bluuebunny/crossref_metadata_2025 huggingface dataset:
First comparison of single-tip versus single-shot pulsed field ablation for pulmonary vein isolation in paroxysmal atrial fibrillation: interim analysis of a randomized trial
Authors: Hartl S , Reinsch N , Fueting A , Neven K
Published: May 2024

Background

Non-thermal pulsed field ablation (PFA) is an emerging technology to perform pulmonary vein isolation (PVI) for atrial fibrillation (AF). Different PFA systems are available, but no comparative data exist.

Purpose

Randomized trial to compare single-tip versus single-shot PFA for initial PVI in paroxysmal AF patients.

Methods

In this single-center trial, paroxysmal AF patients are prospectively enrolled and 1:1 randomized in the single-tip or single-shot PFA group. Single-tip PVI is performed using a PFA generator and a 3.5mm contact-force enabled ablation catheter guided by 3D mapping system. The pulsed electric field dosing is 25 Ampere (A) (anterior) and 22 A (posterior), respectively. In the single-shot PVI group, a 31 or 35mm pentaspline PFA catheter is used for fluoroscopy-guided PVI. Eight PFA applications (2.0 kV) are applied per PV. In this interim analysis, acute efficacy, safety and short term clinical outcome within the 3 months blanking period were assessed. A subset of patients underwent cerebral MRI to detect silent lesions.

Results

To date, 50 patients were enrolled and underwent PVI in conscious sedation (25 single-tip, 25 single-shot, 63 ± 5 years, 42% female, CHA2DS2-VASc 2 [1-3]). There were no differences in baseline characteristics. Acute PVI was achieved in 100%. In the single-tip group, total procedure time was significantly longer (125 ± 31 min vs. 44 ± 12 min, p <0.001) and fluoroscopy time was significantly shorter (4 ± 2 min vs. 15 ± 6 min, p <0.001) as compared to the single-shot group. One groin hematoma was noted in the single-shot group. In the single-tip group, 1 aneurysm spurium was detected and 1 pericardial tamponade requiring drainage resulted from coughing during single-tip PFA while no real-time visualization of the catheter was available. No permanent sequelae occurred. There were no PFA specific complications and no cerebral embolisms were detected in all 14 MRI scans. At 3 months, 92% (single-shot group) and 80% in the single-tip group were free from arrhythmia (p=0.42). AF recurrences in the blanking period occurred in 2 patients in the single-shot group and in 5 patients in the single-tip group after a median of 2 [1-5] days following the procedure.

Conclusions

In this interim analysis of a randomized trial, single-shot or single-tip PFA for PVI both demonstrated high acute efficacy and a favourable 3 months clinical outcome. Procedural time was significantly longer in the single-tip PFA group. No silent lesions were detected in cerebral MRI. Non-availability of real-time visualization and contact-force information of the single-tip ablation catheter during energy application is a current technical limitation that could be associated with complications.
Very high-power short duration ablation metrics predictors of successful pulmonary vein isolation in atrial fibrillation ablation
Authors: Rauber M , Manninger M , Scherr D
Published: May 2024

Background

Previous studies have shown that very high-power short duration (vHPSD) is a safe ablation modality, with similar rate of first pass isolation (FPI) but faster ablation times compared to standard CLOSE protocol guided ablation. While CLOSE protocol uses ablation index to guide energy titration no such index exists for vHPSD ablations yet.

Purpose

Our aim was to evaluate ablation metrics as predictors of FPI in atrial fibrillation ablation (AF) using vHPSD ablation modality.

Methods

In a single centre retrospective analysis, we analysed consecutive patients treated for paroxysmal (PAF) or persistent atrial fibrillation (PeAF) with PVI using vHPSD ablation from May 2021 to January 2023. We excluded patients with previous PVI procedures. The analysis was done via a cloud-based commercially available ablation analysis tool CARTONET. We analysed catheter stability, average contact force, absolute impedance drop, number of ablations and cumulative ablation time in relation to first pass isolation (FAAVI – first attempt all veins isolated).

Results

This is the first larger data study to evaluate ablation metrics in vHPSD using commercially available CARTONET (Figure 1). Based on the inclusion criteria 150 patients were included in the analysis. Baseline characteristics and procedural metrics are presented in Figure 2 - Table. We observed a numerical trend towards higher FAAVI rate with increasing patients number (p=0.10). Complication rate was low (1 pericardial effusion requiring drainage and 1 vascular access site complication).

Ablation metrics analysis yielded statistical differences between FAAVI and no FAAVI groups (Figure 2 - Table). Multivariate analysis identified average contact force (odds ratio (OR) 1.001; 95% confidence interval (CI): 0.999-1.003; p=0.047) and catheter stability (OR 0.985; 95% CI: 0.973-0.997; p=0.019) to be independent predictors of FAAVI. Additionally, number of applications (OR 1.000; 95% CI: 0.999-1.000; p=0.042) and total ablation time (OR 0.995; 95% CI: 0.991-0.999; p=0.021) were also independent predictors of FAAVI, possibly indicating larger vein and/or ablation circumferent line to be predictive of no FAAVI.

Catheter stability of less than 1.16mm (AUC 0.61; p=0.015) was shown to be discriminative of FAAVI, however discrimination value was poor. Average contact force was not discriminative of FAAVI (AUC 0.58; p=0.105) in our patient cohort.

