RAAFT-1 trial[a]
|
70
|
Paroxysmal AF and persistent AF (∼4%); mean age 53 y
|
CA (n = 33) versus AAD (n = 37)
|
PVI
|
None
|
Holter monitoring, symptom journal
|
12 mo
|
At 1-y follow-up: 63% of AAD group had at least 1 recurrence of symptomatic AF compared with 13% in CA arm (p <0.001). Hospitalization occurred in 54% patients in AAD arm versus 9% in CA arm (p <0.001). In the AAD group, the mean (SD) number of AF episodes decreased from 12 (7) to 6 (4), after initiating therapy (p = 0.01).
|
At 6-mo follow-up: the improvement in QOL was significantly better in the CA group in 5 subclasses of the Short-Form 36 health survey
|
CA = 3% (moderate PV stenosis)
|
Wazni et al[10]
|
JAMA 2005
|
AAD = 8.6%
|
APAF study
|
198
|
Paroxysmal AF; mean age 56 y
|
CA (n = 99) versus AAD (n = 99).
|
PVI
|
AAD to CA: 42 (45%)
|
ECG, Holter monitoring, event monitor, symptom journal
|
12 mo
|
93% of patients randomized to ablation were free of recurrence at the end of follow-up as compared with the 35% of patients in AAD arm (p < 0.001) at 1-y follow-up
|
CA was associated with fewer CV hospitalizations (p < 0.01), improved LVEF (p = 0.003) and reduced AF duration (p = 0.015)
|
CA = 1% (1 pericardial effusion not requiring intervention)
|
Pappone et al[6]
|
CA to AAD: 0
|
JACC 2006
|
AAD = 23%
|
|
A4 study
|
112
|
Paroxysmal AF; mean age 51 y
|
CA up to 3 attempts (n = 53) versus AAD (n = 59)
|
PVI
|
AAD to CA: 37 (63%).
|
ECG, SF-36, AF symptom frequency and severity checklist, Holter monitoring, echo and treadmill stress test
|
12 mo
|
23% in AAD group versus 89% in CA group had no recurrence of AF in 1 y (p = 0.0001)
|
CA arm had significantly lower AF burden (p < 0.0001), higher mental and physical component scores (p = 0.01) and lower symptom severity (p < 0.001). There was no difference noted in LA size, LVEDD, and LVEF between the two groups
|
CA = 2% (1 tamponade, 1 PV stenosis)
|
Jaïs P et al[8]
|
Circulation 2008
|
CA to AAD: 5 (9%)
|
AAD = 6%
|
PABA CHF study
|
81
|
Paroxysmal (49%) or persistent AF (51%) with LVEF < 40%); mean age 60 y
|
PVI (n = 41) versus AV nodal ablation with BiV pacing (n = 40)
|
PVI and AV nodal ablation with BiV pacing
|
None
|
Composite of MLWHF score, LVEF on echo and 6MWD
|
6 mo
|
PVI group scored better on MLWHF (60 ± 8 vs. 82 ± 14, p < 0.001), achieved greater 6MWD (340 vs. 297 m, p < 0.001), and a higher LVEF (35 vs. 28%, p < 0.001).
|
In CA group, patients on AAD were 88% free of AF at 6 mo as compared with 71% patients after AV nodal ablation and BiV pacing
|
CA = 17% (1 pericardial effusion, 2 PV stenosis)
|
Khan et al[17]
|
AV Ablation = 7%
|
NEJM 2008
|
THERMOCOOL AF study
|
167
|
Paroxysmal AF; mean age 55 y
|
CA (n = 101) versus AAD (n = 61)
|
PVI and ancillary ablations
|
AAD to CA: 36 (35%) after failing primary end point
|
ECG at follow-up visits, transtelephonic and Holter monitoring
|
9 mo
|
CA patients remained free from protocol-defined treatment failure (66 vs. 16%); free of symptomatic recurrent atrial arrythmia (70 vs. 19%) and free of any recurrent atrial arrhythmia (63 vs. 17%) compared with AAD arm
|
CA patients reported greater improvement in SF-36 mental and physical scores and reported significantly lower symptom frequency and severity
|
CA = 4.9% (1 pericardial effusion)
|
Wilber et al[4]
|
AAD= 8%
|
JAMA 2010
|
ARC-HF trial
|
50
|
Persistent AF in chronic HF patients with LV EF< 35%; mean age 63 y
|
CA (n = 25) versus rate control RC (n = 26)
|
PVI and ancillary ablations
|
RC to CA: 1 (4%)
|
ECG at follow-up visits, 48-h ambulatory monitoring at 6 and 12 mo, device interrogations and echo
|
12 mo
|
Peak oxygen consumption significantly increased in the CA compared with RC (difference +3.07 mL/kg/min) at 12 mo
|
CA improved MLWHF score (p = 0.019) and B-type natriuretic peptide (p = 0.045) and showed nonsignificant trends toward improved 6 MWD (p = 0.095) and LVEF (p = 0.055)
|
One patient with tamponade in CA arm.
