title: Evaluation of the acute and chronic safety of the biosense injection catheter system in porcine hearts.
abstract: Direct myocardial injection of therapeutic agents has been explored as a new method for myocardial revascularization. The integration of a 3D electromechanical mapping catheter with a retractable injection needle should allow for intramyocardial injection to identified sites, obviating the need for open heart surgery. This study assessed the procedural safety and performance characteristics of a novel guided catheter-based transendocardial injection system. The electromagnetic guidance system was coupled with a retrievable 27G needle for left ventricular endocardial injection. Using this system, we injected, transendocardially, methylene-blue (MB) dye tracer at a volume of 0.1 or 0.2 ml per injection in eight normal pigs. Animals were sacrificed acutely, at 1, 3, and 7 days (two animal in each time). Three animals served as controls. The injections were followed by coronary angiography and echocardiogram to assess possible ventricular or coronary perforation and wall motion abnormalities. CK-MB levels were measured up to 24 hr following the procedure. The animals were sacrificed at the assigned time for gross and histopathology evaluation. A total of 101 injections were made in all regions of the heart except the apex and the mitral valve. No animal died as a result of the mapping or injection procedures. Vital signs did not change relative to baseline after the mapping and injection procedures. CK-MB values did not increase over time and there was no evidence of sustained arrhythmia or hemodynamic compromise. There was no evidence of left ventricular or coronary perforation, global or regional wall motion abnormalities, or hemopericardium. On histologic evaluation, the estimated volume of tissue staining was greater than the volume of the injected MB dye due to dispersion of the injectate in the interstitial and intracellular fluid compartments. It is concluded that using this magnetic guidance catheter-based navigational system, it is feasible and safe to perform the transendocardial injection procedure. Thus, if it is determined that direct intramyocardial injection of drugs is a valid therapeutic strategy, this approach offers a clear advantage over surgically based transepicardial injection procedures. Cathet. Cardiovasc. Intervent. 48:447-453, 1999.
authors.affiliation: Cardiovascular Research Foundation, Washington Hospital Center, Washington, D.C 20010, USA. rxk3@mhg.edu
authors.forename: R
authors.initials: R
authors.lastname: Kornowski
authors.forename: S
authors.initials: S
authors.lastname: Fuchs
authors.forename: F O
authors.initials: FO
authors.lastname: Tio
authors.forename: A
authors.initials: A
authors.lastname: Pierre
authors.forename: S E
authors.initials: SE
authors.lastname: Epstein
authors.forename: M B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000818:Animals; D006328:Cardiac Catheterization / Q000295:instrumentation / Q000379:methods*; D004396:Coloring Agents; D017023:Coronary Angiography; D003402:Creatine Kinase / Q000032:analysis; D016503:Drug Delivery Systems; D005069:Evaluation Studies as Topic; D007091:Image Processing, Computer-Assisted; D007527:Isoenzymes; D009206:Myocardium / Q000473:pathology; D013552:Swine
chemical_list: D004396:Coloring Agents; D007527:Isoenzymes; D003402:Creatine Kinase