Randomised comparison of a balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging

N H M Kooistra, M Abawi, M Voskuil, K Urgel, M Samim, F Nijhoff, H M Nathoe, P A F M Doevendans, S A J Chamuleau, G E H Leenders, T Leiner, A C Abrahams, H B van der Worp, P Agostoni, P R Stella, N H M Kooistra, M Abawi, M Voskuil, K Urgel, M Samim, F Nijhoff, H M Nathoe, P A F M Doevendans, S A J Chamuleau, G E H Leenders, T Leiner, A C Abrahams, H B van der Worp, P Agostoni, P R Stella

Abstract

Introduction: Transcatheter aortic valve implantation (TAVI) is a safe and effective treatment for inoperable, intermediate- or high-risk patients with severe symptomatic aortic stenosis and has been associated with excellent clinical outcomes. A clinically relevant remaining problem is aortic regurgitation (AR) post-TAVI, which is associated with increased mortality. Therefore, we conducted a prospective randomised trial to assess the safety and efficacy of a first-generation self-expandable valve (SEV; CoreValve) and a third-generation balloon-expandable valve (BEV; Sapien 3) with respect to clinical outcomes and AR as determined quantitatively by magnetic resonance imaging (MRI).

Methods: The ELECT study was an investigator-initiated, single-centre trial involving patients with severe symptomatic aortic stenosis and with a clinical indication for transfemoral TAVI. Fifty-six patients were randomly assigned to the BEV or SEV group.

Results: AR determined quantitatively by MRI was lower in the BEV than in the SEV group [regurgitant fraction: 1.1% (0-8.0) vs 8.7% (3.0-14.8) for SEV; p = 0.01]. Secondary endpoints according to the criteria of the Second Valve Academic Research Consortium (VARC-2) showed BEV to have better early safety [0 (0%) vs 8 (30%); p = 0.002] at 30 days and a lower risk of stroke [0 (0%) vs 5 (21%); p = 0.01], major adverse cardiac and cerebrovascular events [0 (0%) vs 10 (38%); p < 0.001] or death [0 (0%) vs 5 (19%); p = 0.02] in the 1st year compared with SEV.

Conclusions: The use of the latest generation of BEV was associated with less AR as quantitatively assessed by MRI. Although the use of MRI to quantify AR is not feasible in daily clinical practice, it should be considered as a surrogate endpoint for clinical outcomes in comparative studies of valves for TAVI. ClinicalTrials.gov number NCT01982032.

Keywords: Aortic valve stenosis; Balloon-expandable heart valve; Magnetic resonance imaging; Quantitative aortic regurgitation; Self-expandable heart valve; Transcatheter aortic valve implantation.

Conflict of interest statement

N.H.M. Kooistra, M. Abawi, M. Voskuil, K. Urgel, M. Samim, F. Nijhoff, H.M. Nathoe, P.A.F.M. Doevendans, S.A.J. Chamuleau, G.E.H. Leenders, T. Leiner, A.C. Abrahams, H.B. van der Worp, P. Agostoni and P.R. Stella declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study flowchart. LTFU lost to follow up, TAVI transcatheter aortic valve implantation
Fig. 2
Fig. 2
Quantitative assessment of aortic regurgitation (AR) with magnetic resonance imaging compared per valve type (BEV, SEV). a Boxplot of the continuous quantitative result. b Quantitative results stratified into AR grades. RF regurgitant fraction, BEV balloon-expandable valve, SEV self-expandable valve
Fig. 3
Fig. 3
One-year clinical outcome. a One-year event rates of major VARC-2-related outcomes, comparison between valves. b Changes in aortic mean gradient and aortic valve area over four time points, with comparisons between the BEV and SEV group; between-group differences were significant at discharge and 6 months for both mean gradient and aortic valve area. Error bars represent 1 SD and are visualised one-sided. c Kaplan-Meier graph showing survival in BEV and SEV groups. BEV balloon-expandable valve, SEV self-expandable valve, VARC‑2 Valve Academic Research Consortium‑2, TIA transient ischemic attack, AMI acute myocardial infarction, PM pacemaker, MACCE major adverse cardiac and cerebrovascular events

