Bleeding Complications Drive In-Hospital Mortality of Patients with Atrial Fibrillation after Transcatheter Aortic Valve ReplacementFunding A.L. is funded by the Berta-Ottenstein-Program for Advanced Clinician Scientists, Faculty of Medicine, University of Freiburg.
Background Atrial fibrillation (AF) is a risk factor for poor postoperative outcome after transfemoral transcatheter aortic valve replacement (TF-TAVR). The present study analyses the outcomes after TF-TAVR in patients with or without AF and identifies independent predictors for in-hospital mortality in clinical practice.
Methods and Results Among all 57,050 patients undergoing isolated TF-TAVR between 2008 and 2016 in Germany, 44.2% of patients (n = 25,309) had AF. Patients with AF were at higher risk for unfavorable in-hospital outcome after TAVR. Including all baseline characteristics for a risk-adjusted comparison, AF was an independent risk factor for in-hospital mortality after TAVR. Among patients with AF, EuroSCORE, New York Heart Association classification class, or renal disease had only moderate effects on mortality, while the occurrence of postprocedural stroke or moderate to major bleeding substantially increased in-hospital mortality (odds ratio [OR] 3.35, 95% confidence interval [CI] 2.61–4.30, p < 0.001 and OR 3.12, 95% CI 2.68–3.62, p < 0.001). However, the strongest independent predictor for in-hospital mortality among patients with AF was severe bleeding (OR 18.00, 95% CI 15.22–21.30, p < 0.001).
Conclusion The present study demonstrates that the incidence of bleeding defines the in-hospital outcome of patients with AF after TF-TAVR. Thus, the periprocedural phase demands particular care in bleeding prevention.
Keywordstranscatheter aortic valve replacement - atrial fibrillation - aortic stenosis - bleeding - thromboembolism
* C.M. and P.S. share the last authorship.
Received: 27 February 2020
Accepted: 21 July 2020
22 August 2020 (online)
© 2020. Thieme. All rights reserved.
Georg Thieme Verlag KG
Stuttgart · New York
- 1 Reinöhl J, Kaier K, Reinecke H. , et al. Effect of availability of transcatheter aortic-valve replacement on clinical practice. N Engl J Med 2015; 373 (25) 2438-2447
- 2 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
- 3 Mack MJ, Leon MB, Thourani VH. PARTNER 3 Investigators. , et al; Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019; 380 (18) 1695-1705
- 4 Stachon P, Kaier K, Zirlik A. , et al. Risk-adjusted comparison of in-hospital outcomes of transcatheter and surgical aortic valve replacement. J Am Heart Assoc 2019; 8 (07) e011504
- 5 Leon MB, Smith CR, Mack MJ. PARTNER 2 Investigators. , et al; Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med 2016; 374 (17) 1609-1620
- 6 Généreux P, Cohen DJ, Mack M. , et al. Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement. J Am Coll Cardiol 2014; 64 (24) 2605-2615
- 7 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
- 8 Gilard M, Eltchaninoff H, Donzeau-Gouge P. FRANCE 2 Investigators. , et al; Late outcomes of transcatheter aortic valve replacement in high-risk patients: the FRANCE-2 registry. J Am Coll Cardiol 2016; 68 (15) 1637-1647
- 9 Tarantini G, Mojoli M, Windecker S. , et al. Prevalence and impact of atrial fibrillation in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement: an analysis from the SOURCE XT prospective multicenter registry. JACC Cardiovasc Interv 2016; 9 (09) 937-946
- 10 Vora AN, Dai D, Matsuoka R. , et al. Incidence, management, and associated clinical outcomes of new-onset atrial fibrillation following transcatheter aortic valve replacement: an analysis from the STS/ACC TVT registry. JACC Cardiovasc Interv 2018; 11 (17) 1746-1756
- 11 Mentias A, Saad M, Girotra S. , et al. Impact of pre-existing and new-onset atrial fibrillation on outcomes after transcatheter aortic valve replacement. JACC Cardiovasc Interv 2019; 12 (21) 2119-2129
