Author + information
- Received December 18, 2018
- Revision received April 15, 2019
- Accepted May 17, 2019
- Published online August 19, 2019.
- Arunashis Sau, MBBSa,
- James P. Howard, MB BChira,b,
- Sayed Al-Aidarous, MBBSa,c,
- João Ferreira-Martins, PhDa,
- Becker Al-Khayatt, MBBSa,
- P. Boon Lim, PhDa,b,
- Prapa Kanagaratnam, PhDa,b,
- Zachary I. Whinnett, PhDa,b,
- Nicholas S. Peters, MDa,b,
- Markus B. Sikkel, PhDa,d,
- Darrel P. Francis, MA, MDa,b and
- S.M. Afzal Sohaib, PhDa,e,f,∗ ()
- aNational Heart and Lung Institute, Imperial College London, London, United Kingdom
- bDepartment of Cardiology, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom
- cDepartment of Cardiology, Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom
- dDepartment of Cardiology, Royal Jubilee Hospital, Victoria, Canada
- eDepartment of Cardiac Electrophysiology, Bart’s Heart Centre, St Bartholomew’s Hospital, London, United Kingdom
- fDepartment of Cardiology, King George Hospital, Ilford, United Kingdom
- ↵∗Address for correspondence:
Dr. S.M. Afzal Sohaib, Department of Cardiac Electrophysiology, Bart's Heart Centre, St Bartholomew's Hospital, West Smithfield, London EC1A 7BE, United Kingdom.
Objectives This meta-analysis examined the ability of pulmonary vein isolation (PVI) to prevent atrial fibrillation in randomized controlled trials (RCTs) in which the patients not receiving PVI nevertheless underwent a procedure.
Background PVI is a commonly used procedure for the treatment of atrial fibrillation (AF), and its efficacy has usually been judged against therapy with anti-arrhythmic drugs in open-label trials. There have been several RCTs of AF ablation in which both arms received an ablation, but the difference between the treatment arms was inclusion or omission of PVI. These trials of an ablation strategy with PVI versus an ablation strategy without PVI may provide a more rigorous method for evaluating the efficacy of PVI.
Methods Medline and Cochrane databases were searched for RCTs comparing ablation including PVI with ablation excluding PVI. The primary efficacy endpoint was freedom from atrial fibrillation (AF) and atrial tachycardia at 12 months. A random-effects meta-analysis was performed using the restricted maximum likelihood estimator.
Results Overall, 6 studies (n = 610) met inclusion criteria. AF recurrence was significantly lower with an ablation including PVI than an ablation without PVI (RR: 0.54; 95% confidence interval [CI]: 0.33 to 0.89; p = 0.0147; I2 = 79.7%). Neither the type of AF (p = 0.48) nor the type of non-PVI ablation (p = 0.21) was a significant moderator of the effect size. In 3 trials the non-PVI ablation procedure was performed in both arms, whereas PVI was performed in only 1 arm. In these studies, AF recurrence was significantly lower when PVI was included (RR: 0.32; 95% CI: 0.14 to 0.73; p = 0.007, I2 78%).
Conclusions In RCTs where both arms received an ablation, and therefore an expectation amongst patients and doctors of benefit, being randomized to PVI had a striking effect, reducing AF recurrence by a half.
The authors have received support from the ElectroCardioMaths Programme of the Imperial Centre for Cardiac Engineering. Dr. Sikkel has received research support from the National Institute of Health Research (Clinical Lectureship award #2670). Dr. Francis has received research support from the Biomedical Research Centre, British Heart Foundation (FS 04/079). Dr. Whinnett has received support from the Biomedical Research Centre, British Heart Foundation FS/13/44/30291). Dr. Howard has received research support from Wellcome Trust (212183/Z/18/Z). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received December 18, 2018.
- Revision received April 15, 2019.
- Accepted May 17, 2019.
- 2019 The Authors