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Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation

2019; Oxford University Press; Volume: 21; Issue: 9 Linguagem: Inglês

10.1093/europace/euz155

1532-2092

Ellen Hoffmann, Florian Straube, Karl Wegscheider, Malte Kuniss, Dietrich Andresen, Liqun Wu, Jürgen Tebbenjohanns, Georg Noelker, Roland Richard Tilz, Julian Kyoung Ryul Chun, Andreas Franke, Christoph Stellbrink, Arcadi Garcı́a-Alberola, Uwe Dorwarth, Andreas Metzner, Taoufik Ouarrak, Johannes Brachmann, Karl‐Heinz Kück, Jochen Senges, Joseph Souza, A Stanley, Stefan G. Spitzer, Stephan Willems, T. Dierk, Rolf Borchard, K. Seidl, Ralf Zahn, Guido Groschup, I W P Obel, Jin‐Hong Gerds‐Li, R Gopal, Jan W. Schrickel, Thorsten Lewalter, A Stanley, Werner Moshage, Lars Eckardt, Won‐Sang Jung, P. Kremer, Andrzej Lubiński, Björn Schumacher, Lars Lickfett, Thomas Muenzel, Clemens Steinwender, Michael Efremidis, Thomas Deneke, Dinh Quang Nguyen, Matthias Hochadel, Steffen Schneider,

Cardiac electrophysiology and arrhythmias

Abstract Aims To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF). Methods and results Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was ‘atrial arrhythmia recurrence’, secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P < 0.001). Follow-up duration was 441 (CBA) and 511 days (RFA) (P < 0.0001). Primary endpoint occurred in 30.7% (CBA) and 39.4% patients (RFA) [adjusted hazard ratio (adjHR) 0.85, 95% confidence interval (CI) 0.70–1.04; P = 0.12). In paroxysmal AF, CBA resulted in a lower risk of recurrence (adjHR 0.80, 95% CI 0.64–0.99; P = 0.047). In persistent AF, the primary outcome was not different between groups. Major adverse cardiovascular and cerebrovascular event rates were 1.0% (CBA) and 2.8% (RFA) (adjHR 0.53, 95% CI 0.26–1.10; P = 0.088). Re-ablations (adjHR 0.46, 95% CI 0.34–0.61; P < 0.0001) and adverse events during follow-up (adjHR 0.64, 95% CI 0.48–0.88; P = 0.005) were less common after CBA. Higher rehospitalization rates with RFA were caused by re-ablations. Conclusions The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF. Trial Registration ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.