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