Long-term follow-up and comparison of techniques in radiofrequency ablation of ventricular arrhythmias originating from the aortic cusps (AVATAR Registry)

Introduction: Radiofrequency ablation (RFA) of outflow tract ventricular arrhythmia (VA) that originates from the aortic cusps can be challenging. Data on long-term efficacy and safety as well as optimal technique after aortic cusp ablation have not previously been reported. Objectives: This aim of the study was to determine the short- and long-term outcomes after RFA of aortic cusp VA, and to evaluate aortic valve injuries according to echocardiographic screening. Patients and methods: This was a prospective multicenter registry (AVATAR, Aortic Cusp Ventricular Arrhythmias: Long Term Safety and Outcome from a Multicenter Prospective Ablation Registry) study. A total of 103 patients at a mean age of 56 years (34–64) from the “Electra” Registry (2005–2017) undergoing RFA of aortic cusps VA were enrolled. The following 3 ablation techniques were used: zero-fluoroscopy (ZF; electroanatomical mapping [EAM] without fluoroscopy), EAM with fluoroscopy, and conventional fluoroscopy-based RFA. Data on clinical history, complications after RFA, echocardiography, and 24-hour Holter monitoring were collected. The follow-up was 12 months or longer. Results: There were no major acute cardiac complications after RFA. In one case, a vascular access complication required surgery. The median (interquartile range [IQR]) procedure time was 75 minutes (IQR, 58–95), median follow-up, 32 months (IQR, 12–70). Acute and long-term procedural success rates were 93% and 86%, respectively. The long-term RFA outcomes were observed in ZF technique (88%), EAM with fluoroscopy (86%), and conventional RFA (82%), without differences. During long-term follow-up, no abnormalities were found within the aortic root. Conclusions: Ablation of VA within the aortic cusps is safe and effective in long-term follow-up. The ZF approach is feasible, although it requires greater expertise and more imaging modalities

Non-vitamin K antagonist oral anticoagulants (NOACs) for thromboembolic prevention, are they safe in congenital heart disease? Results of a worldwide study.

Current guidelines consider vitamin K antagonists (VKA) the oral anticoagulant agents of choice in adults with atrial arrhythmias (AA) and moderate or complex forms of congenital heart disease, significant valvular lesions, or bioprosthetic valves, pending safety data on non-VKA oral anticoagulants (NOACs). Therefore, the international NOTE registry was initiated to assess safety, change in adherence and quality of life (QoL) associated with NOACs in adults with congenital heart disease (ACHD). An international multicenter prospective study of NOACs in ACHD was established. Follow-up occurred at 6 months and yearly thereafter. Primary endpoints were thromboembolism and major bleeding. Secondary endpoints included minor bleeding, change in therapy adherence (≥80% medication refill rate, ≥6 out of 8 on Morisky-8 questionnaire) and QoL (SF-36 questionnaire). In total, 530 ACHD patients (mean age 47 SD 15 years; 55% male) with predominantly moderate or complex defects (85%), significant valvular lesions (46%) and/or bioprosthetic valves (11%) using NOACs (rivaroxaban 43%; apixaban 39%; dabigatran 12%; edoxaban 7%) were enrolled. The most common indication was AA (91%). Over a median follow-up of 1.0 [IQR 0.0-2.0] year, thromboembolic event rate was 1.0% [95%CI 0.4-2.0] (n = 6) per year, with 1.1% [95%CI 0.5-2.2] (n = 7) annualized rate of major bleeding and 6.3% [95%CI 4.5-8.5] (n = 37) annualized rate of minor bleeding. Adherence was sufficient during 2 years follow-up in 80-93% of patients. At 1-year follow-up, among the subset of previous VKA-users who completed the survey (n = 33), QoL improved in 6 out of 8 domains (p ≪ 0.05). Initial results from our worldwide prospective study suggest that NOACs are safe and may be effective for thromboembolic prevention in adults with heterogeneous forms of congenital heart disease

Safety and efficacy of non-vitamin K antagonist oral anticoagulants for prevention of thromboembolism in adults with systemic right ventricle: Results from the NOTE international registry

BACKGROUND Patients with systemic right ventricle (sRV), including transposition of great arteries (TGA) after atrial switch procedure and congenitally corrected transposition of great arteries (ccTGA), may require anticoagulation for thromboembolism (TE) prevention. In the absence of data on non-vitamin K antagonist oral anticoagulants (NOACs), vitamin K antagonists (VKAs) remain the agent of choice. We investigated the safety, efficacy and feasibility of NOACs treatment in adults with sRV in a worldwide study. METHODS This is an international multicentre prospective study, using data from the NOTE registry on adults with sRV taking NOACs between 2014 and 2019. The primary endpoints were TE and major bleeding (MB). The secondary endpoint was minor bleeding. RESULTS A total of 76 patients (42.5 ± 10.0 years, 76% male) with sRV (74% TGA, 26% ccTGA) on NOACs were included in the study. During a median follow-up of 2.5 years (IQR1.5-3.9), TE events occurred in 3 patients (4%), while no MB episodes were reported. Minor bleeding occurred in 9 patients (12%). NOAC treatment cessation rate was 1.4% (95%CI:0.3-4%) during the first year of follow-up. All the patients with TE events had a CHA$_{2}$DS$_{2}$-VASc score ≥ 2 and impaired sRV systolic function at baseline. The total incidence of major events during follow-up was significantly lower compared to historical use of VKAs or aspirin before study inclusion (1.4% (95%CI:0.29-4%) vs 6,9% (95%CI:2.5-15.2%); p = .01). CONCLUSIONS In this prospective study, NOACs appear to be well-tolerated, with excellent efficacy and safety at mid-term in patients with sRV