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DOI: 10.1055/s-0037-1607457
Antithrombotic Treatment after Transcatheter Heart Valves Implant
Publication History
Publication Date:
05 January 2018 (online)
Abstract
Transcatheter heart valve replacement technology was introduced as alternative to surgery for the growing high-risk profile population. Developed first, aortic valve replacement (TAVR) became a standard of care for patients with severe aortic stenosis at high operative risk, with a potential future use also for low-risk subjects. In the last decade, a multitude of transcatheter mitral valve replacement (TMVR) devices have been developed for the treatment of severe mitral regurgitation, with encouraging results coming from first-in-man and feasibility studies. As for biological surgical-type valves, transcatheter implanted valves still preserve the risk of thrombosis and embolic events and anticoagulation- or antiplatelet-based strategies are the most widely used options. Unfortunately, these last remain recommended on the basis of empirical or not widely validated evidence. Therefore, given the exponential rise of TAVR and TMVR procedures, it is important to identify the optimal antithrombotic strategies that best fit the risk of thromboembolic and bleeding events. Hereafter, this review evaluates the current guidelines, trials, and observational data discussing antithrombotic strategy after transcatheter aortic or mitral valve replacement.
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References
- 1 Dangas GD, Weitz JI, Giustino G, Makkar R, Mehran R. Prosthetic heart valve thrombosis. J Am Coll Cardiol 2016; 68 (24) 2670-2689
- 2 Spaccarotella C, Mongiardo A, De Rosa S, Indolfi C. Transcatheter aortic valve implantation in patients at intermediate surgical risk. Int J Cardiol 2017; 243: 161-168
- 3 Iung B, Vahanian A. Epidemiology of valvular heart disease in the adult. Nat Rev Cardiol 2011; 8 (03) 162-172
- 4 Solomon RJ, Mehran R, Natarajan MK. , et al. Contrast-induced nephropathy and long-term adverse events: cause and effect?. Clin J Am Soc Nephrol 2009; 4 (07) 1162-1169
- 5 Cribier A, Eltchaninoff H, Bash A. , et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 2002; 106 (24) 3006-3008
- 6 U.S. Food and Drug Administration. FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery. FDA News Release (August 18, 2016). Available at: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm517281.htm . Accessed June 5, 2017
- 7 Alfieri O, Maisano F, De Bonis M. , et al. The double-orifice technique in mitral valve repair: a simple solution for complex problems. J Thorac Cardiovasc Surg 2001; 122 (04) 674-681
- 8 Regueiro A, Granada JF, Dagenais F, Rodés-Cabau J. Transcatheter mitral valve replacement: insights from early clinical experience and future challenges. J Am Coll Cardiol 2017; 69 (17) 2175-2192
- 9 Puri R, Auffret V, Rodés-Cabau J. Bioprosthetic valve thrombosis. J Am Coll Cardiol 2017; 69 (17) 2193-2211
- 10 Smith CR, Leon MB, Mack MJ. , et al; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011; 364 (23) 2187-2198
- 11 Adams DH, Popma JJ, Reardon MJ. , et al; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014; 370 (19) 1790-1798
- 12 Giustino G, Latib A, Panoulas VF. , et al. Early outcomes with direct flow medical versus first-generation transcatheter aortic valve devices: a single-center propensity-matched analysis. J Interv Cardiol 2015; 28 (06) 583-593
- 13 Gargiulo G, Sannino A, Capodanno D. , et al. Transcatheter aortic valve implantation versus surgical aortic valve replacement: a systematic review and meta-analysis. Ann Intern Med 2016; 165 (05) 334-344
- 14 Leon MB, Smith CR, Mack MJ. , et al; PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016; 374 (17) 1609-1620
- 15 Reardon MJ, Van Mieghem NM, Popma JJ. , et al; SURTAVI Investigators. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 2017; 376 (14) 1321-1331
