Table 2.
Descriptions of studies included in meta-analysis
| Study | Study design | Study population | Catheter | Follow-up | Monitoring method | Quality assessment | ||
|---|---|---|---|---|---|---|---|---|
| PFA | ||||||||
| Selection | Comparability | Outcome | ||||||
| Reddy (2018)20 | Single-arm, multicenter, prospective clinical study | Patients with paroxysmal AF refractory or intolerant to at least 1 AAD. Had to have anteroposterior LA diameter <5.5 cm and LVEF ≥40%. | Farawave | 1 mo | NR | ∗∗∗ | ∗∗∗ | |
| Reddy (2019)21 | Combined analysis of prospective nonrandomized feasibility trials, multicenter | Patients with symptomatic paroxysmal AF resistant to class I to IV antiarrhythmic medications, with LVEF > 40% and LA diameter <5.5 cm for Trial 1 (IMPULSE) or LA diameter <5 cm for Trial 2 (PEFCAT). | Farawave | 12 mo | Transtelephonic monitor with weekly transmissions, 24-h Holter at 6 and 12 mo | ∗∗∗ | ∗∗∗ | |
| Loh (2020)22 | Single-arm, single-center, nonrandomized, prospective cohort study | Patients with symptomatic paroxysmal or persistent AF undergoing first ablation with pulmonary vein diameter <23 mm and no LA or LA appendage thrombus. | Custom nondeflectable 8F, 14-polar catheter with a variable hoop diameter (16– 27 mm) | N/A | N/A | ∗∗∗ | ∗∗∗ | |
| Reddy (June 2020)27 | Single-arm, multicenter, prospective clinical study | Patients with symptomatic paroxysmal or persistent AF resistant to class I to IV antiarrhythmic medications undergoing first ablation procedure with LVEF >40% and LA diameter ≤5.5 cm. | Sphere-9 lattice tip | 3 mo | NR | ∗∗∗ | ∗∗∗ | |
| Reddy (September 2020)26 | Single-arm, multicenter feasibility study | Patients with symptomatic persistent AF refractory or intolerant to at least one class I/III antiarrhythmic agent. | Farawave | 75 d | NR | ∗∗∗ | ∗∗∗ | |
| Cochet (2021)24 | Single-center, prospective clinical study | Patients with paroxysmal AF referred for first catheter ablation procedure without contraindication to gadolinium-enhanced cardiac MRI. | Farawave | 3 mo | N/A | ∗∗∗∗ | ∗∗∗ | |
| Nakatani (2021)25 | Single-center, prospective, feasibility study | Patients with paroxysmal AF undergoing first catheter ablation with no contraindication to gadolinium-enhanced cardiac MRI. | Farawave | 9 mo | 12-lead ECG at 1, 3, and 6 mo, 24-h Holter if symptomatic | ∗∗∗∗ | ∗∗∗ | |
| Reddy (2021)28 | Combined analysis of 3 prospective safety and feasibility trials, multicenter | Patients with symptomatic paroxysmal AF resistant to at least 1 class I to IV antiarrhythmic medication, with LVEF >40% and LA diameter <5.5 cm for Trial 1 (IMPULSE) or LA diameter <5 cm for Trials 2, 3 (PEFCAT I and II). | Farawave | 12 mo | Weekly transtelephonic ECGs and 24-h Holter at 6 and 12 mo | ∗∗∗ | ∗∗∗ | |
| Blockhaus (2022)23 | Single-center, retrospective analysis | Patients with AF who were previously selected for pulmonary vein isolation ablation at a single center. | Farawave | N/A | N/A | ∗∗∗ | ∗∗∗ | |
| Ekanem (2022)29 | Retrospective survey of all centers performing PFA | Patients with AF who underwent PFA at 1 of 24 centers after regulatory approval of PFA procedure. | Farawave | N/A | N/A | ∗∗∗ | ∗∗ | |
| Futing (2022)30 | Single-arm, single-center, prospective clinical study | Patients with paroxysmal AF refractory or intolerant to a class I or III antiarrhythmic agent or opted for first-line rhythm control therapy without a history of a previous ablation. | Farawave | 90 d | 12-lead ECG and 7-d Holter | ∗∗∗ | ∗∗∗ | |
| Gunawardene (2022)31 | Single-arm, single-center, prospective clinical study | Patients with AF who were eligible for catheter ablation of AF. | Farawave | N/A | N/A | ∗∗∗ | ∗∗∗ | |
| Kawamura (2022)32 | Retrospective analysis of single-arm, single-center feasibility study | Patients with symptomatic paroxysmal AF resistant to antiarrhythmic medications with LVEF >40% and LA diameter <5 cm. | Farawave | 84 d | N/A | ∗∗∗ | ∗∗ | |
