TY - JOUR
T1 - Paroxysmal and persistent atrial fibrillation ablation outcomes with the pulmonary vein ablation catheter GOLD duty-cycled phased radiofrequency ablation catheter: Quality of life and 12-month efficacy results from the GOLD Atrial Fibrillation Registry
AU - Boersma, Lucas
AU - Koźluk, Edward
AU - Maglia, Giampiero
AU - de Sousa, João
AU - Grebe, Olaf
AU - Eckardt, Lars
AU - Hokanson, Robert B.
AU - Hemingway, Lauren A.
AU - Ostern, Ekaterina
AU - Park, Hyoung-Seob
AU - Rovaris, Giovanni
AU - Arribas, Fernando
AU - Scharf, Christoph
AU - Csanádi, Zoltán
AU - Arenal, Ángel
AU - Laurenzi, Francesco
AU - Klaver, Martijn
AU - Goette, Andreas
PY - 2020/6/1
Y1 - 2020/6/1
N2 - Aims: The GOLD AF Registry has been designed to prospectively assess the population, indications, and outcomes using second-generation phased radiofrequency (RF) ablation (pulmonary vein ablation catheter GOLD) in a global examination of standard-of-care use for the treatment of paroxysmal and persistent atrial fibrillation (AF). Methods and results: GOLD AF (NCT02433613) is a prospective, observational, multi-centre registry designed to characterize efficacy and safety of phased RF ablation in patients with AF. The primary endpoint was freedom from AF recurrence at 12-month follow-up after a 90-day blanking period. Ancillary objectives include safety, procedural efficiency, and quality of life (QoL). The QoL assessment using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and the European Heart Rhythm Association (EHRA) Score of AF-related symptoms was collected at baseline and 12 months. In total, 1054 patients were included in this analysis (age 60.6, 67.6% male, 26.5% PersAF). Kaplan-Meier estimate of freedom from AF recurrence was 77.7% at 12 months. Peri-procedural device or procedure-related complications were observed in 26 (2.5%) patients, with a low stroke rate of 0.3%. One-year post-ablation, the EHRA AF Symptom score decreased in 68% of patients. The AFEQT score improvement was observed in 88.4% and 90.4% of patients who completed the questionnaire in-person or interviewed by phone at 12 month follow-up, respectively. Conclusion: Phased RF ablation for the treatment of paroxysmal and persistent AF demonstrated a 77.7% freedom from AF recurrence at 12 months in addition to a significant reduction in arrhythmia symptoms and clinically meaningful improved QoL. Low peri-procedural complication rate of <3% was reported.
AB - Aims: The GOLD AF Registry has been designed to prospectively assess the population, indications, and outcomes using second-generation phased radiofrequency (RF) ablation (pulmonary vein ablation catheter GOLD) in a global examination of standard-of-care use for the treatment of paroxysmal and persistent atrial fibrillation (AF). Methods and results: GOLD AF (NCT02433613) is a prospective, observational, multi-centre registry designed to characterize efficacy and safety of phased RF ablation in patients with AF. The primary endpoint was freedom from AF recurrence at 12-month follow-up after a 90-day blanking period. Ancillary objectives include safety, procedural efficiency, and quality of life (QoL). The QoL assessment using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and the European Heart Rhythm Association (EHRA) Score of AF-related symptoms was collected at baseline and 12 months. In total, 1054 patients were included in this analysis (age 60.6, 67.6% male, 26.5% PersAF). Kaplan-Meier estimate of freedom from AF recurrence was 77.7% at 12 months. Peri-procedural device or procedure-related complications were observed in 26 (2.5%) patients, with a low stroke rate of 0.3%. One-year post-ablation, the EHRA AF Symptom score decreased in 68% of patients. The AFEQT score improvement was observed in 88.4% and 90.4% of patients who completed the questionnaire in-person or interviewed by phone at 12 month follow-up, respectively. Conclusion: Phased RF ablation for the treatment of paroxysmal and persistent AF demonstrated a 77.7% freedom from AF recurrence at 12 months in addition to a significant reduction in arrhythmia symptoms and clinically meaningful improved QoL. Low peri-procedural complication rate of <3% was reported.
KW - Atrial fibrillation
KW - Catheter ablation
KW - Electrophysiology
KW - PVAC
KW - Phased radiofrequency
KW - Pulmonary vein isolation
UR - http://www.scopus.com/inward/record.url?scp=85086482177&partnerID=8YFLogxK
U2 - https://doi.org/10.1093/europace/euaa042
DO - https://doi.org/10.1093/europace/euaa042
M3 - Article
C2 - 32219388
SN - 1099-5129
VL - 22
SP - 888
EP - 896
JO - EP Europace
JF - EP Europace
IS - 6
ER -