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Acute map after pulsed field ablation of pulmonary veins and visualisation of gaps at time of re-do procedure. Left side acute voltage map after pulsed field ablation and pulmonary vein isolation. Right side shows voltage map at time of re-do procedure showing gaps anteriorly to the right superior pulmonary vein (not visible in left anterior oblique) and posterior-inferiorly to the right inferior pulmonary vein (arrow). Colour-coding magenta is bipolar voltage > 0.5 mV and red is bipolar voltage < 0.2 mV
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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% paroxysm...
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Aims:
A novel irrigated radiofrequency (RF) balloon (RFB) for pulmonary vein (PV) isolation (PVI) was released in selected centres. We pooled the procedural data on efficacy and safety of RFB-PVI from two high volume German centres.
Methods and results:
Consecutive patients with RFB procedures were enrolled. A 3D electroanatomical left atrial ma...
Funding Acknowledgements
Type of funding sources: None.
Background
Phase mapping using software of ExTRa Mapping is a new tool to clarify the localization of rotor in atrial fibrillation (AF), but the spatial distribution of rotor in right atrium (RA) and the effect of ablation is not clear compared with left atrium (LA).
Purpose
This study sough...
Background: Pulmonary vein isolation (PVI) is the standard of care for the treatment of symptomatic atrial fibrillation (AF). Novel techniques for PVI are the thermal size-adjustable cryo-balloon (CB) system and non-thermal pulsed field ablation (PFA) system. There are currently no data available for a direct comparison between these two systems. F...
Background
Cryoballoon ablation, especially Arctic Front Advance Pro (AFA-Pro) (Medtronic, Minneapolis, Minnesota, USA), has been widely recognised as a standard approach to atrial fibrillation (AF). Recently, Boston Scientific has released a novel cryoballoon system (POLARx). Despite comparable acute clinical outcomes of these two cryoballoons, th...
Background
Pulsed-field ablation (PFA) has emerged as a novel treatment technology for patients with atrial fibrillation (AF). Cryoballoon (CB) is the most frequently used single shot technology. A direct comparison to a novel CB system is lacking.
Objective
To compare pulmonary vein isolation (PVI) using PFA versus a novel CB system regarding eff...
Citations
... Recent real-world registries and multi-national surveys from high-volume European AF ablation centers, evaluating procedure efficiency and safety, on early adoption of the novel PFA technology, demonstrated short procedural times, despite a large number of operators, with grading experience, approached this brand-new technique [11,12]. Early data on PFA have shown that from PFA adoption over the implementation period, an overall reduction of procedural and fluoroscopy times can be reached [13]. Therefore, the aim of our analysis from a real-world nationwide registry is to systematically assess the operators' learning curve and related acute outcomes of the FARA-PULSE™ PFA system in the context of AF ablation. ...
... At the end of the procedure, PVI was achieved in all (100%) patients (number of PFA applications to achieve PVI = 32 [32-36]). Additional lesions outside PVs were delivered in 24.0% (n = 181) of the 120 (16) cases (177 (23.5%) cases with PVI plus additional lesions and four (0.5%) cases with additional lesions only) with a median of 16 [12][13][14][15][16][17][18][19][20] PFA deliveries. Additional lesions were deployed mostly at the posterior wall area (n = 175, 96.7%; poster wall area only in 168, 92.8%, cases), whereas roof area (n = 9, 5.0%) or other targets were less frequent (n = 6, 3.3%). ...
... The overall median skin-to-skin time and support time were 63 min [55-80] and 70 min [60-95], respectively; fluoroscopy time was 15 min [12][13][14][15][16][17][18][19][20]. A total of 470 (62.5%) procedures were performed by a primary operator that accomplished > 20 PFA procedures and were included in the learning curve analysis. ...
Background
Recent data on pulsed field ablation (PFA) for atrial fibrillation (AF) ablation suggest a progressive reduction in procedural times. Real-world data regarding the relationship between the learning curve of PFA and clinical outcomes are scarce. The objective was to evaluate the PFA learning curve and its impact on acute outcomes.
