Cryoballoon ablation (Cryoballoon) has emerged as a new alternative for the treatment of symptomatic drug-refractory atrial fibrillation (AF). Whether the results of Cryoballoon are more reproducible ...than those of radiofrequency (RF) ablation remains to be proved.
A total of 860 consecutive patients undergoing a first ablation procedure for paroxysmal AF (467 treated with RF and 393 treated with Cryoballoon) were selected from a prospective multicentre survey of AF ablation (FrenchAF). Radiofrequency and Cryoballoon were compared regarding mid-term efficacy and safety. During a median follow-up of 14 months (interquartile range 8-23), patients treated with Cryoballoon displayed similar rates of freedom from atrial arrhythmia relapse in centres performing this technique (68-80% at 18 months). However, in centres performing RF, a greater heterogeneity in procedural results was observed (46-79% were free from atrial arrhythmia relapse at 18 months). On multivariate analysis, Cryoballoon (HR = 0.47, 95% CI 0.35-0.65, P < 0.001) and annual AF ablation caseload (HR = 0.87 per every 100 AF ablation procedures per year; 95% CI 0.80-0.96, P = 0.003) were independent predictors of procedural success. However, on sensitivity analysis, according to the ablation method, annual AF ablation caseload predicted only sinus rhythm maintenance in the subgroup of patients treated with RF. Analysis of interoperator results with Cryoballoon and RF confirmed lower reproducibility of RF, but suggested that besides caseload, other operator-related factors may play a role.
Cryoballoon seems to be less operator-dependent and more reproducible than RF in the setting of paroxysmal AF ablation.
Abstract
Recent developments in imaging, mapping, and ablation techniques have shown that the epicardial region of the heart is a key player in the occurrence of ventricular arrhythmic events in ...several cardiac diseases, such as Brugada syndrome, arrhythmogenic cardiomyopathy, or dilated cardiomyopathy. At the atrial level as well, the epicardial region has emerged as an important determinant of the substrate of atrial fibrillation, pointing to common underlying pathophysiological mechanisms. Alteration in the gradient of repolarization between myocardial layers favouring the occurrence of re-entry circuits has largely been described. The fibro-fatty infiltration of the subepicardium is another shared substrate between ventricular and atrial arrhythmias. Recent data have emphasized the role of the epicardial reactivation in the formation of this arrhythmogenic substrate. There are new evidences supporting this structural remodelling process to be regulated by the recruitment of epicardial progenitor cells that can differentiate into adipocytes or fibroblasts under various stimuli. In addition, immune-inflammatory processes can also contribute to fibrosis of the subepicardial layer. A better understanding of such ‘electrical fragility’ of the epicardial area will open perspectives for novel biomarkers and therapeutic strategies. In this review article, a pathophysiological scheme of epicardial-driven arrhythmias will be proposed.
Graphical Abstract
Graphical Abstract
From the reactivation of the epicardium to the formation of an arrhythmogenic substrate. Transition from a quiescent epicardium (A) to epicardial reactivation followed by fibro-fatty infiltrations of subepicardial myocardial layers (B). Potential arrhythmogenic mechanisms (C) include (i) at the tissue level, conduction slowing or block and low-voltage area favouring formation of electrical reentry circuit within the myocardial wall and (ii) at the cellular level, altered myocyte coupling and adipokine- and cytokine-induced abnormal excitation contraction coupling and oxidative stress.
No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure.
In the ...investigator-initiated SWISS APERO trial (Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure), patients undergoing LAA closure were randomly assigned (1:1) open label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centers. The primary end point was the composite of justified crossover to a nonrandomized device during LAA closure procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary end points included procedural complications, device-related thrombus, peridevice leak at transesophageal echocardiography, and clinical outcomes at 45 days.
