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Journal of the American College of... Apr 2020Atrial fibrillation (AF) is an increasingly prevalent arrhythmia; its pathophysiology and progression are well studied. Stroke and bleeding risk models have been created... (Review)
Review
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 -
JACC. Clinical Electrophysiology Dec 2019Although implantable cardioverter-defibrillators positively affect survival in patients at increased risk for arrhythmic sudden cardiac death, quality of life can be... (Review)
Review
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 Although treatment of VT initially required open heart surgery, it has since been replaced by percutaneous ablation, a safe and effective catheter-based therapy to ablate myocardium from either the endocardial or the epicardial surface.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 -
JAMA Jan 2023Pulmonary vein isolation (PVI) alone is less effective in patients with persistent atrial fibrillation (AF) compared with paroxysmal AF. The left atrial posterior wall... (Comparative Study)
Comparative Study Randomized Controlled Trial
Effect of Catheter Ablation Using Pulmonary Vein Isolation With vs Without Posterior Left Atrial Wall Isolation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation: The CAPLA Randomized Clinical Trial.
IMPORTANCE
Pulmonary vein isolation (PVI) alone is less effective in patients with persistent atrial fibrillation (AF) compared with paroxysmal AF. The left atrial posterior wall may contribute to maintenance of persistent AF, and posterior wall isolation (PWI) is a common PVI adjunct. However, PWI has not been subjected to randomized comparison.
OBJECTIVE
To compare PVI with PWI vs PVI alone in patients with persistent AF undergoing first-time catheter ablation.
DESIGN, SETTING, AND PARTICIPANTS
Investigator initiated, multicenter, randomized clinical trial involving 11 centers in 3 countries (Australia, Canada, UK). Symptomatic patients with persistent AF were randomized 1:1 to either PVI with PWI or PVI alone. Patients were enrolled July 2018-March 2021, with 1-year follow-up completed March 2022.
INTERVENTIONS
The PVI with PWI group (n = 170) underwent wide antral pulmonary vein isolation followed by posterior wall isolation involving linear ablation at the roof and floor to achieve electrical isolation. The PVI-alone group (n = 168) underwent wide antral pulmonary vein isolation alone.
MAIN OUTCOMES AND MEASURES
Primary end point was freedom from any documented atrial arrhythmia of more than 30 seconds without antiarrhythmic medication at 12 months, after a single ablation procedure. The 23 secondary outcomes included freedom from atrial arrhythmia with/without antiarrhythmic medication after multiple procedures, freedom from symptomatic AF with/without antiarrhythmic medication after multiple procedures, AF burden between study groups at 12 months, procedural outcomes, and complications.
RESULTS
Among 338 patients randomized (median age, 65.6 [IQR, 13.1] years; 76.9% men), 330 (97.6%) completed the study. After 12 months, 89 patients (52.4%) assigned to PVI with PWI were free from recurrent atrial arrhythmia without antiarrhythmic medication after a single procedure, compared with 90 (53.6%) assigned to PVI alone (between-group difference, -1.2%; hazard ratio [HR], 0.99 [95% CI, 0.73-1.36]; P = .98). Of the secondary end points, 9 showed no significant difference, including freedom from atrial arrhythmia with/without antiarrhythmic medication after multiple procedures (58.2% for PVI with PWI vs 60.1% for PVI alone; HR, 1.10 [95% CI, 0.79-1.55]; P = .57), freedom from symptomatic AF with/without antiarrhythmic medication after multiple procedures (68.2% vs 72%; HR, 1.20 [95% CI, 0.80-1.78]; P = .36) or AF burden (0% [IQR, 0%-2.3%] vs 0% [IQR, 0%-2.8%], P = .47). Mean procedural times (142 [SD, 69] vs 121 [SD, 57] minutes, P < .001) and ablation times (34 [SD, 21] vs 28 [SD, 12] minutes, P < .001) were significantly shorter for PVI alone. There were 6 complications for PVI with PWI and 4 for PVI alone.
