Review of evidence and concerns, relating to extension of transcatheter aortic valve implantation usage to low–risk patients.
Methods
Comprehensive literature review was conducted identifying articles relating to transcatheter aortic valve implantation.
Results
Transcatheter aortic valve implantation is effective in patients with aortic stenosis. Currently, long-term durability and cost-effectiveness are unproven, anticoagulation requirement undefined, permanent pacemaker implantation and paravalvular leak rates higher than following surgical aortic valve replacement.
Conclusions
Current evidence supporting transcatheter aortic valve implantation usage in low-risk patients is insufficient. Extending use now, to this large young patient population is premature, and should be delayed.
von ElmEAltmanDGEggerM, et al.
The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet2007;
370: 1453–1457.
2.
PolimeniAAnadolRMünzelT, et al.
Long-term outcome of bioresorbable vascular scaffolds for the treatment of coronary artery disease: a meta-analysis of RCTs. BMC Cardiovasc Disord2017;
17: 147.
3.
ViktorssonSAOrrasonAWVidissonKO, et al.
Immediate and long-term need for permanent cardiac pacing following aortic valve replacement. Scand Cardiovasc J2020;
54: 186–191.
4.
MatthewsIGFazalIABatesMG, et al.
In patients undergoing aortic valve replacement, what factors predict the requirement for permanent pacemaker implantation?Interact Cardiovasc Thorac Surg2011;
12: 475–479.
5.
MehaffeyJHHaywoodNSHawkinsRB, et al.
Need for permanent pacemaker after surgical aortic valve replacement reduces long-term survival. Ann Thorac Surg2018;
106: 460–465.
6.
GreasonKLLahrBDStulakJM, et al.
Long-term mortality effect of early pacemaker implantation after surgical aortic valve replacement. Ann Thorac Surg2017;
104: 1259–1264.
7.
RazaSSLiJMJohnR, et al.
Long-term mortality and pacing outcomes of patients with permanent pacemaker implantation after cardiac surgery. Pacing Clin Electrophysiol2011;
34: 331–338.
8.
BagurRManazzoniJMDumontE, et al.
Permanent pacemaker implantation following isolated aortic valve replacement in a large cohort of elderly patients with severe aortic stenosis. Heart2011;
97: 1687–1694.
9.
KolkailahAADoukkyRPelletierMP, et al.
Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis in people with low surgical risk. Cochrane Database Syst Rev2019;
12: CD013319.
10.
LloydDLucJGYIndjaBE, et al.
Transcatheter, sutureless and conventional aortic valve replacement: a network meta-analysis of 16,432 patients. J Thorac Dis2019;
11: 188–199.
11.
BarbantiMBuccheriSRodes-CabauJ, et al.
Transcatheter aortic valve replacement with new-generation devices: a systematic review and meta-analysis. Int J Cardiol2017;
245: 83–89.
12.
KolteDVlahakesGJPalaciosIF, et al.
Transcatheter versus surgical aortic valve replacement in low-risk patients. J Am Coll Cardiol2019;
74: 1532–1540.
13.
RawasiaWFUsmanMSMujeebFA, et al.
Transcatheter versus surgical aortic valve replacement in low surgical risk patients: a meta-analysis of randomized controlled trials and propensity-matched studies. Cardiovasc Revasc Med2020;
21: 612–618.
14.
GoelSPasamRTWatsK, et al.
Transcatheter aortic valve replacement versus surgical aortic valve replacement in low-surgical-risk patients: an updated meta-analysis. Catheter Cardiovasc Interv2020;
96: 169–178.
15.
WitbergGLandesULadorA, et al.
Meta-analysis of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients at low surgical risk. EuroIntervention2019;
15: e1047–e1056.
16.
KheiriBOsmanMAbubakarH, et al.
Transcatheter versus surgical aortic valve replacement in low-risk surgical patients: a meta-analysis of randomized clinical trials. Cardiovasc Revasc Med2019;
20: 838–842.
17.
NazifTMDizonJMHahnRT, et al.
Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. JACC Cardiovasc Interv2015;
8: 60–69.
18.
BuellesfeldLStorteckySHegD, et al.
Impact of permanent pacemaker implantation on clinical outcome among patients undergoing transcatheter aortic valve implantation. J Am Coll Cardiol2012;
60: 493–501.
