Development of a Simultaneous Cryo-Anchoring and Radiofrequency Ablation Catheter for Percutaneous Treatment of Mitral Valve Prolapse

Abstract

Mitral valve prolapse (MVP) is one subtype of mitral valve (MV) disease and is often characterized by enlarged leaflets that are thickened and have disrupted collagen architecture. The increased surface area of myxomatous leaflets with MVP leads to mitral regurgitation, and there is need for percutaneous treatment options that avoid open-chest surgery. Radiofrequency (RF) ablation is one potential therapy in which resistive heating can be used to reduce leaflet size via collagen contracture. One challenge of using RF ablation to percutaneously treat MVP is maintaining contact between the RF ablation catheter tip and a functioning MV leaflet. To meet this challenge, we have developed a RF ablation catheter with a cryogenic anchor for attachment to leaflets in order to apply RF ablation. We demonstrate the effectiveness of the dual-energy catheter in vitro by examining changes in leaflet biaxial compliance, thermal distribution with infrared (IR) imaging, and cryogenic anchor strength. We report that 1250J of RF energy with cryo-anchoring reduced the determinant of the deformation gradient tensor at systolic loading by 23%. IR imaging revealed distinct regions of cryo-anchoring and tissue ablation, demonstrating that the two modalities do not counteract one another. Finally, cryogenic anchor strength to the leaflet was reduced but still robust during the application of RF energy. These results indicate that a catheter having combined RF ablation and cryo-anchoring provides a novel percutaneous treatment strategy for MVP and may also be useful for other percutaneous procedures where anchored ablation would provide more precise spatial control.