Efficacy Of Pulmonary Vein Isolation Research Articles

The impact of peri-procedural imaging on safety and efficacy of atrial fibrillation ablation: insights from the Israeli AF Catheter Ablation Registry (ICAR).

Pulmonary vein isolation (PVI) is the most effective therapy to achieve rhythm control in atrial fibrillation (AF). Peri-procedural imaging is used in many but not all centers. However, the impact of imaging on safety and efficacy of PVI is not clear. The Israeli Catheter Ablation Registry (ICAR) is a great opportunity to explore this issue in real-world practice. To describe the real-world utilization of peri-procedural imaging technologies in a large cohort of patients undergoing ablation for AF. A prospective-multicenter cohort of AF patients who underwent PVI during the years 2019-2021. Peri-procedural imaging (CT, ICE, TEE) was utilized based on the center and operator discretion. The study endpoints were peri-procedural complications and AF recurrence at 12months follow-up among patients with and without peri-procedural imaging. Between January 2019 and December 2021, a total of 921 patients underwent PVI. Peri-procedural imaging (at least 1 modality of CT, TEE, and or ICE) was utilized in 753 (81.8%) and no imaging among 168 (18.2%) patients. Cryoablation was the dominant energy used for PVI in both groups (92.3% of the non-imaging group, and 95.3% among imaging group), while RF was used in the rest of the patients. Fluoroscopy time was not different between the 2 groups; however, procedure duration was longer among the imaging group (90min) compared to the non-imaging group (74.5min, p = 0.006). By 12months, the incidence of AF recurrence and repeated ablation were not different between the groups. Complications and re-hospitalization for cardiocerebrovascular reasons were not different among the 2 groups. Cox regression model demonstrated no association between preprocedural imaging and the risk of AF recurrence after ablation. This real-world multicenter prospective registry study demonstrated that the rate of complications and the rate of recurrence of AF during 1year follow-up were not different among patients who had PVI either with or without peri-procedural imaging.

Pulmonary Vein Isolation or Pace and Ablate in Elderly Patients With Persistent Atrial Fibrillation (ABLATE Versus PACE)—Rationale, Methods, and Design

Age is a major risk-factor for atrial fibrillation (AF) and associated hospitalisations. With increasing emphasis on rhythm control, pulmonary vein isolation (PVI) is often suggested, even to elderly patients (≥ 75 years of age). Efficacy of PVI aiming at rhythm control is limited in persistent AF. Pacemaker implantation with atrioventricular node (AVN) ablation may represent a reasonable alternative, with the aim of controlling symptoms and improving quality of life in elderly patients. In this investigator-initiated, randomised, multicentre trial, we test the hypothesis that pacemaker implantation and AVN ablation provides superior symptom control over PVI in elderly patients with symptomatic persistent AF, without any increase in adverse event profile. In the ABLATE Versus PACE (NCT 04906668) prospective open-label superiority trial, 196 elderly patients with normal ejection fraction and symptomatic persistent AF despite guideline-indicated medical therapy will be randomised to either cryoballoon PVI (ABLATE) or dual-chamber pacemaker implantation with subsequent AVN ablation (PACE), and followed for a minimum of 12 months. The primary efficacy outcome is a composite end point of rehospitalisation for atrial arrhythmia or cardiac decompensation/heart failure, (outpatient) electrical cardioversion, or upgrade to cardiac resynchronisation therapy owing to worsening of left ventricular ejection fraction to ≤ 35%. Secondary end points include death from any cause, stroke, quality of life, and procedure-related complications. Sample size is designed to achieve 80% power for the primary end point (2-tailed alpha of 5%). ABLATE Versus PACE will determine whether pacemaker implantation and AVN ablation can improve symptom-control in elderly patients with persistent AF over PVI without increasing safety end points.

Objective randomised blinded investigation of therapeutic ablation versus cardioversion for persistent atrial fibrillation- outcomes of the feasibility

