Publication Cover
Structural Heart
The Journal of the Heart Team
Volume 4, 2020 - Issue 5
113
Views
0
CrossRef citations to date
0
Altmetric
Review Article

Thrombosis Risk with Transcatheter Aortic Valve Replacement

, MBBSORCID Icon, , MD, PhD, , MD, , MBBS, , MD, PhD & , MD, PhD
Pages 349-359 | Received 16 Dec 2019, Accepted 10 Jun 2020, Published online: 08 Sep 2020

References

  • Faggiano P, Antonini-Canterin F, Baldessin F, Lorusso R, D’Aloia a, Cas LD. Epidemiology and cardiovascular risk factors of aortic stenosis. Cardiovascular Ultrasound. 2006;4(1):27. doi:10.1186/1476-7120-4-27.
  • Iung B, Cachier a, Baron G, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2005;26(24):2714–2720. doi:10.1093/eurheartj/ehi471.
  • Durko AP, Osnabrugge RL, Van Mieghem NM, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. Eur Heart J. 2018;39(28):2635–2642. doi:10.1093/eurheartj/ehy107.
  • Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597–1607. doi:10.1056/NEJMoa1008232.
  • Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364(23):2187–2198. doi:10.1056/NEJMoa1103510.
  • Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374(17):1609–1620. doi:10.1056/NEJMoa1514616.
  • Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376(14):1321–1331. doi:10.1056/NEJMoa1700456.
  • Baumgartner H, Falk V, Bax JJ, et al. ESC/EACTS guidelines for the management of valvular heart disease the task force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) document review. Thierry Folliguet. 2017;1. doi:10.1093/eurheartj/ehx391.
  • Nishimura RA, Otto CM, Bonow RO, et al. AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. Circulation. 2017;135(25). doi:10.1161/CIR.0000000000000503.
  • Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380(18):1695–1705. doi:10.1056/NEJMoa1814052.
  • Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019;380(18):1706–1715. doi:10.1056/NEJMoa1816885.
  • Nalluri N, Atti V, Munir AB, et al. Valve in valve transcatheter aortic valve implantation (ViV-TAVI) versus redo-surgical aortic valve replacement (redo-SAVR): a systematic review and meta-analysis. J Interv Cardiol. 2018;31(5):661–671. doi:10.1111/joic.12520.
  • Hellhammer K, Piayda K, Afzal S, et al. The latest evolution of the Medtronic Corevalve system in the era of transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2018;11(22):2314–2322. doi:10.1016/j.jcin.2018.07.023.
  • Leon MB, Piazza N, Nikolsky E, et al. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials. J Am Coll Cardiol. 2011;57(3):253–269. doi:10.1016/j.jacc.2010.12.005.
  • Généreux P, Head SJ, Van Mieghem NM, et al. Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions. J Am Coll Cardiol. 2012;59(25):2317–2326. doi:10.1016/j.jacc.2012.02.022.
  • Kleiman NS, Maini BJ, Reardon MJ, et al. Neurological events following transcatheter aortic valve replacement and their predictors. Circ Cardiovasc Interv. 2016;9(9). doi:10.1161/CIRCINTERVENTIONS.115.003551.
  • Tay ELW, Gurvitch R, Wijesinghe N, et al. A high-risk period for cerebrovascular events exists after transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2011;4(12):1290–1297. doi:10.1016/j.jcin.2011.08.012.
  • Jochheim D, Zadrozny M, Ricard I, et al. Predictors of cerebrovascular events at mid-term after transcatheter aortic valve implantation – results from EVERY-TAVI registry. Int J Cardiol. 2017;244:106–111. doi:10.1016/j.ijcard.2017.03.003.
  • Kapadia S, Agarwal S, Miller DC, et al. Insights into timing, risk factors, and outcomes of stroke and transient ischemic attack after transcatheter aortic valve replacement in the PARTNER trial (Placement of aortic transcatheter valves). Circ Cardiovasc Interv. 2016;9(9):9.doi:10.1161/CIRCINTERVENTIONS.115.002981.
  • Nombela-Franco L, Webb J, de Jaegere P, et al. Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation. Circulation. 2012;126(25):3041–3053.doi:10.1161/CIRCULATIONAHA.112.110981.
