Catheter-tissue contact optimizes pulsed electric field ablation with a large area focal catheter.

INTRODUCTION: Pulsed electric field (PEF) ablation relies on the intersection of a critical voltage gradient with tissue to cause cell death. Field-based lesion formation with PEF technologies may still depend on catheter-tissue contact (CTC). The purpose of this study was to assess the impact of CTC on PEF lesion formation with an investigational large area focal (LAF) catheter in a preclinical model. METHODS: PEF ablation via a 10-spline LAF catheter was used to create discrete right ventricle (RV) lesions and atrial lesion sets in 10 swine (eight acute, two chronic). Local impedance (LI) was used to assess CTC. Lesions were assigned to three cohorts using LI above baseline: no tissue contact (NTC: ≤∆10 Ω, close proximity to tissue), low tissue contact (LTC: ∆11-29 Ω), and high tissue contact (HTC: ≥∆30 Ω). Acute animals were infused with triphenyl tetrazolium chloride (TTC) and killed ≥2 h post-treatment. Chronic animals were remapped 30 days post-index procedure and stained with infused TTC. RESULTS: Mean (± SD) RV treatment sizes between LTC (n = 14) and HTC (n = 17) lesions were not significantly different (depth: 5.65 ± 1.96 vs. 5.68 ± 2.05 mm, p = .999; width: 15.68 ± 5.22 vs. 16.98 ± 4.45 mm, p = .737), while mean treatment size for NTC lesions (n = 6) was significantly smaller (1.67 ± 1.16 mm depth, 5.97 ± 4.48 mm width, p < .05). For atrial lesion sets, acute and chronic conduction block were achieved with both LTC (N = 7) and HTC (N = 6), and NTC resulted in gaps. CONCLUSIONS: PEF ablation with a specialized LAF catheter in a swine model is dependent on CTC. LI as an indicator of CTC may aid in the creation of consistent transmural lesions in PEF ablation.

Impact of weight adjusted high frequency low tidal volume ventilation and atrial pacing in lesion metrics in high-power short-duration ablation: Results of a pilot study.

INTRODUCTION: Lesion size index (LSI) was introduced with the use of Tacticath™ and as a surrogate of lesion quality. The metric used to achieve the predetermined values involves combined information of contact force (CF), power and radiofrequency time. Rapid atrial pacing (RAP) and high-frequency low-tidal volume ventilation (HFLTV) independently or in combination improve catheter stability and CF and quality of lesions. Data of the impact of body weight adjusted HFLTV ventilation strategy associated with RAP in the lesion metrics still lacking. The study aimed to compare the results of high-power short-duration (HPSD) atrial fibrillation ablation using simultaneous weight adjusted HFLTV and RAP and standard ventilation (SV) protocol. METHODS: Prospective, nonrandomized study with 136 patients undergoing de novo ablation divided into two groups; 70 in RAP (100 ppm) + HFLTV with 4 mL/kg of tidal volume and 25 breaths/min (group A) and 66 patients with SV in intrinsic sinus rhythm (group B). Ablation using 50 W, CF of 5-10 g/10-20 g and 40 mL/minute flow rate on the posterior and anterior left atrial wall, respectively. RESULTS: No procedure-related complications. Group A: Mean LSI points 70 ± 16.5, mean total lower LSI 3.4 ± 0.5, mean total higher LSI 8.2 ± 0.4 and mean total LSI 5.6 ± 0.6. Anterior and posterior wall mean total LSI was 6.0 ± 0.4 and 4.2 ± 0.3, respectively. Mean local impedance drop (LID) points were 118.8 ± 28.4, mean LID index (%) 12.9 ± 1.5, and mean LID < 12% points 55.9 ± 23.8. Anterior and posterior wall mean total LID index were 13.6 ± 2.0 and 11.9 ± 1.7, respectively. Recurrence in 11 (15.7%) patients. Group B: Mean LSI points 56 ± 2.7, mean total lower LSI 2.9 ± 0.7, mean total higher LSI 6.9 ± 0.9, and mean total LSI 4.8 ± 0.8. Anterior and posterior wall mean total LSI was 5.1 ± 0.3 and 3.5 ± 0.5, respectively. Mean LID points were 111.4 ± 21.5, mean LID index (%) 11.4 ± 1.2, and mean LID < 12% points 54.9 ± 25.2. Anterior and posterior wall mean total LID index were 11.8 ± 1.9 and 10.3 ± 1.7, respectively. Recurrence in 14 (21.2%) patients. Mean follow up was 15.2 ± 4.4 months. CONCLUSION: Weight adjusted HFLTV ventilation with RAP HPSD ablation produced lower recurrence rate and better LSI and LID parameters in comparison to SV and intrinsic sinus rhythm.

