Pulsed-field ablation (PFA) emerges as an innovative nonthermal energy modality for catheter ablation of atrial fibrillation (AF). This study aimed to assess the safety and effectiveness of a novel PFA system that uses a multichannel, circular ablation catheter with adjustable diameters in treating paroxysmal AF.

This clinical trial (PF-Beat-AF) was a prospective, multicenter, single-arm study. Patients with paroxysmal AF underwent pulmonary vein isolation (PVI) using the PFA system, and were followed at discharge, 7-day, 1-, 3-, 6- and 12-month post-procedure. Primary safety endpoint was the incidence of primary adverse events (PAEs). While primary effectiveness endpoint was freedom from documented atrial arrhythmia recurrence lasting >30 s during the 3-12 months evaluation period.

A total of 161 patients were enrolled and 159 patients were treated in eight centers. Conscious sedation was used in 68.6 % of cases, and 40.9 % of procedures were completed without fluoroscopy. The mean total procedure time was 132.3 ± 40.4 min, and fluoroscopy time averaged 6.4 ± 6.8 min. Acute PVI was achieved in 100 % of patients. One PAE (0.6 %) occurred (pericardial tamponade, resolved). At 12 months, 87.7 % (95 % CI: 82.5 %-92.9 %) of patients remained free from atrial arrhythmia after the blanking period. No significant differences in effectiveness were observed between conscious sedation and general anesthesia/deep sedation, or fluoroscopy and zero-fluoroscopy cases.

The results of clinical trial demonstrated the safety and effectiveness of the PFA system in treating paroxysmal AF, including successful use with conscious sedation and zero-fluoroscopy.

The inability to create durable, high-quality lesions in the ventricles has limited ventricular tachycardia (VT) ablation outcomes. With pulsed field ablation (PFA), a new modality offers the potential to overcome limitations of conventional, thermal ablation. The lattice-tip catheter's design makes it a promising and versatile tool for ventricular ablation. Preclinical studies have shown that PFA using this system can penetrate scar and fat, create deep lesions, and address difficult ablation targets. Clinical data are scarce but suggest acute feasibility and safety. More research is necessary to evaluate whether this novel ablation system could take VT ablation to the next level.

Pulsed field ablation (PFA) with a circular-electrode-array catheter (cPFA) has shown to be effective and safe. However, data on procedural workflow are limited.

to analyze the process of streamlining cPFA-procedures including evaluation of fluoroscopy versus 3D-map guidance and lesion characteristics.

Consecutive AF-patients underwent cPFA-based pulmonary vein isolation (PVI) in three phases (learning-phase-I: visualization of cPFA in 3D-map; phase-II: operator blinded to 3D-map with fluoroscopy-guidance only; phase-III: optimized mapping and ablation). Additionally, hemolysis-parameters were collected.

A total of 35 patients (57 % paroxysmal-AF, age 63.4 ± 9.4 years) were enrolled: n = 10 phase-I, n = 15 phase-II, n = 10 in phase III. Total procedure and fluoroscopy time was 51.9 ± 9.4 and 6.7 ± 3.1 min, respectively. First-pass PFA isolation-rate was lowest in the fluoroscopy-only phase-II (I:86 %, II:81 %, III:100 %, p = 0.0079). Insufficient PV ablation with remaining conduction occurred mostly anterior (n = 8/15, 53 %) and at the carina (n = 4/15; 27 %). Following additional PFA, all 142 PVs (100 %) were acutely isolated.Procedure times between phase II and III did not differ (49 ± 8 vs. 46 ± 3 mins p = 0.23). Fluoroscopy times were longer in phase-II (phase-I: 5.8 ± 1.3, phase-II: 9.2 ± 2.9, phase-III: 3.8 ± 1.0 mins, p < 0.0001). No complications occurred. Pre- and post-ablation hemoglobin (14.4 ± 1.4 vs. 13.5 ± 1.2 g/dl, p = 0.0169) and LDH (188 ± 39 vs. 210 ± 29 U/l, p = 0.0007) were different.

The cPFA-catheter allows for fast and efficient PVI. A fluoroscopy-only approach creates distal PV ablation lesions that are associated with residual PV conduction along the carina and anterior antrum. However, with visualization and mapping, creation of wide antral ablation lesions is feasible without prolonging procedural duration.

