Pulsed Field Ablation Index-Guided Ablation for Lesion Formation: Impact of Contact Force and Number of Applications in the Ventricular Model.

BACKGROUND: The effect of contact force (CF) on lesion formation is not clear during pulsed field ablation (PFA). The aim of this study was to evaluate the impact of CF, PFA, and their interplay through the PFA index (PF index) formula on the ventricular lesion size in swine. METHODS: PFA was delivered through the CF-sensing OMNYPULSE catheter. Predefined PFA applications (×3, ×6, ×9, and ×12) were delivered maintaining low (5-25 g), high (26-50 g), and very high (51-80 g) CFs. First, PFA lesions were evaluated on necropsy in 11 swine to investigate the impact of CF/PFA-and their integration in the PF index equation-on lesion size (study characterization). Then, 3 different PF index thresholds-300, 450, and 600-were tested in 6 swine to appraise the PF index accuracy to predict the ventricular lesion depth (study validation). RESULTS: In the study characterization data set, 111 PFA lesions were analyzed. CF was 32±17 g. The average lesion depth and width were 3.5±1.2 and 12.0±3.5 mm, respectively. More than CF and PFA dose alone, it was their combined effect to impact lesion depth through an asymptotically increasing relationship. Likewise, not only was the PF index related to lesion depth in the study validation data set (r2=0.66; P<0.001) but it also provided a prediction accuracy of the observed depth of ±2 mm in 69/73 lesions (95%). CONCLUSIONS: CF and PFA applications play a key role in lesion formation during PFA. Further studies are required to evaluate the best PFA ablation settings to achieve transmural lesions.

Point-by-Point Pulsed Field Ablation Using a Multimodality Generator and a Contact Force-Sensing Ablation Catheter: Comparison With Radiofrequency Ablation in a Remapped Chronic Swine Heart.

BACKGROUND: Pulsed field ablation (PFA) has emerged as an alternative to radiofrequency ablation. However, data on focal point-by-point PFA are scarce. The aim of this study was to compare lesion durability and collateral damage between focally delivered unipolar/biphasic PFA versus radiofrequency in swine. METHODS: Eighteen swine were randomized to low-dose PFA, high-dose PFA, and radiofrequency using a multimodality generator. Radiofrequency delivered by market-available generator served as control group. A contact force-sensing catheter was used to focally deliver PFA/radiofrequency at the pulmonary veins and other predefined sites in the atria. Animals were remapped postprocedurally and 28 days postablation to test lesion durability followed by gross necroscopy and histology. RESULTS: All targeted sites were successfully ablated (contact force value, 13.9±4.1 g). Follow-up remapping showed persistent pulmonary vein isolation in all animals (100%) with lesion durability at nonpulmonary vein sites proven in most (98%). Regardless of the energy source used, the lesion size was similar across the study groups. Transmurality was achieved in 95% of targeted sites and 100% at pulmonary veins. On histology, PFA animals showed more mature scar formation than their radiofrequency counterpart without myocardial necrosis or inflammation. Finally, no sign of collateral damage was observed in any of the groups. CONCLUSIONS: In a randomized preclinical study, focally delivered unipolar/biphasic PFA guided by contact force values was associated with durable lesions on chronic remapping and with mature scar formation on histology without signs of collateral injury on necroscopy. Further studies are needed to investigate the long-term feasibility of this new approach to atrial fibrillation treatment.

Time Course of Irreversible Electroporation Lesion Development Through Short- and Long-Term Follow-Up in Pulsed-Field Ablation-Treated Hearts.

BACKGROUND: Pulsed-field ablation (PFA) is a tissue-selective, nonthermal cardiac ablation modality. A novel PFA ablation system consisted of a multichannel irreversible electroporation generator system and a multielectrode circular irreversible electroporation catheter has been developed for catheter ablation. To understand the progression and immediate impacts of PFA, this study evaluated the subchronic (7±3 day) and chronic (30±3 day) safety and performance of the novel PFA system when simulating pulmonary vein and superior vena cava isolation in a porcine beating heart model. METHODS: Ten swine models were divided into subchronic (n=6) and chronic cohorts (n=4). Lesions were performed within the right and left atrium to conduct right pulmonary veins and superior vena cava isolations, in addition to creating stacked lesions in the left atrium roof and right atrium posterior wall. RESULTS: Acute pulmonary vein and superior vena cava isolation were achieved in 10 out of 10 swine and demonstrated 100% lesion durability in both cohorts, including sustained elimination of electrical activity at the left atrium roof and right atrium posterior wall. Histology demonstrated that all the cardiac sites ablated showed discrete zones of loss of myocardial fibers or smooth muscle cells with preservation of the tissue architecture with resultant fibrocellular replacement, neovascularization, and neocollagen deposition. Mineralization findings were present in association with residual necrotic muscle fibers. Only in 7 days group, areas of mineralization were frequently associated with inflammation. There were no treatment-related changes in other tissues, including complete sparing of the phrenic nerve. CONCLUSIONS: Pulsed-field ablation for pulmonary vein and superior vena cava isolation with the novel PFA system was feasible, safe with myocardial-specific ablative effect. Durable lesions were observed at the target areas. with inflammation phenomena mainly documented at 7 days.

