Publication | Kojodjojo P. et al. 2010 [8] | Vogt J. et al. 2013 [9] | Packer D.L. et al. 2013 [10] | Schmidt M. et al. 2013 [11] | Bordignon S. et al. 2013 [12] | Pokushalov E. et al. 2013 [13] | Malmborg H. et al. 2013 [14] | Pérez- Castellano N. et al. 2014 [15] | |
Study design | Single center cohort study | Single center, prospective observational study | Multi center RCT | German multi-center prospective cohort study | Single center RCT | Single center RCT, Patients blinded | Single center RCT | Single center RCT | |
Intervention | CA vs RF | CA | CA vs AAD | CA vs RF | CA vs LB | CA vs RF | CA vs RF | CA vs RF | |
Number of patients | CA: 124 RF: 53 | CA: 605 | CA: 163 AAD: 82 | CA: 905 RF: 2870 | CA: 70 LB: 70 | CA: 40 RF: 40 | CA: 54 RF: 56 | CA: 25 CA: 25 | |
Major inclusion criteria | Symptomatic PAF (n = 90) or early persistent and AAD refractory AF (n = 34) | Symptomatic PAF (n = 579) or early symptomatic persistent AF (n = 26) | Symptomatic PAF (78%) or symptomatic persistent AF (22%); failure of at least one AAD | Symptomatic PAF; first ablation; patients refractory to at least one AAD | PAF refractory to at least one AAD; age 18 - 75 y; no prior PVI; LA < 50 mm; LVEF > 45% | Patients after previously failed first RF-ablation; CA or RF as a second ablation procedure | Patients with AF, treatment failure of at least one AAD, and scheduled for ablation | Symptomatic recurrent PAF refractory to AAD and considered for the first PV isolation | |
Primary endpoints (selection) | Freedom from AF at 12 mo after a single procedure | Successful PVI of all PV | Freedom from AF after blanking period; freedom from adverse events during 12 mo of follow-up | Procedural outcome; Complication rates | AF recurrence 90 - 365 days after index ablation; procedural complications | AF recurrence rate | Freedom from AF without taking AAD 12 mo after ablation excluding a blanking period of 3 mo | Freedom from AF without taking AAD 12 mo after ablation excluding a blanking period of 3 mo | |
Baseline characteristics | |||||||||
Age (years) | CA: 57.3 ± 9.4 RA: 59.3 ± 9.7* (mean ± SD) | 59 ± 11 (mean ± SD) | Total study Population: 57 ± 9 (mean ± SD) | CA: 62 RF: 63 | CA: 63 ± 12 LB: 63 ± 9 (mean ± SD) | CA: 56 ± 9 RF: 56 ± 11 (mean ± SD) | CA: 59 ± 9 RF: 62 ± 7 | CA: 58 (45 - 62) RF: 56 (40 - 61) | |
Female gender (%) | CA: 25* RF: 23 | CA: 32.9 | CA + AAD: 22.9 | CA: 35.7 RF: 37.3 | CA: 30 LB: 39 | CA: 23 RF: 18 | CA: 20 RF: 29 | CA: 32 RF: 12 | |
HTN (%) | CA: 47* RA: 26 | CA: 42 | CA + AAD: 42 | CA: 57.8 RF: 55.8 | CA: 63 LB: 60 | CA: 15 RF: 17 | CA: 41 RF: 63 | CA: 32 RF: 24 | |
LA size (mm) | CA: 39.6 ± 7.1 RA: 41.5 ± 6.5 | 42.1 ± 5.6 | CA + AAD: 41 ± 5 | nr | CA: 39.8 ± 3.8 LB: 39.9 ± 4.9 (mean ± SD) | CA: 46 ± 5 RF: 48 ± 7 (mean ± SD) | CA: 40 ± 6 RF: 42 ± 5 | nr | |
LVEF (%) | CA: 65.0 ± 8.8 RA: 60.3 ± 7.3 | 57.1 ± 4.0 | CA + AAD: 60 ± 6 | Patients with LVEF > 50% CA: 92.9% RF: 91.4% | CA: 63 ± 4 LB: 63 ± 6 (mean ± SD) | CA: 58 ± 5 RF: 57 ± 6 (mean ± SD) | nr | nr | |
Outcome | |||||||||
Fluoroscopy time (min) | CA: 27 ± 9 RA: 62 ± 36 (mean ± SD) | 25.2 (19.6/32.2) | 63 | CA: 34 (26 - 46) RF: 24 (16 - 37) | CA: 21 ± 9 LB: 15 ± 6 (mean ± SD) | CA: 29 ± 11 RF: 21 ± 17 (mean ± SD) | CA: 32 ± 16 RF: 47 ± 17 (mean ± SD) | CA: 45 ± 16 RF: 45 ± 16 (mean ± SD) | |
Procedural complications, total: | CA: 3 RF: 2 | CA: 43 out of 605 (7.1%) | CA: 54 out of 163 (33%) | CA: 23 out of 849 (2.7%) RF: 118 out of 2578 (4.6%) | CA: 6 LB: 9 | nr | CA: 4 RF: 1 | CA: 2 RF: 1 | |
Death | CA: 0 RF: 0 | CA: 0 | CA: 1 AAD: 0 | CA: 0 RF: 0 | CA: 0 LB: 0 | nr | CA: 0 RF: 0 | CA: 0 RF: 0 | |
AMI | CA: 0 RF: 0 | CA: 0 | CA: 2 AAD: 0 | CA: 0.1% RF: 0 | nr | nr | CA: 0 RF: 0 | CA: 0 RF: 0 | |
Stroke/TIA | CA: 0 RF: 0 | CA: 2 | CA: 7 AAD: 0 | CA: 0.3%**) RF: 0.3% | CA: 0 LB: 1 | CR: 0 RF: 0 | CA: 0 RF: 0 | CA: 0 RF: 0 | |
PE/tamp | CA: 0/1 RF: 0/2 | CA: 2 | CA: 1 AAD: 0 | CA: 0.8% RF: 1.4% | CA: 0 LB: 1 | nr | CA: 0 RF: 0 | CA: 1***) RF: 0 | |