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Is Transient Elastography Needed for Noninvasive Assessment of High-Risk Varices? The REAL Experience

Calvaruso, Vincenza MD, PhD1; Cacciola, Irene MD2; Licata, Anna MD3; Madonia, Salvatore MD4; Benigno, Rosa MD5; Petta, Salvatore MD, PhD1; Bronte, Fabrizio MD, PhD1; Conte, Elisabetta MD1; Malizia, Giuseppe MD6; Bertino, Gaetano MD7; Distefano, Marco MD8; Montineri, Arturo MD9; Digiacomo, Antonio MD10; Alaimo, Giuseppe MD11; Cacopardo, Bruno MD12; Davì, Antonio MD13; Guarneri, Luigi MD14; Scalisi, Ignazio MD15; Colletti, Pietro MD16; Cartabellotta, Fabio MD17; Portelli, Vincenzo MD18; Prestileo, Tullio MD19; Averna, Alfonso MD20; Iacobello, Carmelo MD21; Mondello, Lorenzo MD22; Scifo, Gaetano MD8; Russello, Maurizio MD5; Squadrito, Giovanni MD2; Raimondo, Giovanni MD2; Cammà, Calogero MD1; Craxì, Antonio MD1; DiMarco, Vito MD1 on behalf of RESIST-HCV (Rete Sicilia Selezione Terapia–HCV)

American Journal of Gastroenterology: May 24, 2019 - Volume Publish Ahead of Print - Issue - p
doi: 10.14309/ajg.0000000000000266

INTRODUCTION: The Baveno VI consensus guidelines and an expanded algorithm suggest that transient elastography (TE) and platelet (PLT) count can be used to identify patients with cirrhosis who can avoid esophagogastroduodenoscopy (EGD). The primary aims of this study were to assess the ability of a simple algorithm, which uses only laboratory parameters, to predict medium/large esophageal varices (EV) in patients with hepatitis C virus (HCV) and cirrhosis from the Rete Sicilia Selezione Terapia–HCV (RESIST-HCV) cohort and to compare the performance of the algorithm with Baveno VI and Expanded Baveno VI criteria. The secondary aim was to assess the role of TE in ruling out large EV.

METHODS: In total, 1,381 patients with HCV-associated cirrhosis who had EGD and TE within 1 year of starting treatment with direct-acting antivirals were evaluated. Using multivariate logistic analysis, laboratory variables were selected to determine which were independently associated with medium/large EV to create the RESIST-HCV criteria. These criteria were tested in a training cohort with patients from a single center (Palermo) and validated with patients from the 21 other centers of the RESIST-HCV program (validation cohort).

RESULTS: In the entire cohort, medium/large EV were identified in 5 of 216 patients (2.3%) using the Baveno VI criteria and 13 of 497 patients (2.6%) using the Expanded Baveno VI criteria. PLT count and albumin level were independently associated with medium/large EV. The best cut-off values were a PLT count greater than 120 × 109 cells/μL and serum albumin level greater than 3.6 g/dL; negative predictive values (NPVs) were 97.2% and 94.7%, respectively. In the training cohort of 326 patients, 119 (36.5%) met the RESIST-HCV criteria and the NPV was 99.2%. Among 1,055 patients in the validation cohort, 315 (30%) met the RESIST-HCV criteria and the NPV was 98.1%. Adding TE to the RESIST-HCV criteria reduced the avoided EGDs for approximately 25% of patients and the NPV was 98.2%.

DISCUSSION: The “easy-to-use” RESIST-HCV algorithm avoids EGD for high-risk EV screening for more than 30% of patients and has the same performance criteria as TE. Using these criteria simplifies the diagnosis of portal hypertension.

1Sezione di Gastroenterologia e Epatologia, Dipartimento Biomedico di Medicina Interna e Specialistica (Di.Bi.M.I.S.), University of Palermo, Palermo, Italy;

2UOC Epatologia Clinica e Biomolecolare and AOUP G Martino, Dipartimento di Medicina Interna e Sperimentale, University of Messina, Messina, Italy;

3UOC Medicina Interna, AOUP Paolo Giaccone, Palermo, Italy;

4UOC Medicina Interna, AO Villa Sofia-Cervello, Palermo, Italy;

5UOS Epatologia, ARNAS Garibaldi-Nesima, Catania, Italy;

6UOC Gastroenterologia, AO Villa Sofia-Cervello, Palermo, Italy;

7UOC Medicina Interna, AOUP G Rodolico, Catania, Italy;

8UOC Malattie Infettive, Ospedale Vittorio Emanuele di Siracusa, ASP Siracusa, Siracusa, Italy;

9UOC Malattie Infettive, Presidio Ospedaliero Ferrarotto, Catania, Italy;

10UOC Medicina Interna, Ospedale di Comiso, ASP Ragusa, Ragusa, Italy;

11UOC Medicina Interna, Ospedale di Agrigento, ASP Agrigento, Agrigento, Italy;

12UOC Malattie Infettive, ARNAS Garibaldi-Nesima, Catania, Italy;

13UOC Malattie Infettive, Ospedale di Modica, ASP Ragusa, Ragusa, Italy;

14UOC Malattie Infettive, Ospedale di Enna, ASP Enna, Enna, Italy;

15UOC Medicina Interna, Ospedale di Mazzara Del Vallo, ASP, Trapani, Italy;

16UOC Malattie Infettive, Azienda Ospedaliera Universitaria Paolo Giaccone, Palermo, Italy;

17UOC Medicina Interna, Ospedale Buccheri La Ferla, Palermo, Italy;

18UOC Malattie Infettive, Ospedale di Trapani, ASP Trapani, Trapani, Italy;

19UOC Malattie Infettive, ARNAS Civico-Di Cristina-Benefratelli, Palermo, Italy;

20UOC Malattie Infettive, Ospedale di Caltanissetta, ASP Caltanissetta, Italy;

21UOC Malattie Infettive, AO Cannizzaro, Catania, Italy;

22UOC Malattie Infettive, AO Papardo e Piemonte, Messina, Italy.

Correspondence: Vincenza Calvaruso, MD, PhD. E-mail:

SUPPLEMENTARY MATERIAL accompanies this paper at,, and

Received October 07, 2018

Accepted March 04, 2019

© The American College of Gastroenterology 2019. All Rights Reserved.
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