Jun Liu1, Yu Xia2, Hao Zhang2, Xiaofeng Li2, Shu Zhang2, Pihua Fang2. 1. Center for Arrhythmia Diagnosis and Treatment, Fu Wai Hospital, PUMC & CAMS, Beijing, China. liujundoctor@163.com. 2. Center for Arrhythmia Diagnosis and Treatment, Fu Wai Hospital, PUMC & CAMS, Beijing, China.
Abstract
BACKGROUND: Cryoballoon ablation (CBA) is effective for patients with drug-refractory symptomatic atrial fibrillation (AF). For patients with a high risk of stroke (CHA2DS2-VASc score ≥2), life-long oral anticoagulation therapy should be continued even after successful catheter ablation. We investigated the safety and efficacy of concomitant use of a second-generation CBA catheter for pulmonary vein isolation (PVI) and a left atrial appendage closure (LAAC) device in patients with AF. METHODS: We enrolled 27 patients (64.7 ± 6.3 years, 74% male, 63% paroxysmal AF, 37% persistent AF, 4.8 ± 1.4 CHA2DS2-VASc score, and 3.6 ± 1.3 HAS-BLED score). In total, 85% of the patients had a prior stroke or TIA, and 30% of patients had a clinical history of bleeding. Patients received a CBA for PVI and underwent occlusion of the LAA with an LAAC device. The efficacy of CBA was defined as lack of arrhythmia recurrence (AF, atrial flutter, and/or atrial tachycardia lasting ≥30 s) after a 90-day blanking period. The success of LAAC was determined by the rate of stroke, TIA, and/or bleeding events. RESULTS: The mean procedural time for CBA and LAAC was 80 ± 16 min and 44 ± 12 min, respectively. Acute PVI by CBA was achieved in 100% of the procedures, and 96% of patients obtained acute LAAC device placement during the procedure. Upon complete release of the LAAC device, only 62% patients (16/26) had no detectable leakage during intraprocedural transesophageal echocardiography. Three patients experienced an acute complication: a pericardial effusion and two phrenic nerve palsy events. Mean follow-up was 18 months (range 9-23 months), and freedom from AF recurrence was 74% (20/27). CONCLUSION: The intraprocedural combination of CBA and LAAC is feasible in patients with non-valvular AF with a high risk of stroke, TIA, and/or bleeding. Larger long-term randomized studies are needed to judge the overall safety and efficacy of the combined procedure.
BACKGROUND: Cryoballoon ablation (CBA) is effective for patients with drug-refractory symptomatic atrial fibrillation (AF). For patients with a high risk of stroke (CHA2DS2-VASc score ≥2), life-long oral anticoagulation therapy should be continued even after successful catheter ablation. We investigated the safety and efficacy of concomitant use of a second-generation CBA catheter for pulmonary vein isolation (PVI) and a left atrial appendage closure (LAAC) device in patients with AF. METHODS: We enrolled 27 patients (64.7 ± 6.3 years, 74% male, 63% paroxysmal AF, 37% persistent AF, 4.8 ± 1.4 CHA2DS2-VASc score, and 3.6 ± 1.3 HAS-BLED score). In total, 85% of the patients had a prior stroke or TIA, and 30% of patients had a clinical history of bleeding. Patients received a CBA for PVI and underwent occlusion of the LAA with an LAAC device. The efficacy of CBA was defined as lack of arrhythmia recurrence (AF, atrial flutter, and/or atrial tachycardia lasting ≥30 s) after a 90-day blanking period. The success of LAAC was determined by the rate of stroke, TIA, and/or bleeding events. RESULTS: The mean procedural time for CBA and LAAC was 80 ± 16 min and 44 ± 12 min, respectively. Acute PVI by CBA was achieved in 100% of the procedures, and 96% of patients obtained acute LAAC device placement during the procedure. Upon complete release of the LAAC device, only 62% patients (16/26) had no detectable leakage during intraprocedural transesophageal echocardiography. Three patients experienced an acute complication: a pericardial effusion and two phrenic nerve palsy events. Mean follow-up was 18 months (range 9-23 months), and freedom from AF recurrence was 74% (20/27). CONCLUSION: The intraprocedural combination of CBA and LAAC is feasible in patients with non-valvular AF with a high risk of stroke, TIA, and/or bleeding. Larger long-term randomized studies are needed to judge the overall safety and efficacy of the combined procedure.
Authors: Apostolos Tzikas; David R Holmes; Sameer Gafoor; Carlos E Ruiz; Carina Blomström-Lundqvist; Hans-Christoph Diener; Riccardo Cappato; Saibal Kar; Randal J Lee; Robert A Byrne; Reda Ibrahim; Dhanunjaya Lakkireddy; Osama I Soliman; Michael Nabauer; Steffen Schneider; Johannes Brachmann; Jeffrey L Saver; Klaus Tiemann; Horst Sievert; A John Camm; Thorsten Lewalter Journal: Europace Date: 2016-08-18 Impact factor: 5.214