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The New England Journal of Medicine Nov 2023Catheter-based pulmonary vein isolation is an effective treatment for paroxysmal atrial fibrillation. Pulsed field ablation, which delivers microsecond high-voltage... (Comparative Study)
Comparative Study
BACKGROUND
Catheter-based pulmonary vein isolation is an effective treatment for paroxysmal atrial fibrillation. Pulsed field ablation, which delivers microsecond high-voltage electrical fields, may limit damage to tissues outside the myocardium. The efficacy and safety of pulsed field ablation as compared with conventional thermal ablation are not known.
METHODS
In this randomized, single-blind, noninferiority trial, we assigned patients with drug-refractory paroxysmal atrial fibrillation in a 1:1 ratio to undergo pulsed field ablation or conventional radiofrequency or cryoballoon ablation. The primary efficacy end point was freedom from a composite of initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardioversion, or repeat ablation. The primary safety end point included acute and chronic device- and procedure-related serious adverse events.
RESULTS
A total of 305 patients were assigned to undergo pulsed field ablation, and 302 were assigned to undergo thermal ablation. At 1 year, the primary efficacy end point was met (i.e., no events occurred) in 204 patients (estimated probability, 73.3%) who underwent pulsed field ablation and 194 patients (estimated probability, 71.3%) who underwent thermal ablation (between-group difference, 2.0 percentage points; 95% Bayesian credible interval, -5.2 to 9.2; posterior probability of noninferiority, >0.999). Primary safety end-point events occurred in 6 patients (estimated incidence, 2.1%) who underwent pulsed field ablation and 4 patients (estimated incidence, 1.5%) who underwent thermal ablation (between-group difference, 0.6 percentage points; 95% Bayesian credible interval, -1.5 to 2.8; posterior probability of noninferiority, >0.999).
CONCLUSIONS
Among patients with paroxysmal atrial fibrillation receiving a catheter-based therapy, pulsed field ablation was noninferior to conventional thermal ablation with respect to freedom from a composite of initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardioversion, or repeat ablation and with respect to device- and procedure-related serious adverse events at 1 year. (Funded by Farapulse-Boston Scientific; ADVENT ClinicalTrials.gov number, NCT04612244.).
Topics: Humans; Atrial Fibrillation; Bayes Theorem; Catheter Ablation; Pulmonary Veins; Recurrence; Single-Blind Method; Tachycardia; Treatment Outcome
PubMed: 37634148
DOI: 10.1056/NEJMoa2307291 -
Circulation. Arrhythmia and... Jul 2023The cryoballoon (CB) represents the gold standard single-shot device for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Single-shot pulsed...
BACKGROUND
The cryoballoon (CB) represents the gold standard single-shot device for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Single-shot pulsed field PVI ablation (nonthermal, cardiac tissue selective) has recently entered the arena. We sought to compare procedural data and long-term outcome of both techniques.
METHODS
Consecutive AF patients who underwent pulsed field ablation (PFA) and CB-based PVI were enrolled. CB PVI was performed using the second-generation 28-mm CB; PFA was performed using a 31/35-mm pentaspline catheter. Success was defined as freedom from atrial tachyarrhythmia after a 3-month blanking period.
RESULTS
Four hundred patients were included (56.5% men; 60.8% paroxysmal AF; age 70 [interquartile range, 59-77] years), 200 in each group (CB and PFA), and baseline characteristics did not differ. Acute PVI was achieved in 100% of PFA and in 98% (196/200) of CB patients (=0.123; 4 touch-up ablations). Median procedure time was significantly shorter in PFA (34.5 [29-40] minutes) versus CB (50 [45-60] minutes; <0.001), fluoroscopy time was similar. Overall procedural complications were 6.5% in CB and 3.0% in PFA (=0.1), driven by a higher rate of phrenic nerve palsies using CB. The 1-year success rates in paroxysmal AF (CB, 83.1%; PFA, 80.3%; =0.724) and persistent AF (CB, 71%; PFA, 66.8%; =0.629) were similar for both techniques.
CONCLUSIONS
PFA compared with CB PVI shows a similar procedural efficacy but is associated with shorter procedure time and no phrenic nerve palsies. Importantly, 12-month clinical success rates are favorable but not different between both groups.
