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Structural Heart Disease Zurich Open Repository and Archive University of Zurich Main Library Strickhofstrasse 39 CH-8057 Zurich www.zora.uzh.ch Year: 2015 Treatment and clinical outcomes of transcatheter heart valve thrombosis Latib, Azeem ; Naganuma, Toru ; Abdel-Wahab, Mohamed ; Danenberg, Haim ; Cota, Linda ; Barbanti, Marco ; Baumgartner, Helmut ; Finkelstein, Ariel ; Legrand, Victor ; de Lezo, José Suárez ; Kefer, Joelle ; Messika-Zeitoun, David ; Richardt, Gert ; Stabile, Eugenio ; Kaleschke, Gerrit ; Vahanian, Alec ; Laborde, Jean-Claude ; Leon, Martin B ; Webb, John G ; Panoulas, Vasileios F ; Maisano, Francesco ; Alfieri, Ottavio ; Colombo, Antonio Abstract: BACKGROUND: Valve thrombosis has yet to be fully evaluated after transcatheter aortic valve implantation. This study aimed to report the prevalence, timing, and treatment of transcatheter heart valve (THV) thrombosis. METHODS AND RESULTS: THV thrombosis was defined as follows (1) THV dysfunction secondary to thrombosis diagnosed based on response to anticoagulation therapy, imaging modality or histopathology findings, or (2) mobile mass detected on THV suspicious of thrombus, irrespective of dysfunction and in absence of infection. Between January 2008 and September 2013, 26 (0.61%) THV thromboses were reported out of 4266 patients undergoing transcatheter aortic valve implantation in 12 centers. Of the 26 cases detected, 20 were detected in the Edwards Sapien/Sapien XT cohort and 6 in the Medtronic CoreValve cohort. In patients diagnosed with THV thrombosis, the median time to THV thrombosis post-transcatheter aortic valve implantation was 181 days (interquartile range, 45-313). The most common clinical presentation was exertional dyspnea (n=17; 65%), whereas 8 (31%) patients had no worsening symptoms. Echocardiographic findings included a markedly elevated mean aortic valve pressure gradient (40.5±14.0 mm Hg), presence of thickened leaflets or thrombotic apposition of leaflets in 20 (77%) and a thrombotic mass on the leaflets in the remaining 6 (23%) patients.In23 (88%) patients, anticoagulation resulted in a significant decrease of the aortic valve pressure gradient within 2 months. CONCLUSIONS: THV thrombosis is a rare phenomenon that was detected within the first 2 years after transcatheter aortic valve implantation and usually presented with dyspnea and increased gradients. Anticoagulation seems to have been effective and should be considered even in patients without visible thrombus on echocardiography. DOI: https://doi.org/10.1161/CIRCINTERVENTIONS.114.001779 Posted at the Zurich Open Repository and Archive, University of Zurich ZORA URL: https://doi.org/10.5167/uzh-120094 Journal Article Published Version Originally published at: Latib, Azeem; Naganuma, Toru; Abdel-Wahab, Mohamed; Danenberg, Haim; Cota, Linda; Barbanti, Marco; Baumgartner, Helmut; Finkelstein, Ariel; Legrand, Victor; de Lezo, José Suárez; Kefer, Joelle; Messika-Zeitoun, David; Richardt, Gert; Stabile, Eugenio; Kaleschke, Gerrit; Vahanian, Alec; Laborde, Jean-Claude; Leon, Martin B; Webb, John G; Panoulas, Vasileios F; Maisano, Francesco; Alfieri, Ottavio; Colombo, Antonio (2015). Treatment and clinical outcomes of transcatheter heart valve thrombosis. Circulation. Cardiovascular Interventions, 8(4):e001779. DOI: https://doi.org/10.1161/CIRCINTERVENTIONS.114.001779 2 Structural Heart Disease Treatment and Clinical Outcomes of Transcatheter Heart Valve Thrombosis Azeem Latib, MD*; Toru Naganuma, MD*; Mohamed Abdel-Wahab, MD; Haim Danenberg, MD; Linda Cota, MD; Marco Barbanti, MD; Helmut Baumgartner, MD; Ariel Finkelstein, MD; Victor Legrand, MD; José Suárez de Lezo, MD; Joelle Kefer, MD; David Messika-Zeitoun, MD; Gert Richardt, MD; Eugenio Stabile, MD; Gerrit Kaleschke, MD; Alec Vahanian, MD; Jean-Claude Laborde, MD; Martin B. Leon, MD; John G. Webb, MD; Vasileios F. Panoulas, MD; Francesco Maisano, MD; Ottavio Alfieri, MD; Antonio Colombo, MD Background—Valve thrombosis has yet to be fully evaluated after transcatheter aortic valve implantation. This study aimed to report the prevalence, timing, and treatment of transcatheter heart valve (THV) thrombosis. Methods and Results—THV thrombosis was defined as follows (1) THV dysfunction secondary to thrombosis diagnosed based on response to anticoagulation therapy, imaging modality or histopathology findings, or (2) mobile mass detected on THV suspicious of thrombus, irrespective of dysfunction and in absence of infection. Between January 2008 and September 2013, 26 (0.61%) THV thromboses were reported out of 4266 patients undergoing transcatheter aortic valve implantation in 12 centers. Of the 26 cases detected, 20 were detected in the Edwards Sapien/Sapien XT cohort and 6 in the Medtronic CoreValve cohort. In patients diagnosed