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Abstract:

Introduction: vascular closure devices (VCD) for over 20 years have been used as an alternative to manual compression to achieve hemostasis. Despite the fact that clinical efficacy and safety of occlusive type VCD have been confirmed in a number of studies, their use remains controversial due to the formation of complications at the access site when using these devices.

Aim: was to estimate possible advantages and limitations of vascular closure devices of occlusive type (Angio-Seal) in patients, who had underwent percutaneous coronary interventions (PCI) via femoral access in comparison with traditional manual hemostasis.

Material and methods: data of 231 adult patients who underwent therapeutic endovascular procedures in the City Hospital named after M.P. Konchalovsky, Research and Development Center for Preventive Medicine were selected for retrospective research. The main group, with hemostasis after PCI with Angio-Seal (Terumo) obturating device, consisted of 113 patients, control group - included 118 patients with manual hemostasis. Subjective sensations (pain, numbness, etc.), complication rate, hemostasis time, immobilization and hospitalization duration were evaluated.

Results: success of using VCD was 98.23%, complication rate in the main group was 4.37%, in the control group - 6.78% (however, it was not reliable). The time of hemostasis (2.1 min versus 22.25 min), immobilization (3.5 hours versus 20.6 hours) and hospitalization (4 days versus 8 days) significantly decreased, and the patient comfort level was significantly higher in the main group.

Conclusions: the use of Angio-Seal VCD in patients after percutaneous transfemoral therapeutic endovascular procedures is an effective way to reduce hemostasis time in comparison with using of manual compression; allows to reduce patient's immobilization period, significantly increases patient comfort, and reduces patient's hospital stay.

Along with this procedure, it should be considered as an independent surgical intervention and surgeon should follow all necessary rules and stages of its implementation, should control result of hemostasis.

 

References

1.     Bockeria LA, Alekyan BG. State of endovascular diagnosis and treatment of cardiac and vascular diseases in the Russian Federation (2014). Russian Journal of Endovascular Surgery 2015; 2(1-2):5-20 [In Russ].

2.     Byrne RA, Cassese S, Linhardt M, Kastrati A. Vascular access and closure in coronary angiography and percutaneous intervention. Nat Rev Cardiol. 2013; 10(1):27-40.

3.     Semitko SP, Gubenko IM, Analeev AI, Azarov AV, Maiskov VV, Karpun NA, Iosseliani DG. Vascular complications of percutaneous coronary interventions and clinical results of the use of various devices providing hemostasis. Consilium medicum 2012; 14(10): 51-57 [In Russ].

4.     Dauerman HL, Applegate RJ, Cohen DJ. Vascular closure devices: the second decade. J Am Coll Cardiol. 2007; 50(17):1617-1626.

5.     Biancari F, D’Andrea V, Di Marco C, Savino G, Tiozzo V, Catania A. Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J. 2010; 159(4): 518-531.

6.     Ndrepepa G, Berger PB, Mehilli J et al. 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 Cardiol 2008; 51:690.

7.     Rao SV, Kedev S. Approaching the post-femoral era for coronary angiography and intervention. JACC Cardiovasc. Interv. 2015; 8: 524–526.

8.     Lo TS et al. Radial artery anomaly and its influence on transradial coronary procedural outcome. Heart 2009; 95(5): 410–415.

9.     Sciahbasi A et al. Transradial approach (left versus right) and procedural times during percutaneous coronary procedures: TALENT study. Am. Heart J. 2011; 161: 172–179.

  

Abstract:

Background: the use of vascular closure devices (VCD) reduces the time of hemostasis, accelerates activation and discharge of the patient. Suture-mediated closure devices are closest in it's structure to the traditional surgical method of hemostasis. Advantages and disadvantages of these devices are mainly associated with design features. Stenoses, atherosclerosis, calcification and scars at the site of access are predictors of complications in the use of suturing devices. Although the effectiveness of these devices has been proven in several foreign studies, their data are not sufficient to draw clear conclusions.

Aim: was to evaluate advantages and disadvantages of using the suture-mediated closure devices after PCI.

