{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T19:01:14Z","timestamp":1768590074496,"version":"3.49.0"},"reference-count":18,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2023,4,13]],"date-time":"2023-04-13T00:00:00Z","timestamp":1681344000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pacing Clinical Electrophis"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Leadless pacemakers were developed to reduce complications associated with transvenous pacemaker implantation and long\u2010term follow\u2010up. Existing international guidelines lack detailed instructions on patients suitable for leadless pacemaker implantation. Our aim was to develop a consensus document that provides medical guidance for all health professionals involved in the indication and implantation of Transcatheter Pacing System single\u2010chamber device (VR leadless) pacemakers for patients with atrial fibrillation or in sinus rhythm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A panel of experts, including interventional and non\u2010interventional cardiologists, used the Research ANd Development\/University of California at Los Angeles (RAND\/UCLA) method to rate the appropriateness of leadless pacemaker implantation for 64 scenarios in patients with atrial fibrillation and 192 scenarios in sinus rhythm. The scenarios were rated individually and again during a moderated group session. Median ratings and level of agreement were calculated to classify each scenario as appropriate, inappropriate, or questionable.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>This consensus statement, based on available literature and the experts\u2019 opinions, summarizes recommendations for standardizing and optimizing leadless pacemaker implantation. The limitation for vascular access via the superior vena cava was the most influential variable when indicating leadless pacemaker implantation in both patients with atrial fibrillation and patients in sinus rhythm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Life expectancy, risk of infection, prosthetic valve, left ventricular ejection fraction (LVEF), limitation for vascular access via the superior vena cava, and mobility and exercise capacity determine who is advised to undergo VR leadless pacemaker implantation. More prospective studies are needed to optimize existing recommendations.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pace.14699","type":"journal-article","created":{"date-parts":[[2023,4,13]],"date-time":"2023-04-13T15:59:37Z","timestamp":1681401577000},"page":"358-364","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["The VR leadless pacemaker: Results of an expert panel using the RAND\/UCLA method"],"prefix":"10.1111","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0106-5530","authenticated-orcid":false,"given":"Juan M\u00e1ximo","family":"Molina\u2010Linde","sequence":"first","affiliation":[{"name":"Health Technology Assessment Area\u2010AETSA Andalusian Public Foundation Progress and Health\u2010FPS Seville Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ernesto","family":"D\u00edaz\u2010Infante","sequence":"additional","affiliation":[{"name":"Cardiology Department Virgen Macarena University Hospital Seville Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luis","family":"Tercedor\u2010S\u00e1nchez","sequence":"additional","affiliation":[{"name":"Cardiology Department Virgen de las Nieves University Hospital Granada Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena","family":"Ba\u00f1os\u2010\u00c1lvarez","sequence":"additional","affiliation":[{"name":"Epidemiologist at Seville Primary Care Health District Seville Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mar\u00eda","family":"Piedad\u2010Rosario","sequence":"additional","affiliation":[{"name":"Health Technology Assessment Area\u2010AETSA Andalusian Public Foundation Progress and Health\u2010FPS Seville Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan Antonio","family":"Blasco\u2010Amaro","sequence":"additional","affiliation":[{"name":"Health Technology Assessment Area\u2010AETSA Andalusian Public Foundation Progress and Health\u2010FPS Seville Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,4,13]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2018.10.044"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.15420\/aer.2019.15.3"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1080\/13696998.2019.1652186"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehab364"},{"key":"e_1_2_12_6_1","unstructured":"ECRI.Micra VR and AV Transcatheter Pacing Systems (Medtronic plc.) for cardiac pacing.Clinical Evidence Assessment.2022. Accessed September 1 2022.https:\/\/www.ecri.org\/components\/ProductBriefs\/Pages\/24372.aspx#"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/pace.13601"},{"key":"e_1_2_12_8_1","unstructured":"U.S. Food and Drug Administration [Internet].Aveir Leadless Pacing System \u2013 P150035. September 2022.https:\/\/www.fda.gov\/medical\u2010devices\/recently\u2010approved\u2010devices\/aveir\u2010leadless\u2010pacing\u2010system\u2010aveir\u2010leadless\u2010pacemaker\u2010model\u2010lsp112v\u2010right\u2010ventricular\u2010aveir\u2010delivery"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.120.019212"},{"issue":"11","key":"e_1_2_12_10_1","first-page":"946","article-title":"Spanish pacemaker registry. 19th official report of the Heart Rhythm Association of the Spanish Society of Cardiology (2021)","volume":"75","author":"Pombo Jim\u00e9nez M","year":"2022","journal-title":"Rev Esp Cardiol (Engl Ed)"},{"key":"e_1_2_12_11_1","volume-title":"The RAND\/UCLA Appropriateness Method User's Manual [MR\u20101269]","author":"Fitch K","year":"2001"},{"key":"e_1_2_12_12_1","doi-asserted-by":"crossref","DOI":"10.52766\/KMLY3802","volume-title":"Indicaciones del uso apropiado del marcapasos sin cables. Revisi\u00f3n sistem\u00e1tica y criterios de uso","author":"Molina\u2010Linde JM","year":"2023"},{"key":"e_1_2_12_13_1","first-page":"145","article-title":"A meta\u2010analysis of major complications between traditional pacemakers and leadless pacemakers","volume":"3","author":"Cui D","year":"2021","journal-title":"Carduivasc Innov Appl"},{"key":"e_1_2_12_14_1","volume-title":"Leadless Pacemakers for Right Ventricle Pacing","author":"Semlitsch TH","year":"2020"},{"key":"e_1_2_12_15_1","volume-title":"IBM SPSS Statistics for Windows, Version 23.0","author":"IBM Corp","year":"2015"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehab368"},{"issue":"18","key":"e_1_2_12_17_1","first-page":"e895","article-title":"2022 AHA\/ACC\/HFSA Guideline for the management of heart failure: a report of the American College of Cardiology\/American Heart Association Joint Committee on Clinical Practice Guidelines","volume":"145","author":"Heidenreich PA","year":"2022","journal-title":"Circulation"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euac066"},{"key":"e_1_2_12_19_1","unstructured":"LewisRJ.An introduction to classification and regression tree (CART) analysis. 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