Topics: Male; Humans; Aged; Female; Atrial Fibrillation; Follow-Up Studies; Treatment Outcome; Pulmonary Veins; Cryosurgery; Paralysis; Catheter Ablation; Recurrence
PubMed: 37254781
DOI: 10.1161/CIRCEP.123.011920 -
Europace : European Pacing,... Jul 2023Pulsed field ablation (PFA) is a new, non-thermal ablation modality for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF). The multi-centre...
AIMS
Pulsed field ablation (PFA) is a new, non-thermal ablation modality for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF). The multi-centre EUropean Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation (EU-PORIA) registry sought to determine the safety, efficacy, and learning curve characteristics for the pentaspline, multi-electrode PFA catheter.
METHODS AND RESULTS
All-comer AF patients from seven high-volume centres were consecutively enrolled. Procedural and follow-up data were collected. Learning curve effects were analysed by operator ablation experience and primary ablation modality. In total, 1233 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 (interquartile range: 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 ischaemic attack or stroke (n = 7; 0.6%), of which one was fatal. Prior cryoballoon users had less complication. 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.
Topics: Humans; Male; Middle Aged; Aged; Female; Atrial Fibrillation; Poria; Treatment Outcome; Catheter Ablation; Fluoroscopy; Pulmonary Veins; Recurrence
PubMed: 37379528
DOI: 10.1093/europace/euad185 -
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 -
European Heart Journal Feb 2024Atrial fibrillation (AF) is a chronic progressive disorder. Persistent forms of AF are associated with increased rates of thromboembolism, heart failure, and death.... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND AND AIMS
Atrial fibrillation (AF) is a chronic progressive disorder. Persistent forms of AF are associated with increased rates of thromboembolism, heart failure, and death. Catheter ablation modifies the pathogenic mechanism of AF progression. No randomized studies have evaluated the impact of the ablation energy on progression to persistent atrial tachyarrhythmia.
METHODS
Three hundred forty-six patients with drug-refractory paroxysmal AF were enrolled and randomly assigned to contact-force-guided RF ablation (CF-RF ablation, 115), 4 min cryoballoon ablation (CRYO-4, 115), or 2 min cryoballoon ablation (CRYO-2, 116). Implantable cardiac monitors placed at study entry were used for follow-up. The main outcome was the first episode of persistent atrial tachyarrhythmia. Secondary outcomes included atrial tachyarrhythmia recurrence and arrhythmia burden on the implantable monitor.
RESULTS
At a median of 944.0 (interquartile range [IQR], 612.5-1104) days, 0 of 115 patients (0.0%) randomly assigned to CF-RF, 8 of 115 patients (7.0%) assigned to CRYO-4, and 5 of 116 patients (4.3%) assigned to CRYO-2 experienced an episode of persistent atrial tachyarrhythmia (P = .03). A documented recurrence of any atrial tachyarrhythmia ≥30 s occurred in 56.5%, 53.9%, and 62.9% of those randomized to CF-RF, CRYO-4, and CRYO-2, respectively; P = .65. Compared with that of the pre-ablation monitoring period, AF burden was reduced by a median of 99.5% (IQR 94.0%, 100.0%) with CF-RF, 99.9% (IQR 93.3%-100.0%) with CRYO-4, and 99.1%% (IQR 87.0%-100.0%) with CRYO-2 (P = .38).
CONCLUSIONS
Catheter ablation of paroxysmal AF using radiofrequency energy was associated with fewer patients developing persistent AF on follow-up.
Topics: Humans; Atrial Fibrillation; Cryosurgery; Treatment Outcome; Catheter Ablation; Tachycardia; Recurrence; Pulmonary Veins
PubMed: 37624879
DOI: 10.1093/eurheartj/ehad572 -
European Heart Journal Jul 2023Catheter ablation is an effective strategy in atrial fibrillation (AF). However, its timing in the course of management remains unclear. The aim of this study was to... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Catheter ablation is an effective strategy in atrial fibrillation (AF). However, its timing in the course of management remains unclear. The aim of this study was to determine if an early vs. delayed AF ablation strategy is associated with differences in arrhythmia outcomes during 12-month follow-up.
