Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement

Troels Højsgaard Jørgensen, Hans Gustav Hørsted Thyregod, Nikolaj Ihlemann, Henrik Nissen, Petur Petursson, Bo Juel Kjeldsen, Daniel Andreas Steinbrüchel, Peter Skov Olsen, Lars Søndergaard, Troels Højsgaard Jørgensen, Hans Gustav Hørsted Thyregod, Nikolaj Ihlemann, Henrik Nissen, Petur Petursson, Bo Juel Kjeldsen, Daniel Andreas Steinbrüchel, Peter Skov Olsen, Lars Søndergaard

Abstract

Aims: The aims of the study were to compare clinical outcomes and valve durability after 8 years of follow-up in patients with symptomatic severe aortic valve stenosis at low surgical risk treated with either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR).

Methods and results: In the NOTION trial, patients with symptomatic severe aortic valve stenosis were randomized to TAVI or SAVR. Clinical status, echocardiography, structural valve deterioration, and failure were assessed using standardized definitions. In total, 280 patients were randomized to TAVI (n = 145) or SAVR (n = 135). Baseline characteristics were similar, including mean age of 79.1 ± 4.8 years and a mean STS score of 3.0 ± 1.7%. At 8-year follow-up, the estimated risk of the composite outcome of all-cause mortality, stroke, or myocardial infarction was 54.5% after TAVI and 54.8% after SAVR (P = 0.94). The estimated risks for all-cause mortality (51.8% vs. 52.6%; P = 0.90), stroke (8.3% vs. 9.1%; P = 0.90), or myocardial infarction (6.2% vs. 3.8%; P = 0.33) were similar after TAVI and SAVR. The risk of structural valve deterioration was lower after TAVI than after SAVR (13.9% vs. 28.3%; P = 0.0017), whereas the risk of bioprosthetic valve failure was similar (8.7% vs. 10.5%; P = 0.61).

Conclusions: In patients with severe aortic valve stenosis at low surgical risk randomized to TAVI or SAVR, there were no significant differences in the risk for all-cause mortality, stroke, or myocardial infarction, as well as the risk of bioprosthetic valve failure after 8 years of follow-up.

Clinical trial registration: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT01057173.

Keywords: Bioprosthetic aortic valve durability; Mortality; Stroke; Surgical aortic valve replacement; Transcatheter aortic valve implantation.

© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8347457/bin/ehab375f6.jpg
Clinical and aortic bioprosthetic valve failure 8 years after transcatheter and surgical aortic valve replacement. CI, confidence interval; HR, hazard ratio.
Figure 1
Figure 1
Estimated risk of all-cause mortality. CI, confidence interval; HR, hazard ratio; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.
Figure 2
Figure 2
Estimated risk of all-cause mortality, stroke or myocardial infarction. CI, confidence interval; HR, hazard ratio; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.
Figure 3
Figure 3
Mean gradient and effective orifice area during follow-up. EOA, effective orifice area; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation. *P < 0.05.
Figure 4
Figure 4
Structural valve deterioration. CI, confidence interval; HR, hazard ratio; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.
Figure 5
Figure 5
Bioprosthetic valve failure. CI, confidence interval; HR, hazard ratio; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve implantation.

