Point Shear Wave Elastography by ElastPQ for Fibrosis Screening in Patients with NAFLD: A Prospective, Multicenter Comparison to Vibration-Controlled Elastography

Abstract

Background Since nonalcoholic fatty liver disease (NAFLD) has become the leading cause of liver disease in the Western world, clinicians need reliable noninvasive tools for the identification of NAFLD-associated fibrosis. Limited evidence on the performance of the novel shear wave elastography technique Elast-PQ (EPQ) in NAFLD is available. Method In this prospective, European multinational study we assessed the diagnostic accuracy of EPQ using vibration-controlled transient elastography (VCTE) as a reference standard. Results Among 353 NAFLD patients, 332 (94.1%) fulfilled reliability criteria of VCTE and EPQ (defined by IQR/median ≤0.3; 41.3% female, mean age: 59 [IQR: 16.5], mean BMI: 29.0 (7.1)). 4/353 (1.1%) and 17/353 (4.8%) had unreliable VCTE and EPQ measurements, respectively. VCTE-based NAFLD fibrosis stages were F0/F1: 222(66.9%), F2: 41 (12.3%), F3: 30 (9.1%), F4: 39 (11.7%). We found a strong correlation (Pearson R=0.87; p<0.0001) and concordance (Lin’s concordance correlation coefficient =0.792) of EPQ with VCTE. EPQ was able to identify NAFLD-fibrosis risk with the following EPQ cutoffs: ≥6.5 kPa for significant fibrosis (≥F2) (≥1.47 m/s; sensitivity: 78%; specificity: 95%; AUROC: 0.94), ≥6.9 kPa for advanced fibrosis (≥F3) (≥1.52 m/s; sens.: 88%, spec.: 89%; AUROC: 0.949), and ≥10.4 kPa for cirrhosis (F4) (≥1.86 m/s; sens.: 87%; spec.: 94%; AUROC: 0.949). Conclusion The point shear wave elastography technique EPQ shows excellent correlation to and concordance with VCTE. EPQ can reliably exclude NAFLD fibrosis <6.0 kPa (<1.41 m/s) and indicate a high risk of advanced fibrosis ≥10.4 kPa (≥1.86 m/s).

Zusammenfassung

Hintergrund Die nichtalkoholische Fettleber (NAFLD) ist mittlerweile die häufigste Lebererkrankung in der westlichen Welt. Daher besteht ein Bedarf an nichtinvasiven Methoden zur Einschätzung des Fibrose-Risikos bei NAFLD. Über die Aussagekraft der neue Scherwellen-Technologie Elast-PQ (EPQ) liegen nur wenige Daten vor. Methoden Diese prospektive, europäische multinationale Studie untersuchte die diagnostische Genauigkeit von EPQ bei NAFLD-PatientInnen im Vergleich zur Vibrations-kontrollierten transienten Elastografie (VCTE). Resultate Von 353 NAFLD-Patient*innen erfüllten 332 (94,1%) die Zuverlässigkeitskriterien für VCTE und EPQ (definiert als IQR/median ≤0,3). Die Studienpopulation war zu 41,3% weiblich, mit einem medianen Alter von 59 [IQR: 16,5] Jahren und einem medianen BMI von 29 [IQR: 7] kg/m². Es bestand eine starke Korrelation (Pearson R=0,87; p<0.0001) und Konkordanz (Lin-Konkordanz-Korrelationskoeffizient=0,792) von EPQ mit VCTE. EPQ konnte das NAFLD-Fibrose-Risiko anhand folgender Grenzwerte abschätzen: Signifikante Fibrose (≥F2) ab ≥6,5 kPa (≥1,47 m/s; Sensitivität: 80%; Spezifität: 95%; AUROC: 0,940), fortgeschrittene Fibrose (≥F3) ab ≥6,9 kPa (≥1,52 m/s; Sensitivität: 88%, Spezifität: 89%; AUROC: 0,949), und Zirrhose (F4) ab ≥10,4 kPa (≥1,86 m/s; Sensitivität: 87%; Spezifität: 94%; AUROC: 0,949). Schlussfolgerungen Die Punkt-Scherwellen-Elastografie-Methode EPQ zeigt eine exzellente Korrektion und Konkordanz mit der VCTE. Bei NAFLD-Patient*innen wird durch EPQ <6,0 kPa (<1,41 m/s) eine signifikante Fibrose ausgeschlossen und durch EPQ ≥10,4 kPa (≥1,86 m/s) ein hohes Risiko für eine fortgeschrittene Fibrose angezeigt.

Keywords

Abdomen - Gastrointestinal Tract - Point of care - Physics and Technology

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