Material and methods: study enrolled 208 adult patients, who underwent PCI in City Clinical Hospital named after M.P Konchalovsky, Moscow; FSBI «3 Central clinical military hospital n.a. A. A. Vishnevsky» Defense Ministry RF and SMRC preventive medicine of Department of Healthcare. Study group, where hemostasis after PCI was achieved by means of suture-mediated closure devices Perclose Pro Glide (Abbott Vascular), consisted of 90 patients, control group - 118 patients with manual hemostasis. Subjective feelings (pain, numbness, etc.) were assessed using a rating scale. The incidence of complications in the study group was 5.56%, in the control group - 6.78%. The comfort level of patients was higher in the study group

Results of the study: showed that the use of the Perclose device to achieve hemostasis after PC does not increase the frequency of regional vascular complications in compatison with manual hemostasis. But, at the same time, the use of VCD is an effective way to reduce the time of hemostasis, reduces the period of immobilization of the patient, which increases the patient's comfort and reduces patient's hospital stay.

 

 

References

1.      Caputo RP: Currently approved vascular closure devices. Card Interv Today: 70-76, 2012.

2.      Bechara CF, Annambhotla S, LinP H:Access site management with vascular closure devices for percutaneous transarterial procedures. J VascSurg 2010; 52:1682-1696. http://dx.doi.org/10.1016/j.jvs. 2010. 04.079.

3.      Sheth RA, Walker TG, Saad WE, et al: Quality improvement guidelines for vascular access and closure device use. J Vasc Interv Radiol. 2014; 25: 73-84. http://dx.doi.org/10.1016Zj.jvir.2013.08.011.

4.      Haas PC, Krajcer Z, Diethrich Edward B: Closure of large percutaneous access sites using the Prostar XL percutaneous vascular surgery device. J Endovasc Surg. 1999; 168-170.

5.      Barbetta I, van den Berg J: Access and hemostasis: femora and popliteal approaches and closure devices — Why, what, when, and how? Semin Interv Radiol 2014; 31:353-360. http://dx.doi.org/10. 1055/s-0034-1393972.

6.      Boschewitz J M, Pieper CC, Andersson M, et al: Efficacy and time-to-hemostasis of antegrade femoral access closure using the exoseal vascular closure device: A retrospective single-center study. Eur J Vasc Endovasc Surg 2014; 48:585-591. http://dx.doi.org/10.1016/ j.ejvs.2014. 08.006.

7.      Gutzeit A, van Schie B, Schoch E, et al: Feasibility and safety of vascular closure devices in an antegrade approach to either the common femoral artery or the superficial femoral artery. 2012; Cardiovasc Intervent Radiol 35:1036-1040. http://dx.doi.org/10.1007/s0 0270012-0454-5.

8.      Ward TJ, Weintraub J L: Vascular closure device update. Endovasc Today: 2015; 54-60.

9.      Hon LQ, Ganeshan A, Thomas SM, et al: An overview of vascular closure devices: What every radiologist should know. Eur J Radiol. 2010; 73:181-190,. http://dx.doi.org/10.1016/j.ejrad.2008.09.023.

10.    Krajcer Z: The preclose technique for AAA repair. Endovasc Today: 2011; 46-54.

11.    Gerckens U, Cattelaens N, Lampe EG, Grube E. Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device. Am J Cardiol. 1999; 83:1658-63.

12.    Baim DS, Knopf WD, 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; 85:864-9.

13.    Fram D.B., Giri S., Jamil G., et al. Suture closure of the femoral arteriotomy following invasive cardiac procedures: a detailed analysis of efficacy, complications, and the impact of early ambulation in 1200 consecutive, unselected cases. Cathet Cardiovasc Interv. 2001; 53:163-73.

14.    Balzer J.O., Scheinert D., Diebold T., et al. Postinterventional transcutaneous suture of femoral artery access sites in patients with peripheral arterial occlusive disease: a study of 930 patients. Cathet Cardiovasc Interv. 2001;53.

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