Focal pulsed field ablation and ultrahigh-density mapping - versatile tools for all atrial arrhythmias? Initial procedural experiences.

BACKGROUND: Focal pulsed field ablation (FPFA) is a novel and promising method of cardiac ablation. The aim of this study was to report the feasibility, short-term safety, and procedural findings for a broad spectrum of ablated atrial arrhythmias. METHODS: Patients (n = 51) scheduled for ablation of atrial arrhythmias were prospectively included and underwent FPFA using the Galvanize CENTAURI generator with energy delivery through commercially available ablation catheters with ultrahigh-density (UHDx) 3D electroanatomic voltage/local activation time map evaluations. Workflow, procedural data, and peri-procedural technical errors and complications are described. RESULTS: Planned ablation strategy was achieved with FPFA-only in 48/51 (94%) of the cases. Ablation strategy was first-time pulmonary vein isolation (PVI) in 17/51 (36%), repeat ablation in 18/51 (38%), PVI + in 13/51 (28%), and cavotricuspid isthmus block (CTI)-only in 3/51 (6%). The mean procedure time was 104 ± 31 min (first-time PVI), 114 ± 26 min (repeat procedure), 152 ± 36 min (PVI +), and 62 ± 17 min (CTI). Mean UHDx mapping time to assess lesion formation and block after ablation was 7 ± 4 min with 5485 ± 4809 points. First pass acute (linear) isolation with bidirectional block for anatomical lesion sets was 120/124 (97%) for all PVs, 17/17 (100%) for (any) isthmus, and 14/17 (82%) for left atrium posterior wall (LAPW). We observed several time-consuming integration errors with the used ablation system (mean 3.4 ± 3.7 errors/procedure), one transient inferior ST elevation when ablating CTI resolved by intravenous nitroglycerine and one transient AV block requiring temporary pacing for > 24 h. CONCLUSIONS: FPFA was a highly versatile method to treat atrial arrhythmias with high first-pass efficiency. UHDx revealed acute homogenous low-voltage lesions in ablated areas. More data is needed to establish lesion durability and limitations of FPFA.

Characterization of durability and reconnection patterns at time of repeat ablation after single-shot pulsed field pulmonary vein isolation.

BACKGROUND: Pulsed field ablation (PFA) is a novel method of cardiac ablation where there is insufficient knowledge on the durability and reconnection patterns after pulmonary vein isolation (PVI). The aim of this study was to characterize the electrophysiological findings at time of repeat procedure in real-world atrial fibrillation (AF) patients. METHODS: Patients who underwent a repeat procedure (n=26) for symptomatic recurrent arrhythmias after index first-time treatment with single-shot PFA PVI (n=266) from July 2021 to June 2023 were investigated with 3D high-density mapping and ad-hoc re-ablation by radiofrequency or focal PFA. RESULTS: Index indication for PVI was persistent AF in 17 (65%) patients. The mean time to repeat procedure was 292 ± 119 days. Of the 26 patients (104 veins), complete durable PVI was observed in 11/26 (42%) with a durable vein isolation rate of 72/104 (69%). Two patients (8%) had all four veins reconnected. The posterior wall was durably isolated in 4/5 (80%) of the cases. The predominant arrhythmia mechanism was AF in 17/26 (65%) patients and regular atrial tachycardia (AT) in 9/26 (35%). Reconnection was observed 9/26 (35%) in right superior, 11/26 (42%) in right inferior, 7/26 (27%) in left superior, 5/26 (19%) in left inferior, p=0.31 between veins. The gaps were significantly clustered in the right-sided anterior carina compared to other regions (P=0.009). CONCLUSIONS: Durable PVI was observed in less than half of the patients at time of repeat procedure. No significant difference in PV reconnection pattern was observed, but the gap location was preferentially located at the anterior aspects of the right-sided PVs. Predominant recurrence was AF. More data is needed to establish lesion formation and durability and AT circuits after PFA.

Pulsed field ablation in real-world atrial fibrillation patients: clinical recurrence, operator learning curve and re-do procedural findings.

