Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry.

BACKGROUND: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. RESULTS: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA2DS2-VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P=0.001). Acute major adverse events occurred in 1.9% of patients. CONCLUSIONS: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.

Superior vena cava isolation using a pentaspline pulsed-field ablation catheter: feasibility and safety in patients undergoing atrial fibrillation catheter ablation.

AIMS: Superior vena cava (SVC) isolation during atrial fibrillation catheter ablation is limited by the risk of collateral damage to the sinus node and/or the phrenic nerve. Due to its tissue-specificity, we hypothesized the feasibility and safety of pulsed-field ablation (PFA)-based SVC isolation. METHODS AND RESULTS: One hundred and five consecutive patients undergoing PFA-based AF catheter ablation were prospectively included. After pulmonary vein isolation (±posterior wall isolation and electrical cardioversion), SVC isolation was performed using a standardized workflow. Acute SVC isolation was achieved in 105/105 (100%) patients after 6 ± 1 applications. Transient phrenic nerve stunning occurred in 67/105 (64%) patients but without phrenic nerve palsy at the end of the procedure and at hospital discharge. Transient high-degree sinus node dysfunction occurred in 5/105 (4.7%) patients, with no recurrence at the end of the procedure and until discharge. At the 3-month follow-up visit, no complication occurred. CONCLUSION: SVC isolation using a pentaspline PFA catheter is feasible and safe.

How to improve medical students' ECG interpretation skills ? Multicenter survey and results of a comparative study evaluating a new educational approach.

BACKGROUND: Learning to interpret electrocardiograms (ECGs) is a crucial objective in medical education. Despite its importance, errors in ECGs interpretation are common, and the optimal teaching methods have not yet been clearly established. OBJECTIVES: To evaluate students' confidence in ECGs analysis and their opinion on current teaching methods, and to assess the effectiveness of a new ECG educational approach. METHODS: First, we conducted a survey on ECG learning among fourth to sixth-year medical students. Second, a 5-week multicenter comparative study was conducted with fourth-year medical students during their cardiology internship. Two different teaching methods were used, assigned by center. The first group participated in 5-minutes workshops 4 times a week using a "reversed classroom" method, supervised by a cardiologist, where students took turns selecting, presenting and discussing ECGs. The control group attended a single 2-hour face-to-face ECG course. All participants completed a 30-minute ECGs analysis test at baseline and after 5 weeks. RESULTS: Out of 401 survey respondents, the confidence levels in ECG interpretation were 3/5 (IQR 2-3) for routine situations and 2/5 (IQR 1-3) for emergency situations. Satisfaction with ECG teaching was low (2/5, IQR 1-3) and 96.3% of respondents favored more extensive ECG training. In the comparative study, 52 students from 3 medical schools were enrolled (control group: n = 27; workshop group: n = 25). Both groups showed significant improvement in exam scores from baseline to 5-week (33/100 ± 12/100 to 44/100 ± 12/100, p < 0.0001 for the control group and 36/100 ± 13/100 to 62/100 ± 12/100, p < 0.0001 for the workshop group). The improvement was significantly greater in the workshop group compared to the control group (+ 26 ± 11 vs. + 11 ± 6, p < 0.001). CONCLUSIONS: Among French medical students who initially reported low confidence and insufficient skills in ECG interpretation, the workshop approach using a "reversed classroom" method was found to be more effective than conventional lecture-based teaching during cardiology internship.

Left bundle branch area pacing in patients with baseline narrow, left, or right bundle branch block QRS patterns: insights into electrocardiographic and echocardiographic features.

