Clinical outcomes and the impact of valve morphology for transcatheter aortic valve replacement in bicuspid aortic valves: A systematic review and meta-analysis.
TAVR
aortic stenosis
bicuspid aortic valve
meta-analysis
outcomes
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
10 2023
10 2023
Historique:
revised:
16
05
2023
received:
23
11
2022
accepted:
13
08
2023
medline:
6
10
2023
pubmed:
22
8
2023
entrez:
22
8
2023
Statut:
ppublish
Résumé
Bicuspid aortic valve (BAV) is present in approximately 0.5%-2% of the general population, causing significant aortic stenosis (AS) in 12%-37% of affected individuals. Transcatheter aortic valve replacement (TAVR) is being considered the treatment of choice in patients with symptomatic AS across all risk spectra. Aim Our study aims to compare TAVR outcomes in patients with BAV versus tricuspid aortic valves (TAV). A comprehensive literature search was performed in PubMed, Web of Science, and Cochrane trials. Studies were included if they included BAV and TAV patients undergoing TAVR with quantitative data available for at least one of our predefined outcomes. Meta-analysis was performed by the random-effects model using Stata software. Fifty studies of 203,288 patients were included. BAV patients had increased 30-day all-cause mortality (odds ratio [OR] = 1.23 [1.00-1.50], p = 0.05), in-hospital stroke (OR = 1.39 [1.01-1.93], p = 0.05), in-hospital and 30-day PPI (OR = 1.13 [1.00-1.27], p = 0.04; OR = 1.16 [1.04-1.13], p = 0.01) and in-hospital, 30-day and 1-year aortic regurgitation (AR) (OR = 1.48 [1.19-1.83], p < 0.01; OR = 1.79 [1.26-2.52], p < 0.01; OR = 1.64 [1.03-2.60], p = 0.04). Subgroup analysis on new-generation valves showed a reduced 1-year all-cause mortality (OR = 0.86 [CI = 0.75-0.98], p = 0.03), despite higher in-hospital and 30-day PPI (OR = 0.1.21 [1.04-1.41], p = 0.01; OR = 1.17 [1.05-1.31], p = 0.01) and in-hospital AR (OR = 1.62 [1.14-2.31], p = 0.01) in the BAV group. The quality of included studies was moderate-to-high, and only three analyses presented high heterogeneity. TAVR is associated with comparable outcomes in patients with BAV and TAV. Careful selection of BAV cases by preprocedural assessment of valve anatomy and burden of calcification, pre- and post-procedural dilation, and implementing newer generations of valves may improve the safety and efficacy of TAVR in BAV patients.
Sections du résumé
BACKGROUND
Bicuspid aortic valve (BAV) is present in approximately 0.5%-2% of the general population, causing significant aortic stenosis (AS) in 12%-37% of affected individuals. Transcatheter aortic valve replacement (TAVR) is being considered the treatment of choice in patients with symptomatic AS across all risk spectra.
AIM
Aim Our study aims to compare TAVR outcomes in patients with BAV versus tricuspid aortic valves (TAV).
METHODS
A comprehensive literature search was performed in PubMed, Web of Science, and Cochrane trials. Studies were included if they included BAV and TAV patients undergoing TAVR with quantitative data available for at least one of our predefined outcomes. Meta-analysis was performed by the random-effects model using Stata software.
RESULTS
Fifty studies of 203,288 patients were included. BAV patients had increased 30-day all-cause mortality (odds ratio [OR] = 1.23 [1.00-1.50], p = 0.05), in-hospital stroke (OR = 1.39 [1.01-1.93], p = 0.05), in-hospital and 30-day PPI (OR = 1.13 [1.00-1.27], p = 0.04; OR = 1.16 [1.04-1.13], p = 0.01) and in-hospital, 30-day and 1-year aortic regurgitation (AR) (OR = 1.48 [1.19-1.83], p < 0.01; OR = 1.79 [1.26-2.52], p < 0.01; OR = 1.64 [1.03-2.60], p = 0.04). Subgroup analysis on new-generation valves showed a reduced 1-year all-cause mortality (OR = 0.86 [CI = 0.75-0.98], p = 0.03), despite higher in-hospital and 30-day PPI (OR = 0.1.21 [1.04-1.41], p = 0.01; OR = 1.17 [1.05-1.31], p = 0.01) and in-hospital AR (OR = 1.62 [1.14-2.31], p = 0.01) in the BAV group. The quality of included studies was moderate-to-high, and only three analyses presented high heterogeneity.
