In vitro assessment of a combined radiofrequency ablation and cryo-anchoring catheter for treatment of mitral valve prolapse

Percutaneous approaches to mitral valve repair are an attractive alternative to surgical repair or replacement. Radiofrequency ablation has the potential to approximate surgical leaflet resection by using resistive heating to reduce leaflet size, and cryogenic temperatures on a percutaneous catheter can potentially be used to reversibly adhere to moving mitral valve leaflets for reliable application of radiofrequency energy. We tested a combined cryo-anchoring and radiofrequency ablation catheter using excised porcine mitral valves placed in a left heart flow loop capable of reproducing physiologic pressure and flow waveforms. Transmitral flow and pressure were monitored during the cryo-anchoring procedure and compared to baseline flow conditions, and the extent of radiofrequency energy delivery to the mitral valve was assessed post-treatment. Long term durability of radiofrequency ablation treatment was assessed using statically treated leaflets placed in a stretch bioreactor for four weeks. Transmitral flow and pressure waveforms were largely unaltered during cryo-anchoring. Parameter fitting to mechanical data from leaflets treated with radiofrequency ablation and cryo-anchoring revealed significant mechanical differences from untreated leaflets, demonstrating successful ablation of mitral valves in a hemodynamic environment. Picrosirius red staining showed clear differences in morphology and collagen birefringence between treated and untreated leaflets. The durability study indicated that statically treated leaflets did not significantly change size or mechanics over four weeks. A cryo-anchoring and radiofrequency ablation catheter can adhere to and ablate mitral valve leaflets in a physiologic hemodynamic environment, providing a possible percutaneous alternative to surgical leaflet resection of mitral valve tissue.