Comments

Jaime BOSCH | 02/21/2025

I am excited to see OPTN considering these guidelines. I am strongly supportive of its efforts to align with the American College of Radiology’s CEUS LI-RADS. This represents a relevant step forward for the clinical adoption of liver imaging contarst ultrasound based liver imaging in the United States and recognizes the numerous benefits of CEUS for HCC patients. It is also important for the international community as in many countries we are following the OPTN recommendations and were missing a positive consideration of CEUS, which is a very very useful diagnostic tool.

Jesse Civan | 02/21/2025

As a transplant hepatologist, I enthusiastically support the addition of LI-RADS 5 findings on contrast-enhanced ultrasound as an alternative to LI-RADS 5 findings on MRI and CT to establish a definite radiographic HCC diagnosis for the purpose of HCC MELD exception. I believe this will benefit patient care.

I speak for myself as an individual physician, and do not claim to represent my transplant program or home institution.

International Contrast Ultrasound Society | 02/20/2025

The Board of Directors of the International Contrast Ultrasound Society (ICUS) respectfully submits this letter in response to the OPTN Public Comment Proposal entitled “Updates to National Liver Review Board Guidance (NLRB) & Further Alignment with Liver Imaging Reporting and Data System (LI-RADS®).”

After giving considerable attention to the Proposal, we wish to strongly support the proposed modifications to the Hepatocellular Carcinoma (HCC) policy and guidance, particularly the inclusion of contrast-enhanced ultrasound (CEUS) as an acceptable option for providing a pathway to automatic standard HCC exception approval in Policy 9.5.I, and the alignment of imaging classification criteria to the LI-RADS® terminology.

Background

The International Contrast Ultrasound Society (ICUS) is a non-profit global medical society focused on the safe and appropriate utilization of CEUS where medically indicated, in order to improve patient care and outcomes. Our members bridge the fields of radiology, oncology, hepatology, vascular imaging, cardiology, gastro-intestinal imaging, and other medical subspecialties. Since 2017, ICUS has offered a broad array of CEUS educational programs, including CME-accredited webinars offered live and on demand. Interest in these programs is steadily growing across clinical settings, and hundreds of thousands of learners from the USA, Europe and China have now participated. This growing participation is consistent with indications from our sources that CEUS utilization is likewise expanding across diverse medical settings, including small private clinics as well as advanced academic centers.


Benefits of CEUS in HCC Diagnosis

CEUS offers numerous clinical advantages that make it a valuable imaging modality in the diagnosis and management of HCC:

• Real-Time Dynamic Imaging: CEUS enables dynamic assessment of hepatic lesions in real time. Its ability to capture arterial phase hyperenhancement and subsequent washout patterns is critical for accurate lesion characterization, aligning seamlessly with LI-RADS® criteria.

• Safety Profile: Compared to contrast agents used in computed tomography (CT) and magnetic resonance imaging (MRI), ultrasound contrast agents have a more favorable safety profile, particularly for patients with renal insufficiency or contraindications to iodinated or gadolinium-based contrast agents.

• Cost-Effectiveness and Accessibility: CEUS is widely available, cost-effective, and can often be performed at the bedside. These features facilitate rapid diagnosis, reducing diagnostic delays and expediting the pathway to treatment.

• Enhanced Diagnostic Accuracy: Fully integrated with LI-RADS® terminology, diagnostic and management recommendations, CEUS has demonstrated high sensitivity and specificity for HCC diagnosis.

Support for Policy 9.5.I Modification

ICUS commends the proposal’s provision to include CEUS as an alternative imaging option to provide a pathway to automatic standard HCC exception approval in Policy 9.5.I. We believe that this policy modification is a critical step toward modernizing the diagnostic framework for HCC. By incorporating CEUS, the policy will:

• Improve Patient Access to Timely Diagnosis: The rapid and non-invasive nature of CEUS facilitates early and accurate diagnosis, ensuring that patients receive prompt evaluation and appropriate management.

• Promote Uniformity in Imaging Assessment: Aligning CEUS findings with LI-RADS® categorization will foster uniformity in imaging interpretation across centers, enhancing interobserver reliability and supporting evidence-based decision-making.

• Enhance Clinical Workflow: With its ease of use and immediate availability, CEUS can serve as an effective adjunct, streamlining clinical workflows and reducing the time to treatment initiation for patients eligible for standard HCC exception approval.

Conclusion

The International Contrast Ultrasound Society firmly supports the inclusion of contrast-enhanced ultrasound (CEUS) as an acceptable adjunct diagnostic tool in the updated UNOS/OPTN policy framework for HCC diagnosis. We are confident that the proposed modifications, particularly the pathway to automatic standard HCC exception approval via Policy 9.5.I, will lead to improved diagnostic accuracy, better patient outcomes, and a more efficient evaluation process. We appreciate the Committee’s commitment to integrating innovative imaging modalities and evidence-based practices into the liver transplant policy landscape.

Thank you for considering our perspective. We stand ready to provide additional information or participate in further discussions to support these important policy changes.

Sincerely yours,

The International Contrast Ultrasound Society Board of Directors

Steven B. Feinstein, MD, FACC, FESC;
Stephanie Wilson, MD, FRCPC;
Petros Nihoyannopoulos, MD, FRCP, FESC, FACC, FAHA;
Michael Main, MD; J.
J. Brian Fowlkes, PhD, FAIUM, FAIMBE, FAAPM, FASA, FIEEE;
Richard G. Barr, MD, PhD, FACR, FSRU, FAIUM;
Jordan Strom, MD, MSc, FACC, FASE;
Andrew Appis, MD;
Maria Cristina Chammas, MD, PhD;
Dirk-André Clevert, MD;
Kassa Darge, MD, PhD, DTM&P, FAIUM, FSAR;
Pintong Huang, MD, PhD;
Orpheus Kolokythas, MD, FSAR;
Yuko Kono, MD, PhD, FAIUM, FAASLD;
Andrej Lyshchik MD,PhD, DSc, FAIM, FSRU;
Wilson Mathias, Jr., MD, FACC;
Christina Merrill, BSc, CRGS, CRVS, RDMS, RVT;
Sharon L. Mulvagh, MD FRCP(C), FACC, FASE, FAHA;
Fabio Piscaglia, MD, PhD;
Arnaldo Rabischoffsky, MD;
Roxy Senior, MD, DM, FRCP, FESC, FACC;
Maria Stanczak, MS, RDMS, RVT, R.T(R)(M);
Joan Olson, B.S., ACS, RDCS, RVT, FASE;
Jessica Stout, RDCS, FASE;
Viktor Zhelov, MD (Honorary);
Barry Goldberg, MD (Emeritus);
Beverly Gorman, RDCS (Emeritus);
Edward G. Grant MD, FACR (Emeritus);
Paul A. Grayburn, MD, FACC (Emeritus);
Tom Porter, MD (Emeritus)

View attachment from International Contrast Ultrasound Society

John Eisenbrey | 02/18/2025

I am very excited to see OPTN considering these guidelines and supportive of its efforts to align with the American College of Radiology’s CEUS LI-RADS. This is an important step for clinical adoption and recognizes the numerous benefits to HCC patients that has been well documented for decades. I would also encourage the committee to look into incorporation of the ACR’s CEUS LI-RADS Treatment Response Algorithm in the future.

Flemming Forsberg | 02/18/2025

See attachment

View attachment from Flemming Forsberg

Scott Matherly | 01/21/2025

Overall, I am pleased with the changes suggested. While recently serving on the NLRB, it was mentioned that there would be a potential path to meld exception for intrahepatic cholangiocarcinoma but I do not see that included. Will this be looked at in the future?