Europace最新文献

Aims: The rising burden of cardiovascular diseases, especially atrial fibrillation, has increased demand for electrophysiology (EP) procedures in Europe, driving greater reliance on disposable devices like diagnostic and ablation catheters. Reprocessing single-use medical devices offers potential economic and environmental benefits, yet concerns persist regarding device integrity and safety. Under the European Union Medical Device Regulation, reprocessing is permitted if national laws allow it; however, implementation varies across Member States. This systematic literature review evaluates the safety and performance of reprocessed cardiac EP catheters originally intended for single use.

Methods and results: Following PRISMA guidelines, literature searches of PubMed and Embase identified in vitro and in vivo studies that examined the safety and functionality of reprocessed EP catheters. Key outcomes included infection risk, device sterility, mechanical and electrical integrity, and adverse events. Twelve studies (four in vivo and eight in vitro) involving >1200 patients and multiple catheter brands were included. Under stringent reprocessing protocols, reprocessed EP catheters showed comparable safety and mechanical performance to new devices. However, gaps remain in evidence regarding prion and fungal contamination, the maximum number of safe reprocessing cycles, and the detection of rare complications.

Conclusion: The absence of adverse events and reliable performance associated with reprocessed EP catheters reported in this study may encourage European countries that have not yet authorized single-use medical device reprocessing to consider its adoption. However, the broader implementation of this practice remains contingent on its applicability and logistical feasibility within each national context.

Aims: Cardioneuroablation (CNA) is a catheter-based intervention for reflex syncope and functional bradyarrhythmias that consists in the modulation of the parasympathetic cardiac autonomic nervous by targeting ganglionated plexi (GPs).To compare an ablation strategy of selective GP targeting based on clinical phenotype (tailored approach) vs. the standard approach of targeting all GPs (standard approach).

Methods and results: This is a prospective, multicentre European study (ELEGANCE study), including 123 patients who underwent CNA (73 men; median age 50 years). Among them 54 (44%) were treated with a tailored approach, targeting the superior paraseptal ganglionated plexus (SPSGP) for sinus node dysfunction and the inferior paraseptal ganglionated plexus (IPSGP) for AV block. Procedural data and clinical outcomes were compared with the remaining 69 patients treated using a standard approach.Clinical phenotypes included isolated functional sinus node dysfunction (43.1%), isolated functional AV block (9.8%), and dual presentations (47.2%). In the tailored group 1.6 ± 0.7 GPs were targeted per patient. Compared to the standard approach, the tailored group had significantly shorter procedure times (63 vs. 85 min, P = 0.005) and reduced RF time (5.4 vs. 10.4 min, P < 0.001). Acute procedural success (tailored: 93% vs. standard: 90%, P = 0.98) and the increase in heart rate (tailored: 40 ± 30.7% vs. standard: 40 ± 31.4%, P = 0.96) were similar between groups. During a median 15.9 months [IQR: 9.8, 24.6] follow-up, there were no differences in syncope recurrence rate (log-rank P = 0.96). Inappropriate sinus tachycardia occurred in 8.1% of patients, (tailored 8.6% vs. standard 7.4%; P = 0.79).

Conclusion: An individualized CNA strategy, simplified by targeting specific GPs according to patient's pathophysiology, achieved outcomes equivalent to the standard approach while improving procedural efficiency through reduced RF delivery, shorter procedure duration, and limited ablation extent.

Aims: Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation, but recurrences are frequent. Ablating AF sources beyond PVI may prevent re-initiations. This proof-of-principle in silico study compares a novel source-based ablation approach to conventional strategies in preventing AF re-initiation.

Methods and results: We compared two conventional ablation strategies [PVI and PVI + posterior wall isolation (box ablation)] with our source-based approach. After PVI, a high-density mapping catheter was guided sequentially upstream of local repetitive conduction patterns until a source was identified. Located targets were ablated, connecting them to non-conducting boundaries. Strategies were compared based on their AF re-initiation rates after incremental pacing and ablated and electrically isolated areas. Analyses were performed in seven different scenarios with atria of different sizes, without (n = 3) and with fibrosis (n = 4), to assess different AF progression stages. Compared to no ablation, PVI reduced initiation rates in non-fibrotic atria (23 ± 8% control vs. 15 ± 0% PVI) but was less effective with fibrosis (60 ± 4% vs. 53 ± 10%). Box ablation was not superior to PVI while isolating more of the left atrium (isolated area in PVI: 31.5 ± 0.7% vs. box: 43.6 ± 0.5%). Conversely, source ablation completely prevented AF initiation in all scenarios, achieving comparable left atrial isolation with box ablation (isolated area without fibrosis: 36.3 ± 1.4%; with fibrosis: 43.2 ± 2.6%) and including right atrial lesions. Although macro-re-entrant tachycardias occurred frequently after source ablation, they were terminated with minimal lesions.

Conclusion: Ablating AF sources using our high-density mapping approach was more efficient in preventing AF re-initiation in silico than anatomy-based strategies.

