Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide

被引：42
作者：
Hoffmann P. [1 ]
Al-Ani A. [1 ]
von Lueder T. [2 ]
Hoffmann J. [3 ]
Majak P. [4 ]
Hagen O. [5 ]
Loose H. [6 ]
Kløw N.E. [7 ]
Opdahl A. [1 ]
机构：
[1] Department of Cardiology, Section for Interventional Cardiology, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Ullevål, Oslo
[2] Department of Cardiology B, Division of Medicine, Oslo University Hospital, Ullevål, Oslo
[3] The Lundberg Laboratory, Sahlgrenska Academy, University of Gothenburg, Gothenburg
[4] Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Ullevål, Oslo
[5] Department of Anesthesiology, Division of Emergencies and Critical care, Oslo University Hospital, Ullevål, Oslo
[6] Department of Vascular Diseases, Section for Vascular Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo
[7] Department of Radiology, Section for Interventional Radiology, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Ullevål, and Institute for Clinical Medicine, University of Oslo, Oslo
来源：
CVIR Endovascular | / 1卷 / 1期
关键词：
Access site complications; Manta; ProGlide; Transfemoral TAVI; Vascular closure device;
D O I：
10.1186/s42155-018-0026-0
中图分类号：
学科分类号：
摘要：
Background: Despite decreasing sheath diameter, access site bleeding and vascular complications are still a major concern in transfemoral aortic valve implantation (TAVI), and may increase morbidity and even increase mortality. The aim was to compare safety of arterial closure in transfemoral TAVI with two different principles, pre-suture with ProGlide and collagen plug closure with Manta. Results: Seventy-six patients treated with ProGlide and 75 with Manta were analysed. The endpoints were 1: access site vascular complications and 2: non-planned vascular or endovascular surgery at the puncture site. Complications occurred in 2 (2.7%) ProGlide and in 8 (10.7%) Manta cases, p = 0.047. During the learning phase there were no significant differences. In the established phase there was one event (2%) in the ProGlide group, compared to 6 endpoints (12.0%), p = 0.047, in the Manta group. Unplanned surgery or intervention was seen in two (2.7%) ProGlide and in 7 (9.3%) Manta patients, p = ns. There were no significant differences during the learning phase. In established use, endpoints occurred more frequently in patients treated with the Manta device (12%), than in patients treated with the ProGlide (2%), p = 0.047. Conclusion: The ProGlide presuture closure device was associated with significantly lower rates of vascular complications and lower rates of surgery and interventions compared to the collagen plug Manta system. Trial registration: The data were collected from Internal quality control registry on treatment of patients with valvular heart disease with or without coronary artery disease, No 2014/17280, Oslo University Hospital, Ullevål. © 2018, The Author(s).
引用
收藏
相关论文
共 15 条
  • [1] Arsalan M., Weferling M., Hecker F., Filardo G., Kim W.-K., Pollock B.D., Van Linden A., Arsalan-Werner A., Renker M., Doss M., Kalbas S., Hamm C.W., Liebetrau C., Mack M.J., Walther T., TAVI risk scoring using established versus new scoring systems: role of the new STS/ACC model, EuroIntervention, 13, pp. 1520-1526, (2018)
  • [2] Babaliaros V., Devireddy C., Lerakis S., Leonardi R., Iturra S.A., Mavromatis K., Leshnower B.G., Guyton R.A., Kanitkar M., Keegan P., Simone A., Stewart J.P., Ghasemzadeh N., Block P., Thourani V.H., Comparison of Transfemoral Transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach). Outcomes and cost analysis. JACC: cardiovascular, Interventions, 7, pp. 898-904, (2014)
  • [3] Barbash I.M., Barbanti M., Webb J., Molina-Martin De Nicolas J., Abramowitz Y., Latib A., Nguyen C., Deuschl F., Segev A., Sideris K., Buccheri S., Simonato M., Della Rosa F., Tamburino C., Jilaihawi H., Miyazaki T., Himbert D., Schofer N., Guetta V., Bleiziffer S., Tchetche D., Imme` S., raj R., Makkar R.R., Vahanian A., Treede H., Lange R., Colombo A., Dvir D., Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation, Eur Heart J, 36, pp. 337
  • [4] Biancari F., Romppanen H., Savontaus M., Siljander A., Makikallio T., Piira O.-P., Piuhola J., Vilkki V., Ylitalo A., Vasankari T., Airaksinen J., Niemela M., MANTA versus ProGlide vascular closure devices in transfemoral transcatheter aortic valve implantation, Int J Cardiol, 263, pp. 29-31, (2018)
  • [5] De Palma R., Settergren M., Ruck A., Linder R., Saleh N., Impact of percutaneous femoral arteriotomy closure using the MANTA™ device on vascular and bleeding complications after transcatheter aortic valve replacement, Catheter Cardiovasc Interv, pp. 1-8, (2018)
  • [6] Dencker D., Taudorf M., Luk N.H.V., Nielsen M.B., Kofoed K.F., Schroeder T.V., Sondergaard L., Lonn L., De Backer O., Frequency and effect of access-related vascular injury and subsequent vascular intervention after Transcatheter aortic valve replacement, Am J Cardiol, 118, pp. 1244-1250, (2016)
  • [7] Large Bore Closure, (2018)
  • [8] Kappetein A.P., Head S.J., Gene'reux' P., Piazza N., Van Mieghem N.M., Blackstone E.H., Brott T.G., Cohen D.J., Cutlip D.E., Van Es G.-A., Hahn R.T., Kirtane A.J., Krucoff M.W., Kodali S., Mack M.J., Mehran R., Rode's-Cabau J., Vranckx P., Webb J.G., Windecker S., Serruys P.W., Leon M.B., Updated standardized endpoint definitions for transcatheter aortic valve implantation: the valve academic research Consortium-2 consensus document, Eur Heart J, 33, pp. 2403-2418, (2012)
  • [9] Mangla A., Gupta S., Vascular complications post-transcatheter aortic valve procedures, Indian Heart J, 68, pp. 724-731, (2016)
  • [10] Maniotis C., Andreou C., Karalis I., Koutouzi G., Agelaki M., Koutouzis M., A systematic review on the safety of Prostar XL versus ProGlide after TAVR and EVAR, Cardiovascular Revascularization Medicine, 18, pp. 145-150, (2017)
12