{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T11:07:59Z","timestamp":1789556879553,"version":"build-2803163510"},"reference-count":34,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T00:00:00Z","timestamp":1783555200000},"content-version":"unspecified","delay-in-days":8,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Open Heart"],"accepted":{"date-parts":[[2026,5,30]]},"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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\u2019s 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/openhrt-2026-004150","type":"journal-article","created":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T11:05:41Z","timestamp":1783595141000},"page":"e004150","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Successful off-label use of vascular closure devices in fully percutaneous transaxillary aortic valve implantation"],"prefix":"10.1136","volume":"13","author":[{"given":"Philipp","family":"Lauten","sequence":"first","affiliation":[{"name":"Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany"},{"name":"University of Marburg, Marburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Bleiziffer","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6534-1629","authenticated-orcid":false,"given":"Lisa C","family":"Costello-Boerrigter","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bj\u00f6rn","family":"G\u00f6bel","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Albert","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany"},{"name":"University Clinic for Cardiology and Angiology, Otto von Guericke University Magdeburg, Magdeburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahmoud","family":"Al Jassem","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Gonzalez-Lopez","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernhard","family":"Schieffer","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University of Marburg, Marburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harald","family":"Lapp","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka Gmbh, Bad Berka, Germany"},{"name":"University of Marburg, Marburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,7,9]]},"reference":[{"key":"2026091603500849000_13.2.e004150.1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1008232"},{"key":"2026091603500849000_13.2.e004150.2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1400590"},{"key":"2026091603500849000_13.2.e004150.3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1700456"},{"key":"2026091603500849000_13.2.e004150.4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1816885"},{"key":"2026091603500849000_13.2.e004150.5","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1814052"},{"key":"2026091603500849000_13.2.e004150.6","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1910555"},{"key":"2026091603500849000_13.2.e004150.7","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2018.10.041"},{"key":"2026091603500849000_13.2.e004150.8","doi-asserted-by":"crossref","first-page":"247","DOI":"10.1016\/j.ijcard.2017.01.010","article-title":"Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic valve implantation using various transcatheter heart valves in 100 consecutive patients","volume":"232","author":"Sch\u00e4fer","year":"2017","journal-title":"Int J Cardiol"},{"key":"2026091603500849000_13.2.e004150.9","doi-asserted-by":"crossref","first-page":"S478","DOI":"10.21037\/jtd.2017.05.73","article-title":"Vascular approaches for transcatheter aortic valve implantation","volume":"9","author":"Pascual","year":"2017","journal-title":"J Thorac Dis"},{"key":"2026091603500849000_13.2.e004150.10","doi-asserted-by":"crossref","DOI":"10.1093\/ehjcr\/ytac280","article-title":"Successful management of a bleeding complication during transaxillary transcatheter aortic-valve implantation: a case report","volume":"6","author":"Lauten","year":"2022","journal-title":"Eur Heart J Case 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A systematic review and meta-analysis comparing local and general anaesthesia","volume":"7","author":"Ehret","year":"2017","journal-title":"BMJ Open"},{"key":"2026091603500849000_13.2.e004150.16","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.114.012525"},{"key":"2026091603500849000_13.2.e004150.17","doi-asserted-by":"crossref","first-page":"750","DOI":"10.4244\/EIJ-D-18-00168","article-title":"Propensity-matched comparison of clinical outcomes after transaortic versus transfemoral aortic valve replacement","volume":"14","author":"Chollet","year":"2018","journal-title":"EuroIntervention"},{"key":"2026091603500849000_13.2.e004150.18","doi-asserted-by":"crossref","first-page":"2309","DOI":"10.1016\/j.jcin.2025.08.029","article-title":"Alternative Access for TAVR: A State-of-the-Art Review and Practical Guide","volume":"18","author":"Feistritzer","year":"2025","journal-title":"JACC Cardiovasc 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Heart"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/openhrt-2026-004150","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T10:50:21Z","timestamp":1789555821000},"score":1,"resource":{"primary":{"URL":"https:\/\/openheart.bmj.com\/lookup\/doi\/10.1136\/openhrt-2026-004150"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":34,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2026,7,9]]},"published-print":{"date-parts":[[2026,7]]}},"alternative-id":["10.1136\/openhrt-2026-004150"],"URL":"https:\/\/doi.org\/10.1136\/openhrt-2026-004150","relation":{},"ISSN":["2053-3624"],"issn-type":[{"value":"2053-3624","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7]]}}}