Pulmonary vein anatomy and long-term outcome after multi-electrode pulmonary vein isolation with phased radiofrequency energy for paroxysmal atrial fibrillation (original) (raw)
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Europace, 2015
We compare our experience with available circular multi-electrode catheters for atrial fibrillation (AF) ablation: PVAC w , a phased radiofrequency system, and nMARQ TM , an irrigated tip-CARTO-based technology. Methods and results Prospective observational study of 175 consecutive patients with follow-up duration of at least 5 months who underwent pulmonary vein isolation (PVI) for symptomatic AF using PVAC w (n ¼ 93, age 61.4 + 9.8 years; 60% male, 13% persistent AF) vs. nMARQ TM (n ¼ 82, age 63.2 + 10.6 years; 67% male, 24% persistent AF). Procedure and radiation times were 94 + 27 and 33 + 13 min for PVAC w and 81 + 18 and 30 + 8.5 for nMARQ TM (P ¼ 0.0008 and P ¼ 0.18), respectively. The number of applications and the total burning time (min) were 20 + 7 and 19 + 6.7 for PVAC w and 16 + 5.6 and 11 + 4 for nMARQ TM (P , 0.0001 for both), respectively. In two nMARQ TM patients with small atria and pulmonary veins (PVs) and in two PVAC w patients with large PVs, the procedure failed; switching to the alternative technology was successful. Acute success rate was 97% for PVAC w and 95% for nMARQ TM. There was one tamponade in nMARQ TM group and non-significant different minor complications for both techniques. One-year freedom from AF was 79 and 80.7% with PVAC w vs. nMARQ TM , after one PVI, and 88 vs. 87.7% after two PVIs. Conclusion Both technologies have short procedure and fluoroscopy times, comparable complication rates, and comparable acute and 1-year success rates. The number of applications and total procedure and burning times were shorter with nMARQ TM. nMARQ TM was more suitable for larger atria and PVs. Thus, a patient-based pre-ablation anatomy definition is probably warranted for appropriate selection of technology type.
Europace, 2012
In patients with paroxysmal atrial fibrillation (PAF) the pattern of atrial fibrillation (AF) episodes and the total AF burden, may be related to the efficacy of pulmonary vein isolation (PVI). We evaluated (pre)-procedural factors explaining the long-term outcome after PVI, using a ring-shaped multielectrode ablation catheter [pulmonary vein ablation catheter (PVAC)]. Methods and results A total of 120 consecutive patients with PAF were treated with the PVAC. The patients' histories were obtained by a questionnaire and the clinical charts. Follow-up was performed at 3, 6, 12, 18, and 24 months with serial electrocardiogram, and multiple day Holter at 6, 12, and 24 months, as well as event recording in case of unexplained palpitations. At 1 year, 66 of 120 (55%, 95% confidence interval (CI) [46-63%]) patients were free of any left atrial (LA) arrhythmia without class I or III anti-arrhythmics after a single procedure. At 2 years, freedom from LA arrhythmia slightly declined further to 58 of 119 (49%, 95% CI [40-58%]). The only pre-procedural predictor of long-term success was a shorter duration of the longest episode of AF (hazard ratio (HR) 0.77 95% CI [0.64-0.92]). The only procedural predictor of long-term success was no need for direct current cardioversion (DCCV) for AF (HR 0.36 95% CI [0.21-0.61]). Since other characteristics in these PAF patients were very homogeneous, no further clinical predictors were observed. Conclusion Freedom from LA arrhythmia after PVI for PAF with PVAC is 49% after 2-year follow-up, with little decline between year 1 and 2. Predictors of long-term failure were a longer duration of the longest episode of AF in the pre-procedural questionnaire, and a procedural DCCV for AF.
Journal of Interventional Cardiac Electrophysiology, 2022
Purpose The second-generation multi-electrode catheter, PVAC Gold, was designed to improve the safe delivery of phased radiofrequency energy using a "single shot" approach for pulmonary vein isolation (PVI), while retaining efficacy. This large registry presents long-term performance in a daily practice setting. Methods A total of 1011 patients undergoing first time ablation for atrial fibrillation (AF) using PVAC Gold were included, 639 patients with PVI for paroxysmal AF (PAF PVI) and 372 patients with persistent or long-standing persistent AF, divided into 175 patients receiving PVI only (PersAF PVI) and 197 patients receiving PVI with additional substrate ablation (PersAF PVI +). Results At 24-month follow-up, single procedure freedom from atrial tachyarrhythmia (ATA) was 58% (368/639) in the PAF PVI group, 44% (77/175) in the PersAF PVI group, and 29% (57/197) in the PersAF PVI + group. Allowing one repeat procedure in 33% of patients, 76%, 65%, and 54% were free from ATA at 24 months, respectively. Pulmonary vein reconnection was observed in 98% of patients with recurrent arrhythmia after PVI. Conclusions Although phased RF ablation with PVAC Gold is quick and safe, the efficacy outcomes are modest compared to current mainstream ablation strategies.
Journal of Interventional Cardiac Electrophysiology, 2020
Purpose The second-generation multi-electrode catheter, pulmonary vein ablation catheter (PVAC) GOLD, was designed to improve the delivery of phased radiofrequency energy and reduce procedure times using a ‘single-shot’ approach for pulmonary vein isolation (PVI), while retaining efficacy and safety. This large registry presents acute success rates and safety outcomes in a daily practice setting. Methods A total of 1017 patients undergoing first-time ablation for atrial fibrillation (AF) using PVAC GOLD were included, 644 patients with paroxysmal AF and 373 patients with non-paroxysmal AF, divided into 175 patients receiving PVI only and 198 patients receiving PVI with additional substrate modification. Results High and comparable percentages of successful PVI could be achieved in all groups (98%, 95% and 99%; p = 0.108). The median total procedure time for all groups was 90 min [70–100]. As expected, the total procedure, ablation and fluoroscopy time were significantly longer in th...