CONCLUSIONS AND RELEVANCE
In patients undergoing first-time catheter ablation for persistent AF, the addition of PWI to PVI alone did not significantly improve freedom from atrial arrhythmia at 12 months compared with PVI alone. These findings do not support the empirical inclusion of PWI for ablation of persistent AF.
TRIAL REGISTRATION
anzctr.org.au Identifier: ACTRN12616001436460.
Topics: Aged; Female; Humans; Male; Anti-Arrhythmia Agents; Atrial Fibrillation; Catheter Ablation; Heart Atria; Pulmonary Veins; Recurrence; Treatment Outcome; Middle Aged; Cardiac Surgical Procedures
PubMed: 36625809
DOI: 10.1001/jama.2022.23722 -
Circulation May 2023Pulsed field ablation uses electrical pulses to cause nonthermal irreversible electroporation and induce cardiac cell death. Pulsed field ablation may have effectiveness...
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 -
Current Cardiology Reviews 2019Atrial fibrillation is the most common sustained cardiac arrhythmia. The scope and impact of atrial fibrillation are wide; it can affect cardiac function, functional... (Review)
Review
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 -
Journal of the American College of... Sep 2020Unlike for paroxysmal atrial fibrillation (AF), pulmonary vein isolation (PVI) alone is considered insufficient for many patients with persistent AF. Adjunctive ablation... (Clinical Trial)
Clinical Trial
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 -
Europace : European Pacing,... Aug 2019Ventricular arrhythmias are an important cause of morbidity and mortality and come in a variety of forms, from single premature ventricular complexes to sustained...
Ventricular arrhythmias are an important cause of morbidity and mortality and come in a variety of forms, from single premature ventricular complexes to sustained ventricular tachycardia and fibrillation. Rapid developments have taken place over the past decade in our understanding of these arrhythmias and in our ability to diagnose and treat them. The field of catheter ablation has progressed with the development of new methods and tools, and with the publication of large clinical trials. Therefore, global cardiac electrophysiology professional societies undertook to outline recommendations and best practices for these procedures in a document that will update and replace the 2009 EHRA/HRS Expert Consensus on Catheter Ablation of Ventricular Arrhythmias. An expert writing group, after reviewing and discussing the literature, including a systematic review and meta-analysis published in conjunction with this document, and drawing on their own experience, drafted and voted on recommendations and summarized current knowledge and practice in the field. Each recommendation is presented in knowledge byte format and is accompanied by supportive text and references. Further sections provide a practical synopsis of the various techniques and of the specific ventricular arrhythmia sites and substrates encountered in the electrophysiology lab. The purpose of this document is to help electrophysiologists around the world to appropriately select patients for catheter ablation, to perform procedures in a safe and efficacious manner, and to provide follow-up and adjunctive care in order to obtain the best possible outcomes for patients with ventricular arrhythmias.
Topics: Cardiac Electrophysiology; Catheter Ablation; Consensus; Electrophysiologic Techniques, Cardiac; Heart Conduction System; Heart Diseases; Humans; International Cooperation; Quality Improvement; Societies, Medical; Tachycardia, Ventricular; Treatment Outcome; Ventricular Premature Complexes
PubMed: 31075787
DOI: 10.1093/europace/euz132 -
JACC. Clinical Electrophysiology Jul 2019This study sought to evaluate the safety and short-term performance of a novel catheter for very high power-short duration (vHPSD) ablation in the treatment of...
OBJECTIVES
This study sought to evaluate the safety and short-term performance of a novel catheter for very high power-short duration (vHPSD) ablation in the treatment of paroxysmal atrial fibrillation.
BACKGROUND
The vHPSD catheter is a novel contact force-sensing catheter optimized for temperature-controlled radiofrequency ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring; the associated vHPSD algorithm modulates power to maintain target temperature during 90 W, 4 s lesions.
METHODS
QDOT-FAST (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation) is a prospective, multicenter, single-arm study enrolling patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation. Primary endpoints were short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events). Participants were screened for silent cerebral lesions by magnetic resonance imaging. Patients were followed for 3 months post-ablation.
RESULTS
A total of 52 patients underwent ablation and completed follow-up. Pulmonary vein isolation was achieved in all patients using the study catheter alone, with total procedure and fluoroscopy times of 105.2 ± 24.7 min and 6.6 ± 8.2 min, respectively. Most patients (n = 49; 94.2%) were in sinus rhythm at 3 months. Two primary adverse events were reported: 1 pseudoaneurysm; and 1 asymptomatic thromboembolism. There were no deaths, stroke, atrioesophageal fistula, pulmonary vein stenosis, or unanticipated adverse device effects. Six patients had identified silent cerebral lesions-all classified as asymptomatic without clinical or neurologic deficits.
CONCLUSIONS
This first-in-human study of a novel catheter with optimized temperature control demonstrated the clinical feasibility and safety of vHPSD ablation. Procedure and fluoroscopy times were substantially lower than historical standard ablation with point-by-point catheters. (Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation [QDOT-FAST]; NCT03459196).
Topics: Aged; Atrial Fibrillation; Catheter Ablation; Catheters; Equipment Design; Female; Fluoroscopy; Humans; Male; Microelectrodes; Middle Aged; Prospective Studies; Pulmonary Veins; Therapeutic Irrigation; Treatment Outcome
PubMed: 31320006
DOI: 10.1016/j.jacep.2019.04.009 -
JACC. Clinical Electrophysiology Aug 2023Because of its safety, "single-shot" pulsed field ablation (PFA) catheters have been developed for pulmonary vein isolation (PVI). However, most atrial fibrillation (AF)...
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 -
Journal of the American College of... Jun 2020The CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial randomized 2,204 patients with atrial fibrillation (AF) to catheter... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial randomized 2,204 patients with atrial fibrillation (AF) to catheter ablation or drug therapy. Analysis by intention-to-treat showed a nonsignificant 14% relative reduction in the primary outcome of death, disabling stroke, serious bleeding, or cardiac arrest.
OBJECTIVES
The purpose of this study was to assess recurrence of AF in the CABANA trial.
METHODS
The authors prospectively studied CABANA patients using a proprietary electrocardiogram recording monitor for symptom-activated and 24-h AF auto detection. The AF recurrence endpoint was any post-90-day blanking atrial tachyarrhythmias lasting 30 s or longer. Biannual 96-h Holter monitoring was used to assess AF burden. Patients who used the CABANA monitors and provided 90-day post-blanking recordings qualified for this analysis (n = 1,240; 56% of CABANA population). Treatment comparisons were performed using a modified intention-to-treat approach.
RESULTS
Median age of the 1,240 patients was 68 years, 34.4% were women, and AF was paroxysmal in 43.0%. Over 60 months of follow-up, first recurrence of any symptomatic or asymptomatic AF (hazard ratio: 0.52; 95% confidence interval: 0.45 to 0.60; p < 0.001) or first symptomatic-only AF (hazard ratio: 0.49; 95% confidence interval: 0.39 to 0.61; p < 0.001) were both significantly reduced in the catheter ablation group. Baseline Holter AF burden in both treatment groups was 48%. At 12 months, AF burden in ablation patients averaged 6.3%, and in drug-therapy patients, 14.4%. AF burden was significantly less in catheter ablation compared with drug-therapy patients across the 5-year follow-up (p < 0.001). These findings were not sensitive to the baseline pattern of AF.
CONCLUSIONS
Catheter ablation was effective in reducing recurrence of any AF by 48% and symptomatic AF by 51% compared with drug therapy over 5 years of follow-up. Furthermore, AF burden was also significantly reduced in catheter ablation patients, regardless of their baseline AF type. (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial [CABANA]; NCT00911508).
Topics: Aged; Anti-Arrhythmia Agents; Atrial Fibrillation; Catheter Ablation; Electrocardiography, Ambulatory; Female; Humans; Intention to Treat Analysis; Male; Outcome and Process Assessment, Health Care; Recurrence; Stroke; Time
PubMed: 32586583
DOI: 10.1016/j.jacc.2020.04.065