{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T01:17:43Z","timestamp":1791422263244,"version":"4.3.3"},"reference-count":34,"publisher":"MDPI AG","issue":"15","license":[{"start":{"date-parts":[[2025,8,4]],"date-time":"2025-08-04T00:00:00Z","timestamp":1754265600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"AtriCure, Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Cardiac surgery patients with pre- or post-operative atrial fibrillation are at an increased risk for thromboembolic stroke, often due left atrial appendage (LAA) thrombus. Surgical LAA exclusion (LAAE) can be performed and must be complete to avoid increased thrombus formation. Methods: This prospective, multi-center, post-market study (NCT05101993) evaluated the long-term safety and performance of the epicardial V-shape AtriClip device. Patients \u226518 years who had received V-shape AtriClip devices during non-emergent cardiac surgery consented to a prospective 12-month follow-up visit and LAA imaging. The primary performance was LAAE without residual left atrium-LAA communication, assessed by imaging at the last follow-up visit. The primary safety was device- or implant procedure-related serious adverse events (SAEs) (death, major bleeding, surgical site infection, pericardial effusion requiring intervention, myocardial infarction) within 30 days. Results: Of 155 patients from 11 U.S. centers, 151 patients had evaluable imaging. Complete LAAE was obtained in all patients. Primary performance in the intent-to-treat population was met, with 97% (95% CI 93.52%, 99.29%; p = 0.0001) complete LAAE. Primary safety was met, with 100% (95% CI 97.75%, 100%; p &lt; 0.0001) of patients free from pre-defined SAEs within 30 days. One device-related SAE was reported, which resolved intraprocedurally. Conclusions: AtriClip V-Clip showed safe and successful LAAE through 12 months of follow-up.<\/jats:p>","DOI":"10.3390\/jcm14155473","type":"journal-article","created":{"date-parts":[[2025,8,5]],"date-time":"2025-08-05T08:46:55Z","timestamp":1754383615000},"page":"5473","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Long-Term Follow-Up of Left Atrial Appendage Exclusion: Results of the V-CLIP Multi-Center Post-Market Study"],"prefix":"10.3390","volume":"14","author":[{"given":"Elias","family":"Zias","sequence":"first","affiliation":[{"name":"Department of Cardiothoracic Surgery, New York University Langone Medical Center, 530 1st Ave, Ste 9V, New York, NY 10016, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8257-0899","authenticated-orcid":false,"given":"Katherine G.","family":"Phillips","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, New York University Langone Medical Center, 530 1st Ave, Ste 9V, New York, NY 10016, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Gerdisch","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Franciscan Alliance dba Franciscan Health Indianapolis, 8111 South Emerson Ave, Indianapolis, IN 46237, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Johnson","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Aurora Research Institute LLC, 2901 W Kinnickinnic River Pkwy, Ste 507, Milwaukee, WI 53215, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed","family":"El-Eshmawi","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY 10029, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Saum","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Centra Lynchburg General Hospital, 1901 Tate Springs Rd, Lynchburg, VA 24501, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Moront","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Toledo Hospital, 1 ProMedica Parkway, Toledo, OH 43606, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Kasten","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Mercy Health Physicians, 1000 N Village Ave, Rockville Centre, NY 11570, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chanderdeep","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Albany Medical Center, 43 New Scotland Ave, Albany, NY 12208, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-1029-3395","authenticated-orcid":false,"given":"Gautam","family":"Bhatia","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Prisma Health-Greenville Memorial Hospital, 701 Grove Rd, Greenville, SC 29605, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroo","family":"Takayama","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Columbia University Medical Center, 630 W 168th St, New York, NY 10032, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ralph","family":"Damiano","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Washington University School of Medicine, 660 S Euclid Ave, St. Louis, MO 63110, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,8,4]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"755","DOI":"10.1016\/0003-4975(95)00887-X","article-title":"Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation","volume":"61","author":"Blackshear","year":"1996","journal-title":"Ann. Thorac. Surg."