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.

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.

Initial human feasibility of infusion needle catheter ablation for refractory ventricular tachycardia.

BACKGROUND: Ablation of ventricular tachycardia (VT) is sometimes unsuccessful when ablation lesions are of insufficient depth to reach arrhythmogenic substrate. We report the initial experience with the use of a catheter with an extendable/retractable irrigated needle at the tip capable of intramyocardial mapping and ablation. METHODS AND RESULTS: Sequential consenting patients with recurrent VT underwent ablation with the use of a needle-tipped catheter. At target sites, the needle was advanced 7 to 9 mm into the myocardium, permitting pacing and recording. Infusion of saline/iodinated contrast mixture excluded perforation and ensured intramyocardial deployment. Further infusion was delivered before and during temperature-controlled radiofrequency energy delivery through the needle. All 8 patients included (6 male; mean age, 54) with a mean left ventricular ejection fraction of 29% were refractory to multiple antiarrhythmic drugs, and 1 to 4 previous catheter ablation attempts (epicardial in 4) had failed. Patients had 1 to 7 (median, 2) VTs present or inducible; 2 were incessant. Some intramyocardial VT mapping was possible in 7 patients. A mean of 22 (limits, 3-48) needle ablation lesions were applied in 8 patients. All patients had at least 1 VT terminated or rendered noninducible. During a median of 12 months follow-up, 4 patients were free of recurrent VT, and 3 patients were improved, but had new VTs occur at some point during follow-up. Two died of the progression of preexisting heart failure without recurrent VT. Complications included tamponade in 1 patient and heart block in 2 patients. CONCLUSIONS: Intramyocardial infusion-needle catheter ablation is feasible and permits control of some VTs that have been refractory to conventional catheter ablation therapy, warranting further study.

Evaluation of Ablation Parameters to Predict Irreversible Lesion Size During Pulsed Field Ablation.

BACKGROUND: During pulsed field ablation (PFA), relationships between ablation parameters (contact force [CF], number of burst pulses, impedance decrease, and electrode temperature) and lesion size in beating hearts have not been well validated. METHODS: A 7.5F-catheter with a 3.5-mm ablation electrode and CF sensor (ThermoCool SmartTouch SF-Dual-Energy, Biosense Webster, Inc, Irwindale, CA) was connected to a PFA system (TRUPULSE2, Biosense Webster, Inc). In 11 closed-chest swine, biphasic PFA current was delivered between the ablation electrode and the skin patch at 219 sites in left ventricle and right ventricle using 12, 18, and 24 burst pulses with 4 different levels of CF: (1) low (n=57; CF, 4-15g; median, 10g); (2) moderate (n=60; CF, 16-30g; median, 22.5g); (3) high (n=68; CF, 32-65g; median, 40g); and (4) no electrode contact (n=34), 2 mm away from the endocardium. Swine were euthanized 2 hours after ablation, and lesion size was measured using triphenyl tetrazolium chloride staining. RESULTS: All PFA lesions with electrode-myocardium contact were well demarcated with triphenyl tetrazolium chloride staining, demonstrating (1) pale central zone (contraction band necrosis with minimal coagulation necrosis), (2) dark brown zone (contraction band necrosis with hemorrhage), and (3) hyperstained red zone by triphenyl tetrazolium chloride (unaffected normal myocardium with preserved mitochondrial activity, consistent with reversible zone). Lesion depth increased significantly with increasing CF and the number of PFA burst pulses. An exponential/logarithmic formula combined with CF and the number of PFA burst pulses correlated lesion depth with high accuracy: R=0.809, P<0.0001, ±1.0-mm accuracy in 128 of 163 (79%) lesions, and ±1.5-mm accuracy in 153 of 163 (94%) lesions. Impedance decrease and electrode temperature were poor predictors of lesion size. There were no detectable lesions resulting from ablation without electrode contact. CONCLUSIONS: Acute PFA ventricular lesions demonstrate irreversible and reversible lesion boundaries. Electrode-tissue contact is required for effective lesion formation. Lesion depth increases significantly with increasing CF and PFA burst pulses. A new exponential/logarithmic formula combined with CF and the number of PFA burst pulses correlates lesion depth with high accuracy.

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.

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.