AIMS: Left bundle branch area pacing (LBBAP) is a recent technique aiming at preservation of physiological ventricular electrical activation. Our goal was to assess mechanical synchrony parameters in relation to electrocardiographic features during LBBAP performed in routine practice. METHODS AND RESULTS: From June 2020 to August 2021, all patients of our institution with permanent pacemaker implantation indication were eligible for LBBAP. A 'qR' pattern in V1 and a delay from pacing spike to the peak of the R-wave in V6 < 80 ms defined a successful LBBAP. Electrocardiogram and echocardiography were performed during spontaneous rhythm and LBBAP: left ventricular mechanical synchrony (LVMS) parameters using 2D Speckle tracking and interventricular mechanical delay (IVMD) were collected. LBBAP was attempted with success in 134/163 patients (82.2%). During LBBAP, the mean QRS width was 104 ± 12 ms. In patients with left bundle branch block (n = 47), LBBAP provided a significant decrease of QRS width from 139 ± 16 to 105 ± 12 ms (P < 0.001) with reduction of LVMS (53 ± 21 vs. 90 ± 46 ms, P = 0.009), and IVMD (14 ± 13 vs. 49 ± 18 ms, P < 0.001). In patients with right bundle branch block (n = 38), LBBAP led to a significant decrease of QRS width from 134 ± 14 to 106 ± 13 ms (P < 0.001) with no effect on LVMS and a reduction of IVMD (17 ± 14 vs. 50 ± 16 ms, P < 0.001). CONCLUSION: LBBAP in routine practice preserved intra-ventricular mechanical synchrony in patients with narrow and RBBB QRS and improved asynchrony parameters in patients with LBBB.

Can permanent His bundle pacing be safely started by operators new to this technique? Data from a multicenter registry.

BACKGROUND: Right ventricular pacing (RVP) induces ventricular asynchrony in patients with normal QRS and increases the risk of heart failure and atrial fibrillation in long term. His bundle pacing (HBP) is a physiological alternative to RVP, and could overcome its drawbacks. Recent studies assessed the feasibility and safety of HBP in expert centers with a vast experience of this technique. These results may not apply to less experienced centers. We aim to evaluate the feasibility and safety of permanent HBP performed by physicians who are new to this technique. METHODS: We included all patients who underwent pacemaker implantation with attempt of HBP in three hospitals between September 2017 and January 2020. Indication for HBP was left to operators' discretion. All the operators were new for HBP. His bundle (HB) electrical parameters were recorded at implant, 3- and 12-month follow-up. RESULTS: HBP was successful in 141 of 170 patients (82.9%); selective HBP was obtained in 96 patients and nonselective HBP in 45. The mean procedure and fluoroscopy durations were 67.0 ± 28.8 min, and 7.3 ± 8.1 min (3.1 ± 4.1 Gy·cm2 ), respectively. The mean HB paced QRS duration was 106 ± 18 ms. The mean HB capture threshold was 1.29 ± 0.77 V and did not increase at 3- and 12-month follow-up. The ventricular lead revision was required in five patients. Our results showed a rapid technical learning allowing a high procedure success rate (89.8%) after 15 procedures. CONCLUSION: HBP performed by operators new to this technique appeared feasible and safe. This should encourage HBP to be performed in patients expected to experience high RVP burden.

New safe approach to target symptomatic Hisian ectopy/tachycardia.

AIMS: Although cryoenergy safety profile is appropriate for the ablation of arrhythmogenic foci near the conduction system, mapping using the cryoablation catheter is of limited precision. Combining the safety of cryoenergy and the high precision of a 3D mapping system therefore appears the most appropriate set-up for ablation in the vicinity of the His bundle. METHODS AND RESULTS: A 29-year-old woman with a 3-year history of increasing shortness of breath and palpitations refractory to medical treatment was sent to the electrophysiology (EP) laboratory for catheter ablation. Surface electrocardiogram showed sinus rhythm and frequent ectopic beats with narrow QRS complexes similar to those of the sinus beats. The left ventricular ejection fraction was impaired (38%) with no other aetiology found, apart from frequent ectopies. Detailed intracardiac mapping, using a 3D electroanatomical system, revealed that the ectopy originated from the distal His bundle, which was indicated by both antegrade and reversed His bundle activation sequence during ectopy compared to that during sinus rhythm. Due to the proximity of the conduction system, cryoenergy rather than radiofrequency was chosen to target this Hisian ectopy. A special set-up was made in order to allow the cryoablation catheter to be visualized into the 3D mapping system. Cryoenergy delivered to the site of earliest Hisian ectopy activation completely abolished it. CONCLUSION: Such a combined approach may help to improve the therapeutic strategy for ablation procedures with a high risk of injury to the conduction system. It could notably be extended to the ablation of para-Hisian ectopy or accessory pathways.

Electrophysiologic evidence of epicardial connections between low right atrium and remote right atrial region or coronary sinus musculature: Relevance for catheter ablation of typical atrial flutter.

