The Efficacy and Safety of Angio-Seal Percutaneous Femoral Artery

Original
Acta Cardiol Sin 2007;23:247-53
The Efficacy and Safety of Angio-Seal
Percutaneous Femoral Artery Closure
Device after Diagnostic and Therapeutic
Cardiac Catheterizations ¾ A Single
Center’s Experience
Cheng-Han Lee,1,2 Shu-Fen Hung,3 Ju-Yi Chen,1 Ting-Hsin Chao,1 Yi-Heng Li,1 Li-Jen Lin1 and Liang-Miin Tsai1
Objective: The purpose of this study was to evaluate the safety and efficacy of a hemostatic puncture closure device
(Angio-Seal Vascular Closure Device) in patients undergoing diagnostic and therapeutic cardiac catheterizations.
Methods: All consecutive patients (n = 102) who received a hemostatic puncture closure device from January 2007
to May 2007 in the National Cheng Kung University Hospital were enrolled in the study. Of these, 45 (44%) patients
received therapeutic cardiac catheterizations. Multivariate logistic regression analyses were used to determine the
predictors of vascular complications.
Results: Of 102 patients, there were 68 (67%) males, and the mean age was 67 ± 11 years. All devices were
deployed successfully, and device dysfunction occurred in only one patient (0.98%), in whom successful
hemostasis was achieved later by manual and sandbag compression. There were 17 patients (16.7%) with small
hematoma († 6 cm in diameter) and three (2.9%) with large hematoma after the procedure. Compared with
patients in the diagnostic group, patients in the therapeutic group had insignificantly higher complications of
large hematoma (n = 3) (6.7% vs 0%, p = 0.08). However, no patients developed pseudoaneurysms, arteriovenous
fistulae, and late bleeding in need of vascular repairs and blood transfusion until 7 to 14 days after discharge in
both groups. Using multivariate logistic regression method, older age (‡ 75 years) was the only risk factor for
developing large hematoma.
Conclusion: Angio-Seal device offers a safe and effective hemostasis of the femoral artery in patients undergoing
diagnostic and therapeutic cardiac catheterizations with acceptable morbidity rates.
Key Words:
Angio-Seal device · Femoral artery puncture · Cardiac catheterization · Complications
INTRODUCTION
Femoral artery access is still the most widely used
for diagnostic and therapeutic cardiac catheterization;
however, it may require manual compression at the vascular access site with or without the use of adjunctive
compression tools. Also, patients need prolonged bed
rest, which results in discomfort, longer hospital stay
and additional costs. Reported vascular complication occurs in 0.8% to 1.8% of diagnostic cardiac catheterizations and 1.5% to 9% of percutaneous coronary inter-
Received: June 18, 2007
Accepted: September 10, 2007
1
Division of Cardiology, Department of Internal Medicine, National
Cheng Kung University Hospital; 2Institute of Clinical Medicine,
School of Medicine, National Cheng Kung University; 3Nursing
Department of National Cheng Kung University Hospital, Tainan,
Taiwan.
Address correspondence and reprint requests to: Dr. Liang-Miin Tsai,
Professor of Internal Medicine, Department of Internal Medicine,
National Cheng Kung University Hospital, No. 138 Sheng-Li Rd.,
Tainan 70428, Taiwan. Tel: 886-6-232-3535 ext. 2389; Fax: 886-6275-3834; E-mail: [email protected]
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Acta Cardiol Sin 2007;23:247-53
Cheng-Han Lee et al.
catheter to maintain an activated clotting time (ACT) between 250 and 300 seconds. Blood samples for ACT
measurements were obtained at the end of the procedure.
