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Efficacy and Safety of Circumferential Pulmonary Vein Isolation Using a Novel Cryothermal Balloon Ablation System

Alvaro V. Sarabanda, MD, PhD^_*,, T. Jared Bunch, MD^_*, Susan B. Johnson, BS^_*, Srijoy Mahapatra, MD^_*, Mark A. Milton, MD^_*, Luiz R. Leite, MD^_*, G. Keith Bruce, MD^_* and Douglas L. Packer, MD^_*,_*

^_* Division of Cardiovascular Disease, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota
Instituto do Coração de Brasília, Brasília, DFBrazil, and Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, SP, Brazil

View larger version (110K): [in a new window]   Figure 1 (A) Photograph of the cryothermal balloon catheter. (B) Fluoroscopic image of the inflated balloon engaged at the left superior pulmonary vein (LSPV) orifice (arrows). (C) Intracardiac echocardiographic image of the inflated balloon positioned at the orifice of the LSPV (arrow), illustrating an example of an unsuccessful occlusion of the pulmonary vein orifice, with a peri-balloon flow leak as seen by color Doppler flow. LAO = left anterior oblique projection; RAO = right anterior oblique projection.

View larger version (59K): [in a new window]   Figure 2 Successful circumferential cryoablation of the left superior pulmonary vein. (A) Fluoroscopic image of the Lasso catheter positioned at the pulmonary vein (PV) ostium. (B) Tracings of the surface electrocardiographic leads I and III and PV ostial electrograms as seen by the Lasso catheter (PV1-2 to PV10-1) during distal coronary sinus pacing, and recorded before ablation (left) and after ablation (right). LA = left atrium; other abbreviations as in Figure 1.

View larger version (13K): [in a new window]   Figure 3 Impact of minimum balloon-tip temperature on outcome of ablation in 12 pulmonary veins. The minimum balloon-tip temperature levels related to successful or unsuccessful pulmonary vein isolation (PVI) are shown. Temperature values in some pulmonary veins overlap.

View larger version (89K): [in a new window]   Figure 4 Complete circumferential and transmural lesion at the veno-atrial junction of the left superior pulmonary vein (LSPV). Same ablated pulmonary vein as seen in Figure 2. (A) Fluoroscopic image of the inflated balloon engaged at the LSPV orifice (arrows). (B) Photograph of the left atrium open showing a well-demarcated lesion at the veno-atrial junction that extended to a wide area outside the LSPV ostium. (C) (Masson trichrome stain; 2.5x; bar = 1 mm), photomicrograph of a transverse section at the veno-atrial junction; a circumferential and transmural lesion is shown. LIPV = left inferior pulmonary vein; LMPV = middle branch of the left superior pulmonary vein; other abbreviations as in Figure 1.

View larger version (63K): [in a new window]   Figure 5 Example of unsuccessful cryoablation of the left superior pulmonary vein (LSPV). (A) Venography through the inflated balloon positioned at the LSPV orifice shows an unsuccessful occlusion of the pulmonary vein (PV) orifice, with a peri-balloon flow leak at its inferior aspect. (B) Position of the Lasso catheter at the LSPV orifice during repeated mapping at one week after ablation. (C) The PV potentials recorded by the Lasso catheter (PV1-2 to PV10-1) as shown in panel B. Note that the remaining PV potentials (arrows) predominated at the inferior aspect of the vein. (D) Photograph of the endocardial surface of the left atrium showing a non-circumferential lesion at the veno-atrial junction, with the arrow pointing to the lesion discontinuity. Note that the position of the lesion gap corresponded to both the location of the remaining PV potentials and the peri-balloon flow leak. (E) (Masson trichrome stain; 2.5x), photomicrograph of a transverse section at the veno-atrial junction. Abbreviations as in Figure 5.

View larger version (102K): [in a new window]   Figure 6 Phrenic nerve injury as seen on gross inspection. (A) Right phrenic nerve course is visible after deflecting the right lung rightward. A lesion at the right superior pulmonary vein (RSPV) ostium is visible, extending to adjacent structures and encompassing the right phrenic nerve. (B) Fluoroscopic image illustrating the relative proximity of the right phrenic nerve course to the inflated balloon engaged at the RSPV antrum. Arrows at the anterolateral wall of the superior vena cava (SVC) depict the site where successful phrenic nerve capture was obtained. The plausible course of the right phrenic nerve is marked with arrowheads. CS = coronary sinus; IVC = inferior vena cava; RA = right atrium; RIPV = right inferior pulmonary vein; other abbreviations as in Figure 1.