CONCLUSION
TAVR is associated with comparable outcomes in patients with BAV and TAV. Careful selection of BAV cases by preprocedural assessment of valve anatomy and burden of calcification, pre- and post-procedural dilation, and implementing newer generations of valves may improve the safety and efficacy of TAVR in BAV patients.
Types de publication
Meta-Analysis
Systematic Review
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
721-730Informations de copyright
© 2023 Wiley Periodicals LLC.
Références
Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;143:e72-e227.
Masri A, Svensson LG, Griffin BP, Desai MY. Contemporary natural history of bicuspid aortic valve disease: a systematic review. Heart. 2017;103:1323-1330.
Arai T, Lefèvre T, Hovasse T, et al. The feasibility of transcatheter aortic valve implantation using the Edwards SAPIEN 3 for patients with severe bicuspid aortic stenosis. J Cardiol. 2017;70:220-224.
Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease: developed by 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). Eur Heart J. 2021;43(7):561-632.
Wells GA, Shea B, O'Connell D, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. Oxford; 2000.
Cumpston M, Li T, Page MJ, et al. Updated guidance for trusted systematic reviews: a new edition of the Cochrane Handbook for Systematic Reviews of Interventions. Cochrane Database Syst Rev. 2019;10:ED000142.
Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557-560.
Aalaei-Andabili SH, Beaver TM, Petersen JW, et al. Early and midterm outcomes of transcatheter aortic valve replacement in patients with bicuspid aortic valves. J Card Surg. 2018;33:489-496.
Bauer T, Linke A, Sievert H, et al. Comparison of the effectiveness of transcatheter aortic valve implantation in patients with stenotic bicuspid versus tricuspid aortic valves (from the German TAVI Registry). Am J Cardiol. 2014;113:518-521.
Blackman D, Gabbieri D, Del Blanco BG, et al. Expert consensus on sizing and positioning of SAPIEN 3/Ultra in bicuspid aortic valves. Cardiol Ther. 2021;10:277-288.
Breitbart P, Minners J, Czerny M, Hein M, Neumann FJ, Ruile P. Prosthesis position after TAVI with balloon-expandable SAPIEN 3 in bicuspid aortic valves. J Clin Med. 2021;10:2561.
Chodór P, Wilczek K, Chodór-Rozwadowska K, et al. Comparison of the results of transcatheter aortic valve implantation in patients with bicuspid and tricuspid aortic valve. Adv Interv Cardiol. 2021;17:82-92.
Costopoulos C, Latib A, Maisano F, et al. Comparison of results of transcatheter aortic valve implantation in patients with severely stenotic bicuspid versus tricuspid or nonbicuspid valves. Am J Cardiol. 2014;113:1390-1393.
De Biase C, Mastrokostopoulos A, Philippart R, et al. Aortic valve anatomy and outcomes after transcatheter aortic valve implantation in bicuspid aortic valves. Int J Cardiol. 2018;266:56-60.
Deeb GM, Reardon MJ, Ramlawi B, et al. Propensity-matched 1-year outcomes following transcatheter aortic valve replacement in low-risk bicuspid and tricuspid patients. JACC Cardiovasc Interv. 2022;15:511-522.
Elbadawi A, Saad M, Elgendy IY, et al. Temporal trends and outcomes of transcatheter versus surgical aortic valve replacement for bicuspid aortic valve stenosis. JACC Cardiovasc Interv. 2019;12:1811-1822.
Fan J, Fang X, Liu C, et al. Brain injury after transcatheter replacement of bicuspid versus tricuspid aortic valves. J Am Coll Cardiol. 2020;76:2579-2590.
Forrest JK, Kaple RK, Ramlawi B, et al. Transcatheter aortic valve replacement in bicuspid versus tricuspid aortic valves from the STS/ACC TVT registry. JACC Cardiovasc Interv. 2020;13:1749-1759.
Fu B, Chen Q, Zhao F, et al. Efficacy and safety of transcatheter aortic valve implantation in patients with severe bicuspid aortic stenosis. Ann Transl Med. 2020;8:873.
Halim SA, Edwards FH, Dai D, et al. Outcomes of transcatheter aortic valve replacement in patients with bicuspid aortic valve disease: a report from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Circulation. 2020;141:1071-1079.
Hamdan A, Nassar M, Schwammenthal E, et al. Short membranous septum length in bicuspid aortic valve stenosis increases the risk of conduction disturbances. J Cardiovas Comput Tomogr. 2021;15:339-347.
Hayashida K, Bouvier E, Lefèvre T, et al. Transcatheter aortic valve implantation for patients with severe bicuspid aortic valve stenosis. Circ Cardiovasc Interv. 2013;6:284-291.