Conclusion

Average contact force and catheter stability were predictive of first pass isolation, however only catheter stability was discriminative of FAAVI. Larger data with standardised ablation protocol (interlesion distance) and wider range of ablation metrics is needed to corroborate and further build on these early findings.
Pacemaker dependency after Cox Maze procedure concomitant with cardiac surgery, The road between Scylla and Charybdis
Authors: Hassan M , Keller D , Radakovic D , Madrahimov N , Leyh R , Bening C
Published: May 2024

Background

The Cox Maze (CM) procedure is a well-established treatment for atrial fibrillation. However, recent trials report alarming rates of pacemaker implantation (PMI) during hospitalization after CM. As PMI, generator replacement and Lead management are sometimes accompanied by complications, such as infection or bleeding and represent a burden for patients and healthcare systems. We thought to investigate the rates of pacemaker dependency 6 months after pacemaker implantation regarding the applied energy source and the performed lesion set, to determine whether PPM implantation timing and specific conduction disturbances as indications are associated with late pacemaker dependency.

Methods

We performed a retrospective review of 3695 patients underwent elective cardiac surgery in our institution between the years 2005 and 2022. Patients who use of devices for rhythm control, resynchronisation therapy, implantablecardioverter defibrillator (ICD) or both were excluded from the present study. A total of 283 patients met the inclusion criteria; Various energy sources, including cryoablation (n= 123) and radiofrequency (n= 160) were used. Left atrial (n= 228) and biatrial (n= 55) ablation was performed The distribution of the preoperative and perioperative variables was similar.

Results

There was no statistical difference in the incidence pacemaker dependency regarding the applied energy source whether radiofrequencyablation or cryoablation (25% vs. 30%; p = 0.2 respectively). On the other hand, biatrial ablation led to a significant pacemaker dependency rate compared with isolated left-sided ablation (78,2% vs 14.9%; P = .001 respectively), moreover Sinus node dysfunction as indication for PPM implantation was predictive of being not PPM dependent (OR 6.59; 95% CI, 1.67-26.06; P = .007).

Conclusion

Concomitant CM procedure showed a pacemaker implantation rate of 7,4%. Univariate and multivariate analysis showed biatrial lesion set as the only statistically significant predictor for pacemaker dependency after CM procedure. Further large-scale randomized controlled studies are needed to elucidate the Impact of the CM on the late pacemaker dependency.
Single-shot simplified cardioneuroablation
Authors: Futyma P , Zarebski L , Futyma M , Kulakowski P
Published: May 2024

Introduction

Cardioneuroablation (CNA) is a promising therapy of a spectrum of arrhythmias dependent on increased activity of parasympathetic tone. The right anterior ganglionated plexus (RAGP), localized paraseptally between right atrium and right superior pulmonary vein, is frequently a primary target for CNA. Methods are sought to determine exact locations of RAGP to minimize ablation lesion set during CNA. Immediate and accurate intraprocedural visualization of RAGP area in patients undergoing CNA is desirable.

Methods

Consecutive patients who underwent right-atrial CNA for reflex syncope, symptomatic bradycardia or vagal atrial fibrillation were included into the study. After venous contrast injection a 3-dimensional rotational atrial scan (3DRAS) was used to obtain digital images. Next, manual segmentation (MS) of hypodense areas between the right atrium (RA) and the right superior pulmonary vein (RSPV) was performed to reconstruct RAGP. Using 3-dimensional mapping system such created 3D RAGP area visualisation was automatically synchronized with fluoroscopy and these sites were targeted for CNA. Heart rate (HR) acceleration ≥30% and ultra-short-term deceleration capacity (UST-DC) were used for determination of acute CNA outcomes.

Results

Five patients (3 males, age 37±17) underwent 3DRAS and MS of RAGP area during CNA. A single radiofrequency lesion was delivered in each patient (mean RF time - 33±15s, power - 25W). The mean procedure time was 40±13 minutes. Targeted HR acceleration was achieved in all patients (baseline HR vs post-CNA HR, 57±8bpm vs 93±11bpm; p=0.0007; mean HR acceleration 65±15%). UST-DC significantly decreased after CNA (pre-CNA UST-DC vs post-CNA UST-DC, 13.6ms vs 3.2ms, p=0.00096). There were no complications.

Conclusions

Single-shot simplified CNA is feasible. Visualization of RAGP area using 3DRAS and MS is safe, effective and can very rapidly delineate CNA target.Figure
Comparison of the novel radiofrequency-balloon and the cryo-balloon in pulmonary vein isolation
Authors: Teumer Y , Miesbichler C , Katov L , Melnic R , Bothner C , Rottbauer W , Weinmann-Emhardt K
Published: May 2024

Background

Balloon catheters are often used for pulmonary vein isolation (PVI) in atrial fibrillation (AF) because of their procedural efficiency. Apart from the established cryo-balloon (CB) catheter, there is a novel multi-electrode radiofrequency balloon catheter (RFB) with 3D mapping integration available. There is currently no data regarding a direct comparison of the RFB-PVI and the CB-PVI in a matched population.

Objective

Aim of this study was to assess the procedural data, the safety profile, and the outcome of the RFB-PVI and the CB-PVI.

Methods

This prospective registry study included patients with symptomatic paroxysmal or persistent AF, who underwent first-time PVI between January 2019 and April 2023, either with the RFB or the CB. For reduction of potential confounders patients were matched in a 1:2 ratio.

Results

In total 171 consecutive RFB patients and 342 matched CB patients were included. The baseline characteristics were comparable. The estimated recurrence free survival after 12 months was 81.3% in the RFB group and 76.8% in the CB group (p = 0.359). Longer procedural duration (p < 0.001) and longer fluoroscopy time was observed in the RFB group (p < 0.001). Except for the left inferior pulmonary vein, the single-shot isolation rate was comparable. In the RFB group no major complications occurred. In the CB group one transient ischemic attack, one pericardial tamponade, and two persistent phrenic nerve palsies occurred.

