Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting

The aim of this study was to characterize the clinical safety profile transendocardial injection catheters (TIC) reported in published literature. Transendocardial delivery is a minimally invasive approach deliver potential therapeutic agents directly into myocardium. rate adverse events across TIC uncertain. A systematic search performed for trial publications using TIC. Procedure-associated event data were abstracted, pooled and compared active treatment placebo injected patients. associated serious (TEI-SAE) defined as composite death, myocardial infarction, stroke or transient ischemic attack within 30 days cardiac perforation causing death requiring evacuation, intraprocedural arrhythmias coronary artery peripheral vascular complications. identified 4 systems: helical needle (HN), an electro-anatomically tracked straight (EAM-SN), without tracking elements (SN), curved (CN). Of 1799 patients who underwent injections, combined TEI-SAE 3.4% all catheters, 1.1%, 3.3%, 7.1%, 8.3% HN, EAM-SN, SN CN, respectively. However, procedure duration post procedural biomarker levels only 24% 36% trials, with varied but are very limited. HN catheter appeared be lower TEI-SAE, versus other catheters. Procedure under-reported. Clearly, standardized, procedure-related reporting trials involving transcatheter would improve our understanding complications different systems.