Feasibility and safety of left atrial posterior wall isolation with a new Cryoballoon technology in patients with persistent atrial fibrillation.

BACKGROUND: Left atrial posterior wall isolation (LAPWI) is often performed in addition to pulmonary vein isolation (PVI) in the setting of persistent atrial fibrillation (AF) ablation. The aim of this study was to evaluate the feasibility and safety of a new cryoballoon ablation system in achieving PVI + LAPWI isolation. METHODS: The study was a prospective, non-randomized, single center study. Forty consecutive patients, undergoing PVI + LAPWI with the novel POLARx™, were compared to 40 consecutive patients who underwent the same procedure with the established Arctic Front Advance PRO™. RESULTS: Acute isolation was achieved in all PVs in both groups and left posterior wall isolation (LAPWI) was achieved in 38 patients (95%) in the POLARx group and in 36 patients (90%) in Arctic Front group. Procedural outcomes were similar between both groups, except for lower temperatures during cryoenergy in the POLARx group, for both pulmonary vein isolation (PVI) and LAPWI. CONCLUSION: LAPWI + PVI with the novel POLARx™ Cryoballoon is feasible and safe; the results are comparable with the Arctic Front Advance PRO™ system.

Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation.

AIMS: Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF). METHODS AND RESULTS: A total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence [incidence rate ratio (IRR)=0.79, P = 0.28] of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001). CONCLUSIONS: Cryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy.

Standardized Quantification of Vagal Denervation by Extracardiac Vagal Stimulation during Second Generation Cryoballoon ablation: a Vein per Vein Analysis.

AIMS: The purpose of this study was to evaluate the contribution in the acute loss in vagal innervation after ablation with the second generation cryoballoon (CB-A) in each distinct pulmonary vein (PV) by means of external cardiac vagal stimulation (ECVS) by positioning a catheter in the internal jugular vein in a cohort of 60 patients. METHODS: Sixty patients, 50 starting from the left superior pulmonary vein (LSPV) and 10 from the right superior pulmonary vein with symptomatic paroxysmal atrial fibrillation (PAF), having undergone ECVS before the first and after each PV ablation by means of CB-A ablation, were included. RESULTS: The ECVS performed pre-ablation provoked cardioinhibitory responses in all cases with mean pause duration of 10251.83 ms ± 2826.23 ms. At the end of the procedure, the vagal reactions (VR) were significantly diminished. Specifically, compared against the initial pause, responses were 8957.06 ± 2711.66 ms (p < 0.01) after left superior PV, 10017.36 ± 9127.0 ms (p = 0.88) after left inferior PV, 6020.16 ± 3780.709 ms (p < 0.001) after right inferior PV and 1687.5 ± 2183.7 ms (p < 0.001) after right superior PV. Noteworthy, if starting with ablation in the RSPV, VR was immediately reduced by 90.34%, 990.7 ± 379.78 ms (p < 0.001) as compared to baseline response. CONCLUSION: Although not directly targeting the ganglion plexuses, AF ablation with the CB-A causes a significant acute loss in parasympathetic innervation. The RSPV showed to be associated with the most significant reduction of acute loss in parasympathetic innervation.