Radiofrequency ablation-Real-time visualization of lesions and their correlation with underlying parameters.

BACKGROUND: Lesion durability and transmurality are crucial for successful radiofrequency (RF) ablation. This study provides a model of real-time RF lesion visualization and insights into the role of underlying parameters, as local impedance (LI). METHODS: A force-sensing, LI-sensing catheter was used for lesion creation in an ex vivo model involving cross-sections of porcine cardiac preparations. During 60 s of RF application, one measurement per second was performed regarding lesion size and available ablation parameters. In total, 1847 measurements from n = 36 lesions were performed. Power (20-50 W) and contact force (1-5 g, 10-15 g, 20-25 g) were systematically alternated. RESULTS: Lesion formation was most prominent in the first seconds of RF application during which nonlinear lesion growth was observed (max. 1.08 mm/s for lesion depth and 2.71 mm/s for lesion diameter). Power levels determined the extent of lesion formation in the early phase. After 20 s, lesion size growth velocity approaches 0.1 mm/s at all power levels. LI changes were also highest in the first seconds (up to - 12 Ω/s) and decreased to less than - 0.1Ω/s after prolonged application. CONCLUSION: Lesion formation in irrigated RF ablation is a nonlinear process. Final lesion size resulting from an RF application is mainly influenced by high rates of lesion growth in the first seconds of ablation. LI seems to be a good surrogate for differentiating changes in lesion formation.

Impact of baseline pool impedance on lesion metrics and steam pops in catheter ablation.

INTRODUCTION: Little is known about the impact of blood-pool local impedance (LI) on lesion characteristics and the incidence of steam pops. METHODS: Radiofrequency applications at a range of powers (30, 40, and 50 W), contact forces (CF) (5, 15, and 25 g), and durations (15, 30, 45, and 120 s) using perpendicular/parallel catheter orientation were performed in 40 excised porcine preparations, using a catheter capable of monitoring LI (StablePoint©, Boston Scientific). To simulate the variability in blood-pool impedance, the saline-pool LI was modulated by calibrating saline concentrations. Lesion characteristics were compared under three values of saline-pool LI: 120, 160, and 200 Ω. RESULTS: Of 648 lesions created, steam pops occurred in 175 (27.0%). When power, CF, time, and catheter orientation were adjusted, ablation at a saline-pool impedance of 160 or 200 Ω more than doubled the risk of steam pops compared with a saline-pool impedance of 120 Ω (Odds ratio = 2.31; p = .0002). Lesions in a saline-pool impedance of 120 Ω were significantly larger in surface area (50 [38-62], 45 [34-56], and 41 [34-60] mm2 for 120, 160, and 200 Ω, p < .05), but shallower in depth (4.0 [3-5], 4.4 [3.2-5.3], and 4.5 [3.8-5.5] mmfor 120, 160, and 200 Ω, respectively, p < .05) compared with the other two settings. The correlation between the absolute LI-drop and lesion size weakened as the saline-pool LI became higher (e.g., 120 Ω group (r2 = .30, r2 = .18, and r2 = .16, respectively for 120, 160, and 200 Ω), but the usage of %LI-drop (= absolute LI-drop/initial LI) instead of absolute LI-drop may minimize this effect. CONCLUSIONS: In an experimental model, baseline saline-pool impedance significantly affects the lesion metrics and the risk of steam pops.

Higher power achieves greater local impedance drop, shorter ablation time, and more transmural lesion formation in comparison to lower power in local impedance guided radiofrequency ablation of atrial fibrillation.