References

    1. Jørgensen TH. Transcatheter aortic valve replacement in patients with lower surgical risk. JACC Cardiovasc Interv 2020;13:332–334.
    1. Thyregod HGH, Ihlemann N, Jørgensen TH, Nissen H, Kjeldsen BJ, Petursson P, Chang Y, Franzen OW, Engstrøm T, Clemmensen P, Hansen PB, Andersen LW, Steinbruüchel DA, Olsen PS, Søndergaard L. Five-year clinical and echocardiographic outcomes from the NOTION randomized clinical trial in patients at lower surgical risk. Circulation 2019;139:2714–2723.
    1. Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Søndergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PWJC, Kappetein AP; SURTAVI Investigators. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 2017;376:1321–1331.
    1. Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL, Forrest JK, Tchétché D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 2019;380:1706–1715.
    1. Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019;380:1695–1705.
    1. Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, Webb JG, Douglas PS, Anderson WN, Blackstone EH, Kodali SK, Makkar RR, Fontana GP, Kapadia S, Bavaria J, Hahn RT, Thourani VH, Babaliaros V, Pichard A, Herrmann HC, Brown DL, Williams M, Davidson MJ, Svensson LG, Akin J; PARTNER 1 Trial Investigators. 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;385:2477–2484.
    1. Gleason TG, Reardon MJ, Popma JJ, Deeb GM, Yakubov SJ, Lee JS, Kleiman NS, Chetcuti S, Hermiller JB, Heiser J, Merhi W, Zorn GL, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte JV, Mumtaz M, Oh JK, Huang J, Adams DH; CoreValve U.S. Pivotal High Risk Trial Clinical Investigators. 5-Year outcomes of self-expanding transcatheter versus surgical aortic valve replacement in high-risk patients. J Am Coll Cardiol 2018;72:2687–2696.
    1. Makkar RR, Thourani VH, Mack MJ, Kodali SK, Kapadia S, Webb JG, Yoon S-H, Trento A, Svensson LG, Herrmann HC, Szeto WY, Miller DC, Satler L, Cohen DJ, Dewey TM, Babaliaros V, Williams MR, Kereiakes DJ, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Brown DL, Fearon WF, Russo MJ, Pibarot P, Hahn RT, Jaber WA, Rogers E, Xu K, Wheeler J, Alu MC, Smith CR, Leon MB; PARTNER 2 Investigators. Five-year outcomes of transcatheter or surgical aortic-valve replacement. N Engl J Med 2020;382:799–809.
    1. Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O’Gara PT, Rigolin VH, Sundt TM, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: a Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2021;143:e35–e71.
    1. Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Muñoz D, Rosenhek R, Sjögren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 2017;38:2739–2791.
    1. Otto CM. Informed shared decisions for patients with aortic stenosis. N Engl J Med 2019;380:1769–1770.
    1. Sondergaard L. Transcatheter aortic valve implantation in patients with longer life expectancy: what measures are needed? Eur Heart J 2019;40:1331–1333.
    1. Søndergaard L, Ihlemann N, Capodanno D, Jørgensen TH, Nissen H, Kjeldsen BJ, Chang Y, Steinbrüchel DA, Olsen PS, Petronio AS, Thyregod HGH. Durability of transcatheter and surgical bioprosthetic aortic valves in patients at lower surgical risk. J Am Coll Cardiol 2019;73:546–553.
    1. Thyregod HG, Søndergaard L, Ihlemann N, Franzen O, Andersen LW, Hansen PB, Olsen PS, Nissen H, Winkel P, Gluud C, Steinbrüchel DA. The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial. Trials 2013;14:11.
    1. Thyregod HGH, Steinbrüchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, Chang Y, Franzen OW, Engstrøm T, Clemmensen P, Hansen PB, Andersen LW, Olsen PS, Søndergaard L. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis. J Am Coll Cardiol 2015;65:2184–2194.
    1. Capodanno D, Petronio AS, Prendergast B, Eltchaninoff H, Vahanian A, Modine T, Lancellotti P, Sondergaard L, Ludman PF, Tamburino C, Piazza N, Hancock J, Mehilli J, Byrne RA, Baumbach A, Kappetein AP, Windecker S, Bax J, Haude M. 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 J 2017;38:3382–3390.
    1. Durack DT, Lukes AS, Bright DK. New criteria for diagnosis of infective endocarditis: utilization of specific echocardiographic findings. Duke Endocarditis Service. Am J Med 1994;96:200–209.
    1. Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, Kirtane AJ, Fitzgerald S, Michaels J, Krohn C, Masoudi FA, Brindis RG, Bavaria JE. STS-ACC TVT registry of transcatheter aortic valve replacement. J Am Coll Cardiol 2020;76:2492–2516.
    1. Jørgensen TH, De Backer O, Gerds TA, Bieliauskas G, Svendsen JH, Søndergaard L. Mortality and heart failure hospitalization in patients with conduction abnormalities after transcatheter aortic valve replacement. JACC Cardiovasc Interv 2019;12:52–61.
    1. Faroux L, Chen S, Muntané-Carol G, Regueiro A, Philippon F, Sondergaard L, Jørgensen TH, Lopez-Aguilera J, Kodali S, Leon M, Nazif T, Rodés-Cabau J. Clinical impact of conduction disturbances in transcatheter aortic valve replacement recipients: a systematic review and meta-analysis. Eur Heart J 2020;41:2771–2781.
    1. Sawaya F, Jørgensen TH, Søndergaard L, De Backer O. Transcatheter bioprosthetic aortic valve dysfunction: what we know so far. Front Cardiovasc Med 2019;6:145.
    1. Rodriguez-Gabella T, Voisine P, Puri R, Pibarot P, Rodés-Cabau J. Aortic bioprosthetic valve durability. J Am Coll Cardiol 2017;70:1013–1028.
    1. Pibarot P, Ternacle J, Jaber WA, Salaun E, Dahou A, Asch FM, Weissman NJ, Rodriguez L, Xu K, Annabi M-S, Guzzetti E, Beaudoin J, Bernier M, Leipsic J, Blanke P, Clavel M-A, Rogers E, Alu MC, Douglas PS, Makkar R, Miller DC, Kapadia SR, Mack MJ, Webb JG, Kodali SK, Smith CR, Herrmann HC, Thourani VH, Leon MB, Hahn RT; PARTNER 2 Investigators. Structural deterioration of transcatheter versus surgical aortic valve bioprostheses in the PARTNER-2 trial. J Am Coll Cardiol 2020;76:1830–1843.
    1. Généreux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Mieghem NMV, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J 2021.
    1. Butt JH, Ihlemann N, Backer OD, Søndergaard L, Havers-Borgersen E, Gislason GH, Torp-Pedersen C, Køber L, Fosbøl EL. Long-term risk of infective endocarditis after transcatheter aortic valve replacement. J Am Coll Cardiol 2019;73:1646–1655.
    1. Minami K, Zittermann A, Schulte-Eistrup S, Koertke H, Körfer R. Mitroflow synergy prostheses for aortic valve replacement: 19 years experience with 1,516 patients. Ann Thorac Surg 2005;80:1699–1705.
    1. Kaneyuki D, Nakajima H, Asakura T, Yoshitake A, Tokunaga C, Tochii M, Hayashi J, Takazawa A, Izumida H, Iguchi A. Early first-generation trifecta valve failure: a case series and a review of the literature. Ann Thorac Surg 2020;109:86–92.

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다