Pulse field ablation is a novel, non-thermal alternative for catheter ablation of atrial fibrillation. Preclinical and early clinical studies have demonstrated a favorable safety profile with significant reductions in esophageal and pulmonary vein injury compared to radiofrequency ablation. However, there are still procedural and energy-related complications inherent to electroporation, tissue selectivity, and energy-dosing. Minimizing the frequency of application and extent of energy, as well as careful selection of the energy source, may mitigate these adverse events. There remains controversy and a lack of long-term outcomes, highlighting the need for further evaluation.

Pulsed field ablation (PFA) represents an innovative energy delivery approach for cardiac arrhythmia treatment, characterized by a favorable safety profile and effective myocardial lesion formation. It has demonstrated high acute pulmonary vein isolation rates with a reduced incidence of injury to adjacent anatomical structures. Nonetheless, procedure-specific complications such as haemolysis, intravascular gas formation, and coronary vasospasm have been observed and warrant further evaluation. Clinical evidence supports efficacy comparable to conventional thermal ablation in terms of arrhythmia recurrence. Ongoing advancements in catheter engineering, pulse modulation, and multimodal energy strategies aim to enhance lesion durability and transmurality. These developments position PFA as a promising technology in the field of cardiac ablation.

Pulsed field ablation (PFA) has gained prominence for pulmonary vein isolation (PVI) to treat atrial fibrillation, but there are limited outcome data on PFA to treat persistent atrial fibrillation (PerAF).

This study sought to determine the safety and efficacy of PVI + posterior wall ablation (PWA) with PFA in PerAF.

ADVANTAGE AF (A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation) is a prospective, single-arm, multicenter pivotal investigational device exemption study of PerAF patients undergoing PVI+PWA with the pentaspline PFA catheter. One-year follow-up included 24-hour Holter monitoring at 6 and 12 months and twice monthly and symptomatic transtelephonic monitoring. The primary safety endpoint was incidence of predefined adverse events. The primary effectiveness endpoint included acute success and postblanking 1-year freedom from atrial tachyarrhythmia recurrence (>30 seconds), redo ablation, cardioversion, or antiarrhythmic drug escalation. Endpoint analysis used Kaplan-Meier methodology with 97.5% 1-sided confidence limits compared with a 12% safety and 40% effectiveness goals, with 85% power.

PFA in 339 patients (260 treatment and 79 roll-in) resulted in 99.7% success for both PVI and PWA. The primary safety endpoint was 2.3% (5.1% upper confidence limit), including 1 with pericarditis, 1 with myocardial infarction, and 4 with pulmonary edema; no tamponade, stroke, pulmonary vein stenosis, or esophageal fistula occurred. Primary effectiveness was 63.5% (57.3% lower confidence limit) at 1 year, with 8.5% patients having a single, isolated atrial fibrillation recurrence. Freedom from symptomatic atrial fibrillation was 85.3%; efficacy varied by operator experience.

ADVANTAGE AF, the first large prospective study of PFA to treat PerAF using a strategy of PVI and posterior wall isolation, revealed favorable safety and effectiveness outcomes. (A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation [ADVANTAGE AF]; NCT05443594).

Early evidence showed reduced complications with pulsed field ablation (PFA), but non-target tissue collateral damage created by electroporation effects is poorly understood and may significantly differ between systems.

In this study, the authors evaluated the collateral effects of PFA.

NEMESIS-PFA is a multicenter, observational registry of patients who underwent AF ablation from March 2024 onwards with any approved PFA systems-either a circular multielectrode array, spherical, pentaspline, or variable loop catheter-or radiofrequency ablation (RFA). We assessed procedural characteristics, biomarkers for myocardial injury, hemolytic anemia, and renal function, and left atrial function in select patients.

A total of 871 patients, aged 68.9 ± 10.9 years and male (70.8%), with paroxysmal atrial fibrillation (59.4%), and CHA2DS2VASC of 3.3 ± 1.3 were included. Of these, 87.1% (n = 773) underwent PFA with a pentaspline (70.9%), circular multielectrode (14.1%), spherical (12.4%), and variable loop (2.3%) catheter. Significant postprocedural change in certain biomarkers such as troponin (13,551.0 vs 127.5 ng/dL; P < 0.001), lactate dehydrogenase (107.5 vs 26.5 IU/L; P < 0.001), and haptoglobin (-102.0 vs -33.5 mg/dL; P < 0.001) were detected following the PFA procedures compared with RFA, and the change was dose-dependent. There were also significant differences in biomarkers across PFA systems. Lastly, there was a significant change in left atrial ejection fraction (-20.0% vs. -5.0%, P < 0.001) in PFA vs RFA.

