Biomaterial Database

Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation. 2019

Ellen Hoffmann, and Florian Straube, and Karl Wegscheider, and Malte Kuniss, and Dietrich Andresen, and Li-Qun Wu, and Jürgen Tebbenjohanns, and Georg Noelker, and Roland Richard Tilz, and Julian Kyoung Ryul Chun, and Andreas Franke, and Christoph Stellbrink, and Arcadi Garcia-Alberola, and Uwe Dorwarth, and Andreas Metzner, and Taoufik Ouarrak, and Johannes Brachmann, and Karl-Heinz Kuck, and Jochen Senges, and

Department of Cardiology and Internal Intensive Care Medicine, Heart Center Munich-Bogenhausen - Munich Municipal Hospital Group, Englschalkinger Str. 77, Munich, Germany.

OBJECTIVE 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). 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. BACKGROUND ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.

UI	MeSH Term	Description	Entries
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D010359	Patient Readmission	Subsequent admissions of a patient to a hospital or other health care institution for treatment.	Hospital Readmission,Rehospitalization,Unplanned Hospital Readmissions,Unplanned Readmission,30 Day Readmission,Hospital Readmissions,Readmission, Hospital,Readmissions, Hospital,Thirty Day Readmission,30 Day Readmissions,Hospital Readmission, Unplanned,Hospital Readmissions, Unplanned,Readmission, Patient,Readmission, Thirty Day,Readmission, Unplanned,Rehospitalizations,Thirty Day Readmissions,Unplanned Hospital Readmission,Unplanned Readmissions
D011183	Postoperative Complications	Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery.	Complication, Postoperative,Complications, Postoperative,Postoperative Complication
D011446	Prospective Studies	Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group.	Prospective Study,Studies, Prospective,Study, Prospective
D011829	Radiation Dosage	The amount of radiation energy that is deposited in a unit mass of material, such as tissues of plants or animal. In RADIOTHERAPY, radiation dosage is expressed in gray units (Gy). In RADIOLOGIC HEALTH, the dosage is expressed by the product of absorbed dose (Gy) and quality factor (a function of linear energy transfer), and is called radiation dose equivalent in sievert units (Sv).	Sievert Units,Dosage, Radiation,Gray Units,Gy Radiation,Sv Radiation Dose Equivalent,Dosages, Radiation,Radiation Dosages,Units, Gray,Units, Sievert
D012008	Recurrence	The return of a sign, symptom, or disease after a remission.	Recrudescence,Relapse,Recrudescences,Recurrences,Relapses
D012086	Reoperation	A repeat operation for the same condition in the same patient due to disease progression or recurrence, or as followup to failed previous surgery.	Revision, Joint,Revision, Surgical,Surgery, Repeat,Surgical Revision,Repeat Surgery,Revision Surgery,Joint Revision,Revision Surgeries,Surgery, Revision
D003452	Cryosurgery	The use of freezing as a special surgical technique to destroy or excise tissue.	Cryoablation,Cryoablations,Cryosurgeries
D005260	Female		Females