Andrew Martin1, Marina Fowler2, Toni Breskovic3, Alexandre Ouss4, Lukas Dekker4, Sing-Chien Yap5, Rohit Bhagwandien5, Elizabeth M Albrecht6, Nele Cielen6, Elizabeth Richards6, Binh C Tran6, Nigel Lever2, Ante Anic3. 1. Green Lane Cardiovascular Services, Auckland Mail Centre, Auckland City Hospital, Private Bag 92 189, Auckland, 1142, New Zealand. AndrewMa@adhb.govt.nz. 2. Green Lane Cardiovascular Services, Auckland Mail Centre, Auckland City Hospital, Private Bag 92 189, Auckland, 1142, New Zealand. 3. University Hospital Center Split, Split, Croatia. 4. Catharina Hospital, Eindhoven, Netherlands. 5. Erasmus MC, Rotterdam, Netherlands. 6. Boston Scientific Corp., Electrophysiology, St. Paul, MN, USA.
Abstract
BACKGROUND: Recently, a novel cryoballoon ablation catheter has demonstrated acute safety and efficacy in de novo pulmonary vein isolation (PVI) procedures in patients with paroxysmal atrial fibrillation (PAF). However, there are limited studies demonstrating the long-term efficacy. The aim of this study was to evaluate the long-term safety and efficacy of this novel cryoballoon in treating PAF. METHODS: This was a non-randomized, prospective, multicentre study enrolling 58 consecutive patients. Cryoablation was delivered for 180 s if time to isolation was ≤ 60 s. Otherwise a 240-s cryoablation was performed. One centre performed pre- and post-ablation high-density mapping (n = 9) to characterize lesion formation. After a 3-month blanking period, recurrence was defined as having any documented, symptomatic episode(s) of AF or atrial tachycardia. All patients were followed for 1 year. RESULTS: Acute PVI was achieved in 230 of 231 pulmonary veins (99.6%) with 5.3 ± 1.6 cryoablations per patient (1.3 ± 0.7 cryoablations per vein). Forty-three (77%) patients remained arrhythmia-free at 1-year follow-up. Four patients (6.9%) experienced phrenic nerve injury (3 resolved during the index procedure; 1 resolved at 6 months). One serious adverse device event was reported: femoral arterial embolism event occurring 2 weeks post-index procedure. For patients who underwent high-density mapping, cryoablation was antral with 50% of the posterior wall ablated. CONCLUSIONS: Initial multicentre clinical experience with a novel cryoballoon has demonstrated safety and efficacy of PVI in patients with PAF. Ablation with this cryoballoon provides a wide, antral lesion set with significant debulking of the posterior wall of the left atrium.
BACKGROUND: Recently, a novel cryoballoon ablation catheter has demonstrated acute safety and efficacy in de novo pulmonary vein isolation (PVI) procedures in patients with paroxysmal atrial fibrillation (PAF). However, there are limited studies demonstrating the long-term efficacy. The aim of this study was to evaluate the long-term safety and efficacy of this novel cryoballoon in treating PAF. METHODS: This was a non-randomized, prospective, multicentre study enrolling 58 consecutive patients. Cryoablation was delivered for 180 s if time to isolation was ≤ 60 s. Otherwise a 240-s cryoablation was performed. One centre performed pre- and post-ablation high-density mapping (n = 9) to characterize lesion formation. After a 3-month blanking period, recurrence was defined as having any documented, symptomatic episode(s) of AF or atrial tachycardia. All patients were followed for 1 year. RESULTS: Acute PVI was achieved in 230 of 231 pulmonary veins (99.6%) with 5.3 ± 1.6 cryoablations per patient (1.3 ± 0.7 cryoablations per vein). Forty-three (77%) patients remained arrhythmia-free at 1-year follow-up. Four patients (6.9%) experienced phrenic nerve injury (3 resolved during the index procedure; 1 resolved at 6 months). One serious adverse device event was reported: femoral arterial embolism event occurring 2 weeks post-index procedure. For patients who underwent high-density mapping, cryoablation was antral with 50% of the posterior wall ablated. CONCLUSIONS: Initial multicentre clinical experience with a novel cryoballoon has demonstrated safety and efficacy of PVI in patients with PAF. Ablation with this cryoballoon provides a wide, antral lesion set with significant debulking of the posterior wall of the left atrium.
Authors: Wilber Su; Robert Kowal; Marcin Kowalski; Andreas Metzner; J Thomas Svinarich; Kevin Wheelan; Paul Wang Journal: Heart Rhythm Date: 2015-03-14 Impact factor: 6.343
Authors: David N Kenigsberg; Natalia Martin; Hae W Lim; Marcin Kowalski; Kenneth A Ellenbogen Journal: Heart Rhythm Date: 2014-11-13 Impact factor: 6.343
Authors: Karl-Heinz Kuck; Josep Brugada; Alexander Fürnkranz; Andreas Metzner; Feifan Ouyang; K R Julian Chun; Arif Elvan; Thomas Arentz; Kurt Bestehorn; Stuart J Pocock; Jean-Paul Albenque; Claudio Tondo Journal: N Engl J Med Date: 2016-04-04 Impact factor: 91.245
Authors: M N Klaver; L I S Wintgens; M C E F Wijffels; J C Balt; V F van Dijk; A Alipour; S M Chaldoupi; R Derksen; L V A Boersma Journal: J Interv Card Electrophysiol Date: 2020-04-06 Impact factor: 1.900