BACKGROUND: The coronary sinus (CS) is surrounded by a myocardial coat with extensive connections to the left and right atria that contributes to the interatrial electrical connection. Whereas epicardial connections between CS musculature and the left atrium have largely been demonstrated, clinically relevant epicardial connections from the CS musculature toward the low right atrium (LRA) and epicardial connections between two regions of the right atrium remain questionable. METHODS: Five patients underwent electrophysiology (EP) study for typical atrial flutter (AFl) using either conventional multipolar catheters (four patients) or three-dimensional high-density mapping system (one patient). RESULTS: All five patients had a similar sequence of events during the EP studies. After several cavotricuspid isthmus (CTI) radiofrequency (RF) applications, double potentials were recorded along the ablation line while tachycardia persisted. The right atrial activation pattern strongly suggested the presence of a complete endocardial CTI line of the block. Based on the detailed conventional atrial mapping, RF applications at the middle cardiac vein/CS ostium allowed sinus rhythm restoration in four patients. High-density mapping showed an early breakthrough site at the septal side of the ablation line, close to the CS ostium during counterclockwise AFl, in the fifth patient. RF applications at this site resulted in tachycardia termination. CONCLUSION: Our observations suggested the existence of epicardial fibers connecting the LRA with either the CS musculature or a remote right atrial region. When AFl ablation fails whereas evidence for the local endocardial block is observed, the operators should integrate this finding in the diagnosis and ablation strategy.

Very long-term outcomes after catheter ablation of atrioventricular nodal reentrant tachycardia: How does cryoenergy differ from radiofrequency?

INTRODUCTION: Either cryoenergy or radiofrequency can be used during atrioventricular nodal reentrant tachycardia (AVNRT) ablation. There are still limited data comparing their respective long-term efficacy (>1 year). This study sought to compare the very long-term outcomes of AVNRT ablation using radiofrequency or cryotherapy. METHODS: We retrospectively included all patients who had undergone a first AVNRT ablation in our institution between January 2010 and December 2017. The primary endpoint was recurrence of documented AVNRT. RESULTS: The study population consisted of 409 patients (274 females; mean age, 49.9 years). Ablation was performed using cryoenergy in 260 patients and radiofrequency in 149. High acute procedural success rate (>98%) was obtained and no permanent AV block was observed using both techniques. During a mean follow-up of 3.3 ± 2.3 years, documented AVNRT recurrence occurred in 24 (9.2%) and 4 patients (2.7%) in the cryoablation (CA) and radiofrequency (RF) group, respectively. The risk of AVNRT recurrence was significantly higher in the CA group as compared with the RF group (hazard ratio [HR] = 3.7; 95% confidence interval [CI], 1.3-5.9). Most of the recurrences after CA occurred between 1- and 6-year follow-up (14/24; 58.3%), with one-third of late recurrences after 3-year follow-up. In multivariable analysis, only Koch's triangle anatomical variant was associated with AVNRT recurrence after CA (HR = 6.7; 95% CI, 2.7-16.3). CONCLUSION: While AVNRT recurrence rates were similar at 1 year of follow-up regardless of the energy used, long-term efficacy appeared higher after radiofrequency ablation. Strikingly, recurrences occured much later after cryotherapy compared with radiofrequency ablation.

Pentaspline Pulsed Field Ablation Catheter Versus Cryoballoon for Atrial Fibrillation Ablation: Results From a Prospective Comparative Study.

BACKGROUND: Cryoballoon ablation is currently the gold standard technique for single-shot pulmonary vein isolation (PVI). Pulsed field ablation (PFA) has recently emerged as an interesting nonthermal alternative energy for PVI. The purpose of our study was to evaluate the safety and long-term efficacy of PVI using the pentaspline PFA catheter in comparison to cryoballoon ablation. METHODS AND RESULTS: Between January 2021 and December 2022, we included all consecutive patients of our center in whom a first PVI-only procedure was performed using PFA or cryoballoon. The choice of the energy was based on patients' preference between general anesthesia (PFA) and local anesthesia (cryoballoon). The primary end point was freedom from documented atrial arrhythmia recurrence after a 3-month blanking period. A total of 301 patients (paroxysmal atrial fibrillation in 220 patients) underwent a first PVI procedure performed using PFA (n=151) or cryoballoon (n=150). Complete short-term PVI was obtained in 144 of 150 patients (96%) in the cryoballoon group and in all patients of the PFA group (P=0.01). Procedure duration was significantly longer in the cryoballoon group. Transient and persistent phrenic nerve injuries were observed in the cryoballoon group only (13/150 and 2/150, respectively). One-year freedom from atrial arrhythmia was significantly higher in the PFA group compared with the cryoballoon group (87.9% versus 77.7%; adjusted hazard ratio, 0.53 [95% CI, 0.30-0.96]; P=0.037). CONCLUSIONS: This prospective, comparative, real-life study suggested that PFA could overcome safety limitations of cryoballoon with optimal effectiveness. Randomized controlled studies are required to further investigate the potential superiority of PFA over cryoballoon.

