Arterial access-site complications after use of a vascular closure device related to puncture height

Benjamin Sartorius, Michael Behnes, Melike Ünsal, Ursula Hoffmann, Siegfried Lang, Kambis Mashayekhi, Martin Borggrefe, Ibrahim Akin, Benjamin Sartorius, Michael Behnes, Melike Ünsal, Ursula Hoffmann, Siegfried Lang, Kambis Mashayekhi, Martin Borggrefe, Ibrahim Akin

Abstract

Background: To analyze differences of access-site complications related to the height of femoral arterial puncture and the use of a vascular closure device (VCD) following percutaneous coronary intervention (PCI).

Methods: A subgroup of the FERARI study being treated by femoral arterial access and valuable inguinal angiography before implantation of a VCD were included. Inguinal angiographies were systematically reviewed by two independent cardiologists to determine the correct height of femoral arterial puncture. Bleeding complications were documented within 30 days after PCI and were categorized according to BARC, TIMI, GUSTO and FERARI classifications.

Results: Femoral access point imaging was available in 95 patients compared to 105 patients without. The common femoral artery (CFA) was the most accessed artery in 41%, followed by the femoral arterial bifurcation (39%) and lower access sites distally from the femoral arterial bifurcation (low puncture: 20%). No differences were observed regarding indication of PCI, procedural data and anticoagulation therapies in relation to the heights of femoral arterial access (p > 0.05). Despite using VCD, arterial puncture at the CFA resulted in numerically highest numbers of overall bleedings (62%) compared to femoral arterial bifurcation (41%) (p = 0.059). 58% of bleedings occurred after arterial puncture below the femoral bifurcation (low puncture). Though no significant differences of bleedings regarding classifications of BARC, GUSTO, TIMI and FERARI as well as other vascular endpoints were observed regarding puncture height.

Conclusions: The present analysis demonstrates no significant differences of bleeding complications in relation to the height of femoral arterial puncture and subsequent use of a VCD.

Trial registration: ClinicalTrials.gov NCT02455661.

Keywords: Bleeding; Femoral artery; Vascular closure device.

Figures

Fig. 1
Fig. 1
Flow chart illustrating the selection of patients for the present sub-analysis of the FERARI study
Fig. 2
Fig. 2
Topographic scheme demonstrating the different heights of femoral arterial puncture as well as the distribution of puncture rates being evaluated from inguinal angiographies following PCI. Puncture rates are presented as n (%)