BACKGROUND: Pulsed field ablation (PFA) is a novel method of cardiac ablation demonstrated in early pre-clinical and clinical settings. The aim of this study was to report the safety and clinical efficacy of pulmonary vein isolation (PVI) with PFA for real-world atrial fibrillation (AF) patients. METHODS: All-comer AF patients (n = 121, 59% paroxysmal) were prospectively included and underwent PFA with 100% high-density voltage maps performed after PVI. Clinical outcomes were gathered by chart review. RESULTS: PVI was achieved with PFA-only in 119 (98%) of the cases. During the implementation phase the mean procedure and fluoroscopy time was reduced from 85 ± 34 to 72 ± 18 min (p = 0.044) and 22 ± 9 to 16 ± 4 (p = 0.034). We observed one phrenic nerve palsy with only partial remission at follow-up. Other adverse events were numerically comparable to standard PVI procedures. Over a mean follow-up of 308 ± 87 days, a total of 22/121 (18.2%) cases experienced clinically significant recurrence or initiation of anti-arrhythmic drugs with Kaplan-Meier event-free estimate at 365 days of 80% (88% for paroxysmal versus 69% for persistent). In five of eight re-do procedures, gaps were primarily located at the right pulmonary veins. CONCLUSIONS: PFA was a highly efficient method to achieve PVI with reductions in procedure time and fluoroscopy over the implementation period. The procedural data and clinical recurrence rates from initial trials were confirmed in real-life non-selected AF patients. More data is needed to establish lesion durability and limitations of PFA.

Posterior wall isolation in persistent atrial fibrillation. Long-term outcomes of a repeat procedure strategy.

BACKGROUND: Posterior wall isolation (PWI) added to pulmonary vein isolation (PVI) is increasingly used in ablation for persistent atrial fibrillation (PeAF) despite limited evidence of clinical benefit. We investigated the 5-year outcomes of a PVI + PWI ablation strategy with mandatory repeat procedures in PeAF. METHODS: Twenty-four patients with PeAF participated in this single-arm prospective study and underwent radiofrequency ablation (RFA) with wide area circumferential ablation (WACA), roof, and inferior lines for PVI + PWI which was reinforced if required during mandated repeat procedures after 6 months. Then, patients were followed for 60 months using continuous heart rhythm monitoring by implanted cardiac monitors (ICM) and atrial fibrillation effect on quality-of-life scoring (AFEQT; range: 20-100 points) for the initial 30 months. RESULTS: ICM-verified cumulated AF recurrence was 54% after 30 months but the ensuing AF burden was only median 0‰ [0 to 4.8‰] overall and 1‰ [0 to 8 ‰] among patients with any recurrence. AFEQT scores increased from baseline 60 points [48 to 72] to 93 points [84 to 96] at repeat procedures P < 0.0001 and further to 96 points [93 to 99] P = 0.03 after 30 months. After 60 months, at least one episode of AF had been documented in 63% and two patients (8%) were in permanent AF. CONCLUSION: Reinforced PVI + PWI was associated with low long-term AF burden and corresponding improvements in quality-of-life. Reinforced (or durable) PVI + PWI appears to be a promising strategy to treat PeAF. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT05045131.

Posterior wall isolation in persistent atrial fibrillation feasibility, safety, durability, and efficacy.

INTRODUCTION: Posterior wall isolation (PWI) added to pulmonary vein isolation (PVI) is increasingly used despite limited evidence of clinical benefit. We investigated the feasibility, durability, and efficacy of index-procedure PVI + PWI radio frequency ablation (RFA) in patients with persistent atrial fibrillation (PeAF). METHODS AND RESULTS: Twenty-four patients with PeAF participated in the prospective PeAF-Box study and underwent RFA with wide area circumferential ablation, roof- and inferior lines to achieve PVI + PWI at index procedure. Follow-up included monitoring by an implantable cardiac monitor, esophagoscopy and mandated invasive lesion-reassessment at 6 months. PWI was achieved at minor procedural cost in all patients following PVI. In 33% of patients a median of three ablations in the narrow zone between the center of the posterior wall (PW) and the posterior right carina was pivotal for swift achievement of PWI. At the 6-month reassessment procedure 85% (95% confidence interval [CI]: 77%-92%) of pulmonary veins (PVs) and 46% (95% CI: 26%-67%) of PWs remained durably isolated. AF recurred in 25% and was associated with PV-reconnection (p = .02) but not PW-reconnection (p = .27). AF-burden was 0% (interquartile range [IQR]: 0%-0%) overall and after recurrence 1% (IQR: 0%-7%). CONCLUSION: Index procedure PVI + PWI for PeAF was feasible when recognizing that limited ablation in a PW center-to-right-carina zone was required in a subset of patients. Despite limited chronic PWI durability this strategy was followed by low AF-burden. A PVI + PWI strategy appears promising in ablation for PeAF.