Amish N Raval1, Carl J Pepine2. 1. Department of Medicine and Biomedical Engineering, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Electronic address: anr@medicine.wisc.edu. 2. Division of Cardiovascular Medicine, University of Florida, Gainsville, FL, USA.
Abstract
OBJECTIVES: The aim of this study was to characterize the clinical safety profile of transendocardial injection catheters (TIC) reported in the published literature. BACKGROUND: Transendocardial delivery is a minimally invasive approach to deliver potential therapeutic agents directly into the myocardium. The rate of adverse events across TIC is uncertain. METHODS: A systematic search was performed for trial publications using TIC. Procedure-associated adverse event data were abstracted, pooled and compared across catheters for active treatment and placebo injected patients. The transendocardial injection associated serious adverse events (TEI-SAE) was defined as the composite of death, myocardial infarction, stroke or transient ischemic attack within 30 days and cardiac perforation causing death or requiring evacuation, serious intraprocedural arrhythmias and serious coronary artery or peripheral vascular complications. RESULTS: The search identified 4 TIC systems: a helical needle (HN), an electro-anatomically tracked straight needle (EAM-SN), a straight needle without tracking elements (SN), and a curved needle (CN). Of 1799 patients who underwent transendocardial injections, the combined TEI-SAE was 3.4% across all catheters, and 1.1%, 3.3%, 7.1%, and 8.3% for HN, EAM-SN, SN and CN, respectively. However, TIC procedure duration and post procedural cardiac biomarker levels were reported in only 24% and 36% of published trials, respectively. CONCLUSIONS: Transendocardial injection is associated with varied TEI-SAE but the data are very limited. The HN catheter appeared to be associated with lower TEI-SAE, versus other catheters. Procedure duration and post procedure cardiac biomarker levels were under-reported. Clearly, standardized, procedure-related event reporting for trials involving transcatheter delivery would improve our understanding of complications across different systems.
OBJECTIVES: The aim of this study was to characterize the clinical safety profile of transendocardial injection catheters (TIC) reported in the published literature. BACKGROUND: Transendocardial delivery is a minimally invasive approach to deliver potential therapeutic agents directly into the myocardium. The rate of adverse events across TIC is uncertain. METHODS: A systematic search was performed for trial publications using TIC. Procedure-associated adverse event data were abstracted, pooled and compared across catheters for active treatment and placebo injected patients. The transendocardial injection associated serious adverse events (TEI-SAE) was defined as the composite of death, myocardial infarction, stroke or transient ischemic attack within 30 days and cardiac perforation causing death or requiring evacuation, serious intraprocedural arrhythmias and serious coronary artery or peripheral vascular complications. RESULTS: The search identified 4 TIC systems: a helical needle (HN), an electro-anatomically tracked straight needle (EAM-SN), a straight needle without tracking elements (SN), and a curved needle (CN). Of 1799 patients who underwent transendocardial injections, the combined TEI-SAE was 3.4% across all catheters, and 1.1%, 3.3%, 7.1%, and 8.3% for HN, EAM-SN, SN and CN, respectively. However, TIC procedure duration and post procedural cardiac biomarker levels were reported in only 24% and 36% of published trials, respectively. CONCLUSIONS: Transendocardial injection is associated with varied TEI-SAE but the data are very limited. The HN catheter appeared to be associated with lower TEI-SAE, versus other catheters. Procedure duration and post procedure cardiac biomarker levels were under-reported. Clearly, standardized, procedure-related event reporting for trials involving transcatheter delivery would improve our understanding of complications across different systems.