Abstract
Introduction: Right heart failure and amiodarone are known causes of cirrhosis. Conversely, emerging evidence suggests that non-alcoholic fatty liver disease (NAFLD) is associated with coronary artery diseases and arrhythmias. However, the Fibroscan (Echosens, France), a widely-available, non-invasive device to detect liver fibrosis and steatosis is currently contraindicated in patients with cardiac pacemakers (PM) or implantable cardioverter-defibrillators (ICD). This study aims to determine the safety profile of transient elastography (TE) in patients with PM or ICD and the prevalence of cirrhosis and steatosis in this population. Methods: Consecutive outpatients undergoing routine device interrogations at a tertiary level teaching hospital underwent simultaneous liver stiffness and controlled attenuation parameter measurements by TE using FibroScan M or XL probe as per manufacturer's guidelines. PM or ICD performance data, device types, patient demographics, and medical history were collected. Cutoff values for significant fibrosis (F2-4), cirrhosis (F4), and massive steatosis were set at kPA >9, kPA >14, and >300 dB/m, respectively. Results: Interim analysis of the first 51 of 200 planned subjects with 25 different implanted cardiac devices from 5 companies (Medtronic, Sorin, ELA Medical, Boston Scientific, St. Jude) did not demonstrate any adverse events as defined by abnormal device sensing/pacing or ICD firing. This population included subjects undergoing active pacing (n=23, 45%) and with right sided PM placement (n=1). None of the subjects had any clinical signs of decompensated congestive heart failure or cirrhosis during the exam. Based on their Fibroscan readings, the prevalence of clinically significant fibrosis (F2-F4), cirrhosis (F4), and massive steatosis (S3) were 29% (n=15), 18% (n=9), and 25% (n=13). Conclusion: TE with FibroScan can be safely used in patients with a PM or ICD. Preliminary results suggest the prevalence of significant liver fibrosis and steatosis is increased in this population.
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