Rational and design of the ROTAS study: a randomized study for the optimal  treatment of symptomatic patients with low-gradient severe aortic valve stenosis and preserved left ventricular ejection fraction.

Galli, Elena; Le Ven, Florent; Coisne, Augustin; Sportouch, Catherine; Le Tourneau, Thierry; Bernard, Anne; Bière, Loic; Habib, Gilbert; LANCELLOTTI, Patrizio; Lederlin, Mathieu; Tribouilloy, Christophe; Oger, Emmanuel; Donal, Erwan

doi:10.1093/ehjci/jeaa036

Article (Scientific journals)

Rational and design of the ROTAS study: a randomized study for the optimal treatment of symptomatic patients with low-gradient severe aortic valve stenosis and preserved left ventricular ejection fraction.

Galli, Elena; Le Ven, Florent; Coisne, Augustin et al.

2021 • In European Heart Journal. Cardiovascular Imaging, 22 (2), p. 229-235

Peer reviewed

Permalink
https://hdl.handle.net/2268/291258

DOI
10.1093/ehjci/jeaa036

PubMed
32187352

Files (1)Send to Details Statistics Bibliography Similar publications

Files

Full Text

jeaa036.pdf

Author postprint (454.59 kB)

Download

All documents in ORBi are protected by a user license.

Send to

RIS BibTex APA Chicago Permalink X Linkedin

Details

Keywords :

Aortic Valve/surgery; Aortic Valve Stenosis/diagnostic imaging/surgery; Heart Valve Prosthesis Implantation; Humans; Prognosis; Severity of Illness Index; Stroke Volume; Treatment Outcome; Ventricular Function, Left; aortic stenosis; low gradient; randomized study; stroke volume

Abstract :

[en] AIMS: Fifteen to thirty percentage of patients with severe aortic stenosis (AS) have preserved left ventricular ejection fraction (LVEF) and a discordant AS pattern at Doppler echocardiography, which is characterized by a small (<1 cm2) aortic area and low mean aortic gradient (<40 mmHg). The 'Randomized study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic Stenosis and preserved left ventricular ejection fraction' (ROTAS trial) aims at demonstrating the superiority of aortic valve replacement vs. a 'watchful waiting strategy' in symptomatic patients with low-gradient (LS), severe AS, and preserved LVEF, stratified according to indexed stroke volume, in terms of all-cause mortality or cardiovascular-related hospitalization during follow-up (FU). METHODS AND RESULTS: The ROTAS trial will be a multicentre randomized non-blinded study involving 16 reference centres. AS severity will be confirmed by a multimodality approach (rest and stress echocardiography, calcium scoring, and cardiac magnetic resonance imaging for optimally characterize the population), which could provide important inputs to improve the pathophysiological understanding of this complex disease. Well-characterized patients will be randomized according to the management strategy. The primary endpoint will be the occurrence of all-cause mortality or cardiac related-hospitalizations during 2-year FU. One hundred and eighty subjects per group will be included. CONCLUSION: The management of patients with LS severe AS and preserved LVEF is largely debated. ROTAS trial will allow a comprehensive evaluation of this particular pattern of AS and will establish which is the most appropriate management of these patients.

Disciplines :

Cardiovascular & respiratory systems

Author, co-author :

Galli, Elena; University of Rennes, CHU Rennes, Inserm, LTSI - UMR 1099, F-35000 Rennes,

Le Ven, Florent; Service de cardiologie, hôpital Cavale Blanche, CHRU Brest, 29200 Brest, France.

Coisne, Augustin; Department of Clinical Physiology and Echocardiography, CHU Lille, Heart Valve

Sportouch, Catherine; Clinique du Millénaire, 34000 Montpellier, France.

Le Tourneau, Thierry; Department of Cardiology, Thorax Institute, Centre Hospitalier Universitaire de

Bernard, Anne; Cardiology Department, Trousseau Hospital, University of Tours, Tours, France.

Bière, Loic; Institut MITOVASC, UMR INSERM U1083 and CNRS 6015, Service de Cardiologie, CHU

Habib, Gilbert; Aix Marseille Université, IRD, APHM, MEPHI, IHU-Méditerranée Infection, France.

LANCELLOTTI, Patrizio ; Centre Hospitalier Universitaire de Liège - CHU > > Service de cardiologie

Lederlin, Mathieu; imagerie médicale-CHU de Rennes, 35000 Rennes, France.

More authors (3 more)

Language :

English

Title :

Publication date :

22 January 2021

Journal title :

European Heart Journal. Cardiovascular Imaging

eISSN :

2047-2412

Volume :

Issue :

Pages :

229-235

Peer reviewed :

Peer reviewed

Commentary :

Available on ORBi :

since 24 May 2022

Statistics

Number of views

118 (0 by ULiège)

Number of downloads

185 (0 by ULiège)

