Optimal conditions for high-power, short-duration radiofrequency ablation using a novel, flexible-tipped, force-sensing catheter.

Background: High-power, short-duration (HPSD) radiofrequency ablation (RFA) reduces procedure time; however, safety and efficacy thresholds vary with catheter design. Objective: The study sought to determine optimal HPSD ablation conditions with a novel flexible-tipped, contact force-sensing RFA catheter. Methods: RFA lesions were created in thigh muscle (16 swine) over a range of conditions (51-82 W, 2-40 g, 8-40 mL/min irrigation). An intracardiac study was performed (12 swine) to characterize steam pop thresholds. Lesions were created in a second intracardiac study (14 swine, n = 290 pulmonary vein isolation [PVI] lesions) with combinations of radiofrequency power, duration, and contact force. PVI was tested, animals were sacrificed, and lesions were measured. Results: The likelihood of coagulation formation in the thigh model was <20% when power was ≤79 W, when contact force was ≤40 g, when duration was ≤11 seconds, and when irrigation rates were 8 to 40 mL/min. The impact of contact force on lesion safety and efficacy was more pronounced using HPSD (60 W/8 seconds) compared with conventional ablation (30 W/45 seconds) (P = .038). During PVI, focal atrial lesions ranged in width from 4.2 to 12.5 mm and were transmural 80.8% of the time. PVI was achieved in 13 of 14 veins. Logistic regression identified that the optimal parameters for radiofrequency application were 60 to 70 W with a duration <8 seconds and <15 g contact force. Conclusions: Optimal HPSD lesions with this this flexible-tipped, force-sensing RFA catheter were created at 60 to 70 W for <8 seconds with <15 g contact force. Chronic studies are ongoing to assess radiofrequency parameter refinements and long-term lesion durability using these conditions.

Lesion Index-guided workflow for the treatment of paroxysmal atrial fibrillation is safe and effective - Final results from the LSI Workflow Study.

Background: Pulmonary vein isolation (PVI) ablation is a standard therapy for paroxysmal atrial fibrillation (PAF). Lesion Index (LSI) is a metric to guide radiofrequency (RF) ablation using the TactiCath Ablation Catheter, Sensor Enabled with the EnSite Cardiac Mapping System (Abbott). Objective: This study (NCT-03906461) was designed to capture best practices using LSI-guided catheter ablation to treat PAF subjects in a real-world setting. Methods: This prospective single-arm observational study enrolled 143 PAF subjects in the United States, Europe, and Japan undergoing de novo PVI with RF ablation. PVI lesions were assigned to 10 anatomically defined segments. Mean LSIs achieved for all lesions were analyzed. Follow-up was conducted between 3-6 months and 12 months after the procedure. Results: Pulmonary veins were isolated in all subjects. The mean achieved LSI was 4.9, with lower values in Europe (4.4) and Japan (4.5) than the United States (5.5). First-pass success, defined as no gaps requiring touch-up ablation after 20 minutes post isolation, was achieved in 76.2% of subjects. Use of high LSI (≥5) resulted in shorter procedure, RF, and fluoroscopy times and fewer touch-up ablations compared to low LSI (<5). At 12 months, 99.3% of subjects were free from procedure- or device-related serious adverse events and 95.7% (112/117) (35.0% on antiarrhythmic drugs) were free from recurrence and/or a repeat ablation procedure for atrial fibrillation / atrial flutter / atrial tachycardia. Conclusion: LSI-guided ablation strategies proved safe and effective despite differences in LSI workflows. Use of high LSI values resulted in shorter procedure, RF, and fluoroscopy times and fewer touch-up ablations compared to low LSI.

Continuous and discontinuous radiofrequency energy delivery on the atrial free wall: Lesion transmurality, width, and biophysical characteristics.