In vivo porcine characterization of atrial lesion safety and efficacy utilizing a circular pulsed-field ablation catheter including assessment of collateral damage to adjacent tissue in supratherapeutic ablation applications.

INTRODUCTION: Pulsed-field ablation (PFA), an ablative method that causes cell death by irreversible electroporation, has potential safety advantages over radiofrequency ablation and cryoablation. Pulmonary vein (PV) isolation was performed in a porcine model to characterize safety and performance of a novel, fully-integrated biphasic PFA system comprising a multi-channel generator, variable loop circular catheter, and integrated PFA mapping software module. METHODS: Eight healthy porcine subjects were included. To evaluate safety, multiple ablations were performed, including sites not generally targeted for therapeutic ablation, such as the right inferior PV lumen, right superior PV ostium, and adjacent to the esophagus and phrenic nerve. To evaluate the efficacy, animals were recovered, followed for 30(±3) days, then re-mapped. Gross pathological and histopathological examinations assessed procedural injuries, chronic thrombosis, tissue ablation, penetration depth, healing, and inflammatory response. RESULTS: All eight animals survived follow-up. PV narrowing was not observed acutely nor at follow-up, even when ablation was performed deep to the PV ostium. No injury was seen grossly or histologically in adjacent structures. All PVs were durably isolated, confirmed by bidirectional block at re-map procedure. Histological examination showed complete, transmural necrosis around the circumference of the ablated section of right PVs. CONCLUSION: This preclinical evaluation of a fully-integrated PFA system demonstrated effective and durable ablation of cardiac tissue and PV isolation without collateral damage to adjacent structures, even when ablation was performed in more extreme settings than those used therapeutically. Histological staining confirmed complete transmural cell necrosis around the circumference of the PV ostium at 30 days.

Comparison of In Vivo Tissue Temperature Profile and Lesion Geometry for Radiofrequency Ablation With High Power-Short Duration and Moderate Power-Moderate Duration: Effects of Thermal Latency and Contact Force on Lesion Formation.

[Figure: see text].

Circular Multielectrode Pulsed Field Ablation Catheter Lasso Pulsed Field Ablation: Lesion Characteristics, Durability, and Effect on Neighboring Structures.

BACKGROUND: Pulsed field ablation (PFA) is a nonthermal energy with potential safety advantages over radiofrequency ablation. This study investigated a novel PFA system-a circular multielectrode catheter (PFA lasso) and a multichannel generator designed to work with Carto 3 mapping system. METHODS: A 7.5F bidirectional circular catheter with 10 electrodes and variable expansion was designed for PFA (biphasic, 1800 Volts). This study included a total of 16 swine used to investigate the following 3 experimental aims: Aim 1 examined the feasibility to create a right atrial ablation line of block from the superior vena cava to the inferior vena cava. Aim 2 examined the effect of PFA on lesion maturation including durability after a 30-day survival period. Aim 3 examined the effect of high-intensity PFA (10 applications) on esophageal and phrenic nerve tissue in comparison to normal intensity radiofrequency ablation (1-2 applications). Histopathologic analysis of all cardiac, esophageal, and phrenic nerve tissue was performed. RESULTS: Acute line of block was achieved in 12/12 swine (100%) and required a total PFA time of 14 seconds (interquartile range [IQR], 9-24.5) per line. Ablation line durability after 28±3 days was maintained in 11/12 (91.7%) swine. PFA resulted in transmural lesions in 179/183 (97.8%) sections and a median lesion width of 14.2 mm. High-intensity PFA (9 [IQR, 8-14] application) had no effect on the esophagus while standard intensity radiofrequency ablation (1.5 [IQR, 1-2] applications) resulted in deep esophageal tissue injury involving the muscularis propria and adventitia layers. High-intensity PFA (16 [IQR, 10-28] applications) has no effect on phrenic nerve function and structure while standard dose radiofrequency ablation (1.5 [IQR, 1-2] applications) resulted in acute phrenic nerve paralysis. CONCLUSIONS: In this preclinical model, a multielectrode circular catheter and multichannel generator produced durable atrial lesions with lower vulnerability to esophageal or phrenic nerve damage.