Methods
Consecutive patients undergoing AF ablation with the FARAPULSE™ PFA system were included in a prospective, non-randomized multicenter study. Procedural times were stratified on the operators’ learning curve. Comparative analysis of skin-to-skin time was conducted with radiofrequency (RF) and cryoablation (CB) pulmonary vein isolation (PVI) procedures performed by the same operators in the previous year.
Results
Among 752 patients, 35.1% were females, and 66.9% had paroxysmal AF; mean age was 62.2 ± 10 years. A total of 62.5% of procedures were performed by operators with > 20 PFA procedures. Both time to PVI (25.6 ± 10 min vs 16.5 ± 8, p < 0.0001) and fluoroscopy time (19.8 ± 8 min vs 15.9 ± 8 min, p = 0.0045) significantly improved after 10 associated with consistent linear trend towards procedural time reduction (R² 0.92–0.68 across various procedural metrics). Current PFA skin-to-skin time was lower than the historical skin-to-skin one in 217 (62.4%) procedures; it was similar in 112 (32.2%) cases and higher than the historical skin-to-skin one in 19 (5.5%). No major complications were reported.
Conclusions
In this nationwide multicentric experience, the novel PFA system proved to be fast, safe, and acutely effective in both paroxysmal and persistent AF patients. The learning curve appears to be rapid, as improvements in procedural parameters were observed after only a few procedures.
Clinical Trial Registration
Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/ Identifier: NCT05617456
... However, real-world data are encouraging. Ruwald et al. recently reported, over a mean follow-up of 308 days in a 121-patient court, that 18.2% of the cases experienced clinically significant recurrences or required initiation of anti-arrhythmic drugs [7]. The Kaplan-Meier event-free estimate at 365 days was 80% (88% for paroxysmal AF and 69% for persistent AF). ...
... As already demonstrated with the use of thermal energy, among the most important ones seems to be the pattern of arrhythmia before ablation (paroxysmal vs. persistent). In the study by Ruwald et al., patients with paroxysmal AF had significantly lower recurrences compared to their persistent counterparts (AF-free survival 88% vs. 69%, p = 0.001) [7]. Other authors quantified the risk conferred by the presence of persistent AF in a 39% increase in the risk of recurrences (HR 1.39, p < 0.001) [8]. ...
Pulsed Field Ablation (PFA) is the latest and most intriguing technology for catheter ablation of atrial fibrillation, due to its capability to generate irreversible and cardiomyocytes-selective electroporation of cell membranes by delivering microsecond-lasting high-voltage electrical fields, leading to high expectations. The first trials to assess the clinical success of PFA, reported an arrhythmia-free survival at 1-year of 78.5%, while other trials showed less enthusiastic results: 66.2% in paroxysmal and 55.1% in persistent AF. Nevertheless, real world data are encouraging. The isolation of pulmonary veins with PFA is easily achieved with 100% acute success. Systematic invasive remapping showed a high prevalence of durable pulmonary vein isolation at 75 and 90 days (range 84–96%), which were significatively lower in redo procedures (64.3%). The advent of PFA is prompting a reconsideration of the role of the autonomic nervous system in AF ablation, as PFA-related sparing of the ganglionated plexi could lead to the still undetermined effect on late arrhythmias’ recurrences. Moreover, a new concept of a blanking period could be formulated with PFA, according to its different mechanism of myocardial injury, with less inflammation and less chronic fibrosis. Finally, in this review, we also compare PFA with thermal energy.
... However, postmarket data on PVI durability after PFA PVI are scarce and heterogeneous. [7][8][9] We present the data on lesion durability data from the large EU-PORIA (European Real World Outcomes With Pulsed Field Ablation) registry in patients undergoing a clinically indicated left atrial (LA) redo procedure due to arrhythmia recurrence after PVI using the pentaspline PFA catheter. ...
... 16,22,23 The reported AF free survival aligns with previous studies regarding CB 24,25 and PFA. 26,27 Furthermore, to the best of our knowledge, our study is the first to compare PFA with a novel CB system. Prior studies focused on the comparison between RF energy and CB. ...
