{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T08:07:16Z","timestamp":1791446836846,"version":"4.3.3"},"reference-count":18,"publisher":"Oxford University Press (OUP)","issue":"34","license":[{"start":{"date-parts":[[2025,6,27]],"date-time":"2025-06-27T00:00:00Z","timestamp":1750982400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/501100001411","name":"Indian Council of Medical Research","doi-asserted-by":"publisher","award":["5\/4\/1-13\/14-NCD-II"],"award-info":[{"award-number":["5\/4\/1-13\/14-NCD-II"]}],"id":[{"id":"10.13039\/501100001411","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,9,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>Left-sided mechanical prosthetic valve thrombosis (PVT) is common in low-resource settings. Treatment is either by fibrinolytic therapy (FT) or urgent surgery. This is the first randomized controlled trial (RCT) comparing urgent surgery with FT for symptomatic left-sided PVT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This is a single-centre RCT comparing urgent surgery with FT (low-dose, slow-infusion tissue plasminogen activator [t-PA]) in patients with symptomatic left-sided PVT. The primary outcome was complete clinical response, defined as discharge from hospital with completely restored valve function, without major complications. The primary safety outcome was a composite of death, non-fatal stroke, non-fatal major bleed, or systemic embolism, at discharge. Outcomes were assessed by investigators blinded to treatment allocation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Over a 6-year period, 79 patients were randomized to urgent surgery (n = 39) or FT (n = 40). Patients most often had a thrombosed mitral prosthesis (72%) with 43% in New York Heart Association class III\/IV. All patients allocated to FT received t-PA. Of the 32 patients who had surgery, 17 (53%) underwent the procedure within 48\u2005h. In the intention-to-treat population, the primary outcome was not significantly different between the two arms (odds ratio [OR] 1.22, 95% confidence interval [CI] 0.46\u20133.19; P = .689). However, the composite safety outcome occurred more often with surgery (OR 5.14, 95% CI 1.28\u201320.5; P = .021), driven by the difference in deaths (7\/39 vs 1\/40; P = .035). Twenty-five percent of patients undergoing FT (10\/40) had residual valve dysfunction.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In symptomatic left-sided PVT, urgent surgery is not more efficacious than FT. Surgery is associated with a higher risk of complications, including death, while FT is more often associated with residual valve dysfunction.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/eurheartj\/ehaf391","type":"journal-article","created":{"date-parts":[[2025,5,25]],"date-time":"2025-05-25T07:33:01Z","timestamp":1748158381000},"page":"3373-3381","source":"Crossref","is-referenced-by-count":26,"title":["Urgent surgery vs fibrinolytic therapy for left-sided prosthetic valve thrombosis: a randomized trial"],"prefix":"10.1093","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2073-2917","authenticated-orcid":false,"given":"Ganesan","family":"Karthikeyan","sequence":"first","affiliation":[{"name":"Cardiothoracic Sciences Centre, All India Institute of Medical Sciences , Ansari Nagar, New Delhi 110029 ,","place":["India"]},{"name":"Translational Health Science and Technology Institute , Faridabad, Haryana 120001 ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Palleti","family":"Rajashekar","sequence":"additional","affiliation":[{"name":"Cardiothoracic Sciences Centre, All India Institute of Medical Sciences , Ansari Nagar, New Delhi 110029 ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niveditha","family":"Devasenapathy","sequence":"additional","affiliation":[{"name":"Academic Clinical Trial Unit, The George Institute of Global Health ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shyamashree","family":"Biswas","sequence":"additional","affiliation":[{"name":"Academic Clinical Trial Unit, The George Institute of Global Health ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bharathraj","family":"Kidambi","sequence":"additional","affiliation":[{"name":"Cardiothoracic Sciences Centre, All India Institute of Medical Sciences , Ansari Nagar, New Delhi 110029 ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aayush","family":"Singal","sequence":"additional","affiliation":[{"name":"Cardiothoracic