2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation.

Authors: Stylianos Tzeis, Edward P Gerstenfeld, Jonathan Kalman...

In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society .

Topics: Humans; Atrial Fibrillation; Latin America; Treatment Outcome; Catheters; Asia; Catheter Ablation

PubMed: 38587017
DOI: 10.1093/europace/euae043

Review

Authors: Mina K Chung, Marwan Refaat, Win-Kuang Shen...

Atrial fibrillation (AF) is an increasingly prevalent arrhythmia; its pathophysiology and progression are well studied. Stroke and bleeding risk models have been created and validated. Decision tools for stroke prophylaxis are evolving, with better options at hand. Utilization of various diagnostic tools offer insight into AF burden and thromboembolic risk. Rate control, rhythm control, and stroke prophylaxis are the cornerstones of AF therapy. Although antiarrhythmic drugs are useful, AF ablation has become a primary therapeutic strategy. Pulmonary vein isolation is the cornerstone of AF ablation, and methods to improve ablation safety and efficacy continue to progress. Ablation of nonpulmonary vein sites is increasingly being recognized as an important strategy for treating nonparoxysmal AF. Several new ablation techniques and technologies and stroke prophylaxis are being explored. This is a contemporary review on the prevalence, pathophysiology, risk prediction, prophylaxis, treatment options, new insights for optimizing treatment outcomes, and emerging concepts of AF.

Topics: Anti-Arrhythmia Agents; Anticoagulants; Atrial Fibrillation; Catheter Ablation; Humans; Risk Assessment; Stroke; Treatment Outcome

PubMed: 32273035
DOI: 10.1016/j.jacc.2020.02.025

Authors: Atul Verma, David E Haines, Lucas V Boersma...

BACKGROUND

Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness comparable to traditional catheter ablation while preventing thermally mediated complications.

METHODS

The PULSED AF pivotal study (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF) was a prospective, global, multicenter, nonrandomized, paired single-arm study in which patients with paroxysmal (n=150) or persistent (n=150) symptomatic atrial fibrillation (AF) refractory to class I or III antiarrhythmic drugs were treated with pulsed field ablation. All patients were monitored for 1 year using weekly and symptomatic transtelephonic monitoring; 3-, 6-, and 12-month ECGs; and 6- and 12-month 24-hour Holter monitoring. The primary effectiveness end point was freedom from a composite of acute procedural failure, arrhythmia recurrence, or antiarrhythmic escalation through 12 months, excluding a 3-month blanking period to allow recovery from the procedure. The primary safety end point was freedom from a composite of serious procedure- and device-related adverse events. Kaplan-Meier methods were used to evaluate the primary end points.

RESULTS

Pulsed field ablation was shown to be effective at 1 year in 66.2% (95% CI, 57.9 to 73.2) of patients with paroxysmal AF and 55.1% (95% CI, 46.7 to 62.7) of patients with persistent AF. The primary safety end point occurred in 1 patient (0.7%; 95% CI, 0.1 to 4.6) in both the paroxysmal and persistent AF cohorts.

CONCLUSIONS

PULSED AF demonstrated a low rate of primary safety adverse events (0.7%) and provided effectiveness consistent with established ablation technologies using a novel irreversible electroporation energy to treat patients with AF.

REGISTRATION

URL: https://www.

CLINICALTRIALS

gov; Unique identifier: NCT04198701.

Topics: Humans; Atrial Fibrillation; Prospective Studies; Treatment Outcome; Anti-Arrhythmia Agents; Electrocardiography; Catheter Ablation; Recurrence; Pulmonary Veins

PubMed: 36877118
DOI: 10.1161/CIRCULATIONAHA.123.063988

Review

Authors: Gustavo S Guandalini, Jackson J Liang, Francis E Marchlinski...