Background
Pulsed-field ablation (PFA) has emerged as a novel treatment technology for patients with atrial fibrillation (AF). Cryoballoon (CB) is the most frequently used single shot technology. A direct comparison to a novel CB system is lacking.
Objective
To compare pulmonary vein isolation (PVI) using PFA versus a novel CB system regarding efficiency, safety, myocardial injury, and outcomes.
Methods
181 consecutive patients underwent PVI and were included (age 64 ± 9.7 years, ejection fraction 0.58 ± 0.09, left atrial size 40 ± 6.4 mm, paroxysmal AF 64%). 106 patients (59%) underwent PFA (FARAPULSE, Boston Scientific) and 75 patients (41%) underwent CB ablation (PolarX, Boston Scientific).
Results
The median procedure time, left atrial dwell time and fluoroscopic time were similar between the PFA and the CB group with 55 (IQR 43-64) min versus 58 (IQR 48-69) min (p < 0.087), 38 [30 - 49] min vs. 37 [31 - 48] min, (p = 0.871), and 11 (IQR 9.3-14) min versus 11 (IQR 8.7-16) min, (p < 0.81), respectively. Three procedural complications were observed in the PFA group (2 tamponades, 1 temporary ST elevation) and three complications in the CB group (3x reversible phrenic nerve palsies). During the median follow-up of 404 days (IQR 208-560), AF recurrence was similar in the PFA group and the CB group with 24% vs. 30%, p = 0.406.
Conclusion
Procedural characteristics were very similar between PFA and CB in regard to procedure duration fluoroscopy time and complications. AF free survival did not differ between the PFA and CB groups.
... Although there was increased fluoroscopy time in the PFA arm, this is likely explained by operator inexperience and the wide use of non-fluoroscopic, electroanatomical mapping systems with thermal ablation. Fluoroscopy time should decrease as familiarity with PFA increases and with the incorporation of mapping systems with PFA in the future [20][21][22][23][24][25]. ...
Background
Pulsed field ablation (PFA) induces cell death through electroporation using ultrarapid electrical pulses. We sought to compare the procedural efficiency characteristics, safety, and efficacy of ablation of atrial fibrillation (AF) using PFA compared with thermal energy ablation.
Methods
We performed an extensive literature search and systematic review of studies that compared ablation of AF with PFA versus thermal energy sources. Risk ratio (RR) 95% confidence intervals (CI) were measured for dichotomous variables and mean difference (MD) 95% CI were measured for continuous variables, where RR < 1 and MD < 0 favor the PFA group.
Results
We included 6 comparative studies for a total of 1012 patients who underwent ablation of AF: 43.6% with PFA (n = 441) and 56.4% (n = 571) with thermal energy sources. There were significantly shorter procedures times with PFA despite a protocolized 20-min dwell time (MD − 21.95, 95% CI − 33.77, − 10.14, p = 0.0003), but with significantly longer fluroscopy time (MD 5.71, 95% CI 1.13, 10.30, p = 0.01). There were no statistically significant differences in periprocedural complications (RR 1.20, 95% CI 0.59–2.44) or recurrence of atrial tachyarrhythmias (RR 0.64, 95% CI 0.31, 1.34) between the PFA and thermal ablation cohorts.
Conclusions
Based on the results of this meta-analysis, PFA was associated with shorter procedural times and longer fluoroscopy times, but no difference in periprocedural complications or rates of recurrent AF when compared to ablation with thermal energy sources. However, larger randomized control trials are needed.
... Irreversible electroporation of the cardiac myocytes by pulsed field ablation (PFA) has emerged as a novel non-thermal energy source to create sufficiently deep lesions suggesting a good lesion durability without any apparent extracardiac damage [2][3][4]. Early clinical studies showed high 3-month durability in scheduled remapping studies [5], and the safety and clinical efficacy of single-shot PFA has now been documented in larger datasets [5][6][7][8][9][10][11][12][13]. Still, however, the clinical efficacy seems only comparable to, and not superior to, the ablations performed with traditional thermal energy sources and randomized trials are eagerly awaited on this matter. ...