World Journal of Cardiovascular Diseases, 2013
Purpose: Pulmonary vein isolation (PVI) is the accepted primary endpoint for catheter ablation of atrial fibrillation (AF). The aim of this study was to evaluate the level of PVI by PVAC, a multipolar circular catheter utilizing bipolar/unipolar radiofrequency (RF) energy. Methods: Twenty patients with paroxysmal AF underwent PVAC ablation. PVI was validated by voltage reduction and pacing tests. Before and after RF ablation, left atrium (LA) and PV electroanatomic mapping (EAM) were performed by EnSite NavX system. Voltage abatement was considered for potentials < 0.5 mV. RF lesion setting was compared to the PVs anatomy previously acquired by a cardiac CT scan. Results: Seventeen patients had four veins and three had a left common PV. All 77 PVs were isolated by PVAC. After RF, EAM showed low voltages areas at the proximal PV ostium and LA. Segmental voltage abatement slightly distal to the anatomic PV ostia was achieved in 20/77 (26%) PVs, more frequently in veins > 24mm: 9/20 (45%) vs 11/57 (19%), p < 0.05. Antral lesions were evident in 38/77 PVs (49%), limited to a part of the antrum in 29/38 (76%) veins, with larger occurrence in round than in oval PVs ostia: 25/36 (69%) vs 13/41 (32%), p < 0.001. Conclusions: Electrophysiological PVI with PVAC is achieved in all the veins with low voltages areas at the proximal PV ostium. A low voltage circumferential lesion at the anatomic PV ostia is more challenging in larger veins. Antral lesions, frequently affecting part of the antra, were more frequent in round PV ostia.
Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation
Journal of the American College of Cardiology, 2019
BACKGROUND Catheter ablation of atrial fibrillation using thermal energies such as radiofrequency or cryothermy is associated with indiscriminate tissue destruction. During pulsed field ablation (PFA), subsecond electric fields create microscopic pores in cell membranes-a process called electroporation. Among cell types, cardiomyocytes have among the lowest thresholds to these fields, potentially permitting preferential myocardial ablation. OBJECTIVES The purpose of these 2 trials was to determine whether PFA allows durable pulmonary vein (PV) isolation without damage to collateral structures. METHODS Two trials were conducted to assess the safety and effectiveness of catheter-based PFA in paroxysmal atrial fibrillation. Ablation was performed using proprietary bipolar PFA waveforms: either monophasic with general anesthesia and paralytics to minimize muscle contraction, or biphasic with sedation because there was minimal muscular stimulation. No esophageal protection strategy was used. Invasive electrophysiological mapping was repeated after 3 months to assess the durability of PV isolation. RESULTS In 81 patients, all PVs were acutely isolated by monophasic (n ¼ 15) or biphasic (n ¼ 66) PFA with #3 min elapsed delivery/patient, skin-to-skin procedure time of 92.2 AE 27.4 min, and fluoroscopy time of 13.1 AE 7.6 min. With successive waveform refinement, durability at 3 months improved from 18% to 100% of patients with all PVs isolated. Beyond 1 procedure-related pericardial tamponade, there were no additional primary adverse events over the 120-day median follow-up, including: stroke, phrenic nerve injury, PV stenosis, and esophageal injury. The 12-month Kaplan-Meier estimate of freedom from arrhythmia was 87.4 AE 5.6%. CONCLUSIONS In first-inhuman trials, PFA preferentially affected myocardial tissue, allowing facile ultra-rapid PV isolation with excellent durability and chronic safety.
Cardiology Journal, 2013
Background: Radiofrequency (RF) catheter ablation is a first-line therapy for patients with drug-refractory atrial fibrillation (AF). Complete isolation of electrical potentials at the ostium of pulmonary vein (PV) is a challenging procedure. There are different techniques and devices used for PV isolation (PVI). The objective of this study was to evaluate the efficacy and safety of PV ablation catheter (PVAC). Methods: A total of 67 consecutive patients with paroxysmal and persistent AF were treated with the PVAC. The patients' information were obtained from clinical charts. Follow-up was obtained by one day Holter monitoring at 2, 4, 6, 8, 10 and 12 months after ablation and ECG registration if any symptoms or arrhythmia occurred. Results: The median follow-up duration was 16 months (IQR: 12-20 months). In the population which was available at follow-up (n = 60), 22 (36.7%) patients were in sustained sinus rhythm (SR) without anti-arrhythmic drugs (AAD). Overall 26 (43.3%) patients were in sustained SR with and without AAD. In the paroxysmal AF group, after a single PVAC ablation procedure (n = 39), 19 (48.7%) patients had sustained SR without AAD. In the persistent AF group (n = 15), after the single PVAC ablation, 2 (13.3%) patients had sustained SR without AAD. Conclusions: PVI with PVAC is a safe procedure with 48.7% efficacy in patients with paroxysmal AF. The efficacy of PVAC in patients with persistent or long-standing persistent AF is not acceptable. (Cardiol J 2013; 20, 6: 618-625)