Although implantable cardioverter-defibrillators positively affect survival in patients at increased risk for arrhythmic sudden cardiac death, quality of life can be negatively affected by recurrent therapies. Ventricular tachycardia (VT) ablation targets clinical arrhythmias to prevent recurrence. Although treatment of VT initially required open heart surgery, it has since been replaced by percutaneous ablation, a safe and effective catheter-based therapy to ablate myocardium from either the endocardial or the epicardial surface. Four basic mapping techniques are used to guide VT ablation: activation, entrainment, and pace and substrate mapping. Current recommendations for VT ablation, especially in the setting of structural heart disease, mostly reserve this treatment for patients for whom antiarrhythmic therapy has failed or is not tolerated or desired. These recommendations derive from multiple observational reports and several randomized prospective studies in patients with VT in the setting of ischemic cardiac disease. Patients are usually referred late in their clinical course for VT ablation, limiting enrollment in clinical trials and resulting in limited prospective randomized data on long-term outcomes with ablative therapy. Future research efforts should address unmet needs, including more rigorous assessment of survival benefit from VT ablation, outcomes data of VT ablation in patients with nonischemic cardiomyopathy, and assessment of strategies to improve intramural substrate ablation. Emerging technologies with disruptive potential include the use of lower ionic strength irrigants, energy delivery guided by impedance modulation, simultaneous unipolar and bipolar ablation, and novel ablation catheters, including the retractable needle-tip electrode catheter. Promising alternatives to radiofrequency ablation include alcohol ablation from the coronary arterial or venous system, direct current or pulsed field electroporation, and stereotactic body radiotherapy guided by noninvasive substrate mapping. Future studies are needed to demonstrate the safety and efficacy of these novel technologies compared with standard radiofrequency catheter ablation.

Topics: Catheter Ablation; Electrocardiography; Humans; Tachycardia, Ventricular

PubMed: 31857035
DOI: 10.1016/j.jacep.2019.09.015

Review

Authors: Kyoung-Ryul Julian Chun, Damijan Miklavčič, Konstantinos Vlachos...

Pulsed field ablation (PFA) is an innovative approach in the field of cardiac electrophysiology aimed at treating cardiac arrhythmias. Unlike traditional catheter ablation energies, which use radiofrequency or cryothermal energy to create lesions in the heart, PFA utilizes pulsed electric fields to induce irreversible electroporation, leading to targeted tissue destruction. This state-of-the-art review summarizes biophysical principles and clinical applications of PFA, highlighting its potential advantages over conventional ablation methods. Clinical data of contemporary PFA devices are discussed, which combine predictable procedural outcomes and a reduced risk of thermal collateral damage. Overall, these technological developments have propelled the rapid evolution of contemporary PFA catheters, with future advancements potentially impacting patient care.

Topics: Humans; Arrhythmias, Cardiac; Electroporation; Treatment Outcome; Forecasting; Catheter Ablation; Ablation Techniques; Cardiac Catheters; Animals

PubMed: 38848447
DOI: 10.1093/europace/euae134

Clinical Trial

Authors: Vivek Y Reddy, Ante Anic, Jacob Koruth...

BACKGROUND

Unlike for paroxysmal atrial fibrillation (AF), pulmonary vein isolation (PVI) alone is considered insufficient for many patients with persistent AF. Adjunctive ablation of the left atrial posterior wall (LAPW) may improve outcomes, but is limited by both the difficulty of achieving lesion durability and concerns of damage to the esophagus-situated behind the LAPW.

OBJECTIVES

This study sought to assess the safety and lesion durability of pulsed field ablation (PFA) for both PVI and LAPW ablation in persistent AF.

METHODS

PersAFOne is a single-arm study evaluating biphasic, bipolar PFA using a multispline catheter for PVI and LAPW ablation under intracardiac echocardiographic guidance. A focal PFA catheter was used for cavotricuspid isthmus ablation. No esophageal protection strategy was used. Invasive remapping was mandated at 2 to 3 months to assess lesion durability.

