Real-time intracardiac echocardiography validation of saline-enhanced radiofrequency needle-tip ablation: lesion characteristics and gross pathology correlation.

AIMS: With the implementation of saline-enhanced radiofrequency (SERF) needle-tip ablation, real-time validation of lesion formation is needed for the controllable creation of transmural lesions. The aim of the study was to analyse the ability of two-dimensional intracardiac echocardiography (2D-ICE) to guide and validate SERF ablation in real-time. METHODS AND RESULTS: Fifty-six SERF energy deliveries at left ventricular sites of 11 dogs guided by 2D-ICE were analysed (power: 15-50 W; time: 25-120 s; irrigation saline: 60°C with 10 mL/min flow rate). Catheter tip/tissue orientation and lesion formation could be well detected by 2D-ICE in 49 (87.5%) energy deliveries. Gross pathology analysis confirmed excellent 2D-ICE lesion localization, the ability to detect transmural lesions (70% sensitivity, 47% specificity) and positive correlation between 2D-ICE and the corresponding gross pathology measurements of 'maximal lesion depth'; (repeated measures correlation: rrm = 0.43, P = 0.012) and 'depth at maximal lesion width' (D@MW; rrm = 0.51, P = 0.003). The median angle between SERF catheter tip and endocardium was 76° [interquartile range (IQR) 58-83°]. The more perpendicular the catheter tip/tissue orientation was the deeper D@MW (rrm = 0.32, P = 0.045). Grade 3 microbubbles on 2D-ICE during ablation, indicating inadequate catheter tip/tissue contact, was associated with smaller lesion volumes than with Grade 1 microbubbles (284.8 mm3 [IQR 151.3-343.1] vs. 2114.1 mm3 [IQR 1437.0-3026.3], P < 0.001). CONCLUSION: With excellent lesion localization and a 70% detection rate of transmural lesions, 2D-ICE is well suited to validate SERF ablation lesion formation in real-time. The catheter tip/tissue angle impacts the lesion formation and through perpendicular catheter positioning, deeper intramural areas of the myocardium can be reached.

Characterization of warm saline-enhanced radiofrequency ablation lesions in the infarcted porcine ventricular myocardium.

BACKGROUND: Radiofrequency (RF) ablation of scar-mediated ventricular tachycardia is limited by the size of lesions achieved with conventional catheters. We examined the gross and histopathology characteristics of warm saline-enhanced radiofrequency (SERF) ablation delivered to left ventricular (LV) infarction scars via a novel catheter employing an extendable infusion needle electrode. METHODS AND RESULTS: Yorkshire pigs (n = 14) underwent LV infarction by left anterior descending artery balloon occlusion. After 4-6 weeks, baseline hemodynamic data were obtained and endocardial electroanatomic mapping was performed in 13 surviving animals. Following single, 40 Watt SERF ablations delivered endocardially to the center of infarctions, 4 were examined the same day (day 0). The rest underwent repeat measurements and were sacrificed at 1 week (n = 6), and at 4 weeks (n = 3). Average lesion depth and diameter were: 1.85 ± 0.7 cm and 2.33 ± 0.7 cm at day 0, 0.91 ± 0.1 cm and 1.9 ± 0.4 cm after 1 week, and 1.0 ± 0.2 cm and 1.89 ± 0.76 cm after 4 weeks, respectively. Histopathology at 1 week showed that ablation lesions covered 41 ± 10.6% of the infarct area. SERF ablation lesions extended 100%, 90%, and 68% of the total wall thickness at day 0, 1 week, and 4 weeks, respectively. Hemodynamic parameters were unchanged. There were no myocardial wall perforations or aneurysms. CONCLUSION: SERF ablation within myocardial infarct tissue produced large, near-transmural lesions, without evidence of myocardial perforation, wall thinning, or aneurysm formation. Ablations did not produce any negative hemodynamic effects in this small group of experiments.

Potential microemboli formation risk and its management during the heated saline-enhanced radiofrequency needle-tip catheter ablation.

BACKGROUND: The potential risk of embolic events during ablation in the left ventricle (LV) with a heated saline-enhanced radiofrequency (SERF) needle-tip ablation catheter has not been characterized. OBJECTIVE: This study aimed to investigate the formation of microemboli or other untoward events during SERF ablation. METHODS: Ninety-three radiofrequency (RF) ablation procedures were performed in the LV of 14 pigs by using a SERF catheter (35 W, 70 seconds, and 60°C; normal or degassed saline [NS or DS] irrigation with a flow rate of 10 mL/min) vs a standard irrigated-tip radiofrequency (S-RF) catheter (30 or 50 W, 30 seconds, and 17 mL/min). Microbubble formation was graded on the basis of intracardiac echocardiography. Microbubbles, microembolic signals, and microparticles were monitored using our established model. RESULTS: There was no significant difference in microbubble volume among SERF-NS, SERF-DS, and S-RF 30 W with "grade 1" intracardiac echocardiography microbubbles (median and 25th-75th percentiles 0.201 [0.011-3.13], 0.455 [0.06-2.66], and 0.004 µL [0.00-0.16 µL], respectively). There was no significant difference in microembolic signals among SERF-NS, SERF-DS, and S-RF 30 W with grade 1 bubbles (n = 8.0 ± 5.8, n = 7.6 ± 4.2, and n = 6.1 ± 6.1, respectively). Both SERF-NS and SERF-DS created larger lesions than did both S-RF 30 W and S-RF 50 W deliveries (mean 1241.5 ± 658.6, 1497.7 ± 893.4, 75.0 ± 24.8, and 184.0 ± 93.8 mm3; P < .001). There was no significant difference in microparticle incidence among groups (P = .675). No evidence of embolic events was found in the brain and other organs at the histology assessment. CONCLUSION: In the setting of SERF ablation, significantly large LV lesions can be created without any increment in embolic microbubble or particle events. Grade 1 microbubble is related to the efficacy and safety.