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"2081","DOI":"10.1056\/NEJMoa2101897","article-title":"Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke","volume":"384","author":"Whitlock","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_3","unstructured":"Writing Committee Members, Joglar, J.A., Chung, M.K., Armbruster, A.L., Benjamin, E.J., Chyou, J.Y., Cronin, E.M., Deswal, A., Eckhardt, L.L., and Goldberger, Z.D. (2023). 2023 ACC\/AHA\/ACCP\/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology\/American Heart Association Joint Committee on Clinical Practice Guidelines. J. Am. Coll. Cardiol., 83, 109\u2013279."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"841","DOI":"10.1002\/joa3.12939","article-title":"2023 APHRS expert consensus statements on surgery for AF","volume":"39","author":"Nitta","year":"2023","journal-title":"J. Arrhythmia"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"921","DOI":"10.1007\/s10840-024-01771-5","article-title":"2024 European Heart Rhythm Association\/Heart Rhythm Society\/Asia Pacific Heart Rhythm Society\/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation","volume":"67","author":"Tzeis","year":"2024","journal-title":"J. Interv. Card. Electrophysiol."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"291","DOI":"10.1016\/j.thorsurg.2024.04.012","article-title":"The Society of Thoracic Surgeons 2023 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation","volume":"118","author":"Hui","year":"2024","journal-title":"Ann. Thorac. Surg."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1078","DOI":"10.1007\/s11239-020-02291-5","article-title":"The relationship between incomplete surgical obliteration of the left atrial appendage and thromboembolic events after mitral valve surgery (from the ISOLATE Registry)","volume":"51","author":"Kalkan","year":"2021","journal-title":"J. Thromb. Thrombolysis"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1431","DOI":"10.1016\/j.hrthm.2015.03.028","article-title":"Association between incomplete surgical ligation of left atrial appendage and stroke and systemic embolization","volume":"12","author":"Aryana","year":"2015","journal-title":"Heart Rhythm."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"288","DOI":"10.1016\/j.ahj.2004.09.054","article-title":"Left Atrial Appendage Occlusion Study (LAAOS): Results of a randomized controlled pilot study of left atrial appendage occlusion during coronary bypass surgery in patients at risk for stroke","volume":"150","author":"Healey","year":"2005","journal-title":"Am. Heart J."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"2357","DOI":"10.4022\/jafib.2357","article-title":"Prevalence and Risk Factors of Incomplete Surgical Closure of the Left Atrial Appendage on Follow-up Transesophageal Echocardiogram","volume":"13","author":"Lin","year":"2020","journal-title":"J. Atr. Fibrillation"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"675","DOI":"10.1016\/j.athoracsur.2015.07.071","article-title":"Left Atrial Appendage Patency at Cardioversion After Surgical Left Atrial Appendage Intervention","volume":"101","author":"Cullen","year":"2016","journal-title":"Ann. Thorac. Surg."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"924","DOI":"10.1016\/j.jacc.2008.03.067","article-title":"Success of surgical left atrial appendage closure: Assessment by transesophageal echocardiography","volume":"52","author":"Kanderian","year":"2008","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"468","DOI":"10.1016\/S0735-1097(00)00765-8","article-title":"Surgical left atrial appendage ligation is frequently incomplete: A transesophageal echocardiograhic study","volume":"36","author":"Katz","year":"2000","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1253","DOI":"10.1016\/S0735-1097(03)00954-9","article-title":"Role of left atrial appendage obliteration in stroke reduction in patients with mitral valve prosthesis: A transesophageal echocardiographic study","volume":"42","author":"Quiles","year":"2003","journal-title":"J. Am. Coll. Cardiol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1075","DOI":"10.1016\/j.jtcvs.2016.06.009","article-title":"A randomized, prospective pilot comparison of 3 atrial appendage elimination techniques: Internal ligation, stapled excision, and surgical excision","volume":"152","author":"Lee","year":"2016","journal-title":"J. Thorac. Cardiovasc. Surg."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1002","DOI":"10.1016\/j.jtcvs.2011.07.052","article-title":"Exclusion of the left atrial appendage with a novel device: Early results of a multicenter trial","volume":"142","author":"Ailawadi","year":"2011","journal-title":"J. Thorac. Cardiovasc. Surg."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"655","DOI":"10.1093\/icvts\/ivz156","article-title":"Outcomes of left atrial appendage occlusion using the AtriClip device: A systematic review. Interact","volume":"29","author":"Toale","year":"2019","journal-title":"Cardiovasc. Thorac. Surg."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"463","DOI":"10.1177\/15569845221123796","article-title":"Prophylactic Left Atrial Appendage Exclusion in Cardiac Surgery Patients With Elevated CHA(2)DS(2)-VASc Score: Results of the Randomized ATLAS Trial","volume":"17","author":"Gerdisch","year":"2022","journal-title":"Innovations"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"126","DOI":"10.1093\/ejcts\/ezt204","article-title":"Safe, effective and durable epicardial left atrial appendage clip occlusion in patients with atrial fibrillation undergoing cardiac surgery: First long-term results from a prospective device trial","volume":"45","author":"Emmert","year":"2014","journal-title":"Eur. J. Cardiothorac. Surg."