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

A randomized, multicenter, single-blind trial

Vergleich von Exo-Seal® und Angio-Seal® zum Verschluss einer arteriellen Punktionsstelle

Randomisierte, einfach verblindete Multizenterstudie

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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.

Zusammenfassung

Hintergrund

Die Verwendung extravaskulärer Verschlusssysteme für die Femoralarterie bei Patienten mit Koronarangiographie/perkutaner Intervention wurde bisher nicht ausreichend untersucht. Ziel der Autoren war, den Einfluss eines extravaskulären Polyglykolsäure (PGA) Anker basierten Verfahrens auf den Verschluss des Zugangs in der Leiste bei Patienten zu ermitteln, bei denen eine Koronarangiographie und/oder eine perkutane Koronarintervention erfolgte.

Methoden

In der vorliegenden prospektiven, einfach verblindeten Multizenterstudie wurden 319 Patienten randomisiert dem Gefäßverschluss mit Angio-Seal™ oder Exo-Seal® zugeteilt. Die Hypothese der Autoren bestand darin, dass der Einsatz eines extravaskulären Verschlusssystems einem System auf PGA/Ankerbasis im Hinblick auf das Auftreten des kombinierten primären Endpunkts aus Hämatom > 5 cm, erheblicher Blutung in der Leistenregion (schwere Blutung nach TIMI-Kriterien), Aneurysma spurium und „device“-Versagen nicht unterlegen sei.

Ergebnisse

Es fand sich kein signifikanter Unterschied bei den Ausgangsmerkmalen der Patienten oder den Ergebnissen der Prozedur. Nach 24 h trat der primäre Endpunkt bei 9 Patienten (5,6 %) in der Angio-Seal™- und bei 13 Patienten (8,2 %) der Exo-Seal®-Gruppe auf (p = 0,38). Ein Hämatom > 5 cm wurde bei 3 Patienten (1,9 %) unter Verwendung von Angio-Seal™ vs. 2 Patienten (1,3 %) unter Verwendung von Exo-Seal® (p = 0,99) festgestellt. Bei einem Patienten (0,6 %) der Exo-Seal®-Gruppe trat eine schwere Blutung nach TIMI-Kriterien auf, die eine Transfusion notwendig machte (p = 0,49). Es wurden 4 (2,5 %) falsche Aneurysmen bei den mit Angio-Seal™ behandelten Patienten und 2 (1,3 %) bei den mit Exo-Seal® behandelten Patienten (p = 0,68) diagnostiziert. Eine Tendenz zu einer höheren Inzidenz von „device“-Versagen bestand in der Exo-Seal®-Gruppe mit 1,2 vs. 5,2 % (p = 0,06). Bei einer telefonischen Befragung nach 30 Tagen war kein signifikanter Unterschied hinsichtlich der Ereignisse Wiederaufnahme mit chirurgischem Eingriff an der Punktionsstelle, Infektion, Blutung, Hämatom oder Schmerzen festzustellen.

Schlussfolgerung

In der vorliegenden Studie wurden keine signifikanten Unterschiede in Bezug auf das Auftreten eines Hämatoms > 5 cm, einer schweren Blutung, eines falschen Aneurysmas und eines „device“-Versagens zwischen Angio-Seal™ und Exo-Seal® 24 h nach Implantation des Systems festgestellt.

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Abbreviations

ACS:

Acute coronary syndrome

PCI:

Percutaneous coronary intervention

PGA:

Polyglycolic acid

VCD:

Vascular closure device

References

  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 13:354–362

    CAS  PubMed  Google Scholar 

  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 9:183–190

    Article  Google Scholar 

  4. Byrne RA, Cassese S, Linhardt M, Kastrati A (2013) Vascular access and closure in coronary angiography and percutaneous intervention. Nat Rev Cardiol 10:27–40