METHODS AND RESULTS
One hundred patients with symptomatic AF referred to a tertiary centre for management were randomized in a 1:1 ratio to either an early ablation strategy (within 1 month of recruitment) or a delayed ablation strategy (optimized medical therapy followed by catheter ablation at 12 months post recruitment). The primary endpoint was atrial arrhythmia free survival at 12 months post-ablation. Secondary outcomes included: (i) AF burden, (ii) AF burden by AF phenotype, and (iii) antiarrhythmic drug (AAD) use at 12 months. Overall, 89 patients completed the study protocol (Early vs. Delayed: 48 vs. 41). Mean age was 59 ± 12.9 years (29% women). Pulmonary vein isolation was achieved in 100% of patients. At 12 months, 56.3% of patients in the early ablation group were free from recurrent arrhythmia, compared with 58.6% in the delayed ablation group (HR 1.12, 95% CI 0.59-2.13, P = 0.7). All secondary outcomes showed no significant difference including median AF burden (Early vs. Delayed: 0% [IQR 3.2] vs. 0% [5], P = 0.66), median AF burden amongst paroxysmal AF patients (0% [IQR 1.1] vs. 0% [4.5], P = 0.78), or persistent AF patients (0% [IQR 22.8] vs. 0% [5.6], P = 0.45) or AAD use (33% vs. 37%, P = 0.8).
CONCLUSION
Compared with an early ablation strategy, delaying AF ablation by 12 months for AAD management did not result in reduced ablation efficacy.
Topics: Female; Male; Humans; Atrial Fibrillation; Treatment Outcome; Anti-Arrhythmia Agents; Catheter Ablation; Recurrence; Pulmonary Veins
PubMed: 37062010
DOI: 10.1093/eurheartj/ehad247 -
Advances in Experimental Medicine and... 2024The development of the inflow tract is undoubtedly one of the most complex remodeling events in the formation of the four-chambered heart. It involves the creation of...
The development of the inflow tract is undoubtedly one of the most complex remodeling events in the formation of the four-chambered heart. It involves the creation of two separate atrial chambers, the formation of an atrial/atrioventricular (AV) septal complex, the incorporation of the caval veins and coronary sinus into the right atrium, and the remodeling events that result in pulmonary venous return draining into the left atrium. In these processes, the atrioventricular mesenchymal complex, consisting of the major atrioventricular (AV) cushions, the mesenchymal cap on the primary atrial septum (pAS), and the dorsal mesenchymal protrusion (DMP), plays a crucial role.
Topics: Animals; Humans; Coronary Sinus; Heart; Heart Atria; Mesoderm; Pulmonary Veins
PubMed: 38884709
DOI: 10.1007/978-3-031-44087-8_7 -
Europace : European Pacing,... Nov 2023Pulmonary vein isolation (PVI) plays a central role in the interventional treatment of atrial fibrillation (AF). Uncertainties remain about the durability of ablation... (Meta-Analysis)
Meta-Analysis
AIMS
Pulmonary vein isolation (PVI) plays a central role in the interventional treatment of atrial fibrillation (AF). Uncertainties remain about the durability of ablation lesions from different energy sources. We aimed to systematically review the durability of ablation lesions associated with various PVI-techniques using different energy sources for the treatment of AF.
METHODS AND RESULTS
Structured systematic database search for articles published between January 2010 and January 2023 reporting PVI-lesion durability as evaluated in the overall cohort through repeat invasive remapping during follow-up. Studies evaluating only a proportion of the initial cohort in redo procedures were excluded. A total of 19 studies investigating 1050 patients (mean age 60 years, 31% women, time to remap 2-7 months) were included. In a pooled analysis, 99.7% of the PVs and 99.4% of patients were successfully ablated at baseline and 75.5% of the PVs remained isolated and 51% of the patients had all PVs persistently isolated at follow-up across all energy sources. In a pooled analysis of the percentages of PVs durably isolated during follow-up, the estimates of RFA were the lowest of all energy sources at 71% (95% CI 69-73, 11 studies), but comparable with cryoballoon (79%, 95%CI 74-83, 3 studies). Higher durability percentages were reported in PVs ablated with laser-balloon (84%, 95%CI 78-89, one study) and PFA (87%, 95%CI 84-90, 2 studies).
CONCLUSION
We observed no significant difference in the durability of the ablation lesions of the four evaluated energies after adjusting for procedural and baseline populational characteristics.