References

    1. Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, et 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. Lancet. 2015;385(9986):2477–2484. doi: 10.1016/S0140-6736(15)60308-7.
    1. Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Søndergaard L, Mumtaz M, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376(14):1321–1331. doi: 10.1056/NEJMoa1700456.
    1. Athappan G, Patvardhan E, Tuzcu EM, Svensson LG, Lemos P, Fraccaro C, et al. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol. 2013;61(15):1585–1595. doi: 10.1016/j.jacc.2013.01.047.
    1. Généreux P, Head SJ, Hahn R, Daneault B, Kodali S, Williams MR, et al. Paravalvular leak after transcatheter aortic valve replacement: the new achilles’ heel? A comprehensive review of the literature. J Am Coll Cardiol. 2013;61:1125–1136. doi: 10.1016/j.jacc.2012.08.1039.
    1. Abdelghani M, Soliman OII, Schultz C, Vahanian A, Serruys PW. Adjudicating paravalvular leaks of transcatheter aortic valves: a critical appraisal. Eur Heart J. 2016;37(34):2627–2644. doi: 10.1093/eurheartj/ehw115.
    1. Ribeiro HB, Le Ven F, Larose E, Dahou A, Nombela-Franco L, Urena M, et al. Cardiac magnetic resonance versus transthoracic echocardiography for the assessment and quantification of aortic regurgitation in patients undergoing transcatheter aortic valve implantation. Heart. 2014;100(24):1924–1932. doi: 10.1136/heartjnl-2014-305615.
    1. Orwat S, Diller G-P, Kaleschke G, Kerckhoff G, Kempny A, Radke RM, et al. Aortic regurgitation severity after transcatheter aortic valve implantation is underestimated by echocardiography compared with MRI. Heart. 2014;100(24):1933–1938. doi: 10.1136/heartjnl-2014-305665.
    1. Salaun E, Jacquier A, Theron A, Giorgi R, Lambert M, Jaussaud N, et al. Value of CMR in quantification of paravalvular aortic regurgitation after TAVI. Eur Heart J Cardiovasc Imaging. 2016;17(1):41–50.
    1. Ribeiro HB, Orwat S, Hayek SS, Larose E, Babaliaros V, Dahou A, et al. Cardiovascular magnetic resonance to evaluate aortic regurgitation after transcatheter aortic valve replacement. J Am Coll Cardiol. 2016;68(6):577–585. doi: 10.1016/j.jacc.2016.05.059.
    1. Lee JC, Branch KR, Hamilton-Craig C, Krieger EV. Evaluation of aortic regurgitation with cardiac magnetic resonance imaging: a systematic review. Heart. 2018;104(2):103–110.
    1. Gonska B, Seeger J, Baarts J, Rodewald C, Scharnbeck D, Rottbauer W, et al. The balloon-expandable Edwards Sapien 3 valve is superior to the self-expanding Medtronic CoreValve in patients with severe aortic stenosis undergoing transfemoral aortic valve implantation. J Cardiol. 2017;69(6):877–882. doi: 10.1016/j.jjcc.2016.08.008.
    1. Webb J, Gerosa G, Lefèvre T, Leipsic J, Spence M, Thomas M, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64(21):2235–2243. doi: 10.1016/j.jacc.2014.09.026.
    1. Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370(19):1790–1798. doi: 10.1056/NEJMoa1400590.
    1. Abawi M, Agostoni P, Kooistra NHM, Samim M, Nijhoff F, Voskuil M, et al. Rationale and design of the Edwards SAPIEN-3 periprosthetic leakage evaluation versus Medtronic CoreValve in transfemoral aortic valve implantation (ELECT) trial. Neth Heart J. 2017;25(5):318–329. doi: 10.1007/s12471-016-0934-3.
    1. Gabriel RS, Renapurkar R, Bolen M, Verhaert D, Leiber M, Flamm SD, et al. Comparison of severity of aortic regurgitation by cardiovascular magnetic resonance versus transthoracic echocardiography. Am J Cardiol. 2011;108(7):1014–1020. doi: 10.1016/j.amjcard.2011.05.034.
    1. Kooistra NHM, Nijhoff F, Abawi M, Agostoni P, Araya Roos DM, van Tuijl S, et al. Ex vivo pilot study of cardiac magnetic resonance velocity mapping for quantification of aortic regurgitation in a porcine model in the presence of a transcatheter heart valve. J Cardiovasc Transl Res. 2019;12(4):310–320. doi: 10.1007/s12265-019-09878-1.
