A Noninvasive Ultrasound Based Technique to Identify Treatment Responders in Patients with Portal Hypertension

Abstract

Subharmonic aided pressure estimation (SHAPE) is based on the inverse relationship between the subharmonic amplitude of ultrasound contrast microbubbles and ambient pressure. The aim of this study was to verify if SHAPE can accurately monitor disease progression in patients identified with portal hypertension. A modified Logiq 9 scanner with a 4C curvi-linear probe (GE, Waukesha, WI) was used to acquire SHAPE data (transmitting and receiving at 2.5 and 1.25 MHz, respectively) using Sonazoid (GE Healthcare, Oslo, Norway; FDA IND 124,465). Twenty-one (median age 59 years; 12 Males) of the 178 patients enrolled in this institutional review board approved study (14F.113) were identified as having clinically significant portal hypertension based on their hepatic venous pressure gradient results ≥ 10 mmHg. Repeat SHAPE examinations were done every 6.2 months. Liver function tests and clinical indicators were used to establish treatment response. Of the 21 portal hypertensive subjects, 11 had successful follow up scans with an average follow up time of 6.2 months. There was a significantly larger SHAPE signal reduction in the group who were classified as treatment responders (n = 10; -4.01±3.61 dB) compared to the single nonresponder (2.33 dB; p < 0.001). Results for responders matched the corresponding clinical outcomes of improved model for end stage liver disease (MELD) scores, improvement in underlying cause of portal hypertension, improved liver function tests and reduced ascites. SHAPE can potentially monitor disease progression in portal hypertensive patients and hence, may help clinicians in patient management. A larger study would further validate this claim.