Current PFA technologies are associated with worse troponin leak, hemolysis, and renal dysfunction than RFA. As PFA becomes mainstream, future studies appraising these effects and understanding the short term and long-term implications are needed.

Intravascular hemolysis with consecutive acute kidney injury (AKI) has been described after pulsed-field ablation (PFA) in atrial fibrillation (AF).

This study aimed to evaluate the risk of intravascular hemolysis and AKI after PFA with different numbers and forms of applications.

From May 2022 to August 2024, consecutive patients undergoing AF ablation were prospectively enrolled in 4 groups, including equally distributed numbers of patients undergoing PFA (pentaspline catheter) with 8 applications per vein (PFA-8), with 16 applications per vein (PFA-16), CardioFocus focal PFA, and radiofrequency ablation (RFA). Blood samples were collected immediately before and after the ablation, and on the following day to analyze hemolysis markers and indicators for AKI.

A total of 200 patients (68.4 ± 10.8 years) could be included in the final analysis. The blood samples revealed a significant increase in total bilirubin and lactate dehydrogenase across all PFA modalities and RFA 24 hours after ablation compared with baseline levels. Potassium levels increased significantly in all PFA modalities immediately post-ablation as compared with baseline, followed by a return to approximately baseline after 24 hours. No significant potassium fluctuations were observed in RFA. Serum creatinine levels showed no significant increase in any PFA modality or RFA within the 24-hour assessment period.

PFA using a multispline catheter with 8 and 16 applications per PV and focal PFA using CardioFocus (CardioFocus Inc., Massachusetts) platform showed no safety concerns with respect to hemolysis-induced AKI.

Hemolysis-related renal failure after pulsed field ablation (PFA) has been described in recently published cases, we reported the incidence of bilirubin elevation after PFA utilizing a novel hexaspline PFA catheter.

PFA was performed in patients with paroxysmal atrial fibrillation using novel hexaspline PFA catheter, and serum bilirubin, hemoglobin and renal function were measured at baseline and the next day post ablation.

A total of 94 patients were analyzed, and 30 of 94 (31.9%) patients had obvious total bilirubin elevation the next day post PFA. In the 30 patients, 26 (86.7%) patients had a predominantly indirect hyperbilirubinemia, suggesting a likely presence of PFA-induced hemolysis. The liver enzyme contents post ablation were normal in all patients and no signs of hemolytic anemia and renal function injury were detected. The impact factors associated with indrect hyperbilirubinemia were also analyzed and higher number of applications tented to produce PFA-induced hemolysis. More than 86.5 applications seem to have a better sensivity and specificity to predict hemolysis.

Intravascular hemolysis can occur after utilizing novel hexaspline catheter, but the severity of hemolysis was mild and temporary. The number of applications appears to be a determining factor leading to hemolysis.

The extensive use of pulsed field ablation (PFA) in clinical settings has unveiled new evidence suggesting potential involvement in red blood cell structural impairment resulting in hemolysis and potential acute kidney injury (AKI).

In this study, blood samples were collected from 16 patients before and 24 h after pulmonary vein isolation (PVI) via a novel investigational PFA-based technology. Biochemical analyses were performed to assess hemolysis and AKI, including total and indirect bilirubin, lactate dehydrogenase (LDH), haptoglobin, plasma free hemoglobin, urea, creatinine, and estimated glomerular filtration rate (eGFR).

Based on the periprocedural changes in hemolysis biomarkers, none of the patients displayed evidence of clinically relevant hemolysis following PVI with the PFA catheter.

Pulsed-field ablation (PFA) offers notable advantages in atrial fibrillation (AF) ablation by selectively targeting cardiomyocytes via an irreversible electroporation mechanism, thereby minimizing damage to surrounding tissues. Although clinical studies demonstrate that PFA is both safe and effective, PFA-mediated hemolysis and potential acute kidney injury (AKI) have been recently reported. This study comprehensively reviews the literature on PFA-associated hemolysis, analyzing the underlying mechanisms, risk factors, and preventive management strategies. In addition, the review discusses approaches to minimize the risk of PFA-induced hemolysis and AKI while offering insights for improving PFA-associated techniques.

Earlier studies have documented the risk for sinoatrial node injury and phrenic nerve paralysis as complications following radiofrequency catheter ablation for electrical isolation of the superior vena cava (SVCI).