Conclusion

Although longer procedural duration was observed in the RFB group, both technologies enable an efficient and a safe PVI. Despite the 3D mapping integration of the RFB, no reduction in the fluoroscopy time was seen in comparison to the CB.
Lock Protocol : a new robust workflow for a very high first pass pulmonary vein isolation during atrial fibrillation ablation
Authors: Zarra S , Di Cori A , Zucchelli G , Parollo M , Segreti L , De Lucia R , Barletta V , Fiorentini F , Torre M , Canu A , Pistelli L
Published: May 2024

Introduction

Pulmonary vein isolation (PVI) is the gold standard for atrial fibrillation (AF) ablation. First pass PVI is often demanding when a raw geometry reconstruction is used in combination with an inaccurate automarks annotation, accounting for discontinuous or non-transmural lesions and related AF recurrences. We hypothesized that a magnetic-post processing of left atrial geometry in combination with an LSI-guided high power short duration (HPSD) automarks annotation could improve procedural efficiency.

Purpose

The aim of this study was to determine the impact on procedural outcomes of the new "Lock PVI protocol" during AF ablation with the new voxel mode EnSite X mapping system.

Methods

We included in the study consecutive patients with AF scheduled for pulmonary vein isolation (PVI) at our Departement between January 2021 and December 2022. Patients were divided in two Groups, the Lock-PVI Group and the control No Lock-PVI Group. The "Lock PVI" Group was ablated with the new Ensite X System using the new protocol, which consisted in (1) performing a road map with contact-force annotation at potential PVI sites after High Density reconstruction, (2) shaving the magnetic geometry reconstruction to unearth true 3D location of contact points, (3) Use of 3D-Automarks color-coded with a Lesion Index (LSI) target of 5.5 (anterior) and 4.5 (posterior) (4) Inter-lesion distance <6 mm (5) High Power Short Duration Approach (50 W). The No-Lock PVI was represented by patients ablated with and HPSD ablation with the previous version of the EnSite Precision mapping suit as per local standard practice. Groups were compared in term of procedural duration, radiological exposure and "first pass" isolation.

Results

Forty-four patients (22 "Lock PVI" and 22 controls mean age 63,3±8 years, 65,9% male, 47,7% persistent AF), for a total of 88 PVI circles were enrolled. Procedural duration was similar between approaches (121,1±43,6 vs 125,3±30,1 min; P=0,72) but RF time was shorter in the "Lock PVI" group (19,6±4 vs 29,55±9,1 min; P<0,001), although with with a longer fluoroscopy (19,5±10,1 vs 13,4±4,9 min; P=0,01). Of note, first pass isolation was significantly higher in the "Lock PVI" group: 40/44 (90,9%) vs 28/44 (63,6%) circles (P=0,002).

Conclusion

The new "Lock PVI" approach resulted in consistently better first-pass isolation (>90%) with less RF time when compared to standard of care PVI.Graphical AbstractLock PVI
Multielectrode catheter-based pulsed field ablation of persistent and long-standing persistent atrial fibrillation
Authors: Della Rocca D , Sorgente A , Pannone L , Stroker E , Vetta G , Doundoulakis I , Del Monte A , Mouram S , Mene R , Betancur A , Boveda S , Natale A , Sarkozy A , De Asmundis C , Chierchia G B
Published: May 2024

Background

Rhythm control of non-paroxysmal atrial fibrillation (AF) is significantly more challenging, as a result of arrhythmia perpetuation promoting atrial substrate changes and AF maintenance.

Purpose

We describe a tailored ablation strategy targeting multiple left atrial (LA) sites via the multielectrode FarawaveTM pulsed field ablation (PFA) catheter in patients with persistent AF sustained beyond 6 months (PerAF>6m) and long-standing persistent AF (LSPAF).

Methods

The ablation protocol included the following stages: pulmonary vein antral and posterior wall isolation plus anterior roof line ablation (Stage 1); electrogram-guided substrate ablation (Stage 2); atrial tachyarrhythmia (AT) regionalization and ablation (Stage 3).

Results

Seventy-two [age:68±10y, 61.1%males; AF history: 25 (18-45) months] patients with PerAF>6m (52.8%) and LSPAF (47.2%) underwent their first PFA via the FarapulseTM system. LA substrate ablation (Stage 1 and 2) led to AF termination in 95.8% of patients. AF termination occurred while ablating the mitral edge of the postero-lateral ridge (40.3%), the inferior left atrium above the proximal coronary sinus (27.4%), the interatrial septum (22.6%), the superior aspect of the postero-lateral ridge (6.5%), the base of the appendage (3.2%). AF organized into a left-sided atrial flutter (AFlu) in 46 (74.2%) patients. The FarawaveTM catheter was used to identify LA sites showing diastolic, low-voltage electrograms and entrainment from its splines was performed to confirm the pacing site was inside the AFlu circuit (Figure 1). Left AFlu termination was achieved in all cases via PFA delivery. Total procedural and LA dwell times were 112±25min and 59±22 min, respectively. Major complications occurred in 2 (2.8%) patients with pre-existing left ventricular systolic dysfunction (EF<35%) who required inotropic therapy due to acute heart failure. Hemodynamics normalized within 24h and both patients were discharged after 2 and 3 additional hospital days.

Transient ST-segment elevation was documented in 4 patients after peri-mitral PFA; timely nitrate administration led to ECG normalization within 10 minutes.

Single-procedure success rate was 81.8% after 13.3±1.9 months of follow-up; AF-free survival was 93.1% (Figure 2).

A subgroup of 36 patients completed a follow-up transthoracic echocardiography study to assess left atrial mechanical contraction changes after ablation. Median A-wave velocity was 30 (IQR: 20-35) cm/s post-ablation and 50 (IQR: 41-70) cm/s after a mean of 7.3±1.8 months post-ablation.