    1. Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol. 2012;60(15):1438–1454. doi: 10.1016/j.jacc.2012.09.001.
    1. Kodali S, Thourani VH, White J, Malaisrie SC, Lim S, Greason KL, et al. Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. Eur Heart J. 2016;37(28):2252–2262. doi: 10.1093/eurheartj/ehw112.
    1. Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012;366(18):1705–1715. doi: 10.1056/NEJMoa1114705.
    1. Kodali S, Pibarot P, Douglas PS, Williams M, Xu K, Thourani V, et al. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes. Eur Heart J. 2015;36(7):449–456. doi: 10.1093/eurheartj/ehu384.
    1. Schymik G, Lefèvre T, Bartorelli AL, Rubino P, Treede H, Walther T, et al. European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry. JACC Cardiovasc Interv. 2015;8(5):657–669. doi: 10.1016/j.jcin.2014.10.026.
    1. Moat NE, Ludman P, De Belder M, Bridgewater B, Cunningham AD, Young CP, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: The U.K. TAVI (United Kingdom transcatheter aortic valve implantation) registry. J Am Coll Cardiol. 2011;58(20):2130–2138. doi: 10.1016/j.jacc.2011.08.050.
    1. Dulce MC, Mostbeck GH, O’Sullivan M, Cheitlin M, Caputo GR, Higgins CB. Severity of aortic regurgitation: interstudy reproducibility of measurements with velocity-encoded cine MR imaging. Radiology. 1992;185(1):235–240. doi: 10.1148/radiology.185.1.1523315.
    1. Chatzimavroudis GP, Oshinski JN, Franch RH, Walker PG, Yoganathan AP, Pettigrew RI. Evaluation of the precision of magnetic resonance phase velocity mapping for blood flow measurements. J Cardiovasc Magn Reson. 2001;3(1):11–19. doi: 10.1081/JCMR-100000142.
    1. Van Belle E, Juthier F, Susen S, Vincentelli A, Iung B, Dallongeville J, et al. 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. Circulation. 2014;129(13):1415–1427. doi: 10.1161/CIRCULATIONAHA.113.002677.
    1. Pibarot P, Hahn RT, Weissman NJ, Arsenault M, Beaudoin J, Bernier M, et al. Association of paravalvular regurgitation with 1-year outcomes after transcatheter aortic valve replacement with the SAPIEN 3 valve. JAMA Cardiol. 2017;2(11):1208–1216. doi: 10.1001/jamacardio.2017.3425.
    1. Abdel-Wahab M, Neumann FJ, Mehilli J, Frerker C, Richardt D, Landt M, et al. 1-year outcomes after transcatheter aortic valve replacement with balloon-expandable versus self-expandable valves: results from the CHOICE randomized clinical trial. J Am Coll Cardiol. 2015;66(7):791–800. doi: 10.1016/j.jacc.2015.06.026.
    1. Linke A, Wenaweser P, Gerckens U, Tamburino C, Bosmans J, Bleiziffer S, et al. Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study. Eur Heart J. 2014;35(38):2672–2684. doi: 10.1093/eurheartj/ehu162.
    1. Manoharan G, Van Mieghem NM, Windecker S, Bosmans J, Bleiziffer S, Modine T. et al. 1-Year outcomes with the Evolut R self-expanding transcatheter aortic valve: from the international FORWARD study. JACC Cardiovasc Interv. 2018;11(22):2326–2334. doi: 10.1016/j.jcin.2018.07.032.
    1. Giannini C, De Carlo M, Tamburino C, Ettori F, Latib AM, Bedogni F, et al. Transcathether aortic valve implantation with the new repositionable self-expandable Evolut R versus CoreValve system: a case-matched comparison. Int J Cardiol. 2017;243:126–131. doi: 10.1016/j.ijcard.2017.05.095.
    1. Button KS, Ioannidis JPA, Mokrysz C, Nosek BA, Flint J, Robinson ESJ, et al. Power failure: why small sample size undermines the reliability of neuroscience. Nat Rev Neurosci. 2013;14(5):365–376. doi: 10.1038/nrn3475.

Source: PubMed

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