The aim of this study was to assess the safety and feasibility of SVCI in patients with atrial fibrillation undergoing pulsed field ablation (PFA) METHODS: A total of 1,600 consecutive patients undergoing PFA for pulmonary vein isolation plus SVCI were included in this multicenter analysis. Superior vena cava (SVC) ablation was performed under the continuous guidance of intracardiac echocardiography. The PFA catheter was placed at the junction between the SVC and the right atrium at the level of the lower border of the pulmonary artery. A total of 4 applications were given to achieve complete electrical isolation of the SVC. Sinus node injury and phrenic nerve stunning were checked during the procedure, before discharge, and at 2-month follow-up.

A total of 616 patients receiving SVCI were included in the analysis. Acute SVCI was achieved in all 616 patients (100%). In the flower configuration used in the first 10 patients, 2 transient sinus node injuries and 2 episodes of phrenic nerve stunning were observed, which resolved spontaneously during the procedure. In the remaining patients, the basket configuration was used; only 1 episode of phrenic nerve stunning was registered, which regressed before the end of the procedure. No permanent damages were registered at discharge and at 2-month follow-up.

Intracardiac echocardiography-guided PFA can effectively isolate the SVC with a good safety profile.

Pulsed field ablation (PFA) is an emerging technology that utilizes ultra-short high-voltage electric pulses to create nanopores in cell membranes, leading to cell death through irreversible electroporation (IRE). PFA is touted to be highly tissue-selective, which may mitigate the risk of collateral injury to vital adjacent structures. In the field of cardiac electrophysiology, initial studies have shown promising results for acute pulmonary vein isolation (PVI) and lesion durability, with overall freedom from recurrent atrial arrhythmia comparable to traditional thermal ablation modalities. While further large studies are required for long-term efficacy and safety data, PFA has the potential to become a preferred energy source for cardiac ablation for some indications. This review outlines the basic principles and biophysics of IRE and its application to cardiac electrophysiology through a review of the existing preclinical and clinical data.

Pulsed field ablation (PFA) is gaining recognition as a nonthermal, tissue-specific technique for the treatment of atrial fibrillation (AF). The preclinical evaluation of the investigated novel PFA system from Insight Medtech Co. Ltd has demonstrated feasibility, safety, and 30-day efficacy for pulmonary vein isolation (PVI) in the swine model. We are currently conducting a randomized controlled trial to compare the PFA directly with ablation-index (AI)-guided radiofrequency ablation (RFA) for PVI.

The InsightPFA trial is a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of PFA versus RFA for PVI in Chinese patients with symptomatic paroxysmal AF. Two hundred and ninety-two patients diagnosed with symptomatic paroxysmal AF will be randomly assigned to either the PFA group or the RFA group in a 1:1 ratio. All subjects will undergo PVI using PFA or AI-guided RFA and be followed up to 12 months. The primary endpoint is defined as freedom from any episodes of AF/AFL/AT without Class I or III antiarrhythmic drugs during the 9-month follow-up period after a 90-day blank period. The secondary endpoints of effectiveness include acute treatment success and procedural data. The safety evaluation includes a composite of death, stroke and transient ischemic attack, procedure-related complications, device-related adverse events, and serious adverse events. A noninferiority comparison will be conducted between the novel PFA system and the existing RFA system in terms of both effectiveness and safety.

This trial aims to determine whether the InsightPFA for PVI is as effective and safe as standard RFA in the treatment of symptomatic paroxysmal AF.

https://www.

gov/study/NCT06014996; NCT06014996.

Pulsed-field ablation (PFA) is a novel nonthermal ablation approach using rapid electrical pulses to cause cardiac cell apoptosis via electroporation. Our study aims to investigate the feasibility and safety of PFA for persistent atrial fibrillation (PeAF).

Thirty-two consecutive patients diagnosed with PeAF were enrolled in our study. All patients underwent PFA treatment using the strategy including pulmonary vein isolation (PVI), left atrial posterior wall (LAPW) isolation, cavotricuspid isthmus (CTI) block, and mitral isthmus (MI) block. Acute and follow-up procedure outcomes were evaluated, and adverse events related to the ablation procedure were also observed.

One-year survival free from atrial tachyarrhythmia post-ablation was 65.6%. Acute success rates for PVI, LAPW isolation, CTI block, and MI block were 100%, 100%, 96.9%, and 81.3%, respectively. Eleven cases (34.4%) experienced atrial tachyarrhythmia recurrence, with eight cases being atrial fibrillation (AF) recurrence and three cases being atrial flutter recurrence. Three patients underwent repeat ablation. Minor complications were encountered in four patients with asymptomatic cerebral lesions. Vagal responses were commonly observed during the procedure. No severe coronary vasospasm or severe hemolysis occurred in our cohort.

