Restricted accessResearch articleFirst published online 2021-1
The International Society for Minimally Invasive Cardiothoracic Surgery Expert Consensus Statement on Transcatheter and Surgical Aortic Valve Replacement in Low- and Intermediate-Risk Patients: A Meta-Analysis of Randomized and Propensity-Matched Studies
There is an increasing amount of evidence supporting use of transcatheter aortic valve replacement (TAVR) for treatment of aortic stenosis in patients at low or intermediate risk for surgical aortic valve replacement (SAVR). TAVR is now approved for use in all patient cohorts. Despite this, there remains debate about the relative efficacy of TAVR compared with SAVR in lower-risk cohorts and various subgroups of patients. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and propensity-matched trials to guide a consensus among expert cardiologists and surgeons.
Methods
Studies comparing TAVR and SAVR in low- and intermediate-risk patients were identified by a thorough search of the major databases. Mortality, stroke, and other perioperative outcomes were assessed at 30 days and 1 year.
Results
Early mortality was lower in TAVR compared to SAVR in RCTs, but not propensity-matched studies in low-risk cohorts (0.66% vs 1.5%; odds ratio [OR] = 0.44, 95% confidence interval [CI] 0.20 to 0.98, I2 = 0%). No difference in mortality between TAVR and SAVR was identified in intermediate-risk patients at early or later time points. Incidence of perioperative stroke in 3 low-risk RCTs was significantly lower in TAVR (0.4%) than SAVR (1.4%; OR = 0.33, 95% CI 0.13 to 0.81, I2 = 0%). There was no difference in stroke for intermediate-risk patients between TAVR and SAVR. The expert panel of cardiologists and cardiac surgeons provided recommendations for TAVR and SAVR in various clinical scenarios.
Conclusions
In RCTs comparing TAVR and SAVR in low-risk patients, early mortality and stroke were lower in TAVR, but did not differ at 1 year. There was no difference in mortality and stroke in intermediate-risk patients. The Multidisciplinary Heart Team must consider individual patient characteristics and preferences when recommending TAVR or SAVR. The decision must consider the long-term management of each patient’s aortic valve disease.
LeonMB.SmithCR.MackMet al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med2010; 363: 1597–1607.20961243
2.
AdamsDH.PopmaJJ.ReardonMJet al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med2014; 370: 1790–1798.24678937
3.
MackMJ.LeonMB.SmithCRet al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet2015; 385: 2477–2484.25788234
4.
GleasonTG.ReardonMJ.PopmaJJet al. 5-year outcomes of self-expanding transcatheter versus surgical aortic valve replacement in high-risk patients. J Am Coll Cardiol2018; 72: 2687–2696.30249462
5.
LeonMB.SmithCR.MackMJet al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med2016; 374: 1609–1620.27040324
6.
ReardonMJ.Van MieghemNM.PopmaJJet al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med2017; 376: 1321–1331.28304219
7.
SøndergaardL.IhlemannN.CapodannoDet al. Durability of transcatheter and surgical bioprosthetic aortic valves in patients at lower surgical risk. J Am Coll Cardiol2019; 73: 546–553.30732707
8.
MackMJ.LeonMB.ThouraniVHet al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med2019; 380: 1695–1705.30883058
9.
PopmaJJ.DeebGM.YakubovSJet al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med2019; 380: 1706–1715.30883053
10.
ThouraniVH.SuriRM.GunterRLet al. Contemporary real-world outcomes of surgical aortic valve replacement in 141,905 low-risk, intermediate-risk, and high-risk patients. Ann Thorac Surg2015; 99: 55–61.25442986
11.
LatibA.MaisanoF.BertoldiLet al. Transcatheter vs surgical aortic valve replacement in intermediate-surgical-risk patients with aortic stenosis: a propensity score-matched case-control study. Am Heart J2012; 164: 910–917.23194492
12.
OsnabruggeRLJ.HeadSJ.GendersTSSet al. Costs of transcatheter versus surgical aortic valve replacement in intermediate-risk patients. Ann Thorac Surg2012; 94: 1954–1960.22959568
13.
PiazzaN.KalesanB.van MieghemNet al. A 3-center comparison of 1-year mortality outcomes between transcatheter aortic valve implantation and surgical aortic valve replacement on the basis of propensity score matching among intermediate-risk surgical patients. JACC Cardiovasc Interv2013; 6: 443–451.23702009
14.
TamburinoC.BarbantiM.D’ErrigoPet al. 1-year outcomes after transfemoral transcatheter or surgical aortic valve replacement. J Am Coll Cardiol2015; 66: 804–812.
15.