BACKGROUND: Since the local impedance (LI) of the ablation catheter reflects tissue characteristics, the efficacy of higher power (HP) compared to lower power (LP) in LI-guided ablation may differ from other index-guided ablations. OBJECTIVE: This study aimed to assess the efficacy of HP ablation in LI-guided ablation of atrial fibrillation (AF). METHODS: A prospective observational study was conducted, enrolling patients undergoing de novo ablation for AF. Pulmonary vein isolation was performed using point-by-point ablation with a RHYTHMIA HDxTM Mapping System and an open-irrigated ablation catheter with mini-electrodes (IntellaNav MIFI OI). Ablation was stopped when the LI drop reached 30 ohms, three seconds after the LI plateaued, or when ablation time reached 30 s. To balance the baseline differences, a unique method was used in which the power was changed between HP (45 W to anterior wall/40 W to posterior wall) and LP (35 W/30 W) alternately for each adjacent point. RESULTS: A total of 551 ablations in 10 patients were analyzed (HP, n = 276; LP, n = 275). The maximum LI drop was significantly larger (HP: 28.3 ± 5.4 vs. LP: 24.8 ± 6.3 ohm), and the time to minimum LI was significantly shorter (HP: 15.0 ± 6.3 vs. LP: 19.3 ± 6.6 s) in the HP setting. The unipolar electrogram analysis of three patients revealed that the electrogram indicating transmural lesion formation was observed more frequently in the HP setting. CONCLUSION: In LI-guided ablation, the HP could achieve a larger LI drop and shorter time to minimum LI, which may result in more transmural lesion formation compared to a LP setting.

Optimal local impedance parameters for successful pulmonary vein isolation in patients with atrial fibrillation.

INTRODUCTION: Local impedance (LI) parameters of IntellaNav STABLEPOINT for successful pulmonary vein isolation (PVI) of atrial fibrillation (AF) remain unclear. The purpose of this study was to seek LI data achieving successful PVI. METHODS: Consecutive AF patients who underwent catheter ablation with STABLEPOINT were prospectively enrolled in two centers. PVI was performed under a constant 35-or 40-watt power, 20-s duration, and >5-g contact force. The operators were blinded to the LI data. The characteristics of all ablation points with/without conduction gaps (Unsuccess or Success tags) after the first-attempt PVI were evaluated for the right/left PVs and anterior/posterior wall (RPV/LPV and AW/PW, respectively), and cutoff values of LI data were calculated for successful lesion formation. RESULTS: A total of 5257 ablation points in 102 patients (65 [58-72] years old, 65.7% male) were evaluated. The LI drop values were higher in the Success tags than Unsuccess tags on the LPV-AW and RPV-AW/PW (p < .001), except for the LPV-PW (p = .105). The %LI drop values (LI drop/initial LI) were higher for the Success tags in all areas (15.8 [12.2%-19.6%] vs. 11.6 [9.7%-15.6%] in LPV-AW: p < .001, 15.0 [11.5%-19.3%] vs. 11.4 [8.7%-17.3%] in LPV-PW: p = .035, 15.3 [11.5%-19.4%] vs. 9.9 [8.1%-13.7%] in RPV-AW: p < .001, and 13.3 [10.1%-17.4%] vs. 8.1 [6.3%-9.5%] in RPV-PW, p < .001). The LI drop and %LI drop cutoff values were 20.0 ohms and 11.6%, respectively. CONCLUSIONS: An insufficient LI drop with STABLEPOINT was associated with a gap formation during PVI, and the best cutoff values for the LI drop and %LI drop were 20.0 ohms and 11.6%, respectively.

The influence of electrode-tissue-coverage on RF lesion formation and local impedance: Insights from an ex vivo model.

BACKGROUND: The influence of power, duration and contact force (CF) on radiofrequency (RF) lesion formation is well known, whereas data on local impedance (LI) and electrode-tissue-coverage (ETC) is scarce. The objective was to investigate their effect on lesion formation in an ex vivo model. METHODS AND RESULTS: An ex vivo model was developed utilizing cross-sections of porcine heart preparations and a force-sensing, LI-measuring catheter. N = 72 lesion were created systematically varying ETC (minor/full), CF (1-5 g, 10-15 g, 20-25 g) and power (20 W, 30 W, 40 W, 50 W). In minor ETC, the distal tip of the catheter was in electric contact with the tissue, in full ETC the whole catheter tip was embedded within the tissue. Lesion size and all parameters were measured once per second (n = 3320). LI correlated strongly with lesion depth (r = -0.742 for ΔLI; r = 0.781 for %LI-drop). Lesions in full ETC were significantly wider and deeper compared to minor ETC (p < .001) and steam pops were more likely. Baseline LI, ΔLI, and %LI-drop were significantly higher in full ETC (p < .001). In lesions resulting in steam pops, baseline LI, and ΔLI were significantly higher. The influence of CF on lesion size was higher in minor ETC than in full ETC. CONCLUSIONS: ETC is a main determinant of lesion size and occurrence of steam pops. Baseline LI and LI-drop are useful surrogate parameters for real-time assessment of ETC and ΔLI correlates strongly with lesion size.

