Table 2.

Procedural details

	INDI-FREEZE	Control	P-value
Number of PVs, n	200	198
Total number of isolated PVs	199 (99.5)	198 (100)	0.999
Total CB cycles	1.1 ± 0.3	1.2 ± 0.4	0.867
Single-shot isolations	185 (93)	162 (82)	<0.01
Minimum CB temperature (°C)	−46.1 ± 6.3	−45.3 ± 6.9	0.941
Minimum oesophageal temperature (°C)	32.5 ± 5.2	33.1 ± 3.8	0.954
Time to PVI (s)	43 ± 23	50 ± 31	0.073
TTE recordings	138 (69)	99 (50)	<0.001
Duration of total freezing time/PV (s)	157 ± 56	212 ± 83	<0.001
Duration of total freezing time/patient (s)	619 ± 127	842 ± 162	<0.001
Total procedure time (min)	57.9 ± 17.9	63.2 ± 20.2	0.172
Total fluoroscopy time (min)	15.0 ± 10.3	14.2 ± 7.5	0.698
Total amount of contrast medium (mL)	63 ± 17	74 ± 23	0.006
INDI-FREEZE protocol only
Interruption of freezing cycle (TTE not <90 s), n (%)	2 (1)
Interruption of freezing cycle (temp not −30° after 40 s), n (%)	8 (4)
Major complications	3 (6)	1 (2)	0.307
Cardiac tamponade	0 (0)	0 (0)	0.999
Phrenic nerve injury	2 (4)	1 (2)	0.558
Stroke/TIA	1 (2)	0 (0)	0.879
Severe bleeding	0 (0)	0 (0)	0.999
Atrioesophageal fistula	0 (0)	0 (0)	0.999
Death	0 (0)	0 (0)	0.999

Values are counts (n), n (%), or mean ± standard deviation.

CB, cryoballoon; PV(s), pulmonary vein(s); PVI, pulmonary vein isolation; temp, temperature; TIA, transient ischaemic attack; TTE, time to effect.