His bundle pacing versus left bundle branch area pacing in patients undergoing atrioventricular node ablation: A prospective and comparative study.

BACKGROUND: Pacemaker implantation combined with atrioventricular node ablation (AVNA) is a well-established strategy for uncontrolled atrial arrhythmias. Limited data are available regarding His bundle pacing (HBP) and left bundle branch area pacing (LBBAP) in this setting. AIM: To compare the outcomes of HBP and LBBAP in patients undergoing pacemaker implantation combined with AVN in routine clinical practice. METHODS: We prospectively included all patients who underwent AVNA after successful conduction system pacing (CSP) in two hospitals between September 2017 and May 2023. The primary outcome was the 1-year composite of first episode of heart failure hospitalization, symptomatic atrioventricular node reconduction requiring a second AVNA procedure, lead revision or death from any cause. RESULTS: A total of 164 patients underwent AVNA following successful CSP (68 HBP and 96 LBBAP). Mean pacemaker implantation and AVNA procedure times were shorter in the LBBAP group than the HBP group (46±18 vs 59±23min; P<0.001 and 31±12 vs 43±22min, respectively; P<0.001). Complete atrioventricular block was more frequently obtained in the LBBAP group (88/96 patients [92%] vs 54/68 patients [79%]; P=0.04). One-year freedom from the composite outcome was more frequent in the LBBAP group (89.7% vs 72.9%; hazard ratio 0.32, 95% confidence interval 0.14-0.72; P=0.01). The strategy was similarly effective in both groups with a significant improvement in NYHA class and left ventricular ejection fraction. A secondary pacing threshold elevation >1V occurred only in the HBP group (11%). CONCLUSION: In this prospective, comparative study, LBBAP provided better 1-year outcomes than HBP.

Prospective 1-year results of atrial fibrillation ablation using the pentaspline pulsed field ablation catheter: The initial French experience.

BACKGROUND: Pulsed field ablation has recently emerged as an interesting non-thermal energy for atrial fibrillation ablation. At a time of rapid spread of this technology, there is still a lack of prospective real-life data. AIM: To describe multicentre prospective safety and 1-year efficacy data in three of the first French centres to use pulsed field ablation. METHODS: All consecutive patients undergoing a first pulsed field ablation were included prospectively. The primary outcome was freedom from documented atrial arrhythmia. The safety endpoint was a composite of major adverse events. Univariate and multivariable analyses, including patient and procedural characteristics, were performed to identify factors predictive of recurrence. RESULTS: Between May 2021 and June 2022, 311 patients were included (paroxysmal atrial fibrillation in 53%, persistent atrial fibrillation in 35% and long-standing persistent atrial fibrillation in 11%). Additional non-pulmonary vein pulsed field ablation applications were performed in 104/311 patients. One-year freedom from arrhythmia recurrence was 77.6% in the overall population and was significantly higher in patients with paroxysmal atrial fibrillation (88.4%) compared with patients with persistent atrial fibrillation (69.7%; P<0.001) and those with long-standing persistent atrial fibrillation (49.0%; P<0.001). The major complication rate was 2.6% (tamponade in four patients, stroke in two patients and coronary spasm in one patient). Besides the usual predictors of recurrences (left atrium size, CHA2DS2-VASc score, type of atrial fibrillation), the presence of atrial fibrillation at procedure start was independently associated with arrhythmia recurrence (hazard ratio: 2.04, 95% confidence interval: 1.10-3.77). CONCLUSION: In this prospective multicentre real-world study, pulsed field ablation for atrial fibrillation ablation seems to be associated with a good safety profile and rather favourable acute and 1-year success rates.