Patients receiving intracoronary stents would receive aspirin 100-300 mg/day and clopidogrel 300 mg as a loading dose followed by 75 mg/day if there were no contraindications.
vention (PCI) cases when performed via transfemoral
access, and 20% to 40% of these patients who experience such complications require surgical repair.1-5 Since
the introduction of vascular closure devices, the efficacy
and safety of these devices have been evaluated.6-8 A recent meta-analysis of 30 randomized trials showed that
there is only marginal evidence that arterial puncture
closing devices are effective and they may increase the
risk of hematoma and pseudoaneurysm.9 The frequent
use of antiplatelet and anticoagulant agents in PCI cases
usually has higher rate of vascular complications. Therefore, we sought to compare the efficacy and safety of the
Angio-Seal Vascular Closure Device (St. Jude Medical,
St Paul, MN) in patients undergoing diagnostic and therapeutic cardiac catheterizations in this referred medical center.
Femoral artery closure
Following successful diagnostic catheterization or
PCI procedures, hemostatic puncture closure was then
achieved using the Angio-Seal Vascular Closure Device.
If cardiologists had suspicion of unusual puncture site, a
femoral arteriogram would be performed via the arterial
sheath. Patients generally did not undergo arterial closure if the arteriostomy site was at or below the common
femoral artery bifurcation, extensively calcified, or significantly stenotic (< 5 mm in diameter). The Angio-Seal
device consists of an absorbable plug component and delivery system (Figure 1). Initial arterial sheaths with size
7F were used in all patients, and delivery of the device
was then initiated by first exchanging the existing sheath
over a wire for an 8F sheath. The carrier tube containing
the plug was inserted through the sheath. After ensuring
the carrier tube in the arterial lumen, the anchor was deployed. The sheath and carrier tube assembly was then
retracted (Figure 1), maintaining tension on the assembly while pushing down the temper tube for 10 seconds.
MATERIALS AND METHODS
Study population
The study was conducted at the cardiac catheterization laboratory, National Cheng Kung University Hospital, in southern Taiwan. Patients in our institution undergoing diagnostic cardiac catheterization or PCI using the
femoral artery approach were included in the study. Patients were not eligible for a percutaneous femoral artery
closure device if they had peripheral arterial occluded
disease, presence of ST-segmental elevation myocardial
infarction, presence of hematoma before sheath removal,
or suspicion of profunda femoris puncture. Finally, a total of 102 diagnostic catheterization and PCI procedures
between January 2007 and May 2007 were retrospectively enrolled. There were 45 patients (44%) experiencing PCI procedures and the others received only diagnostic cardiac catheterizations.
Cardiac catheterization and PCI procedures
Diagnostic cardiac catheterization and PCI procedures were performed via the percutaneous femoral approach using 7 French introducers and guide catheters.
Our cardiovascular fellows performed the arterial puncture. If patients just received diagnostic procedures, we
did not give heparin during the procedure. If patients received elective PCI procedures, we routinely gave 10000
U heparin into the coronary artery through the guiding
Acta Cardiol Sin 2007;23:247-53
Figure 1. The Angio-Seal hemostatic puncture closure device. The
Angio-Seal device consists of a delivery system (A and B) and an
absorbable plug component (C). After the sheath and carrier tube assembly is retracted, the device creates a mechanical seal by sandwiching the arteriotomy between a bio-absorbable anchor and collagen
sponge (D).
248
Experience with Angio-Seal Device in Taiwan
procedure duration was significantly longer and activated clotting time was significantly greater in patients
undergoing PCI (Table 1). Immediately before device
deployment, the systolic blood pressure and pulse rate
were similar in both groups (Table 1). Higher percentages of patients received combination anti-platelet therapy in the PCI group. No patients received intravenous
GP IIb/IIIa receptor inhibitor after the PCI procedures.