Local impedance for the optimization of radiofrequency lesion delivery: A review of bench and clinical data.

INTRODUCTION: Radiofrequency catheter ablation is a cornerstone of treatment for many cardiac arrhythmias. Progression in three-dimensional mapping and contact-force sensing technologies have improved our capability to achieve success, but challenges still remain. METHODS: In this article, we discuss the importance of overall circuit impedance in radiofrequency lesion formation. This is followed by a review of the literature regarding recently developed "local impedance" technology and its current and future potential applications and limitations, in the context of established surrogate markers currently used to infer effective ablation. RESULTS: We discuss the role of local impedance in assessing myocardial substrate, as well as its role in clinical studies of ablation. We also discuss safety considerations, limitations and ongoing research. CONCLUSION: Local impedance is a novel tool which has the potential to tailor ablation in a manner distinct from other established metrics.

Catheter contact angle influences local impedance drop during radiofrequency catheter ablation: Insight from a porcine experimental study with 2 different LI-sensing catheters.

BACKGROUND: Local impedance (LI) can indirectly measure catheter contact and tissue temperature during radiofrequency catheter ablation (RFCA). However, data on the effects of catheter contact angle on LI parameters are scarce. This study aimed to evaluate the influence of catheter contact angle on LI changes and lesion size with two different LI-sensing catheters in a porcine experimental study. METHODS: Lesions were created by the INTELLANAV MiFi™ OI (MiFi) and the INTELLANAV STABLEPOINT™ (STABLEPOINT). RFCA was performed with 30 W and a duration of 30 s. The contact force (CF) (0, 5, 10, 20, and 30 g) and catheter contact angle (30°, 45°, and 90°) were changed in each set (n = 8 each). The LI rise, LI drop, and lesion size were evaluated. RESULTS: The LI rise increased as CF increased. There was no angular dependence with the LI rise under all CFs in the MiFi. On the other hand, the LI rise at 90° was lower than at 30° under 5 and 10 g of CF in STABLEPOINT. The LI drop increased as CF increased. Regarding the difference in catheter contact angles, the LI drop at 90° was lower than that at 30° for both catheters. The maximum lesion widths and surface widths were smaller at 90° than at 30°, whereas there were no differences in lesion depths. CONCLUSION: The LI drop and lesion widths at 90° were significantly smaller than those at 30°, although the lesion depths were not different among the 3 angles for the MiFi and STABLEPOINT.

The correlation between local impedance drop and catheter contact in clinical pulmonary vein isolation use.

INTRODUCTION: Local impedance (LI) drop during radiofrequency (RF) application is monitored to assess the lesion formation. Recently, a novel ablation catheter has been introduced to clinical setting, which is capable of monitoring LI and catheter contact parameters including contact force (CF) and contact angle (CA). This study aimed to clarify the correlation between LI drop and catheter contact parameters. METHODS AND RESULTS: This prospective study included 15 paroxysmal atrial fibrillation (AF) patients who underwent initial pulmonary vein isolation (PVI). First-pass encircling point-by-point PV ablation was performed by using a 4.5-mm irrigated ablation catheter, with monitoring LI, CF, and CA. RF energy was applied for 30 s at each site with 30 W. Stable ablation points were analyzed to examine the correlation between LI drop and catheter contact parameters. Among 903 ablation points, 499 stable ablation points (55.2%) were analyzed. CA showed good correlation with LI drop (ρ = 0.418, p < .001). Maximum CF, minimum CF, average CF, and initial CF all showed weak correlation with LI drop (ρ = 0.201, p < .001; ρ = 0.224, p < .001; ρ = 0.258, p < .001; and ρ = 0.212, p < .001, respectively). Multivariate analysis demonstrated that CA was an independent factor of LI drop among the catheter contact parameters (ß = 0.139, 95% CI = 0.111-0.167, p < .001). The LI drop in the blocked segments was significantly higher than that in the electrical conduction gap segments (27.3 ± 9.8 vs. 19.6 ± 6.4 Ω, p < .001) CONCLUSION: In clinical PVI use, both CF and CA were correlated with LI drop. More parallel CA could induce higher LI drop, which may lead to effective lesion formation.

Optimized radiofrequency lesions through local impedance guidance for effective CTI ablation in right atrial flutter.