  • Omran H, Schmidt H, Hackenbroch M, et al. Silent and apparent cerebral embolism after retrograde catheterisation of the aortic valve in valvular stenosis: a prospective, randomised study. Lancet. 2003;361(9365):1241–1246. doi:10.1016/S0140-6736(03)12978-9.
  • Bijuklic K, Haselbach T, Witt J, et al. Increased risk of cerebral embolization after implantation of a balloon-expandable aortic valve without prior balloon valvuloplasty. JACC Cardiovasc Interv. 2015;8(12):1608–1613.
  • Van Mieghem NM, El Faquir N, Rahhab Z, et al. Incidence and predictors of debris embolizing to the brain during transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2015;8(5):718–724. doi:10.1016/j.jcin.2015.01.020.
  • Eggebrecht H, Schmermund a, Voigtländer T, Kahlert P, Erbel R, Mehta RH. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention. 2012;8(1):129–138. doi:10.4244/EIJV8I1A20.
  • Kapadia SR, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol. 2017;69(4):367–377. doi:10.1016/j.jacc.2016.10.023.
  • Dangas GD, Weitz JI, Giustino G, Makkar R, Mehran R. Prosthetic heart valve thrombosis. J Am Coll Cardiol. 2016;68(24):2670–2689. doi:10.1016/j.jacc.2016.09.958.
  • Mylotte D, Andalib a, Theriault-Lauzier P, et al. Transcatheter heart valve failure: a systematic review. Eur Heart J. 2015;36(21):1306–1327. doi:10.1093/eurheartj/ehu388.
  • Chakravarty T, Søndergaard L, Friedman J, et al. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet. 2017;389(10087):2383–2392. doi:10.1016/S0140-6736(17)30757-2.
  • Salemi a, Sedrakyan a, Mao J, et al. Individual operator experience and outcomes in transcatheter aortic valve replacement. JACC Cardiovasc Interv. December 2018;4111. doi:10.1016/j.jcin.2018.10.030.
  • van Wiechen MP, Van Mieghem NM. Maturation from COREVALVE ® to Evolut Pro ®: a clinical overview. Future Cardiol. 2019;15(1):1–8. doi:10.2217/fca-2018-0064.
  • Landes U, Bental T, Barsheshet a, et al. Comparative matched outcome of Evolut-R vs Corevalve transcatheter aortic valve implantation. J Invasive Cardiol. 2017;29(2):69–74.
  • Forrest JK, Mangi AA, Popma JJ, et al. Early outcomes with the Evolut PRO repositionable self-expanding transcatheter aortic valve with pericardial wrap. JACC Cardiovasc Interv. 2018;11(2):160–168. doi:10.1016/j.jcin.2017.10.014.
  • Linke a, Wenaweser P, Gerckens U, et al. Treatment of aortic stenosis with a self-expanding transcatheter valve: the international multi-centre ADVANCE study. Eur Hear J Adv Access. 2014;6. doi:10.1093/eurheartj/ehu162.
  • Corcione N, Biondi-Zoccai G, Ferraro P, et al. Long-term follow-up of transcatheter aortic valve implantation with portico versus Evolut devices. Am J Cardiol. 2020;125:8. doi:10.1016/J.AMJCARD.2020.01.018.
  • Mas-Peiro S, Seppelt P, Weiler H, et al. A direct comparison of self-expandable portico versus balloon-expandable Sapien 3 devices for transcatheter aortic valve replacement: a case-matched cohort study. J Invasive Cardiol. 2019;31(7). E199–E204.
  • Reardon MJ, Feldman TE, Meduri CU, et al. Two-year outcomes after transcatheter aortic valve replacement with mechanical vs self-expanding valves. JAMA Cardiol. 2019;4(3):223. doi:10.1001/jamacardio.2019.0091.
  • Vora AN, Dai D, Matsuoka R, et al. Incidence, management, and associated clinical outcomes of new-onset atrial fibrillation following transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2018;11(17):1746–1756. doi:10.1016/j.jcin.2018.05.042.
  • Jørgensen TH, Thyregod HGH, Tarp JB, Svendsen JH, Søndergaard L. Temporal changes of new-onset atrial fibrillation in patients randomized to surgical or transcatheter aortic valve replacement. Int J Cardiol. 2017;234:16–21. doi:10.1016/j.ijcard.2017.02.098.
  • Hansson NC, Grove EL, Andersen HR, et al. Transcatheter aortic valve thrombosis: incidence, predisposing factors, and clinical implications. J Am Coll Cardiol. 2016;68(19):2059–2069. doi:10.1016/J.JACC.2016.08.010.