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1269","DOI":"10.1016\/j.jtcvs.2009.06.033","article-title":"Left atrial appendage clip occlusion: Early clinical results","volume":"139","author":"Salzberg","year":"2010","journal-title":"J. Thorac. Cardiovasc. Surg."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1177\/15569845221091998","article-title":"Left Atrial Appendage Ligation Using the AtriClip Device: Single-Center Study of Device Safety and Efficacy","volume":"17","author":"Kiankhooy","year":"2022","journal-title":"Innovations"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"1754","DOI":"10.1161\/CIRCULATIONAHA.120.050117","article-title":"Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial","volume":"143","author":"Kar","year":"2021","journal-title":"Circulation"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"340","DOI":"10.1016\/j.jtcvs.2006.04.021","article-title":"Evaluation of a novel device for left atrial appendage exclusion: The second-generation atrial exclusion device","volume":"132","author":"Kamohara","year":"2006","journal-title":"J. Thorac. Cardiovasc. Surg."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"1639","DOI":"10.1016\/j.jtcvs.2005.08.019","article-title":"A novel device for left atrial appendage exclusion","volume":"130","author":"Kamohara","year":"2005","journal-title":"J. Thorac. Cardiovasc. Surg."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"766","DOI":"10.1016\/j.ejcts.2008.05.058","article-title":"Surgical left atrial appendage occlusion: Evaluation of a novel device with magnetic resonance imaging","volume":"34","author":"Salzberg","year":"2008","journal-title":"Eur. J. Cardiothorac. Surg."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"416","DOI":"10.1093\/icvts\/ivs136","article-title":"Epicardial left atrial appendage clip occlusion also provides the electrical isolation of the left atrial appendage","volume":"15","author":"Starck","year":"2012","journal-title":"Interact. Cardiovasc. Thorac. Surg."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"109","DOI":"10.1161\/CIRCULATIONAHA.109.928903","article-title":"Left atrial appendage: An underrecognized trigger site of atrial fibrillation","volume":"122","author":"Burkhardt","year":"2010","journal-title":"Circulation"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"663","DOI":"10.1093\/icvts\/ivz176","article-title":"Incidence and characteristics of left atrial appendage stumps after device-enabled epicardial closure","volume":"29","author":"Caliskan","year":"2019","journal-title":"Interact. Cardiovasc. Thorac. Surg."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"1356","DOI":"10.1016\/j.jacep.2017.03.008","article-title":"Angiographic efficacy of the AtriClip left atrial appendage exclusion device placed by minimally invasive thoracoscopic approach","volume":"3","author":"Ellis","year":"2017","journal-title":"JACC Clin. Electrophysiol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"193","DOI":"10.1016\/j.amjcard.2023.06.026","article-title":"Long-Term Imaging and Clinical Outcomes of Surgical Left Atrial Appendage Occlusion With AtriClip","volume":"201","author":"Ahmed","year":"2023","journal-title":"Am. J. Cardiol."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"e193","DOI":"10.1161\/CIR.0000000000000885","article-title":"Considerations for Reduction of Risk of Perioperative Stroke in Adult Patients Undergoing Cardiac and Thoracic Aortic Operations: A Scientific Statement From the American Heart Association","volume":"142","author":"Gaudino","year":"2020","journal-title":"Circulation"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"566","DOI":"10.1016\/j.athoracsur.2022.12.033","article-title":"The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2022 Update on Outcomes and Research","volume":"115","author":"Kim","year":"2023","journal-title":"Ann. Thorac. Surg."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"2127","DOI":"10.1016\/j.jcin.2022.09.001","article-title":"Peridevice Leak After Transcatheter Left Atrial Appendage Occlusion: An Analysis of the Amulet IDE Trial","volume":"15","author":"Price","year":"2022","journal-title":"JACC Cardiovasc. Interv."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"469","DOI":"10.1016\/j.jacc.2022.04.062","article-title":"Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure","volume":"80","author":"Dukkipati","year":"2022","journal-title":"J. Am. Coll. Cardiol."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/15\/5473\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T18:22:39Z","timestamp":1760034159000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/15\/5473"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,4]]},"references-count":34,"journal-issue":{"issue":"15","published-online":{"date-parts":[[2025,8]]}},"alternative-id":["jcm14155473"],"URL":"https:\/\/doi.org\/10.3390\/jcm14155473","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,4]]}}}