Abstract Background Patients with persistent atrial fibrillation (pers.AF) commonly undergo catheter ablation (CA) for symptom relief and improved quality of life(QoL). However,the benefits of CA compared to DC cardioversion (DCCV) or medical therapy lack substantial evidence from blinded randomized trials. Purpose Conducting such a large-scale trial presents substantial challenges in terms of recruitment, maintaining blinding, and implementation.To address this, we conducted a pilot study prior to a definitive larger study. Methods This feasibility trial is a single-centre, prospective, randomised, double-blinded placebo control study. Patients with early pers AF (<2 years) eligible for pulmonary vein isolation (PVI) or DCCV were enrolled. Twenty patients were recruited, accounting for 10% of the proposed larger trial based on power calculation. The intervention arm (PVI + DCCV) and placebo arm (Placebo + DCCV) were randomised in a 1:1 manner after ultrasound-guided vascular access with local anaesthetic and deep sedation (Midazolam + opioid). All procedures were performed as day cases on uninterrupted oral anticoagulation. Phrenic nerve pacing was performed in the Placebo group, mimicking lab interactions and fluoroscopy system movements. Implantable loop monitors were inserted immediately after heparin reversal and groin sheath removal. A 6-week(wk) blanking period was observed post-procedure. Blinding was assessed using Bang's blinding index (BI) for both patients and medical staff and a successful blinding is considered BI between -0.2 to 0.2. Health-related quality of life (HRQoL) was evaluated using SF12, EQ5D-5L, and AF PROMS. The study obtained ethical approval (REC ref 19/LO/0775),adhered to the principles of the Declaration of Helsinki,and obtained written informed consent from all participants. Results A remarkable 92% of patients approached, expressed a willingness to participate in the study. Procedure time and time to discharge were similar between groups. The study successfully achieved blinding among the patients at day0 (BI = PVI-0.2 vs placebo- 0) and was maintained throughout the 6-wk and 3M follow-up, among the patients as well as clinical staff. HRQoL improved in the active group in terms of AF PROMS [Improved difference from baseline PVI 23 (±22); vs Placebo 2 (±10), p=<0.001 and SF-12 mental component (MCS) at 12M (PVI 11.8 (±11) vs placebo 8.54(±11.5), p= 0.017). Over a follow up period of 12M, there was a trend towards greater recurrence (60% vs 30%; p=0.07) and repeat procedures (70% vs 40%; p=0.4) in the placebo group. Conclusion: Performing a blinded placebo-controlled interventional study to assess the efficacy of PVI is feasible and high recruitment rates are achievable. CA appears to result in better arrhythmic and QoL outcomes;a full-scale follow-on study will assess the true efficacy of CA in patients with early pers.AF and allow consideration of whether there is a role for DCCV in many patients.

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

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. 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). 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.

Duration of atrial fibrillation persistence: Implications for recurrence risk after catheter ablation and efficacy of additional substrate ablation

BackgroundThe optimal duration of atrial fibrillation (AF) persistence for predicting poor outcomes after catheter ablation of long-standing AF (LsAF) and the best ablation strategy for these patients remain unclear. ObjectiveWe aimed to assess the impact of the duration of AF persistence on outcomes after catheter ablation of AF. MethodsWe analyzed the Efficacy of Pulmonary Vein Isolation Alone in Patients with Persistent Atrial Fibrillation (EARNEST-PVI) trial data comparing pulmonary vein isolation (PVI) alone (PVI-alone) with additional linear ablation or defragmentation (PVI-plus) in persistent AF (PerAF). Patients who received catheter ablation by contact force–sensing catheter were enrolled in the study. In patients with LsAF, the optimal cutoff duration of AF persistence was evaluated. With use of the threshold, patients with LsAF were divided into 2 groups and compared with PerAF <1 year for arrhythmia-free survival after a 3-month blanking period. ResultsThe optimal cutoff duration was 2.4 years. Of 458 patients, arrhythmia-free survival rates for LsAF 1–2.4 years were comparable to those of PerAF (hazard ratio [HR], 1.01; 95% CI, 0.67–1.52). However, LsAF >2.4 years had a higher recurrence risk than PerAF (HR, 2.22; 95% CI, 1.42–3.47). In LsAF >2.4 years, the PVI-plus strategy showed advantages over the PVI-alone strategy (HR, 0.36; 95% CI, 0.14–0.89). However, the interaction effect between LsAF 1–2.4 years and LsAF >2.4 years did not reach statistical significance (P = .116). ConclusionWhereas LsAF 1–2.4 years has similar outcomes to those of PerAF, LsAF >2.4 years was linked to higher arrhythmia recurrence risks. For LsAF >2.4 years, the PVI-plus strategy showed a potential to be superior to the PVI-alone strategy.

Mapping Atrial Fibrillation Drivers.