Conclusions

In our cohort, PFA-based AF substrate ablation led to AF termination in 95.8% of cases. Very favorable clinical outcomes were observed at one year of follow-up.Entrainment from the PFA Catheter.Kaplan-Meier Analysis.
Efficacy and safety of very high-power short-duration posterior wall ablation in persistent atrial fibrillation: a propensity score-matched comparison with standard power long-duration ablation
Authors: Volpato G , Compagnucci P , Cipolletta L , Parisi Q , Molini S , Misiani A , Carboni L , Valeri Y , Campanelli F , D'angelo L , Stronati G , Guerra F , Casella M , Natale A , Dello Russo A
Published: May 2024

Background

Catheter ablation (CA) with pulmonary vein isolation (PVI) is an optimal treatment option in patients with paroxysmal atrial fibrillation (AF). PVI alone in patients with persistent AF has proved to have suboptimal results. Ablation of additional atrial structures, such as posterior wall (PW) and left atrial appendage has been investigated as a tool to improve procedural efficacy. Recently very high-power short-duration (vHPSD) ablation was developed to allow rapid PVI, limiting complication through the maximization of resistive heating, and minimization of conductive heating.

Objectives

Compare PVI plus PWI using vHPSD versus standard-power (SP) ablation index-guided CA among consecutive patients with persistent AF

Methods

Forty consecutive patients underwent PVI plus PW isolation using vHPSD, compared to 40 controls underwent standard power (SP) PVI plus PW isolation. The primary efficacy endpoint outcome was recurrence of atrial tachyarrhythmias after a 3-month blanking period. The primary safety outcome was a composite of major complications within 30 days of CA.

Results

Treated patients have a median age of 62.8±9 years, 68 (85%) are male. Median left atrial volume is 42.4 (36-50) ml/m2. 61 (78.8%) patients had never undergone catheter ablation before. There are no statistically significant differences between groups. PW isolation was obtained more commonly in the vHPSD compared to the SP group (98% vs. 75%, p=0.007), despite shorter procedure and fluoroscopy times (p<0.001).

Survival free from recurrent atrial tachyarrhythmias at 18 months was 68% in the vHPSD and 47% in SP groups, respectively (log-rank p=0.071), without major adverse events. The vHPSD approach was significantly associated with reduced risk of recurrent AF at multivariable analysis (HR, 0.39, p=0.030).

Conclusions

The results show feasibility and safety of posterior wall vHPSD ablation for persistent AF using this new temperature-controlled catheter without intraprocedural and periprocedural major complications at follow-up. vHPSD ablation for PW isolation may be more effective in term of atrial tachyarrhythmias recurrences with a trend for superior efficacy. However, this remains a single center experience in a small group of patients. Comparative trials involving greater number of patients with long-term follow-up are necessary to definitive results.
First multicenter experience of pulmonary vein and posterior wall isolation via a novel focal 9mm lattice tip catheter in a real-world scenario
Authors: Vetta G , Della Rocca D G , Pannone L , Sorgente A , Cespon-Fernandez M , Del Monte A , Mene R , Almorad A , Sieira J , Bala G , Stroker E , Boveda S , Sarkozy A , De Asmundis C , Chierchia G B
Published: May 2024

Background

Pulsed field ablation (PFA) is an innovative technology recently adopted for the treatment of atrial fibrillation (AF). Preclinical and clinical studies have reported a remarkable safety profile, as a result of its tissue specific effect targeting cardiomyocytes and sparing adjacent tissues. The AfferaTM system is a focal 9-mm lattice tip catheter that has recently received regulatory approval. No data currently exist on the feasibility of this technology for first-time pulmonary vein isolation (PVI) and posterior wall isolation (PWI) in a real-world scenario.

Objective

To evaluate the safety and efficacy of the focal 9-mm lattice tip catheter Sphere-9 (Affera Inc) in a real-world population undergoing PVI and PWI.

Methods

Consecutive AF patients undergoing first-time PVI plus PWI with the AfferaTM system in two different centres between August and November 2023 were prospectively included. PFA was always used to ablate the posterior left atrium, whereas anterior applications were performed using either radiofrequency energy (RF/PF strategy) or PFA (PF/PF strategy) based on operator's discretion. Primary efficacy endpoint was acute procedural success (successful PVI with evidence of bidirectional block at the end of the procedure). Primary safety endpoint included major technology-related complications occurring within 7 days post-ablation. Secondary endpoints were first pass isolation, acute reconnection, overall complications, procedural, dwelling, and fluoroscopy time.

Results

Thirty consecutive patients [mean age: 68±6.8 years; 61.7% males; CHA2DS2-VASc Score 2.0 (1.5 – 3.5)] were included. Among them, 66.7% (n=20) had non-paroxysmal AF.

PVI was performed with an RF/PF strategy or PF/PF one in 10 (33.3%) and 20 (66.7%) patients, respectively. Posterior wall isolation (PWI) was performed in 30 (100%) cases.

The primary endpoint was achieved in 100% of patients for both PVI and PWI with average procedural time of 95 min (77-120 min), dwelling time of 78 min (55-92 min) and fluoroscopy time of 6 min (5-10.5 min) (Figure 1). No technology-related complications were observed. First-pass isolation occurred in 100% of PVI and PWI, with no acute reconnection for PW and 1 case of right PV reconnection in the RF/PF strategy group.

Conclusions

AF ablation with the focal 9-mm lattice tip catheter Sphere-9 confirmed high efficacy and safety in PVI + PW in a real-world population.Figure 1
Prophylactic administration of glycopyrrolate prevents vasovagal responses induced by pulsed field ablation in patients with atrial fibrillation
Authors: Vetta G , Della Rocca D G , Cespon-Fernandez M , Del Monte A , Magnocavallo M , Mene R , Pannone L , Sorgente A , Sieira J , Stroker E , Rossi P , Boveda S , Sarkozy A , De Asmundis C , Chierchia G B
Published: May 2024

Background

The FarapulseTM system was the first pulsed field ablation device to receive regulatory approval. Vagal Responses (VR) during pulmonary vein isolation (PVI) with this pentaspline device are frequent and often require back-up pacing or the administration of parasympathetic drugs. Glycopirrolate (GLY) is a medication of the muscarinic anticholinergic group; its efficacy for VR prevention when administered prophylactically before PVI has never been reported.

