Efficacy and Safety of the Perclose Closer S Device After Neurointerventional Procedures: Prospective Study and Literature Review

Kamran Khaghany; Firas Al-Ali; Thomas Spigelmoyer; Ron Pimentel; Kurt Wharton

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TABLE 1:

Baseline characteristics

Characteristic	Device Group (n = 475)	Manual-Compression Group (n = 79)	P Value
Male/Female	197 (41)/278 (59)	30 (38)/49 (62)	>.05
Age (years)^a	58.8 ± 14.4	50.1 ± 17.0	<.0001
Diabetes	108 (23)	3 (3.8)	<.0001
Coronary artery disease	84 (18)	10 (13)	>.05
TIA/CVA	184 (39)	8 (10)	<.0001
Preprocedural drug
Heparin	104 (22)	5 (6.3)	.0013
Abciximab	14 (2.9)	0	>.05
Aspirin/clopidogrel	268 (56)	12 (15)	<.0001
Previous device procedures
0	337 (71)	54 (68)	>.05
1	90 (19)	15 (19)	>.05
2	34 (7.2)	8 (10)	>.05
3	9 (1.9)	1 (1.3)	>.05
4	4 (0.8)	0	>.05
5	1 (0.2)	1 (1.3)	>.05

Note.—Data in parentheses are percentages.
a Mean ± standard deviation.

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TABLE 2:

Safety and efficacy results overall and in virgin vessels

Result	Overall^a		Virgin Vessels
Result	Device (n = 475)	Manual Compression (n = 79)	Device (n = 337)	Manual Compression (n = 54)	P Value
Success	450 (95)	76 (96)	320 (95)	53 (98)	>.05
Complication	3 (0.6)	2 (2.5)	2 (0.6)	2 (3.7)	>.05
Pseudoaneurysm	1 (0.2)	2 (2.5)	0	2 (3.7)	.0201
Infection	1 (0.2)	0	1 (0.3)	0	>.05
Subintimal dissection	1 (0.2)	0	1 (0.3)	0	>.05
Surgical intervention	3 (0.6)	2 (2.5)	2 (0.6)	2 (3.7)	>.05
Transfusion	0	0	0	0	NA

Note.—Data in parentheses are percentages. NA = not applicable.
a All P > .05.

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TABLE 3:

Safety and efficacy results no. of previous device procedures

Result	One Procedure^a		Two Procedures^a		Three or More Procedures^a
Result	Device (n = 90)	Manual Compression (n = 15)	Device (n = 34)	Manual Compression (n = 8)	Device (n = 14)	Manual Compression (n = 2)
Success	88 (98)	13 (87)	31 (91)	8 (100)	11 (79)	2 (100)
Complication	0	0	1 (2.9)	0	0	0
Pseudoaneurysm	0	0	1 (2.9)	0	0	0
Infection	0	0	0	0	0	0
Subintimal dissection	0	0	0	0	0	0
Surgical intervention	0	0	1 (2.9)	0	0	0
Transfusion	0	0	0	0	0	0

Note.—Data in parentheses are percentages.
a All P > .05, when applicable.

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TABLE 4:

Comparison of safety and efficacy results

Previous Device Procedure	Success		Complications
Previous Device Procedure	No.	P Value^a	No.	P Value^a
0 (n = 337)	320 (95)	NA	2 (0.6)	NA
1 (n = 90)	88 (98)	>.05	0	>.05
2 (n = 34)	31 (91)	>.05	1 (2.9)	>.05
3 (n = 9)	7 (78)	.0256^b	0	>.05^c
4 (n = 4)	3 (75)	>.05^b	0	>.05^c
5 (n = 1)	1 (100)	>.05^b	0	>.05^c

Note.—Data in parentheses are percentages. NA = not applicable.
a Compared with results for 0 previous procedures.
b Groups with three to five procedures pooled, P = .0096.
c Groups with three to five procedures pooled, P > .05.

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TABLE 5:

Review of the literature

Reference	Device	Total Complications		Hematomas		Arteriovenous Fistulas		Pseudoaneurysms
Reference	Device	Device	Control	Device	Control	Device	Control	Device	Control
9 (Tron et al, 1998)	Perclose Techstar	5/82 (6.1)	2/67 (3.0)	5/82 (6.1)	2/67 (3.0)	0/82 (0)	0/67 (0)	0/82 (0)	0/67 (0)
10 (Gerckens et al, 1999)	Perclose Techstar	12/298 (4.0)	22/292 (7.5)	11/298 (3.7)	21/292 (7.2)	0/298 (0)	0/292 (0)	1/298 (0.3)	1/292 (0.3)
11 (El Amine et al, 1999)	Perclose Techstar	6/50 (12.0)	4/50 (8.0)	5/50 (10.0)	4/50 (8.0)	0/50 (0)	0/50 (0)	1/50 (2.0)	0/50 (0)
12 (Baim et al, 2000)	Perclose Techstar	8/251 (3.2)	6/264 (2.3)	6/251 (2.4)	3/264 (1.1)	0/251 (0)	0/264 (0)	2/251 (0.8)	3/264 (1.1)
13 (Noguchi et al, 2000)	Perclose Techstar	4/30 (13.3)	10/30 (33.3)	4/30 (13.3)	10/30 (33.3)	0/30 (0)	0/30 (0)	0/30 (0)	0/30 (0)
14 (Rindner et al, 2001)	Perclose Techstar	134/880 (15.2)	215/874 (24.6)	40/880 (4.5)	55/874 (6.3)	2/880 (0.2)	6/874 (0.7)	7/880 (0.8)	16/874 (1.8)
15 (Duffin et al, 2001)	Perclose Techstar, Angioseal	31/280 (11.1)	12/197 (6.1)	25/280 (8.9)	7/197 (3.6)	0/280 (0)	0/197 (0)	0/280 (0)	0/197 (0)
18 (Hahn et al, 2001)	Perclose Closer S	2/22 (9.1)	NA	2/22 (9.1)	NA	0/22 (0)	NA	0/22 (0)	NA
16 (Kahn et al, 2002)	Perclose Closer Plus	145/1420 (10.2)	356/8581 (4.1)	73/1420 (5.1)	255/8581 (3.0)	0/1420 (0)	0/8581 (0)	26/1420 (1.8)	25/8581 (0.3)
17 (Rickli et al, 2002)	Perclose Techstar	8/96 (8.3)	6/97 (6.2)	7/96 (7.3)	5/97 (5.2)	0/96 (0)	0/97 (0)	1/96 (1.0)	1/97 (1.0)
4 (Assali et al, 2003)	Perclose Techstar, Angioseal	18/123 (14.6)	13/123 (10.6)	15/123 (12.2)	12/123 (9.8)	0/123 (0)	0/123 (0)	1/123 (0.8)	0/123 (0)
19 (Henk et al, 2003)	Perclose Closer S	41/117 (32.0)	NA	19/117 (16.2)	NA	0/117 (0)	NA	1/117 (0.8)	NA
Present study	Perclose Closer S	3/475 (0.6)	2/79 (2.5)	NA	NA	0/475 (0)	0/79	1/475 (0.2)	2/79 (2.5)