Understanding the initiating role of pulmonary veins in atrial fibrillation (AF) has led to the development of pulmonary vein isolation (PVI). The efficacy of PVI is high for paroxysmal AF, whereas it is limited for non-paroxysmal AF. This fact highlights the necessity of understanding the mechanism through which AF is maintained, to develop ablation strategies that would be required in addition to the PVI. Mapping AF in animal models and humans has led to the identification of focal or rotational drivers. New technologies have been developed to identify those AF drivers and are used as a guide for catheter ablation. This review article aims to provide a comprehensive overview of the current state of knowledge regarding AF drivers and the various mapping approaches used to identify them.

Methods and techniques for increasing the safety and efficacy of pulmonary vein isolation in patients with atrial fibrillation.

The most common type of sustained arrhythmia is atrial fibrillation (AF). Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation for atrial fibrillation, which has emerged as the primary therapeutic strategy for atrial fibrillation patients. Unfortunately, about one-third of patients experience recurrent atrial arrhythmias after the procedure.

Long-Term Impact of Additional Ablation After Pulmonary Vein Isolation: Results From EARNEST-PVI Trial.

Background An optimal strategy for left atrial ablation in addition to pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) has not been determined. Methods and Results We conducted an extended follow-up of the multicenter randomized controlled EARNEST-PVI (Efficacy of Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation) trial, which compared 12-month rhythm outcomes in patients with persistent AF between patients randomized to a PVI-alone strategy (n=248) or PVI-plus strategy (n=248; PVI followed by left atrial additional ablation, including linear ablation or ablation targeting areas with complex fractionated electrograms). The present study extended the follow-up period to 3 years after enrollment. Outcomes were compared not only between randomly allocated groups but also between on-treatment groups categorized by actually created ablation lesions. Recurrence rate of AF or atrial tachycardia (AT) was lower in the randomly allocated to PVI-plus group than the PVI-alone group (29.0% versus 37.5%, P=0.036). On-treatment analysis revealed that patients with PVI+linear ablation (n=205) demonstrated a lower AF/AT recurrence rate than those with PVI only (26.3% versus 37.8%, P=0.007). In contrast, patients with PVI+complex fractionated electrograms ablation (n=37) had an AF/AT recurrence rate comparable to that of patients with PVI only (40.5% versus 37.8%, P=0.76). At second ablation in 126 patients with AF/AT recurrence, ATs excluding common atrial flutter were more frequent in patients with PVI+linear ablation than in those with PVI only (32.6% versus 5.7%, P<0.0001). Conclusions Left atrial ablation in addition to PVI was efficacious during 3-year follow-up. Linear ablation was superior to other ablation strategies but may increase iatrogenic ATs. Registration URL: http://www.umin.ac.jp/ctr/index-j.htm; Unique identifier: UMIN000019449.

Safety and efficacy of pulmonary vein isolation using pulsed field ablation with or without 3D mapping system for paroxysmal atrial fibrillation

Abstract Funding Acknowledgements Type of funding sources: None. Background Pulsed field ablation (PFA) has recently been introduced as a novel routine ablation technology for paroxysmal atrial fibrillation (PAF). PFA can be performed "cryo-style" using fluoroscopy only, or additional pre- and post-ablation high-density 3D bipolar voltage maps can be performed to assess lesion formation and acute pulmonary vein isolation. We compared 6-month outcome after PFA using fluoroscopy only (X-ray) vs. PFA guided by 3D mapping (3D). Methods In PAF patients, PVI in conscious sedation using a steerable sheath and a pentaspline over-the-wire basket and flower PFA catheter was performed. In a subset of patients, pre- and post-ablation high-density bipolar voltage 3D maps (Carto 3D) were performed. Procedural parameters, acute success, in-hospital safety and arrhythmia recurrence were assessed over 6-month follow-up. Efficacy was evaluated by freedom from a ≥ 30-sec. recurrence of AF/atrial flutter (AFL)/atrial tachycardia (AT). Follow-up included 7-day Holter ECGs and/or telephonic interviews at days 90 and 180 after ablation. Results This study included a total of 101 patients (mean age: 65±10 years; 42% female) in whom 6-month follow-up data were available. There were no selection criteria for the use of 3D mapping. Pre- and post-ablation high-density maps were performed in 34/101 (34%) of patients. Mean CHA2DS2-VASc-score was 2,1±1,6. Median duration since first AF diagnosis was 21 [3-60] months. Skin-to skin procedure time was 56±20 in the X-ray group vs. 118±22 min in the 3D group, respectively (p&amp;lt;0,0001). Fluoroscopy time was 17±7 in the X-ray group vs. 21±6 in the 3D group, respectively (p&amp;lt;0,01). Acute pulmonary vein isolation rate was 100% in both groups. Primary adverse events occurred in 0% of patients in the X-ray group vs. 2/34 (6%) in the 3D group (2 pericardial tamponades), respectively (p=ns). During a mean follow-up of 204±82 days, 54/67 (81%) in the X-ray group vs. 27/34 (79%) in the 3D group remained free of any symptomatic or documented AF/AFL/AT episode after a single procedure (p=ns). In 4/13 (31%) patients in the X-ray group, a re-do procedure was performed, 2 patients had durable PVI with typical or atypical atrial flutter, 1 patient had reconnection of both posterior carinae and 1 patient had typical atrial flutter degenerating in AF. In 3/7 (43%) patients in the 3D group, a re-do procedure was performed, 2 patients had durable PVI with typical or atypical atrial flutter and 1 patient had reconnection of the LIPV. Conclusions PVI using PFA with or without 3D mapping system resulted in a similar 6-month atrial arrhythmia recurrence rate and safety profile. Procedure and fluoroscopy times were significantly shorter in the fluoroscopy only group.