PFA with the strategy including PVI, LAPW isolation, CTI block, and MI block is feasible, safe, and associated with a high rate of freedom from atrial tachyarrhythmia recurrence at 1 year in patients with PeAF.

This study registered at the Chinese Clinical Trial Registry (ChiCTR2300068980).

Atrial fibrillation ablation is an established procedure for the treatment of atrial fibrillation, in which Pulsed Field Ablation (PFA) is a novel method alongside radiofrequency and cryoablation. The article explains the technical basics of PFA, describes different types of catheters and gives detailed instructions on how to perform the procedure, from patient selection to sedation strategies and imaging. Important safety aspects and possible complications are also covered. Finally, the further development of PFA technology for the treatment of other arrhythmias and integration into 3D mapping systems is discussed. This work is part of a series of articles on further training in special rhythmology.

Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia worldwide, posing significant health burdens. Pulsed field ablation (PFA) is an emerging non-thermal technique that is gaining traction due to the ability to selectively target myocardial cells and minimize damage to surrounding tissues. We conducted a comprehensive bibliometric analysis of PFA use in AF treatment to map research trends, collaborations, and future directions.

We extracted data from the Web of Science Core Collection on September 6, 2024, using search terms related to PFA and AF. Publication trends, citation trajectories, collaborative networks, and keyword co-occurrences were analyzed utilizing tools such as Bibliometrix R, VOSviewer, and CiteSpace.

In total, 217 publications were retrieved. The number of publications increased rapidly from 2019 to 2024, with a notable surge occurring after 2022. Contributions from the United States, Germany, and China accounted for more than 60% of all publications. The institution with the largest output was The Icahn School of Medicine at Mount Sinai. The most productive journals were Europace and the Journal of Interventional Cardiac Electrophysiology. Prolific authors were identified, underscoring significant international collaborations. The most cited publications highlighted the efficacy and safety of PFA. Keywords with strong recent citation bursts included "tissue", "cardiomyopathy", and "closed chest ablation".

PFA is becoming established as a viable alternative for AF ablation, showing promising safety and efficacy. This bibliometric analysis confirmed the growing scientific interest and collaborative efforts in this field, suggesting that robust future developments will occur.

The goal of a cardiac pulsed field ablation (PFA) system is to provide safe, effective, and usable therapy for the treatment of cardiac arrhythmias. Achieving this goal is a complex exercise in system design, requiring optimization of catheter, waveform, and dosing. This optimization is often iterative, as myriad design factors are balanced to achieve the goal while making use of computational modeling, bench testing, preclinical animal studies, and human clinical studies to evaluate system performance. It is important for both engineers and clinicians to understand the fundamentals of cardiac PFA system design in order to partner to continuously improve performance of this expanding ablation modality.

Pulsed field ablation (PFA) of atrial fibrillation is a new method in clinical practice. Despite a favorable safety profile of PFA in atrial fibrillation ablation, rare cases of renal failure, probably due to hemolysis, have recently been reported.

The aim of this study was to determine the rate of hemolysis and cardiac cell death during in vitro PFA with different electric field intensities.

Blood samples from healthy volunteers and mouse HL-1 cardiomyocyte cell lines were subjected to in vitro irreversible electroporation using 216 bipolar pulses, each lasting 2 μs with intervals of 5 μs, repeated 20 times at a frequency of 1 Hz. These pulses varied from 500 V to 1500 V. Cell-free hemoglobin levels were assessed spectrophotometrically, and red blood cell microparticles were evaluated by flow cytometry. Cardiomyocyte death was quantified with propidium iodide.

Pulsed field energy (1000 V/cm, 1250 V/cm, and 1500 V/cm) was associated with a significant increase in cell-free hemoglobin (0.32 ± 0.16 g/L, 2.2 ± 0.96 g/L, and 5.7 ± 0.39 g/L; P < .01) and similar increase in the concentration of red blood cell microparticles. Significant rates of cardiomyocyte death were observed at electric field strengths of 750 V/cm, 1000 V/cm, 1250 V/cm, and 1500 V/cm (26.5% ± 5.9%, 44.3% ± 6.2%, 55.5% ± 6.9%, and 74.5% ± 17.8% of cardiomyocytes; P < .01).

The most effective induction of cell death in vitro was observed at 1500 V/cm. This intensity was also associated with a significant degree of hemolysis.