BACKGROUND: Although radiofrequency (RF) catheter ablation of cavo-tricuspid isthmus (CTI) is an established treatment for typical right atrial flutter (RAFL), it remains to be established whether local tissue impedance (LI) is able to predict effective CTI ablation and what LI drop values during ablation should be used to judge a lesion as effective. We aimed to investigate the ability of LI to predict ablation efficacy in patients with RAFL. METHODS: RF delivery was guided by the DirectSense™ algorithm. Successful single RF application was defined according to a defragmentation of atrial potentials (DAP), reduction of voltage (RedV) by at least 80% or changes on unipolar electrogram (UPC). The ablation endpoint was the creation of bidirectional conduction block (BDB) across the isthmus. RESULTS: 392 point-by-point RF applications were analyzed in 48 consecutive RAFL patients. The mean baseline LI was 105.4 ± 12Ω prior to ablation and 92.0 ± 11Ω after ablation (p < 0.0001). According to validation criteria, absolute drops in impedance were larger at successful ablation sites than at ineffective ablation sites (DAP: 17.8 ± 6Ω vs. 8.7 ± 4Ω; RedV: 17.2 ± 6Ω vs. 7.8 ± 5Ω; UPC: 19.6 ± 6Ω vs. 10.1 ± 5Ω, all p < 0.0001). LI drop values significantly increased according to the number of criteria satisfied (ranging from 7.5Ω to 19.9). BDB was obtained in all cases. No procedure-related adverse events were reported. CONCLUSIONS: A LI-guided approach to CTI ablation was safe and effective in treating RAFL. The magnitude of LI drop was associated with effective lesion formation and BDB and could be used as a marker of ablation efficacy. CLINICAL TRIAL REGISTRATION: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998.

Local impedance-guided ablation and ultra-high density mapping versus conventional or contact force-guided ablation with mapping for treatment of cavotricuspid isthmus dependent atrial flutter.

INTRODUCTION: - Local impedance (LI) guided ablation as a method of judging lesion effectiveness for cavotricuspid isthmus dependent atrial flutter (CTI-AFL), and ultra-high density (UHD) mapping when breakthrough occurred across an ablation line has not previously been assessed. METHODS: This retrospective observational study evaluated patients undergoing CTI-AFL ablation using conventional, contact force (CF) and LI guided strategies. Ablation metrics were collected, and in the LI cohort, the use of UHD mapping for breakthrough evaluated. RESULTS: 30 patients were included, 10 per group. Mean total ablation time was significantly shorter with LI (3.2 ± 1.3min) vs conventional (5.6 ± 2.7min) and CF (5.7 ± 2.0min, p = 0.0042). Time from start of ablation to CTI block was numerically shorter with LI (14.2 ± 8.0min) vs conventional and CF (19.7 ± 14.1 and 22.5 ± 19.1min, p = 0.4408). Mean lesion duration was significantly shorter with LI, but there were no differences in the number of lesions required to achieve block, procedural success, complication rates or recurrence. 15/30 patients did not achieve block following first-pass ablation. UHD mapping rapidly identified breakthrough in the five LI patients, including epicardial-endocardial breakthrough (EEB). CONCLUSION: - The use of LI during ablation for real-time lesion assessment was as efficacious as the conventional and CF methods. UHD mapping rapidly identified breakthrough, including EEB.

Local impedance-guided radiofrequency ablation with standard and high power: Results of a preclinical investigation.