He Y, Fan J, Zhu Q, et al. Ascending aortic dilatation rate after transcatheter aortic valve replacement in patients with bicuspid and tricuspid aortic stenosis: a multidetector computed tomography follow-up study. World J Emerg Med. 2019;10:197-204.
Jung JH, Kim HK, Park JB, et al. Progression of ascending aortopathy may not occur after transcatheter aortic valve replacement in severe bicuspid aortic stenosis. Korean J Intern Med. 2021;36:332-341.
Kawamori H, Yoon SH, Chakravarty T, et al. Computed tomography characteristics of the aortic valve and the geometry of SAPIEN 3 transcatheter heart valve in patients with bicuspid aortic valve disease. Eur Heart J Cardiovasc Imaging. 2018;19:1408-1418.
Kim WK, Bhumimuang K, Renker M, et al. Determinants of paravalvular leakage following transcatheter aortic valve replacement in patients with bicuspid and tricuspid aortic stenosis. Eur Heart J Cardiovasc Imaging. 2021;22:1387-1396. https://doi.org/10.1093/ehjci/jeab011
Kochman J, Huczek Z, Ścisło P, et al. Comparison of one- and 12-month outcomes of transcatheter aortic valve replacement in patients with severely stenotic bicuspid versus tricuspid aortic valves (results from a multicenter registry). Am J Cardiol. 2014;114:757-762.
Li YM, Xiong TY, Xu K, et al. Characteristics and outcomes following transcatheter aortic valve replacement in China: a report from China aortic valve transcatheter replacement registry (CARRY). Chin Med J. 2021;134:2678-2684.
Liao Y, Li Y, Xiong T, et al. Comparison of procedural, clinical and valve performance results of transcatheter aortic valve replacement in patients with bicuspid versus tricuspid aortic stenosis. Int J Cardiol. 2018;254:69-74.
Liu X, Jiang J, Zhou Q, et al. Evaluation of the safety and efficacy of transcatheter aortic valve implantation in patients with a severe stenotic bicuspid aortic valve in a Chinese population. J Zhejiang Univ Sci B. 2015;16:208-214.
Makkar RR, Yoon SH, Leon MB, et al. Association between transcatheter aortic valve replacement for bicuspid vs tricuspid aortic stenosis and mortality or stroke. JAMA. 2019;321:2193-2202.
Makkar RR, Yoon SH, Chakravarty T, et al. Association between transcatheter aortic valve replacement for bicuspid vs tricuspid aortic stenosis and mortality or stroke among patients at low surgical risk. JAMA. 2021;326:1034-1044.
Mangieri A, Chieffo A, Kim WK, et al. Transcatheter aortic valve implantation using the ACURATE neo in bicuspid and tricuspid aortic valve stenosis: a propensity-matched analysis of a European experience. EuroIntervention. 2018;14:e1269-e1275.
Medranda GA, Rogers T, Forrestal BJ, et al. Balloon-expandable valve geometry after transcatheter aortic valve replacement in low-risk patients with bicuspid versus tricuspid aortic stenosis. Cardiovasc Revasc Med. 2021;33:7-12.
Michel JM, Frangieh AH, Giacoppo D, et al. Safety and efficacy of minimalist transcatheter aortic valve implantation using a new-generation balloon-expandable transcatheter heart valve in bicuspid and tricuspid aortic valves. Clin Res Cardiol. 2021;110:1993-2006.
Nagaraja V, Suh W, Fischman DL, et al. Transcatheter aortic valve replacement outcomes in bicuspid compared to trileaflet aortic valves. Cardiovasc Revasc Med. 2019;20:50-56.
Pineda AM, Rymer J, Wang A, et al. Transcatheter aortic valve replacement for patients with severe bicuspid aortic stenosis. Am Heart J. 2020;224:105-112.
Sannino A, Cedars A, Stoler RC, Szerlip M, Mack MJ, Grayburn PA. Comparison of efficacy and safety of transcatheter aortic valve implantation in patients with bicuspid versus tricuspid aortic valves. Am J Cardiol. 2017;120:1601-1606.
Shiyovich A, Kornowski R, Plakht Y, et al. Increased rate of new-onset left bundle branch block in patients with bicuspid aortic stenosis undergoing transcatheter aortic valve implantation (from a National Registry). Am J Cardiol. 2021;156:101-107.
Song G, Jilaihawi H, Wang M, et al. Severe symptomatic bicuspid and tricuspid aortic stenosis in China: characteristics and outcomes of transcatheter aortic valve replacement with the Venus-A valve. Struct Heart. 2018;2:60-68.