In patients with atrial arrhythmias originating from the superior vena cava (SVC), the use of radiofrequency energy to isolate the SVC is associated with a significant risk of injury both to the phrenic nerve and the sinus node. Pulsed field ablation (PFA) may overcome the disadvantages of thermal energy and improve both ablation efficacy and safety.

We report the feasibility, safety, and clinical efficacy of focal monopolar PFA in patients with the origin of their atrial arrhythmia in the SVC.

Nine patients (7 men, age 66 ± 8 years) with SVC-induced paroxysmal AF (n = 3), persistent AF (n = 5), or frequent premature atrial beats (n = 1) underwent SVC isolation using focal monopolar PFA.

Acute circumferential SVC isolation was achieved in all cases, using 22 Ampere (A) or 25 A in areas with or without phrenic capture, respectively. The safety profile was excellent: two patients had transient sinus arrest and two had transient phrenic nerve stunning. Sinus node and phrenic nerve function recovered during the procedure, and no permanent damage was observed at follow-up. Coronary vasospasm occurred (and quickly resolved after injection of nitroglycerin) in one patient during additional ablation of a focal atrial tachycardia at the coronary sinus ostium. Kidney function remained stable before and after ablation in all patients.

In this patient cohort with SVC-triggered atrial arrhythmia, isolation using focal monopolar PFA was feasible, effective, and safe. No permanent injury to the phrenic nerve or sinus node was observed.

This review examines the selective cardiac injury induced by pulsed electric fields during atrial fibrillation ablation. It consolidates findings from both preclinical and clinical studies on cardiac selectivity and explores the potential mechanisms behind this selectivity.

Preclinical studies indicate that pulsed electric fields cause significantly more myocardial injury compared with other tissues. Clinical studies have similarly shown that complication rates for pulsed field ablation are notably lower than those for radiofrequency and cryoballoon ablation.

Pulsed field ablation demonstrates a notable selectivity for myocardial injury, likely because of the unique functional and metabolic characteristics of cardiomyocytes. This review delves into the underlying principles of cardiac selectivity and proposes future directions for improving this selectivity. It is important to note that while pulsed field ablation shows promise, its cardiac selectivity is not absolute, as some complications still occur, necessitating further research.

Clinical outcomes of catheter ablation remain suboptimal in patients with atrial fibrillation (AF), particularly in those with persistent AF, despite decades of research, clinical trials, and technological advancements. Recently, pulsed-field ablation (PFA), a promising non-thermal technology, has been introduced to improve procedural outcomes. Its unique feature of myocardial selectivity offers safety advantages by avoiding potential harm to vulnerable adjacent structures during AF ablation. However, despite the global enthusiasm within the electrophysiology community, recent data indicate that PFA is still far from being a "magic wand" for addressing such a complex and challenging arrhythmia as AF. More progress is needed in mapping processes rather than in ablation technology. This editorial reviews relevant available data and explores future research directions for PFA.

The role of catheter ablation in elderly patients with atrial fibrillation (AF) is unclear. Pulsed field ablation (PFA) demonstrates a favorable clinical profile, however, data on elderly patients are lacking.

We aimed to assess the safety and efficacy of PFA in the elderly, using data from the EU-PORIA registry.

Periprocedural complications and long-term safety and efficacy outcomes of AF ablation using the pentaspline PFA catheter (Farapulse™) were compared between patients older than 80 years old and their younger counterparts, across seven European centers.

Among the 1233 patients in the registry, 88 (7.1 %) were older than 80 years. Elderly patients were more often females (51.1 % vs 37.8 %, p = 0.01) with a lower median BMI (26.0, IQR:23.5-29.2 vs 26.9, IQR:24.4-30.4 kg/m2, p = 0.02), a higher median CHA2DS2-VASc score (4, IQR:3-5 vs 2, IQR:1-3, p < 0.001) and a higher incidence of hypertension (73.9 % vs 52.7 %, p < 0.001). In both groups, most patients had paroxysmal AF (58.0 % vs 60.3 %, p = 0.65). Ablation in the elderly was more frequently performed with minimally interrupted anticoagulation (87.5 % vs 59.7 %, p < 0.001). Despite comparable rates of overall complications (5.7 % vs 3.5 %, p = 0.29), elderly patients had a higher incidence of stroke (2.3 % vs 0.3 %, p = 0.04). At 12 months, major adverse clinical events (4.5 % vs. 2.1 %, p = 0.12) and arrhythmia-free survival (70 % vs 74 %, p = 0.69) were comparable in both groups. None of the recurrence-free elderly patients were on antiarrhythmic drugs at the end of follow-up.

