Evaluation of the safety and effectiveness of the CryoMedix cryoablation catheter system for the treatment of atrial flutter and fibrillation.

BACKGROUND: Catheter ablation of atrial flutter and fibrillation (AFL and AF) has typically been performed with radiofrequency energy. Cryoablation has recently been used for AF and AFL, but its success has been limited by the nadir temperature achievable using nitrous oxide as a refrigerant. In this study, a novel approach allowing for use of a liquid refrigerant capable of achieving lower nadir temperatures was tested in a canine model with cavo-tricuspid isthmus (CTI) and left atrial (LA) ablation. METHODS AND RESULTS: In six dogs, under general anesthesia, standard catheters were placed in the coronary sinus and right ventricular apex, and the CryoMedix cryoablation catheter (CAC) in the right (CTI) and left atrium (for ablation, across the LA roof, mitral isthmus, and LA septum). Double-freezes up to 2 min each were performed, with a 30-s thaw cycle between freezes. Ablated areas were subsequently grossly inspected and photographed and tissues fixed in formalin for histologic analysis to determine if the lesions were contiguous and transmural. In all animals, long linear (from 4-8 cm) transmural atrial lesions were observed on gross and histological examination in the left atrial roof, septum and mitral isthmus, and across the cavo-trisucpid isthmus. In all animals, bi-directional cavo-tricuspid isthmus block was observed after ablation, during pacing from the coronary sinus ostium and low lateral right atrium, respectively. Up to 50% thickness lesions were observed in the right ventricle below the tricuspid valve in all animals. There were no acute complications noted in any animals. CONCLUSIONS: The CAC system produces extremely negative freezing temperatures, significantly lower than those reported for nitrous oxide based systems. The CTI was easily ablated with the CAC system, producing bi-directional conduction block, suggesting a potential role for the system in the treatment of isthmus-dependent atrial flutter. Transmural LA lesions were also produced with the CAC system, suggesting a potential role in treating AF.

Efficacy of a microwave antenna for ablation of the tricuspid valve--inferior vena cava isthmus in dogs as a treatment for type 1 atrial flutter.

INTRODUCTION: Radiofrequency catheter ablation of the tricuspid valve-inferior vena cava (TV-IVC) isthmus for treatment of atrial flutter (AFL), may in some cases require a large number of energy applications and a long procedure and fluoroscopy time. AIMS OF STUDY: Therefore, we studied the safety and efficacy of a 4 cm long microwave antenna mounted on a steerable 9Fr catheter for linear ablation of the TV-IVC isthmus. METHODS: In 6 anesthetized dogs, multi-electrode catheters were positioned in the coronary sinus (decapolar), at the His bundle (quadripolar) and around the TV annulus (decapolar) for pacing and recording atrial activation sequences before and after ablation. The microwave antenna was then positioned across the TV-IVC isthmus from the TV annulus (identified by equal A and V potentials) to the inferior vena cava with slight traction on the catheter to ensure adequate endocardial contact. Microwave energy was then applied at a fixed power for 120 seconds during each ablation attempt. Ablation was repeated until bi-directional isthmus block was demonstrated during pacing from the coronary sinus ostium and low lateral right atrium, respectively. RESULTS: Linear microwave ablation of the TV-IVC isthmus was completed in all ten dogs using a total of 2.6 +/- 1.17 energy applications per dog. Power was applied in a range of 45-50 watts. There were no acute procedural complications. Bi-directional TV-IVC isthmus block was achieved in all ten dogs, as demonstrated by a strictly descending activation wavefront in the ipsilateral atrial wall, during pacing from the CSO and LLRA respectively. In addition, after ablation conduction time to the LLRA during pacing from the CSO increased from 52 +/- 16.62 before to 87 +/- 12.74 msec (p <.05), and to the CSO during pacing from the LLRA from 51 +/- 12.43 before to 79.50 +/- 9.85 msec (p <.05). Gross and histological examination of the TV-IVC isthmus after ablation revealed continuous transmural lesions, ranging from 3-5 mm in width, spanning the entire TV-IVC isthmus in all ten dogs. CONCLUSIONS: (1) Microwave ablation of the TV-IVC isthmus was safe and effective in this study. (2) Ablation of the entire width and thickness of the TV-IVC isthmus can be rapidly achieved using a long microwave antenna in a fixed trans-isthmus position.

Conduction velocity around the tricuspid valve annulus during type 1 atrial flutter: defining the location of areas of slow conduction by three-dimensional electroanatomical mapping.

