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      Comparison of Complication and Success Rates of ProGlide Closure Device in Patients Undergoing TAVI and Endovascular Aneurysm Repair

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          Abstract

          Introduction

          Usage of the Perclose ProGlide ® (PP: Abbott Laboratories, Chicago, IL, USA) closure device is becoming increasingly prevalent during percutaneous endovascular aortic repair (EVAR) and transcatheter aortic valve implantation (TAVI). The respective conditions treated via these procedures, abdominal aortic aneurysm and aortic valve stenosis, share risk factors but are two different physiopathological problems.

          Aim

          Our aim was to compare the complication and success rates of PP closure device use in patients undergoing EVAR and TAVI.

          Materials and Methods

          A total of 74 patients, including 58 undergoing TAVI and 16 undergoing EVAR, were analysed in our study.

          Results

          Of the TAVI patients treated using the PP closure device, two (3.4%) had access to site-related bleeding complications and two (3.4%) experienced device failure. Of the EVAR patients who received the PP closure device, three (18.8%) had bleeding complications and three (18.8%) experienced device failure.

          Conclusion

          Due to the underlying diffuse aortic wall pathology, the success rate of PP closure device use was lower and the complication rate of PP closure device was higher in the EVAR group versus the TAVI group.

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          Most cited references17

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          A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).

          Peter R Nelson, Zvonimir Kracjer, Nikhil Kansal … (2014)
          The first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair (PEVAR) with use of a 21F endovascular stent graft system and either an 8 F or 10 F suture-mediated closure system (the PEVAR trial, NCT01070069). A noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure.
          Article 0 comments Cited 51 times – based on 0 reviews     Review now
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            Percutaneous access for endovascular aneurysm repair: a systematic review.

            A.H. Malkawi, R.J. Hinchliffe, P.J. Holt … (2010)
            Recent developments in aortic stent-graft technology have led to an increase in the use of wholly percutaneous endovascular aneurysm repair (P-EVAR). The literature was systematically reviewed to analyse the results of P-EVAR. A systematic review of P-EVAR was performed using Ovid-MEDLINE in-process and other nonindexed citations and Ovid-MEDLINE and EMBASE (January 1991-July 2009). Primary outcomes reviewed were success rate and loco-regional complications. Secondary outcomes included; operative time, hospital stay, time to ambulation, blood loss and cost. Prospective randomised and controlled nonrandomised studies were included as were case series (retrospective and prospective). Case reports, letters, review articles and non-English language articles were excluded. Twenty-two papers were identified. These included randomised trials (n=1); prospective nonrandomised (n=10) and retrospective studies (n=11). P-EVAR was attempted in 1087 patients (1751 groins). Overall success rate of percutaneous arterial closure was 92% (90.1-93.9, 95% CI). Access related complication rate was 4.4% (3.5-5.3, 95% CI). Seven studies provided data on access related complications in open access cohorts (O-EVAR). In these studies, P-EVAR was associated with fewer access related complications (RR 0.47, 95% CI 0.28-0.78, p=0.004). P-EVAR was associated with reduced operative time. P-EVAR appears safe and effective in selected patients. Local access related complications were low. Further work is required to identify the most suitable candidates for P-EVAR. Copyright (c) 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
            Article 0 comments Cited 18 times – based on 0 reviews     Review now
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              Endovascular suture versus cutdown for endovascular aneurysm repair: a prospective randomized pilot study.

              J Tessarek, G Torsello, Nani Osada … (2003)
              To evaluate safety and cost benefits of the percutaneous technique for treatment of aortic aneurysm, a prospective randomized study was performed that compared the endovascular suture technique with conventional cutdown access and repair. From January 2002 through July 2002, 30 endografts, including 14 Talent stent-grafts (Medtronic, Sunrise, Fla) and 16 Zenith endografts (Cook, Bloomington, Ind) were implanted in 30 patients for endovascular aneurysm treatment. The patients were randomized to either percutaneous technique (group A) or conventional cutdown (group B). Fifty-five femoral arteries were cannulated with large-bore (14F-25F) introducers and were included in the study. Safety and efficiency of both techniques were assessed by recording the complication rates, operation time, discharge, and time to ambulation. Comparison of selected estimated costs included both variable and fixed costs for femoral access and expenses for treatment of complications. No operative deaths occurred. The complication rates were similar and included 1 arterial thrombosis in each group, 3 lymphoceles in group B, and 1 conversion to cutdown because of bleeding in group A. Mean surgery time (86.7 +/- 27 minutes vs 107.8 +/- 38.5 minutes; P <.05) and time to ambulation (20.1 +/- 4.3 hours vs 33.1 +/- 18.4 hours; P <.001) were significantly shorter in the group treated percutaneously. Because of the cost of the closure device, total cost of the percutaneous technique averaged 99.2 euro; more than cutdown. The percutaneous technique decreases the invasiveness of endovascular therapy of aortic aneurysm and reduces operative time and time to ambulation. Complications were roughly equivalent in severity. The additional cost for the device appears to justify its use for this form of aneurysm treatment.
              Article 0 comments Cited 17 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Akif Bayyiğit:
                ORCID: http://orcid.org/0000-0002-9963-4809
                Journal
                Journal ID (nlm-ta): Biomed Res Int
                Journal ID (iso-abbrev): Biomed Res Int
                Journal ID (publisher-id): BMRI
                Title: BioMed Research International
                Publisher: Hindawi
                ISSN (Print): 2314-6133
                ISSN (Electronic): 2314-6141
                Publication date Collection: 2018
                Publication date (Electronic): 9 August 2018
                Volume: 2018
                Electronic Location Identifier: 2687862
                Affiliations
                1Department of Cardiology, Haseki Education and Research Hospital, Istanbul, Turkey
                2Department of Internal Medicine, Okmeydanı Education and Research Hospital, Istanbul, Turkey
                Author notes

                Academic Editor: Nazario Carrabba

                Author information
                http://orcid.org/0000-0002-2232-2858
                http://orcid.org/0000-0003-1634-1750
                http://orcid.org/0000-0002-9963-4809
                http://orcid.org/0000-0003-2602-6594
                Article
                DOI: 10.1155/2018/2687862
                PMC ID: 6106714
                PubMed ID: 30175119
                SO-VID: 6fa6d5f3-b36e-4cc8-b9d4-6bd94ef8e438
                Copyright © Copyright © 2018 Gündüz Durmuş et al.
                License:

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 24 February 2018
                Date revision received : 9 May 2018
                Date accepted : 15 July 2018
                Categories
                Subject: Research Article

                Data availability:

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