BACKGROUND: Local impedance (LI) drop measured with microfidelity electrodes embedded in the tip of an ablation catheter accurately reflects tissue heating during radiofrequency (RF) ablation. Previous studies found 15-30 Ω LI drops created successful lesions, while more than 40 Ω drops were associated with steam pops. The objective of this study was to evaluate the safety and efficacy of LI-guided ablation using standard (30 W) and high-power (50 W) in a preclinical model. METHODS: RF lesions were created in explanted swine hearts (n = 6) to assess the feasibility of LI-guided ablation by targeting 10, 20, or 30 Ω (n = 20/group) drops. Subsequently, LI-guided ablation was evaluated in a chronic animal model (n = 8 Canines, 25-29 kg, 30/50 W). During the index procedure point-by-point intercaval line ablation and left inferior pulmonary vein (PV) isolation were performed. RF duration was at the operators' discretion but discontinued early if a 15-30 Ω drop was achieved. Operators attempted to avoid LI drops of more than 40 Ω. At 1-month, durable conduction block was evaluated with electroanatomic mapping followed by necropsy and histopathology. RESULTS: In explanted tissue, terminating ablation at 10, 20, or 30 Ω LI drops created statistically larger lesions (p < .05; 1.8 [1.6-2.4] mm, 3.3 [3.0-3.7] mm; 4.9 [4.3-5.5] mm). LI-guided high-power ablation in vivo significantly reduced RF duration per application compared to standard-power (p < .05; intercaval: 8.9 ± 5.2 vs. 18.1 ± 11.0 s, PV: 9.6 ± 5.4 vs. 23.2 ± 10.3 s). LI drops of 15-40 Ω were more readily achievable for high-power (90.1%, 318/353) than standard-power (71.7%, 243/339). All intercaval lines and PV isolations were durable (16/16) at 1-month. Necropsy revealed no major collateral injury to the pericardium, phrenic nerve, esophagus, or lungs. There was no pericardial effusion, stroke, tamponade, or PV stenosis. Vagal nerve injury was found in two 30 W animals after using 19.7 ± 13.9 and 19.5 ± 11.8 s RF applications. CONCLUSION: LI-guided ablation was found to be safe and efficacious in a chronic animal model. High-power ablation more readily achieved more than 15 Ω drops, reduced RF duration compared with standard-power, and had no major RF collateral injury.

Pulmonary vein isolation in atrial fibrillation patients guided by a novel local impedance algorithm: 1-year outcome from the CHARISMA study.

BACKGROUND: Highly localized impedance (LI) measurements during atrial fibrillation (AF) ablation have recently emerged as a viable real-time indicator of tissue characteristics and durability of the lesions created. We report the outcomes of acute and long-term clinical evaluation of the new DirectSense algorithm in AF ablation. METHODS: Consecutive patients undergoing AF ablation were included in the CHARISMA registry. RF delivery was guided by the DirectSense algorithm, which records the magnitude and time-course of the impedance drop. The ablation endpoint was pulmonary vein isolation (PVI), as assessed by the entrance and exit block. RESULTS: 3556 point-by-point first-pass RF applications of >10 s duration were analyzed in 153 patients (mean age=59 ± 10 years, 70% men, 61% paroxysmal AF, 39% persistent AF). The mean baseline LI was 105 ± 15 Ω before ablation and 92 ± 12 Ω after ablation (p < .0001). Both absolute drops in LI and the time to LI drop (LI drop/τ) were greater at successful ablation sites (n = 3122, 88%) than at ineffective ablation sites (n = 434, 12%) (14 ± 8 Ω vs 6 ± 4 Ω, p < .0001 for LI; 0.73 [0.41-1.25] Ω/s vs. 0.35[0.22-0.59 Ω/s, p < .0001 for LI drop/τ). No major complications occurred during or after the procedures. All PVs had been successfully isolated. During a mean follow-up of 366 ± 130 days, 18 patients (11.8%) suffered an AF/atrial tachycardia recurrence after the 90-day blanking period. CONCLUSION: The magnitude and time-course of the LI drop during RF delivery were associated with effective lesion formation. This ablation strategy for PVI guided by LI technology proved safe and effective and resulted in a very low rate of AF recurrence over 1-year follow-up.

Characteristics and optimal ablation settings of a novel, contact-force sensing and local impedance-enabled catheter in an ex vivo perfused swine ventricle model.

BACKGROUND: Local impedance (LI) has emerged as a new technology that informs on electrical catheter-tissue coupling during radiofrequency (RF) ablation. Recently, IntellaNav StablePoint, a novel LI-enabled catheter that equips contact force (CF) sensing, has been introduced. Although StablePoint and its predecessor IntellaNav MiFi OI share the common technology that reports LI, distinct mechanics for LI sensing between the two products raise a concern that the LI-RF lesion formation relationship may differ. METHODS: In an ex vivo swine cardiac tissue model, we investigated the initial level and range of a reduction in LI during a 60-s RF ablation and the resultant lesion characteristics at nine combinations of three energy power (30, 40, and 50 W) and CF (10, 30, and 50 g) steps. Correlations and interactions between CF, LI, wattage, and formed lesions were analyzed. Incidence of achieving LI drop plateau and that of a steam pop were also determined. RESULTS: Positive correlations existed between CF and initial LI, CF and absolute/relative LI drop, CF and lesion volume, and LI drop and lesion volume. At the same LI drop, wattage-dependent gain in lesion volume was observed. Steam pops occurred in all CF steps and the prevalence was highest at 50 W. LI drop predicted a steam pop with a cutoff value at 89Ω. CONCLUSION: In StablePoint, wattage crucially affects LI drop and lesion volume. Because 30 W ablation may by underpowered for intramural lesion formation and 50 W often resulted in a steam pop, 40 W appears to achieve the balance between the safety and efficacy.

