Table 3.

Clinical end points and adverse events among patients at stage II and III.

End point or event	Pilot study (N=20)	Clinical trial (N=120)	Ablation (N=97)	P *
Clinical end points before discharge, N (%)
Sinus rhythm restoration	20 (100)	96 (80.0)	69 (71.1)	0.128
A wave of transmitral and transtricuspid flow reappearance	17 (85)	76 (63.3)	48 (49.5)	0.01
Hours of ICU stay	24.5 (21.0, 44.5)	29.0 (23.3, 49.0)	40.0 (26.0, 65.5)	0.006
Total hospitalized cost (USD)	12899.3 (11 594, 13 762)	16863.8 (14 524.1, 20 790.1)	22 551.4 (18708.1, 26 429.9)	<0.001
Death	0	2 (1.67)	1 (1.03)	0.999
Clinical end points at 12 months after operation, N (%)
Sinus rhythm restoration	20 (100)	98 (81.7)	71 (73.2)	0.135
A wave of transmitral and transtricuspid flow reappearance	18 (90)	84 (70)	58 (59.8)	0.116
Death	0	4 (3.33)	2 (2.06)	0.627
Stroke	0	2 (1.67)	1 (1.03)	0.999
Reoperation	0	1 (0.83)	1 (1.03)	0.999
Heart failure	0	1 (0.83)	1 (1.03)	0.999
Permanent pacemaker implantation	0	1 (0.83)	3 (3.09)	0.47
Composite end point	0	8 (6.7)	7 (7.2)	0.874
Renal failure	0	4 (3.33)	4 (4.12)	0.999
Pneumonia	1 (5)	6 (5)	6 (6.19)	0.704
Respiratory failure	0	2 (1.67)	1 (1.03)	0.999
Infective endocarditis	0	1 (0.83)	0	0.999
Deep sternal infection	0	1 (0.83)	1 (1.03)	0.999
Superficial wound infection	0	2 (1.67)	1 (1.03)	0.999
Sepsis	0	1 (0.83)	0	0.999
Multiple organ dysfunction syndrome	0	1 (0.83)	1 (1.03)	0.999

^* P value was obtained by the comparison between clinical trial group and ablation group.