In vivo evaluations of a phased ultrasound array for transesophageal cardiac ablation

Atrial fibrillation is one of the most common arrhythmias that affects over 2.2 million Americans each year. Catheter ablation, one of the effective treatments, has shown high rate of success in treating paroxysmal atrial fibrillation. Currently, radiofrequency which is being used for catheter ablation is an invasive procedure. Measurable morbidity and significant costs and time are associated with this modality of treatment of permanent or persistent atrial fibrillation. In order to address these issues, a transesophageal ultrasound applicator for noninvasive cardiac ablation was designed, developed and evaluated. The ultrasound energy delivered by the phased array was used to create a lesion in the myocardial tissue. Various factors, simulation results of transducer arrays, current transesophageal medical devices, and throat anatomy, were considered while designing a phased ultrasound transducer that can be inserted into the esophagus. For this research, a two-dimensional sparse phased array with flat tapered elements was fabricated and evaluated in in vivo experiments. Five pigs were anesthetized; the array was passed transesophagealy and positioned over the heart. An operating frequency of 1.6 MHz and 8∼15 minutes of array operation resulted in both single and multiple lesions on atrial and ventricular myocardium. The average size of lesions was 5.1±2.1mm in diameter and 7.8±2.5mm in length. Experimental results indicate that the array delivered sufficient power to produce ablation at the focal point while not grossly damaging the tissue surrounding the area of interest. These results demonstrate a potential application of the ultrasound applicator for noninvasive transesophageal cardiac surgery in atrial fibrillation treatment.