Long-Term Freedom From Ventricular Arrhythmias in ARVC With Endocardial Only Ablation: Predictors of Success.

BACKGROUND: Although the epicardial predominance of substrate abnormalities has been well demonstrated in early stages of arrhythmogenic right ventricular cardiomyopathy (ARVC), endocardial (ENDO) ablation may suffice to eliminate ventricular tachycardia (VT) in some patients. OBJECTIVES: This study aimed to report the long-term outcomes of ENDO-only ablation in ARVC patients and factors that predict VT-free survival. METHODS: We included consecutive patients with Task Force Criteria diagnosis of ARVC undergoing a first ENDO-only VT ablation between 1998 and 2020. Ablation was predominantly guided by activation/entrainment mapping for mappable VTs and pace mapping/targeting abnormal electrograms for unmappable VTs. The primary endpoint was freedom from any recurrent sustained VT after the last ENDO-only ablation. RESULTS: Seventy-four ARVC patients underwent ENDO-only VT ablation. VT noninducibility was achieved in 49 (66%) patients. During median follow-up of 6.6 years (Q1-Q3: 3.4-11.2 years), 40 (54.1%) patients remained free from any VT recurrence with rare VT ≤2 episodes in additional 12.2%. Among patients with noninducibility, VT-free survival was 75.5% during long-term follow-up. In multivariable analysis, >45 y of age at diagnosis (HR: 0.41; 95% CI: 0.17-0.98) and VT noninducibility (HR: 0.36; 95% CI: 0.16-0.80) were predictors of VT-free survival. CONCLUSIONS: Long-term VT-free survival can be achieved in over half of ARVC patients following ENDO-only VT ablation, increasing to over 75% if VT noninducibility is achieved. Our results support consideration of a stepwise ENDO-only approach before proceeding to epicardial ablation if VT noninducibility can be achieved particularly in older patients.

Incremental Benefit of Stepwise Nonpulmonary Vein Trigger Provocation During Catheter Ablation of Atrial Fibrillation.

BACKGROUND: The importance of nonpulmonary vein (PV) triggers for the initiation/recurrence of atrial fibrillation (AF) is well established. OBJECTIVES: This study sought to assess the incremental benefit of provocative maneuvers for identifying non-PV triggers. METHODS: We included consecutive patients undergoing first-time AF ablation between 2020 and 2022. The provocation protocol included step 1, identification of spontaneous non-PV triggers after cardioversion of AF and/or during sinus rhythm; step 2, isoproterenol infusion (3, 6, 12, and 20-30 µg/min); and step 3, atrial burst pacing to induce AF followed by cardioversion during residual or low-dose isoproterenol infusion or induce focal atrial tachycardia. Non-PV triggers were defined as non-PV ectopic beats triggering AF or sustained focal atrial tachycardia. RESULTS: Of 1,372 patients included, 883 (64.4%) underwent the complete stepwise provocation protocol with isoproterenol infusion and burst pacing, 334 (24.3%) isoproterenol infusion only, 77 (5.6%) burst pacing only, and 78 (5.7%) no provocative maneuvers (only step 1). Overall, 161 non-PV triggers were found in 135 (9.8%) patients. Of these, 51 (31.7%) non-PV triggers occurred spontaneously, and the remaining 110 (68.3%) required provocative maneuvers for induction. Among those receiving the complete stepwise provocation protocol, there was a 2.2-fold increase in the number of patients with non-PV triggers after isoproterenol infusion, and the addition of burst pacing after isoproterenol infusion led to a total increase of 3.6-fold with the complete stepwise provocation protocol. CONCLUSIONS: The majority of non-PV triggers require provocative maneuvers for induction. A stepwise provocation protocol consisting of isoproterenol infusion followed by burst pacing identifies a 3.6-fold higher number of patients with non-PV triggers.

The Safety and Efficacy of Epicardial Carbon Dioxide Insufflation Compared With Conventional Epicardial Access.

