{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T17:29:15Z","timestamp":1761845355517,"version":"build-2065373602"},"reference-count":23,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2021,4,1]],"date-time":"2021-04-01T00:00:00Z","timestamp":1617235200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>The LAmbreTM device is a novel system designed for left atrial appendage closure (LAAC). First registries showed a high rate of device implantation success. However, few mid-term results are available. We present our 1- and 12-month follow-up results for this device. This prospective, single-center registry included consecutive patients with nonvalvular atrial fibrillation who underwent LAAC with the LAmbreTM device. Transesophageal echocardiography (TEE) was performed at 1-month follow-up. In total, 55 patients were included. The population was elderly (75 \u00b1 9.4 years), with a high proportion of comorbidities. The mean CHA2DS2-VASc and HAS-BLED scores were 4.6 \u00b1 1.6 and 3.9 \u00b1 1.0, respectively. Previous history of a major bleeding event was present in 37 patients (67.3%). Procedural success was achieved in 54 patients (98.2%). Device success was achieved in 100% of patients in whom device implantation was attempted (54 patients). Major in-hospital device-related complications included mortality of one patient (1.8%) and pericardial tamponade in two patients (3.6%); the incidence of stroke was 0%. No thrombus or significant leaks (\u22655 mm) were observed on 1-month TEE. At 12 months, adverse events were overall death (1.8%), transient ischemic attack\/ischemic stroke (1.8%), and major bleeding events (Bleeding Academic Research Consortium (BARC) 3a and 3c; 11%). In this high-risk population, the LAmbreTM device seems to be a safe and effective option for LAAC with a remarkable mid-term performance.<\/jats:p>","DOI":"10.3390\/jcm10071421","type":"journal-article","created":{"date-parts":[[2021,4,1]],"date-time":"2021-04-01T07:23:17Z","timestamp":1617261797000},"page":"1421","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Left Atrial Appendage Closure with a New Occluder Device: Efficacy, Safety and Mid-Term Performance"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6211-7453","authenticated-orcid":false,"given":"Marc","family":"Llagostera-Mart\u00edn","sequence":"first","affiliation":[{"name":"Interventional Cardiology Unit, Cardiology Department, Hospital del Mar, 08003 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hector","family":"Cubero-Gallego","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Unit, Cardiology Department, Hospital del Mar, 08003 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4947-4111","authenticated-orcid":false,"given":"Aleksandra","family":"Mas-Stachurska","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Unit, Cardiology Department, Hospital del Mar, 08003 Barcelona, Spain"},{"name":"Heart Diseases Biomedical Research Group (GREC), Hospital del Mar Medical Investigation Institute-IMIM, 08003 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neus","family":"Salvatella","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Unit, Cardiology Department, Hospital del Mar, 08003 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"S\u00e1nchez-Carpintero","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Unit, Cardiology Department, Hospital del Mar, 08003 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7942-9413","authenticated-orcid":false,"given":"Helena","family":"Tizon-Marcos","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Unit, Cardiology Department, Hospital del Mar, 08003 Barcelona, Spain"},{"name":"Heart Diseases Biomedical Research Group (GREC), Hospital del Mar Medical Investigation Institute-IMIM, 08003 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcos","family":"Garcia-Guimaraes","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Unit, Cardiology Department, Hospital del Mar, 08003 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alicia","family":"Calvo-Fernandez","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Unit, Cardiology Department, Hospital del Mar, 08003 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luis","family":"Molina","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Unit, Cardiology Department, Hospital del Mar, 08003 Barcelona, Spain"},{"name":"Heart Diseases Biomedical Research Group (GREC), Hospital del Mar Medical Investigation Institute-IMIM, 08003 Barcelona, Spain"},{"name":"Medicine Department, Autonomous University of Barcelona-UAB, 08193 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1428-3596","authenticated-orcid":false,"given":"Beatriz","family":"Vaquerizo","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Unit, Cardiology Department, Hospital del Mar, 08003 Barcelona, Spain"},{"name":"Heart Diseases Biomedical Research Group (GREC), Hospital del Mar Medical Investigation Institute-IMIM, 08003 Barcelona, Spain"},{"name":"Medicine Department, Autonomous University of Barcelona-UAB, 08193 Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2021,4,1]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2746","DOI":"10.1093\/eurheartj\/eht280","article-title":"Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060","volume":"34","author":"Krijthe","year":"2013","journal-title":"Eur. Heart J."},{"key":"ref_2","first-page":"1","article-title":"Gu\u00eda ESC 2016 sobre el diagn\u00f3stico y tratamiento de la fibrilaci\u00f3n auricular, desarrollada en colaboraci\u00f3n con la EACTS","volume":"70","author":"Kirchhof","year":"2017","journal-title":"Rev. Espa\u00f1ola Cardiol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"e1","DOI":"10.1016\/j.jacc.2014.03.022","article-title":"2014 AHA\/ACC\/HRS guideline for the management of patients with atrial fibrillation: A report of the American college of Cardiology\/American heart association task force on practice guidelines and the heart rhythm society","volume":"64","author":"January","year":"2014","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"519","DOI":"10.1016\/j.amjmed.2013.12.022","article-title":"\u201cReal-World\u201d antithrombotic treatment in atrial fibrillation: The eorp-af pilot survey","volume":"127","author":"Lip","year":"2014","journal-title":"Am. J. Med."