Skip to main content
Hauptrubriken
CME Facharzt-Training Webinare Zeitschriften Bücher e.Medpedia Podcast
Service
Jobbörse Info & Hilfe
Fachgebiete
Anästhesiologie Allgemeinmedizin Arbeitsmedizin Augenheilkunde Chirurgie Dermatologie Gynäkologie und Geburtshilfe HNO Innere Medizin Kardiologie Neurologie Onkologie und Hämatologie Orthopädie und Unfallchirurgie Pädiatrie Pathologie Psychiatrie Radiologie Rechtsmedizin Urologie Zahnmedizin
Themen
Typ-2-Diabetes und Adipositas Klimawandel und Gesundheit Neues aus dem Markt COVID-19 Praxis und Beruf Seltene Erkrankungen GOÄ & EBM Panorama
Sammlungen
Kasuistiken Algorithmen & Infografiken Blickdiagnosen Arthropedia FlapFinder (für Dermatochirurgen) Videos Kongressberichterstattung Medizin für Apothekerinnen und Apotheker Für Ärztinnen und Ärzte in Weiterbildung Für Medizinstudierende

Die Highlights vom Kongress des American College of Cardiology 2024

Im April diskutierten die Herz-Kreislauf-Spezialisten aus der ganzen Welt auf dem  Kongress des American College of Cardiology (ACC) u.a. neue Therapieansätze bei akutem Myokardinfarkt, koronarer Herzerkrankung, kardiogenem Schock oder Aortenklappenstenose. In unserem Kongress-Dossier haben wir für Sie Berichte über die „Late-Breaking Trials“ und andere wichtige Studien zusammengestellt. 
Erweiterte Suche
Anmelden
nach oben
Herz
Erschienen in: Herz 5/2015

01.08.2015 | Original article

Comparison of Exo-Seal® and Angio-Seal® for arterial puncture site closure

A randomized, multicenter, single-blind trial

verfasst von: Johannes Ketterle, MD, Harald Rittger, MD, Inga Helmig, Lutz Klinghammer, Stefan Zimmermann, Wolfgang Hohenforst-Schmidt, Johannes Brachmann, Holger Nef, Stephan Achenbach, Christian Schlundt

Erschienen in: Herz | Ausgabe 5/2015

Einloggen, um Zugang zu erhalten

Abstract

Background

The use of extravascular femoral closure devices in patients undergoing coronary angiography/intervention has not been sufficiently evaluated. We sought to define the impact of an extravascular polyglycolic acid (PGA) plug for the closure of a femoral access site in patients undergoing coronary angiography and/or percutaneous coronary intervention.

Methods

In this prospective, single-blind, multicenter trial we randomly assigned 319 patients to vessel closure with Angio-Seal® or Exo-Seal®. We hypothesized that the use of an extravascular closure device is not inferior to an anchor/plug-mediated device regarding the occurrence of the composite primary endpoint: hematoma > 5 cm, significant groin bleeding (TIMI major bleed), false aneurysm, and device failure.

Results

There was no significant difference in patient baseline characteristics or procedural results. After 24 h the primary endpoint occurred in nine patients (5.6 %) in the Angio-Seal® group and in 13 patients (8.2 %) inthe Exo-Seal® group (p = 0.38). Hematoma > 5 cm was noted in three patients (1.9 %) receiving Angio-Seal® vs. two patients (1.3 %) receiving Exo-Seal® (p = 0.99). In one patient (0.6 %) of the Exo-Seal® group, TIMI major bleeding occurred, requiring transfusion (p = 0.49). There were four (2.5 %) false aneurysms found in patients treated with Angio-Seal® and two (1.3 %) in patients treated with Exo-Seal® (p = 0.68). There was a trend for a higher incidence of device failure in the Exo-Seal® group (1.2 vs. 5.2 %, p = 0.06). At telephone interview after 30 days, there was no significant difference found regarding the events readmission with surgery of puncture site, infection, bleeding, hematoma, or pain.