BACKGROUND: Epicardial (Epi) access is commonly required during ventricular tachycardia ablation. Conventional Epi (ConvEpi) access targets a "dry" pericardial space presenting technical challenges and risk of complications. Recently, intentional puncture of coronary venous branches with Epi carbon dioxide insufflation (EpiCO2) has been described as a technique to improve Epi access. The safety of this technique relative to conventional methods remains unproven. OBJECTIVES: The authors sought to compare the feasibility and safety of EpiCO2 to ConvEpi access. METHODS: All patients at a high-volume center undergoing Epi access between January 2021 and December 2023 were included and grouped according to ConvEpi or EpiCO2 approach. Access technique was according to the discretion of the operator. RESULTS: Epi access was attempted in 153 cases by 17 different operators (80 ConvEpi vs 73 EpiCO2). There was no difference in success rate whether the ConvEpi or EpiCO2 approach was used (76 [95%] cases vs 67 [91.8%] cases; P = 0.4). Total Epi access time was shorter in the ConvEpi group compared with the EpiCO2 group (16.3 ± 11.6 minutes vs 26.9 ± 12.7 minutes; P < 0.001), though the total procedure duration was similar. Major Epi access-related complications occurred in only the ConvEpi group (6 [7.5%] ConvEpi vs 0 [0%] EpiCo2; P = 0.02). Bleeding ≥80 mL was more frequently observed following ConvEpi access (14 [17.5%] cases vs 4 [5.5%] cases; P = 0.02). After adjusting for age, repeat Epi access, and antithrombotic therapy, EpiCO2 was associated with a reduction in bleeding ≥80 mL (OR: 0.27; 95% CI: 0.08-0.89; P = 0.03). CONCLUSIONS: EpiCO2 access is associated with lower rates of major complication and bleeding when compared with ConvEpi access.

Predictors of nonpulmonary vein triggers for atrial fibrillation: A clinical risk score.

BACKGROUND: Targeting non-pulmonary vein triggers (NPVTs) after pulmonary vein isolation may reduce atrial fibrillation (AF) recurrence. Isoproterenol infusion and cardioversion of spontaneous or induced AF can provoke NPVTs but typically require vasopressor support and increased procedural time. OBJECTIVE: The purpose of this study was to identify risk factors for the presence of NPVTs and create a risk score to identify higher-risk subgroups. METHODS: Using the AF ablation registry at the Hospital of the University of Pennsylvania, we included consecutive patients who underwent AF ablation between January 2021 and December 2022. We excluded patients who did not receive NPVT provocation testing after failing to demonstrate spontaneous NPVTs. NPVTs were defined as non-pulmonary vein ectopic beats triggering AF or focal atrial tachycardia. We used risk factors associated with NPVTs with P <.1 in multivariable logistic regression model to create a risk score in a randomly split derivation set (80%) and tested its predictive accuracy in the validation set (20%). RESULTS: In 1530 AF ablations included, NPVTs were observed in 235 (15.4%). In the derivation set, female sex (odds ratio [OR] 1.40; 95% confidence interval [CI] 0.96-2.03; P = .080), sinus node dysfunction (OR 1.67; 95% CI 0.98-2.87; P = .060), previous AF ablation (OR 2.50; 95% CI 1.70-3.65; P <.001), and left atrial scar (OR 2.90; 95% CI 1.94-4.36; P <.001) were risk factors associated with NPVTs. The risk score created from these risk factors (PRE2SSS2 score; [PRE]vious ablation: 2 points, female [S]ex: 1 point, [S]inus node dysfunction: 1 point, left atrial [S]car: 2 points) had good predictive accuracy in the validation cohort (area under the receiver operating characteristic curve 0.728; 95% CI 0.648-0.807). CONCLUSION: A risk score incorporating predictors for NPVTs may allow provocation of triggers to be performed in patients with greatest expected yield.

Safety and Effectiveness of Pulsed Field Ablation for Atrial Fibrillation in Patients With Heart Failure.

