Table 4.

Serious adverse events

Adverse event, events (subjects)	Cryoballoon CA (n = 107)			AAD (n = 111)
	All	Procedure related	System related	All	Drug related	Procedure related (cross over)
Total	42 (26)	11 (9)	2 (1)	56 (37)	4 (4)	1 (1)
Acute coronary syndrome	0	0	0	1 (1)	0	0
Acute kidney injury	0	0	0	1 (1)	0	0
Adverse drug reaction	0	0	0	3 (3)	2 (2)	0
Arteriospasm coronary	1 (1)	1 (1)	0	0	0	0
Atrial arrhythmia recurrence	15 (11)	1 (1)	0	34 (28)	2 (2)	0
AVNRT	1 (1)	0	0	0	0	0
Bronchitis	1 (1)	0	0	0	0	0
Chest pain	1 (1)	0	0	0	0	0
Gastrointestinal pain	1 (1)	0	0	0	0	0
Impaired gastric emptying	1 (1)	1 (1)	0	1 (1)	0	0
Impaired healing	0	0	0	1 (1)	0	0
Lung disorder/infection	4 (1)	1 (1)	0	0	0	0
Non-sustained ventricular tachycardia	0	0	0	1 (1)	0	0
Oedema peripheral	0	0	0	1 (1)	0	0
Orthostatic hypotension	0	0	0	1 (1)	0	0
Palpitations	0	0	0	1 (1)	0	0
Pericardial disordera	3 (3)	3 (3)	1 (1)	0	0	0
Phrenic nerve paralysis	0	0	0 0	1 (1)b	0	1 (1)
Pneumonia	1 (1)	0	0	0	0	0
Procedural failurec	1 (1)	1 (1)	0	0	0	0
Pyrexia	1 (1)	1.(1)	0	0	0	0
Syncope	0	0	0	1 (1)	0	0
Transient ischaemic attack	1 (1)	1 (1)	1 (1)	0	0	0
Vascular access site haemorrhage	1 (1)	1 (1)	0	0	0	0
Other	9 (9)	0	0	9 (7)	0	0

Atrial arrhythmia recurrence was only classified as a serious adverse event if it resulted in hospitalization.

^aNone of these events resulted in cardiac tamponade.

^bTransient phrenic nerve palsy was experienced by one subject randomized to AAD who underwent CA.

^cFailure of the transseptal puncture was observed in one subject randomized to cryoballoon; a second procedure was successful.

AAD, antiarrhythmic drug; AVNRT, atrioventricular nodal reentry tachycardia; CA, catheter ablation.