BACKGROUND: Conduction velocity (CV) around the tricuspid valve annulus (TVA) during type 1 atrial flutter (AFL) has been shown to be slowest in the tricuspid valve-inferior vena cava (TV-IVC) isthmus, compared to the septal or free wall segments of the TVA. However, fiber orientation in the triangle-of-Koch suggests that the inferior septum and medial TV-IVC isthmus should be the most slowly conducting segments around the TVA. METHODS: To test this hypothesis we evaluated CV around the TVA during type 1 atrial flutter in 11 patients, using an electro-anatomical mapping system (Carto). CV was first calculated in 4 segments around the TVA including the TV-IVC isthmus, lateral free wall, superior free wall and septum, and then calculated in 8 segments around the TVA including medial (MI) and lateral isthmus (LI), inferior (IL) and superior lateral (SL) free wall, lateral (LS) and medial superior (MS) free wall, and superior (SS) and inferior septum (IS). Statistical comparison of CV from these multiple segments was made by one-way analysis of variance. RESULTS: Measured in 4 segments around the TVA, mean CV (m/sec) in the TV-IVC isthmus (0.81 +/- 0.23) and the septum (0.93 +/- 0.18) was significantly slower than CV in the lateral free wall (1.16 +/- 0.23) and superior free wall (1.10 +/- 0.20), and CV in the TV-IVC isthmus was significantly slower than in the septum (p < 0.05). However, when analyzed in 8 segments, mean CV in the MI (0.56 +/- 0.16) and IS (0.59 +/- 0.24) was significantly (p < 0.05) slower than in all other segments including the LI (1.06 +/- 0.46), IL (1.17 +/- 0.40), SL (1.15 +/- 0.40), LS (1.04 +/- 0.25), MS (1.15 +/- 0.28), and SS (1.26 +/- 0.36) segments. CONCLUSIONS: Consistent with previous reports, CV around the TVA during type 1 AFL was slowest in the TV-IVC isthmus, compared to the septum, superior and lateral free wall regions. However, when the TVA was further subdivided into 8 segments, CV in the MI and IS segments was significantly slower than in all other segments around the TVA. These observations more precisely define the regions of slow conduction in human type 1 AFL, and are consistent with the known anisotropy and slow conduction in the Triangle of Koch.

Acute and chronic effects of cryoablation of the pulmonary veins in the dog as a potential treatment for focal atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) may be triggered by premature atrial depolarizations originating in the pulmonary veins (PV). Radiofrequency catheter ablation of PV foci may prevent recurrence of AF, but may cause PV stenosis. Therefore, a safer method for ablation of PV foci is needed. This study evaluated the acute and chronic effects of PV ablation using a cryocatheter ablation (CCA) system, which may be less likely to cause PV stenosis. METHODS: CCA was performed by freezing for 5 minutes or more in one or more PVs in 10 anesthetized dogs. Pacing threshold and vessel diameter were measured before and after PV cryoablation. All dogs were restudied at 4.0 +/- 1.64 months (range 2-7) in a manner identical to baseline. RESULTS: CCA was performed in 27 PVs (range 1-4/dog), with a mean freeze time of 8.62 +/- 5.42 minutes per vein (range 5.23-22.06). Mean temperature for all freezes was -65 +/- 5.3 degrees C. Mean PV diameter was 6.49 +/- 1.73 vs 6.24 +/- 1.83 mm (p = NS) and mean pacing threshold 1.32 +/- 0.75 vs 9.36 +/- 5.93 mA (p <.01), before vs. acutely after ablation. At followup, at the ablation sites PV diameter (7.02 +/- 1.88 mm) was unchanged from baseline, whereas pacing threshold remained elevated (2.54 +/- 1.44 mA, p <.05 vs baseline). There were no acute or long-term complications. CONCLUSIONS; (1) CCA of PVs produced a significant rise in acute and chronic pacing threshold indicating loss of atrial conductivity. (2) CCA of PVs did not cause PV stenosis or other complications. (3) The data suggest that CCA of PVs may be a safe and effective method for treating focal AF.

Comparison of open- and closed-chest canine model for quantification of coronary stenosis severity by myocardial contrast echocardiography.

RATIONALE AND OBJECTIVES: The objective of the present study was to compare the data regarding the ability of real-time myocardial contrast echocardiography (MCE) to assess altered myocardial blood flow produced by graded coronary stenoses between open- and closed-chest canine models. MATERIALS AND METHODS: Three grades of left anterior descending coronary artery stenosis and occlusion were created in 6 open- and 6 closed-chest canine models. MCE used FS-069 infusion and real-time imaging. Myocardial signal intensity versus time plots were fitted to a 1-exponential function to obtain the peak signal intensity (A) and rate of signal intensity rise (b) for quantification of myocardial blood flow. RESULTS: The value of b obtained from closed-chest canine models (without stenosis = 0.995 +/- 0.087, mild stenosis = 0.968 +/- 0.076, moderate stenosis = 0.569 +/- 0.077, severe stenosis = 0.288 +/- 0.032, occlusion = 0.085 +/- 0.031) was not significantly different from that obtained from open-chest canine models (without stenosis = 1.028 +/- 0.107, mild stenosis = 0.998 +/- 0.098, moderate stenosis = 0.601 +/- 0.055, severe stenosis = 0.321 +/- 0.029, occlusion = 0.079 +/- 0.028) at any grade of stenosis (P = 0.09, 0.08, 0.44, 0.11, 0.74, respectively). CONCLUSIONS: In myocardial regions where attenuation of the ultrasound beam and artifacts produced by the chest wall are minimal, the data from transthoracic MCE in the closed-chest model may show values similar to those from MCE in the open-chest model.