Development of a clinically relevant ex vivo model of cardiac ablation for testing of ablation catheters.

INTRODUCTION: Reliable ex vivo cardiac ablation models have the potential to increase catheter testing throughput while minimizing animal usage. The goal of this work was to develop a physiologically relevant ex vivo swine model of cardiac ablation displaying minimal variability and high repeatability and identify and optimize key parameters involved in ablation outcomes. METHODS AND RESULTS: A root cause analysis was conducted to identify variables affecting ablation outcomes. Parameters associated with the tissue, bath media, and impedance were identified. Variables were defined experimentally and/or from literature sources to best mimic the clinical cardiac ablation setting. The model was validated by performing three independent replicates of ex vivo myocardial ablation and a direct comparison of lesion outcomes of the ex vivo swine myocardial and in vivo canine thigh preparation (TP) models. Replicate experiments on the ex vivo model demonstrated low variance in ablation depth (6.5 ± 0.6, 6.3 ± 0.6, 6.2 ± 0.4 mm) and width (10.4 ± 1.1, 9.7 ± 1.0, 9.9 ± 0.9 mm) and no significant differences between replicates. In a direct comparison of the two models, the ex vivo model demonstrated ablation depths similar to the canine TP model at 35 W (6.9 ± 1.0, and 7.0 ± 0.9 mm) and 50 W (8.0 ± 0.7, and 8.4 ± 0.7 mm), as well as similar power to depth ratios (15% and 19% for the ex vivo cardiac and in vivo TP models, respectively). CONCLUSION: The ex vivo model exhibited strong lesion reproducibility and power-to-depth ratios comparable to the in vivo TP model. The optimized ex vivo model minimizes animal usage with increased throughput, lesion characteristics similar to the in vivo TP model, and ability to discriminate minor variations between different catheter designs.

A novel octaray multielectrode catheter for high-resolution atrial mapping: Electrogram characterization and utility for mapping ablation gaps.

INTRODUCTION: Multielectrode mapping catheters improve the ability to map within the heterogeneous scar. A novel Octaray catheter with eight spines and 48 electrodes may further improve the speed and resolution of atrial mapping. The aims of this study were to (1) establish the Octaray's baseline mapping performance and electrogram (EGM) characteristics in healthy atria and to (2) determine its utility for identifying gaps in a swine model of atrial ablation lines. METHODS AND RESULTS: The right atria of eight healthy swine were mapped with Octaray and Pentaray catheters (Biosense Webster, Irvine, CA) before and after the creation of ablation lines with intentional gaps. Baseline mapping characteristics including EGM amplitude, duration, number of EGMs, and mapping time were compared. Postablation maps were created and EGM characteristics of continuous lines and gaps were correlated with pathology. Compared with Pentaray, the Octaray collected more EGMs per map (2178 ± 637 vs 1046 ± 238; P < 0.001) at a shorter mapping duration (3.2 ± 0.79 vs 6.9 ± 2.67 minutes; P < 0.001). In healthy atria, the Octaray recorded lower bipolar voltage amplitude (1.96 ± 1.83 mV vs 2.41 ± 1.92 mV; P < 0.001) while ablation gaps were characterized by higher voltage amplitude (1.24 ± 1.12 mV vs 1.04 ± 1.27 mV; P < 0.001). Ablation gaps were similarly identified by both catheters (P = 1.0). The frequency of "false gaps," defined as intact ablation lines with increased voltage amplitude was more common with Pentaray (6 vs 2) and resulted from erroneous annotation of far-field EGMs. CONCLUSION: The Octaray increases the mapping speed and density compared with the Pentaray catheter. It is as sensitive for identifying ablation gaps and more specific for mapping intact ablation lines.

Automated Identification of Ventricular Tachycardia Ablation Targets: Multicenter Validation and Workflow Characterization.