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1136\/heartjnl-2016-309782","article-title":"Efficacy and safety of left atrial appendage closure versus medical treatment in atrial fibrillation: A network meta-analysis from randomised trials","volume":"103","author":"Sahay","year":"2017","journal-title":"Heart"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1016\/j.recesp.2019.02.009","article-title":"Cierre de orejuela izquierda en pacientes mayores de 85 a\u00f1os: Seguridad y eficacia del registro EWOLUTION","volume":"73","author":"Ince","year":"2020","journal-title":"Rev. Espa\u00f1ola Cardiol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"460","DOI":"10.1002\/ccd.26358","article-title":"EWOLUTION: Design of a registry to evaluate real-world clinical outcomes in patients with AF and high stroke risk-treated with the WATCHMAN left atrial appendage closure technology","volume":"88","author":"Boersma","year":"2016","journal-title":"Catheter. Cardiovasc. Interv."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"299","DOI":"10.1016\/j.jjcc.2018.10.010","article-title":"Left atrial appendage occlusion using LAmbre Amulet and Watchman in atrial fibrillation","volume":"73","author":"Chen","year":"2019","journal-title":"J. Cardiol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1161\/CIRCINTERVENTIONS.115.002942","article-title":"Left atrial appendage and closure","volume":"9","author":"Holmes","year":"2016","journal-title":"Circ. Cardiovasc. Interv."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"97","DOI":"10.1016\/j.ijcard.2018.02.120","article-title":"Left atrial appendage occlusion with lambre in atrial fibrillation: Initial European experience","volume":"265","author":"Park","year":"2018","journal-title":"Int. J. Cardiol."},{"key":"ref_11","first-page":"251","article-title":"Percutaneous left atrial appendage closure using the LAmbre device. First clinical results in Poland","volume":"15","author":"Burysz","year":"2019","journal-title":"Postepy Kardiol. Interwencyjnej"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"2188","DOI":"10.1016\/j.jcin.2017.06.072","article-title":"Percutaneous Left Atrial Appendage Closure with the LAmbre Device for Stroke Prevention in Atrial Fibrillation: A Prospective, Multicenter Clinical Study","volume":"10","author":"Huang","year":"2017","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"134","DOI":"10.1016\/j.carrev.2013.04.003","article-title":"A new left atrial appendage occluder (Lifetech LAmbreTM Device) for stroke prevention in atrial fibrillation","volume":"14","author":"Lam","year":"2013","journal-title":"Cardiovasc. Revascularization Med."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"491","DOI":"10.2459\/JCM.0000000000000663","article-title":"Initial experience of percutaneous left atrial appendage closure using the LAmbre device for thromboembolic prevention","volume":"19","author":"Reinsch","year":"2018","journal-title":"J. Cardiovasc. Med."},{"key":"ref_15","first-page":"4","article-title":"Percutaneous left atrial appendage occlusion: The Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies","volume":"19","author":"Tzikas","year":"2017","journal-title":"Europace"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"2736","DOI":"10.1161\/CIRCULATIONAHA.110.009449","article-title":"Standardized bleeding definitions for cardiovascular clinical trials: A consensus report from the bleeding academic research consortium","volume":"123","author":"Mehran","year":"2011","journal-title":"Circulation"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1302","DOI":"10.1016\/j.hrthm.2017.05.038","article-title":"Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-Year follow-up outcome data of the EWOLUTION trial","volume":"14","author":"Boersma","year":"2017","journal-title":"Heart Rhythm"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"867","DOI":"10.4244\/EIJ-D-17-00493","article-title":"Left atrial appendage occlusion with the AMPLATZER Amulet device: Periprocedural and early clinical\/echocardiographic data from a global prospective observational study","volume":"13","author":"Landmesser","year":"2017","journal-title":"EuroIntervention"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"656","DOI":"10.1007\/s00392-015-0828-1","article-title":"Early results of first versus second generation Amplatzer occluders for left atrial appendage closure in patients with atrial fibrillation","volume":"104","author":"Gloekler","year":"2015","journal-title":"Clin. Res. Cardiol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"720","DOI":"10.1161\/CIRCULATIONAHA.112.114389","article-title":"Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation 2.3-year follow-up of the PROTECT AF (Watchman left atrial appendage system for embolic protection in patients with atrial fibrillation) trial","volume":"127","author":"Reddy","year":"2013","journal-title":"Circulation"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.jacc.2014.04.029","article-title":"Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL trial","volume":"64","author":"Holmes","year":"2014","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"E111","DOI":"10.1002\/ccd.26903","article-title":"Device-associated thrombus formation after left atrial appendage occlusion: A systematic review of events reported with the Watchman, the Amplatzer Cardiac Plug and the Amulet","volume":"90","author":"Lempereur","year":"2017","journal-title":"Catheter. Cardiovasc. Interv."},{"key":"ref_23","first-page":"2","article-title":"Left atrial appendage occlusion with Amplatzer Cardiac Plug and Amplatzer Amulet: A clinical trials update","volume":"10","author":"Tzikas","year":"2017","journal-title":"J. Atric. Fibrillation"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/7\/1421\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,13]],"date-time":"2025-10-13T13:55:59Z","timestamp":1760363759000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/7\/1421"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4,1]]},"references-count":23,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2021,4]]}},"alternative-id":["jcm10071421"],"URL":"https:\/\/doi.org\/10.3390\/jcm10071421","relation":{},"ISSN":["2077-0383"],"issn-type":[{"type":"electronic","value":"2077-0383"}],"subject":[],"published":{"date-parts":[[2021,4,1]]}}}