|
Jones et al[16]
|
JACC 2013
|
CA to RA: 0
|
MANTRA—PAF study[a]
|
294
|
Paroxysmal AF; mean age 55 y
|
AAD (n = 148) versus CA (n = 146).
|
PVI
|
AAD to CA: 54 (36%)
|
QOL survey; 7-d Holter monitor; Patient logbook; echo
|
24 mo
|
No episodes of AF reported in 85% of RFA group compared with 71% in AAD group (p = 0.004). At 24-mo follow-up visit, burden of atrial fibrillation was reduced with CA compared with AAD: 9 versus 18% (p = 0.007). Above results were durable at 5-y follow-up also
|
Freedom from any atrial fibrillation: 85% versus 71% at 5-y follow-up (p = 0.004) Decreased ASTA index in CA group at 24 mo 47 versus 57% (p < 0.001)
|
CA = 17% (3 tamponades, 1 PV stenosis)
|
Cosedis Nielsen J et al[11]
|
CA to AAD: 13 (9%)
|
AAD = 14%
|
NEJM 2012
|
STOP AF trial
|
245
|
78% paroxysmal, 22% early persistent; mean age 57 y
|
Cryoablation (n = 163) versus AAD (n = 82)
|
PVI and ancillary ablations
|
AAD to CA: 65 (79%) at 12-mo follow-up
|
ECG at follow-up visits, transtelephonic and Holter monitoring
|
12 mo
|
Cryoablation therapy successfully isolated ≥3 PV in 98.2% and all 4 PV in 97.6%. This was achieved with balloon catheter alone in 83%. Ablation group showed higher treatment success (69.9 vs. 7.3%) compared with AAD group at 12-mo follow-up
|
None
|
All serious adverse events: cryoablation 12.3% versus AAD 14.6%; p = 0.69.(5 PV stenosis, 26 phrenic nerve palsy, 1 tamponade)
|
Packer et al[5]
|
JACC 2013
|
CAMTAF study
|
50
|
Persistent AF, and LVEF <50%; mean age 57 y
|
CA (n = 26) versus AAD (n = 24)
|
PVI and ancillary ablations
|
None
|
ECG, serum BNP, echo, treadmill stress test, peak exercise VO2 max
|
6 mo; 12 mo for CA arm
|
Freedom from AF after the last CA was achieved in 81% at 6 mo and was sustained up to a year in 73% patients off AAD. At 6 mo, CA group had greater LVEF which was sustained on 1-year follow-up. The CA arm also had greater reduction in LV end-systolic volume at 6 mo (–14 vs. +4%).
|
At 6 mo, CA resulted in improved exercise capacity and HF symptoms, BNP (126 vs. 327 pg/mL), NYHA class (1.6 vs. 2.4) and QOL (MLWHF score 23.7 vs. 47) compared with AAD
|
CA = 7% (1 stroke, 1 tamponade)
|
Hunter et al[18]
|
AAD = 8%
|
Circulation 2014
|
RAAFT-2 trial[a]
|
127
|
Paroxysmal AF; mean age 55 y
|
CA (n = 66) versus AAD (n = 61)
|
PVI and ancillary ablations
|
AAD to CA: 26 (42%)
|
ECG or transtelephonic monitor
|
24 mo
|
Time to first recurrence of symptomatic or asymptomatic AF, atrial flutter, or atrial tachycardia lasting more than 30 s occurred in 44 patients (72.1%) in the AAD group and 36 pts (54.5%) in the CA (p = 0.02).