References

    1. Mehran R, Pocock S, Nikolsky E, Dangas GD, Clayton T, Claessen BE, Caixeta A, Feit F, Manoukian SV, White H, Bertrand M, Ohman EM, Parise H, Lansky AJ, Lincoff AM, Stone GW. Impact of bleeding on mortality after percutaneous coronary intervention results from a patient-level pooled analysis of the REPLACE-2 (randomized evaluation of PCI linking angiomax to reduced clinical events), ACUITY (acute catheterization and urgent intervention triage strategy), and HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trials. JACC Cardiovasc Interv. 2011;4(6):654–64. doi: 10.1016/j.jcin.2011.02.011.
    1. Dauerman HL, Applegate RJ, Cohen DJ. Vascular closure devices: the second decade. J Am Coll Cardiol. 2007;50(17):1617–26. doi: 10.1016/j.jacc.2007.07.028.
    1. Cox T, Blair L, Huntington C, Lincourt A, Sing R, Heniford BT. Systematic review of randomized controlled trials comparing manual compression to vascular closure devices for diagnostic and therapeutic arterial procedures. Surg Technol Int. 2015;XXVII:32–44.
    1. Holm NR, Sindberg B, Schou M, Maeng M, Kaltoft A, Bottcher M, Krusell LR, Hjort J, Thuesen L, Terkelsen CJ, Christiansen EH, Botker HE, Kristensen SD, Lassen JF, group C-Us Randomised comparison of manual compression and FemoSeal vascular closure device for closure after femoral artery access coronary angiography: the CLOSure dEvices Used in everyday Practice (CLOSE-UP) study. Euro Intervention. 2014;10(2):183–90.
    1. Verheugt FW, Steinhubl SR, Hamon M, Darius H, Steg PG, Valgimigli M, Marso SP, Rao SV, Gershlick AH, Lincoff AM, Mehran R, Stone GW. Incidence, prognostic impact, and influence of antithrombotic therapy on access and nonaccess site bleeding in percutaneous coronary intervention. JACC Cardiovasc Interv. 2011;4(2):191–7. doi: 10.1016/j.jcin.2010.10.011.
    1. Vavalle JP, Clare R, Chiswell K, Rao SV, Petersen JL, Kleiman NS, Mahaffey KW, Wang TY. Prognostic significance of bleeding location and severity among patients with acute coronary syndromes. JACC Cardiovasc Interv. 2013;6(7):709–17. doi: 10.1016/j.jcin.2013.03.010.
    1. Schulz-Schupke S, Helde S, Gewalt S, Ibrahim T, Linhardt M, Haas K, Hoppe K, Bottiger C, Groha P, Bradaric C, Schmidt R, Bott-Flugel L, Ott I, Goedel J, Byrne RA, Schneider S, Burgdorf C, Morath T, Kufner S, Joner M, Cassese S, Hoppmann P, Hengstenberg C, Pache J, Fusaro M, Massberg S, Mehilli J, Schunkert H, Laugwitz KL, Kastrati A, Instrumental Sealing of Arterial Puncture Site CDvMCTI Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial. JAMA. 2014;312(19):1981–7. doi: 10.1001/jama.2014.15305.
    1. Duffin DC, Muhlestein JB, Allisson SB, Horne BD, Fowles RE, Sorensen SG, Revenaugh JR, Bair TL, Lappe DL. 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(5):354–62.
    1. Piper WD, Malenka DJ, Ryan TJ, Jr, Shubrooks SJ, Jr, O’Connor GT, Robb JF, Farrell KL, Corliss MS, Hearne MJ, Kellett MA, Jr, Watkins MW, Bradley WA, Hettleman BD, Silver TM, McGrath PD, O’Mears JR, Wennberg DE. Northern New England Cardiovascular Disease Study G. Predicting vascular complications in percutaneous coronary interventions. Am Heart J. 2003;145(6):1022–9. doi: 10.1016/S0002-8703(03)00079-6.
    1. Matic DM, Asanin MR, Stankovic S, Mrdovic IB, Marinkovic JM, Kocev NI, Antonijevic NM, Marjanovic MM, Nesic ZI, Prostran MS, Stankovic GR. Incidence, predictors and prognostic implications of bleeding complicating primary percutaneous coronary intervention. Vojnosanit Pregl. 2015;72(7):589–95. doi: 10.2298/VSP140223064M.
    1. Behnes M, Unsal M, Hoffmann U, Fastner C, El-Battrawy I, Lang S, Mashayekhi K, Lehmann R, Borggrefe M, Akin I. Design and Rationale of the Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) Study. Clin Med Insights Cardiol. 2015;9:97–103. doi: 10.4137/CMC.S31932.
    1. Fastner C, Behnes M, Unsal M, El-Battrawy I, Ansari U, Mashayekhi K, Hoffmann U, Lang S, Kuschyk J, Borggrefe M, Akin I. Clinical outcomes of femoral closure compared to radial compression devices following percutaneous coronary intervention: the FERARI study. Heart Vessels. 2016. doi:10.1007/s00380-016-0901-3.
    1. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123(23):2736–47. doi: 10.1161/CIRCULATIONAHA.110.009449.
    1. Bovill EG, Terrin ML, Stump DC, Berke AD, Frederick M, Collen D, Feit F, Gore JM, Hillis LD, Lambrew CT, et al. 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. 1991;115(4):256–65. doi: 10.7326/0003-4819-115-4-256.
    1. Akin I, Tolg R, Hochadel M, Bergmann MW, Khattab AA, Schneider S, Senges J, Kuck KH, Richardt G, Nienaber CA, Group DDS. No evidence of “obesity paradox” after treatment with drug-eluting stents in a routine clinical practice: results from the prospective multicenter German (German Drug-Eluting Stent) Registry. JACC Cardiovasc Interv. 2012;5(2):162–9. doi: 10.1016/j.jcin.2011.09.021.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera