A novel catheter system for percutaneous intracoronary artery cardiomyoplasty.

Abstract

BACKGROUND: Current medical and invasive treatment strategies are often found to be inadequate to treat patients with acute myocardial infarction. Cell and tissue therapies are a promising treatment alternative for patients with severe ischemic heart disease. OBJECTIVES: The objective of this study was to evaluate the efficacy of a new means of direct myocardial access using the percutaneous coronary intervention (PCI) technique. METHODS: We used a system consisting of an injection needle catheter that implants cells and the injection guide catheter that delivers the injection needle catheter into the target lesion. We harvested skeletal myoblasts from Yorkshire swine (n = 8; 50-60 kg), expanded them in culture and labeled them with a fluorescent cell-linker kit. The myoblasts (106 cells), along with green dye, were injected into the normal heart of swine using this novel system. Histological analysis was performed on Days 0 (n = 4) and 14 (n = 4) after injection. RESULTS: Working along the coronary artery, the catheter was easily delivered to the left anterior descending (LAD) coronary artery with the conventional PCI technique. No events of death, cardiac tamponade or other procedural complication occurred. Electrocardiography did not detect cardiac arrhythmia during the 14 days following the injection. On gross inspection, the heart was observed through its outer surface, and the myoblasts and green dye were well localized in the LAD area. CONCLUSIONS: The present study demonstrates the feasibility of a new means of a direct myocardial injection system without any adverse outcomes.