|
59% in the AAD group and 47% in the CA group experienced the first recurrence of symptomatic AF, atrial flutter, atrial tachycardia (p = 0.03). Total number of recurrent AF, flutter or atrial tachycardia episodes was significantly lower (213 vs 502) in CA arm. QOL measurements based on surveys were not significantly different between CA and AAD
|
CA = 9% (6% tamponade)
|
Morillo et al[12]
|
CA to AAD: 6 (9%)
|
AAD = 3%
|
JAMA 2014
|
AATAC study
|
203
|
Persistent AF; presence of dual chamber ICD or LVEF < 40%. Mean age 61 y
|
CA (n = 102) versus amiodarone (n = 101)
|
PVI and ancillary ablations
|
Drug to CA: 25 (25%)
|
ECG, echocardiogram, MLHFQ, and 6MWT
|
24 mo
|
71 (70%) patients in gr CA group were recurrence free after an average of 1.4 ± 0.6 procedures in comparison with 34 (34%) in amiodarone group (p <0.001).
|
Over the 2-y follow-up, unplanned hospitalization rate was 31% in CA and 57% in drug arm; P < 0.001, showing a 45% relative risk reduction. A significantly lower mortality rate was observed in CA (8 vs. 18%; p = 0.037).
|
CA = ∼1% (pericardial effusion)
|
DiBiase et al[8]
|
CA to drug: 15 (15%)
|
Amiodarone = 18% (p = 0.037).
|
Circulation 2016
|
CAMERA-MRI study
|
66
|
Persistent AF; LVEF < 45%; no CAD. Mean age 60 y
|
CA (n = 33) versus AAD (n = 33)
|
PVI and posterior wall isolation
|
AAD to CA: 3 (9%)
|
ECHO, Holter monitor, implantable loop recorder, CMRI, 6MWT, serum BNP
|
6 mo
|
LVEF increased 18.3% in CA arm versus 4.4% in drug group. (p < 0.0001). Freedom from AT/AF (>30 s in RFA group was 56% and on AAD was 75%.
|
LVESV was significantly decreased in the CA group (24 vs 20 mL/m2; p = 0.007). Left atrial volume was also significantly decreased in the CA group with no change in the drug group (p < 0.0001)
|
CA = 6%
|
Prabhu et al[20]
|
CA to AAD: 0
|
AAD = 12%
|
JACC 2017
|
CASTLE-AF study
|
397
|
Paroxysmal and persistent AF with LVEF <35% or implanted ICD; median age 64 y
|
CA (n = 179) versus AAD (n = 184)
|
PVI
|
AAD to CA: 18 (9%)
|
ICDs or CRT-Ds interrogation, ECHO, 6MWT
|
60 mo
|
Death or hospitalization for worsening HF occurred in significantly fewer patients in the CA group (28.5 vs. 44.6%; p = 0.006) compared with AAD
|
Heart failure–related admissions was significantly lower in CA group (20.7 vs. 35.9%; p = 0.004). CV deaths were also lower in CA arm (11 vs. 22%; p = 0.009)
|
CA = 13.4% (3 pericardial effusion, 1 pulmonary vein stenosis)
|
Marrouche et al[19]
|
CA to AAD: 28 (15%)
|
AAD = 25.0%
|
NEJM 2018
|
CABANA study
|
2200
|
Paroxysmal (43%), persistent and long-standing persistent (47%); mean age 55 y
|
CA (n = 1108) versus AAD (n = 1096)
|
PVI and ancillary ablations.
|
AAD to CA: 301 (28%)
|
Event monitoring every 6 mo
|
48 mo
|
Composite of death, disabling stroke, serious bleeding, or cardiac arrest at 4 y for CA versus AAD (8 vs. 9.2%) was not significantly different
|
All-cause mortality (5.2 vs. 6.1%), P = NS
|
CA = 5% (8 tamponade, 1 pulmonary vein stenosis, 1 phrenic nerve injury)
|
Packer et al.
|
|
CA to AAD: 99 (9%)
|
Death or CV hospitalization (51.7 vs. 58.1%), p = 0.001
|
JAMA 2019
|
AF recurrence (49.9 vs. 69.5%), p < 0.001
|