Decrement evoked potentials (EPs) (DeEPs) constitute an accepted method to identify physiological ventricular tachycardia (VT) ablation targets without inducing VT. The feasibility of automated software (SW) in the detection of arrhythmogenic VT substrate has been documented. However, multicenter validation of automated SW and workflow has yet to be characterized. The objective of this study was to describe the functionality of a novel DeEP SW (Biosense Webster, Diamond Bar, CA, USA) and evaluate the independent performance of the automated algorithm using multicenter data. VT ablation cases were performed in the catheterization laboratory and retrospectively analyzed using the DeEP SW. The algorithm indicated and mapped DeEPs by first identifying capture in surface electrocardiograms (ECGs). Once capture was confirmed, the EPs of S1 paces were detected. The algorithm checked for the stability of S1 EPs by comparing the last 3 of the 8 morphologies and attributing standard deviation values. The extra-stimulus EP was then detected by comparing it to the S1 EP. Once detected, the DeEP value was computed from the extra-stimulus and displayed as a sphere on a voltage map. A total of 5,885 DeEP signals were extracted from 21 substrate mapping cases conducted at 3 different centers (in Spain, Canada, and Australia). A gold standard was established from ECGs manually marked by subject experts. Once the algorithm was deployed, 91.6% of S2 algorithm markings coincided with the gold standard, 1.9% were false-positives, and 0.1% were false-negatives. Also, 6.4% were non-specific DeEP detections. In conclusion, the automated DeEP algorithm identifies and displays DeEP points, revealing VT substrates in a multicenter validation study. The automation of identification and mapping display is expected to improve efficiency.

Activation Mapping With Integration of Vector and Velocity Information Improves the Ability to Identify the Mechanism and Location of Complex Scar-Related Atrial Tachycardias.

BACKGROUND: Activation mapping of scar-related atrial tachycardias (ATs) can be difficult to interpret because of inaccurate time annotation of complex electrograms and passive diastolic activity. We examined whether integration of a vector map can help to describe patterns of propagation to better explain the mechanism and location of ATs. METHODS: The investigational mapping algorithm calculates vectors and applies physiological constraints of electrical excitation in human atrial tissue to determine the arrhythmia source and circuit. Phase I consisted of retrospective evaluation in 35 patients with ATs. Phase II consisted of prospective validation in 20 patients with ATs. Macroreentry was defined as a continuous propagation in a circular path >30 mm; localized reentry was defined as a circular path ≤30 mm; a focal source had a centrifugal spread from a point source. RESULTS: In phase I, standard activation mapping identified 28 of 40 ATs (70%): 25 macroreentry and 3 focal tachycardias. In the remaining 12 ATs, the mechanism and location could not be identified by activation and required entrainment or empirical ablation for termination (radiofrequency time, 17.3±6.6 minutes). In comparison, the investigational algorithm identified 37 of 40 (92.5%) ATs, including 5 macroreentry, 3 localized reentry, and 1 focal AT not identified by standard mapping. It also predicted the successful termination site of all 37 of 40 ATs. In phase II, the investigational algorithm identified 12 macroreentry, 6 localized reentry, and 2 focal tachycardias that all terminated with limited ablation (3.2±1.7 minutes). It identified 3 macroreentry, 3 localized reentry, and 1 focal AT not well characterized by standard mapping. The diagnosis of localized reentry was supported by highly curved vectors, resetting with increasing curve and termination with limited ablation (22±6 s). CONCLUSIONS: Activation mapping integrating vectors can help determine the arrhythmia mechanism and identify its critical components. It has particular value for identifying complex macroreentrant circuits and for differentiating a focal source from a localized reentry.

Chamber-Specific Radiofrequency Lesion Dimension Estimation Using Novel Catheter-Based Tissue Interface Temperature Sensing: A Preclinical Assessment.

