Laura Rottner

Background and Aims: Vascular access site complications are the most common procedure-related adverse event of atrial fibrillation catheter ablation. Whether ultrasound-guided femoral venous puncture reduces these vascular access complications remains uncertain. Methods: In this investigator-initiated, multicentre, open-label, superiority trial, patients undergoing atrial fibrillation or left atrial tachycardia catheter ablation were randomized to an ultrasound-guided venous puncture strategy (intervention group) or to a conventional venous puncture group guided by palpation (control group). The composite primary outcome was the occurrence of venous access site complications until 30 days after the procedure, defined as arteriovenous fistula, false aneurysm, or access site bleeding requiring intervention or leading to prolonged hospitalization. Secondary endpoints included procedure duration, puncture duration, procedure-related stroke/transient ischaemic attack within 30 days, number of unintended arterial punctures, and number of failed venous access attempts, as well as hospital stay duration. Results: In six centres, 986 patients were randomized. A total of 496 patients were assigned to the ultrasound-guided puncture group, and 490 patients to the conventional puncture group. The trial was stopped for efficacy, following the first interim analysis after enrolment of half of the planned patients. The composite primary outcome occurred in 3 patients (0.6%) in the intervention group and 16 patients (3.3%) in the control group (risk ratio 0.19; 95% confidence interval 0.05–0.63; P = .002). Additionally, ultrasound-guided venous puncture significantly reduced the rate of an unintended arterial puncture (2% vs 16%, P < .0001) and the rate of unsuccessful venous access attempts requiring crossover to the other group (0.2% vs 8.2%, P < .0001). Conclusions: Ultrasound-guided venous access for atrial fibrillation ablation procedures significantly reduced vascular access site complications. ULYSSES ClinicalTrials.gov number: NCT06403527.

Background: Atrial fibrillation (AF) is common in hypertrophic cardiomyopathy (HCM) and increases stroke risk, primarily due to thromboembolism from the left atrial appendage (LAA). Oral anticoagulation (OAC) is recommended, but data on LAA thrombus (LAAT) in HCM and AF are limited. The current study aimed to assess LAAT prevalence in patients with HCM and AF. Methods: We retrospectively analyzed 170 patients with HCM and AF (mean age, 67.7±12.4 years; 57.1% men) who underwent at least one transesophageal echocardiogram (TEE) during a median follow‐up of 41.5 months (interquartile range, 15–77 months). Results: At the time of TEE, 147 (86.5%) patients were undergoing OAC, with 52 (30.6%) taking vitamin K antagonists and 95 (55.9%) taking non–vitamin K antagonist oral anticoagulants. LAAT was found in 36 patients (21.2%), with prevalence rates of 23.1% (n=12) in vitamin K antagonist users, 16.8% (n=16) in non–vitamin K antagonist oral anticoagulant users, and 34.8% (n=8) in those without OAC. Non–vitamin K antagonist oral anticoagulant use was associated with a significant LAAT risk reduction compared with no OAC (odds ratio, 0.20 [95% CI, 0.05–0.73]; P =0.02). Decreased LAA flow velocity ( P <0.001) was independently linked to LAAT. Conclusions: LAAT is common in patients with HCM and AF, even among those receiving OAC. Reduced LAA flow velocity may increase thrombus risk. TEE should be considered before rhythm‐control strategies, even in patients with HCM receiving anticoagulation, to minimize thromboembolic complications.

Aims: Optimal outcomes for patients with cardiac arrhythmias can be achieved through multimodal therapy including lifestyle support, medication, and interventions. Planning of these therapy concepts requires a detailed understanding of phenotypes, responses to therapies, and outcomes. Objective: The prospective Long-term Outcome and Predictors for Recurrence after Medical and Interventional Treatment of Arrhythmias at the University Heart Center Hamburg (TRUST) combines deep phenotypic, procedural, and follow-up information in a contemporary cohort of patients with cardiac arrhythmias. Methods and results: TRUST is an investigator-initiated, prospective, cohort study enrolling consecutive patients at the UHZ Hamburg. Comprehensive baseline work-up, imaging, and biobanking at baseline is combined with follow-up using a combination of in-person visits, online questionnaires, and remote rhythm-monitoring. Enrolment started in March 2021 and is ongoing. This paper describes the design and the clinical characteristics of the first 1500 enrolled patients with verified baseline datasets (562 women (37%), median age 64 (IQR 55, 74) years). Overall, 1077/1500 patients (71%) were seen for atrial fibrillation, 161/1500 (11%) for ventricular tachycardia and premature ventricular complexes, 239/1500 (16%) for supraventricular tachycardia, and 23/1500 (2%) patients for other reasons. Ablations, rhythm surgery, or invasive procedures were performed in 1363/1500 (91%) within 1 month after inclusion. Conclusion: This snapshot of the first 1500 patients enrolled in TRUST illustrates current characteristics and comorbidity burden in patients undergoing arrhythmia treatment. This rich data set will provide information on treatment patterns, detailed phenotypes, and follow-up, offering insights into the natural progression and treatment responses of arrhythmias in routine care.