Objective

To evaluate the effectiveness of prophylactic intravenous administration of GLY on VRs induced by PFA.

Methods

Consecutive AF patients undergoing first-time PVI with PFA via the FarapulseTM system between April and October 2023 were prospectively enrolled in 3 European centers. Prophylactic administration of GLY (0.2 mg intravenous administration before femoral vein puncture) [Group GLY(+)] was adopted based on operator’s preference. VR was defined as at least one of the following: sinus bradycardia (<40 beats/min), asystole (>6 sec), or atrioventricular block (AVB) occurring immediately after a pulsed electric field application. VRs and maximum pause duration (maximum RR interval) were determined for each PV. Temporary backup pacing was performed as per the operator's preference.

Results

We enrolled 141 patients [GLY(+): 64 patients; GLY(-): 77 patients] undergoing PVI with the pentaspline FarapulseTM system. Median age was 54.1 years (54.1- 70), and 76 (54%) patients were males with an average CHA2DS2-VASc Score of 1.0 (0 – 2). A total of 563 PVs, including 3 left common PVs and 2 accessory middle PVs, were successfully isolated with the FarapulseTM PFA system. There were no statistically significant differences in baseline and procedural characteristics between two groups. VRs during PVI occurred in a total of 53 (37.6%) patients. GLY administration reduced significantly the incidence of any VRs (4.7% vs 64.9%; p<0.001) (Figure 1A). Additionally, GLY resulted in a lower incidence of VRs during LSPV (4.7% vs 62.3%; p<0.001) and LIPV (1.6% vs 9.1%; p<0.001) (Figure 1B) isolation and the need for temporary backup pacing during LSPV (24.7% vs 1.6%; p<0.001) isolation. Maximum pause duration was significantly shorter in the GLY(+) group after PFA of LSPV (1195 vs 3459 sec; p<0.001), LIPV (1128 vs 1556 sec; p<0.001), RSPV (1138 vs 1607 sec; p<0.001) and RIPV (1103 vs 1343 sec; p<0.001) compared to GLY(-) group (Figure 1C).

Conclusions

Glycopyrrolate is highly effective in the prevention of VRs induced by PFA ablation in AF patients undergoing first-time PVI.Figure 1
Impact of the timing of early recurrences during the blanking period in patients after cryoballoon ablation: insights from the COMPARE CRYO study using continuous rhythm monitoring
Authors: Rehman S , Kueffer T , Knecht S , Madaffari A , Badertscher P , Maurhofer J , Krisai P , Thalmann G , Heg D , Servatius H , Tanner H , Kuhne M , Roten L , Sticherling C , Reichlin T
Published: May 2024

Background

Early recurrences (ER) during the blanking period after pulmonary vein isolation (PVI) are common. While many of those correlate to late recurrences (LR) after the blanking period, some do not. The impact of the timing of ER is difficult to assess with non-invasive Holter monitoring due to under sampling.

Purpose

To evaluate the impact of the timing of ER after cryoballoon ablation using continuous rhythm monitoring by means of an implantable cardiac monitor (ICM).

Methods

This is a prespecified sub study of the COMPARE-CRYO study. The trial enrolled patients with paroxysmal atrial fibrillation and compared PVI with the PolarX cryoballoon and the ArcticFront cryoballoon. All patients underwent ICM implantation at the end of the PVI. ER was defined as recurrence of any atrial arrhythmia > 30 seconds between days 0-90 after PVI. LR was defined as recurrence of any atrial arrhythmia > 30 seconds between days 91-365.

Results

ER occurred in 116 of 201 patients (58%). A total of 5330 episodes occurred, 4210 in patients with LR and 1120 in patients without LR (Figure 1A). Median time to the latest episode of ER in the blanking period was 18 days (IQR 8.5-36.5) in patients with no LR and 80 days (IQR 27-89) in patients with LR (p<0.001). The latest episode of ER occurred between days 0-30, 31-60 and 61-90 in 41%, 13% and 46% of patients respectively. Freedom from recurrence of atrial arrhythmias 1 year after the PVI was 81% in patients without ER and 37% in patients with ER (p<0.001, Figure 1B). When patients were classified according to their latest episode of ER occurring between days 0-30, 31-60 and 61-90, freedom from any atrial arrhythmia at 1 year was 60%, 53% and 11% (p<0.001, Figure 1C) respectively. ROC analyses revealed a strong correlation of LR with the timing of the latest episode of ER in the blanking period (AUC=0.81, p<0.001) with an optimal cutoff value at 61 days (SN 64%, SP 88%).

Median AF burden in the blanking period was 0% (IQR 0-0) in patients with ER but no LR and 0.2% (IQR 0-2) in patients with ER and LR (p<0.001). This was similarly true for all individual months (0-30 days: 0% vs. 1.8%, p<0.001, 31-60 days: 0% vs. 0.1%, p<0.001, 61-90 days: 0% vs. 0.1%, p p<0.001). There were no differences in the duration of ER episodes or in clinical characteristics between patients with and without LR

Conclusion

ER after cryoballoon PVI is common. While ER during the first and second month after PVI disappear in the majority of patients, presence of ER in the third month after PVI are highly predictive for ablation failure.
High efficacy and safety of endocardial pulsed electrical field ablation via contact force-controlled catheters for mitral isthmus ablation
Authors: Schreieck J , Kranert M , Scheckenbach C , Gawaz M , Heinzmann D
Published: May 2024

Background

A new technology of a pulsed field generator enables established contact force-controlled radiofrequency (RF) catheters to apply point by point monopolar pulsed electrical field (PEF) energy for linear lesions in atrial fibrillation (AF) ablation.