Sciences Centre, All India Institute of Medical Sciences , Ansari Nagar, New Delhi 110029 ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohsin Raj","family":"Mantoo","sequence":"additional","affiliation":[{"name":"Cardiothoracic Sciences Centre, All India Institute of Medical Sciences , Ansari Nagar, New Delhi 110029 ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manoj","family":"Soni","sequence":"additional","affiliation":[{"name":"Academic Clinical Trial Unit, The George Institute of Global Health ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gaurav","family":"Purohit","sequence":"additional","affiliation":[{"name":"Cardiothoracic Sciences Centre, All India Institute of Medical Sciences , Ansari Nagar, New Delhi 110029 ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Milind P","family":"Hote","sequence":"additional","affiliation":[{"name":"Cardiothoracic Sciences Centre, All India Institute of Medical Sciences , Ansari Nagar, New Delhi 110029 ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandeep","family":"Singh","sequence":"additional","affiliation":[{"name":"Cardiothoracic Sciences Centre, All India Institute of Medical Sciences , Ansari Nagar, New Delhi 110029 ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Devagourou","family":"Velayoudam","sequence":"additional","affiliation":[{"name":"Cardiothoracic Sciences Centre, All India Institute of Medical Sciences , Ansari Nagar, New Delhi 110029 ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,6,27]]},"reference":[{"key":"2025090719570859600_ehaf391-B1","doi-asserted-by":"publisher","first-page":"e72","DOI":"10.1161\/CIR.0000000000000923","article-title":"2020 ACC\/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology\/American Heart Association Joint Committee on Clinical Practice Guidelines","volume":"143","author":"Otto","year":"2021","journal-title":"Circulation"},{"key":"2025090719570859600_ehaf391-B2","doi-asserted-by":"publisher","first-page":"1219","DOI":"10.1016\/j.athoracsur.2007.04.115","article-title":"Aortic valve replacement with mitral valve repair compared with combined aortic and mitral valve replacement","volume":"84","author":"Talwar","year":"2007","journal-title":"Ann Thorac Surg"},{"key":"2025090719570859600_ehaf391-B3","doi-asserted-by":"crossref","first-page":"1108","DOI":"10.1161\/CIRCULATIONAHA.109.876706","article-title":"Accelerated infusion of streptokinase for the treatment of left-sided prosthetic valve thrombosis: a randomized controlled trial","volume":"120","author":"Karthikeyan","year":"2009","journal-title":"Circulation"},{"key":"2025090719570859600_ehaf391-B4","doi-asserted-by":"crossref","first-page":"269","DOI":"10.1016\/j.acvd.2009.01.007","article-title":"Management of prosthetic heart valve obstruction: fibrinolysis versus surgery. Early results and long-term follow-up in a single-centre study of 263 cases","volume":"102","author":"Roudaut","year":"2009","journal-title":"Arch Cardiovasc Dis"},{"key":"2025090719570859600_ehaf391-B5","doi-asserted-by":"publisher","first-page":"2115","DOI":"10.1016\/j.jacc.2023.03.412","article-title":"Management of mechanical prosthetic heart valve thrombosis: JACC Review Topic of the Week","volume":"81","author":"Soria Jimenez","year":"2023","journal-title":"J Am Coll Cardiol"},{"key":"2025090719570859600_ehaf391-B6","doi-asserted-by":"publisher","first-page":"561","DOI":"10.1093\/eurheartj\/ehab395","article-title":"2021 ESC\/EACTS guidelines for the management of valvular heart disease","volume":"43","author":"Vahanian","year":"2022","journal-title":"Eur Heart J"},{"key":"2025090719570859600_ehaf391-B7","doi-asserted-by":"publisher","first-page":"1557","DOI":"10.1093\/eurheartj\/ehs486","article-title":"Urgent surgery compared with fibrinolytic therapy for the treatment of left-sided prosthetic heart valve thrombosis: a systematic review and meta-analysis of observational studies","volume":"34","author":"Karthikeyan","year":"2013","journal-title":"Eur Heart J"},{"key":"2025090719570859600_ehaf391-B8","doi-asserted-by":"publisher","first-page":"532","DOI":"10.1161\/CIRCULATIONAHA.113.001145","article-title":"Thrombolytic therapy for the treatment of prosthetic heart valve thrombosis in pregnancy with low-dose, slow infusion of tissue-type plasminogen