BACKGROUND: Although lesion transmurality is required for durable pulmonary vein isolation, excess ablation is associated with increased risk of complications. OBJECTIVE: We sought to understand the impact of interrupted radiofrequency (RF) delivery conditions on lesion characteristics in the atrial free wall. METHODS: Thirty-three (11 left atrial, 22 right atrial) RF ablation lesions were created in the atria of 6 swine using power control mode (25 W, target contact force 15 g) with 1 of 3 conditions: 15 seconds ablation (n = 8), 30 seconds ablation (n = 14), or 2 15-second ablations at the same site separated by a 2-minute interruption (15 seconds × 2) (n = 11). RESULTS: Thirty of 33 lesions were transmural. Rates of transmurality (P = .45) and endocardial lesion width (5.6 ± 1.2 mm, P = .70) were similar between conditions. Mean tissue thickness was 1.7 ± 0.8 mm for transmural lesions. Wide variability in bipolar electrogram attenuation was observed across and within conditions and there were no significant between-group differences. Although impedance reductions were numerically greater in the 30-second and 15-second × 2 conditions (-14.6 ± 6.6 ohms and -14.0 ± 4.4 ohms, respectively) compared to the 15-second condition (-10.3 ± 6.4 ohms), variability was large, and differences were not statistically significant (P = .243). Impedance changes after ablation were largely transient. CONCLUSION: A single 15-second ablation at 25 W (target contact force of 15 g) with good stability produced similarly sized lesions compared to 30-second ablations and 2 15-second ablations at the same site in atrial free wall tissue. These data suggest over-ablation in the atria is common, larger-diameter lesions may require greater power, and many clinically available parameters of lesion size may be unreliable on the posterior wall.

Impact of interruptions in radiofrequency energy delivery on lesion characteristics.

BACKGROUND: During catheter ablation, delivery of radiofrequency (RF) energy to a target site is sometimes interrupted by catheter instability and clinical factors. The impact of interruption of RF delivery on lesion characteristics has not been characterized. OBJECTIVE: The purpose of this study was to determine the impact of interruption of RF application on lesion size. METHODS: Forty-two RF ablation lesions (21 left ventricle, 21 right ventricle) were created in the ventricles of 6 swine using power control mode (30 W; target contact force 15g) with 1 of 3 conditions: 15-second ablation (15s), 30-second ablation (30s), or two 15-second ablations (15s×2) at the same site separated by a 2-minute pause. RESULTS: Lesion volume was significantly larger for 30s lesions (501 ± 146 mm3) compared to both 15s×2 (314 ± 98 mm3) and 15s (242 ± 104 mm3) lesions (P <.001 for both pairwise comparisons). Compared to 15s lesions, lesion volume was numerically greater for 15s×2 lesions, but this did not reach statistical significance (P = .087). Differences in lesion volume between 30s and 15s×2 lesions were driven mainly by differences in lesion width (10.7 ± 1.1 mm vs 9.1 ± 1.7 mm; P = .04) rather than depth (9 ± 1.2 mm vs 8.4 ± 1.2 mm; P = .29). There were no differences in mean contact force by group. There was no difference in total force-time integral for the 30s and 15s×2 lesion groups [median 444 (interquartile range 312) g∙s vs 380 (164) g∙s; P = 1]. CONCLUSION: Compared to lesions resulting from continuous RF ablation, lesions resulting from interrupted ablation have a smaller overall lesion volume, predominantly due to smaller lesion width. These data suggest that if disruption in energy delivery occurs, lesions may need closer spacing to avoid gaps.

Atrial fibrillation ablation using very short duration 50 W ablations and contact force sensing catheters.

PURPOSE: The optimal radiofrequency (RF) power and lesion duration using contact force (CF) sensing catheters for atrial fibrillation (AF) ablation are unknown. We evaluate 50 W RF power for very short durations using CF sensing catheters during AF ablation. METHODS: We evaluated 51 patients with paroxysmal (n = 20) or persistent (n = 31) AF undergoing initial RF ablation. RESULTS: A total of 3961 50 W RF lesions were given (average 77.6 ± 19.1/patient) for an average duration of only 11.2 ± 3.7 s. As CF increased from < 10 to > 40 g, the RF application duration decreased from 13.7 ± 4.4 to 8.6 ± 2.5 s (p < 0.0005). Impedance drops occurred in all ablations, and for patients in sinus rhythm, there was loss of pacing capture during RF delivery suggesting lesion creation. Only 3% of the ablation lesions were at < 5 g and 1% at > 40 g of force. As CF increased, the force time integral (FTI) increased from 47 ± 24 to 376 ± 102 gs (p < 0.0005) and the lesion index (LSI) increased from 4.10 ± 0.51 to 7.63 ± 0.50 (p < 0.0005). Both procedure time (101 ± 19.7 min) and total RF energy time (895 ± 258 s) were very short. For paroxysmal AF, the single procedure freedom from AF was 86% at 1 and 2 years. For persistent AF, it was 83% at 1 year and 72% at 2 years. There were no complications. CONCLUSIONS: Short duration 50 W ablations using CF sensing catheters are safe and result in excellent long-term freedom from AF for both paroxysmal and persistent AF with short procedure times and small amounts of total RF energy delivery.