Temperature-Controlled Radiofrequency Ablation Using Irrigated Catheters: Maximizing Ventricular Lesion Dimensions While Reducing Steam-Pop Formation.

OBJECTIVES: The goal of this study was to examine the safety and efficacy of radiofrequency ablation (RFA) with irrigated catheters operated in a temperature-controlled mode for ventricular ablation. BACKGROUND: Techniques to increase RFA dimensions are associated with higher risk for steam-pops. A novel irrigated catheter with circumferential thermocouples embedded in its ablation surface provides real-time surface temperature data. This study hypothesized that RFA operated in a temperature-controlled mode may allow maximizing lesion dimensions while reducing the occurrence of steam-pops. METHODS: RFA with an irrigated catheter incorporating surface thermocouples was examined in 6 swine thigh muscle preparations and 15 beating ventricles at higher (50 W/60 s, Tmax50oC) and lower (50 W/60 s, Tmax45oC) temperature limits. Biophysical properties, lesion dimensions, and steam-pop occurrence were compared versus RFA with a standard catheter operated in power-control mode at higher (50 W/60 s) and lower (40W/60 s) power, and additionally at high power with half-normal saline (50 W/60 s). RESULTS: In the thigh muscle preparation, lesion depth and width were similar between all groups (p = 0.90 and p = 0.17, respectively). Steam-pops were most frequent with power-controlled ablation at 50 W/60 s (82%) and least frequent with temperature-controlled ablation at 50 W/60 s, Tmax45oC (0%; p < 0.001). In the beating ventricle, lesion depth was comparable between all RFA settings (p = 0.09). Steam-pops were most frequent using power-controlled ablation at 50 W/60 s (37%) and least frequent with temperature-controlled ablation at 50 W/60 s, Tmax45oC (7%; p < 0.001). Half-normal saline had no incremental effect on lesion dimensions at 50 W in either the thigh muscle or the beating heart. CONCLUSIONS: RFA using a novel irrigated catheter with surface thermocouples operated in a temperature-controlled mode can maximize lesion dimensions while reducing the risk for steam-pops.

Pulmonary Vein Isolation With a Novel Multielectrode Radiofrequency Balloon Catheter That Allows Directionally Tailored Energy Delivery: Short-Term Outcomes From a Multicenter First-in-Human Study (RADIANCE).

BACKGROUND: Balloon catheters facilitate pulmonary vein (PV) isolation, but current technology is limited by either a single ablative element, potentially leading to over-ablation of thin and under-ablation of thick tissue, or prolonged procedure times. Visualized by electroanatomical mapping, a novel compliant radiofrequency balloon catheter with 10 irrigated, flexible electrodes can simultaneously and independently deliver energy. Herein, we evaluated the feasibility, safety, and short-term efficacy of this radiofrequency balloon in a multicenter, single-arm, first-in-human study. METHODS: Paroxysmal atrial fibrillation patients underwent PV isolation with the radiofrequency balloon delivered over-the-wire with a deflectable 13.5F sheath. Radiofrequency energy is delivered simultaneously from all electrodes-up to 30 s posteriorly and 60 s anteriorly. Esophageal temperature was monitored in all patients; the esophagus was also mechanically deviated in 10 patients. RESULTS: At 4 sites, 39 patients were treated by 9 operators. The radiofrequency balloon isolated all targeted PVs (152/152), 79.6% with a single application. Electrical reconnection occurred in only 7/150 PVs (4.7%) on adenosine/isoproterenol challenge. Mean procedure, balloon dwell, and fluoroscopy times were 101.6, 40.5, and 17.4 min, respectively. Esophagogastroduodenoscopy revealed asymptomatic esophageal erythema in 5 patients. Phrenic nerve palsy occurred in a patient in whom phrenic pacing was inadvertently omitted. At 3 months, imaging revealed no PV stenosis, and early atrial arrhythmia recurrence occurred in only 10/39 (25.6%) patients. CONCLUSIONS: The compliant radiofrequency balloon can directionally tailor energy delivery for efficient, effective, and reasonably safe acute PV isolation. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: ISRCTN 11764506.

