Zusammenfassung
Für diagnostische Herzkatheter und Koronarinterventionen ist die A. femoralis
mit über 95 % der meist benutzte Zugang. Die Blutstillung der A. femoralis nach
erfolgter Katheteruntersuchung mittels manuellen „Abdrückens” und anschließendem
Anlegen eines Druckverbandes führt jedoch zur unbequemen, mehrstündigen Immobilisierung
der Patienten.
Seit der Einführung des ersten femoralen Verschlusssystems 1991 haben zahlreiche
Verschlusssysteme das Konzept der signifikanten Verringerung der Hämostasezeit
bei gleichzeitiger Steigerung des Wohlbefindens der Patienten unter Beweis gestellt.
Es gibt 24 arterielle Verschlusssyteme mit unterschiedlichen Konzepten, wie z.
B. reines Kollagen, Kollagen+Thrombin, Kollagen+Anker, Gefäßnaht, Scheiben,
hämostatische Pflaster, Klammern und andere. Die vier z. Zt. gebräuchlichsten
Systeme sind Angio-Seal® (46 %), Perclose® (32 %), VasoSeal® (14 %) und Duett® (3 %). Für alle diese vier Verschlusssysteme wurde ihre Wirksamkeit in jeweils
einer prospektiven, randomisierten, kontrollierten Multicenterstudie unter Beweis
gestellt. Basierend auf zehn Vergleichsstudien mit überwiegenden bzw. ausschließlichen
Koronarinterventionen an 8832 Patienten wurde die Wirksamkeit und Sicherheit der
Verschlusssysteme analysiert. Eine gesicherte Überlegenheit des einen oder anderen
Verschlusssystems konnte jedoch nicht abgeleitet werden. Erfreulicherweise
zeichnet sich in den letzten Jahren der Trend ab, dass Verschlusssysteme im Vergleich
zur manuellen Kompression die Rate an peripheren Komplikationen reduzieren. Somit
sind arterielle Verschlusssysteme zunehmend kosteneffizient. Verschlusssysteme
sollten immer dann eingesetzt werden, wenn längere Liegezeiten in Rückenlage vom
Patienten nicht gut toleriert werden können, Glykoprotein IIb/IIIa Inhibitoren
eingesetzt werden oder eine rasche Entlassung vorgesehen ist. Bei peripherer arterieller
Verschlusskrankheit, sehr dünnkalibrigen Gefäßen insbesondere mit relevanten
Plaques in der A. femoralis sollten Verschlusssysteme in der Regel nicht verwendet
werden. Arterielle Verschlusssysteme nach Femoralispunktion sind heute ein wichtiger
Bestandteil der invasiven Kardiologie.
Summary
The femoral approach is the most commonly used route for diagnostic cardiac catheterization
and coronary interventions today. Manual compression and pressure bandages usually
lead to immobilisation of the patient for several hours and may result in significant
discomfort. Since the introduction of the first femoral closure device in 1991,
many devices have proven their efficacy in significantly reducing time to hemostasis
while simultaneously improving patient comfort. Twenty four closure device systems
with different concepts are on the market, e. g. pure collagen, collagen + thrombin,
collagen + anchor, vascular suture, hemostatic patches and pads, staples and more.
The four predominantly used are Angio-Seal (46 %), Perclose (32 %), VasoSeal
(14 %) and Duett (3 %). The effectiveness of all four systems has been proven
in a prospective, randomized, controlled multicenter trial each. Efficacy and
safety were analyzed using data from ten comparative studies in 8832 predominantly
or exclusively interventional patients, however none of the closure systems proved
to be superior.
Fortunately, recent years have shown a trend toward a reduction in local complications
by vascular closure devices compared to manual compression. Closure devices are
thus becoming increasingly cost effective. Vascular closure systems should be
preferred when the prolonged supine position is not tolerated, a protein IIb/IIIa-inhibitor
was used during the procedure, or early discharge of patient is anticipated. In
the presence of peripheral vascular disease, small diameter of the femoral vessels
or stenotic lesions in the femoral artery, closure devices should be used with
caution. Closure systems for immediate femoral puncture site hemostasis are now
an important tool of invasive cardiology today.