    Article  CAS  PubMed  Google Scholar 

  5. Dauerman LH (2014) Rewriting the history of vascular closure devices. Eurointervention 10:175–177

    Article  PubMed  Google Scholar 

  6. Applegate R, Sacrinty M, Little W, Gandhi S, Kutcher M, Santos R (2009) Prognostic implications of vascular complications following PCI. Catheter Cardiovasc Interv 74:74–75

    Article  Google Scholar 

  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 69:961–966

    Article  PubMed  Google Scholar 

  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 285:1987–1991

    Article  CAS  PubMed  Google Scholar 

  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 26:804–847

    Article  PubMed  Google Scholar 

  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 115:256–265

    Article  CAS  PubMed  Google Scholar 

  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 26:922–930

    Article  Google Scholar 

  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 51:690–697

    Article  Google Scholar 

  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 7:242–247

    Article  PubMed  Google Scholar 

  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 153:606–611

    Article  PubMed  Google Scholar 

  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 88:493–496

    Article  CAS  PubMed  Google Scholar 

  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 16:459–464

    PubMed  Google Scholar 

  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 303:2156–2164

    Article  Google Scholar 

  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 44:1200–1209

    PubMed  Google Scholar 

  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 71:518–523

    Article  CAS  PubMed  Google Scholar 

  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 67:556–562

    Article  PubMed  Google Scholar 

  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 147:31–34

    Article  CAS  PubMed  Google Scholar 

  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 16:217–221

    Article  PubMed  Google Scholar 

  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 86:780–782

    Article  CAS  PubMed  Google Scholar 

  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

    Google Scholar 

  26. Applegate RJ (2010) Unintended consequences of femoral artery closure devices. J Invasive Cardiol 22:353–357

    Google Scholar 

  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 110:177–182

    Article  PubMed  Google Scholar 

  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 159:518–531

    Article  PubMed  Google Scholar 

  29. Turi ZG (2008) An evidence-based approach to femoral arterial access and closure. Rev Cardiovasc Med 9:6–18

    Google Scholar 

  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 58:285–291

    Article  PubMed  Google Scholar 

  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 57:486–495

    Article  Google Scholar 

  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 13:221–226

    Article  PubMed  Google Scholar 

  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 2:785–793

    Article  Google Scholar 

  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 36:659–668

    Article  PubMed  Google Scholar 

  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 5:518–525

    Article  Google Scholar 

  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 24:698–702

    Article  PubMed  Google Scholar 

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Authors and Affiliations

  1. Medizinische Klinik 2, Universitätsklinikum Erlangen, Ulmenweg 18, 91054, Erlangen, Germany

    Johannes Ketterle MD, Lutz Klinghammer, Stefan Zimmermann, Stephan Achenbach & Christian Schlundt

  2. Medizinische Klinik 1, Klinikum Fürth, Fürth, Germany

    Harald Rittger MD & Wolfgang Hohenforst-Schmidt

  3. Medizinische Klinik I, Universitätsklinikum Giessen, Giessen, Germany

    Inga Helmig & Holger Nef

  4. Medizinische Klinik II, Klinikum Coburg, Coburg, Germany

    Johannes Brachmann

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  1. Johannes Ketterle MD
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  2. Harald Rittger MD
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  3. Inga Helmig
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  4. Lutz Klinghammer
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Correspondence to Harald Rittger MD.

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Conflict of interest

J. Ketterle, H. Rittger, I. Helmig, L. Klinghammer, S. Zimmermann, W.Hohenforst-Schmidt, J. Brachmann, H. Nef, S. Achenbach, C. Schlundt state that there are no conflicts of interest.

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J. Ketterle and H. Rittger contributed equally to this paper.

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Ketterle, J., Rittger, H., Helmig, I. et al. Comparison of Exo-Seal® and Angio-Seal® for arterial puncture site closure. Herz 40, 809–816 (2015). https://doi.org/10.1007/s00059-015-4306-3

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  • DOI: https://doi.org/10.1007/s00059-015-4306-3

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