Key result
Pulmonary vein isolation using PVAC had a similar major complication rate compared to irrigated RF (2% vs 6%), but with a different risk profile including more thromboembolic events.
Why the study?
Does PVAC compared to irrigated RF alter the safety profile and complication rates in patients undergoing first pulmonary vein isolation for atrial fibrillation?
Cohort (n=450)
Does PVAC compared to irrigated RF alter the safety profile and complication rates in patients undergoing first pulmonary vein isolation for atrial fibrillation?
PVAC has a comparable overall complication rate to irrigated RF for pulmonary vein isolation, but presents a different risk profile with fewer pericardial effusions but potentially more thromboembolic events.
Answers are grounded in this paper and cite their sources.
May warrant thromboembolic caution with PVAC for PVI; leaves open need for randomized safety confirmation versus irrigated RF.
BACKGROUND: Silent cerebral lesions with the multielectrode-phased radiofrequency (RF) pulmonary vein ablation catheter (PVAC(®)) have recently been investigated. However, comparative data on safety in relation to irrigated RF ablation are missing. METHODS AND RESULTS: One hundred and fifty consecutive patients (58 ± 12 years, 56 female) underwent first pulmonary vein isolation (PVI) for atrial fibrillation (61% paroxysmal) using PVAC(®) (PVAC). Procedure data as well as in-hospital complications were compared with 300 matched patients who underwent PVI using irrigated RF (iRF). Procedure duration (148 ± 63 vs. 208 ± 70 min; P < 0.001), RF duration (24 ± 10 vs. 49 ± 25 min; P < 0.001), and fluoroscopy time (21 ± 10 vs. 35 ± 13 min; P < 0.001) were significantly shorter using PVAC. Major complication rates [major bleeding, transitoric ischaemic attack (TIA), and pericardial tamponade] were not significantly different between groups (PVAC, n = 3; 2% vs. iRF n = 17; 6%). Overall complication rate, including minor events, was similar in both groups [n = 21 (14%) vs. n = 48 (16%)]. Most of these were bleeding complications due to vascular access [n = 8 (5.3%) vs. n = 22 (7.3%)], which required surgical intervention in five patients [n = 1 (0.7%) vs. n = 4 (1.3%)]. Pericardial effusion [n = 4 (2.7%) vs. n = 19 (6.3%); pericardial tamponade requiring drainage n = 0 vs. n = 6] occurred more frequently using iRF. Two patients in each group developed a TIA (1.3% vs. 0.6%). Of note, four of five thromboembolic events in the PVAC group (two TIAs and three transient ST elevations during ablation) occurred when all 10 electrodes were used for ablation. CONCLUSION: Pulmonary vein isolation using PVAC as a 'one-shot-system' has a comparable complication rate but a different risk profile. Pericardial effusion and tamponade occurred more frequently using iRF, whereas thromboembolic events were more prevalent using PVAC. Occurrence of clinically relevant thromboembolic events might be reduced by avoidance of electrode 1 and 10 interaction and uninterrupted anticoagulation, whereas contact force sensing for iRF might minimize pericardial effusion.
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Wasmer et al. (2015) conducted a cohort in Atrial fibrillation (n=450). Multielectrode-phased radiofrequency pulmonary vein ablation catheter (PVAC) vs. Irrigated radiofrequency catheter (iRF) was evaluated on Major complication rates (major bleeding, TIA, and pericardial tamponade). Pulmonary vein isolation using PVAC had a similar major complication rate compared to irrigated RF (2% vs 6%), but with a different risk profile including more thromboembolic events.
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