High efficacy single catheter standardized workflow for radiofrequency ablation of atrial fibrillation in the high-power short-duration era

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): Dr. Valeriano and Dr. Fabbricatore have been supported by a research grant provided by the Cardiopath PhD program (University of Naples Federico II) Background Recent developments in radiofrequency (RF) ablation technologies have improved the efficacy of pulmonary vein isolation (PVI). The combination of the ablation index, lesion tags, and optimized inter-lesion distance (CLOSE protocol) has further reduced the incidence of gaps along the ablation lines. This high acute success rate challenged the use of conventional circular mapping catheters and prompted a single catheter-approach ablation strategy. Modulating the relationship between resistive and conductive heating, high-power short-duration (HPSD) ablation technology can potentially increase lesion-to-lesion consistency. A novel catheter with optimized temperature control and microelectrodes has been recently designed to further improve workflow efficiency. Purpose: This study aimed to assess the efficacy and efficiency of HPSD ablation in a standardized single-catheter workflow for PVI. Methods: Data on consecutive AF ablations performed with HPSD catheter from December 2020 to December 2021 at a single tertiary-care center were prospectively collected. The workflow consisted of a procedure sequence including single transeptal access with a bidirectional steerable sheath, 3D modeling with 3D rotational angiography, assessment of PV potentials with microelectrodes in each vein (figure 1), followed by radiofrequency encircling of the PVs using a high-power setting of 50W in a temperature- and flow-controlled mode with CLOSE-guided protocol. Isolation was validated by reassessing the previously observed PV potentials and by pacing within the lesion set. Results: A total of 73 consecutive AF patients (67% paroxysmal, 33% persistent) were included. All patients received PVI, 15 underwent additional cavotricuspid isthmus ablation and 6 received additional treatments (table 1). Mean procedure time was 68±27 min with minimal fluoroscopy time and dose (3.2±2.1 min; 4.7±3.9 Gycm2). Complications were infrequent with 1 cardiac tamponade and 1 pericarditis. First-pass isolation was achieved in 91% of the circles and validation by microelectrodes successfully identified the residual gaps with 100% of acute procedural success. In a selected cohort of 20 patients with paroxysmal AF undergoing PVI-only procedure performed by an expert operator, the ablation time was 22.8±5.1 min with a skin-to-skin time of 47.3±7.1 min (table 2). The median follow-up duration was 397 days (IQR: 367-462). AT/AF free survival rate was 90% at 12 months. Conclusions: HPSD ablation using a standardized single-catheter workflow improved the procedural efficiency of PVI and resulted in a high rate of first-pass isolation with a low recurrence rate at 12-month follow-up.

Pulsed field ablation in real-life atrial fibrillation patients: 1-year clinical recurrence, operator learning curve and re-do procedural findings