High-Power and Short-Duration Ablation for Pulmonary Vein Isolation: Biophysical Characterization.

OBJECTIVES: This study sought to examine the biophysical properties of high-power and short-duration (HP-SD) radiofrequency ablation for pulmonary vein isolation. BACKGROUND: Pulmonary vein isolation is the cornerstone of atrial fibrillation ablation. However, pulmonary vein reconnection is frequent and is often the result of catheter instability, tissue edema, and a reversible nontransmural injury. We postulated that HP-SD ablation increases lesion-to-lesion uniformity and transmurality. METHODS: This study included 20 swine and a novel open-irrigated ablation catheter with a thermocouple system able to record temperature at the catheter-tissue interface (QDOT Micro Catheter). Step 1 compared 3 HP-SD ablation settings: 90 W/4 s, 90 W/6 s, and 70 W/8 s in a thigh muscle preparation. Ablation at 90 W/4 s was identified as the best compromise between lesion size and safety parameters, with no steam-pop or char. In step 2, a total of 174 single ablation applications were performed in the beating heart and resulted in 3 (1.7%) steam-pops, all occurring at catheter-tissue interface temperature ≥85°C. Additional 233 applications at 90 W/4 s and temperature limit of 65°C were applied without steam-pop. Step 3 compared the presence of gaps and lesion transmurality in atrial lines and pulmonary vein isolation between HP-SD (90 W/4 s, T ≤65°C) and standard (25 W/20 s) ablation. RESULTS: HP-SD ablation resulted in 100% contiguous lines with all transmural lesions, whereas standard ablation had linear gaps in 25% and partial thickness lesions in 29%. Ablation with HP-SD produced wider lesions (6.02 ± 0.2 mm vs. 4.43 ± 1.0 mm; p = 0.003) at similar depth (3.58 ± 0.3 mm vs. 3.53 ± 0.6 mm; p = 0.81) and improved lesion-to-lesion uniformity with comparable safety end points. CONCLUSIONS: In a preclinical model, HP-SD ablation (90 W/4 s, T ≤65°C) produced an improved lesion-to-lesion uniformity, linear contiguity, and transmurality at a similar safety profile of conventional ablation.

Safety and efficacy of delivering high-power short-duration radiofrequency ablation lesions utilizing a novel temperature sensing technology.

Aims: Delivery of high-power short-duration radiofrequency (RF) ablation lesions is not commonly used, in part because conventional thermocouple (TC) technology underestimates tissue temperature, increasing the risk of steam pop, and thrombus formation. We aimed to test whether utilization of an ablation catheter equipped with a highly accurate novel TC technology could facilitate safe and effective delivery of high-power RF lesions. Methods and results: Adult male Yorkshire swine were used for the study. High-power short-duration ablations (10-s total; 90 W for 4 s followed by 50 W for 6 s) were delivered using an irrigated force sensing catheter, equipped with six miniature TC sensors embedded in the tip electrode shell. Power modulation was automatically performed when the temperature reached 65°C. Ablation parameters were recorded and histopathological analysis was performed to assess lesion formation. One hundred and fourteen RF applications, delivered using the study ablation protocol in the ventricles of eight swine [53 in the right ventricle (RV), 61 in the left ventricle (LV)], were analysed. Average power delivered was 55.4 ± 5.3 W and none of the ablations resulted in a steam pop. Fourteen out of the 114 (12.3%) lesions were transmural. The mean lesion depth was 3.9 ± 1.1 mm for the 100 non-transmural lesions. Similar ablation parameters resulted in bigger impedance drop (11.6 Ω vs. 9.1 Ω, P = 0.009) and deeper lesions in the LV compared with the RV (4.3 ± 1.2 mm vs. 3.3 ± 0.8 mm, P < 0.001). Conclusion: Delivery of high-power short-duration RF energy applications, facilitated by a novel ablation catheter system equipped with advanced TC technology, is feasible, safe, and results in the formation of effective ablation lesions.

Prediction of radiofrequency ablation lesion formation using a novel temperature sensing technology incorporated in a force sensing catheter.

