Esophageal heat transfer devices and methods for cardiac tissue ablation

1. A method for achieving a durable atrial lesion and preventing or reducing the risk of thermal injury to esophageal tissue in a patient undergoing a cardiac tissue ablation procedure, the method comprising:

orally or nasally inserting an esophageal heat transfer device into the patient, wherein the heat transfer device includes a heat transfer region and one or more lumens configured to provide a heat transfer fluid to the heat transfer region and to remove the heat transfer fluid from the heat transfer region;

positioning the heat transfer region in thermal contact with esophageal tissue susceptible to damage during the cardiac tissue ablation procedure;

selecting a temperature setting for the heat transfer fluid, wherein the temperature setting is from about 0° C. to about 10° C.;

circulating the heat transfer fluid through the one or more lumens at the selected temperature setting to maintain a target temperature of the esophageal tissue susceptible to damage; and

performing the cardiac tissue ablation procedure;

wherein the method achieves a durable atrial lesion while simultaneously protecting esophageal tissue during the cardiac tissue ablation procedure.

2. The method of claim 1 , further comprising: adjusting, via a controller, a fluid source to provide the fluid to the esophageal heat transfer device in accordance with the temperature setting.

3. The method of claim 1 , further comprising: collecting data via one or more sensing elements of the esophageal heat transfer device.

4. The method of claim 3 , wherein the one or more sensing elements includes a temperature sensor or a location sensing element.

5. The method of claim 1 , wherein the cardiac tissue ablation procedure is a radiofrequency ablation procedure.

6. The method of claim 1 , wherein the method does not comprise luminal esophageal temperature (LET) monitoring.

7. The method of claim 5 , further comprising: improving an outcome in the patient undergoing the radiofrequency ablation procedure.

8. The method of claim 7 , wherein the outcome is at least one of achievement of a durable lesion on a posterior segment of an atrial wall; freedom from any symptomatic atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) 12 months post-RF ablation procedure; or reduction in amount and/or severity of damage to esophageal tissue relative to performing the RF ablation procedure without such temperature management.

9. The method of claim 5 , wherein the radiofrequency ablation procedure comprises application of ablation energy to a posterior atrial wall segment of the patient and a target minimum Ablation Index (AI min ) value of from 300 to 550 on the posterior atrial wall segment.

10. The method of claim 1 , wherein the esophageal heat transfer device further comprises a device-location sensing element.

11. The method of claim 10 , wherein the device-location sensing element includes a fiducial marker detectable by a mapping and/or imaging system.

12. The method of claim 10 , wherein the device-location sensing element includes one or more magnetic field sensors.

13. The method of claim 12 , wherein the one or more magnetic field sensors create a signal in response to a magnetic field emitted by a magnetic field emitter.

14. The method of claim 10 , wherein the device-location sensing element includes a tri-axial sensor.

15. The method of claim 14 , wherein the tri-axial sensor includes three orthogonally configured coils.