{
  "abstract": "Background The axillary artery is an alternative access- site for transcatheter aortic valve implantation (TAVI) when femoral arteries are unfavourable. Simplified transaxillary-TAVI (TAx-TAVI) is performed completely percutaneously, using vascular closure device (VCD) techniques for arteriotomy closure. Concerns exist regarding major vascular complications with this technique. This registry-study describes off-label VCD use during simplified TAx-TAVI.Methods Consecutive severe aortic stenosis patients unsuitable for both surgery and transfemoral access were enrolled in our heart valve registry and underwent simplified TAx-TAVI using VCDs for arteriotomy closure. At the operator’s discretion, closure was performed with a collagen-based plug (MANTA) or a suture-based system (double ProGlide). The primary endpoint was axillary access-related major vascular complications in hospital and at 30 days according to Valve Academic Research Consortium (VARC-3) definitions. Secondary endpoints included axillary access-site bleeding and all-cause mortality during hospitalisation to 30 days post-TAx-TAVI.Results From January 2022 to January 2024, 32 patients (mean age 77 years, 31.3% female) underwent simplified TAx-TAVI using VCDs. MANTA and ProGlide were each used in 50.0% of cases (n=16). Local anaesthesia with conscious sedation was used in 21.9% (n=7). Overall VARC-3 device success was 96.9% (31/32). VCD failure occurred in 25.0% (8/32) and was numerically more frequent with ProGlide (31.3%) than MANTA (18.8%). A covered stent was required for definitive axillary haemostasis in 12.5% (4/32). The 30-day axillary major vascular complication rate was 3.1% (1/32). No major bleeding complications occurred. All-cause 30-day mortality was 3.1% (1/32). New permanent pacemaker implantation occurred in 12.5% (4/32). At 30 days, New York Heart association (NYHA) class improved by at least one category in 68.8% (22/32).Conclusions In these simplified TAx-TAVI cases, MANTA and ProGlide VCDs performed well in terms of vascular and bleeding complications. Simplified TAx-TAVI requires advanced access-site management skills, including covered stent use. We found VCDs approved for femoral use safe with axillary access.",
  "authors": [
    {
      "affiliations": [
        "Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany",
        "University of Marburg, Marburg, Germany"
      ],
      "name": "Philipp Lauten"
    },
    {
      "affiliations": [
        "Department of Cardiac Surgery, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany"
      ],
      "name": "Sabine Bleiziffer"
    },
    {
      "affiliations": [
        "Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany"
      ],
      "name": "Lisa C Costello-Boerrigter"
    },
    {
      "affiliations": [
        "Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany"
      ],
      "name": "Björn Göbel"
    },
    {
      "affiliations": [
        "Department of Nephrology, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany",
        "University Clinic for Cardiology and Angiology, Otto von Guericke University Magdeburg, Magdeburg, Germany"
      ],
      "name": "Christian Albert"
    },
    {
      "affiliations": [
        "Department of Cardiac Surgery, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany"
      ],
      "name": "Mahmoud Al Jassem"
    },
    {
      "affiliations": [
        "Department of Cardiac Surgery, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany"
      ],
      "name": "David Gonzalez-Lopez"
    },
    {
      "affiliations": [
        "Department of Cardiology, University of Marburg, Marburg, Germany"
      ],
      "name": "Bernhard Schieffer"
    },
    {
      "affiliations": [
        "Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany",
        "University of Marburg, Marburg, Germany"
      ],
      "name": "Harald Lapp"
    }
  ],
  "title": "Successful off-label use of vascular closure devices in fully percutaneous transaxillary aortic valve implantation",
  "uid": "2bfbffc4-8f7f-5acf-8b3c-95adb71e82c5"
}