Abstract Funding Acknowledgements Type of funding sources: None. Pulsed field ablation (PFA) is a novel method of cardiac ablation demonstrated in early preclinical and clinical settings. The aim of this study was to report the safety and clinical efficacy of pulmonary vein isolation (PVI) with PFA for real-world atrial fibrillation (AF) patients. Methods and results All-comer AF patients (n=121, 59% paroxysmal) were prospectively included and underwent PFA with 100% HD voltage maps performed after PVI. PVI was achieved with PFA-only in 119 (98%) of the cases. During the implementation phase the mean procedure and fluoroscopy time was reduced from 85 ± 34 to 72 ± 18 minutes (p=0.044) and 22 ±9 to 16 ±4 (p=0.034). We observed one phrenic nerve palsy with only partial remission at follow-up. Other adverse events were numerically comparable to standard PVI procedures. Over a mean follow-up of 308 ± 87 days a total of 22/121 (18.2%) cases experienced clinically significant recurrence or initiation of anti-arrhythmic drugs with Kaplan-Meier event-free estimate at 365 days of 80% (88% for paroxysmal versus 69% for persistent) Figure 1. HD mapping post-PVI showed insufficient acute lesion formation in up to 20% (60% of these right sided) resulting in additional PFA for sufficient isolation. In four of six re-do procedures significant gaps were located at the right pulmonary veins. Conclusion PFA was a highly efficient method to achieve PVI with reductions in procedure time and fluoroscopy over the implementation period. The safety, procedural data and clinical recurrence rates from initial trials were confirmed in real-life non-selected AF patients. More data is needed to investigate and understand the lesion durability and limitations of PFA.

Is pulmonary vein isolation using pulse field ablation safe and efficient ? data from a prospective registry

Abstract Funding Acknowledgements Type of funding sources: None. Background Pulsed field ablation (PFA) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. As the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while sparing adjacent tissues. This new ablation modality could increase the safety of pulmonary vein isolation (PVI) procedures compared to PVI using thermal energies. Real-life clinical data are still limited regarding safety and efficacy of PFA. Purpose To assess safety and mid-term efficacy of PVI performed using PFA. Methods We included all patients who underwent PVI for symptomatic atrial fibrillation (AF) using PFA in our hospital between June 2021 and June 2022. All procedures were performed under general anaesthesia. After patients received IV heparin and achieved ACT &amp;gt; 300 s, a 12 Fr multi-electrode pentaspline PFA catheter was advanced through a 13 Fr deflectable sheath into the left atrium. The catheter was positioned so that the splines achieved circumferential contact at the PV antra. Two applications (2.5 sec and 2 kV per application) were performed in "basket" configuration, then the catheter was slightly rotated (30-40°) before delivery of 2 additional applications. This sequence of ablation was repeated in "flower" configuration. This protocol was applied at each pulmonary vein. PVI was assessed with the PFA catheter. A 24-hour holter monitoring was performed at 4-month and one-year follow-up. Results The population consisted of 102 patients (73 paroxysmal AF, 29 persistent AF) with a mean age of 56 ± 13 yo. The mean procedure duration was 38 ± 9 min, and mean fluoroscopy duration was 8 ± 4 min (4 ± 4.2 Gy.cm2). The pulmonary vein signal completely disappeared after the first PFA application for each targeted vein and PVI was confirmed for all veins in all patients at the end of the procedure. Pericardial effusion requiring percutaneous drainage occurred in 1 patient during the early phase of our experience (patient n°8). There was no other complication. At 4-month follow-up, 91/102 patients (89%) were asymptomatic with no recurrence of AF. At one-year follow-up, 34/38 patients (89%) had no reccurence of documented atrial arrhythmia. 6 patients underwent a redo procedure : pulmonary vein reconnection was observed in 4/6. Conclusion PVI performed with PFA appeared safe and efficient with short procedure and acceptable fluoroscopy durations. Further data are required regarding long-term efficacy.

AB-453068-2 IS PULMONARY VEIN ISOLATION USING PULSE FIELD ABLATION SAFE AND EFFICIENT ? DATA FROM A PROSPECTIVE REGISTRY

Pulsed field ablation (PFA) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. As the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while sparing adjacent tissues. This new ablation modality could increase the safety of pulmonary vein isolation (PVI) procedures compared to PVI using thermal energies. Real-life clinical data are still limited regarding safety and efficacy of PFA. To assess safety and mid-term efficacy of PVI performed using PFA. We included all patients who underwent PVI for symptomatic atrial fibrillation (AF) using PFA in our hospital between June 2021 and June 2022. All procedures were performed under general anaesthesia. After patients received IV heparin and achieved ACT > 300 s, a 12 Fr multi-electrode pentaspline PFA catheter was advanced through a 13 Fr deflectable sheath into the left atrium. The catheter was positioned so that the splines achieved circumferential contact at the PV antra. Two applications (2.5 sec and 2 kV per application) were performed in "basket" configuration, then the catheter was slightly rotated (30-40°) before delivery of 2 additional applications. This sequence of ablation was repeated in "flower" configuration. This protocol was applied at each pulmonary vein. PVI was assessed with the PFA catheter. A 24-hour holter monitoring was performed at 4-month and one-year follow-up. The population consisted of 102 patients (73 paroxysmal AF, 29 persistent AF) with a mean age of 56 ± 13 yo. The mean procedure duration was 38 ± 9 min, and mean fluoroscopy duration was 8±4 min (4±4.2 Gy.cm2). The pulmonary vein signal completely disappeared after the first PFA application for each targeted vein and PVI was confirmed for all veins in all patients at the end of the procedure. Pericardial effusion requiring percutaneous drainage occurred in 1 patient during the early phase of our experience (patient n°8). There was no other complication. At 4-month follow-up, 91/102 patients (89%) were asymptomatic with no recurrence of AF. At one-year follow-up, 34/38 patients (89%) had no reccurence of documented atrial arrhythmia. 6 patients underwent a redo procedure : pulmonary vein reconnection was observed in 4/6. PVI performed with PFA appeared safe and efficient with short procedure and acceptable fluoroscopy durations.