In this real-world cohort, the efficacy of PFA for AF was similar in elderly and younger patients. Despite comparable complication rates, a higher incidence of stroke was observed in the elderly.

Pulsed field ablation (PFA) is a promising nonthermal method for treating atrial fibrillation. However, the potential for erythrocyte rupture and subsequent hemolysis remains a significant concern, particularly with high-intensity applications. In this study, we explored the protective effects of gadolinium-diethylenetriamine-penta-acetic acid (Gd-DTPA), a common magnetic resonance imaging contrast agent, against PFA-induced hemolysis both in vitro and in vivo. Our in vitro experiments involved subjecting fresh heparinized rat blood to PFA in the presence of various concentrations of Gd-DTPA. We found that Gd-DTPA concentrations of 100 μM and 1,000 μM significantly mitigated hemolysis caused by PFA application. For in vivo studies, rats were administered Gd-DTPA at dosages of 10 μmol/kg and 100 μmol/kg before PFA. The results indicated that preadministration of Gd-DTPA effectively reduced erythrocyte destruction and intravascular hemolysis after PFA. The protective effect of Gd-DTPA is attributed to its ability to stiffen erythrocyte membranes, rendering them more resistant to the destabilizing effects of PFA-induced electroporation. These findings suggest that Gd-DTPA could play a crucial role in minimizing hemolysis and associated complications in clinical applications of PFA for atrial fibrillation. Further studies are needed to confirm these protective effects in larger animal models and eventually in clinical settings.

Pulsed electric field (PEF) has emerged as a promising energy source for catheter ablation of atrial fibrillation (AF). However, data regarding the in-vivo effect of PEF energy on erythrocytes during AF ablation procedures are scarce. This study aimed to quantify the impact of PEF energy on erythrocyte damage during AF ablation by assessing specific hemolytic biomarkers.

A total of 60 patients (age: 68 years, males: 72%, serum creatinine: 91 µmol/L) with AF underwent catheter ablation of AF using PEF energy delivered by a multipolar pentaspline Farawave catheter (Farapulse, Boston Scientific, Inc.). Ablation beyond pulmonary vein isolation was performed at the operator's discretion. Peripheral venous blood was sampled for assessing the plasma levels of free hemoglobin (fHb), direct (conjugated) bilirubin, lactate dehydrogenase (LDH), and creatinine before, immediately after the ablation, and on the next day.

Following the PEF ablation with duration of [median (interquartile range)] 75 (58, 95) min, with 74 (52, 92) applications and PVI only in 27% of patients, fHb, LDH, and direct bilirubin significantly increased, from 40 (18, 65) to 493 (327, 848) mg/L, from 3.1 (2.6, 3.6) to 6.8 (5.0, 7.9) µkat/L, and from 12 (9, 17) to 28 (16, 44) µmol/L, respectively (all p < .0001). A strong linear correlation was found between the peak fHb and the number of PEF applications (R = 0.81, p < .001). The major hemolysis (defined as fHb >500 mg/L) was predicted by the number of PEF applications with the corresponding area under the receiver operating characteristic curve of 0.934. The optimum cut-off value of >74 PEF applications predicted the major hemolysis with 89% sensitivity and 87% specificity.

Catheter ablation of AF using PEF energy delivered from a pentaspline catheter is associated with significant intravascular hemolysis. More than 74 PEF applications frequently resulted in major hemolysis. However, the critical amount of PEF energy that may cause kidney injury in susceptible patients remains to be investigated.

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.

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.

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.

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.

Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/ Identifier: NCT05617456.