  • Yanagisawa R, Hayashida K, Yamada Y, et al. Incidence, predictors, and mid-term outcomes of possible leaflet thrombosis after TAVR. JACC Cardiovasc Imaging. 2017;10(1):1–11. doi:10.1016/j.jcmg.2016.11.005.
  • Mangione FM, Jatene T, Gonçalves a, et al. Leaflet thrombosis in surgically explanted or post-mortem TAVR valves. JACC Cardiovasc Imaging. 2017;10(1):82–85. doi:10.1016/j.jcmg.2016.11.009.
  • Nijenhuis VJ, Brouwer J, Søndergaard L, Collet J-P, Grove EL, Ten Berg JM. Antithrombotic therapy in patients undergoing transcatheter aortic valve implantation. Heart. 2019;105(10):742–748. doi:10.1136/heartjnl-2018-314313.
  • Sellers SL, Turner CT, Sathananthan J, et al. Transcatheter aortic heart valves: histological analysis providing insight to leaflet thickening and structural valve degeneration. JACC Cardiovasc Imaging. 2019;12(1):135–145. doi:10.1016/j.jcmg.2018.06.028.
  • Ruile P, Jander N, Blanke P, et al. Course of early subclinical leaflet thrombosis after transcatheter aortic valve implantation with or without oral anticoagulation. Clin Res Cardiol. 2017;106(2):85–95. doi:10.1007/s00392-016-1052-3.
  • Overtchouk P, Guedeney P, Rouanet S, et al. Long-term mortality and early valve dysfunction according to anticoagulation use. J Am Coll Cardiol. 2019;73(1):13–21. doi:10.1016/j.jacc.2018.08.1045.
  • Yanagisawa R, Tanaka M, Yashima F, et al. Early and late leaflet thrombosis after transcatheter aortic valve replacement. Circ Cardiovasc Interv. 2019;12:2. doi:10.1161/CIRCINTERVENTIONS.118.007349.
  • Kalra a, Raza S, Puri R, et al. Subclinical leaflet thrombosis and clinical outcomes after TAVR: a systematic review and meta-analysis. Struct Heart. 2018;2(3):223–228. doi:10.1080/24748706.2018.1440678.
  • Makkar R. PARTNER 3 low-risk computed tomography substudy: subclinical leaflet thrombosis in transcatheter and surgical bioprosthetic valves. In: Tct 2019. San Fancisco CA; 2019. https://www.tctmd.com/slide/partner-3-low-risk-computed-tomography-substudy-subclinical-leaflet-thrombosis-transcatheter.
  • De Backer O, Dangas GD, Jilaihawi H, et al. Reduced leaflet motion after transcatheter aortic-valve replacement. N Engl J Med. 2019;NEJMoa1911426. doi:10.1056/NEJMoa1911426.
  • Yoon S, Bleiziffer S, De Backer O, et al. Outcomes in transcatheter aortic valve replacement for bicuspid versus tricuspid aortic valve stenosis. J Am Coll Cardiol. 2017;69:21. doi:10.1016/J.JACC.2017.03.017.
  • Makkar RR, Yoon S-H, Leon MB, et al. Association between transcatheter aortic valve replacement for bicuspid vs tricuspid aortic stenosis and mortality or stroke. JAMA. 2019;321(22):2193. doi:10.1001/jama.2019.7108.
  • Halim SA, Edwards FH, Dai D, et al. Outcomes of transcatheter aortic valve replacement in patients with bicuspid aortic valve disease. Circulation. 2020;141(13):1071–1079. doi:10.1161/CIRCULATIONAHA.119.040333.
  • Ueshima D, Fovino LN, Brener SJ, et al. Transcatheter aortic valve replacement for bicuspid aortic valve stenosis with first- and new-generation bioprostheses: a systematic review and meta-analysis. Int J Cardiol. 2020;298:76–82. doi:10.1016/J.IJCARD.2019.09.003.
  • Eitan a, Brinkmann C, Haselbach T, Witt J, Schofer J. Does valve in valve TAVR carry a higher risk for thromboembolic events compared to native valve TAVR? Catheter Cardiovasc Interv. 2020;95(5):1017–1021. doi:10.1002/ccd.28391.