Impact of myocardial fiber orientation on lesions created by a novel heated saline-enhanced radiofrequency needle-tip catheter: An MRI lesion validation study.

BACKGROUND: Irrigated needle catheter ablation is efficacious for creation of transmural lesions in the left ventricle (LV). However, interdependence of needle orientation and myocardial fiber orientation and the resulting influence on lesion creation remain unclear. OBJECTIVE: The purpose of this study was to investigate the impact of myocardial fiber orientation on reproducibility and controllability of lesion creation in LV myocardium using a heated saline-enhanced radiofrequency (SERF) needle-tip catheter system. METHODS: Eleven dogs underwent catheter ablation using this novel catheter. Ablative lesions were created using different power and ablation times (15-50 W; application 25-120 seconds; 60°C irrigation saline at 10 mL/min). Hearts were explanted, and lesions were evaluated using 3-T cardiac magnetic resonance (CMR), gross pathologic, and histologic investigations. RESULTS: Forty-three of 57 lesions (75.4%) were transmural, and lesion depth reached approximately 90% of LV wall thickness. Lesion volume in both gross pathology and ex vivo CMR showed a positive linear correlation with power × radiofrequency (RF) time index (r = 0.637, P <.001; and r = 0.786, P <.001, respectively). Maximum width (circumferential direction of LV) and maximum length (long-axis direction) of all lesions were distributed in the middle layer of LV where myocardium runs circumferentially. Paired-sample t-test showed maximum lesion width was significantly greater than maximum lesion length by both CMR and gross pathologic evaluation (26.1 ± 9.6 mm vs 17.2 ± 6.7 mm, P <.001; and 22.5 ± 7.7 mm vs 18.6 ± 5.9 mm, P <.001, respectively). CONCLUSION: This catheter showed feasibility in creating transmural LV lesions. Power × RF time index was strongly correlated with lesion volume and predicted lesion size. More importantly, SERF lesions extended along the myocardial fiber orientation.

Characterization of Lesions Created by a Heated, Saline Irrigated Needle-Tip Catheter in the Normal and Infarcted Canine Heart.

BACKGROUND: Inability to eliminate intramural arrhythmogenic substrate may lead to recurrent ventricular tachycardia after catheter ablation. The aim of the present study was to evaluate intramural and full thickness lesion formation using a heated saline-enhanced radiofrequency (SERF) needle-tip catheter, compared with a conventional ablation catheter in normal and infarcted myocardium. METHODS: Twenty-two adult mongrel dogs (30-40 kg, 15 normal and 7 myocardial infarct group) were studied. Lesions were created using the SERF catheter (40 W/50 °C) or a standard contact force (CF) catheter in both groups. RESULTS: Comparing SERF to CF ablation, the SERF catheter produced larger lesion volumes than the standard CF catheter-even with >20 g of CF-in both normal (983.1±905.8 versus 461.9±178.3 mm3; P=0.023) and infarcted left ventricular myocardium (1052.3±543.0 versus 340.3±160.5 mm3; P=0.001). SERF catheter lesions were more often transmural than standard CF lesions with >20 g of CF in both groups (59.1% versus 7.7%; P<0.001 and 60.0% versus 12.5%; P=0.017, respectively). Using the SERF catheter, mean depth of ablated lesions reached 90% of the left ventricular wall in both normal and infarcted myocardium. CONCLUSIONS: The SERF catheter created more transmural and larger ablative lesions in both normal and infarcted canine myocardium. SERF ablation is a promising new approach for endocardial intramural and full thickness ablation of ventricular tachycardia substrate that is not accessible with current techniques.

Intracardiac phased-array imaging: methods and initial clinical experience with high resolution, under blood visualization: initial experience with intracardiac phased-array ultrasound.

OBJECTIVES: This study was designed to test the feasibility of high-resolution phased-array intracardiac imaging. BACKGROUND: Intracardiac echocardiographic imaging of the heart during interventional electrophysiologic (EP) procedures has been limited by inadequate ultrasound penetration and absence of Doppler hemodynamic and flow information produced by rotating mechanical ultrasound elements. METHODS: A 10F (3.2 mm) phased-array, variable 5.5 to 10 MHz frequency imaging catheter with a four-way deflectable tip was applied in 24 patients undergoing EP studies. Sixteen prespecified cardiac targets were imaged from a right heart venue. RESULTS: Fifteen patients had no underlying organic heart disease; nine had ischemic, cardiomyopathic, valvular or congenital heart disorders. Longitudinal and short-axis imaging readily disclosed each cardiac valve, support structures and chamber, as well as the pericardium, right and left atrial appendages, the junction of the right atrium and superior vena cava, crista terminalis, tricuspid valve isthmus, coronary sinus orifice, membranous fossa ovalis and pulmonary veins. The average target depth was 8.8+/-1.5 cm (range 0.5 to 15 cm), with adequate penetration at a 7.5 MHz imaging frequency. Color flow and Doppler utilities clearly characterized transaortic and pulmonic valve and pulmonary vein blood flow, including during low output states. CONCLUSIONS: These first human studies with this technology demonstrate the methods, feasibility and utility of intracardiac phased-array vector and Doppler imaging for long-axis, apex-to-base global cardiac imaging. High resolution of endocardial structures and catheters suggests additional utility for visualizing interventional procedures from the right heart.