19.
RegueiroAAbdul-Jawad AltisentODel TrigoM, et 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.
20.
Van BelleEJuthierFSusenS, et al.
FRANCE 2 Investigators. Postprocedural aortic regurgitation in balloon-expandable and self-expandable transcatheter aortic valve replacement procedures: analysis of predictors and impact on long-term mortality: insights from the FRANCE2 Registry. Circulation2014;
129: 1415–1427.
21.
MuralidharanAThiagarajanKVan HamR, et al.
Meta-analysis of perioperative stroke and mortality in transcatheter aortic valve implantation. Am J Cardiol2016:
118: 1031–1045.
22.
LanskyAJBrownDPenaC, et al.
Neurologic complications of unprotected transcatheter aortic valve implantation (from the Neuro-TAVR Trial). Am J Cardiol2016;
118: 1519–1526.
23.
BurkeHBoronALeeJH, et al. Exploring the difference in post-procedural stroke rates between patients with aortic stenosis who undergo transcatheter aortic valve replacement versus surgical aortic valve replacement. Cureus2018;
10: e2494.
24.
CapodannoDPetronioASPrendergastB, et al.
Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J2017;
38: 3382–3390.
25.
MackMLeonMSmithC, et al.
5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic valve stenosis (PARTNER 1): a randomised controlled trial. Lancet2015;
385: 2477–2484.
26.
BlackmanDJSarafSMacCarthyPA, et al.
Long-term durability of transcatheter aortic valve prostheses. J Am Coll Cardiol2019;
73: 537–545.
27.
EltchaninoffHDurandEAvinéeG, et al.
Assessment of structural valve deterioration of transcatheter aortic bioprosthetic balloon-expandable valves using the new European consensus definition. EuroIntervention2018;
14: e264–e271.
28.
SøndergaardLIhlemannNCapodannoD, et al.
Durability of transcatheter and surgical bioprosthetic aortic valves in patients at lower surgical risk. J Am Coll Cardiol2019;
73: 546–553.
29.
SokoloffAEltchaninoffHDacherJN.Assessment of long-term durability of transcatheter aortic valves, a French multicenter retrospective study. Arch Cardiovasc Dis2018;
10: 220.
30.
ForoutanFGuyattGHOttoCM, et al.
Structural valve deterioration after transcatheter aortic valve implantation. Heart2017;
103: 1899–1905.
31.
ForcilloJPellerinMPerraultLP, et al.
Carpentier-Edwards pericardial valve in the aortic position: 25-years’ experience. Ann Thorac Surg2013;
96: 486–493.
32.
PoirerNCPelletierLCPellerinM, et al.
15-year experience with the Carpentier-Edwards pericardial bioprosthesis. Ann Thorac Surg1998;
66: S57–S61.
33.
Rodriguez-GabellaTVoisinePDagenaisF, et al.
Long-term outcomes following surgical aortic bioprosthesis implantation. J Am Coll Cardiol2018;
71: 1401–1412.
34.
HammermeisterKSethiGKHendersonWG, et al.
Outcomes 15 years after valve replacement with a mechanical versus a bioprosthetic valve: final report of the Veterans Affairs randomized trial. J Am Coll Cardiol2000;
36: 1152–1158.
35.
OxenhamHBloomfieldPWheatleyDJ, et al.
Twenty year comparison of a Bjork Shiley mechanical heart valve with porcine bioprostheses. Heart2003;
89: 715–721.
36.
StassanoPDi TommasoLMonacoM, et al.
Aortic valve replacement: a prospective randomized evaluation of mechanical versus biological valves in patients ages 55 to 70 years. J Am Coll Cardiol2009;
54: 1862–2186.
37.
BrownMLSchaffHVLahrBD, et al.
Aortic valve replacement in patients aged 50 to 70 years: improved outcome with mechanical versus biologic prostheses. J Thorac Cardiovasc Surg2008;
135: 878–884.
TsvelodubSPieperBStockS, et al.
Long-term (up to 21 years) follow up after biological and mechanical aortic valve replacement in younger patients. J Heart Valve Dis2017;
5: 528–536.
40.
ChakravartyTSøndergaardLFriedmanJ, et al.
Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet2017;
389: 2383–2392.
41.