... The index single-shot PFA procedure was done as described previously [10]. In short, patients were under general anesthesia and intubated and had standard vein punctures and access to the left atrium (LA). ...
... Thereafter, attempted induction of trigger activity or AT with isoprenaline infusion to a heart rate> 100 bpm and atrial burst pacing was performed. ATs were mapped accordingly using local activation time maps and coherence conduction vectors to establish critical isthmuses and circuits with supplementary entrainment mapping if needed, as per clinical standard, and described earlier [10,16,17]. Ad-hoc ablation based on the above findings was performed with RFA through steerable sheaths with irrigated SmartTouch surround flow catheters (Biosense Webster) adhering best possible to the CLOSE protocol in terms of interlesion distance and ablation index [18] or by focal PFA utilizing the Galvanize EP (Galvanize EP) system through SmartTouch catheters (Biosense Webster) as described previously [19]. ...
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.
... The fact that several preclinical and clinical studies have already demonstrated the feasibility and safety of PFA for the treatment of atrial fibrillation provided a cornerstone for the application of PFA in the field of supraventricular tachycardia 9,10 . Moreover, recently published study demonstrated the successful application of PFA for the ablation of premature ventricular contractions, atrial tachycardia and atrial flutter confirming its efficacy and safety in treating various types of arrhythmias 11, 12 . ...
Introduction: We present the application of pulsed-field ablation (PFA) for the treatment of para-Hisian accessory pathways (APs). Medthods: We consecutively enrolled patients diagnosed with paroxysmal supraventricular tachycardia (PSVT) to undergo PFA isolation. Two patients of this series exhibited para-Hisian AP and experienced frequent palpitations. The JJEC PFA catheter were used to deliver PFA applications. Results: No complications occurred, even when pulsed ablation was performed in proximity to the His bundle. During the 6-month follow-up visits, the patients remained free of palpitations and arrhythmias. Conclusions: This report suggests that PFA serve as a novel and effective modality for para-Hisian AP ablation.
... This has generated high expectations that PFA could be the tool to overcome the durability issue leading to improved outcomes after AF ablation. Post-market data on PVI durability after PFA PVI however is scarce and conflicting [6,7]. Here we present our data on PVI durability collected during redo ablations after an initial PFA PVI. ...
... These data were in line with the pre-market PFA data [13] and indicate superiority in terms of PVI durability compared to data from studies investigating thermal energies. A recent small report from Copenhagen with 8 patients however reported durable PVI in only 38% of redo procedures after PFA PVI [7]. Our findings are similar with durable PV isolation in 62% of the veins and 21% of the patients. ...
Background
A novel multipolar pulsed-field ablation (PFA) catheter has recently been introduced for pulmonary vein isolation (PVI). Pre-market data showed high rates for PVI-durability during mandatory remapping studies.
Objective: To present post-market data in patients with recurrent arrhythmias.
Methods
Consecutive patients undergoing a redo procedure after an index PFA PVI using a bipolar-biphasic PFA system were included. 3-D electro-anatomical maps (3D-EAM) on redo procedure were compared to the 3D-EAM acquired after ablation during the index procedure. PVI durability was assessed on a per-vein and per-patient level and the sites of reconnections were identified. Furthermore, lesion extent around veins with durable isolation was compared to study lesion regression.
Results
Of 341 patients treated with a PFA PVI, 29 (8.5%) underwent a left atrial redo ablation due to arrhythmia recurrence. At the end of the index procedure, 110/112 veins (98%, four common ostia) were isolated. On redo procedures performed a median of 6 months after the first ablation, 3D-EAM identified 69/110 (63%) PVs with durable isolation. In 6 (21%) patients, all PVs were durably isolated. Reconnections were more often found on the right-sided veins and on the anterior aspects of the upper veins. Only minor lesion regression was observed between the index and redo procedure (a median of 3 mm (0 – 9.5) on the posterior wall).