PO-02-125 EVALUATION OF A GENOME-WIDE AND PITX2 POLYGENIC RISK SCORE FOR THE PREDICTION OF ATRIAL FIBRILLATION RECURRENCE AFTER PULMONARY VEIN ISOLATION

Polygenic risk scores (PRS) were recently shown to be associated with preexisting atrial fibrillation (AF) and to be predictive of incident AF. Previous studies using limited PRS to predict recurrent AF following pulmonary vein isolation (PVI) showed inconsistent results. We sought to evaluate the association of PRS with AF recurrence following ablation using a genome-wide PRS combining >6 million single nucleotide polymorphisms (PRSAF) and, in a secondary analysis, a PRS limited to a locus involved in pulmonary vein development comprising the PITX2 gene (PRSPITX2). To assess whether a genome-wide PRS was associated with time to recurrence of atrial arrhythmia following a first PVI. We included patients from our hospital biobank who underwent genome-wide array genotyping and imputation, had successful PVI performed in our center with at least 1 year of follow-up and absence of moderate-severe structural heart disease. We computed PRSAF and PRSPITX2 using weights from Khera et al (PRS catalog ID PGS000016) and assessed their association with time to first atrial arrhythmia recurrence following a blanking period of 90 days using Cox proportional hazards models (including covariables listed in table 1). A total of 411 patients in our biobank were identified to have had PVI for paroxysmal or persistent AF between 2002 and 2020. Of these, 342 met inclusion criteria (fig. 1A). Over a median follow-up time of 6.06 years (IQR 2.73-10.2), a total of 218 patients (62%) experienced atrial arrhythmia recurrence (fig. 1C). AF type (persistent vs. paroxysmal) and left atrial diameter were significantly associated with arrhythmia recurrence in univariate and multivariate analyses (table 1). Neither PRSAF (fig. 1B) nor PRSPITX2 were associated with the primary endpoint (HR 1.04, p=0.6 and HR 1.02, p=0.8, respectively). Furthermore, neither PRS was associated with recurrence in a subgroup analysis restricted to 287 patients with paroxysmal AF. A genome-wide PRS comprised of >6million markers and a targeted PITX2 PRS were not significantly associated with time to first atrial arrhythmia recurrence following a first acutely successful PVI for paroxysmal or persistent AF. These findings are in line with recent studies assessing a limited PRS. Further studies are required to explore the potential role of genetic susceptibility to AF in predicting AF recurrence in the absence of pulmonary vein reconnection and in predicting AF burden as an endpoint for PVI efficacy.

Comparison of efficacy of pulmonary vein isolation between cryoballoon ablation and high-power short-duration ablation

BackgroundHigh-power short-duration (HPSD) and cryoballoon ablation (CBA) has been used for pulmonary vein isolation (PVI). ObjectiveWe aimed to compare the efficacy of PVI between CBA and HPSD ablation in patients with paroxysmal atrial fibrillation (PAF). MethodsWe retrospectively analyzed 251 consecutive PAF patients from January 2018 to July 2020. Of them, 124 patients (mean age 57.2 ± 10.1 year) received HPSD and 127 patients (mean age 59.6 ± 9.4 year) received CBA. In HPSD group, the radiofrequency energy was set as 50 W/10 s at anterior wall and 40 W/10 s at posterior wall. In CBA group, 28 mm s generation cryoballoon was used for PVI according the guidelines. ResultsThere was no significant difference in baseline characteristics between these 2 groups. The time to achieve PVI was significantly shorter in cryoballoon ablation group than in HPSD group (20.6 ± 1.7 min vs 51.8 ± 36.3, P = 0.001). The 6-month overall recurrence for atrial tachyarrhythmias was not significantly different between the two groups (HPSD:14.50% vs CBA:11.0%, P = 0.40). There were different types of recurrent atrial tachyarrhythmia between these 2 groups. Recurrence as atrial flutter was significantly more common in CBA group compared to HPSD group (57.1% vs 12.5%, P = 0.04). ConclusionIn PAF patients, CBA and HPSD had a favourable and comparable outcome. The recurrence pattern was different between CBA and HPSD groups.