Tchetche D, de Biase C, van Gils L, et al. Bicuspid aortic valve anatomy and relationship with devices: the BAVARD Multicenter Registry. Circ Cardiovasc Interv. 2019;12:e007107.
Unbehaun A, Meyer A, Hamandi M, et al. Transcatheter aortic valve implantation in bicuspid versus tricuspid valve pathologies-a propensity matched comparison. Thorac Cardiovasc Surg. 2017;65:S1-S110.
Waksman R, Craig PE, Torguson R, et al. Transcatheter aortic valve replacement in low-risk patients with symptomatic severe bicuspid aortic valve stenosis. JACC Cardiovasc Interv. 2020;13:1019-1027.
Wang M, Song G, Chen M, et al. Twelve-month outcomes of the TaurusOne valve for transcatheter aortic valve implantation in patients with severe aortic stenosis. EuroIntervention. 2022;17:1070-1076.
Watanabe Y, Chevalier B, Hayashida K, et al. Comparison of multislice computed tomography findings between bicuspid and tricuspid aortic valves before and after transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2015;86:323-330.
Williams MR, Jilaihawi H, Makkar R, et al. The PARTNER 3 Bicuspid Registry for Transcatheter Aortic Valve Replacement in Low-Surgical-Risk Patients. JACC Cardiovasc Interv. 2022;15:523-532.
Xiong TY, Zheng MX, Wei X, et al. Hemodynamic changes after transcatheter aortic valve implantation during sequential follow-ups in patients with bicuspid aortic valve compared with tricuspid aortic valve. Cardiol J. 2017;24:350-357.
Xiong TY, Wang X, Li YJ, et al. Less pronounced reverse left ventricular remodeling in patients with bicuspid aortic stenosis treated with transcatheter aortic valve replacement compared to tricuspid aortic stenosis. Int J Cardiovasc Imaging. 2018;34:1761-1767.
Xu YN, Xiong TY, Li YJ, et al. Balloon sizing during transcatheter aortic valve implantation: comparison of different valve morphologies. Herz. 2020;45:192-198.
Xu Q, Liu X, Jiang J, et al. Transcatheter aortic valve replacement in atypical valve anatomy using the Lotus valve: a Chinese single-center experience. Herz. 2021;46:63-70.
Yoon SH, 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;69:2579-2589.
Zhou N, Pan C, Zhao W, et al. Role of three-dimensional transesophageal echocardiography in transcatheter aortic valve implantation of bicuspid aortic valve stenosis: a controlled study and comparison with tricuspid aortic valve stenosis. Cardiol Plus. 2018;3:1-7.
Zhou D, Pan W, Wang J, et al. VitaFlow transcatheter valve system in the treatment of severe aortic stenosis: one-year results of a multicenter study. Catheter Cardiovasc Interv. 2020;95:332-338.
Zhou JY, Liew D, Duffy SJ, Walton A, Htun N, Stub D. Cost-effectiveness of transcatheter versus surgical aortic valve replacement in low-risk patients with severe aortic stenosis. Heart, Lung Circ. 2021;30:547-554.
Zhu G, Fan J, Zhou D, et al. Subclinical leaflets thrombosis after transcatheter replacement of bicuspid vs. tricuspid aortic valve. Front Cardiovasc Med. 2021;8:790069.
Gasecka A, Walczewski M, Witkowski A, et al. Long-term mortality after TAVI for bicuspid vs. tricuspid aortic stenosis: a propensity-matched multicentre cohort study. Front Cardiovasc Med. 2022;9:894497.
Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71
Généreux P, Piazza N, Alu MC, et al. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. J Am Coll Cardiol. 2021;77:2717-2746.
Mahajan S, Gupta R, Malik AH, et al. Predictors of permanent pacemaker insertion after TAVR: a systematic review and updated meta-analysis. J Cardiovasc Electrophysiol. 2021;32:1411-1420.
Gupta R, Mahajan S, Behnoush AH, et al. Short- and long-term clinical outcomes following permanent pacemaker insertion post-TAVR: a systematic review and meta-analysis. JACC Cardiovasc interv. 2022;15:1690-1692.
Chen M, Michel J, Kasel AM. Application of Balloon-Expandable transcatheter heart valve in bicuspid aortic valve. JACC Asia. 2021;1:147-161.
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;11:160-168.
Didier R, Benic C, Nasr B, et al. High post-procedural transvalvular gradient or delayed mean gradient increase after transcatheter aortic valve implantation: incidence, prognosis and associated variables. The France-2 registry. J Clin Med. 2021;10:3221.