Korean single-center experience with femoral access closure using the ExoSeal device

Table 1 Patient and procedure characteristics

Characteristic	n = 179
Age (yr)	59.4 (20–87)
Men	145 (81)
Hypertension	59 (33)
Diabetes	52 (29.1)
Smoking status
Current smoker	37 (20.7)
Ex-smoker	53 (29.6)
Nonsmoker	89 (49.7)
Alcohol intake	57 (31.8)
Anticoagulation	10 (5.6)
Aspirin	7 (3.9)
Warfarin	1 (0.6)
Heparin	2 (1.1)
Interventional procedure	171 (95.5)
Consecutive	78 (43.6)
TACE for HCC	76 (42.5)
Visceral embolization of gastrointestinal bleeding	2 (1.1)
Single	93 (51.9)
Diagnostic procedure	8 (4.5)
Antegrade puncture	5 (2.8)
ExoSeal
5-Fr	172 (96.1)
6-Fr	6 (3.4)
7-Fr	1 (0.5)

Data are presented as n (%), unless indicated otherwise. HCC: Hepatocellular carcinoma; TACE: Transarterial chemoembolization.

Table 2 Success rate comparison between the repeated-procedure group and the single-procedure group n (%)

	Technical success	Procedural success	Success within 5 min
Repeated-procedure, n = 78	77 (98.7)	52 (66.7)	76 (97.4)
Single-procedure, n = 101	99 (98.0)	76 (75.2)	96 (95.0)
Overall, n = 179	176 (98.3)	128 (71.5)	172 (96.1)

Table 3 Student’s t-test for assessing whether the frequency of use of ExoSeal affected the patients’ hemostasis time

	ExoSeal	n	Mean ± SD	P-value
Hemostasis time	Repeat use	78	4.79 ± 4.32	0.606
	Single use	101	4.46 ± 4.38

Table 4 Chi-square test for assessing whether the frequency of ExoSeal use affected the patients’ hemostasis time

Cross table of hemostasis time and ExoSeal repeatability, P-value = 0.137
			ExoSeal repeatability		Total
			Repeat use	Single use
Hemostasis time	< 3 min	Frequency	52	76	128
		% of hemostasis time	40.6	59.4	100
		% of ExoSeal repeated use	66.7	75.2	71.5
		% of total	29.1	42.5	71.5
	> 3 min	Frequency	26	25	51
		% of hemostasis time	51	49	100
		% of ExoSeal repeated use	33.3	24.8	28.5
		% of total	14.5	14	28.5
Total		Frequency	78	101	179
		% of hemostasis time	43.6	56.4	100
		% of ExoSeal repeated use	100	100	100
		% of total	43.6	56.4	100

Table 5 Multiple logistic regressions of the continuous hemostasis-relevant variables

	B	P < 0.05	OR	95%CI for OR
				Lower limit	Upper limit
Women	0.186	0.707	1.204	0.457	3.176
Age	0.013	0.354	1.013	0.985	1.042
DM, yes	0.666	0.135	1.946	0.813	4.662
HTN, yes	-0.500	0.251	0.606	0.258	1.424
Smoking	0.000	0.241	0.000	0.000	0.000
Ex-smoker	-0.752	0.094	0.471	0.196	1.137
Current smoker	-0.280	0.599	0.756	0.266	2.149
Alcohol use	1.215	0.010	3.370	1.345	8.440
5-Fr	0.000	0.559	0.000	0.000	0.000
6-Fr	-0.992	0.281	0.371	0.061	2.252
7-Fr	-21.226	1.000	0.000	0.000	0.000
Anticoagulation	-0.447	0.599	0.640	0.121	3.386
PT-INR	-2.732	0.001	0.065	0.012	0.343

DM: Diabetes mellitus; HTN: Hypertension; PT-INR: Prothrombin time-international normalized ratio; CI: Confidence inteval; OR: Odd ratio.

Table 6 Wilcoxon rank sum test of hemostasis-relevant laboratory findings

Variable	< 3 min			> 3 min			P-value
	n	mean ± SD	Median (min, max)	n	mean ± SD	Median (min, max)
aPTT	100	36.54 ± 8.53	34.6 (22, 77.4)	40	39.53 ± 10.13	36.25 (24.9, 71.7)	0.108
PLT count	128	171.27 ± 93.64	172.5 (27, 706)	51	140.37 ± 86.87	155.5 (28, 347)	0.032a
PT-INR	128	1.17 ± 0.18	1.11 (0.91, 1.93)	51	1.26 ± 0.27	1.14 (0.97, 2.34)	0.037a

^aP < 0.05. aPTT: Activated partial thromboplastin time; PLT count: Platelet count; PT-INR: Prothrombin time-international normalized ratio; SD: Standard definition.