activator","volume":"128","author":"Ozkan","year":"2013","journal-title":"Circulation"},{"key":"2025090719570859600_ehaf391-B9","doi-asserted-by":"publisher","first-page":"977","DOI":"10.1016\/j.jacc.2021.12.027","article-title":"Thrombolysis or surgery in patients with obstructive mechanical valve thrombosis: the multicenter HATTUSHA study","volume":"79","author":"Ozkan","year":"2022","journal-title":"J Am Coll Cardiol"},{"key":"2025090719570859600_ehaf391-B10","doi-asserted-by":"crossref","first-page":"868","DOI":"10.1016\/S1010-7940(03)00568-2","article-title":"Surgery for prosthetic valve obstruction. A single center study of 136 patients","volume":"24","author":"Roudaut","year":"2003","journal-title":"Eur J Cardiothorac Surg"},{"key":"2025090719570859600_ehaf391-B11","doi-asserted-by":"publisher","first-page":"192","DOI":"10.1016\/j.ihj.2024.06.013","article-title":"Surgery compared to fibrinolytic therapy for symptomatic left-sided prosthetic heart valve thrombosis (SAFE-PVT): rationale and design of a randomized controlled trial","volume":"76","author":"Devasenapathy","year":"2024","journal-title":"Indian Heart J"},{"key":"2025090719570859600_ehaf391-B12","doi-asserted-by":"crossref","first-page":"58","DOI":"10.1016\/S0002-9149(99)00607-4","article-title":"Role of cine-fluoroscopy, transthoracic, and transesophageal echocardiography in patients with suspected prosthetic heart valve thrombosis","volume":"85","author":"Montorsi","year":"2000","journal-title":"Am J Cardiol"},{"key":"2025090719570859600_ehaf391-B13","doi-asserted-by":"publisher","first-page":"692","DOI":"10.1111\/j.1538-7836.2005.01204.x","article-title":"Subcommittee on Control of Anticoagulation of the S, Standardization Committee of the International Society on T, Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients","volume":"3","author":"Schulman","year":"2005","journal-title":"J Thromb Haemost"},{"key":"2025090719570859600_ehaf391-B14","doi-asserted-by":"publisher","first-page":"176","DOI":"10.1093\/eurheartj\/ehr352","article-title":"The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities","volume":"33","author":"Pocock","year":"2012","journal-title":"Eur Heart J"},{"key":"2025090719570859600_ehaf391-B15","doi-asserted-by":"publisher","first-page":"206","DOI":"10.1016\/j.jcmg.2012.10.016","article-title":"Comparison of different TEE-guided thrombolytic regimens for prosthetic valve thrombosis: the TROIA trial","volume":"6","author":"Ozkan","year":"2013","journal-title":"JACC Cardiovasc Imaging"},{"key":"2025090719570859600_ehaf391-B16","doi-asserted-by":"publisher","first-page":"1484","DOI":"10.1016\/j.jacc.2014.12.062","article-title":"Spontaneous normalization of valve function after failed fibrinolytic therapy for left-sided prosthetic valve thrombosis","volume":"65","author":"Karthikeyan","year":"2015","journal-title":"J Am Coll Cardiol"},{"key":"2025090719570859600_ehaf391-B17","doi-asserted-by":"publisher","first-page":"821","DOI":"10.1136\/hrt.2004.044123","article-title":"Fibrinolytic treatment for recurrent left sided prosthetic valve thrombosis","volume":"91","author":"Balasundaram","year":"2005","journal-title":"Heart"},{"key":"2025090719570859600_ehaf391-B18","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1016\/j.jacc.2003.08.028","article-title":"Transesophageal echocardiography improves risk assessment of thrombolysis of prosthetic valve thrombosis: results of the international PRO-TEE registry","volume":"43","author":"Tong","year":"2004","journal-title":"J Am Coll Cardiol"}],"container-title":["European Heart Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/eurheartj\/article-pdf\/46\/34\/3373\/63603750\/ehaf391.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/eurheartj\/article-pdf\/46\/34\/3373\/63603750\/ehaf391.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,7]],"date-time":"2025-09-07T23:57:15Z","timestamp":1757289435000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/eurheartj\/article\/46\/34\/3373\/8176447"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,27]]},"references-count":18,"journal-issue":{"issue":"34","published-online":{"date-parts":[[2025,6,27]]},"published-print":{"date-parts":[[2025,9,8]]}},"URL":"https:\/\/doi.org\/10.1093\/eurheartj\/ehaf391","relation":{},"ISSN":["0195-668X","1522-9645"],"issn-type":[{"value":"0195-668X","type":"print"},{"value":"1522-9645","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,9,7]]},"published":{"date-parts":[[2025,6,27]]}}}