Purpose

We evaluated this novel monopolar PEF ablation technique for creating lateral mitral isthmus ablation lines in case of perimitral flutter or complex AF patients non responder to pulmonary vein isolation (PVI).

Methods

Patients (n=44, age 65±11 years) referred for ablation/re-ablation of AF with spontaneous or inducible perimitral atrial flutter (n=34, 77%) or persistent AF and severe enlarged atrium (n=7) or de novo longstanding persistent AF (n=3) without signs of atrial fibrosis were included in our patient cohort for lateral mitral isthmus ablation with PEF applications. After 3D high density voltage mapping of the left atrium with multipolar microelectrode catheters, and confirmation/completion of PVI, an endocardial lateral mitral isthmus line was performed. Using contact force sensing catheter, 25A PEF energy pulses were applied targeting a minimum of 10g contact force and an interlesion distance ≤5mm. Before PEF application 0.2 mg nitroglycerin was intravenously injected. If the inferolateral mitral isthmus line to the left inferior pulmonary vein could not be blocked, a more superior lateral line to the left superior pulmonary vein was performed. If the mitral isthmus could not be blocked by endocardial PEF application or conduction recurred after adenosine injection an additional epicardial ablation via RF application in the coronary sinus was performed.

Results

Exclusively endocardial PEF application blocked the lateral mitral line in 37 out of 42 cases (88%) with 23±14 PEF applications. After an unsuccessful inferior lateral mitral line, in 34% of cases a second superior lateral mitral line have to be performed. Only in five cases additional epicardial RF applications via coronary sinus were necessary to complete the mitral isthmus block. Block time between superior lateral mitral anulus and infero lateral coronary sinus was 196±48 ms. One pericardial tamponade which could be successfully drained, and no other serious complication occurred throughout all procedures (no ST segment elevation, no tamponade requiring surgery, no cerebrovascular event). Limited follow-up will be available at the time of presentation.

Conclusion

Blockade of left atrial mitral isthmus line with PEF application via contact force-sensing catheters for ablation of complex atrial fibrillation patients is very efficient and safe. Especially the high efficacy of exclusively endocardial PEF application for creation of a lateral mitral isthmus block in most patients is very promising. However, the long term permanence of the linear lines have to be awaited.
Long-term effects of catheter ablation versus antiarrhythmic drugs on health-related quality of life in patients with atrial fibrillation: the CAPTAF randomized clinical trial revisited
Authors: Svedung Wettervik V , Schwieler J , Bergfeldt L , Kenneback G , Jensen S M , Rubulis A , Sciaraffia E , Blomstrom Lundqvist C
Published: May 2024

Background

Data on long-term effects of catheter ablation versus antiarrhythmic drugs (AAD) on health-related quality of life (HRQoL) and atrial fibrillation (AF) burden are limited. The study aimed to assess long-term HRQoL and rhythm data in symptomatic AF patients.

Methods

The 75 patients who underwent ablation and 74 receiving AAD in the Catheter Ablation compared with Pharmacological Therapy for Atrial Fibrillation (CAPTAF) trial were followed for 48 months comparison of General Health using 36-Item Short-Form Health Survey, time to first AF-episode ≥1 hour, and AF burden, recorded by implantable cardiac monitors.

Results

147 patients completed follow-up, with seven crossovers in the ablation group and 34 crossovers in the AAD group. General Health improved by ablation, median 62 points at baseline to 79.2 points at follow-up (p<0.001), and by AAD from median 67 to 77 points (p<0.001), without treatment differences (p=0.77). Time to first AF-episode ≥1 hour was longer, median 257 days (ablation group) versus 180 days (AAD group), p=0.025. The cumulative AF burden during follow-up was lower in the ablation (median 0.3% [interquartile range 0, 1.4]) versus AAD group (1.6% [0.1, 11.0]), p=0.01. The cumulative reduction in AF burden compared with baseline was greater in the ablation (median -89.5% [-98.4, -51.3]) versus AAD group (-52.7% [-92.6, 263.6]), p=0.001).

Conclusions

HRQoL improvement at long-term did not differ between ablation and AAD despite a larger reduction in AF burden after ablation. The results should be interpreted in the light of a four times higher crossover rate in the AAD group.
Impact of additional pulsed field ablation in unsuccessful radiofrequency linear lesions -acute and chronic data
Authors: Yokoyama M , Vlachos K , Kowalewski C , Ascione C , Moussaoui N , Arnaud M , Bouyer B , Tixier R , Duchateau J , Pambrun T , Derval N , Hocini M , Sacher F , Haissaguerre M , Jais P , Monaco C , Benali K , Popa M , Spittler R , Kneizeh K , Buliard S , Chauvel R , Cochet H
Published: May 2024

Background

Performing linear ablation such as roof line, inferior line in the posterior part of LA and posterior mitral isthmus (MI) line in addition to PVI is one of the strategies for treating persistent atrial fibrillation. However, remnant conduction or reconnection in the lines is linked with atrial arrhythmia recurrence, either AF or AT. Radiofrequency ablation (RFA) is often unsuccessful achieving durable linear ablation. It is not yet well known whether using pulsed field ablation (PFA) would be superior in achieving complete linear lesions.

Purpose

We sought to evaluate the benefit of using PFA in unsuccessful RF ablation linear lesions.

Methods

We studied 17 patients that underwent redo procedures due to atrial arrhythmia recurrence. All of them underwent PFA (using a pentaspline PFA catheter) ablation lines due to previous unsuccessful RF ablation, either due to remnant conduction in the line or to reconnection of the line. Lines of block were evaluated based on activation mapping and differential pacing maneuvers close to the lines.