- 16 Giustino G, Van der Boon RM, Molina-Martin de Nicolas J. , et al. Impact of permanent pacemaker on mortality after transcatheter aortic valve implantation: the PRAGMATIC (Pooled Rotterdam-Milan-Toulouse in Collaboration) Pacemaker substudy. EuroIntervention 2016; 12 (09) 1185-1193
- 17 Généreux P, Head SJ, Hahn R. , et al. Paravalvular leak after transcatheter aortic valve replacement: the new Achilles' heel? A comprehensive review of the literature. J Am Coll Cardiol 2013; 61 (11) 1125-1136
- 18 Franzone A, Piccolo R, Siontis GC. , et al. Transcatheter aortic valve replacement for the treatment of pure native aortic valve regurgitation: a systematic review. JACC Cardiovasc Interv 2016; 9 (22) 2308-2317
- 19 Guerrero M, Dvir D, Himbert D. , et al. Transcatheter mitral valve replacement in native mitral valve disease with severe mitral annular calcification: results from the first multicenter global registry. JACC Cardiovasc Interv 2016; 9 (13) 1361-1371
- 20 Rodés-Cabau J, Hahn RT, Latib A. , et al. Transcatheter therapies for treating tricuspid regurgitation. J Am Coll Cardiol 2016; 67 (15) 1829-1845
- 21 Capretti G, Urena M, Himbert D. , et al. Valve thrombosis after transcatheter mitral valve replacement. J Am Coll Cardiol 2016; 68 (16) 1814-1815
- 22 Rakita V, Lakhter V, Patil P, O'Neill BP. Intermediate term hemodynamic effects of single inferior vena cava valve implant for the treatment of severe tricuspid regurgitation. Catheter Cardiovasc Interv 2017; 90 (03) 521-525
- 23 Laule M, Stangl V, Sanad W, Lembcke A, Baumann G, Stangl K. Percutaneous transfemoral management of severe secondary tricuspid regurgitation with Edwards Sapien XT bioprosthesis: first-in-man experience. J Am Coll Cardiol 2013; 61 (18) 1929-1931
- 24 Bapat V, Buellesfeld L, Peterson MD. , et al. Transcatheter mitral valve implantation (TMVI) using the Edwards FORTIS device. EuroIntervention 2014; 10 (Suppl U): U120-U128
- 25 Cheung A, Webb J, Verheye S. , et al. Short-term results of transapical transcatheter mitral valve implantation for mitral regurgitation. J Am Coll Cardiol 2014; 64 (17) 1814-1819
- 26 Grover FL, Vemulapalli S, Carroll JD. , et al; STS/ACC TVT Registry. 2016 Annual Report of The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. J Am Coll Cardiol 2017; 69 (10) 1215-1230
- 27 Giustino G, Sorrentino S, Mehran R, Faggioni M, Dangas G. Cerebral embolic protection during TAVR: A clinical event meta-analysis. J Am Coll Cardiol 2017; 69 (04) 465-466
- 28 Giustino G, Mehran R, Veltkamp R, Faggioni M, Baber U, Dangas GD. Neurological outcomes with embolic protection devices in patients undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis of randomized controlled trials. JACC Cardiovasc Interv 2016; 9 (20) 2124-2133
- 29 Dangas GD, Lefèvre T, Kupatt C. , et al; BRAVO-3 Investigators. Bivalirudin versus heparin anticoagulation in transcatheter aortic valve replacement: the randomized BRAVO-3 trial. J Am Coll Cardiol 2015; 66 (25) 2860-2868
- 30 Van Belle E, Hengstenberg C, Lefevre T. , et al; BRAVO-3 MRI Study Investigators. Cerebral embolism during transcatheter aortic valve replacement: the BRAVO-3 MRI study. J Am Coll Cardiol 2016; 68 (06) 589-599
- 31 Webb J, Rodés-Cabau J, Fremes S. , et al. Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement. Can J Cardiol 2012; 28 (05) 520-528
- 32 Vahanian A, Alfieri O, Andreotti F. , et al; Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 2012; 33 (19) 2451-2496
- 33 Holmes Jr DR, Mack MJ, Kaul S. , et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol 2012; 59 (13) 1200-1254
- 34 Nishimura RA, Otto CM, Bonow RO. , et al. 2017 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. J Am Coll Cardiol 2017; 70 (02) 252-289
- 35 Makkar RR, Fontana G, Jilaihawi H. , et al. Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med 2015; 373 (21) 2015-2024
- 36 Rodés-Cabau J, Masson JB, Welsh RC. , et al. Aspirin versus aspirin plus clopidogrel as antithrombotic treatment following transcatheter aortic valve replacement with a balloon-expandable valve: the ARTE (aspirin versus aspirin + clopidogrel following transcatheter aortic valve implantation) randomized clinical trial. JACC Cardiovasc Interv 2017; 10 (13) 1357-1365
