1 Introduction
2 Methods
3 Results
3.1 Study selection
3.2 Study characteristics
Study | Kuroki et al. [14] | Cochet et al. [13] | Nakatani et al. [15] | Blockhause et al. [17] | Reddy et al. [12] | Maurhofer et al. [16] | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
PFA | Thermal | PFA | Thermal | PFA | Thermal | PFA | Thermal | PFA | Thermal | PFA | Thermal | |
Patients (n) | 37 | 43 | 18 | 23 | 18 | 23 | 23 | 20 | 305 | 302 | 40 | 160 |
Male (n (%)) | 28 (76) | 31 (72) | 15 (83) | 17 (74) | 15 (83) | 17 (74) | 15 (65) | 16 (80) | 202 (66) | 195 (65) | 30 (75) | 121 (76) |
Age (yr) | 59 ± 10 | 62 ± 0 | 58 ± 9 | 59 ± 9 | 56 ± 9 | 60 ± 8 | 57 ± 10 | 59 ± 9 | 62 ± 9 | 63 ± 9 | 62 ± 9 | 12 (8) |
BMI | NR | NR | NR | NR | 26 ± 4 | 26 ± 3 | 28 ± 4 | 26 ± 4 | 28 ± 5 | 29 ± 5 | 26 ± 4 | 26 ± 4 |
Persistent AF (n (%)) | 0 (0) | 0 (0) | NR | NR | NR | NR | 11 (48) | 10 (50) | 0 (0) | 0 (0) | 40 (100) | 160 (100) |
CHA2DS2VASc | NR | NR | NR | NR | 0.5 ± 0.8 | 0.6 ± 0.8 | 1.5 ± 1.1 | 1.7 ± 1.4 | 1.7 ± 1.2 | 1.7 ± 1.2 | NR | NR |
Congestive heart failure | NR | NR | NR | NR | 0 (0) | 1 (4) | 3 (13) | 5 (25) | 59 (19) | 59 (20) | NR | NR |
Hypertension | 23 (62) | 20 (47) | 4 (22) | 4 (17) | 4 (22) | 4 (17) | 15 (65) | 8 (40) | 174 (57) | 159 (53) | 26 (65) | 98 (61) |
Diabetes mellitus | 4 (11) | 2 (5) | 1 (6) | 0 (0) | 1 (6) | 0 (0) | NR | NR | 33 (11) | 32 (11) | 3 (8) | 17 (11) |
Stroke or TIA | 2 (5) | 3 (7) | 2 (11) | 1 (4) | 1 (6) | 1 (4) | 0 (0) | 2 (10) | 12 (4) | 15 (5) | 2 (5) | 4 (5) |
CAD/vascular disease | 0 (0) | 6 (14) | 1 (6) | 2 (9) | 1 (6) | 2 (9) | 2 (9) | 5 (25) | 32 (11) | 51 (17) | 8 (20) | 24 (15) |
Dyslipidemia | NR | NR | 3 (17) | 4 (17) | NR | NR | NR | NR | 133 (44) | 141 (47) | NR | NR |
Ejection fraction (%) | 63 ± 3 | 60 ± 6 | 62 ± 6 | 61 ± 8 | 62 ± 6 | 61 ± 8 | 56 ± 8 | 55 ± 8 | NR* | NR* | 58 ± 4 | 59 ± 5 |
Left atrial diameter (mm) | 41 ± 4 | 38 ± 7 | NR | NR | NR | NR | 41 ± 3 | 41 ± 3 | 39 ± 6 | 40 ± 6 | 42 ± 6 | 41 ± 6 |
AAD (n (%)) | NR | NR | 14 (78) | 17 (74) | 13 (72) | 18 (78) | NR | NR | 185 (61) | 173 (57) | NR | NR |
Prior AF ablation (n (%)) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | NR | NR | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Study | Kuroki et al. [14] | Cochet et al. [13] | Nakatani et al. [15] | Blockhause et al. [17] | Reddy et al. [12] | Maurhofer et al. [16] |
---|---|---|---|---|---|---|
Study design | Prospective Non-randomized Single center | Prospective Non-randomized Single center | Prospective Non-randomized Single center | Retrospective Non-randomized Single center | Prospective Randomized Multi-center | Prospective Non-randomized Single center |
Study population | Patients with symptomatic paroxysmal AF resistant to AAD, LVEF > 40% and LA diameter < 5.5 cm (IMPULSE) or LA diameter < 5 cm (PEFCAT I and II) | Patients with paroxysmal AF referred for first catheter ablation procedure without contraindication to gadolinium-enhanced cardiac MRI | Patients with paroxysmal AF undergoing first catheter ablation with no contraindication to gadolinium-enhanced cardiac MRI | Patients with AF who were previously selected for pulmonary vein isolation ablation at a single center | Patients with symptomatic paroxysmal AF resistant to AAD, LVEF > 40% and LA diameter < 5.5 cm | Patients with paroxysmal AF undergoing first catheter ablation |
Pulsed field ablation catheter | Farawave (Farapulse-Boston Scientific) | Farawave (Farapulse-Boston Scientific) | Farawave (Farapulse-Boston Scientific) | Farawave (Farapulse-Boston Scientific) | Farawave (Farapulse-Boston Scientific) | Farawave (Farapulse-Boston Scientific) |
Pulsed field waveform | Monophasic or biphasic | Biphasic | Biphasic | NR | Biphasic | Biphasic |
Type of thermal ablation | Radiofrequency | Radiofrequency in 16 (70%) and cryoablation in 7 (30%) | Radiofrequency in 16 (70%) and cryoablation in 7 (30%) | Cryoablation | Radiofrequency in 167 (55%) and cryoablation in 135 (45%) | Radiofrequency in 80 (50%) and cryoablation in 80 (50%) |