Conclusion

In the present study, there were no significant differences found regarding the occurrence of hematoma > 5 cm, major bleeding, false aneurysm, and device failure between Angio-Seal® and Exo-Seal® 24 h after device implantation.
Literatur
1.
Piper WD, Malenka DJ, Ryan TJ Jr, Shubrooks SJ Jr, OʼConnor GT, Robb JF, Farrel KL, Corliss MS, Hearne MJ, Kellett MA Jr, Watkins MW, Bradley WA, Hettleman BD, Silver TM, Mc Grath PD, OʼMears JR, Wennberg DE (2003) Northern New England cardiovascular disease study group. Predicting vascular complications in percutaneous coronary interventions. Am Heart J 145:1022–1029
2.
Duffin DC, Muhlestein JB, Allison SB, Horne BD, Fowles RE, Sorensen SG, Revenaugh JR, Bair TL, Lappe DL (2001) 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 13:354–362PubMed
3.
Holm NR, Sindberg B, Schou M, Maeng M, Kaltoft A, Bottcher M, Krusell L, Hjort J, Thuesen L, Terkelsen C, Christiansen E, Botker HE, Kristensen SD, Lassen JF; For the CLOSE-UP study group (2014) Randomised comparison of manual compression and FemoSealTM vascular closure device for closure after femoral artery access coronary angiography: the CLOSure dEvices Used in everyday Practice (CLOSE-UP) study. Eurointervention 9:183–190CrossRef
4.
Byrne RA, Cassese S, Linhardt M, Kastrati A (2013) Vascular access and closure in coronary angiography and percutaneous intervention. Nat Rev Cardiol 10:27–40CrossRefPubMed
5.
Dauerman LH (2014) Rewriting the history of vascular closure devices. Eurointervention 10:175–177CrossRefPubMed
6.
Applegate R, Sacrinty M, Little W, Gandhi S, Kutcher M, Santos R (2009) Prognostic implications of vascular complications following PCI. Catheter Cardiovasc Interv 74:74–75CrossRef
7.
Yatskar L, Selzer F, Feit F, Cohen HA, Jacobs AK, Williams DO, Slater J (2007) Access site hematoma requiring blood transfusion predicts mortality in patients undergoing percutaneous coronary intervention: data from the National Heart, Lung, and blood Institute Dynamic Registry. Catheter Cardiovasc Interv 69:961–966CrossRefPubMed
8.
Moher D, Schulz KF, Altman D; for the CONSORT group (2001) The CONSORT statement revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 285:1987–1991CrossRefPubMed
9.
Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force Members (2005) Guidelines for percutaneous coronary interventions: the task force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J 26:804–847CrossRefPubMed
10.
Bovill EG, Terrin ML, Stump DC, Berke AD, Frederick M, Collen D, Feit F, Gore JM, Hillis LD, Lambrew CT (1991) Hemorrhagic events during therapy with recombinant tissue-type plasminogen activator, heparin, and aspirin for acute myocardial infarction. Results of the Thrombolysis in Myocardial infarction (TIMI), Phase II Trial. Ann Intern Med 115:256–265CrossRefPubMed
11.
Borg G (2003) An index for relations between perceptual magnitudes based on level-anchored ratio scaling. In: Berglund B, Borg E (Eds) Fechner Day. International Society for Psychophysics, Stockholm
12.
Omoifui NA, Califf RM, Pieper K, Keeler G, OʼHanesian MA, Berdan LG, Mark DB, Talley JD, Topol EJ (1995) Peripheral vascular complications in the Coronary Angioplasty versus Excisional Atherectomy Trial (CAVEAT-1). J Am Coll Cardiol 26:922–930CrossRef
13.
Ndrepepa G, Berger PB, Mehilli J, Seyfarth M, Neumann FJ, Schömig A, Kastrati A (2008) Periprocedural bleeding and 1-year outcome after percutaneous coronary interventions: appropriateness of including bleeding as a component of a quadruple end point. J Am Coll Cardio 51:690–697CrossRef
14.
Rittger H, Schmidt M, Breithardt OA, Mahnkopf C, Brachmann J, Sinha AM (2011) Cardio-respiratory exercise testing early after the use of the Angio-Seal system for arterial puncture site closure after coronary angioplasty. Eurointervention 7:242–247CrossRefPubMed
15.
Arora N, Matheny ME, Sepke C, Resnic FS (2007) A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. Am Heart J 153:606–611CrossRefPubMed
16.
Resnic FS, Blake GH, Ohno-Machado L, Swlwyn AP, Popma JJ, Rogers C (2001) Vascular closure devices and the risk of vascular complications after percutaneous coronary intervention in patietns receiving glycoprotein IIb-IIIa inhibitors. Am J Cardiol 88:493–496CrossRefPubMed
17.
Tavris DR, Gallauresi BA, Lin B, Rich SE, Shaw RE, Weintraub WS, Brindis RG, Hewitt K (2004) Risk of local adverse events following cardiac catheterization by hemostasis device use and gender. J Invasive Cardiol 16:459–464PubMed
18.
Marco SP, Amin AP, House JA, Kennedy KF, Sperus JA, Rao SV, Cohen DJ, Messenger JC, Rumsfeld JS; National Cardiovascular Dtat Registry (2010) Association between use of bleeding avoidance strategies and rik of periprocedural bleeding among patients undergoing percutaneous coronary intervention. JAMA 303:2156–2164CrossRef
19.
Nikolsky E, Mehran R, Halkin A, Aymong ED, Mintz GS, Lasic Z, Negoita M, Fahy M, Krieger S, Moussa I, Moses JW, Stone GW, Leon MB, Pocock SJ, Dangas G (2004) Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol 44:1200–1209PubMed
20.