De BackerODangasGDJilaihawiH, et al.Reduced leaflet motion after transcatheter aortic-valve replacement. N Engl J Med2020;
382: 130–139.
42.
DangasGDTijssenJGPWöhrleJ, et al.
A controlled trial of rivaroxaban after transcatheter aortic-valve replacement. N Engl J Med2020;
382: 120–129.
43.
GiustinoGTijssenJWindeckerS, et al.
Rivaroxaban after transcatheter aortic valve replacement: the GALILEO trial. Cardiovasc Res2020;
116: e39–e41.
44.
D’AscenzoFVerardiRViscontiM.Independent impact of extent of coronary artery disease and percutaneous revascularisation on 30-day and one-year mortality after TAVR: a meta-analysis of adjusted observational results. EuroIntervention2018;
14: e1169–e1177.
45.
FranzoneAStorteckySRäberL, et al.
Effects of coronary artery disease in patients undergoing transcatheter aortic valve implantation: a study of age- and gender matched cohorts. Int J Cardiol2017;
243: 150–155.
46.
OzakiYGarcia-GarciaHMRogersT, et al. Coronary artery disease assessed by computed tomography-based leaman score in patients with low-risk transcatheter aortic valve implantation. Am J Cardiol2020;
9149: 30063–30071.
47.
PuymiratEDidierREltchaninoffH, et al.
Impact of coronary artery disease in patients undergoing transcatheter aortic valve replacement: insights from the FRANCE-2 registry. Clin Cardiol2017;
40: 1316–1322.
48.
SankaramangalamKBanerjeeKKandregulaK, et al. Impact of coronary artery disease on 30-day and 1-year mortality in patients undergoing transcatheter aortic valve replacement: a meta-analysis. J Am Heart Assoc2017;
6: e006092.
49.
WitbergGZusmanOCodnerP, et al.
Impact of coronary artery revascularization completeness on outcomes of patients with coronary artery disease undergoing transcatheter aortic valve replacement: a meta-analysis of studies using the residual SYNTAX Score (Synergy Between PCI With Taxus and Cardiac Surgery). Circ Cardiovasc Interv2018;
11: e006000.
50.
MackMJLeonMBThouraniVH, et al.
Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. PARTNER 3 Investigators. N Engl J Med2019;
380: 1695–1705.
51.
PopmaJJDeebGMYakubovSJ, et al.
Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med2019;
380: 1706–1715.
52.
BekeredjianRSzaboGBalabanÜ, et 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.
53.
ReynoldsMRMagnusonEAWangK, et al.
Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the Placement of Aortic Transcatheter Valves (PARTNER) Trial (Cohort B). Circulation2012;
125: 1102–1109.
54.
ReynoldsMRLeiYWangK, et al.
Cost-effectiveness of transcatheter aortic valve replacement with a self-expanding prosthesis versus surgical aortic valve replacement. J Am Coll Cardiol2016;
67: 29–38.
55.
OsnabruggeRLHeadSJGendersTS, et al.
Costs of transcatheter versus surgical aortic valve replacement in intermediate-risk patients. Ann Thorac Surg2012;
94: 1954–1960.
56.
TamDYHughesAFremesSE, et al.
A cost-utility analysis of transcatheter versus surgical aortic valve replacement for the treatment of aortic stenosis in the population with intermediate surgical risk. J Thorac Cardiovasc Surg2018;
155: 1978–1988.
57.
BaronSJWangKHouseJA, et al.
Cost-effectiveness of transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at intermediate risk. Circulation2019;
139: 877–888.
58.
AzraaiMGaoLAjaniAE.Cost-effectiveness of transcatheter aortic valve intervention (TAVR) compared to surgical aortic valve replacement (SAVR) in low intermediate surgical risk patients. Cardiovasc Revasc Med2020;
9: 1164–1168.
59.
GeislerBPJørgensenTHThyregodHGH, et al.
Cost-effectiveness of transcatheter versus surgical aortic valve replacement in patients at lower surgical risk: results from the NOTION trial. EuroIntervention2019;
11: e959–e967.
60.
DellingFNHassanZKPiatkowskiG, et al.
Tricuspid regurgitation and mortality in patients with transvenous permanent pacemaker leads. Am J Cardiol2016;
117: 988–992.
61.
YuCMChanJYZhangQ, et al.