The optimal ablation setting for a local impedance guided catheter in an in vitro experimental model.

BACKGROUND: The local impedance (LI) reflects the electrical catheter-tissue coupling and correlates with the local tissue temperature. However, there have been few clinical studies showing the recommended method for LI monitoring catheters. This study aimed to investigate the optimal ablation setting for this catheter in an in vitro experimental model. METHODS: LI monitoring catheters were used in an excised swine heart experimental model. The tissue contact force (CF) was directly monitored from an external weight scale. Radiofrequency ablation was performed with a combination of various energy power settings (30, 40, and 50 W), and various CFs (10, 30, and 50 g) for 60 s. The correlation between the LI-related indexes, power, and CF with the lesion formation was statistically analyzed. RESULTS: A positive correlation between the LI or lesion formation and CF was observed under all powers. Although the LI drop always correlated with the maximum lesion depth, lesion diameter, and lesion volume, the coefficient of the correlation value was lower under a high CF (lesion depth, diameter, and volume; 10 g, r = 0.8064, r = 0.8389, r = 0.8477; 30 g, r = 0.7590, r = 0.8063, r = 0.8060; 50 g r = 0.5555, r = 0.5701, and r = 0.5678, respectively). Steam pops occurred only under a 50 W ablation and the LI drop cutoff value for steam pops was 46 Ω. CONCLUSION: The same LI drop did not always lead to the same lesion size when the CF differed. Monitoring the LI and not exceeding 46 Ω would be useful for a safe ablation.

Incidence and characteristics of silent cerebral embolisms after radiofrequency-based atrial fibrillation ablation: A propensity score-matched analysis between different mapping catheters and indices for guiding ablation.

INTRODUCTION: The difference in the incidence and characteristics of silent cerebral events (SCEs) after radiofrequency-based atrial fibrillation (AF) ablation between the different mapping catheters and indices used for guiding radiofrequency ablation remains unclear. This study aimed to compare the incidence and characteristics of postablation SCEs between the following two groups: Group C, Ablation Index-guided ablation using two circular mapping catheters with CARTO (Biosense Webster); Group R, local impedance-guided ablation using one mini-basket catheter and one circular mapping with Rhythmia (Boston Scientific). METHODS AND RESULTS: Of 211 consecutive patients who underwent an AF ablation and brain magnetic resonance (MR) imaging after the ablation, 120 patients (each group, n = 60) were selected by propensity score matching. SCEs were detected in 37 patients (30.8%). Group R had a higher incidence of SCEs (51.7% vs. 10.0%; p < .001) and more SCEs per patient (median, 3 vs. 1, p = .028) than Group C. A multivariate analysis demonstrated that nonparoxysmal AF and being Group R were independent positive predictors of SCEs (odds ratios, 6.930 and 15.464; both p < .001). On the follow-up MR imaging, all SCEs in Group C and 87.9% of the SCEs in Group R disappeared (p = .537). CONCLUSIONS: Group R had a significantly higher incidence of SCEs than Group C. Most probably the use of a complexly designed basket mapping catheter is the reason for the difference in the incidence of SCEs but further validation is needed. A nonparoxysmal form of AF may also increase the risk of SCEs during these ablation procedures.

Prevalence, characteristics, and predictors of endocardial and nonendocardial conduction gaps during local impedance-guided extensive pulmonary vein isolation of atrial fibrillation with high-resolution mapping.

