Characterizing lesion morphology of a novel diamond-tip temperature-controlled irrigated radiofrequency ablation catheter.

BACKGROUND: The DiamondTemp ablation (DTA) system is a novel temperature-controlled irrigated radiofrequency (RF) ablation system that accurately measures tip-tissue temperatures for real-time power modulation. Lesion morphologies from longer RF durations with the DTA system have not been previously described. We sought to evaluate lesion characteristics of the DTA system when varying the application durations. METHODS: A bench model using porcine myocardium was used to deliver discrete lesions in a simulated clinical environment. The DTA system was power-limited at 50 W with temperature set-points of 50 °C and 60 °C (denoted Group_50 and Group_60). Application durations were randomized with a range of 5-120 s. RESULTS: In total, 280 applications were performed. Steam pops were observed in five applications: two applications at 90 s and three applications at 120 s. Lesion size (depth and maximum width) increased significantly with longer applications, until 60 s for both Group_50 and Group_60 (depth: 4.5 ± 1.2 mm and 5.6 ± 1.3 mm; maximum width: 9.3 ± 2.7mm and 11.2 ± 1.7mm, respectively). As lesions transition from resistive to conductive heating (longer than 10 s), the maximum width progressed in a sub-surface propagation. Using a "Time after Temperature 60 °C" (TaT60) analysis, depths of 2-3 mm occur in 0-5 s and depths plateau at 4.6 ± 0.8 mm between 20 and 30 s. CONCLUSIONS: The DTA system rapidly creates wide lesions with lesion depth increasing over time with application durations up to 60 s. Using a TaT60 approach is a promising ablation guidance that would benefit from further investigation.

Effect of contact force on pulsed field ablation lesions in porcine cardiac tissue.

INTRODUCTION: Contact force has been used to titrate lesion formation for radiofrequency ablation. Pulsed field ablation (PFA) is a field-based ablation technology for which limited evidence on the impact of contact force on lesion size is available. METHODS: Porcine hearts (n = 6) were perfused using a modified Langendorff set-up. A prototype focal PFA catheter attached to a force gauge was held perpendicular to the epicardium and lowered until contact was made. Contact force was recorded during each PFA delivery. Matured lesions were cross-sectioned, stained, and the lesion dimensions measured. RESULTS: A total of 82 lesions were evaluated with contact forces between 1.3 and 48.6 g. Mean lesion depth was 4.8 ± 0.9 mm (standard deviation), mean lesion width was 9.1 ± 1.3 mm, and mean lesion volume was 217.0 ± 96.6 mm3 . Linear regression curves showed an increase of only 0.01 mm in depth (depth = 0.01 × contact force + 4.41, R2 = 0.05), 0.03 mm in width (width = 0.03 × contact force + 8.26, R2 = 0.13) for each additional gram of contact force, and 2.20 mm3 in volume (volume = 2.20 × contact force + 162, R2 = 0.10). CONCLUSION: Increasing contact force using a bipolar, biphasic focal PFA system has minimal effects on acute lesion dimensions in an isolated porcine heart model and achieving tissue contact is more important than the force with which that contact is made.

Assessing the Relationship of Applied Force and Ablation Duration on Lesion Size Using a Diamond Tip Catheter Ablation System.

[Figure: see text].

Contact Forces Required to Record Monophasic Action Potentials: A Complement to Catheter Contact Force Measurement.

OBJECTIVE: The ability to monitor catheter contact force (CF) plays a major role in assessing radiofrequency ablation, impacting lesion size and arrhythmia recurrence, and dictating ablation duration and/or overall patient safety. Our study sought to determine the relative CFs required to elicit reproducible monophasic action potential (MAP) recordings. METHODS: The study utilized four swine in which: first, median sternotomies were performed and MAPs were collected from seven ventricular locations on the epicardial surface of each heart; and second, a subset of endocardial signals was recorded from a reanimated heart. In these studies, the initial elicitation and then loss of stable MAP waveforms were recorded, as were their associated catheter CFs (n = 371). RESULTS: Mean CF at the onset of stable MAP recordings was 14.2 ± 2.9 g for epicardial and 16.6 ± 2.5 g for endocardial locations. Across epicardial locations, no significant differences in CF were required to elicit MAPs. Additionally, endocardial and epicardial CFs for MAPs did not significantly differ for respective locations, i.e., right ventricular septum endocardial versus epicardial. In our study, the catheter CFs required to elicit MAPs were within optimal ranges previously reported for eliciting clinically viable radiofrequency ablations. CONCLUSION: We believe that MAP recordings could complement CF measurements with electrical data, providing additional clinical feedback for physicians performing cardiac ablation. SIGNIFICANCE: If applied clinically, MAP recordings could potentially improve ablation outcomes in patients with cardiac arrhythmias.

The Ability to Reproducibly Record Cardiac Action Potentials From Multiple Anatomic Locations: Endocardially and Epicardially, In Situ and In Vitro.

OBJECTIVE: For cardiac arrhythmia mapping and ablation procedures, the ability to record focal cardiac action potentials could aid in precisely identifying lesions, scarred tissue, and/or arrhythmic foci. Our study objective was to validate the electrophysiologic properties of a routinely employed large mammalian in vitro working heart model. METHODS: Monophasic action potentials (MAPs) were recorded from 18 swine hearts during viable hemodynamic function both in situ (postmedian sternotomy) and in vitro (using Visible Heart methodologies). We placed specially designed mapping catheters in epicardial and endocardial locations. High-quality MAP signals were recorded for up to 2 h, and MATLAB was utilized to evaluate relative duration and temporal/regional changes in waveform morphology. RESULTS: MAPs were reproducibly recorded from both epicardial and endocardial locations in situ and in vitro. No significant differences were noted in right atrial endocardial, right ventricular endocardial, right ventricular epicardial, or left atrial epicardial waveforms, when baseline recordings were compared to all other in situ and in vitro time points. Furthermore, MAP duration between right ventricular endocardial and epicardial waveforms was not significantly different, in situ or in vitro. CONCLUSION: The use of in vitro models like the Visible Heart is considered invaluable for the study of cardiac arrhythmias, the development of novel therapies, and/or preclinical testing of future cardiac mapping catheters and systems. SIGNIFICANCE: Preclinical studies assessing in situ and/or in vitro recorded cardiac monophasic action potentials could be critical for the future development and validation of cardiac devices.

The Visible Heart® project and methodologies: novel use for studying cardiac monophasic action potentials and evaluating their underlying mechanisms.

INTRODUCTION: This review describes the utilization of Visible Heart® methodologies for electrophysiologic studies, specifically in the investigation of monophasic action potential (MAP) recordings, with the aim to facilitate new catheter/device design and development that may lead to earlier diagnosis, treatment, and ultimately a higher quality of life for patients with atrial fibrillation. AREAS COVERED: We describe the historically proposed mechanisms behind which electrode is responsible for the MAP recording, new catheters for recording these signals, and how Visible Heart methodologies can be utilized to develop and test new technologies for electrophysiologic investigations. EXPERT OPINION: When compared to traditional electrogram recordings, MAP waveforms provide clinical information vital to the understanding, diagnosis, and treatment of cardiac arrhythmias. New catheters and ablation technologies are routinely being assessed on reanimated large mammalian hearts (swine and human) in our laboratory. These abilities, combined with continued enhancements in imaging modalities and computational systems for electrical mapping, are being applied to the MAP catheter design process. Through this testing we are hopeful that the time from concept to product can be reduced, and that an array of MAP catheters can be placed in the hands of physicians, where they will improve patient outcomes.