Conclusion
In patients with arrhythmia recurrence after PFA PVI using a first-generation PFA device, durable isolation was observed in 63% of the veins and 21% of the patients showed durable isolation of all previously isolated veins.
Graphical abstract
... Since its commercial release, the pentaspline, multi-electrode PFA catheter has shown encouraging acute efficacy and safety profiles. 13,[17][18][19][20][21][22] Feasibility studies and early single-centre experiences have demonstrated lesion durability, safety, and initial long-term outcomes. 13,17,[19][20][21][22][23][24][25] However, real-world outcomes in large patient populations are still scarce. ...
... 13,[17][18][19][20][21][22] Feasibility studies and early single-centre experiences have demonstrated lesion durability, safety, and initial long-term outcomes. 13,17,[19][20][21][22][23][24][25] However, real-world outcomes in large patient populations are still scarce. 18 Chronic data are needed to further evaluate the use of this novel technology in a real-world setting and understand the learning curve. ...
Background and aims:
Pulsed field ablation (PFA) is a new, non-thermal ablation modality for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). The multi-center EU-PORIA (EUropean Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation) registry sought to determine the safety, efficacy, and learning curve characteristics for the pentaspline, multielectrode PFA catheter.
Methods:
All-comer AF patients from seven high-volume centers were consecutively enrolled. Procedural and follow-up data were collected. Learning curve effects were analyzed by operator ablation experience and primary ablation modality.
Results:
In total, 1,233 patients (61% male, mean age 66±11years, 60% paroxysmal AF) were treated by 42 operators. In 169 patients (14%), additional lesions outside the PVs were performed, most commonly at the posterior wall (n=127). Median procedure and fluoroscopy times were 58 [IQR: 40-87] and 14 [9-21] min, respectively, with no differences due to operator experience. Major complications occurred in 21/1233 procedures (1.7%) including pericardial tamponade (14; 1.1%) and transient ischemic attack or stroke (n=7; 0.6%), of which one was fatal. Prior cryo-balloon users had less complications. At a median follow-up of 365 [323-386] days, the Kaplan-Meier estimate of arrhythmia-free survival was 74% (80% for paroxysmal and 66% for persistent AF). Freedom from arrhythmia was not influenced by operator experience. In 149 (12%) patients a repeat procedure was performed due to AF recurrence and 418/584 (72%) PVs were durably isolated.
Conclusion:
The EU-PORIA registry demonstrates a high single-procedure success rate with an excellent safety profile and short procedure times in a real-world, all-comer AF patient population.
... Potentially, this new method reduces the risk of collateral organ tissue damage when ablating in the heart, limiting feared complications such as damage to the oesophagus and phrenic nerves and pulmonary vein stenosis [6][7][8][9]. Prospective results and recurrence rates using three different multielectrode PFA catheters designed for "single-shot" pulmonary vein isolation (PVI) have now been reported [1,4,5,[10][11][12][13]. Although the 1-year recurrence rates seem comparable to thermal ablation methods, lesion durability, predictability, and safety profile of the systems make PFA very promising. ...
... In case of isthmus ablation, an administration of intravenous nitroglycerine 0.2 mg over 1 min was given prior to ablation with an additional dose of 0.2 mg if possible after (any) hypotension had been resolved by concomitant vasopressor and/or saline infusion. Atrial tachycardias were mapped accordingly using local activation time maps and coherence conduction vectors to establish critical isthmuses and circuits with supplementary entrainment mapping if needed as per clinical standard and described [10,[16][17][18]. Following ablations, one or more confirmatory detailed UHDx bipolar voltage amplitude 3D maps of the ablation line(s) in LA or right atrium were performed with the multielectrode catheter using proximal CS pacing. ...
... Although multielectrode PFA has been shown to be useful and feasible for successful ablation of the LAPW with or without supplementary mapping [10,16,24], feedback on contact and force values may be important for optimal and durable lesion formation of PFA [26]. These parameters are not yet available in clinical practice. ...
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.