Between June 2018 and May 2021, 221 patients were randomly assigned to Amulet (111 50.2%) or Watchman (110 49.8%), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary end point was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) patients receiving Amulet and 70 (70.0%) patients receiving Watchman, respectively (risk ratio, 0.97 95% CI, 0.80-1.16;
=0.713). A single justified crossover occurred in a patient with Amulet who fulfilled LAA patency criteria at 45-day CCTA. Major procedure-related complications occurred more frequently in the Amulet group (9.0% versus 2.7%;
=0.047) because of more frequent bleeding (7.2% versus 1.8%). At 45 days, the peridevice leak rate at transesophageal echocardiography was higher with Watchman than with Amulet (27.5% versus 13.7%,
=0.020), albeit none was major (ie, >5 mm), whereas device-related thrombus was detected in 1 (0.9%) patient with Amulet and 3 (3.0%) patients with Watchman at CCTA and in 2 (2.1%) and 5 (5.5%) patients at transesophageal echocardiography, respectively. Clinical outcomes at 45 days did not differ between the groups.
Amulet was not associated with a lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, however, was associated with lower peridevice leak rates at transesophageal echocardiography, higher procedural complications, and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation.
URL: https://www.
gov; Unique identifier: NCT03399851.
Abstract
Aims
Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This ...study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF).
Methods and results
A total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence incidence rate ratio (IRR)=0.79, P = 0.28 of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001).
Conclusions
Cryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy.
Graphical Abstract
Background:Frequency and distribution of left ventricular (LV) venous collaterals were studied in vivo to evaluate the ease and feasibility of implanting a new ultra-thin LV quadripolar microlead for ...cardiac resynchronization therapy (CRT).Methods and Results:Evaluable venograms were analyzed to define the prevalence of venous collaterals (>0.5 mm diameter) between: (1) different LV segments; and (2) different major LV veins in: unselected patients who underwent CRT from 2008 to 2012 at Rouen Hospital, France (retrospective); and CRT patients from the Axone Acute pilot study in 2018 (prospective). In prospective patients with evaluable venograms, LV microlead implantation was attempted. Thirty-six (21/65 retrospective, 15/20 prospective) patients had evaluable venograms with ≥1 visible venous collaterals. Collaterals were found between LV veins in all CRT patients with evaluable venograms. Regionally, prevalence was highest between: the apical inferior and apical lateral (42%); and mid inferior and mid inferolateral (42%) segments. Collateral connections were most prevalent between: the inferior interventricular vein (IIV) and lateral vein (64% 23/36); and IIV and infero-lateral vein (36% 13/36). Cross-vein microlead implantation was possible in 18 patients (90%), and single-vein implantation was conducted in the other 2 patients (10%).Conclusions:Venous collaterals were found in vivo between LV veins in all CRT patients with evaluable venograms, making this network an option for accessing multiple LV sites using a single LV microlead.
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.
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.
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%, CHA
DS
-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%;
=0.001). Acute major adverse events occurred in 1.9% of patients.
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.
Sudden cardiac arrest remains a major complication of acute myocardial infarction (AMI) and is frequently related to ventricular fibrillation (VF). Incidence and impact of VF among patients ...hospitalized for AMI were evaluated.
Data from the FAST-MI programme consisting of 5 French nationwide prospective cohort studies between 1995 and 2015 were analysed, totally including 14 423 patients with AMI (66 ± 14 years, 72% males, 59% ST-elevation myocardial infarction). Overall, proportion of patients presenting in-hospital VF decreased from 3.9% in 1995 to 1.8% in 2015 (P < 0.001). One-year mortality decreased from 60.7% to 24.6% (P < 0.001). However, compared with patients who did not develop VF, the over-risk of 1-year mortality associated with VF was stable over time hazard ratio (HR) 6.78, 95% confidence interval (CI) 5.03-9.14 in 1995 and HR 6.64, 95% CI 4.20-10.49 in 2015, P = 0.52. This increased mortality in the VF group was mainly related to fatal events occurring prior to hospital discharge, representing 86.2% of 1-year mortality, despite the very low rate of implantable cardioverter defibrillator in the VF group (2.6%).