Aims: To explore the prevalence and incidence of paediatric implantable cardioverter-defibrillator (ICD) patients in Sweden and identify risk factors associated with appropriate shocks and adverse events.

Methods and results: We performed a nationwide, retrospective cohort study of ICD use in paediatric patients (<19 years) between 1995 and 2017; 120 patients underwent ICD implantation at median age 14.7 (range 1.1-18.9) years and were followed for 7.1 (0.3-20.4) years. Fifty-four patients (45%) received a primary preventive ICD; 46% had cardiomyopathy, and 41% had primary electrical disease. The estimated 5-year survival without appropriate shocks was 68% (confidence interval 59-78). Secondary preventive ICDs and lower weight (<30 kg) at implantation were associated with a higher rate of appropriate shocks, respectively. Lower weight at implantation was not a risk factor for adverse events. Inadequate medication and insufficient compliance were common in patients who experienced shocks. Less than half (46%) of the cases with inappropriate shocks were adequately medicated with good compliance. Secondly, an incidence and prevalence study of all paediatric and adult patients who had an ICD implanted in Sweden was analysed in 4-year periods between 2002 and 2021. The incidence of paediatric ICD implantations in Sweden peaked at 0.56 per 100 000 person-years in 2010-13, decreasing to 0.45 per 100 000 person-years in the last study period (2018-21).

Conclusion: Appropriate shocks were more than twice as common in the youngest patient group, whereas adverse events were not more frequent than in the older patient group. Inadequate medication and lack of compliance were common in connection with ICD shocks.

Atrial fibrillation (AF) is a growing unmet medical need. To reduce its impact on patients' lives, improvements in stroke prevention therapy, treatment of concomitant conditions, and rhythm control therapy are actively developed: Innovations in anti-thrombotic agents, new anti-arrhythmic drugs (AADs), and novel interventional rhythm control therapies emerge alongside AF-reducing effects of general cardiometabolic therapies. Simple risk scores are slowly replaced by personalized AF risk estimation using quantifiable features. These developments were discussed by over 80 experts from academia and industry during the 10th Atrial Fibrillation NETwork /European Heart Rhythm Association consensus conference from 5 to 7 May 2025. The emerging consensus, described here, is multi-domain therapy combining stroke prevention, rhythm control, and therapy of concomitant cardiovascular conditions. This combines anti-coagulants, AADs, and AF ablation with old and new cardiometabolic drugs that can reduce AF risk, AF burden, and AF-related complications at scale. The paper furthermore describes quantitative traits that may enable a shift towards risk-driven therapy based on AF phenotypes. These can enable adjusted therapy strategies that are safe, accessible, and patient-centred. Applying modern data science and artificial intelligence methods to quantitative phenotypic and genetic features can further improve risk estimation and personalized therapy selection. At the same time, translational and clinical research into reversing the drivers of AF and into improved stroke prevention through new drugs and through combination therapies is needed. Together, these efforts offer pathways towards personalized, patient-centred, multi-modal, and accessible AF management that integrates rhythm control, stroke prevention, and therapy of concomitant conditions to bridge today's practical needs with tomorrow's therapeutic innovation.

Aims: A personalized pulmonary vein isolation (PVI) approach aimed at ablation index (AI) titration according to multidetector computed tomography-derived left atrial wall thickness (LAWT) maps reported high effectiveness and efficiency outcomes for persistent atrial fibrillation (PeAF) ablation. To date, no randomized trials have compared this approach with the standard CLOSE protocol. This non-inferiority randomized controlled trial sought to compare a LAWT-guided PVI with CLOSE protocol-based for PeAF (NCT05396534).

Methods and results: Consecutive patients referred for first-time PeAF ablation were randomized on a 1:1 basis. In the by-LAWT arm, the AI was titrated according to local LAWT, and the ablation line was personalized to avoid the thickest regions at the pulmonary vein antrum. In the CLOSE arm, LAWT information was not available to the operator; the ablation was performed according to the CLOSE study settings: AI is ≥400 at the posterior wall and ≥550 at the anterior wall. Primary endpoint was freedom from atrial arrhythmias recurrence. Secondary endpoints were the major complication rate, procedure time, radiofrequency time, and first-pass PVI rate. One hundred fifty-six patients were included. At 12 month follow-up, no significant difference occurred in atrial arrhythmia-free survival between groups (P = 0.50). In the by-LAWT group, a significant reduction in procedure time (60.5 vs. 80.0 min; P < 0.01) and RF time (14.4 vs. 28.6 min; P < 0.01) was observed. No difference was observed regarding first-pass PVI (P = 0.72) and the major complication rate (P = 0.99).

Conclusions: The PeAF-by-LAWT trial is the first prospective randomized study to demonstrate that a personalized LAWT-guided PVI for PeAF ablation is non-inferior to the standard CLOSE protocol in terms of arrhythmia-free survival while significantly improving procedural efficiency. The study was not powered to detect differences in safety outcomes.