ThyregodHGH.SteinbrüchelDA.IhlemannNet al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis. J Am Coll Cardiol2015; 65: 2184–2194.
16.
HannanEL.SamadashviliZ.StamatoNJet al. Utilization and 1-year mortality for transcatheter aortic valve replacement and surgical aortic valve replacement in New York patients with aortic stenosis: 2011 to 2012. JACC Cardiovasc Interv2016; 9: 578–585.27013157
17.
ThouraniVH.KodaliS.MakkarRRet al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet2016; 387: 2218–2225.27053442
18.
CastrodezaJ.Amat-SantosIJ.BlancoMet al. Propensity score matched comparison of transcatheter aortic valve implantation versus conventional surgery in intermediate and low risk aortic stenosis patients: a hint of real-world. Cardiol J2016; 23: 541–551.27439368
19.
AuffretV.Becerra MunozV.LoiratAet al. Transcatheter aortic valve implantation versus surgical aortic valve replacement in lower-surgical-risk patients with chronic obstructive pulmonary disease. Am J Cardiol2017; 120: 1863–1868.28886850
20.
BrennanJM.ThomasL.CohenDJet al. Transcatheter versus surgical aortic valve replacement. J Am Coll Cardiol2017; 70: 439–450.
21.
FrerkerC.BestehornK.SchlüterMet al. In-hospital mortality in propensity-score matched low-risk patients undergoing routine isolated surgical or transfemoral transcatheter aortic valve replacement in 2014 in Germany. Clin Res Cardiol2017; 106: 610–617.28283745
22.
RepossiniA.Di BaccoL.PassarettiBet al. Early hemodynamics and clinical outcomes of isolated aortic valve replacement with stentless or transcatheter valve in intermediate-risk patients. J Thorac Cardiovasc Surg2017; 153: 549–558.27939031
23.
FurukawaN.KussO.EmmelEet al. Minimally invasive versus transapical versus transfemoral aortic valve implantation: a one-to-one-to-one propensity score-matched analysis. J Thorac Cardiovasc Surg2018; 156: 1825–1834.29861110
24.
WaksmanR.RogersT.TorgusonRet al. Transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis. J Am Coll Cardiol2018; 72: 2095–2105.30170075
25.
WernerN.ZahnR.BeckmannAet al. Patients at intermediate surgical risk undergoing isolated interventional or surgical aortic valve implantation for severe symptomatic aortic valve stenosis. Circulation2018; 138: 2611–2623.30571255
26.
BekeredjianR.SzaboG.BalabanÜet al. Patients at low surgical risk as defined by the Society of Thoracic Surgeons Score undergoing isolated interventional or surgical aortic valve implantation: in-hospital data and 1-year results from the German Aortic Valve Registry (GARY). Eur Heart J2019; 40: 1323–1330.30445543
27.
KappeteinAP.HeadSJ.GénéreuxPet al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J2012; 33: 2403–2418.23026477
28.
Review Manager (RevMan) [Computer program]. Version 5.3. Copenhagen: The Nordic Cochrane Centre. The Cochrane Collaboration, 2014.
29.
MatsudaY.Nai FovinoL.GiacoppoDet al. Association between surgical risk and 30‐day stroke after transcatheter versus surgical aortic valve replacement: a systematic review and meta‐analysis. Catheter Cardiovasc Interv. Epub ahead of print 25 June 2020.doi:10.1002/ccd.29105.
30.
KhanMR.KayaniWT.MananMet al. Comparison of surgical versus transcatheter aortic valve replacement for patients with aortic stenosis at low-intermediate risk. Cardiovasc Diagn Ther2020; 10: 135–144.32420093
31.
HoferF.HengstenbergC.GoliaschGet al. Transcatheter versus surgical aortic valve replacement in low-risk patients: a meta-analysis of randomized trials. Clin Res Cardiol2020; 109: 761–775.31863174
32.
MalikAH.ZaidS.AhmadHet al. A meta-analysis of 1-year outcomes of transcatheter versus surgical aortic valve replacement in low-risk patients with severe aortic stenosis. J Geriatr Cardiol2020; 17: 43–50.32095133
33.
ThyregodHGH.IhlemannN.JørgensenTHet al. Five-year clinical and echocardiographic outcomes from the NOTION randomized clinical trial in patients at lower surgical risk. Circulation2019; 139: 2714–2723.
34.
MakkarRR.ThouraniVH.MackMJet al. Five-year outcomes of transcatheter or surgical aortic-valve replacement. N Engl J Med2020; 382: 799–809.31995682
35.
SmithCR.LeonMB.MackMJet al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med2011; 364: 2187–2198.21639811
36.