Aims: The aim of this study was to assess the risk of haemolysis and the extent of myocardial and neural injury after monopolar, monophasic pulsed field ablation (PFA) using a lattice-tip catheter in comparison to single-shot PF ablation platforms employing bipolar, biphasic waveforms. Methods and results: This prospective study included consecutive patients undergoing PFA for atrial fibrillation (AF) using the Affera™ mapping and ablation system (n = 40). Biomarkers for haemolysis (haptoglobin, lactate dehydrogenase, bilirubin), myocardial injury [high-sensitive troponin T, creatine kinase (CK), creatine kinase MB (CK-MB)], neurocardiac injury (S100), and renal function (creatinine) were assessed pre- and within 24 h post-ablation. A subgroup analysis of first-time pulmonary vein isolation-only procedures compared biomarker changes across Affera™, Farapulse™ (PFA-F), and PulseSelect™ (PFA-P). Post-procedural haemolysis occurred across all PFA platforms. The decrease in Δhaptoglobin was most pronounced in PFA-F [AfferaTM: (−) 13.8 ± 18.5 vs. PFA-P: (−) 36.8 ± 35.9 vs. PFA-F: (−) 60.7 ± 26.3 mg/dL, P = <0.001], without haemolysis-related complications. AfferaTM shows a trend towards a higher increase in myocardial injury markers (Δtroponin, 1537 [580] vs. 970 [1023] vs. 1051 [592] pg/mL, P = 0.180; ΔCK, 232 [168] vs. 153 [132] vs. 102 [144] U/L, P = 0.006; ΔCK-MB, 28.5 [15.3] vs. 14.6 [12.4] vs. 13.6 [10.5] U/L, P = 0.055, for Affera TM, PFA-P, and PFA-F, respectively). After ablation, S100 increased in PFA-P and PFA-F, but not in AfferaTM. Conclusion: Post-procedural haemolysis after PFA for AF treatment is common and occurs across all PFA platforms. Pulsed field ablation using AfferaTM results in more myocardial injury than bipolar PFA systems with no indication of neural damage.

Aims: Concerns exist about the safety of amiodarone and dronedarone. We assessed the long-term outcome of both drugs for early rhythm control (ERC) in the EAST-AFNET 4 trial. Methods and Results: Patients randomized for ERC and treated with amiodarone or dronedarone were compared to other ERC-therapies. Patients receiving amiodarone or dronedarone at initial therapy (n = 653/1395) were older with more comorbidities and less paroxysmal atrial fibrillation (AF, 29%) compared to patients never receiving amiodarone or dronedarone (Amiodarone/Dronedarone^never, 43% paroxysmal AF). Patients treated with amiodarone had more often heart failure (HF, 42%) and persistent AF (40%) compared to patients treated with dronedarone (16% HF, 15% persistent AF) and Amiodarone/Dronedarone^never (25% HF, 22% persistent AF). 115/398 amiodarone-treated patients (6.7/100 patient-years) and 51/255 dronedarone-treated patients (4.2/100 patient-years) experienced a primary efficacy outcome (cardiovascular death, stroke, HF-hospitalization or acute coronary syndrome), while 98/398 (5.3/100 patient-years) and 43/255 (3.4/100 patient-years) experienced a primary safety outcome (death, stroke or serious adverse events related to rhythm-control therapy). Serious adverse events related to drug therapy were similar for amiodarone (1.4/100 patient-years), dronedarone (1.2/100 patient-years), and other ERC (0.8/100 patient-years). Dronedarone (hazard ratio (HR) 0.5; CI 0.28–0.91), age (HR 1.05; CI 1.03–1.07), coronary artery disease (HR 1.84; CI 1.38–2.46) and stable HF (HR 1.66; CI 1.28–2.16) were associated with efficacy outcome upon multivariate Cox regression. Age (HR 1.07; CI 1.05–1.09) and left ventricular hypertrophy (HR 1.94; CI 1.13–3.32) were associated with safety outcome. Conclusion: Early rhythm control using amiodarone or dronedarone rarely led to drug-related serious adverse events in EAST-AFNET 4. Clinical Trial Registration: ISRCTN04708680, NCT01288352, EudraCT2010-021258-20. Graphical Central illustration