Table 2 describes the vascular complications in both
groups. Fourteen patients (13.7%) had mild groin oozing
immediately after the device was deployed; however,
oozing was quickly stopped by manual pressure within 5
minutes. All devices were successfully deployed. However, there was one procedure failure. Immediate swelling and active bleeding after the deployment developed
in one patient. After manual pressure and sandbag compression for 6 hours, hemostasis was achieved successfully. Although we reported any hematoma, including
small size († 6 cm in diameter), only large hematoma (>
6 cm in diameter) was regarded as a vascular complication. The overall vascular complication rate was insignificantly lower in the diagnostic catheterization group
as compared with the PCI group (0% vs 6.7%, n = 3, p =
0.08). Table 3 describes the detailed data for patients developing large hematoma. These complications occurred
among the first 30 patients, but werenot observed in the
next 72 patients. In addition, nobody developed other
vascular complications in need of blood transfusion and
vascular repairs. All patients received follow-up between 7 and 14 days after discharge and they were examined for the puncture site, including hematoma, thrills, and bruits. No additional vascular complications
were found in either group during the period. Multivariate logistic regression models for determining predictors of vascular complications showed that older age (‡
75 years) was the only independent risk factor (odds
ratio: 1.3; 95% confidence interval: 1.0~1.7, p = 0.05).
The device created a mechanical seal by sandwiching the
arteriotomy between a bio-absorbable anchor and collagen sponge.
Efficacy and safety of the Angio-Seal device
The efficacy of the Angio-Seal device is defined by
the ability of the device to cover the arteriotomy site and
stop bleeding after the deployment. Procedure failure is
defined as immediate hematoma formation and necessity
of manual and sandbag compression after the deployment. The safety end points included vascular complications, as follows: groin bleeding (defined as blood loss at
the access site resulting in blood transfusion, drop in hemoglobin > 3 g/dl, or late bleeding), large hematoma (>
6 cm in diameter), vascular injury (need for vascular repair, pseudoaneurysm, arteriovenous fistula, acute limb
ischemia). In our hospital, vascular ultrasound investigation of the femoral artery was performed only when
there was clinical suspicion of a vascular complication.
Follow-up of patients after discharge was done at 7 to 14
days.
Statistical analysis
We analyzed the data using SPSS 12.0 software
(SPSS Inc., Chicago, Illinois). Data are expressed as
mean ± standard deviation, or percentage. The c 2 test
was used for comparisons of categorical data, and the
two-tailed Student t test was used to compare continuous
variables. The multiple regression analysis using a stepwise forward regression model in which each variable
with a P value < 0.1 in the univariate analysis for predicting vascular complications was entered into the model. All reported P-values are two-tailed, and statistical
significance was set at P < 0.05.
RESULTS
Baseline characteristics of the 102 study patients, of
which 45 (44%) underwent percutaneous coronary intervention and 57 (56%) underwent diagnostic cardiac catheterization, are listed in Table 1. In the therapeutic
group, male patients significantly predominated, and
higher percentages of diabetes mellitus were found. Before catheterizations, there were no laboratory differences between these two groups. Furthermore, the mean
DISCUSSION
This study documented the use of the Angio-Seal
Vascular Closure Device as a means of achieving early
hemostasis following diagnostic and therapeutic cardiac
catheterization in selected patients. The device was successfully deployed in all study patients, and only one de249
Acta Cardiol Sin 2007;23:247-53
Cheng-Han Lee et al.