BACKGROUND: Real-time radiofrequency (RF) ablation lesion assessment is a major unmet need in cardiac electrophysiology. OBJECTIVE: The purpose of this study was to assess whether improved temperature measurement using a novel thermocoupling (TC) technology combined with information derived from impedance change, contact force (CF) sensing, and catheter orientation allows accurate real-time prediction of ablation lesion formation. METHODS: RF ablation lesions were delivered in the ventricles of 15 swine using a novel externally irrigated-tip catheter containing 6 miniature TC sensors in addition to force sensing technology. Ablation duration, power, irrigation rate, impedance drop, CF, and temperature from each sensor were recorded. The catheter "orientation factor" was calculated using measurements from the different TC sensors. Information derived from all the sources was included in a mathematical model developed to predict lesion depth and validated against histologic measurements. RESULTS: A total of 143 ablation lesions were delivered to the left ventricle (n = 74) and right ventricle (n = 69). Mean CF applied during the ablations was 14.34 ± 3.55g, and mean impedance drop achieved during the ablations was 17.5 ± 6.41 Ω. Mean difference between predicted and measured ablation lesion depth was 0.72 ± 0.56 mm. In the majority of lesions (91.6%), the difference between estimated and measured depth was ≤1.5 mm. CONCLUSION: Accurate real-time prediction of RF lesion depth is feasible using a novel ablation catheter-based system in conjunction with a mathematical prediction model, combining elaborate temperature measurements with information derived from catheter orientation, CF sensing, impedance change, and additional ablation parameters.

High-Resolution Mapping of Ventricular Scar: Evaluation of a Novel Integrated Multielectrode Mapping and Ablation Catheter.

OBJECTIVES: This study sought to evaluate an investigational catheter that incorporates 3 microelectrodes embedded along the circumference of a standard 3.5-mm open-irrigated catheter. BACKGROUND: Mapping resolution is influenced by both electrode size and interelectrode spacing. Multielectrode mapping catheters enhance mapping resolution within scar compared with standard ablation catheters; however, this requires the use of 2 separate catheters for mapping and ablation. METHODS: Six swine with healed infarction and 2 healthy controls underwent mapping of the left ventricle using a THERMOCOOL SMARTTOUCH SF catheter with 3 additional microelectrodes (0.167 mm2) along its circumference (Qdot, Biosense Webster, Diamond Bar, California). Mapping resolution in healthy and scarred tissue was compared between the standard electrodes and microelectrodes using electrogram characteristics, cardiac magnetic resonance, and histology. RESULTS: In healthy myocardium, bipolar voltage amplitude was similar between the standard electrodes and microelectrodes, with a fifth percentile of 1.19 and 1.30 mV, respectively. In healed infarction, the area of low bipolar voltage (defined as <1.5 mV) was smaller with microelectrodes (16.8 cm2 vs. 25.3 cm2; p = 0.033). Specifically, the microelectrodes detected zones of increased bipolar voltage amplitude, with normal electrogram characteristics occurring at the end of or after the QRS, consistent with channels of preserved subendocardium. Identification of surviving subendocardium by the microelectrodes was consistent with cardiac magnetic resonance and histology. The microelectrodes also improved distinction between near-field and far-field electrograms, with more precise identification of scar border zones. CONCLUSIONS: This novel catheter combines high-resolution mapping and radiofrequency ablation with an open-irrigated, tissue contact-sensing technology. It improves scar mapping resolution while limiting the need for and cost associated with the use of a separate mapping catheter.

Magnetic resonance imaging-compatible circular mapping catheter: an in vivo feasibility and safety study.

AIMS: Interventional cardiac catheter mapping is routinely guided by X-ray fluoroscopy, although radiation exposure remains a significant concern. Feasibility of catheter ablation for common flutter has recently been demonstrated under magnetic resonance imaging (MRI) guidance. The benefit of catheter ablation under MRI could be significant for complex arrhythmias such as atrial fibrillation (AF), but MRI-compatible multi-electrode catheters such as Lasso have not yet been developed. This study aimed at demonstrating the feasibility and safety of using a multi-electrode catheter [magnetic resonance (MR)-compatible Lasso] during MRI for cardiac mapping. We also aimed at measuring the level of interference between MR and electrophysiological (EP) systems. METHODS AND RESULTS: Experiments were performed in vivo in sheep (N = 5) using a multi-electrode, circular, steerable, MR-compatible diagnostic catheter. The most common MRI sequences (1.5T) relevant for cardiac examination were run with the catheter positioned in the right atrium. High-quality electrograms were recorded while imaging with a maximal signal-to-noise ratio (peak-to-peak signal amplitude/peak-to-peak noise amplitude) ranging from 5.8 to 165. Importantly, MRI image quality was unchanged. Artefacts induced by MRI sequences during mapping were demonstrated to be compatible with clinical use. Phantom data demonstrated that this 10-pole circular catheter can be used safely with a maximum of 4°C increase in temperature. CONCLUSIONS: This new MR-compatible 10-pole catheter appears to be safe and effective. Combining MR and multipolar EP in a single session offers the possibility to correlate substrate information (scar, fibrosis) and EP mapping as well as online monitoring of lesion formation and electrical endpoint.