- 12 Baumgartner H, Falk V, Bax JJ. ESC Scientific Document Group. , et al; 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 2017; 38 (36) 2739-2791
- 13 January CT, Wann LS, Calkins H. , et al. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2019; 74 (01) 104-132
- 14 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
- 15 Dangas GD, Lefèvre T, Kupatt C. BRAVO-3 Investigators. , et al; Bivalirudin versus heparin anticoagulation in transcatheter aortic valve replacement: the randomized BRAVO-3 trial. J Am Coll Cardiol 2015; 66 (25) 2860-2868
- 16 Kaier K, Oettinger V, Reinecke H. , et al. Volume-outcome relationship in transcatheter aortic valve implantations in Germany 2008-2014: a secondary data analysis of electronic health records. BMJ Open 2018; 8 (07) e020204
- 17 Kaier K, Reinecke H, Schmoor C. , et al. Learning curves among all patients undergoing transcatheter aortic valve implantation in Germany: a retrospective observational study. Int J Cardiol 2017; 235: 17-21
- 18 Arnold SV, Zhang Y, Baron SJ. , et al. Impact of short-term complications on mortality and quality of life after transcatheter aortic valve replacement. JACC Cardiovasc Interv 2019; 12 (04) 362-369
- 19 Mojoli M, Gersh BJ, Barioli A. , et al. Impact of atrial fibrillation on outcomes of patients treated by transcatheter aortic valve implantation: a systematic review and meta-analysis. Am Heart J 2017; 192: 64-75
- 20 Biviano AB, Nazif T, Dizon J. , et al. Atrial fibrillation is associated with increased mortality in patients undergoing transcatheter aortic valve replacement: insights from the Placement of Aortic Transcatheter Valve (PARTNER) trial. Circ Cardiovasc Interv 2016; 9 (01) e002766
- 21 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 (09) e002981
- 22 Huded CP, Tuzcu EM, Krishnaswamy A. , et al. Association between transcatheter aortic valve replacement and early postprocedural stroke. JAMA 2019; 321 (23) 2306-2315
- 23 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; 9 (16) 1706-1717
- 24 Guedeney P, Mehran R, Collet JP, Claessen BE, Ten Berg J, Dangas GD. Antithrombotic therapy after transcatheter aortic valve replacement. Circ Cardiovasc Interv 2019; 12 (01) e007411
- 25 Mangieri A, Montalto C, Poletti E. , et al. Thrombotic versus bleeding risk after transcatheter aortic valve replacement: JACC review topic of the week. J Am Coll Cardiol 2019; 74 (16) 2088-2101
- 26 Dangas GD, Tijssen JGP, Wohrle J. GALILEO Investigators. , et al; A controlled trial of rivaroxaban after transcatheter aortic-valve replacement. N Engl J Med 2020; 382 (02) 120-129
- 27 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
- 28 Mangner N, Crusius L, Haussig S. , et al. Continued versus interrupted oral anticoagulation during transfemoral transcatheter aortic valve implantation and impact of postoperative anticoagulant management on outcome in patients with atrial fibrillation. Am J Cardiol 2019; 123 (07) 1134-1141
- 29 Brinkert M, Keller LS, Moriyama N. , et al. Safety and efficacy of transcatheter aortic valve replacement with continuation of oral anticoagulation. J Am Coll Cardiol 2019; 73 (15) 2004-2005
- 30 Sun Y, Liu X, Chen Z. , et al. Meta-analysis of predictors of early severe bleeding in patients who underwent transcatheter aortic valve implantation. Am J Cardiol 2017; 120 (04) 655-661
- 31 Power D, Schäfer U, Guedeney P. , et al. Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: a post hoc analysis from the BRAVO-3 randomized trial. Catheter Cardiovasc Interv 2019; 93 (07) 1374-1381
- 32 Chamandi C, Abi-Akar R, Rodés-Cabau J. , et al. Transcarotid compared with other alternative access routes for transcatheter aortic valve replacement. Circ Cardiovasc Interv 2018; 11 (11) e006388