Experimental Ablation of Outflow Tract Muscle With a Thermal Balloon Catheter

Abstract

Background Pulmonary balloon valvuloplasty has been performed in selected patients with tetralogy of Fallot as an alternative to surgical palliation; this technique is limited, however, by the fact that the balloon has little effect on the dynamic, muscular contribution to outflow tract obstruction. In an experimental model, we used a new thermal balloon catheter to ablate right ventricular outflow tract muscle. We evaluated the acute efficacy and muscle ablation parameters of this technology and its effects after myocardial healing. Methods and Results A prototype electrolyte-filled balloon catheter, heated by radiofrequency energy, was constructed. Studies were conducted to determine the optimum electrolyte solution needed to minimize balloon heating time with an unmodified, commercially available radiofrequency generator. In vivo ablations of right ventricular outflow tract muscle with the thermal balloon were performed in lambs that were divided into three groups (n=5 each) according to the duration of thermal energy delivery (20, 40, and 60 seconds, respectively). Ablated lesion volume increased (460±63 to 1156±256 mm 3 ) as the energy delivery time increased (20 to 60 seconds) and was correlated with delivered energy, temperature integral, and maximum epicardial surface temperature ( r =.85, .82, and .72, respectively). All five lesions in the 60-second group showed an acute decrease of the wall thickness. Additional in vivo ablations were performed in 6 animals in which survival studies showed muscle thinning, healing by fibrosis, and no evidence of aneurysm formation. Conclusions Thermal energy can be used with a balloon catheter delivery system to ablate myocardium. This study suggests that this energy delivery technology might be useful for relief of muscular outflow tract obstruction and that further studies are warranted.