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.
| Original language | English |
|---|---|
| Journal | Europace |
| Volume | 21 |
| Issue number | 9 |
| Pages (from-to) | 1313-1324 |
| Number of pages | 12 |
| ISSN | 1099-5129 |
| DOIs | |
| Publication status | Published - 01.09.2019 |
Funding
The first author acknowledges funding received from the European Society of Cardiology in form of an ESC Research Grant. We thank all the local investigators and assistant personnel for their great work. We thank Drs Stephanie Fichtner and Daniel Zimmer (both Munich, Germany) for their independent work in the critical event committee. Conflict of interest: An investigator-initiated study; the non-profit foundation ‘Stiftung Institut fuer Herzinfarktforschung’ institute (Ludwigshafen, Germany) conducted the trial and was reimbursed by Medtronic GmbH, Meerbusch, Germany for their services. The participants, investigators, centres or members of the steering committee received no compensation. E.H. reports personal fees from Medtronic, outside the submitted work, and E.H. is head of the department. The department received compensation for participation in clinical research trials outside the submitted work from: Abbott, Bayer, Biotronik, Boehringer Ingelheim, Edwards, Elixier, Medtronic, and Stentys. F.S. reports personal fees from Medtronic, outside the submitted work. K.W. reports grants from Biotronik and personal fees from Boston Scientific, outside the submitted work. U.D. reports personal fees from Medtronic, outside the submitted work. M.K. reports grants from Medtronic, outside the submitted work, and fees for lectures, consulting, and advisory board activities received from Medtronic. A.G.-A. reports non-financial support from Medtronic during the time of the study and personal fees from Medtronic, outside the submitted work. J.K.R.C. reports personal fees from Medtronic, outside the submitted work. R.T. reports grants from Abbott, grants from Hansen Medical, grants and personal fees from Biosense Webster, and grants and personal fees from Medtronic during the time of the study. C.S. reports grants, personal fees, and nonfinancial support from Medtronic during the time of the study. A.M. reports personal fees from Medtronic, outside the submitted work. J.B. reports grants and personal fees from Medtronic, grants and personal fees from Pfizer, grants and personal fees from Biotronik, and grants and personal fees from St. Jude, during the time of the study, as well as grants from Medtronic, grants from St. Jude, and grants from Biotronik, outside the submitted work. K.H.K. reports grants and personal fees from Abbott Vascular, grants and personal fees from Medtronic, and grants and personal fees from Biosense Webster, outside the submitted work. J.S. and T.O. report unrestricted grants from Medtronic to the IHF foundation. D.A. has nothing to declare.