Deuling JH, Vermeulen RP, Anthonio RA, van den Heuvel AF, Jaarsma T, Jessrung G, de Smet BJ, Tan ES, Zijlstra F (2008) Closure of the femoral artery afere cardiac catheterization: a comparison of Angio-Seal, StarClose, and manual compression. Catheter Cardiovasc Interv 71:518–523CrossRefPubMed
21.
Applegate RJ, Sacrinty MT, Kutcher MA, Baki TT, Gandhi SK, Santos RM, Little WC (2006) Propensity score analysis of vascular comolications after diagnostic cardiac catherziuation and percutaneous coronary intervention 1998–2003. Catheter Cardiovasc Interv 67:556–562CrossRefPubMed
22.
Exaire JE, Dauerman HL, Topol EJ, Blankenship JC, Wolski K, Raymond RE, Cohen EA, Moliterno DJ; TARGET Investigators (2004) Triple antiplatelet therapy does not increase femoral access bleeding with vascular closure devices. Am heart J 147:31–34CrossRefPubMed
23.
Tron C, Kning R, Eltchaninoff H, Douillet R, Chassaing S, Sanchez-Giron C, Cribier A (2003) An randomized comparison of a percutaneous suture device versus manual compression for femoral artery hemostais after PTCA. J Interv Cardiol 16:217–221CrossRefPubMed
24.
Cura FA, Kapadia SR, LʼAllier PL, Schneider JP, Kreindel MS, Silver MJ, Yadav JS, Simpfendorfer CC, Raymond RR, Tuzcu EM, Franco I, Whitlow PL, Topol EJ, Ellis SG (2000) Safety of femoral closure devices after percutaneous coronary interventions in the era of glycoprotein IIb/IIIa platelet blockade. Am J Cardiol 86:780–782CrossRefPubMed
25.
Brueck M, Bandorski D, Rauber K, Boening A (2010) Percutaneous transluminal dilatation of inadvertent parital or complete occlusion of the femoral artery caused by Angio-Seal deployment for puncture site closure after cardiac catheterization. J Invasive Cardiol 303:2156–2164
26.
Applegate RJ (2010) Unintended consequences of femoral artery closure devices. J Invasive Cardiol 22:353–357
27.
Smilowitz N, Kirtane A, Guiry M, Gray W, Dolcimascolo P, Querijero M, Echeverry C, Kalcheva N, Flores B, Sing VP, rabbani LR, Kodali S, Collins M, Leon B, Mosis J, Weisz G (2012) Practices and complications of vascular closure devices and manual compression in patients undergoing elective transfemoral coronary procedures. Am J Cardiol 110:177–182CrossRefPubMed
28.
Biancari F, Andrea VD, Di Mario C, Savino G, Tiozzo V, Catania A (2010) Meta-analysis of randomized trials on the efficadcy of vascular closure devices afer diagnostic angiography and angioplasty. Am Heart J 159:518–531CrossRefPubMed
29.
Turi ZG (2008) An evidence-based approach to femoral arterial access and closure. Rev Cardiovasc Med 9:6–18
30.
Chevalier B, Lancelin B, Koning R, Henry M, Gommeaux A, Pilliere R, Lefevre T, Boughalem K, Marco J, Dupouy P; Hemostase Trial Investigators (2003) Effect of a closure device on complication rates in high-local-risk patients: results of a randomized multicentre trial. Catheter Cardiovasc Interv 58:285–291CrossRefPubMed
31.
Eggebrecht H, Haude M, Woertgen U, Schmermund A, von Birgelen C, Naber C, Baumgart D, Kaiser C, Oldenburg O, Bartel T, Kroeger K, Erbel R (2002) Sysmtetic use of a collagen-based vascular closure device immediately after cardiac catheterization procedures in 1,317 conscutive patients. Catheter Cardiovac Interv 57:486–495CrossRef
32.
Sindberg B, Schou M, Hansen L, Christiansen KJ, Jǿrgensen KS, Sǿltoft M, Holm NR, Maeing M, Kristensen SD, Lassen JF (2013) Pain and discomfort in closure of femoral accesss coronary angiography. The CLOSuredEvices used in everyday practice (CLOSE-UP) pain sub study. Eur J Cardiovasc Nurs 13:221–226CrossRefPubMed
33.
Wong SC, Bachinsky W, Cambier P, Stoler R, Aji J, Roger J, Hermiller J, Nair R, Hutman H, Wang H (2009) A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of hemostatis after percutaneous femoral procedures. J Am Coll Cardiol Intv 2:785–793CrossRef
34.
Schmelter C, Liebl A, Poullos N, Ruppert V, Vorwerk D (2013) Suitability of Exo-Seal closure device for antegrade femoral artery puncture site closure. Cardiovasc Intervent Radiol 36:659–668CrossRefPubMed
35.
Wiemer M, Langer C, Fichtlscherer S, Firschke C, Hofbauer F, Lins M, Haude M, Debéfve C, Stoll HP, Hanefeld C (2012) First-in-man experience with a new 7F vascular closure device (EXOSEALTM): the 7F ECLIPSE study. J Interv Cardiol 5:518–525CrossRef
36.
Boschewitz JM, Andersson M, Naehle CP, Schild HH, Wilhelm K, Meyer C (2013) Retrospective evaluation of safety and effectiveness of the Exo-Seal vascular closure device for single vascular closure and closure after repeat puncture in diagnostic and interventional radiology: single center experience. J Vasc Interv Radiol 24:698–702CrossRefPubMed
Metadaten
Titel
Comparison of Exo-Seal® and Angio-Seal® for arterial puncture site closure
A randomized, multicenter, single-blind trial
verfasst von
Johannes Ketterle, MD
Harald Rittger, MD
Inga Helmig
Lutz Klinghammer
Stefan Zimmermann
Wolfgang Hohenforst-Schmidt
Johannes Brachmann
Holger Nef
Stephan Achenbach
Christian Schlundt
Publikationsdatum
01.08.2015
Verlag
Urban & Vogel
Erschienen in
Herz / Ausgabe 5/2015
Print ISSN: 0340-9937
Elektronische ISSN: 1615-6692
DOI
https://doi.org/10.1007/s00059-015-4306-3

