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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Circulation
2015 ; 132
(14
): 1311-9
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With
Paroxysmal Atrial Fibrillation: The Prospective, Randomized, Controlled,
Noninferiority FreezeAF Study
#MMPMID26283655
Luik A
; Radzewitz A
; Kieser M
; Walter M
; Bramlage P
; Hörmann P
; Schmidt K
; Horn N
; Brinkmeier-Theofanopoulou M
; Kunzmann K
; Riexinger T
; Schymik G
; Merkel M
; Schmitt C
Circulation
2015[Oct]; 132
(14
): 1311-9
PMID26283655
show ga
BACKGROUND: There is a lack of data on the comparative efficacy and procedural
safety of open irrigated radiofrequency (RF) and cryoballoon catheter (CB)
ablation for pulmonary vein isolation in patients with paroxysmal atrial
fibrillation. METHODS AND RESULTS: In a prospective, noninferiority study, 315
patients were randomly assigned to RF (n=159) or CB (n=156) ablation. The primary
end point was freedom from atrial arrhythmia with absence of persistent
complications. Patients were largely comparable between groups with more vascular
disease in the RF group (8.2% versus 2.6% for CB; P=0.028). The primary end point
at 12 months was achieved by 70.7% with RF and 73.6% with CB (multiple procedure
success), including 31 redo procedures in each group (19.5% of RF versus 19.9% of
CB; P=0.933). For the intention-to-treat population, noninferiority of CB was
revealed for the predefined inferiority margin (risk difference, 0.029; 95%
confidence interval, -0.074 to 0.132; P<0.001). Rates at 6 months were 63.1% and
64.1% for the RF and CB groups (single procedure success), and noninferiority was
confirmed (risk difference, 0.010; 95% confidence interval, -0.097 to 0.116;
P=0.002). Periprocedural complications for the index procedure were more frequent
in the CB group (5.0% RF, 12.2% CB; P=0.022) with a significant difference in
phrenic nerve palsies (0% RF, 5.8% CB; P=0.002). CONCLUSION: This large,
prospective, randomized, controlled study demonstrates noninferiority of CB
ablation versus RF ablation for treating patients with paroxysmal atrial
fibrillation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov.
Unique identifier: NCT00774566.
|Adrenergic beta-Antagonists/therapeutic use
[MESH]
|Aged
[MESH]
|Anticoagulants/adverse effects/therapeutic use
[MESH]