Multielectrode Pulmonary Vein Isolation Versus Single Tip Wide Area Catheter Ablation for Paroxysmal Atrial Fibrillation

Abstract

Background— Single-shot ablation techniques may facilitate safe and simple pulmonary vein isolation to treat paroxysmal atrial fibrillation. Multielectrode pulmonary vein isolation versus single tip wide area catheter ablation-paroxysmal atrial fibrillation is the first multinational, multicenter, prospective, noninferiority randomized clinical trial comparing multielectrode-phased radiofrequency ablation (MEA) to standard focal irrigated radiofrequency ablation (STA) using 3-dimensional navigation. Methods and Results— Patients with paroxysmal atrial fibrillation were randomized to MEA (61 patients) or STA (59 patients). Preprocedure transesophageal echocardiogram and computed tomography/magnetic resonance imaging (also 6-month postprocedure) were performed. Mean age was 57 years, 25% female sex, BMI was 28, CHA 2 DS 2 –VASc score was 0 to 1 in 82%, 8% had previous right atrial ablation, whereas all had at least 1 antiarrhythmic drug failure. The MEA group had significantly shorter mean procedure time (96±36 versus 166±46 minutes, P <0.001) and fluoroscopy time (23±9 versus 27±9 minutes, P =0.023). The total radiofrequency energy duration was 22±8 minutes for MEA versus 36±13 minutes for STA ( P <0.001) with confirmed pulmonary vein isolation in all patients. Hospital admission was 1 day in both groups, without major adverse events either during the procedure or during 30-day follow-up. Two patients in the STA group had 1 PV with asymptomatic narrowing >50%. Freedom of atrial fibrillation for MEA and STA was 86.4% and 89.7% at 6 months, dropping to 76.3% and 81.0% at 12 months. Conclusions— In this multicenter, randomized clinical trial, MEA and STA had similar rates of single-procedure acute pulmonary vein isolation without serious adverse events in the first 30 days. MEA had slightly lower long-term arrhythmia freedom, but showed marked and significantly shorter procedure, fluoroscopy, and radiofrequency energy times. Clinical Trial Registration— URL: www.clinicaltrials.gov ; Unique identifier: NCT01696136.

2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation

“… 731 , 732 This ablation system was not approved for clinical use by the FDA due in part to this initial safety signal and the occurrence of 4 strokes (2.9% of patients randomized to ablation) following ablation in the pivotal Tailored Treatment of Permanent Atrial Fibrillation study. 733 , 734 An additional single-arm study to again elucidate the safety of PVAC technology, the Evaluation of Multielectrode Phased RF Technology in Persistent AF (NCT01693120), was subsequently launched but has recently been closed due to lack of enrollment. In summary, there is considerable reason and data to believe that PVAC technology in its redesigned format has achieved at least a similar safety profile as CB or irrigated tip catheter ablation.…”

2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation

“… 731 , 732 This ablation system was not approved for clinical use by the FDA due in part to this initial safety signal and the occurrence of 4 strokes (2.9% of patients randomized to ablation) following ablation in the pivotal Tailored Treatment of Permanent Atrial Fibrillation study. 733 , 734 An additional single-arm study to again elucidate the safety of PVAC technology, the Evaluation of Multi-electrode Phased RF Technology in Persistent AF (NCT01693120), was subsequently launched but has recently been closed due to lack of enrollment. In summary, there is considerable reason and data to believe that PVAC technology in its redesigned format has achieved at least a similar safety profile as CB or irrigated tip catheter ablation.…”

Multielectrode Pulmonary Vein Isolation Versus Single Tip Wide Area Catheter Ablation-Paroxysmal Atrial Fibrillation

“…The results of the prospective, randomized Multielectrode Pulmonary Vein Isolation Versus Single Tip Wide Area Catheter Ablation (MYSTIC) trial are reported in this edition, 5 which compared standard, irrigated tip radiofrequency ablation with multielectrode-phased radiofrequency ablation (PVAC). As per the reports from 4 experienced centers in the Netherlands and Belgium, rates of single-procedure acute success rates were identical and without any serious adverse events in the first 30 days.…”