sampling variability. The liver may have heterogeneous stiffness, and a single-point measurement may not capture this variability as well as 2D-SWE.
Greater operator dependence than VCTE. Proper positioning and selection of the measurement site require more skill (Dietrich et al., 2017).
No steatosis metric equivalent to CAP. Unlike FibroScan, pSWE does not provide integrated steatosis quantification, though some newer systems offer attenuation imaging.

5.3 Advantages of 2D-SWE

Large ROI and real-time elastography map allow visualization of stiffness across a region, enabling the operator to select optimal measurement areas and avoid zones with poor wave propagation.
Excellent performance in BMI >30 patients. The larger sampling region and visual quality indicators help ensure reliable measurements in challenging body habitus (Ferraioli et al., 2018).
Lower interobserver variability than pSWE and VCTE in many studies, attributed to the visual feedback that allows operators to confirm measurement quality before recording results.
“Quality boxes” displayed on-screen help operators identify and avoid areas of poor shear wave propagation, improving measurement reliability.

5.4 Limitations of 2D-SWE

Cut-offs cannot be interchanged across vendors—this is critically important and often underappreciated. Stiffness values from different 2D-SWE manufacturers (and even different software versions from the same manufacturer) are not directly comparable.
Requires higher operator skill than FibroScan. The flexibility of 2D-SWE means operators must make more decisions about ROI placement and quality assessment.
More expensive equipment than basic pSWE. The most advanced 2D-SWE platforms represent significant capital investment.

5.5 FibroScan Advantages

Best standardization and reproducibility. FibroScan serves as the reference device in most major international guidelines, including those from EASL, AASLD, and Baveno VII (de Franchis et al., 2022).
Extensive validation across diseases. With over 5,000 peer-reviewed publications, FibroScan has the largest evidence base of any elastography technique.
Simple, fast learning curve. The standardized measurement protocol minimizes operator-dependent variability.
Integrated CAP/CAP-c for steatosis quantification, providing a comprehensive liver assessment (fibrosis and fat) in a single examination.
Point-of-care deployment. The portability of newer models enables screening in community settings, primary care offices, and mobile health units.

5.6 FibroScan Limitations

Limited performance in obesity unless the XL probe is used. Even with the XL probe, technical failure rates increase in morbidly obese patients (BMI >40 kg/m²).
Cannot measure through ascites. The presence of ascites prevents shear wave propagation to the liver, rendering VCTE technically impossible.
No B-mode guidance. Operators cannot visualize vessels, ribs, or focal lesions, potentially leading to suboptimal probe positioning.
Dedicated device cost. FibroScan represents a significant capital investment ($50,000–100,000+ depending on model), and CAP measurement is proprietary to the Echosens platform.

6. Manufacturer-Specific Overview

Several major ultrasound manufacturers have integrated shear wave elastography capabilities into their diagnostic imaging platforms. Each offers distinct features and varying levels of clinical validation.

6.1 Supersonic Imagine (Aixplorer)

Pioneers of 2D-SWE technology
Uses ultrafast imaging (>20,000 frames/s) for real-time elastography mapping
Excellent MASLD validation (Ferraioli et al., 2018)
Strong body of published literature supporting clinical use

6.2 GE Healthcare (LOGIQ E9/E10, Voluson series)

Robust 2D-SWE with high penetration capabilities
Real-time color elasticity mapping with confidence index
Widely adopted in radiology departments globally
Included in multi-vendor comparison studies demonstrating comparable performance (Potthoff et al., 2018)

6.3 Canon Medical / Toshiba (Aplio Series)

Reliable ARFI and SWE capabilities on i-series and a-series platforms
Reliability Measurement Index (RMI) for quality assurance
Good performance in obesity
Measurement depth-dependent accuracy demonstrated in multi-vendor studies (Potthoff et al., 2018)
Used extensively in Asia

6.4 Philips Healthcare (EPIQ, Affiniti series)

ElastPQ (point shear wave quantification) and ElastQ Imaging (2D-SWE)
Propagation map for visual assessment of measurement quality
Strong 2D-SWE implementation with high reproducibility (Barr et al., 2020)
Prospective validation showing diagnostic performance comparable to VCTE (Atzori et al., 2023)

6.5 Samsung Medison (RS85, HS70A, RS80A)

S-Shearwave Elastography (S-SWE) using pSWE technology
Multicenter prospective validation: AUROC 0.842 (F≥2), 0.844 (F≥3), 0.850 (F4) (Kim et al., 2019)
Reliability Measurement Index (RMI ≥0.4 indicates acceptable quality)
Proposed cut-offs: >7.0 kPa for F≥3 and >9.7 kPa for F4

