Description of Event or Problem · 0
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED, "ENDOSCOPIC ULTRASOUND-GUIDED PORTO-SYSTEMIC PRESSURE GRADIENT MEASUREMENT CORRELATES WITH HISTOLOGICAL HEPATIC FIBROSIS." BACKGROUND AND AIMS: ENDOSCOPIC ULTRASOUND IS A NOVEL DIAGNOSTIC APPROACH TO CHRONIC LIVER DISEASES (CLDS), AND EUS-GUIDED PORTO-SYSTEMIC PRESSURE GRADIENT MEASUREMENT (EUS-PPG) IS AN IMPORTANT EXPANSION WITH A WELL-DEVELOPED TECHNIQUE. HOWEVER, THE CLINICAL VALUE AND APPLICABILITY OF EUS-PPG MEASUREMENT IN PREDICTING HISTOLOGICALLY ADVANCED HEPATIC FIBROSIS REMAIN UNKNOWN. METHODS: THIS WAS A SINGLE-CENTER RETROSPECTIVE STUDY ON PATIENTS WITH VARIOUS CLDS UNDERGOING EUS-PPG AND EUS-GUIDED LIVER BIOPSY (EUS-BX) TO ASSESS IF EUS-PPG MEASUREMENTS CORRELATE WITH HISTOLOGICAL FIBROSIS STAGE AND VARIOUS SURROGATE MARKERS FOR SEVERITY OF CLDS AND ITS SAFETY. CASES WITH EUS-PPG WERE IDENTIFIED AT (B)(6), A TERTIARY ENDOSCOPY CENTER, BETWEEN JANUARY 2014 AND MARCH 2020. RESULTS IN 64 PATIENTS, THE MEAN AGE WAS 57.5; 40 (62.5%), MALES; MEAN CHILD-TURCOTTE-PUGH (CTP) AND MODEL FOR END-STAGE LIVER DISEASE (MELD) SCORES, 5.9 AND 10.4, RESPECTIVELY. THE PROCEDURE SUCCESS RATE WAS 100%. TWENTY-NINE (45.3%) HAD EUS-PPG=5 MMHG THAT WAS ASSOCIATED WITH CLINICAL CIRRHOSIS (P<0.0001), CLINICAL PORTAL HYPERTENSION (P=0.002), HEPATIC DECOMPENSATION (P=0.013), MELD-NA>10 (P=0.036), PLTS=120×109/L (P=0.001), INR=1.05 (P=0.007), PRESENCE OF EV, GV, OR PHG (P<0.0001), BIOPSY-PROVEN FIBROSIS STAGE=3 (P=0.002), APRI>2 (P=0.001), AND FIB-4>3.25 (P=0.001). MULTIVARIABLE ANALYSIS CONFIRMED THAT EUS-PPG=5 MMHG WAS SIGNIFICANTLY ASSOCIATED WITH LIVER BIOPSY-PROVEN FIBROSIS STAGE=3 (LR 27.0, 95% CI=1.653¿360.597, P=0.004), INDEPENDENT OF C-CIRRHOSIS, C-PHTN, THROMBOCYTOPENIA, SPLENOMEGALY, AND APRI SCORE>2, AND FIB-4 SCORE>3.25. THERE WERE NO SERIOUS COMPLICATIONS RELATED TO EUS-PPG PROCEDURES. CONCLUSIONS: EUS-PPG MEASUREMENTS PROVIDE EXCELLENT CORRELATION WITH HISTOLOGICAL HEPATIC FIBROSIS STAGE AND VARIOUS CLINICAL, LABORATORY, ENDOSCOPIC AND IMAGING VARIABLES INDICATIVE OF ADVANCED LIVER DISEASE WITHOUT SERIOUS ADVERSE EVENTS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: CIRRHOSIS THROMBOCYTOPENIA. THIS LITERATURE ARTICLE REQUIRES 3 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6). THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.