Literatur
- 1
Applegate R J, Grabarczyk M A, Little W C. 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
- 2
Assali A R, Sdringola S, Moustapha A. et al .
Outcome of access site in patients treated with platelet glycoprotein IIb/IIIa
inhibitors in the era of closure devices.
Catheter Cardiovasc Interv.
2003;
58
1-5
- 3
Baim D S, Knopf W D, Hinohara T. et al .
Suture-mediated closure of the femoral access site after cardiac catheterization:
results of the suture to ambulate and discharge (STAND I and STAND II) trials.
Am J Cardiol.
2000;
85
864-869
- 4
Bos J J, Hunink M G, Mali W P.
Use of a collagen hemostatic closure device to achieve hemostasis after arterial
puncture: a cost-effectiveness analysis.
J Vasc Interv Radiol.
1996;
7
479-486
- 5
Brachmann J, Ansah M, Kosinski E J. et al .
Improved clinical effectiveness with a collagen vascular hemostasis device for
shortened immobilization time following diagnostic angiography and percutaneous
transluminal coronary angioplasty.
Am J Cardiol.
1998;
81
1502-1505
- 6
Camenzind E, Grossholz M, Urban P. et al .
Collagen application versus manual compression: a prospective randomized trial
for arterial puncture site closure after coronary angioplasty.
J Am Coll Cardiol.
1994;
24
655-662
- 7
Carey D, Martin J R, Moore C A. et al .
Complications of femoral artery closure devices.
Catheter Cardiovasc Interv.
2001;
52
3-7
- 8
Chamberlin J R, Lardi A B, McKeever L S. et al .
Use of vascular sealing devices (VasoSeal and Perclose) versus assisted manual
compression (Femostop) in transcatheter coronary interventions requiring abciximab
(ReoPro).
Catheter Cardiovasc Interv.
1999;
47
143-147
- 9
Chevalier B, Lancelin B, Koning R. et al .
Effect of a closure device on complication rates in high-local-risk patients:
results of a randomized multicenter trial.
Catheter Cardiovasc Interv.
2003;
58
285-291
- 10
Christensen B V, Manion R V, Iacarella C L. et al .
Vascular complications after angiography with and without the use of sandbags.
Nurs Res.
1998;
47
51-53
- 11
Cura F A, Kapadia S R, L’Allier P L. et al .
Safety of femoral closure devices after percutaneous coronary interventions
in the era of glycoprotein IIb/IIIa platelet blockade.
Am J Cardiol.
2000;
86
780-782
- 12
Dangas G, Mehran R, Kokolis S. et al .
Vascular complications after percutaneous coronary interventions following hemostasis
with manual compression versus arteriotomy closure devices.
J Am Coll Cardiol.
2001;
38
638-641
- 13
Dick R J, Popma J J, Muller D W. et al .
In-hospital costs associated with new percutaneous coronary devices.
Am J Cardiol.
1991;
68
879-885
- 14
Duffin D C, Muhlestein J B, Allisson S B. 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;
13
354-362
- 15
Eggebrecht H, Haude M, Baumgart D. et al .
Hemostatic closure of arterial puncture site using Angio-Seal after diagnostic
heart catheterization or coronary intervention. Hämostatischer Verschluss der
arteriellen Punktionsstelle mittels Angio-Seal nach diagnostischer Herzkatheteruntersuchung
oder Koronarintervention.
Herz.
1999;
24
607-613
- 16
Ernst S, Kloss R, Schräder R. et al .
Immediate sealing of arterial puncture sites after catheterization and PTCA
using a vascular hemostasis device with collagen: an international registry.
Circulation.
1991;
84
I-272
- 17
Forßmann W.
Die Sondierung des rechten Herzens.
Klin Wochenschr.
1929;
8
2085-2087
- 18
Gemmete J J, Dasika N, Forauer A R. et al .