Topics: Humans; Female; Middle Aged; Male; Atrial Fibrillation; Pulmonary Veins; Cryosurgery; Catheter Ablation; Time Factors; Treatment Outcome; Recurrence
PubMed: 37944133
DOI: 10.1093/europace/euad335 -
JACC. Cardiovascular Interventions Nov 2023Superior sinus venosus defect is a communication between the right and left atrium located above the upper margin of the oval fossa, immediately inferior to the junction... (Review)
Review
Superior sinus venosus defect is a communication between the right and left atrium located above the upper margin of the oval fossa, immediately inferior to the junction of the superior vena cava and the right atrium. It is systematically associated with partial anomalous pulmonary venous drainage, especially of the right upper pulmonary vein. Surgical repair has been the gold standard approach to close that defect. Introduced in 2014, percutaneous closure has gradually become a safe and effective alternative to surgery in carefully selected patients, although worldwide experience remains limited. This article provides an appraisal of the patients' selection process and a step-by-step description of the procedure as well as a comprehensive review of its outcomes.
Topics: Humans; Vena Cava, Superior; Treatment Outcome; Heart Septal Defects, Atrial; Pulmonary Veins
PubMed: 37855807
DOI: 10.1016/j.jcin.2023.07.024 -
JAMA Cardiology Aug 2023The overall success rate of circumferential pulmonary vein isolation (CPVI) treatment in patients with paroxysmal atrial fibrillation (AF) remains suboptimal, especially...
Circumferential Pulmonary Vein Isolation With vs Without Additional Low-Voltage-Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation: A Randomized Clinical Trial.
IMPORTANCE
The overall success rate of circumferential pulmonary vein isolation (CPVI) treatment in patients with paroxysmal atrial fibrillation (AF) remains suboptimal, especially in older patients.
OBJECTIVE
To explore the incremental benefit of low-voltage-area ablation after CPVI in older patients with paroxysmal AF.
DESIGN, SETTING, AND PARTICIPANTS
This randomized clinical trial was an investigator-initiated trial to compare the efficacy of additional low-voltage-area ablation beyond CPVI vs CPVI alone in older patients with paroxysmal AF. Participants were patients aged 65 to 80 years with paroxysmal AF who were referred for catheter ablation. They were enrolled in 14 tertiary hospitals in China from April 1, 2018, to August 3, 2020, and follow-up occurred through August 15, 2021.
INTERVENTIONS
Patients were randomized (1:1) to undergo CPVI plus low-voltage-area ablation or CPVI alone. Low-voltage areas were defined as areas with amplitude less than 0.5 mV in more than 3 adjacent points. If low-voltage areas existed, additional substrate ablation was performed in the CPVI plus group but not the CPVI alone group.
MAIN OUTCOMES AND MEASURES
The primary end point of the study was freedom from atrial tachyarrhythmia as documented by electrocardiogram during a clinical visit or lasting longer than 30 seconds during Holter recordings occurring after a single ablation procedure.
RESULTS
Among 438 patients who were randomized (mean [SD] age, 70.5 [4.4] years; 219 men [50%]), 24 (5.5%) did not complete the blanking period and were not included for efficacy analysis. After a median follow-up of 23 months, the recurrence rate of atrial tachyarrhythmia was significantly lower in the CPVI plus group (31/209 patients, 15%) compared with the CPVI alone group (49/205, 24%; hazard ratio [HR], 0.61; 95% CI, 0.38-0.95; P = .03). In subgroup analyses, among all patients with low-voltage area, CPVI plus substrate modification was associated with a 51% decreased risk of ATA recurrence compared with CPVI alone (HR, 0.49; 95% CI, 0.25-0.94; P = .03).
CONCLUSIONS AND RELEVANCE
This study found that additional low-voltage-area ablation beyond CPVI decreased the ATA recurrence in older patients with paroxysmal AF compared with CPVI alone. Our findings merit further replication by larger trials with longer follow-up.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03462628.
Topics: Male; Humans; Aged; Atrial Fibrillation; Pulmonary Veins; Treatment Outcome; Heart Atria; Electrocardiography; Catheter Ablation
PubMed: 37378966
DOI: 10.1001/jamacardio.2023.1749