KleimanNS.MainiBJ.ReardonMJet al. Neurological events following transcatheter aortic valve replacement and their predictors: a report from the CoreValve trials. Circ Cardiovasc Interv2016; 9: e003551.27601429
37.
KapadiaS.AgarwalS.MillerDCet 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 Interv2016; 9: e002981.27601428
38.
MakkarRR.FontanaG.JilaihawiHet al. Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med2015; 373: 2015–2024.26436963
39.
BlankeP.LeipsicJA.PopmaJJet al. Bioprosthetic aortic valve leaflet thickening in the Evolut Low Risk sub-study. J Am Coll Cardiol2020; 75: 2430–2442.32234463
40.
MakkarRR.BlankeP.LeipsicJet al. Subclinical leaflet thrombosis in transcatheter and surgical bioprosthetic valves. J Am Coll Cardiol2020; 75: 3003–3015.
41.
AndoT.BriasoulisA.TelilaTet al. Does mild paravalvular regurgitation post transcatheter aortic valve implantation affect survival? A meta-analysis. Catheter Cardiovasc Interv2018; 91: 135–147.28963761
42.
BonowRO.RosingDR.McIntoshCLet al. The natural history of asymptomatic patients with aortic regurgitation and normal left ventricular function. Circulation1983; 68: 509–517.6872164
43.
FadahunsiOO.OlowoyeyeA.UkaigweAet al. Incidence, predictors, and outcomes of permanent pacemaker implantation following transcatheter aortic valve replacement. JACC Cardiovasc Interv2016; 9: 2189–2199.
44.
RegueiroA.Abdul-Jawad AltisentO.Del TrigoMet al. Impact of new-onset left bundle branch block and periprocedural permanent pacemaker implantation on clinical outcomes in patients undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis. Circ Cardiovasc Interv2016; 9: e003635.27169577
45.
KayeG.NgJY.AhmedSet al. The prevalence of pacing-induced cardiomyopathy (PICM) in patients with long term right ventricular pacing - is it a matter of definition?Heart Lung Circ2019; 28: 1027–1033.30017634
46.
LandesU.WebbJG.De BackerOet al. Repeat transcatheter aortic valve replacement for transcatheter prosthesis dysfunction. J Am Coll Cardiol2020; 75: 1882–1893.32327098
SedeekAF.GreasonKL.SandhuGSet al. Transcatheter valve-in-valve vs surgical replacement of failing stented aortic biological valves. Ann Thorac Surg2019; 108: 424–430.31055036
49.
HirjiSA.PercyED.ZoggCKet al. Comparison of in-hospital outcomes and readmissions for valve-in-valve transcatheter aortic valve replacement vs reoperative surgical aortic valve replacement: a contemporary assessment of real-world outcomes. Eur Heart J2020; 41: 2747–2755.32445575
50.
MakkarRR.YoonS-H.LeonMBet al. Association between transcatheter aortic valve replacement for bicuspid vs tricuspid aortic stenosis and mortality or stroke. JAMA2019; 321: 2193–2202.31184741
51.
HalimSA.EdwardsFH.DaiDet al. Outcomes of transcatheter aortic valve replacement in patients with bicuspid aortic valve disease. Circulation2020; 141: 1071–1079.
52.
EdelmanJJ.ShultsC.ThouraniVH. Transcatheter aortic valve replacement valve durability: good enough for young, low-risk patients?J Thorac Cardiovasc Surg2020; 159: 1249–1255.31619329
53.
WitbergG.RegevE.ChenSet al. The prognostic effects of coronary disease severity and completeness of revascularization on mortality in patients undergoing transcatheter aortic valve replacement. JACC Cardiovasc Interv2017; 10: 1428–1435.28728656
54.
FihnSD.BlankenshipJC.AlexanderKPet al. ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease. Circulation2014; 2014: 1749–1767.
MackMJ.AdamsDH. Regulatory approval and practice guidelines involving cardiovascular valve devices: determining the right Evidentiary bar. J Am Coll Cardiol2020; 76: 992–995.32819473
57.
WoldendorpK.DoyleMP.BannonPGet al. Aortic valve replacement using stented or sutureless/rapid deployment prosthesis via either full-sternotomy or a minimally invasive approach: a network meta-analysis. Ann Cardiothorac Surg2020; 9: 347–363.33102174
58.
BonowRO.BrownAS.GillamLDet al. ACC/AATS/AHA/ASE/EACTS/HVS/SCA/SCAI/SCCT/SCMR/STS 2017 appropriate use criteria for the treatment of patients with severe aortic stenosis. J Am Coll Cardiol2017; 70: 2566–2598.
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