This study demonstrates that in-hospital VF incidence and mortality in the setting of AMI have significantly decreased over the past 20 years. Nevertheless, VF remained steadily associated with approximately a 10-fold increased relative risk of in-hospital mortality, without an impact on post-discharge mortality. Beyond long-term cardiac defibrillation strategy, these results emphasize the need to identify in-hospital interventions to further reduce mortality in VF patients.
ClinicalTrials.gov Identifier: NCT00673036, NCT01237418, NCT02566200.
Abstract
Aims
The field of conduction system pacing (CSP) is evolving, and our aim was to obtain a contemporary picture of European CSP practice.
Methods and results
A survey was devised by a ...European CSP Expert Group and sent electronically to cardiologists utilizing CSP. A total of 284 physicians were invited to contribute of which 171 physicians (60.2%; 85% electrophysiologists) responded. Most (77%) had experience with both His-bundle pacing (HBP) and left bundle branch area pacing (LBBAP). Pacing indications ranked highest for CSP were atrioventricular block (irrespective of left ventricular ejection fraction) and when coronary sinus lead implantation failed. For patients with left bundle branch block (LBBB) and heart failure (HF), conventional biventricular pacing remained first-line treatment. For most indications, operators preferred LBBAP over HBP as a first-line approach. When HBP was attempted as an initial approach, reasons reported for transitioning to utilizing LBBAP were: (i) high threshold (reported as >2 V at 1 ms), (ii) failure to reverse bundle branch block, or (iii) > 30 min attempting to implant at His-bundle sites. Backup right ventricular lead use for HBP was low (median 20%) and predominated in pace-and-ablate scenarios. Twelve-lead electrocardiogram assessment was deemed highly important during follow-up. This, coupled with limitations from current capture management algorithms, limits remote monitoring for CSP patients.
Conclusions
This survey provides a snapshot of CSP implementation in Europe. Currently, CSP is predominantly used for bradycardia indications. For HF patients with LBBB, most operators reserve CSP for biventricular implant failures. Left bundle branch area pacing ostensibly has practical advantages over HBP and is therefore preferred by many operators. Practical limitations remain, and large randomized clinical trial data are currently lacking.
Collateral Nervous Damages.
Introduction: Various types of complications have been reported after atrial fibrillation (AF) ablation using radiofrequency energy, but those have not been well defined ...when using cryoballoon ablation technique. The objective of this prospective study was to assess types, incidence, and outcome of complications after cryoballoon pulmonary vein isolation (PVI).
Methods and Results: This prospective monocentric study included 66 consecutive patients (39 males, age 57 ± 11 years) who underwent cryoballoon PVI for symptomatic paroxysmal AF. Phrenic nerve (PN) integrity was assessed by pacing from the superior vena cava during isolation of the right PVs. Before discharge, all patients were subjected to 24‐hour Holter electrocardiograms, echocardiography, and esophagogastroduodenoscopy. Cardiac MRI was scheduled between 1 and 3 months postprocedure. At 3.7 ± 1.7 months after ablation, patients underwent clinical review and 24‐hour Holter electrocardiograms.
The mean number of cryoballoon applications was 10.0 ± 2.1 per patient and 2.5 ± 1.0 per vein. A 28 mm cryoballoon was used in 49 patients (74%) and a 23 mm cryoballoon in the remaining 17 patients (26%). Twelve complications (18%) attributing to collateral nervous damage were noticed in 9 patients: asymptomatic gastroparesis was observed in 6 patients (9%), transient PN palsy (PNP) in 5 (8%), and symptomatic inappropriate sinus tachycardia requiring beta‐blocker treatment in 1 (1%). Neither cryoballoon‐related esophageal ulceration nor PV stenosis was observed.
Conclusion: Gastroparesis and PNP could be observed in a significant number of cases after cryoballoon ablation of AF. These complications are likely due to cryo‐induced damages to nervous structures surrounding the heart.
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