6.6 Mindray (Resona series, DC-80)

Sound Touch Elastography (2D-SWE)
Rapidly growing platform
Good accuracy in independent validations
Cost-effective option for emerging markets

6.7 Siemens Healthineers (Acuson Sequoia, S3000 series)

Among earliest ARFI adopters with Virtual Touch Quantification (VTQ) and Virtual Touch Imaging Quantification (VTIQ)
The Acuson S3000 served as the reference scanner in multi-vendor comparison studies (Potthoff et al., 2018)
Deep abdominal transducer (DAX) enables assessment in obese patients with reduced failure rates
VTQ demonstrates AUROC values of 0.84–0.91 for advanced fibrosis staging

6.8 Fujifilm/Hitachi (Arietta series)

ARFI pioneers with consistent pSWE accuracy
Variable elastography capabilities by model
Limited liver-specific validation studies compared to larger manufacturers

7. Practical Cut-offs and the Non-Interchangeability Problem

7.1 The Non-Interchangeability Problem

This is perhaps the most critical concept for clinicians to understand: cut-offs cannot be transferred from one machine to another, and even software upgrades can change thresholds.

EFSUMB (Dietrich et al., 2017), SRU Consensus (Barr et al., 2015), and WFUMB (Ferraioli et al., 2015) all emphasize this point clearly:

“Cut-offs derived from one elastography system should not be applied to measurements obtained with a different system.”

Each elastography technique uses different shear wave frequencies, measurement algorithms, and processing methods. The result is that identical liver tissue will produce different stiffness values on different machines. This is why FibroScan cut-offs (e.g., ≥8 kPa for ≥F2; ≥12 kPa for F4) must not be used for SWE interpretation without device-specific validation.

The multi-vendor comparison study by Potthoff et al. (2018) demonstrated significant inter-device variability when measuring the same healthy volunteers, confirming the need for vendor-specific interpretation guidelines.

7.2 Typical Example Ranges (Device-Specific)

The following are example ranges from published manufacturer-validated studies. These must be validated for each vendor and software version and should not be applied universally:

pSWE (ARFI) — expressed in m/s:

F≥2: ~1.55–1.65 m/s
F≥3: ~1.75–1.85 m/s
F=4: ≥1.90–2.00 m/s

(Friedrich-Rust et al., 2009; Bota et al., 2013)

2D-SWE — expressed in kPa:

F≥2: ~7.0–8.0 kPa
F≥3: ~9.0–10.5 kPa
F=4: ≥12–14 kPa

(Ferraioli et al., 2018; Imajo et al., 2016)

SRU “Rule of Four” for ARFI techniques (vendor-neutral guidance):

<5 kPa (1.3 m/s): Normal stiffness
<9 kPa (1.7 m/s): Excludes cACLD
9–13 kPa (1.7–2.1 m/s): Suggestive of cACLD; additional testing may be needed
>13 kPa (2.1 m/s): Highly suggestive of cACLD

(Barr et al., 2020)

7.3 Clinical Implications

When interpreting SWE results, clinicians should:

Know which device and software version was used
Apply only cut-offs validated for that specific platform
Not compare absolute values between different manufacturers
Consider trends over time on the same device rather than single measurements
Use quality indicators (IQR/median, success rate, reliability indices) to confirm measurement validity

8. Clinical Decision Guide: When to Choose Which Modality

The optimal elastography modality depends on clinical context, patient characteristics, and available resources.

8.1 When to Choose FibroScan (VCTE)

FibroScan remains the preferred choice for:

Large-scale MASLD screening programs where standardization is essential
Community practice and primary care settings
When integrated steatosis measurement (CAP) is needed for comprehensive MASLD assessment
Serial monitoring where directly comparable values over time are required
Clinical scenarios aligned with Baveno VII criteria, which use VCTE-specific cut-offs for portal hypertension assessment

8.2 When to Choose 2D-SWE

Consider 2D-SWE for:

Obese patients (BMI >30–35) who may have unreliable VCTE results despite XL probe
When B-mode visualization of liver parenchyma is needed to confirm tissue quality and avoid focal lesions
Complex anatomy or narrow intercostal windows where visual guidance improves probe positioning
Part of a comprehensive abdominal ultrasound examination where elastography is one component of the assessment
Patients with suspected regional heterogeneity where sampling a larger area may be advantageous