Weitere Artikel der Ausgabe 5/2015

Herz 5/2015 Zur Ausgabe

Original article

Prevalence of atrial fibrillation and the HATCH score

Schwerpunkt

Mitralklappeninterventionen

Schwerpunkt

Trikuspidalklappeninterventionen

Original article

Galectin-3 as a new biomarker of diastolic dysfunction in hemodialysis patients

Editorial

Interventionelle Therapie struktureller Herzerkrankungen

Erratum

Erratum to: Left ventricular pseudoaneurysm after mitral valve replacement

Neu im Fachgebiet Kardiologie

„Jeder Fall von plötzlichem Tod muss obduziert werden!“

17.05.2024 Plötzlicher Herztod Nachrichten

Ein signifikanter Anteil der Fälle von plötzlichem Herztod ist genetisch bedingt. Um ihre Verwandten vor diesem Schicksal zu bewahren, sollten jüngere Personen, die plötzlich unerwartet versterben, ausnahmslos einer Autopsie unterzogen werden.

Hirnblutung unter DOAK und VKA ähnlich bedrohlich

17.05.2024 Direkte orale Antikoagulanzien Nachrichten

Kommt es zu einer nichttraumatischen Hirnblutung, spielt es keine große Rolle, ob die Betroffenen zuvor direkt wirksame orale Antikoagulanzien oder Marcumar bekommen haben: Die Prognose ist ähnlich schlecht.

Schlechtere Vorhofflimmern-Prognose bei kleinem linken Ventrikel

17.05.2024 Vorhofflimmern Nachrichten

Nicht nur ein vergrößerter, sondern auch ein kleiner linker Ventrikel ist bei Vorhofflimmern mit einer erhöhten Komplikationsrate assoziiert. Der Zusammenhang besteht nach Daten aus China unabhängig von anderen Risikofaktoren.

Semaglutid bei Herzinsuffizienz: Wie erklärt sich die Wirksamkeit?

17.05.2024 Herzinsuffizienz Nachrichten

Bei adipösen Patienten mit Herzinsuffizienz des HFpEF-Phänotyps ist Semaglutid von symptomatischem Nutzen. Resultiert dieser Benefit allein aus der Gewichtsreduktion oder auch aus spezifischen Effekten auf die Herzinsuffizienz-Pathogenese? Eine neue Analyse gibt Aufschluss.

Update Kardiologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.

Newsletter bestellen
Bildnachweise