Aims: High-sensitivity cardiac troponin (hs-cTn) assays indicating myocardial injury are critical for the diagnosis of acute myocardial infarction (AMI), but their use to differentiate between acute and chronic myocardial injury is limited. This study aimed to assess the differential utility of three hs-cTn assays, targeting different troponin epitopes (proximal and/or central), to detect myocardial injury in a clinical model of acute myocardial injury by left-atrial ablation. Methods and results: First, pre- and post-procedural serum samples were prospectively collected from 158 patients undergoing pulmonary vein isolation in a standardised setting. cTn-concentrations were measured using the high-sensitive Architect-cardiac troponin I (cTnI)-, Atellica-IM-cTnI-, and Elecsys-cTnT assays. Cardiac troponin I/T-concentrations and -ratios were compared, also to established AMI rule-in-thresholds. Second, 48 patients in which hs-cTn measurements were performed in clinical routine after ablation with a clinical indication were assessed for correlations between hs-cTn-levels, symptoms and electrocardiogram changes. The Atellica-assessed cTnI showed a doubled relative pre-to-post-procedural concentration increase compared to Architect-cTnI (39.6-fold vs. 20.5-fold; P = 0.0036). The Atellica-hs-cTnI/T-ratio had a 2.5 (95% confidence intervals (CI) 1.1,5.2) relative increase, while the Architect-cTnI-to-Elecsys-cTnT-ratio showed a 6.9 (95% CI 2.3,11.8) relative increase (P < 0.0001). In 78% of patients, at least one post-procedural cTn-concentration exceeded AMI rule-in-thresholds. Chronic kidney disease predicted higher pre-to-post-increases. In retrospectively analysed routine cTn-assessments after ablation, cTn-levels after ablation did not correlate with neither symptoms, electrocardiogram changes nor angiography findings. Conclusion: The Atellica assay demonstrated enhanced sensitivity for very acute myocardial injury, likely via its additional recognition of the proximally located cTnI epitope. This suggests its potential to improve differentiation of acute from chronic myocardial injury, warranting further investigation to confirm its clinical utility in that setting.

Background: Catheter ablation is the primary treatment option for idiopathic ventricular tachycardia (VT). It plays a key role in acute therapy of electrical storm, treatment of VTs in patients with structural heart disease (SHD), and can reduce VT burden. Here we report on 10‐year clinical outcomes following VT ablation from patients enrolled in the prospective German Ablation Registry. Methods and Results: Long‐term follow‐up was conducted on 334 patients undergoing VT ablation (118/334, 35%) with structurally normal hearts and 216 out of 334 (65%) with SHD, including 161 out of 216 (75%) with ischemic heart disease at 38 centers. Follow‐up was completed in 94.8% of patients. Median observation time was 10.8 (4.3–12.3) years, with a 10‐year all‐cause mortality rate of 39.4%. VT ablation in patients with SHD was associated with worse outcome when compared with patients with structurally normal hearts (estimated 10‐year mortality for SHD 54.8% versus structurally normal hearts 12.1%). Estimated 10‐year mortality following VT ablation was highest in patients with ischemic heart disease (62.4%). Significant predictors of mortality following VT ablation included age (hazard ratio [HR], 2.35 [1.90–2.92] per decade), left ventricular ejection fraction ≤30% (HR, 2.11 [1.44–3.10]), diabetes (HR, 1.73 [1.14–2.61]), incessant VT (HR, 2.96 [1.74–5.03]), linear lesion (HR, 1.46 [0.99–2.16]), and acute procedural failure (HR, 2.57 [1.39–4.77]). Procedural failure was the only statistically significant predictor for VT recurrence during follow‐up (HR, 3.76 [1.59–8.91]). Conclusions: Within an all‐comer patient cohort, estimated 10‐year all‐cause mortality following VT ablation is 39.4%. Mortality after VT ablation is worse in patients with SHD and highest for patients with ischemic heart disease. Acute procedural success plays a major role in predicting VT recurrence and long‐term mortality.