Results

We conducted 16 dome-posterior lines and 6 posterolateral mitral isthmus lines using PFA after unsuccessful RF ablation linear lesions. PFA was performed after several unsuccessful procedure, 1.3±0.4 for the roof line, 1.3±0.5 for the postero-inferior line and 1.7±0.9 for the MI line. In 4 out of 6 pts with MI isthmus ablation using PFA ethanol injection within vein of Marshall (Et-VOM) was conducted in a previous procedure and in 4 out of 6 patients with MI isthmus RF ablation within coronary sinus (CS) was performed in a previous procedure. Specifically, for the dome-posterior line, 2 patients underwent PFA deliveries only at the gap region in the posterior LA and in other 14 cases, PFA deliveries were performed at 3.2±0.8 sites of the posterior wall between LPV and RPV. We used a total of 15.5±4.6 PFA deliveries to complete the dome-posterior line. Dome-posterior line bidirectional block based on activation mapping and differential pacing maneuvers was achieved in all cases (16/16, 100%) after PFA. For the MI line, we performed a total of 11.8±2.3 application deliveries at 2.5±0.5 sites in the MI region. Posterior MI line bidirectional block based on activation mapping and differential pacing maneuvers was achieved in 5 out of 6 patients (83.3%). In one case additional Et-VOM was needed to achieve MI block. There was no AT/AF recurrence in all these 17 patients.

Conclusion

PFA treatment seems promising to back-up RF failed linear lesions. But we cannot exclude that it is in fact the combination of the 2 energies that was successful in those resistant cases.
Long-term follow-up of pulmonary vein cryoballoon isolation using a double 120s vs single 240s standard freeze protocol
Authors: Urbani A , Bordignon S , Schaack D , Tohoku S , Hirokami J , Urbanek L , Chen S , Gaggiotti G , Pedretti S , Schmidt B , Chun J
Published: May 2024

Background

Recently, pulmonary vein isolation (PVI) using a double 120s freeze protocol has demonstrated to be non-inferior to a single 240s protocol despite a potentially increased procedural safety. Main advantages of a double 120s protocol are a reduction of phrenic nerve injury and an increase of the mean minimal esophageal temperature during the procedure.

Methods

We performed a long-term follow-up comparison between groups of patients with history of symptomatic atrial fibrillation undergoing PVI with second generation cryoballoon (CB) between 2019 and 2020. Our usual energy dosing protocol was modified including 2 times 120 seconds applications instead of a single 240 seconds application. Of A total of 160 consecutive patients, 80 were treated with double 120s (CB120) and 80 with single 240s (CB240) freeze protocol. 107 patients were, successfully, followed-up. The primary end-point was freedom from atrial tachyarrhythmia.

Results

Before PVI a total of 11/52 patients (21%) had persistent AF and 41/52 (79%) had paroxysmal AF in the CB120 group; a total of 20/55 patients (36%) had persistent AF and 35/55 (64%) had paroxysmal AF in the CB240 group.

On a mean follow-up time of 17 months, freedom from atrial tachyarrhythmia was 63% in those patients undergoing CB240 and 74% with CB120 (log-rank P=0.255).

Conclusions

The double 120s freeze protocol is not-inferior as compared to the standard 240s in terms of freedom from recurrences on a long term follow-up, but with a more favorable procedural safety profile.
Acute and long-term lesion durability and reconnection patterns following hybrid atrial fibrillation ablation
Authors: Mouram S , Della Rocca D G , Doundoulakis I , Pannone L , Vetta G P , Stroker E , Almorad A , Sieira J , Sarkozy A , Chierchia G B , La Meir M , De Asmundis C
Published: May 2024

Background/introduction

Hybrid ablation (AF) is a well-established rhythm control strategy in non-paroxysmal AF patients and can be performed as a staged or one-step epicardial-endocardial approach. Data on need for endocardial touch-up acutely after epicardial ablation are limited, as well as long-term reconnection patterns in patients undergoing redo procedures.

Purpose

to evaluate the lesion transmurality detected via endocardial mapping acutely after epicardial radiofrequency (RF) ablation, as well as anatomical and clinical predictors of residual endocardial gaps in a large cohort of patients undergoing hybrid AF ablation. Furthermore, long-term lesion durability will be assessed in patients undergoing repeat endocardial ablation.

Methods

Hybrid procedures were performed in a one-step fashion (endocardial mapping +/- ablation immediately following left thoracoscopy epicardial ablation). Epicardial pulmonary vein (PV) isolation was achieved via a bipolar RF clamp; further epicardial linear ablation was performed with a RF bipolar linear device. Additional lesions were performed according to physician’s preference on a patient basis. At the end of the procedure, the left atrial appendage (LAA) was clipped.

Results

A total of 130 patients were included (mean age: 65±9.4; 72.3% males); among them, 19.2% and 55.4% had persistent or long-standing persistent AF. All patients received epicardial PV and posterior wall (PW) isolation plus additional RF applications to the LAA/posterolateral ridge. Other targets included the right inferior ganglionted plexus in 36.2% (n=47) and anterior mitral line (AML) in 3.8% (n=5). In 13.1% (n=17) epicardial lesions could not be completed due to difficult anatomy. At the end of the procedure, an attempt to clip the LAA was done in all patients, resulting in 97.7% success (3 LAA clip failures due to anatomical reasons). Acute endocardial mapping revealed a PV reconnection rate of 4.6% (n=24), left superior and right superior PVs being the veins most commonly reconnected (6.15% and 5.38%, respectively). PW and AML reconnections were documented in 8.5 % and 60% (3 out of 5 patients). Multivariate analysis showed left atrial (LA) volume and male gender as predictors for acute endocardial gaps after complete epicardial lesions.