INTRODUCTION: Local impedance (LI) drops during radiofrequency ablation can predict lesion formation. Some conduction gaps during pulmonary vein isolation (PVI) can be associated with nonendocardial connections. This study aimed to investigate the incidence, characteristics, and predictors of endocardial and nonendocardial conduction gaps during an LI-guided PVI. METHODS AND RESULTS: We prospectively enrolled 157 consecutive patients undergoing an initial LI-guided extensive PVI of atrial fibrillation (AF). After the first-pass encirclement, the residual conduction gaps and reconnected gaps were mapped using Rhythmia (Boston Scientific) and a mini-basket catheter. Right and left PV (RPV/LPV) gaps were observed in 22.3% and 18.5% of the patients, respectively: 27 endocardial and 49 nonendocardial gaps. The carina regions were common sites for the gaps (51 carina-related vs. 25 noncarina-related). The carina-related gaps consisted of more nonendocardial gaps than endocardial gaps (RPVs: 90.0% vs. 10.0%, p = .001; LPVs: 76.2% vs. 23.8%, p < .001). A univariate analysis revealed that paroxysmal AF and the left atrial (LA) volume index for RPV endocardial gaps (odds ratio [OR]: 8.640 and 0.946; p = .043 and 0.009), minor right inferior PV diameter for RPV nonendocardial gaps (OR: 1.165; p = .028), and major left inferior PV diameter for LPV endocardial gaps (OR: 1.233; p = .028) were significant predictors. CONCLUSIONS: During the LI-guided PVI, approximately two-thirds of the conduction gaps were nonendocardial. The carina regions had more conduction gaps than noncarina regions, which was due to the presence of nonendocardial connections. Paroxysmal AF, a lower LA volume index, and larger inferior PV diameters may increase the risk of conduction gaps.

Local catheter impedance drop during pulmonary vein isolation predicts acute conduction block in patients with paroxysmal atrial fibrillation: initial results of the LOCALIZE clinical trial.

AIMS: Radiofrequency ablation creates irreversible cardiac damage through resistive heating and this temperature change results in a generator impedance drop. Evaluation of a novel local impedance (LI) technology measured exclusively at the tip of the ablation catheter found that larger LI drops were indicative of more effective lesion formation. We aimed to evaluate whether LI drop is associated with conduction block in patients with paroxysmal atrial fibrillation (AF) undergoing pulmonary vein isolation (PVI). METHODS AND RESULTS: Sixty patients underwent LI-blinded de novo PVI using a point-by-point ablation workflow. Pulmonary vein rings were divided into 16 anatomical segments. After a 20-min waiting period, gaps were identified on electroanatomic maps. Median LI drop within segments with inter-lesion distance ≤6 mm was calculated offline. The diagnostic accuracy of LI drop for predicting segment block was assessed using receiver operating characteristic analysis. For segments with inter-lesion distance ≤6 mm, acutely blocked segments had a significantly larger LI drop [19.8 (14.1-27.1) Ω] compared with segments with gaps [10.6 (7.8-14.7) Ω, P < 0.001). In view of left atrial wall thickness differences, the association between LI drop and block was further evaluated for anterior/roof and posterior/inferior segments. The optimal LI cut-off value for anterior/roof segments was 16.1 Ω (positive predictive value for block: 96.3%) and for posterior/inferior segments was 12.3 Ω (positive predictive value for block: 98.1%) where inter-lesion distances were ≤6 mm. CONCLUSION: The magnitude of LI drop was predictive of acute PVI segment conduction block in patients with paroxysmal AF. The thinner posterior wall required smaller LI drops for block compared with the thicker anterior wall.

Clinical utility of local impedance monitoring during pulmonary vein isolation.

INTRODUCTION: Local impedance (LI) at the tip of ablation catheter can be measured using a recently available technology. We aimed to explore target LI measurements at each radiofrequency application (RFA) for creating sufficient ablation lesions during pulmonary vein (PV) isolation. METHODS: This prospective study included 15 consecutive patients scheduled to undergo an initial ablation of paroxysmal atrial fibrillation (AF). Circumferential ablation around both ipsilateral PVs was performed using a 4-mm irrigated ablation catheter with an LI sensor. Point-by-point ablation was used with a 4-mm inter-ablation-point distance. Operators were blinded to LI measurements during the procedure. Creation of sufficient ablation lesions was assessed by the absence of a conduction gap. RESULTS: After first-pass encircling PV antrum ablation, left atrium to PV conduction remained in 12 of 30 (40%) ipsilateral PVs. Mapping using the minibasket catheter identified 48 ablation points through which the propagation wave entered the PV. At ablation points with a gap, the LI drop during RFA was half that at points without a gap (12 ± 7 vs. 23 ± 12 Ω; p < .001). The generator impedance drop did not differ between ablation points with and without a gap (12 ± 7 vs. 14 ± 10 Ω; p = .10). An LI drop of 13.4 Ω predicted sufficient lesion formation without a gap with a sensitivity of 0.78, specificity of 0.75, and predictive accuracy of 0.75. CONCLUSION: An LI drop of 13.4 Ω at each RFA under the conditions of a 4-mm inter-ablation-point distance and RFA duration ≥20 s may facilitate creation of sufficient lesions during PV isolation.