Table 1. Baseline clinical characteristics in 102 adult patients
Overall
n = 102
Therapeutic
n = 45
Diagnostic
n = 57
P value
Demographics
Mean age, years
Male
Hypertension
Diabetes mellitus
Renal insufficiency
Hemodialysis
Dyslipidemia
CVA
Smoking
Heart failure
Body mass index
67 ± 11
68%
69%
38%
10.3%
08.2%
33%
12.4%
28%
19%
25.5 ± 4.1
66 ± 11
78%
80%
49%
8.9%
8.9%
33%
13.3%
29%
4.4%
25.2 ± 3.7
67 ± 12
58%
61%
29.1%
14%
8.8%
30%
10.5%
28%
29.8%
25.5 ± 4.4
0.47
0.04
00.052
0.04
0.54
1
0.83
0.76
1
00.002
0.73
Laboratory data
WBC, /mm3
Hemoglobin, mg/dl
Platelets, /mm3
PT, seconds
APTT, seconds
BUN, mg/dl
Creatinine, mg/dl
07224 ± 2334
13 ± 2
232 ± 71
12 ± 1
32 ± 7
025 ± 22
01.8 ± 2.6
07355 ± 2384
13 ± 2
235 ± 65
12 ± 1
32 ± 6
023.7 ± 18.1
01.8 ± 2.4
07116 ± 2330
13 ± 2
226 ± 76
12 ± 1
32 ± 8
027.6 ± 25.4
01.9 ± 2.7
0.62
1
0.52
1
0.99
0.38
0.89
79%
64%
2.1%
84%
93%
0
75%
40%
3.5%
0.33
< 0.001.
0.50
283 ± 620
137 ± 240
77 ± 14
71 ± 44
290 ± 58
134 ± 24
077 ± 15
101 ± 46
234 ± 90
141 ± 23
076 ± 12
047 ± 24
0.09
0.12
0.68
< 0.001.
Features
Medications
Aspirin
Clopidogrel
Warfarin
Before device deployment
ACT, seconds
Systolic BP, mmHg
Heart rate, /minute
Procedure*, minutes
CVA means cerebrovascular accident, which includes ischemic stroke and hemorrhagic stroke; ACT activated clotting time; *stands
for the procedure duration from successful arterial puncture to Angio-Seal deployment.
Table 2. Vascular complications
Complications
Small hematoma (£ 6 cm)
Large hematoma (> 6 cm)
Procedure failure
Pseudoaneurysm
Arteriovenous fistula
Retriperitoneal hemorrhage
Acute limb ischemia
Surgical repairs
Therapeutic group (n = 45)
Diagnostic group (n = 57)
P value
9 (20%).
3 (6.7%)
1 (2.2%)
0
0
0
0
0
8 (14%)
0
0
0
0
0
0
0
0.44
0.08
0.44
-
low-up periods. There seemed to be a learning curve for
Angio-Seal device deployment in this study.
Vascular complications at the access site always lead
vice was dysfunctional. We did not observe any adverse
cardiac events and major vascular complications in need
of vascular repairs and blood transfusion during the folActa Cardiol Sin 2007;23:247-53
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Experience with Angio-Seal Device in Taiwan
Table 3. Detailed data for 3 patients developing large hematoma after device deployment
Patient number
Sex
Age, years
BMI
PT, seconds
aPTT, seconds
Platelets, ´ 103/mm3
Creatinine, mg/dl
Single antiplatelet use
Double antiplatelet use
Indication for catheterization
Procedure duration*, minutes
ACT, seconds
1
2
3
Male
86
24.7
11.7
26.2
152
01.2
Yes
Stable angina
090
266
Male
79
20
10.5
33.2
171
06.1
Yes
AMI
060
318
Female
76
25.2
11.6
26.7
176
00.9
Yes
Stable angina
150
372
BMI means body mass index; AMI, acute myocardial infarction and *stands for the procedure duration from successful arterial
puncture to Angio-Seal deployment.