- 37 Ussia GP, Scarabelli M, Mulè M. , et al. Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation. Am J Cardiol 2011; 108 (12) 1772-1776
- 38 Stabile E, Pucciarelli A, Cota L. , et al. SAT-TAVI (single antiplatelet therapy for TAVI) study: a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation. Int J Cardiol 2014; 174 (03) 624-627
- 39 Capodanno D, Angiolillo DJ. Antithrombotic therapy for prevention of cerebral thromboembolic events after transcatheter aortic valve replacement: evolving paradigms and ongoing directions. JACC Cardiovasc Interv 2017; 10 (13) 1366-1369
- 40 Luszczak J, Undas A, Gissel M, Olszowska M, Butenas S. Activated factor XI and tissue factor in aortic stenosis: links with thrombin generation. Blood Coagul Fibrinolysis 2011; 22 (06) 473-479
- 41 Jose J, Sulimov DS, El-Mawardy M. , et al. Clinical bioprosthetic heart valve thrombosis after transcatheter aortic valve replacement: incidence, characteristics, and treatment outcomes. JACC Cardiovasc Interv 2017; 10 (07) 686-697
- 42 Latib A, Naganuma T, Abdel-Wahab M. , et al. Treatment and clinical outcomes of transcatheter heart valve thrombosis. Circ Cardiovasc Interv 2015; 8 (04) e001779
- 43 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
- 44 Wendler O, Schymik G, Treede H. , et al. SOURCE 3 registry: design and 30-day results of the European Postapproval Registry of the latest generation of the SAPIEN 3 transcatheter heart valve. Circulation 2017; 135 (12) 1123-1132
- 45 Chakravarty T, Søndergaard L, Friedman J. , et al; RESOLVE; SAVORY Investigators. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet 2017; 389 (10087): 2383-2392
- 46 Leetmaa T, Hansson NC, Leipsic J. , et al. Early aortic transcatheter heart valve thrombosis: diagnostic value of contrast-enhanced multidetector computed tomography. Circ Cardiovasc Interv 2015; 8 (04) e001596
- 47 Seeger J, Gonska B, Rodewald C, Rottbauer W, Wöhrle J. Apixaban in Patients With Atrial Fibrillation After Transfemoral Aortic Valve Replacement. JACC Cardiovasc Interv 2017; 10 (01) 66-74
- 48 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
- 49 Butnaru A, Shaheen J, Tzivoni D, Tauber R, Bitran D, Silberman S. Diagnosis and treatment of early bioprosthetic malfunction in the mitral valve position due to thrombus formation. Am J Cardiol 2013; 112 (09) 1439-1444
- 50 Oliver JM, Gallego P, Gonzalez A, Dominguez FJ, Gamallo C, Mesa JM. Bioprosthetic mitral valve thrombosis: clinical profile, transesophageal echocardiographic features, and follow-up after anticoagulant therapy. J Am Soc Echocardiogr 1996; 9 (05) 691-699
- 51 Egbe AC, Pislaru SV, Pellikka PA. , et al. Bioprosthetic valve thrombosis versus structural failure: clinical and echocardiographic predictors. J Am Coll Cardiol 2015; 66 (21) 2285-2294
- 52 Iakovou I, Dangas G, Mehran R. , et al. Impact of gender on the incidence and outcome of contrast-induced nephropathy after percutaneous coronary intervention. J Invasive Cardiol 2003; 15 (01) 18-22
- 53 Muller DW, Farivar RS, Jansz P. , et al; Tendyne Global Feasibility Trial Investigators. Transcatheter mitral valve replacement for patients with symptomatic mitral regurgitation: a global feasibility trial. J Am Coll Cardiol 2017; 69 (04) 381-391
- 54 Mitchell LB, Southern DA, Galbraith D, Ghali WA, Knudtson M, Wilton SB. ; APPROACH investigators. Prediction of stroke or TIA in patients without atrial fibrillation using CHADS2 and CHA2DS2-VASc scores. Heart 2014; 100 (19) 1524-1530
- 55 Hamid T, Choudhury TR, Anderson SG. , et al. Does the CHA2DS2-Vasc score predict procedural and short-term outcomes in patients undergoing transcatheter aortic valve implantation?. Open Heart 2015; 2 (01) e000170
- 56 Melgaard L, Gorst-Rasmussen A, Lane DA, Rasmussen LH, Larsen TB, Lip GY. Assessment of the CHA2DS2-VASc score in predicting ischemic stroke, thromboembolism, and death in patients with heart failure with and without atrial fibrillation. JAMA 2015; 314 (10) 1030-1038
- 57 Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest 2010; 138 (05) 1093-1100