A Pilot Trial to Compare the Long-Term Efficacy of Pulmonary Vein Isolation with High-Power Short-Duration Radiofrequency Versus Laser Energy with Rapid Ablation Mode.

Pulmonary vein (PV) reconnection is the major cause of atrial fibrillation (AF) recurrence after pulmonary vein isolation (PVI). The probability of reconnection is higher if the primary lesion is not sufficiently effective, which can be unmasked with an adenosine provocation test (APT). High-power short-duration radiofrequency energy (HPSD) guided with ablation index (AI) and the third generation of the visually guided laser balloon (VGLB) are new methods for PVI. A total of 70 participants (35 in each group) who underwent a PVI with either AI-guided HPSD (50 W; AI 500 for the anterior and 400 for the posterior wall, respectively) or VGLB ablation were included in this observational pilot trial. Twenty minutes after each PVI, an APT was performed. The primary endpoint was the event-free survival from AF after three years. A total of 137 (100%) PVs in the HPSD arm and 131 PVs (98.5%) in the VGLB arm were initially successfully isolated (p = 0.24). The overall procedure duration was similar in both arms (155 ± 39 in HPSD vs. 175 ± 58 min in VGLB, p = 0.191). Fluoroscopy time, left atrial dwelling time and duration from the first to the last ablation were longer in the VGLB arm (23 ± 8 vs. 12 ± 3 min, p < 0.001; 157 (111-185) vs. 134 (104-154) min, p = 0.049; 92(59-108) vs. 72 (43-85) min, p = 0.010). A total of 127 (93%) in the HPSD arm and 126 (95%) PVs in the VGLB arm remained isolated after APT (p = 0.34). The primary endpoint was met 1107 ± 68 days after ablation in 71% vs. 66% in the VGLB and HPSD arms, respectively (p = 0.65). HPSD and VGLB did not differ with respect to long-term outcome of PVI. A large, randomized study should be conducted to compare clinical outcomes with respect to these new ablation techniques.

Pulsed field ablation in real-world atrial fibrillation patients: clinical recurrence, operator learning curve and re-do procedural findings.

Pulsed field ablation (PFA) is a novel method of cardiac ablation demonstrated in early pre-clinical and clinical settings. The aim of this study was to report the safety and clinical efficacy of pulmonary vein isolation (PVI) with PFA for real-world atrial fibrillation (AF) patients. All-comer AF patients (n = 121, 59% paroxysmal) were prospectively included and underwent PFA with 100% high-density voltage maps performed after PVI. Clinical outcomes were gathered by chart review. PVI was achieved with PFA-only in 119 (98%) of the cases. During the implementation phase the mean procedure and fluoroscopy time was reduced from 85 ± 34 to 72 ± 18min (p = 0.044) and 22 ± 9 to 16 ± 4 (p = 0.034). We observed one phrenic nerve palsy with only partial remission at follow-up. Other adverse events were numerically comparable to standard PVI procedures. Over a mean follow-up of 308 ± 87days, a total of 22/121 (18.2%) cases experienced clinically significant recurrence or initiation of anti-arrhythmic drugs with Kaplan-Meier event-free estimate at 365days of 80% (88% for paroxysmal versus 69% for persistent). In five of eight re-do procedures, gaps were primarily located at the right pulmonary veins. PFA was a highly efficient method to achieve PVI with reductions in procedure time and fluoroscopy over the implementation period. The procedural data and clinical recurrence rates from initial trials were confirmed in real-life non-selected AF patients. More data is needed to establish lesion durability and limitations of PFA.

Persistent Atrial Fibrillation in Elderly Patients: Limited Efficacy of Pulmonary Vein Isolation.