OBJECTIVES: This study sought to compare a novel lesion dimension estimation approach to actual measurements of lesion dimensions on necropsy in porcine atria and ventricles. BACKGROUND: An irrigated-tip, force-sensing radiofrequency catheter with 6 temperature (tip-tissue interface) sensors allows for assessment of lesion dimensions based on estimated tissue temperature. Lesion dimension assessment has not been attempted previously in atrial tissue. METHODS: Ablations were performed using this catheter in all chambers. Irrigated radiofrequency was delivered using 20 to 50 W for durations that ranged from 15 to 90 s with contact force ranging from 5 to 45 g to replicate a wide spectrum of clinical conditions. All swine were then sacrificed and lesions were identified and photographed. Three independent observers made offline measurements, which were then averaged to obtain lesion width and depth for comparison with estimated dimensions based on interface tissue temperature. RESULTS: In 9 swine, 54 atrial and 61 ventricular lesions were assessed. In the atria, the mean difference between the measured and estimated depth and width was 0.9 ± 0.74 mm and 1.2 ± 0.9 mm, respectively. Eighty percent of all lesions had a difference of ≤1.7 mm for depth and ≤1.74 mm for width. In the ventricle, the mean difference between the measured and estimated depth and width was 0.75 ± 0.6 mm and 1.66 ± 1.1 mm, respectively. Eighty percent of all lesions had a difference of ≤1.1 mm ventricular depth and ≤2.6 mm for width. CONCLUSIONS: Estimation of lesion dimensions can be achieved with clinically relevant accuracy using unique temperature signatures. These data have important implications for understanding the adequacy of lesion overlap and assessment of transmurality.

Real-Time Localization of Ventricular Tachycardia Origin From the 12-Lead Electrocardiogram.

OBJECTIVES: The aim of this study was to develop rapid computational methods for identifying the site of origin of ventricular activation from the 12-lead electrocardiogram. BACKGROUND: Catheter ablation of ventricular tachycardia in patients with structural heart disease frequently relies on a substrate-based approach, which may use pace mapping guided by body-surface electrocardiography to identify culprit exit sites. METHODS: Patients undergoing ablation of scar-related VT (n = 38) had 12-lead electrocardiograms recorded during pacing at left ventricular endocardial sites (n = 1,012) identified on 3-dimensional electroanatomic maps and registered to a generic left ventricular endocardial surface divided into 16 segments and tessellated into 238 triangles; electrocardiographic data were reduced for each lead to 1 variable, consisting of QRS time integral. Two methods for estimating the origin of activation were developed: 1) a discrete method, estimating segment of activation origin using template matching; and 2) a continuous method, using population-based multiple linear regression to estimate triangle of activation origin. A variant of the latter method was derived, using patient-specific multiple linear regression. RESULTS: The optimal QRS time integral included the first 120 ms of the QRS interval. The mean localization error of population-based regressions was 12 ± 8 mm. Patient-specific regressions can achieve localization accuracy better than 5 mm when at least 10 training-set pacing sites are used; this accuracy further increases with each added pacing site. CONCLUSIONS: Computational intraprocedure methods can automatically identify the segment and site of left ventricular activation using novel algorithms, with accuracy within <10 mm.

An impedance-based catheter positioning system for cardiac mapping and navigation.

Over the last years, nonfluoroscopic in vivo cardiac mapping and navigation systems have been developed and successfully applied in clinical electrophysiology. Clearly, a trend can be observed to introduce more sensors into the measurement system so that physiological information can be gathered simultaneously and more efficiently and the duration of procedure can be shortened significantly. However, it would not be realistic to equip each catheter electrode with a localizer, e.g., by embedding a miniature magnetic location sensor. Therefore, in this paper, an alternate approach has been worked out to efficiently localize multiple catheter electrodes by considering the impedance between electrodes in the heart and electrode patches on the body surface. In application of the new technique, no additional expensive and sophisticated hardware is required other than the currently existing cardiac navigation system. A tank model and a computerized realistic human model are employed to support the development of the positioning system. In the simulation study, the new approach achieves an average localization error of less than 1 mm, which proves the feasibility of the impedance-based catheter positioning system. Consequently, the new positioning system can provide an inexpensive and accurate solution to improve the efficiency and efficacy of catheter ablation.