| Lemoine (2022)33 | Retrospective analysis of single-arm, multicenter clinical study | Patients with symptomatic AF undergoing first time ablation with LA diameter <6 cm and without severe valvular heart disease or contraindications to oral anticoagulation. | Farawave | 12 mo | 12-lead ECG and Holter for symptoms at 3-, 6-, and 12-mo visits | ∗∗∗ | ∗∗∗ | |
| Schmidt (2022)34 | Single-arm, nonrandomized, multicenter real-world series | Patients with symptomatic AF refractory to treatment of at least 1 AAD undergoing first-time ablation without moderate or severe mitral valve disease, intracardiac thrombus, or contraindications to oral anticoagulation. | Farawave | 3 mo | 72-h Holter at 3 mo and 24-h Holter or external monitor for symptoms | ∗∗∗ | ∗∗∗ | |
| Verma (2022)35 | Single-arm, multicenter, prospective clinical trial | Patients with AF refractory to at least 1 AAD, LVEF ≥35%, and LA diameter < 5cm undergoing first-time ablation. | PulseSelect | 30 d | 12-lead ECG | ∗∗∗ | ∗∗∗ | |
| Verma (2023)36 | Paired, single-arm, multicenter, prospective nonrandomized study | Patients with paroxysmal or persistent AF refractory to class I or III AADs. | PulseSelect | 12 mo | Weekly and symptomatic transtelephonic monitoring, 3-, 6-, and 12-mo 12-lead ECGs, and 6- and 12-mo 24-h Holter | ∗∗∗ | ∗∗∗ | |
| Thermal ablation | ||||||||
| RAAFT-1 (2005)13 | Multicenter, prospective randomized trial | Patients experiencing monthly symptomatic AF episodes for at least 3 mo who had not been treated with AADs or ablation. | 8-mm-tip RF catheter | 12 mo | 1-mo loop event recorder at discharge and 3 mo, 24-h Holter at 3, 6, and 12 mo | N/A | ||
| MANTRA (2012)14 | Multicenter, randomized trial | Patients with symptomatic paroxysmal AF who had not been treated with AADs or ablation, but had LVEF ≥40%, LA diameter >5 cm, absence of moderate-to-severe mitral valve disease, and absence of severe heart failure. | 3.5-mm RF catheter with irrigated tip or 8-mm solid-tip RF catheter | 24 mo | 7-d Holter at 3, 6, 12, 18, and 24 mo | N/A | ||
| RAAFT-2 (2014)15 | Multicenter, randomized trial | Patients with symptomatic paroxysmal AF who had not been treated with AADs or ablation, but had LVEF ≥40%, LA diameter <5.5 cm, absence of moderate-to-severe left ventricular hypertrophy, absence of valvular heart disease, and absence of coronary artery disease. | Left to discretion of operator | 24 mo | Transtelephonic monitoring and biweekly recordings with 1-, 3-, 6-, 12-, and 24-mo follow-up | N/A | ||
| FIRE AND ICE (2016)16 | Multicenter, randomized trial | Patients with symptomatic paroxysmal AF that was refractory to class I or III AADs or beta-blockers. | First- and second-generation cryoballoon catheters, the combined first-generation RF catheters, or the advanced-generation RF catheter | 18 mo | Weekly transtelephonic monitoring, 12-lead ECG and 24-h Holter at 3, 6, and 12 mo then every 6 mo thereafter | N/A | ||
| CABANA (2019)17 | Multicenter, randomized trial | Patients with AF who were ≥65 years or <65 years with ≥1 risk factors for stroke. Patients were excluded if they had a history of ablation or failed ≥2 AADs. | Left to discretion of operator | 48.5 mo | ECG event recorder for symptoms, quarterly 24-h recordings, and 96-h Holter every 6 mo | N/A | ||
| STOP AF (2020)18 | Multicenter, randomized trial | Patients with recurrent symptomatic paroxysmal AF with LA diameter <5 cm, no previous treatment with AADs, and no previous history of ablation. | Second-generation cryoballoon catheter | 12 mo | 12-lead ECG at 1, 3, 5, and 12 mo and 24-h Holter at 6 and 12 mo | N/A | ||
| EARLY-AF (2021)19 | Multicenter, randomized trial | Patients with symptomatic AF who did not have a history of regular (daily) use of a class I or III AAD at therapeutic doses. | 23-mm or 28-mm cryoballoon catheter | 12 mo | Implantable cardiac monitor | N/A | ||
ECG = electrocardiogram; LA = left atrium; MRI = magnetic resonance imaging; N/A = not applicable; NR = not reported; PFA = pulsed field ablation; RF = radiofrequency; other abbreviations as in Table 1.