Moloy Das1, Gareth J Wynn2, Yawer Saeed3, Sean Gomes4, Maureen Morgan3, Christina Ronayne3, Laura J Bonnett5, Johan E P Waktare3, Derick M Todd3, Mark C S Hall3, Richard L Snowdon3, Simon Modi3, Dhiraj Gupta6. 1. Institute of Cardiovascular Medicine and Science, Department of Cardiology, Liverpool Heart and Chest Hospital, Liverpool, United Kingdom; Department of Cardiology, Freeman Hospital, Newcastle upon Tyne, United Kingdom. 2. Institute of Cardiovascular Medicine and Science, Department of Cardiology, Liverpool Heart and Chest Hospital, Liverpool, United Kingdom; The Royal Melbourne Hospital, Melbourne, Australia. 3. Institute of Cardiovascular Medicine and Science, Department of Cardiology, Liverpool Heart and Chest Hospital, Liverpool, United Kingdom. 4. Institute of Cardiovascular Medicine and Science, Department of Cardiology, Liverpool Heart and Chest Hospital, Liverpool, United Kingdom; The Prince of Wales Hospital, Sydney, Australia. 5. Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom. 6. Institute of Cardiovascular Medicine and Science, Department of Cardiology, Liverpool Heart and Chest Hospital, Liverpool, United Kingdom. Electronic address: dhiraj.gupta@lhch.nhs.uk.
Abstract
OBJECTIVES: The goal of this study was to determine whether a strategy of early re-isolation of pulmonary vein (PV) reconnection in all patients, regardless of symptoms, would reduce the recurrence of atrial fibrillation (AF) and improve quality of life. BACKGROUND: Lasting pulmonary vein isolation (PVI) remains elusive. PV reconnection is strongly linked to the recurrence of arrhythmia. METHODS: A total of 80 patients with paroxysmal AF were randomized 1:1 after contact force-guided PVI to receive either standard care or undergo a repeat electrophysiology study after 2 months regardless of symptoms (repeat study). At the initial procedure, PVI was demonstrated by entrance/exit block and adenosine administration after a minimum 20-min wait. At the repeat study, all sites of PV reconnection were re-ablated. Patients recorded electrocardiograms daily and whenever symptomatic for 12 months using a handheld monitor. Recurrence was defined as ≥30 s of atrial tachyarrhythmia (AT) after a 3-month blanking period. The Atrial Fibrillation Effect on Quality-of-Life Questionnaire was completed at baseline and at 6 and 12 months. RESULTS: All 40 patients randomized to repeat study attended for this after 62 ± 6 days, of whom 25 (62.5%) had reconnection of 41 (26%) PVs. There were no complications related to these procedures. Subjects recorded a total of 32,203 electrocardiograms (380 [335 to 447] per patient) during 12.6 (12.2 to 13.2) months of follow-up. AT recurrence was significantly lower for the repeat study group (17.5% vs. 42.5%; p = 0.03), as was AT burden (p = 0.03). Scores on the Atrial Fibrillation Effect on Quality-of-Life Questionnaire were higher in the repeat study group at 6 months (p < 0.001) and 12 months (p = 0.02). CONCLUSIONS: A strategy of routine repeat assessment with re-isolation of PV reconnection improved freedom from AT recurrence, AT burden, and quality of life compared with current standard care. (The Effect of Early Repeat Atrial Fibrillation [AF] on AF Recurrence [PRESSURE]; NCT01942408).
RCT Entities:
OBJECTIVES: The goal of this study was to determine whether a strategy of early re-isolation of pulmonary vein (PV) reconnection in all patients, regardless of symptoms, would reduce the recurrence of atrial fibrillation (AF) and improve quality of life. BACKGROUND: Lasting pulmonary vein isolation (PVI) remains elusive. PV reconnection is strongly linked to the recurrence of arrhythmia. METHODS: A total of 80 patients with paroxysmal AF were randomized 1:1 after contact force-guided PVI to receive either standard care or undergo a repeat electrophysiology study after 2 months regardless of symptoms (repeat study). At the initial procedure, PVI was demonstrated by entrance/exit block and adenosine administration after a minimum 20-min wait. At the repeat study, all sites of PV reconnection were re-ablated. Patients recorded electrocardiograms daily and whenever symptomatic for 12 months using a handheld monitor. Recurrence was defined as ≥30 s of atrial tachyarrhythmia (AT) after a 3-month blanking period. The Atrial Fibrillation Effect on Quality-of-Life Questionnaire was completed at baseline and at 6 and 12 months. RESULTS: All 40 patients randomized to repeat study attended for this after 62 ± 6 days, of whom 25 (62.5%) had reconnection of 41 (26%) PVs. There were no complications related to these procedures. Subjects recorded a total of 32,203 electrocardiograms (380 [335 to 447] per patient) during 12.6 (12.2 to 13.2) months of follow-up. AT recurrence was significantly lower for the repeat study group (17.5% vs. 42.5%; p = 0.03), as was AT burden (p = 0.03). Scores on the Atrial Fibrillation Effect on Quality-of-Life Questionnaire were higher in the repeat study group at 6 months (p < 0.001) and 12 months (p = 0.02). CONCLUSIONS: A strategy of routine repeat assessment with re-isolation of PV reconnection improved freedom from AT recurrence, AT burden, and quality of life compared with current standard care. (The Effect of Early Repeat Atrial Fibrillation [AF] on AF Recurrence [PRESSURE]; NCT01942408).
Authors: J Siebermair; B Neumann; F Risch; L Riesinger; N Vonderlin; M Koehler; K Lackermaier; S Fichtner; K Rizas; S M Sattler; M F Sinner; S Kääb; H L Estner; R Wakili Journal: Sci Rep Date: 2019-06-20 Impact factor: 4.379
Authors: René Worck; Samuel K Sørensen; Arne Johannessen; Martin Ruwald; Martin Haugdal; Jim Hansen Journal: J Cardiovasc Electrophysiol Date: 2022-05-31 Impact factor: 2.942