Novel dyeless and fluoro-less approach to cryoballoon pulmonary vein occlusion assessment

Background Pulmonary vein (PV) occlusion is essential for PV isolation (PVI) using the cryoballoon. Currently occlusion is arbitrarily determined using fluoroscopy and contrast media. This study aimed to create an objective measure without utilizing excessive fluoroscopy and using no contrast media. Objective To ensure PV occlusion without fluoroscopy and contrast dye. Methods In 4 in vivo hearts 113 PV occlusions were tested with a 50% cold dye saline mix at 4°C. Occlusions were rated Good, Fair, and Poor by dye dissipation seen via fluoroscopy and correlated to temperature profiles recorded concurrently. Using these temperature profiles and no dye, cryoablations were placed in 12 additional hearts (56 unique veins, 126 occlusions). Two 180-second cryoablation applications were placed per vein with occlusion testing in between. PVI was defined by electrophysiology mapping, gross pathology, and histology after ≥4 weeks recovery. Results Dye results were as follows: With Good, Fair, and Poor the maximal postinjection PV temperature dropped (ΔT) by 6.2 ± 4.2°C, 5.1 ± 3.7°C, and 2.4 ± 2.0°C. At 5 seconds post nadir temperature, injection temperature recovered 18% ± 14%, 36% ± 23%, and 50% ± 33%. Console thaw time to 0°C was 11.5 ± 4.8 seconds, 8.5 ± 2.1 seconds, and 4.3 ± 1.3 seconds. Success rate for PVI was 100%, 97%, and 0%. With no dye: ΔT: 7.7 ± 4.4°C, 5.8 ± 5.0°C, and 3.4 ± 2.3°C; % recovery at 5 seconds: 15% ± 12%, 31% ± 23%, 45% ± 30%; thaw time to 0°C: 11.9 ± 4.8 seconds, 10.5 ± 5.2 seconds, 6.0 ± 2.8 seconds; success rate: 97%, 91%, and 10%. Conclusion PV occlusion profile determination using 4°C cold saline injection is an effective approach to define the occlusion grade. Quality occlusions correlate strongly with PVI success.