Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial

Abstract

Aims To evaluate the safety and effectiveness of pulmonary vein isolation in paroxysmal atrial fibrillation (PAF) using a standardized workflow aiming to enclose the veins with contiguous and optimized radiofrequency lesions. Methods and results This multicentre, prospective, non-randomized study was conducted at 17 European sites. Pulmonary vein isolation was guided by VISITAG SURPOINT (VS target ≥550 on the anterior wall; ≥400 on the posterior wall) and intertag distance (≤6 mm). Atrial arrhythmia recurrence was stringently monitored with weekly and symptom-driven transtelephonic monitoring on top of standard-of-care monitoring (24-h Holter and 12-lead electrocardiogram at 3, 6, and 12 months follow-up). Three hundred and forty participants with drug refractory PAF were enrolled. Acute effectiveness (first-pass isolation proof to a 30-min wait period and adenosine challenge) was 82.4% [95% confidence interval (CI) 77.4–86.7%]. At 12-month follow-up, the rate of freedom from any documented atrial arrhythmia was 78.3% (95% CI 73.8–82.8%), while freedom from atrial arrhythmia by standard-of-care monitoring was 89.4% (95% CI 78.8–87.0%). Freedom fromrepeat ablations by the Kaplan–Meier analysis was 90.4% during 12 months of follow-up. Of the 34 patients with repeat ablations, 14 (41.2%) demonstrated full isolation of all pulmonary vein circles. Primary adverse event (PAE) rate was 3.6% (95% CI 1.9–6.3%). Conclusions The VISTAX trial demonstrated that a standardized PAF ablation workflow aiming for contiguous lesions leads to low rates of PAEs, high acute first-pass isolation rates, and 12-month freedom from arrhythmias approaching 80%. Further research is needed to improve the reproducibility of the outcomes across a wider range of centres. Clinical trial registration: ClinicalTrials.gov, number NCT03062046, https://clinicaltrials.gov/ct2/show/NCT03062046.

Impact of the combined use of intracardiac ultrasound and a steerable sheath visualized by a 3D mapping system on pulmonary vein isolation

“…Past studies have suggested that catheter instability often causes arrhythmia recurrences in patients undergoing AF ablation 17,18 . Although the use of a CF sensing catheter and the real‐time ablation parameters improved the ablation outcomes, 19 the stabilization of the catheter contact during the entire RF application duration is still challenging. For a stable catheter contact and durable PVI, an adjustment of the sheath position and deflection is often required 20 …”

Optimizing Durability in Radiofrequency Ablation of Atrial Fibrillation

“…Atrial tachyarrhythmia burden decreased from 2.68% at baseline to 0% at both one and two years, with rates of single-procedure freedom from atrial tachyarrhythmia of 87% at one year and 78% at two years, respectively. 34 Recent results of the Evaluation of AI and VISITAG™ (ABI-173) (VISTAX) 35 trial, the first multicenter prospective study (n = 340) evaluating the effectiveness and safety of CLOSE protocol-guided RFA in patients with PAF, demonstrated a high rate of first-pass isolation (82.4%) with a rate of 12-month freedom from arrhythmia close to 80% and that of 12-month freedom from repeat ablation of 90.4%, with 14 of 34 patients undergoing repeat ablation demonstrating a durable PVI lesion set. The follow-up protocol consisted of 24-hour Holter monitoring at three, six, and 12 months and weekly and symptom-driven transtelephonic monitoring.…”

Atriale Tachykardien nach Vorhofflimmerablation: Fluch oder Segen?

“…Im Umkehrschluss kommt es bei zirkumferenzieller Isolation der Pulmonalvenen mit einheitlichen Ablationswerten und Läsionsabstand (z.B. CLOSE-Protokoll) oder bei Kryoablation relativ selten zu ATs [9,13] (▶ Tab. 1).…”