with THV thrombosis, the median time to THV thrombosis post– transcatheter aortic valve implantation was 181 days (interquartile range, 45–313). The most common clinical presentation was exertional dyspnea (n=17; 65%), whereas 8 (31%) patients had no worsening symptoms. Echocardiographic findings included a markedly elevated mean aortic valve pressure gradient (40.5±14.0 mm Hg), presence of thickened leaflets or thrombotic apposition of leaflets in 20 (77%) and a thrombotic mass on the leaflets in the remaining 6 (23%) patients. In 23 (88%) patients, anticoagulation resulted in a significant decrease of the aortic valve pressure gradient within 2 months. Conclusions—THV thrombosis is a rare phenomenon that was detected within the first 2 years after transcatheter aortic valve implantation and usually presented with dyspnea and increased gradients. Anticoagulation seems to have been effective and should be considered even in patients without visible thrombus on echocardiography. (Circ Cardiovasc Interv. 2015;8:e001779. DOI: 10.1161/CIRCINTERVENTIONS.114.001779.) Key Words: anticoagulants ◼ aortic valve stenosis ◼ bioprosthesis ◼ echocardiography ◼ thrombosis ◼ transcatheter aortic valve replacement ranscatheter aortic valve implantation (TAVI) has emerged See Editorial by Mylotte and Piazza Tas an alternative to surgical aortic valve replacement (AVR) in high operative risk or inoperable patients.1,2 Given its mini- of several causes of prosthetic valve dysfunction, such as valve mally invasive nature and acceptable clinical outcomes, TAVI thrombosis, pannus formation, calcification, endocarditis, etc, has recently become an established and popular treatment option have yet to be reported in the literature. Of these, valve thrombo- for high-risk groups with severe aortic stenosis.3–5 However, sis is of particular interest as the optimal antithrombotic therapy because of their rare occurrence, the incidence and characteristics after TAVI remains controversial. Even in the context of surgical Received August 14, 2014; accepted February 11, 2015. From the Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy (A.L., T.N., V.F.P., A.C.); Interventional Cardiology Unit, EMO- GVM Centro Cuore Columbus, Milan, Italy (A.L., T.N., V.F.P., A.C.); Heart Center, Segeberger Kliniken GmbH, Bad Segeberg, Germany (M.A.-W., G.R.); Department of Cardiology, Hadassah Hebrew University Medical Center, Jerusalem, Israel (H.D.); Division of Cardiology, Cardiac Catheterization Laboratories, Clinica Montevergine, Mercogliano, Italy (L.C., E.S.); Division of Cardiology, St. Paul’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada (M.B., J.G.W.); Division of Adult Congenital and Valvular Heart Disease, Department of Cardiovascular Medicine, University Hospital Muenster, Muenster, Germany (H.B., G.K.); Interventional Cardiology, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel (A.F.); Department of Cardiology, CHU de Liege, Liege, Belgium (V.L.); Department of Cardiology, Reina Sofia University Hospital, Cordoba, Spain (J.S.d.L.); Division of Cardiology, Cliniques Universitaires Saint-Luc, Universite´ Catholique de Louvain, Brussels, Belgium (J.K.); Department of Cardiology, Assistance Publique-Hôpitaux de Paris, Bichat Hospital, Paris, France (D.M.-Z., A.V.); Deaprtment of Cardiology, St. George’s Hospital, London, United Kingdom (J.-C.L.); Columbia University Medical Center and Cardiovascular Research Foundation, New York (M.B.L.); and Department of Cardiothoracic Surgery, San Raffaele Scientific Institute, Milan, Italy (F.M., O.A.). *Drs Latib and Naganuma contributed equally to this work and are joint first authors. The Data Supplement is available at http://circinterventions.ahajournals.org/lookup/suppl/doi:10.1161/CIRCINTERVENTIONS.114.001779/-/DC1. Correspondence to Azeem Latib, MD, EMO-GVM Centro Cuore Columbus, 48 Via M. Buonarroti, 20145 Milan, Italy. E-mail [email protected] © 2015 American Heart Association, Inc. Circ Cardiovasc Interv is available at http://circinterventions.ahajournals.org DOI: 10.1161/CIRCINTERVENTIONS.114.001779 Downloaded from http://circinterventions.ahajournals.org/1 at Universitaet Zuerich on February 2, 2016 2 Latib et al THV Thrombosis velocity ≥3 m/s, or (2) moderate or more prosthetic valve regurgita- tion, which was not recorded post procedure. THV thrombosis was WHAT IS KNOWN defined as follows: (1) THV dysfunction secondary to thrombosis diagnosed based on response to anticoagulation therapy, imaging •฀ The reported incidence of valve thrombosis postsur- modality (echo or computed tomography), or histopathology find- gical bioprosthetic aortic valve replacement ranges ings, or (2) mobile mass detected on THV suspicious of thrombus, from as low as 0.03% to 5.0%, but data on transcath-
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