RESULTS

In 25 patients, acute PVI (96 of 96 pulmonary veins [PVs]; mean ablation time: 22 min; interquartile range [IQR]: 15 to 29 min) and LAPW ablation (24 of 24 patients; median ablation time: 10 min; IQR: 6 to 13 min) were 100% acutely successful with the multispline PFA catheter alone. Using the focal PFA catheter, acute cavotricuspid isthmus block was achieved in 13 of 13 patients (median: 9 min; IQR: 6 to 12 min). The median total procedure time was 125 min (IQR: 108 to 166 min) (including a median of 28 min [IQR: 25 to 33 min] for voltage mapping), with a median of 16 min (IQR: 12 to 23 min) fluoroscopy. Post-procedure esophagogastroduodenoscopy and repeat cardiac computed tomography revealed no mucosal lesions or PV narrowing, respectively. Invasive remapping demonstrated durable isolation (defined by entrance block) in 82 of 85 PVs (96%) and 21 of 21 LAPWs (100%) treated with the pentaspline catheter. In 3 patients, there was localized scar regression of the LAPW ablation, albeit without conduction breakthrough.

CONCLUSIONS

The unique safety profile of PFA potentiated efficient, safe, and durable PVI and LAPW ablation. This extends the potential role of PFA beyond paroxysmal to persistent forms of AF. (Pulsed Fields for Persistent Atrial Fibrillation [PersAFOne]; NCT04170621).

Topics: Aged; Atrial Fibrillation; Cardiac Catheterization; Catheter Ablation; Electrocardiography; Female; Follow-Up Studies; Humans; Male; Middle Aged; Pulmonary Veins; Treatment Outcome

PubMed: 32854842
DOI: 10.1016/j.jacc.2020.07.007

Review

Authors: Stacy Westerman, Nanette Wenger

Atrial fibrillation is the most common sustained cardiac arrhythmia. The scope and impact of atrial fibrillation are wide; it can affect cardiac function, functional status, and quality of life, and it confers a stroke risk. There are sex differences in atrial fibrillation across the scope of the disease process, from epidemiology and causative mechanisms to management and outcomes. The approach to management of atrial fibrillation differs between women and men, and there are sex differences in response to medical therapy and catheter ablation. There are many gaps in our knowledge of the gender differences in atrial fibrillation, and many opportunities for future research.

Topics: Atrial Fibrillation; Catheter Ablation; Female; Gender Identity; Humans; Male; Treatment Outcome

PubMed: 30516110
DOI: 10.2174/1573403X15666181205110624

Authors: Vivek Y Reddy, Petr Peichl, Elad Anter...

BACKGROUND

Because of its safety, "single-shot" pulsed field ablation (PFA) catheters have been developed for pulmonary vein isolation (PVI). However, most atrial fibrillation (AF) ablation procedures are performed with focal catheters to permit flexibility of lesion sets beyond PVI.

OBJECTIVES

This study sought to determine the safety and efficacy of a focal ablation catheter able to toggle between radiofrequency ablation (RFA) or PFA to treat paroxysmal or persistent AF.

METHODS

In a first-in-human study, a focal 9-mm lattice tip catheter was used for PFA posteriorly and either irrigated RFA (RF/PF) or PFA (PF/PF) anteriorly. Protocol-driven remapping was at ∼3 months postablation. The remapping data prompted PFA waveform evolution: PULSE1 (n = 76), PULSE2 (n = 47), and the optimized PULSE3 (n = 55).

RESULTS

The study included 178 patients (paroxysmal/persistent AF = 70/108). Linear lesions, either PFA or RFA, included 78 mitral, 121 cavotricuspid isthmus, and 130 left atrial roof lines. All lesion sets (100%) were acutely successful. Invasive remapping of 122 patients revealed improvement of PVI durability with waveform evolution: PULSE1: 51%; PULSE2: 87%; and PULSE3: 97%. After 348 ± 652 days of follow-up, the 1-year Kaplan-Meier estimates for freedom from atrial arrhythmias were 78.3% ± 5.0% and 77.9% ± 4.1% for paroxysmal and persistent AF, respectively, and 84.8% ± 4.9% for the subset of persistent AF patients receiving the PULSE3 waveform. There was 1 primary adverse event-inflammatory pericardial effusion not requiring intervention.