Background and Aims: Various pulsed field ablation (PFA) systems are currently being developed. Recently, a novel CE-approved circular array PFA catheter (PulseSelect™ PFA System, Medtronic, Minneapolis, MN, USA) was introduced. Data on this commercially available system are sparse. The aim was to elucidate real-world data assessing the feasibility, safety, and acute efficacy of pulmonary vein isolation (PVI) and ablation beyond PVI with this novel ablation system. Methods: Consecutive patients with paroxysmal and persistent atrial fibrillation (AF) undergoing first-time ablation with the circular PFA catheter were enrolled in this study. In patients with persistent AF and left atrial (LA) enlargement (LA area > 20 cm2), additional left atrial roof ablation (LARA) was performed. Those with concomitant typical atrial flutter received adjunctive cavo-tricuspid isthmus (CTI) ablation. Results: A total of 100 AF patients were included (29% female, 50% persistent AF). Of these, 33 patients (33%) underwent adjunctive LARA, 1 patient (1%) received posterior wall isolation, and 6 patients (6%) required additional CTI ablation. The skin-to-skin procedural time averaged 66.3 ± 13.8 min, while the fluoroscopy time and dose area product were 13.7 ± 4.7 min and 6.8 ± 4.9 Gycm2, respectively. Acute PVI was achieved in 100% of pulmonary veins. A bidirectional conduction block of the LARA and CTI lines was confirmed in all patients, and no major adverse events were reported. Conclusions: These real-world data demonstrate the feasibility, safety, and acute efficacy of PVI and ablation beyond PVI using a novel circular array PFA catheter in patients with atrial fibrillation and flutter. The system can easily be integrated with standard PVI workflows. Further and larger studies are warranted to assess the clinical long-term effectiveness and safety of this PFA system.

In clinical practice, intravascular hemolysis is not common after interventional cardiovascular procedures. Although diagnostic and treatment techniques have developed, with the increasing importance placed on people's own health and the popularity of cardiovascular intervention, there have been occasional reports of hemolysis after different cardiovascular interventions, mainly including cardiac pacemaker implantation, atrial-fibrillation radiofrequency ablation, transcatheter aortic-valve implantation (TAVI), transcatheter mitral valve replacement (TMVR) and percutaneous repair of Gerbode defect and percutaneous coronary intervention (PCI) with Impella. However, so far, there have been no relevant reports on postoperative hemolysis after percutaneous coronary intervention (PCI).

This article reports a very rare case of a 42-year-old male who developed hemolysis after PCI. The patient had dark brown urine for two days. Blood test showed significant decreases in red blood cell (RBC) and hemoglobin (Hb). After blood transfusion of 2 units, dexamethasone treatment and repeat PCI, he gradually recovered with no symptoms of further episodes of hemolysis.

Due to the use of antiplatelet and anticoagulation drugs in PCI patients, gastrointestinal bleeding (GIB) is often believed to be the main cause of postoperative bleeding events. Identifying the etiology of anemia in patients after PCI is crucial for targeted treatment in the later stage. Based on the symptoms of dark brown urine and the levels of RBC, HB, reticulocyte and unconjugated bilirubin (UCB), we finally diagnosed the patient with hemolytic anemia (HA), rather than the traditional consciousness of GIB. This is an uncommon case of hemolysis after PCI. Although the association between PCI and HA is very rare, PCI is now a commonly used treatment for patients with acute coronary syndromes (ACS). Therefore, clinicians should recognize that in addition to GBI, HA may also occur after PCI. Early recognition of the cause of anemia and early treatment is one of the key steps to ensure the later life and health of PCI patients.

Different iterations of catheter and energy delivery system configurations are evolving for pulsed field ablation (PFA); however, some have used large and complex catheters, required large sheaths, and had a recognized risk of hemolysis.

The purpose of this study was to evaluate the acute safety and efficacy of a custom designed 8F variable loop multielectrode mapping and PFA catheter with contact sensing.

This acute feasibility study recruited 30 patients undergoing de novo ablation of paroxysmal or persistent atrial fibrillation (AF). The ElectroPulse Study is a first-in-human, nonrandomized, prospective study of a novel PFA system that utilizes an 8F, 10-electrode variable loop steerable mapping and ablation catheter with 2800-V biphasic bipolar waveform. All patients had pulmonary vein isolation (PVI) and posterior wall isolation (PWI) using the PFA system. The main outcomes were the acute success of PV/PWI and periprocedural serious adverse events.

Complete PVI/PWI was successfully achieved in all 30 patients using 59.7 ± 7.2 applications. Total procedural time was 113.6 ± 26.3 minutes, fluoroscopy time 8.0 ± 5.5 minutes, and left atrial dwell time 78.7 ± 18.6 minutes. There was no esophageal injury, phrenic nerve palsy, clinical stroke, or death. Brain magnetic resonance imaging detected 2 new but transient silent cerebral lesions. Two patients (6.7%) had vascular access complications. Although there were changes in the biomarkers for hemolysis, none of the patients experienced clinical hemolysis or related acute kidney injury.

This first-in-human study demonstrated that PFA using a novel variable loop catheter with a contact sensing system safely achieved 100% acute PVI/PWI with safety profile comparable to existing PFA systems.