Biventricular pacing in patients with bradycardia and normal ejection fraction. N Engl J Med2009;
22: 2123–2134.
62.
ElderDHLangCCChoyAM.Pacing-induced heart disease: understanding the pathophysiology and improving outcomes. Expert Rev Cardiovasc Ther2011;
9: 877–886.
63.
Nombela-FrancoLRodés-CabauJDeLarochellièreR, et al.
Predictive factors, efficacy, and safety of balloon post-dilation after transcatheter aortic post-procedural aortic regurgitation after TAVR valve implantation with a balloon-expandable valve. JACC Cardiovasc Interv2012;
5: 499–512.
64.
BaumgartnerHFalkVBaxJJ, et al.
2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J2017;
38: 2739–2791.
65.
NishimuraRAOttoCMBonowRO, 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. Circulation2017;
135: e1159–e1195.
66.
ButchartEGPayneNLiHH, et al.
Better anti-coagulation control improves survival after valve replacement. J Thorac Cardiovasc Surg2002;
123: 715–723.
67.
EikelboomJWConnollySJBrueckmannM, et al.
RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med2013;
369: 1206–1214.
68.
KoertkeHZittermannATenderichG, et al.
Low dose oral anti-coagulation in patients with mechanical heart valve prostheses: final report from the early self-management anti-coagulation trial II. Eur Heart J2007;
28: 2479–2484.
69.
PuskasJGerdischMNicholsD, et al.
Reduced anticoagulation after mechanical aortic valve replacement: interim results from the prospective randomized on-X valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial. J Thorac Cardiovasc Surg2014;
147: 1202–1210.
70.
KoertkeHZittermannAWagnerO, et al.
Telemedicine guided, very low-dose international normalized ratio self-control in patients with mechanical heart valve implants. Eur Heart J2015;
36: 1297–1305.
71.
IungBRodes-CabauJ.The optimal management of anti-thrombotic therapy after valve replacement: certainties and uncertainties. Eur Heart J2014;
35: 2942–2949.
72.
GherliTColliAFragnitoC, et al.
Comparing warfarin with aspirin after biological aortic valve replacement: a prospective study. Circulation2004;
110: 496–500.
73.
DunningJGaoHChambersJ, et al.
Aortic valve surgery: marked increases in volume and significant decreases in mechanical valve use–an analysis of 41,227 patients over 5 years from the Society for Cardiothoracic Surgery in Great Britain and Ireland National database. J Thorac Cardiovasc Surg2011;
142: 776–782.
74.
IsaacsAJShuhaiberJSalemiA, et al.
National trends in utilization and in-hospital outcomes of mechanical versus bioprosthetic aortic valve replacements. J Thorac Cardiovasc Surg2015;
149: 1262–1269.
75.
YoonSHBleizifferSDe BackerO, et al.
Outcomes in transcatheter aortic valve replacement for bicuspid versus tricuspid aortic valve stenosis. J Am Coll Cardiol2017;
69: 2579–2589.
76.
MakkarRRYoonSHLeonMB, et al.
Association between transcatheter aortic valve replacement for bicuspid vs tricuspid aortic stenosis and mortality or stroke. J Am Med Assoc2019;
321: 2193–2202.
77.
RogersTGreenspunBCWeissmanG, et al.
Feasibility of coronary access and aortic valve reintervention in low-risk TAVR patients. JACC Cardiovasc Interv2020;
13: 726–735.
78.
OchiaiTChakravartyTYoonSH, et al.
Coronary access after TAVR. JACC Cardiovasc Interv2020;
13: 693–705.
79.
Nai FovinoLScottiAMassussiM, et al.
Incidence and feasibility of coronary access after transcatheter aortic valve replacement. Catheter Cardiovasc Interv2020;
96: E535–E541.
80.
FarouxLGuimaraesLWintzer-WehekindJ, et al.
Coronary artery disease and transcatheter aortic valve replacement: JACC state-of-the-art review. J Am Coll Cardiol2019;
74: 362–372.
81.
WoodDALauckSBCairnsJA, et al.
The Vancouver 3M (multidisciplinary, multimodality, but minimalist) clinical pathway facilitates safe next-day discharge home at low-, medium-, and high-volume transfemoral transcatheter aortic valve replacement centers: the 3M TAVR study. JACC Cardiovasc Interv2019;
12: 459–469.
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.