CONCLUSIONS

AF ablation with a focal RF/PF catheter allows efficient procedures, chronic lesion durability, and good freedom from atrial arrhythmias-for both paroxysmal and persistent AF. (Safety and Performance Assessment of the Sphere-9 Catheter and the Affera Mapping and RF/PF Ablation System to Treat Atrial Fibrillation; NCT04141007 and NCT04194307).

Topics: Humans; Atrial Fibrillation; Catheters; Catheter Ablation; Pulmonary Veins; Ablation Techniques

PubMed: 37227340
DOI: 10.1016/j.jacep.2023.04.002

Authors: Baptiste Davong, Raquel Adeliño, Hubert Delasnerie...

BACKGROUND

Pulsed-field ablation (PFA) is a new and promising modality of ablation that has been shown to specifically ablate cardiac tissue while sparing other anatomic structures, thus avoiding thermal ablation-related complications. Recent studies have certified safety and efficacy of PFA for pulmonary vein isolation (PVI) in the setting of paroxysmal atrial fibrillation (AF). However, there are very limited data assessing the feasibility and safety of PFA ablation of different substrates within the left atrium in the setting of persistent AF.

OBJECTIVES

The purpose of this study was to evaluate the feasibility and safety of mitral isthmus (MI) ablation in addition to PVI and posterior wall (PW) ablation with PFA in patients with persistent AF.

METHODS

We prospectively included all consecutive patients with persistent AF who underwent a first ablation procedure with PFA. We performed in all these patients a substrate ablation strategy comprising PVI, PW, and MI ablation with the use of PFA only. The primary feasibility endpoint was obtaining a persistent MI block at the end of the procedure. The safety endpoint was a composite of major safety events.

RESULTS

From November 2021 to September 2022, we included 45 patients. Complete MI block was achieved in all 45 (100%). Three patients presented with complications, among them 2 cases (4.4%) of reversible and nonfatal coronary spasm. During a mean follow-up time of 107.8 ± 59.5 days, a 20% recurrence rate was observed.

CONCLUSIONS

PFA is a feasible and safe ablation approach for mitral isthmus ablation in addition to PVI in patients with persistent AF.

Topics: Humans; Atrial Fibrillation; Preliminary Data; Treatment Outcome; Heart Atria; Pulmonary Veins; Catheter Ablation

PubMed: 37354173
DOI: 10.1016/j.jacep.2023.03.021

Review

Authors: Fred H M Wittkampf, René van Es, Kars Neven...

Irreversible electroporation can be used as a nonthermal energy source to ablate tissue. Cardiac catheter ablation by irreversible electroporation may be a safe and effective alternative for thermal ablation techniques such as radiofrequency or cryoablation. Total applied current, not delivered power (watts), energy (joules), or voltage, is the parameter that most directly relates to the local voltage gradient that causes electroporation. Electroporation can be achieved with various modalities: direct current, alternating current, pulsed direct current, or any combination of these. Experimental cardiac and noncardiac studies have demonstrated tissue specificity with survival of arteries and nerves in large lesions. In addition, porcine data suggest that application inside a pulmonary vein does not lead to pulmonary vein stenosis and that the esophagus is remarkably insensitive to electroporation. Therefore, irreversible electroporation is a very promising technique for cardiac catheter ablation and especially for electrical pulmonary vein isolation.

Topics: Animals; Atrial Fibrillation; Cardiac Catheterization; Catheter Ablation; Electroporation; Humans; Pulmonary Veins; Swine

PubMed: 30139498
DOI: 10.1016/j.jacep.2018.06.005