Thermal ablation catheter | Contact force–sensing TactiCath catheter (St. Jude Medical) or ThermoCool NaviStar catheter (Biosense Webster) | Contact-force irrigated radiofrequency ablation catheter (Thermocool Smarttouch, Biosense Webster) or a 28-mm cryoballoon catheter (Arctic Front Advance, Medtronic) | Contact-force irrigated radiofrequency ablation catheter (Thermocool Smarttouch, Biosense Webster) or a 28-mm cryoballoon catheter (Arctic Front Advance, Medtronic) | 28-mm cryoballoon catheter (2nd generation, Arctic Front Advance, Medtronic) | Saline-irrigated force-sensing radiofrequency ablation catheter or 23-mm or 28-mm cryoballoon catheter (2nd generation, Arctic Front Advance, Medtronic) | Contact-force irrigated radiofrequency ablation catheter (Thermocool Smarttouch, Biosense Webster) or a 28-mm cryoballoon catheter (Artctic Front Advance, Medtronic) |
Follow-up | 3 months | 3 months | 9 months | None | 12 months | 12 months |
Monitoring | None | None | 12-lead ECG at 1, 3, and 6 months, 24-h Holter if symptomatic | None | 72-h Holter at 6 and 12 months, and trans-telephonic ECG weekly for symptoms | 7-day Holter at 3, 6, and 12 months |
Imaging obtained | Baseline and 3-month cardiac computed tomography scan | Baseline, within 3-h post-ablation, and 3-month cardiac magnetic resonance imaging | Baseline, within 3-h post-ablation, and 3-month cardiac magnetic resonance imaging | None | 3-month cardiac computed tomography scan or magnetic resonance imaging | None |
3.3 Quality assessment
Quality assessment criteria | Acceptable (*) | Kuroki et al. [15] | Cochet et al. [13] | Nakatani et al. [14] | Blockhause et al. [16] | Maurhofer et al. [16] |
---|---|---|---|---|---|---|
Selection | ||||||
Representativeness of the exposed cohort? | Truly or somewhat representative of the average patient referred for ablation | * | * | * | * | * |
Selection of the non-exposed cohort? | Drawn from the same community as the exposed cohort | * | * | * | * | * |
Ascertainment of exposure? | Secure record | * | * | * | * | * |
Demonstration that outcome of interest was not present at start of study? | Yes | * | * | * | * | * |
Comparability | ||||||
Study controls for antiarrhythmic drug use? | Yes | - | - | - | - | - |
Study controls for at least 3 additional factors? | Age, sex, HTN, HLD, DM, CAD, CVA/TIA | - | - | - | - | * |
Outcome | ||||||
Assessment of outcome? | Independent blind assessment or record linkage | - | - | - | - | - |
Was follow-up long enough for outcomes to occur? | Yes | - | * | * | * | * |
Adequacy of follow up of cohorts? | Complete follow up or subjects lost to follow up unlikely to introduce bias | * | * | * | * | * |
Overall quality score (maximum = 9) | 5 | 6 | 6 | 6 | 7 |
3.4 Study endpoints
Study | Kuroki et al. [15] | Cochet et al. [13] | Nakatani et al. [14] | Blockhause et al. [16] | Reddy et al. [12] | Maurhofer et al. [16] | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
PFA | Thermal | PFA | Thermal | PFA | Thermal | PFA | Thermal | PFA | Thermal | PFA | Thermal | |
Patients (n) | 37 | 43 | 18 | 23 | 18 | 23 | 23 | 20 | 305 | 302 | 40 | 160 |
Access site complication | NR | NR | 1 (6) | 2 (9) | 1 (6) | 2 (9) | 0 (0) | 0 (0) | 1 (0) | 2 (1) | NR | NR |
Cardiac effusion or tamponade | NR | NR | 0 (0) | 0 (0) | NR | NR | 0 (0) | 0 (0) | 2 (1) | 0 (0) | 2 (5) | 0 (0) |
Major bleeding | NR | NR | 0 (0) | 0 (0) | NR | NR | 0 (0) | 0 (0) | 0 (0) | 0 (0) | NR | NR |
TIA or stroke | NR | NR | 0 (0) | 0 (0) | NR | NR | 1 (4) | 0 (0) | 1 (0) | 1 (0) | 0 (0) | 0 (0) |
Coronary vasospasm | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
Myocardial infarction | NR | NR | 0 (0) | 0 (0) | NR | NR | NR | NR | 0 (0) | 0 (0) | NR | NR |
Phrenic nerve injury | NR | NR | 0 (0) | 0 (0) | NR | NR | 0 (0) | 0 (0) | 0 (0) | 2 (1) | 0 (0) | 0 (0) |
Pulmonary vein stenosis | 0 (0) | 2 (5) | 0 (0) | 0 (0) | NR | NR | NR | NR | 0 (0 | 0 (0) | NR | NR |
Atrioesophageal fistula | NR | NR | 0 (0) | 0 (0) | NR | NR | NR | NR | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Death | NR | NR | 0 (0) | 0 (0) | NR | NR | 0 (0) | 0 (0) | 1 (0) | 0 (0) | 0 (0) | 0 (0) |