8.3 When to Choose pSWE

pSWE is appropriate for:

Resource-limited settings with ARFI-enabled ultrasound but no dedicated FibroScan device
When elastography needs to be integrated into routine ultrasound workflow without additional equipment
Quick, single-point confirmation of liver stiffness during diagnostic ultrasound
Focal lesion characterization contexts where point measurements around lesions are needed

8.4 When to Consider MRE

Although covered in detail in Part 2 of this series, MRE should be considered for:

Obese patients with unreliable ultrasound-based measurements
Discordant results between other modalities
Clinical trial endpoints requiring the highest accuracy
Whole-liver assessment when regional heterogeneity is a concern

9. Limitations Common to All Elastography Methods

Regardless of which elastography technique is used, several factors can affect accuracy and reliability:

9.1 Pre-Examination Requirements

Fasting state required: Patients should fast for ≥2–3 hours before examination. Post-prandial portal hyperemia can increase LSM by 10–20% (de Franchis et al., 2022).

9.2 Factors Causing Falsely Elevated Liver Stiffness

Factor	Effect on LSM	Clinical Action
Acute hepatitis (ALT >5× ULN)	Falsely elevated	Defer LSM until ALT normalizes
Extrahepatic cholestasis	Falsely elevated	Exclude/treat obstruction first
Congestive heart failure	Falsely elevated	Optimize cardiac status
Recent meal (<2–3 hours)	Mildly elevated	Ensure adequate fasting
Severe steatosis	Mild independent effect	CAP helps contextualize

(Dietrich et al., 2017; de Franchis et al., 2022)

9.3 Technical Limitations

Operator skill affects reliability across all techniques, though to varying degrees
Ascites prevents measurement with any ultrasound-based elastography technique
Inter-device variability means results from different manufacturers are not interchangeable
Cannot distinguish fibrosis from inflammation—both increase tissue stiffness
Acute inflammation can confound values, potentially leading to overestimation of fibrosis stage

9.4 Quality Criteria

For VCTE:

≥10 valid measurements
Success rate ≥60%
IQR/Median ratio <30% when median LSM >7.1 kPa

For pSWE/2D-SWE:

Manufacturer-specific reliability indices (e.g., Samsung RMI ≥0.4)
Adequate shear wave propagation on quality maps
Absence of artifacts in the measurement region

10. FibroScan vs. “Liver Elastography”—Clarifying Terminology

A common source of confusion among clinicians and patients is the interchangeable use of “FibroScan” and “liver elastography.” This conflation mirrors the historical use of “Xerox” as a generic term for photocopying—a brand name becoming synonymous with an entire category.

“FibroScan” is: - A brand name owned by Echosens (Paris, France) - A specific device using VCTE technology - One method among several for measuring liver stiffness

“Liver elastography” encompasses: - VCTE (including FibroScan) - pSWE (ARFI-based point shear wave elastography) - 2D-SWE (two-dimensional shear wave elastography) - MRE (magnetic resonance elastography)

This distinction matters clinically because liver stiffness values from different elastography methods are not directly interchangeable. When interpreting or reporting results, always specify which technique and device was used.

11. Summary

Ultrasound-based shear-wave elastography (pSWE and 2D-SWE) represents a mature, validated alternative to FibroScan® for non-invasive liver fibrosis assessment in MASLD and other chronic liver diseases. Each modality has distinct strengths:

FibroScan (VCTE) remains the most standardized and widely validated tool, with extensive guideline integration and integrated CAP for steatosis assessment. It is the reference device for Baveno VII and EASL criteria.
pSWE offers reliable point measurements integrated within conventional ultrasound, with lower failure rates than VCTE in some studies and the advantage of B-mode guidance.
2D-SWE provides superior visualization through real-time elastography mapping, often demonstrating better performance in obesity and lower interobserver variability due to visual quality feedback.

For clinicians managing MASLD/MASH, understanding the strengths and limitations of each modality—along with their non-interchangeable cut-offs—is critical for correct interpretation and clinical decision-making. The choice of technique should be guided by patient characteristics (particularly BMI), clinical setting, available equipment, and the specific clinical question being addressed.

When quality criteria are met, all three ultrasound-based elastography techniques achieve excellent diagnostic performance for ruling out and ruling in advanced fibrosis (F≥3) and cirrhosis, with AUROC values generally exceeding 0.85–0.90. This enables clinicians to accurately stratify patients, guide management decisions, and monitor disease progression without the need for repeated liver biopsies.

12. References

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