Improved cardiac magnetic resonance thermometry and dosimetry for monitoring lesion formation during catheter ablation.

PURPOSE: A new real-time MR-thermometry pipeline was developed to measure multiple temperature images per heartbeat with 1.6×1.6×3 mm3 spatial resolution. The method was evaluated on 10 healthy volunteers and during radiofrequency ablation (RFA) in sheep. METHODS: Multislice, electrocardiogram-triggered, echo-planar imaging was combined with parallel imaging, under free breathing conditions. In-plane respiratory motion was corrected on magnitude images by an optical flow algorithm. Motion-related susceptibility artifacts were compensated on phase images by an algorithm based on Principal Component Analysis. Correction of phase drift and temporal filter were included in the pipeline implemented in the Gadgetron framework. Contact electrograms were recorded simultaneously with MR thermometry by an MR-compatible ablation catheter. RESULTS: The temporal standard deviation of temperature in the left ventricle remained below 2 °C on each volunteer. In sheep, focal heated regions near the catheter tip were observed on temperature images (maximal temperature increase of 38 °C) during RFA, with contact electrograms of acceptable quality. Thermal lesion dimensions at gross pathology were in agreement with those observed on thermal dose images. CONCLUSION: This fully automated MR thermometry pipeline (five images/heartbeat) provides direct assessment of lesion formation in the heart during catheter-based RFA, which may improve treatment of cardiac arrhythmia by ablation. Magn Reson Med 77:673-683, 2017. © 2016 International Society for Magnetic Resonance in Medicine.

Three-dimensional ultrasound for image-guided mapping and intervention: methods, quantitative validation, and clinical feasibility of a novel multimodality image mapping system.

BACKGROUND: Multiple factors create discrepancies between electroanatomic maps and merged, preacquired computed tomographic images used in guiding atrial fibrillation ablation. Therefore, a Carto-based 3D ultrasound image system (Biosense Webster Inc) was validated in an animal model and tested in 15 atrial fibrillation patients. METHODS AND RESULTS: Twelve dogs underwent evaluation using a newly developed Carto-based 3D ultrasound system. After fiducial clip markers were percutaneously implanted at critical locations in each cardiac chamber, 3D ultrasound geometries, derived from a family of 2D intracardiac echocardiographic images, were constructed. Point-source error of 3D ultrasound-derived geometries, assessed by actual real-time 2D intracardiac echocardiographic clip sites, was 2.1+/-1.1 mm for atrial and 2.4+/-1.2 mm for ventricular sites. These errors were significantly less than the variance on CartoMerge computed tomographic images (atria: 3.3+/-1.6 mm; ventricles: 4.8+/-2.0 mm; P<0.001 for both). Target ablation at each clip, guided only by 3D ultrasound-derived geometry, resulted in lesions within 1.1+/-1.1 mm of the actual clips. Pulmonary vein ablation guided by 3D ultrasound-derived geometry resulted in circumferential ablative lesions. Mapping in 15 patients produced modestly smaller 3D ultrasound versus electroanatomic map left atrial volumes (98+/-24 cm(3) versus 109+/-25 cm(3), P<0.05). Three-dimensional ultrasound-guided pulmonary vein isolation and linear ablation in these patients were successfully performed with confirmation of pulmonary vein entrance/exit block. CONCLUSIONS: These data demonstrate that 3D ultrasound images seamlessly yield anatomically accurate chamber geometries. Image volumes from the ultrasound system are more accurate than possible with CartoMerge computed tomographic imaging. This clinical study also demonstrates the initial feasibility of this guidance system for ablation in patients with atrial fibrillation.