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). OBJECTIVE: This study sought to assess the outcomes of pulsed field ablation (PFA) in HF. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a multicenter, patient-level registry of consecutive patients undergoing PFA for paroxysmal AF or persistent AF (PerAF). In this substudy, patients were stratified as no history of HF (no-HF), HF with preserved EF (HFpEF) (left ventricular EF of ≥50%) or HF with reduced/mildly reduced EF (HFmr/rEF) (left ventricular EF of <50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30 seconds and major adverse events, respectively. RESULTS: Of the 1,381 patients, 85% (n = 1,174) were no-HF, 6.2% (n = 87) were HFpEF, and 8.6% (n = 120) were HFmr/rEF. No-HF patients had less PerAF than patients with HF (P < 0.001), with no difference between HF subtypes (P = >0.99). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF patients than in those with HFpEF or HFmr/rEF (79.9%, 71.3%, and 67.5%, respectively; P < 0.001) but similar between patients with HFmr/rEF and HFpEF (P = 0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFpEF vs HFmr/rEF for those with paroxysmal AF (82.8%, 82.4%, and 71.7%, respectively; P = 0.09) and PerAF (73.3%, 64.2%, and 64.9%, respectively; P = 0.14). Major adverse event rates were similar between the no-HF, HFpEF, and HFmr/rEF groups (1.9%, 0%, and 2.5%, respectively). CONCLUSIONS: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

Impact of Left Atrial Posterior Wall Ablation During Pulsed-Field Ablation for Persistent Atrial Fibrillation.

BACKGROUND: Pulmonary vein isolation (PVI) alone is insufficient to treat many patients with persistent atrial fibrillation (PersAF). Adjunctive left atrial posterior wall (LAPW) ablation with thermal technologies has revealed lack of efficacy, perhaps limited by the difficulty in achieving lesion durability amid concerns of esophageal injury. OBJECTIVES: This study aims to compare the safety and effectiveness of PVI + LAPW ablation vs PVI in patients with PersAF using pulsed-field ablation (PFA). METHODS: In a retrospective analysis of the MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-approval Clinical Use of Pulsed Field Ablation) registry, we studied consecutive PersAF patients undergoing post-approval treatment with a pentaspline PFA catheter. The primary effectiveness outcome was freedom from any atrial arrhythmia of ≥30 seconds. Safety outcomes included the composite of acute and chronic major adverse events. RESULTS: Of the 547 patients with PersAF who underwent PFA, 131 (24%) received adjunctive LAPW ablation. Compared to PVI-alone, patients receiving adjunctive LAPW ablation were younger (65 vs 67 years of age, P = 0.08), had a lower CHA2DS2-VASc score (2.3 ± 1.6 vs 2.6 ± 1.6, P = 0.08), and were more likely to receive electroanatomical mapping (48.1% vs 39.0%, P = 0.07) and intracardiac echocardiography imaging (46.1% vs 17.1%, P < 0.001). The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmias was not statistically different between groups in the full (PVI + LAPW: 66.4%; 95% CI: 57.6%-74.4% vs PVI: 73.1%; 95% CI: 68.5%-77.2%; P = 0.68) and propensity-matched cohorts (PVI + LAPW: 71.7% vs PVI: 68.5%; P = 0.34). There was also no significant difference in major adverse events between the groups (2.2% vs 1.4%, respectively, P = 0.51). CONCLUSIONS: In patients with PersAF undergoing PFA, as compared to PVI-alone, adjunctive LAPW ablation did not improve freedom from atrial arrhythmia at 12 months.

Safety and Effectiveness of Pulsed Field Ablation for Atrial Fibrillation in Patients with Heart Failure: A MANIFEST-PF Sub-analysis.

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). OBJECTIVE: To assess the outcomes of pulsed-field ablation (PFA) in HF. METHODS: MANIFEST-PF is a multicenter patient-level registry of consecutive patients undergoing PFA for paroxysmal (PAF) or persistent AF (PerAF). In this sub-study, patients were stratified as: no history of HF (no-HF), HF with preserved EF (HFPEF; LVEF≥50%) or HF with reduced/mildly-reduced EF (HFMR/REF; LVEF<50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30s and major adverse events (MAEs), respectively. RESULTS: Of the 1,381 patients, 85% (n=1,174) were no-HF, 6.2% (n=87) were HFPEF, and 8.6% (n=120) were HFMR/REF. No-HF patients had less PerAF than patients with HF (p<0.001), with no difference between HF subtypes (p=1.00). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF than with HFPEF or HFMR/REF (79.9%, 71.3%, 67.5%, p<0.001), but similar between HFMR/REF and HFPEF (p=0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFPEF vs HFMR/REF for those with PAF (82.8%/82.4%/71.7%, p=0.09) and PerAF (73.3%, 64.2%, and 64.9%, p=0.14.MAE rates were similar between the no-HF, HFPEF and HFMR/REF groups (1.9%, 0%, and 2.5%, respectively). CONCLUSION: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.