(1) Background: Cryoballoon pulmonary vein isolation (cryoPVI) is established for symptomatic paroxysmal atrial fibrillation (AF) treatment, but its value in persistent AF is less clear. In particular, limited data are available on its efficacy in elderly patients (≥75 years) with persistent AF. Age is an important modifier of AF progression and represents a risk-factor for AF recurrence. (2) Methods: Prospective, single-center observational study to evaluate the impact of age on efficacy and safety of cryoPVI in elderly patients. Primary efficacy endpoint was symptomatic AF recurrence after 90-day blanking period. Primary safety endpoints were death from any cause, procedure-associated complications or stroke/transient ischemic attack. Median follow-up was 17 months (range 3–24). (3) Results: We included 268 patients with persistent AF (94 ≥ 75 years of age). Multivariate Cox regression analysis identified age as the only independent factor influencing AF recurrence in the overall cohort (p = 0.006). To minimize confounding bias in efficacy and safety analysis of cryoPVI, we matched younger and elderly patients with respect to baseline characteristics. At 24 months, primary efficacy endpoint occurred in 13/69 patients <75 years and 31/69 patients ≥75 years of age (24 months Kaplan–Meier event-rate estimates, HR 0.34; 95% CI, 0.19 to 0.62; log-rank p = 0.0004). No differences were observed in the occurrence of safety end points. (4) Conclusions: Elderly (≥75 years) patients with persistent AF undergoing cryoPVI had an approximately threefold higher risk of symptomatic AF recurrence than matched younger patients. Accordingly, other treatment modalities may be evaluated in this population.

Pulmonary Vein Isolation in Obese Compared to Non-Obese Patients: Real-Life Experience from a Large Tertiary Center.

1. Introduction: Pulmonary vein isolation (PVI) is an established procedure used to achieve rhythm control in atrial fibrillation (AF). In obese patients (pts), in whom AF occurs more frequently, a reduced effectiveness of PVI has been observed. Therefore, this study’s aim was to compare the long-term efficacy of PVI between obese and non-obese patients. 2. Methods: We enrolled 111 consecutive pts with a body mass index (BMI) of >30 kg/m2 undergoing PVI from our large registry. Procedural data and outcomes were compared with a matched group of 115 non-obese PVI pts and the long-term outcomes were analyzed. 3. Results: Overall follow-up duration was 314 patient-years in the obese and 378 patient-years in the non-obese group. The follow-up rate was 71% in the obese and 76% in the non-obese group. In both groups, their AF-characteristics did not differ significantly, while known risk factors were significantly more prevalent in the obese group. Procedural characteristics were similar in both groups. During follow-up, the obese pts demonstrated significant weight loss compared to the non-obese pts, while at the same time, the overall recurrence rate during follow-up did not differ significantly between both groups (obese: 39.2% and non-obese: 43.7%). PVI related and long-term complications were comparable between both groups. In the univariate analysis, obesity was not found to be associated with an increased AF recurrence risk. 4. Conclusion: These real-life data demonstrate that obese pts may not show higher AF recurrence rates after PVI compared to pts with normal body weight. Furthermore, PVI was found to be safe and effective in obese patients; thus, a BMI alone may not be a criterion for refusal of PVI.

Twelve-month efficacy of second-generation cryoballoon ablation for atrial fibrillation performed at community hospitals: results of the German register on cryoballoon ablation in local hospitals (regional).

The 12-month follow-up (F/U) efficacy of CBA PVI performed at community hospitals for treatment of symptomatic paroxysmal and persistent atrial fibrillation (AF) is unknown. This study determined the 12-month efficacy of pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) performed at community hospitals with limited annual case numbers. This registry study included 983 consecutive patients (pts) from 19 hospitals, each with an annual procedural volume of < 100 PVI procedures/year. Pts underwent CBA PVI for paroxysmal AF (n = 520), persistent AF (n = 423), or redo PVI (n = 40). The primary endpoint was frequency of documented recurrent AF, the occurrence of atrial flutter or tachycardia following a 90-day period after the index ablation and up to 12months. The frequency of repeat ablation was determined. Isolation of all PVs was documented in 98% of pts at the end of the procedure. Twelve-month F/U data could be obtained in 916 pts. A 24-h ECG registration was performed in 641 pts (70.0%); in 107 pts (16.7%) of them, recurrent AF was documented. The primary endpoint was met in 193 F/U pts (21.1%). It occurred in 80/486 F/U pts with paroxysmal AF (16.4%), and in 107/390 F/U pts with persistent AF (27.4%). Redo PVI was performed in 71 pts (7.8%), and atrial flutter ablation was performed in 12 pts (1.4%). CBA PVI for paroxysmal or persistent AF can be performed at community hospitals with adequate rates of 12-month symptom freedom and arrhythmia recurrence. The study was registered at the German register of clinical studies (DRKS00016504).