  • Malik AH, Yandrapalli S, Zaid S, et al. Valve-in-valve transcatheter implantation versus redo surgical aortic valve replacement. Am J Cardiol. 2020;125(9):1378–1384. doi:10.1016/J.AMJCARD.2020.02.005.
  • Nijenhuis V, Ten Berg J, Hengstenberg C, et al. Usefulness of clopidogrel loading in patients who underwent transcatheter aortic valve implantation (from the BRAVO-3 randomized trial). Am J Cardiol. 2019;123:9. doi:10.1016/J.AMJCARD.2019.01.049.
  • Rodés-Cabau J, J-B M, RC W, et al. Aspirin versus aspirin plus clopidogrel as antithrombotic treatment following transcatheter aortic valve replacement with a balloon-expandable valve. JACC Cardiovasc Interv. 2017;10(13):1357–1365. doi:10.1016/j.jcin.2017.04.014.
  • Mangieri a, Jabbour RJ, Montalto C, et al. Single-antiplatelet therapy in patients with contraindication to dual-antiplatelet therapy after transcatheter aortic valve implantation. Am J Cardiol. 2017;119(7):1088–1093. doi:10.1016/j.amjcard.2016.11.065.
  • Hassell MECJ, Hildick-Smith D, Durand E, et al. Antiplatelet therapy following transcatheter aortic valve implantation. Heart. 2015;101(14):1118–1125. doi:10.1136/heartjnl-2014-307053.
  • Dangas G, Lefèvre T, Kupatt C, et al. Bivalirudin versus heparin anticoagulation in transcatheter aortic valve replacement: the randomized BRAVO-3 trial. J Am Coll Cardiol. 2015;66:25. doi:10.1016/J.JACC.2015.10.003.
  • Ruile P, Jander N, Blanke P, et al. Course of early subclinical leaflet thrombosis after transcatheter aortic valve implantation with or without oral anticoagulation. Clin Res Cardiol. 2017;106(2):85–95. doi:10.1007/s00392-016-1052-3.
  • Banerjee K, Poddar K, Mick S, et al. Meta-analysis of usefulness of anticoagulation after transcatheter aortic valve implantation. Am J Cardiol. 2017;120:1612–1617. doi:10.1016/j.amjcard.2017.07.059.
  • Geis N, Kiriakou C, Chorianopoulos E, Pleger S, Katus H, Bekeredjian R. Feasibility and safety of vitamin K antagonist monotherapy in atrial fibrillation patients undergoing transcatheter aortic valve implantation. EuroIntervention. 2017;12(17):2058–2066. doi:10.4244/EIJ-D-15-00259.
  • Abdul-Jawad Altisent O, Durand E, Muñoz-García AJ, et al. Warfarin and antiplatelet therapy versus warfarin alone for treating patients with atrial fibrillation undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2016. doi:10.1016/j.jcin.2016.06.025.
  • Windecker S, Tijssen J, Giustino G, et al. Trial design: rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: rationale and design of the GALILEO study. Am Heart J. 2017;184:81–87. doi:10.1016/j.ahj.2016.10.017.
  • Cooper T. Rivaroxaban (Xarelto): increase in all-cause mortality, thromboembolic and bleeding events in patients after transcatheter aortic valve replacement in a prematurely stopped clinical trial; 2018. https://www.hpra.ie/docs/default-source/default-document-library/important-safety-information—xarelto-(rivaroxaban)-(oct-2018).pdf?sfvrsn=0.
  • Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883–891. doi:10.1056/NEJMoa1009638.
  • Collet J-P, Berti S, Cequier a, et al. Oral anti-Xa anticoagulation after trans-aortic valve implantation for aortic stenosis: the randomized ATLANTIS trial. Am Heart J. 2018;200:44–50. doi:10.1016/j.ahj.2018.03.008.
  • Van Mieghem NM, Unverdorben M, Valgimigli M, et al. Edoxaban versus standard of care and their effects on clinical outcomes in patients having undergone transcatheter aortic valve implantation in atrial fibrillation – rationale and design of the ENVISAGE-TAVI AF trial. Am Heart J. 2018;205:63–69. doi:10.1016/j.ahj.2018.07.006.
  • Nijenhuis VJ, Brouwer J, Delewi R, et al. Anticoagulation with or without clopidogrel after transcatheter aortic-valve implantation. N Engl J Med. 2020;382(18):1696–1707. doi:10.1056/NEJMoa1915152.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.