to prolonged hospital stay, increased costs, and patient
discomfort. Although manual compression is effective in
achieving hemostasis in most patients, it takes 15-20
minutes to compress the puncture site followed by 4- to
6-hour bed rest. Reported vascular complications occur
in 0.8% to 1.8% of diagnostic cardiac catheterizations
and 1.5% to 9% of percutaneous coronary intervention
cases when performed via transfemoral access. 1-5 The
drawbacks of manual compression have led to a search
for methods of puncture site hemostasis that are more
comfortable and effective for both physicians and patients. Since the introduction of vascular closure devices,
the FDA has approved several devices for use in clinical
practice, and the Angio-Seal Vascular Closure Device is
one of them.10-12 The present study showed that the risk
of vascular complications was none in the diagnostic
group and 6.7% in the therapeutic group, which is comparable with previously published literature. The AngioSeal device was effective in achieving hemostasis in
99% of patients. One patient had active groin bleeding
and a large hematoma immediately. An efficacy of 95100% exists in different reports.1-5 Our final results were
all satisfying because manual compression was effective
in achieving hemostasis without any further complications. No serious vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hemorrhage, and surgical repairs, were observed in our study. However, a large-sample study reported that the rate
of serious vascular complications was around 0.2% in
the diagnostic group and 0.7% in the therapeutic group.7
In our series, multivariate logistic regression method
for determining predictors of vascular complications
showed that older age (‡ 75 years) was the only independent risk factor. The frequent use of antiplatelet or
anticoagulant agents created a tendency to an increased
rate of access site complications by manual compression.
Although patients in the therapeutic group had higher
tendency of wound bleeding such as higher activated
clotting time, longer procedure duration, and higher percentages of antiplatelet use, the occurrence of vascular
complications seemed to be not related to these factors.
The Angio-Seal device consists of an anchor composed
of a polylactide and polyglycolide polymer, a collagen
plug, and suture contained within a special carrier system. If appropriately inserted, the device achieves hemostasis by mechanically compressing the arteriotomy site
between the anchor and the collagen plug. Because the
collagen plug instead of vessel wall itself seals off the
puncture hole, antiplatelet and anticoagulant therapy will
not increase the rate of vascular complications. A recent
study also found that older age (‡ 70 years) was an independent predictor of vascular complications. 7 Although older age is not a contraindication, we should be
very careful when applying the Angio-Seal device in
these patients. We are not sure why older patients have
higher incidences of major hematoma. We infer that the
agglutination between the vessel wall and device’s collagen plug in older patients may decrease. According to
our experience, when we retract the sheath and carrier
tube assembly, we should maintain tension on the assem251
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Cheng-Han Lee et al.
3. Resnic F, Blake G, Ohno-Machado L, et al. Vascular closure devices and the risk of vascular complications after percutaneous
coronary intervention in patients receiving glycoprotein IIb-IIIa
inhibitors. Am J Cardiol 2001;88:493-6.
4. Waksman R, King SB, Douglas JS, et al. Predictors of groin complications after balloon and new-device coronary intervention.
Am J Cardiol 1995;75:886-9.
5. Omoigui N, Califf R, Pieper K, et al. Peripheral vascular complications in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I). J Am Coll Cardiol 1995;26:922-30.
6. Aksoy M, Becquemin JP, Desgranges P, et al. The safety and efficacy of Angioseal in therapeutic endovascular interventions. Eur
J Vasc Endovasc Surg 2006;32:90-3.
7. Arora N, Matheny ME, Sepke C, Resnic FS. A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. Am
Heart J 2007;153:606-11.
8. Ward SR, Casale P, Raymond R, et al. Efficacy and safety of a
hemostatic puncture closure device with early ambulation after
coronary angiography. Am J Cardiol 1998;81:569-72.
9. Koreny M, Riedmuller E, Nikfardjam M, et al. Arterial puncture
closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis.
JAMA 2004;291:350-7.
10. Gerckens U, Cattelaens N, Lampe EG, et al. Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device. Am J Cardiol 1999;83:1658-63.
11. Amin FR, Yousufuddin M, Stables R, et al. Femoral haemostasis
after transcatheter therapeutic intervention: a prospective randomized study of the Angio-Seal device vs. the FemoStop device.
Int J Cardiol 2000;76:235-40.