Successful Angioplasty of a Superficial Femoral Artery Stenosis Caused by a
Suture-Mediated Closure Device.
Cardiovasc Intervent Radiol.
2003;
26
410-412
- 19
Gerckens U, Cattelaens N, Muller R. et al .
Percutaneous suture closure of the femoral artery access after diagnostic heart
catheter examination or coronary intervention. Perkutaner Nahtverschluss von
Femoralarterienzugängen nach diagnostischer Herzkatheteruntersuchung oder Koronarintervention.
Dtsch Med Wochenschr.
1996;
121
1487-1491
- 20
Kiemeneij F, Laarman G J, Odekerken D. et al .
A randomized comparison of percutaneous transluminal coronary angioplasty by
the radial, brachial and femoral approaches: the access study.
J Am Coll Cardiol.
1997;
29
1269-1275
- 21
Kim M C, Kini A S, Lee P C. et al .
Does the Use of Vascular Closure Devices Decrease Vascular Complications in
the Current Era of Percutaneous Coronary Interventions?.
Am J Cardiol.
2002;
90
169H
- 22
Krajcer Z, Howell M.
A novel technique using the percutaneous vascular surgery device to close the
22 French femoral artery entry site used for percutaneous abdominal aortic aneurysm
exclusion.
Catheter Cardiovasc Interv.
2000;
50
356-360
- 23
Krone R J, Johnson L, Noto T.
Five year trends in cardiac catheterization: a report from the Registry of the
Society for Cardiac Angiography and Interventions.
Cathet Cardiovasc Diagn.
1996;
39
31-35
- 24
Kussmaul W G, Buchbinder M, Whitlow P L. et al .
Rapid arterial hemostasis and decreased access site complications after cardiac
catheterization and angioplasty: results of a randomized trial of a novel hemostatic
device.
J Am Coll Cardiol.
1995;
25
1685-1692
- 25
Lehmann K G, Heath-Lange S J, Ferris S T.
Randomized comparison of hemostasis techniques after invasive cardiovascular
procedures.
Am Heart J.
1999;
138
1118-1125
- 26
Michalis L K, Rees M R, Patsouras D. et al .
A prospective randomized trial comparing the safety and efficacy of three commercially
available closure devices (Angioseal, Vasoseal and Duett).
Cardiovasc Intervent Radiol.
2002;
25
423-429
- 27
Resnic F S, Blake G J, 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
493-649
- 28
Rickli H, Unterweger M, Sutsch G. et al .
Comparison of costs and safety of a suture-mediated closure device with conventional
manual compression after coronary artery interventions.
Catheter Cardiovasc Interv.
2002;
57
297-302
- 29
Sanborn T A, Gibbs H H, Brinker J A. et al .
A multicenter randomized trial comparing a percutaneous collagen hemostasis
device with conventional manual compression after diagnostic angiography and
angioplasty.
J Am Coll Cardiol.
1993;
22
1273-1279
- 30
SEAL-Investigators.
Assessment of the safety and efficacy of the DUETT vascular hemostasis device:
final results of the safe and effective vascular hemostasis (SEAL) trial.
Am Heart J.
2002;
143
612-619
- 31
Sesana M, Vaghetti M, Albiero R. et al .
Effectiveness and complications of vascular access closure devices after interventional
procedures.
J Invasive Cardiol.
2000;
12
395-399
- 32
Shammas N W, Rajendran V R, Alldredge S G. et al .
Randomized comparison of Vasoseal and Angioseal closure devices in patients
undergoing coronary angiography and angioplasty.
Catheter Cardiovasc Interv.
2002;
55
421-425
- 33
Shimshak T.
Use of a New Suture Closure Device Is Associated with a Low Rate of Bleeding
Complication.
Am J Cardiol.
2002;
90
166H
- 34
Shrake K L.
Comparison of major complication rates associated with four methods of arterial
closure.
Am J Cardiol.
2000;
85
1024-1025
- 35
Silber S.
