Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation

Summary

This is a prospective study designed to evaluate the structural and functional integrity of transcatheter or surgical bioprosthetic valves with multimodality imaging. The study further aims to confirm resolution of the early bioprosthetic valve thrombotic changes with anticoagulation.

Timeline

Start

2014-12

Primary completion

2028-12

Completion

2028-12

Publications

• Background Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.
• Background Chakravarty T, Sondergaard L, Friedman J, De Backer O, Berman D, Kofoed KF, Jilaihawi H, Shiota T, Abramowitz Y, Jorgensen TH, Rami T, Israr S, Fontana G, de Knegt M, Fuchs A, Lyden P, Trento A, Bhatt DL, Leon MB, Makkar RR; RESOLVE; SAVORY Investigators. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet. 2017 Jun 17;389(10087):2383-2392. doi: 10.1016/S0140-6736(17)30757-2. Epub 2017 Mar 19.
• Nagasaka T, Patel V, Suruga K, Guo Y, Koren O, Shechter A, Friedman M, Patel D, Chakravarty T, Cheng W, Gupta A, Ishii H, Jilaihawi H, Nakamura M, Makkar RR. Prognostic implications and predictive factors of subclinical leaflet thrombosis following valve-in-valve transcatheter aortic valve implantation. EuroIntervention. 2025 May 5;21(9):e482-e492. doi: 10.4244/EIJ-D-24-00711.
• Nagasaka T, Patel V, Shechter A, Suruga K, Koren O, Chakravarty T, Cheng W, Ishii H, Jilaihawi H, Nakamura M, Makkar RR. Impact of Balloon-Expandable TAVR Valve Deformation and Calcium Distribution on Outcomes in Bicuspid Aortic Valve. JACC Cardiovasc Interv. 2024 Sep 9;17(17):2023-2037. doi: 10.1016/j.jcin.2024.07.018.
• Raschpichler M, Flint N, Yoon SH, Kaewkes D, Patel C, Singh C, Patel V, Kashif M, Borger MA, Chakravarty T, Makkar R. Commissural Alignment After Balloon-Expandable Transcatheter Aortic Valve Replacement Is Associated With Improved Hemodynamic Outcomes. JACC Cardiovasc Interv. 2022 Jun 13;15(11):1126-1136. doi: 10.1016/j.jcin.2022.04.006.
• Ochiai T, Oakley L, Sekhon N, Komatsu I, Flint N, Kaewkes D, Yoon SH, Raschpichler M, Patel V, Tiwana R, Enta Y, Mahani S, Kim Y, Stegic J, Chakravarty T, Nakamura M, Cheng W, Makkar R. Risk of Coronary Obstruction Due to Sinus Sequestration in Redo Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020 Nov 23;13(22):2617-2627. doi: 10.1016/j.jcin.2020.09.022.
• Ochiai T, Chakravarty T, Yoon SH, Kaewkes D, Flint N, Patel V, Mahani S, Tiwana R, Sekhon N, Nakamura M, Cheng W, Makkar R. Coronary Access After TAVR. JACC Cardiovasc Interv. 2020 Mar 23;13(6):693-705. doi: 10.1016/j.jcin.2020.01.216.

Drugs

Indications

No indication recorded.