A redo procedure after first recurrence was performed in 24.6% (n=32), showing lesion durability of 100% for left PVs, 90.6% for right superior and 93.7% for right inferior PVs. PW remained isolated in 78.1% of patients. Age was a predictive factor for chronic gaps after recurrence. At a mean follow-up of 51±35 months, arrhythmia-free survival after multiple procedures was 68.5%.

Conclusion

In a large cohort of AF patients undergoing hybrid ablation,acute and chronic lesion durability was hight.LA volume and male gender were predictors of acute reconnection after epicardial ablation.
Incidence and outcome of periinterventional atrial fibrillation in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention
Authors: Jost J , Rohla M , Hamacher L , Burger L A , Zweiker D , Kaufmann C , Tscharre M , Wessely E , Huber K , Tinhofer F
Published: May 2024

Background

Peri-interventional atrial fibrillation (AF) may be detected in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). Data on the thromboembolic risk and long-term clinical outcome in patients with AF limited to the peri-interventional period is scarce.

Purpose

To assess the incidence and impact on long-term clinical outcome of peri-interventional de-novo AF in STEMI patients.

Methods and Results

This retrospective single-center cohort study included all patients who underwent PCI between January 2016 and November 2020 (n=491) due to STEMI. Patients were stratified to three cohorts of AF status: Pre-existing AF: n=42 [8.6%], newly diagnosed peri-interventional AF: n=56 [11.4%] and no AF: n=393 [80.0%].

Patients with newly diagnosed peri-interventional AF as well as patients with pre-existing AF had in median a mild-moderately reduced left ventricular ejection fraction (LVEF), patients in sinus rhythm in median a normal LVEF.

During the average follow-up time of 4.7 years (min. 2 years, max. 7 years) the rate for readmission for AF or occurrence of AF without hospital admission was increased in patients with peri-interventional de-novo AF or pre-existing AF (n=6 [10.7%], n=10 [23.8%]) compared to those in sinus rhythm n=22 [5.6%] (p<0,001)

The occurrence of ischemic stroke was higher in patients with peri-interventional de-novo AF (n=2 [3.6%] or with pre-existing AF (n=2 [4.8%]) compared to those in sinus rhythm (n=6 [1.5%]. (p=0.256)

The risk of cardiovascular death was significantly higher in patients with newly diagnosed peri- interventional AF compared to patients with pre-existing or no AF (n=13 [23.2%], n=5 [11.9%], n= 37 [9.4%]) (p=0.009).

In the patient group with peri-interventional de-novo AF, only 25.0% (n=13) received long-term oral anticoagulation therapy (OAK). The rate of stroke in patients who received OAK after peri- interventional de-novo AF was 7.7% (n=1) compared to those without OAK 2.6% (n=1).

Conclusion

Peri-interventional AF is a frequent finding in STEMI patients undergoing primary PCI. Patients with peri-interventional AF had a significantly increased risk for an adverse cardiovascular outcome. Optimal secondary prophylactic measures appear mandatory in this patient population. The significance of long-term OAK therapy is to be determined.
Management of edoxaban therapy in patients undergoing emergency/urgent procedures: a subanalysis of the global, prospective, observational, multinational EMIT-AF/VTE programme
Authors: Colonna P , Souza J , Saxena M , Vanassche T , Santamaria A , Jin J , Kohler S , Borrow A , Unverdorben M , Von Heymann C
Published: May 2024

Background

Physicians are often unable to follow recommendations for preprocedural oral anticoagulant interruption before emergency/urgent (unplanned) procedures, which may lead to a higher incidence of adverse outcomes in these patients compared with those who undergo planned procedures. The Global EMIT-AF/VTE programme found low bleeding and thromboembolic event rates for patients receiving edoxaban who underwent diagnostic or therapeutic procedures. However, edoxaban management and clinical outcomes may differ among the subgroup of patients with emergency/urgent procedures.

Purpose

To describe periprocedural edoxaban management and clinical outcomes for patients in the EMIT-AF/VTE programme who underwent emergency/urgent procedures.

Methods

In this subanalysis, only physician-reported unplanned (emergency/urgent) procedures were included, of which dental and dermatological procedures were excluded. Only a patient’s first emergency procedure was included, with the exception of 3 patients having 2 procedures on the same day (in these cases the 2 procedures were combined). Procedure bleeding risk was classified according to EHRA criteria, and baseline characteristics and edoxaban interruption data were collected. Clinical event and procedure dates were compared to determine whether they were related.

Results

Among 156 patients undergoing emergency/urgent procedures, the mean ± standard deviation age at baseline was 74.5 ± 8.7 years, and the CHA2DS2-VASc score was 3.8 ± 1.6. Medical histories of hypertension and dyslipidaemia were reported in 84.0% and 40.4% of patients, respectively; approximately one-quarter of patients had diabetes mellitus (26.9%) or creatinine clearance ≤50 mL/min (24.4%). The most common procedure types were vascular access and transcatheter diagnostics/interventions (34.6%) and gastroenterological procedures (27.6%). Procedures were more often EHRA-classified as minor (35.9%) or low (35.3%) vs high risk (20.5%). Preprocedure edoxaban interruption rates ranged from 39.3%–50.9% across risk groups, with more than half of the procedures being performed with edoxaban interruption (53%–66%; Figure). By 20 days postprocedure, edoxaban therapy was resumed in approximately 86% and 88% of patients with minor- or low-risk procedures vs 70% with high-risk procedures. Overall, 33 clinical events were recorded, of which 18 (54.5%) preceded a procedure (Table). Five bleeding events and one thrombotic event occurred after and were caused by the procedure.

Conclusions

Edoxaban resumption was protracted after high- vs minor- or low-risk procedures. Bleeding and thrombotic events resulting from a procedure occurred in <4% of patients, indicating that postprocedure edoxaban therapy can be effectively tailored to optimise clinical outcomes.FigureTable