12. Duffin DC, Muhlestein JB, Allisson SB, et al. Femoral arterial
puncture management after percutaneous coronary procedures: a
comparison of clinical outcomes and patient satisfaction between
manual compression and two different vascular closure devices. J
Invasive Cardiol 2001;3:354-62.
bly while pushing down the temper tube for more than
the recommended 10 seconds. Furthermore, if blood
oozes from the puncture site after the Angio-Seal device
deployment, applying short-duration manual pressure is
safe and may decrease vascular complications.
This study has several limitations. Its size did not allow for the evaluation of rare vascular complications
such as pseudoaneurysm, arteriovenous fistula, and acute
limb ischemia. We did not know the duration from the
initial arterial puncture to successful sheath placement,
which may affect the size of the hematoma after AngioSeal device deployment. We did not do routine vascular
ultrasound in every patient during the follow-up period.
However, we would perform the vascular duplex if thrills, bruits, or large hematoma were detected.
In conclusion, Angio-Seal Vascular Closure Device
deployment is an easy, safe, and effective tool to achieve
quick hemostasis. Even in patients undergoing therapeutic cardiac catherterizations, the complications of the
puncture site are acceptable. We should be very careful
when implanting this device in the elderly.
REFERENCES
1. Nasser TK, Mohleri ER, Wilensky RL, Hathaway DR. Peripheral
vascular complications following coronary interventional procedures. Clin Cardiol 1995;18:609-14.
2. Applegate R, Grabarczk M, Little W, et al. Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor
inhibitors during percutaneous revascularization. J Am Coll
Cardiol 2002;40:78-83.
Acta Cardiol Sin 2007;23:247-53
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Original
Acta Cardiol Sin 2007;23:247−53
在診斷和治療性心導管後使用 Angio-Seal 動脈黏合器之
有效度及安全性
李政翰 1,2 洪淑芬 3 陳儒逸 1 趙庭興 1 李貽恆 1 林立人 1 蔡良敏 1
台南市 國立成功大學醫學院附設醫院 內科部 心臟內科1
台南市 國立成功大學醫學院 臨床醫學研究所2
台南市 國立成功大學醫學院附設醫院 護理部3
目的 本研究目的在評估做完診斷和治療性心導管後使用 Angio-Seal 動脈黏合器的有效度
和安全性的比較。
方法 從 2007 年一月至 2007 年五月，共有 102 位病人在國立成功大學附設醫院接受完診
斷或治療性心導管後使用 Angio-Seal 動脈黏合器。其中，有 45 (44%) 位病人同時接受診斷
和治療性心導管。利用多變數回歸分析方法找出使用 Angio-Seal 動脈黏合器後會發生血管
併發症的危險因子。
結果 102 位病人的平均年齡為 67 ± 11 歲而有 68 (67%) 位男性。所有 Angio-Seal 動脈黏
合器都被成功植入，但是有一個 (0.98%) 病人在放完動脈黏合器後並無法立即止血，必須
以手壓止血及後續使用沙袋加壓後才成功獲得止血。在之後出院前追蹤中，共有 17 (16.7%)
位病人出現小血腫 (直徑 / 6 公分) 及 3 (2.9%) 位病人出現大血腫 (直徑 > 6 公分)。與接
受診斷性心導管的病人比較起來，接受治療性心導管的病人似乎有較高比例會出現大血腫
(3 位) (6.7% vs 0%, p = 0.08)，不過並無統計學的意義。但是，在後續出院後 7 至 14 天的追
蹤中並沒有任何病人發生重大血管併發症需要手術治療或輸血，包括假血管瘤、動靜脈瘻
管、延遲傷口出血。利用多變數回歸分析方法找出年老 (年紀 0 75 歲) 是唯一在使用
Angio-Seal 動脈黏合器後會出現大血腫的危險因子。
結論 接受完診斷或治療性心導管後使用 Angio-Seal 動脈黏合器都可以安全並有效的讓股
動脈止血，而它所造成的血管併發症是可以接受的。
關鍵詞：Angio-Seal 動脈黏合器、股動脈穿刺、心導管手術、併發症。
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