Rapid hemostasis of arterial puncture sites with collagen in patients undergoing
diagnostic and interventional cardiac catheterization.
Clin Cardiol.
1997;
20
981-992
- 36
Silber S.
Hemostasis success rates and local complications with collagen after femoral
access for cardiac catheterization: analysis of 6007 published patients.
Am Heart J.
1998;
135
152-156
- 37
Silber S.
10 years of arterial closure devices: a critical analysis of their use after
PTCA. 10 Jahre arterielle Verschlusssysteme: Eine kritische Analyse ihrer Anwendung
nach PTCA.
Z Kardiol.
2000;
89
383-389
- 38
Silber S, Bjorvik A, Mühling H. et al .
Usefulness of collagen plugging with VasoSeal after PTCA as compared to manual
compression with identical sheath dwell times.
Cathet Cardiovasc Diagn.
1998;
43
421-427
- 39
Silber S, Dörr R, Mühling H. et al .
Sheath pulling immediately after PTCA: comparison of two different deployment
techniques for the hemostatic puncture closure device: a prospective, randomized
study.
Cathet Cardiovasc Diagn.
1997;
41
378-383
- 40
Silber S, Gershony G, Schön B. et al .
A novel vascular sealing device for closure of percutaneous arterial access
sites.
Am J Cardiol.
1999;
83
1248-1252
- 41
Silber S, Levenson B, Schräder R. et al .
Second and Third Annual Report of the German Society of Coronary Angiography
and Interventions in Private Practice (BNK) concerning quality assurance in
invasive cardiology. Zweiter und dritter Jahresbericht des BNK zur Qualitätssicherung
in der Invasivkardiologie.
Herz.
2000;
25
143-150
- 42
Silber S, Schön N, Seidel N. et al .
Accidental occlusion of the common femoral artery after Angio-Seal-application.
Akzidenteller Verschluss einer A. femoralis communis nach Angio-Seal Applikation.
Z Kardiol.
1998;
87
51-55
- 43
Silber S, Tofte A J, Kjellevand T O. et al .
Final report of the European multi-center registry using the Duett vascular
sealing device.
Herz.
1999;
24
620-623
- 44
Sones F MJ, Shirey E K.
Cine coronary arteriography.
Mod Conc Cardiovasc Dis.
1962;
31
735
- 45
Stiel G M, Beythien C, Kalkowski H. et al .
Peripheral embolism of hemostasis collagen (VasoSeal).
Z Kardiol.
1992;
81
543-545
- 46
Turi Z G.
News you can’t use much longer: the low-volume retrospective closure device
comparison.
Catheter Cardiovasc Interv.
2003;
58
6-7
- 47
von Hoch F, Neumann F J, Theiss W. et al .
Efficacy and safety of collagen implants for haemostasis of the vascular access
site after coronary balloon angioplasty and coronary stent implantation. A randomized
study.
Eur Heart J.
1995;
16
640-646
- 48
Waksman R, King S B, Douglas J S. et al .
Predictors of groin complications after balloon and new-device coronary intervention.
Am J Cardiol.
1995;
75
886-889
- 49 Weinstein M. Vascular Closure. New York: J.P. Morgan Securities Inc In: Cardiovascular
Device Handbook 2003: 91-95
- 50
Yakubov S J, Kahn J K, Bergman G W. et al .
Device Reliability and Safety Using the Angio-Seal STS Vascular Closure Device
in Interventional Patients.
Am J Cardiol.
2001;
88
32G
- 51
Zhang Z, Mahoney E M, Gershony G. et al .
Impact of the Duett sealing device on quality of life and hospitalization costs
for coronary diagnostic and interventional procedures: Results from the Study
of Economic and Quality of Life substudy of the SEAL trial.
Am Heart J.
2001;
142
982-988
Prof. Dr. med. Sigmund Silber
Kardiologische Gemeinschaftspraxis und Praxisklinik in der Klinik Dr. Müller
Am Isarkanal 36
81379 München
Telefon: +49/89/74215130
Fax: +49/89/74215131
eMail: silber@med.de