More statistics

Scopus citations^®

Scopus citations^®
without self-citations

OpenCitations

OpenAlex citations

Bibliography

Iung B, Vahanian A. Valvular disease: implications of the new AHA/ACC valvular disease guidelines. Nat Rev Cardiol 2014;11:317-8.
Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ et al.; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 2017;38:2739-91.
Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63:2438-88.
Clavel MA, Magne J, Pibarot P. Low-gradient aortic stenosis. Eur Heart J 2016;37: 2645-57.
Clavel MA, Burwash IG, Pibarot P. Cardiac imaging for assessing low-gradient severe aortic stenosis. JACC Cardiovasc Imaging 2017;10:185-202.
Tribouilloy C, Rusinaru D, Marechaux S, Castel AL, Debry N, Maizel J et al. Lowgradient, low-flow severe aortic stenosis with preserved left ventricular ejection fraction: characteristics, outcome, and implications for surgery. J Am Coll Cardiol 2015;65:55-66.
Herrmann HC, Pibarot P, Hueter I, Gertz ZM, Stewart WJ, Kapadia S et al. Predictors of mortality and outcomes of therapy in low-flow severe aortic stenosis: a Placement of Aortic Transcatheter Valves (PARTNER) trial analysis. Circulation 2013;127:2316-26.
Dayan V, Vignolo G, Magne J, Clavel MA, Mohty D, Pibarot P. Outcome and impact of aortic valve replacement in patients with preserved LVEF and lowgradient aortic stenosis. J Am Coll Cardiol 2015;66:2594-603.
Mohty D, Magne J, Deltreuil M, Aboyans V, Echahidi N, Cassat C et al. Outcome and impact of surgery in paradoxical low-flow, low-gradient severe aortic stenosis and preserved left ventricular ejection fraction: a cardiac catheterization study. Circulation 2013;128:S235-42.
Chadha G, Bohbot Y, Rusinaru D, Marechaux S, Tribouilloy C. Outcome of normal-flow low-gradient severe aortic stenosis with preserved left ventricular ejection fraction: a propensity-matched study. J Am Heart Assoc 2019;8:e012301.
Tribouilloy C, Rusinaru D, Charles V, Boulif J, Maes F, Levy F et al. Progression of low-gradient, low-flow, severe aortic stenosis with preserved left ventricular ejection fraction. Am J Cardiol 2015;116:612-7.
Ozkan A, Hachamovitch R, Kapadia SR, Tuzcu EM, Marwick TH. Impact of aortic valve replacement on outcome of symptomatic patients with severe aortic stenosis with low gradient and preserved left ventricular ejection fraction. Circulation 2013;128:622-31.
Rusinaru D, Bohbot Y, Ringle A, Marechaux S, Diouf M, Tribouilloy C. Impact of low stroke volume on mortality in patients with severe aortic stenosis and preserved left ventricular ejection fraction. Eur Heart J 2018;39:1992-9.
Chahal NS, Drakopoulou M, Gonzalez-Gonzalez AM, Manivarmane R, Khattar R, Senior R. Resting aortic valve area at normal transaortic flow rate reflects true valve area in suspected low-gradient severe aortic stenosis. JACC Cardiovasc Imaging 2015;8:1133-9.
Strange G, Stewart S, Celermajer D, Prior D, Scalia GM, Marwick T et al. Poor long-term survival in patients with moderate aortic stenosis. J Am Coll Cardiol 2019;74:1851-63.
Kang DH, Jang JY, Park SJ, Kim DH, Yun SC, Song JM et al. Watchful observation versus early aortic valve replacement for symptomatic patients with normal flow, low-gradient severe aortic stenosis. Heart 2015;101:1375-81.
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J 2016;37:2129-200.
Ternacle J, Krapf L, Mohty D, Magne J, Nguyen A, Galat A et al. Aortic stenosis and cardiac amyloidosis: JACC review topic of the week. J Am Coll Cardiol 2019; 74:2638-51.
Clavel MA, Ennezat PV, Marechaux S, Dumesnil JG, Capoulade R, Hachicha Z et al. Stress echocardiography to assess stenosis severity and predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis and preserved LVEF. JACC Cardiovasc Imaging 2013;6:175-83.
Clavel MA, Burwash IG, Mundigler G, Dumesnil JG, Baumgartner H, Bergler- Klein J et al. Validation of conventional and simplified methods to calculate projected valve area at normal flow rate in patients with low flow, low gradient aortic stenosis: the multicenter TOPAS (True or Pseudo Severe Aortic Stenosis) study. J Am Soc Echocardiogr 2010;23:380-6.
Clavel MA, Messika-Zeitoun D, Pibarot P, Aggarwal SR, Malouf J, Araoz PA et al. The complex nature of discordant severe calcified aortic valve disease grading: new insights from combined Doppler echocardiographic and computed tomographic study. J Am Coll Cardiol 2013;62:2329-38.
Everett RJ, Tastet L, Clavel MA, Chin CWL, Capoulade R, Vassiliou VS et al. Progression of hypertrophy and myocardial fibrosis in aortic stenosis: a multicenter cardiac magnetic resonance study. Circ Cardiovasc Imaging 2018;11:e007451.
Weidemann F, Herrmann S, StöRk S, Niemann M, Frantz S, Lange V et al. Impact of myocardial fibrosis in patients with symptomatic severe aortic stenosis. Circulation 2009;120:577-84.
Simard L, Cote N, Dagenais F, Mathieu P, Couture C, Trahan S et al. Sex-related discordance between aortic valve calcification and hemodynamic severity of aortic stenosis: is valvular fibrosis the explanation? Circ Res 2017;120:681-91.
Shen M, Tastet L, Capoulade R, Larose E, Bedard E, Arsenault M et al. Effect of age and aortic valve anatomy on calcification and haemodynamic severity of aortic stenosis. Heart 2017;103:32-9.