Table 3 Safety endpoint and procedural adverse events

Event^a	Tailored (n = 187)	Anatomical (n = 183)	P value^b
Subjects with major procedure-related complications	5	5^c	>0.99
Cardiac tamponade or perforation	2	2	>0.99
Bradycardia with pacemaker implantation	1	1	>0.99
Severe cardiac decompensation	1	1	>0.99
Puncture-site hemorrhage requiring transfusion	0	1	>0.99
Transient phrenic nerve palsy	1	0	>0.99
Pneumonia aspiration	0	1	>0.99
Subjects with minor procedure-related complications	15^d	6^d	0.07
Fluid overload^e	9	3	0.14
Pericarditis or pericardial effusion^f	4	0	0.12
Vascular access complication	3	3	>0.99
Post-ablation fever	1	0	>0.99
Abnormal ECG requiring hospitalization	0	1	>0.99
Subjects with non-procedure-related adverse events	3	0	0.25
Death^g	2	0	0.50
Transient ischemic attack	1	0	>0.99

^aThe primary safety endpoint was a composite of death, cerebrovascular events, or treatment-related serious adverse events. Serious adverse events are reported for patients who underwent an ablation procedure, regardless of whether they completed at least 3 months of follow-up. There were no significant differences between groups.
^bTwo-sided Fisher’s exact test was used for the categorical data.
^cOne patient who had a severe cardiac decompensation was subsequently implanted with a pacemaker; accordingly, the individual components add to more than the total number of patients with any event.
^dTwo patients had vascular access complications and fluid overload events; one patient who had a mild pericardial effusion subsequently had a fluid overload event; accordingly, the individual components add to more than the total number of patients with any event.
^ePatients were treated with diuretics only and had favorable outcomes.
^fPatients were treated with corticosteroids or colchicine, and the events resolved without drainage or surgical intervention.
^gTwo patients died as a result of Guillain–Barré syndrome and sarcoma, 5 and 7 months after the ablation, respectively, without arrhythmia recurrence; thus, both deaths were classified as unrelated to the ablation procedure or cardiac disease.

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