Rationale and design of the ELEANOR trial early aortic valve
surgery versus watchful waiting strategy in severe asymptomatic
aortic regurgitation, ACRONYM: ELEANOR

J 2024

Rationale and design of the ELEANOR trial early aortic valve surgery versus watchful waiting strategy in severe asymptomatic aortic regurgitation, ACRONYM: ELEANOR

KOCKOVA, Radka, Jan VOJACEK, Helena BEDANOVA, Petr FILA, Ivo SKALSKY et. al.

Basic information

Original name

Rationale and design of the ELEANOR trial early aortic valve surgery versus watchful waiting strategy in severe asymptomatic aortic regurgitation, ACRONYM: ELEANOR

Authors

KOCKOVA, Radka (203 Czech Republic), Jan VOJACEK (203 Czech Republic), Helena BEDANOVA (203 Czech Republic), Petr FILA (203 Czech Republic, belonging to the institution), Ivo SKALSKY (203 Czech Republic), Daniela ZAKOVA (203 Czech Republic), Michal KLAN (203 Czech Republic), Barbora MIKOVA (203 Czech Republic), Karel MEDILEK (203 Czech Republic), Martin TUNA (203 Czech Republic), Monika FIALOVA (203 Czech Republic), Radka DVORAKOVA (203 Czech Republic), Zuzana HLUBOCKA (203 Czech Republic), Roman PANOVSKY (203 Czech Republic), Krystof SLABY (203 Czech Republic), de Oliveira Elayne KELEN, Filip CASSELMANK and Martin PENICKA (203 Czech Republic)

Edition

Heliyon, OXFORD, ELSEVIER, 2024, 2405-8440

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 4.000 in 2022

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.heliyon.2024.e29470

UT WoS

001229006600001

Keywords in English

Aortic regurgitation; Asymptomatic; Magnetic resonance; Early surgery; Randomization

Abstract

V originále

Background: The optimal treatment of patients with severe symptomatic aortic regurgitation (AR) is state-of-the-art surgery. Asymptomatic patients with advanced left ventricular (LV) dilatation and/or impaired ejection fraction should undergo surgical treatment, but there is no guidelines consensus on cut-off values for this recommendation. Multimodality imaging has brought new tools for the accurate selection of asymptomatic patients at risk of early clinical deterioration, however, prospective and randomized data are pending. Cardiac magnetic resonance (CMR)derived AR quantification along with LV remodeling assessment appears to be the most accurate tool for a selection of such patients at risk. Trial design: The objective of our prospective and multicenter study is to determine whether patients at risk of early clinical deterioration as per CMR assessment will benefit from early surgical treatment. The study is designed as a superiority trial to demonstrate that early surgical treatment is safe and more effective than the standard treatment. A total of 217 asymptomatic patients with severe AR, but without current guidelines -based surgical indication, will be enrolled across all centers. We expect 24 % of patients identified as high clinical risk and therefore eligible for 1:1 randomization to early surgical treatment within 3 months or a watchful waiting strategy. Follow-up will be annual. We expect a complete restoration of LV size and function along with improved quality of life and physical performance in a short-term follow-up of 12 months. The primary endpoint will be a composite safety and efficacy with all criteria mandatory: 15 % or larger reduction of baseline CMR-derived LV end -diastolic volume index, LV ejection fraction >50 %, and no major adverse cardiovascular events. The annual follow-up will continue for a minimum of 4 years until the required number of endpoints is achieved to show a statistically significant difference in cardiovascular morbidity and mortality in early surgically treated patients. Conclusion: The ELEANOR trial is the first multicenter randomized controlled study to compare early surgical treatment with a watchful waiting strategy in asymptomatic patients with chronic severe AR at high risk of early clinical deterioration as per CMR assessment but without guidelines -based indications for surgical treatment.

Citovat

KOCKOVA, Radka, Jan VOJACEK, Helena BEDANOVA, Petr FILA, Ivo SKALSKY, Daniela ZAKOVA, Michal KLAN, Barbora MIKOVA, Karel MEDILEK, Martin TUNA, Monika FIALOVA, Radka DVORAKOVA, Zuzana HLUBOCKA, Roman PANOVSKY, Krystof SLABY, de Oliveira Elayne KELEN, Filip CASSELMANK and Martin PENICKA. Rationale and design of the ELEANOR trial early aortic valve surgery versus watchful waiting strategy in severe asymptomatic aortic regurgitation, ACRONYM: ELEANOR. Heliyon. OXFORD: ELSEVIER, 2024, vol. 10, No 8, p. 1-8. ISSN 2405-8440. Available from: https://dx.doi.org/10.1016/j.heliyon.2024.e29470.

@article{2409381,
   author = {Kockova, Radka and Vojacek, Jan and Bedanova, Helena and Fila, Petr and Skalsky, Ivo and Zakova, Daniela and Klan, Michal and Mikova, Barbora and Medilek, Karel and Tuna, Martin and Fialova, Monika and Dvorakova, Radka and Hlubocka, Zuzana and Panovsky, Roman and Slaby, Krystof and Kelen, de Oliveira Elayne and Casselmank, Filip and Penicka, Martin},
   article_location = {OXFORD},
   article_number = {8},
   doi = {http://dx.doi.org/10.1016/j.heliyon.2024.e29470},
   keywords = {Aortic regurgitation; Asymptomatic; Magnetic resonance; Early surgery; Randomization},
   language = {eng},
   issn = {2405-8440},
   journal = {Heliyon},
   title = {Rationale and design of the ELEANOR trial early aortic valve surgery versus watchful waiting strategy in severe asymptomatic aortic regurgitation, ACRONYM: ELEANOR},
   url = {https://www.sciencedirect.com/science/article/pii/S2405844024055014?via%3Dihub},
   volume = {10},
   year = {2024}
}

TY  - JOUR
ID  - 2409381
AU  - Kockova, Radka - Vojacek, Jan - Bedanova, Helena - Fila, Petr - Skalsky, Ivo - Zakova, Daniela - Klan, Michal - Mikova, Barbora - Medilek, Karel - Tuna, Martin - Fialova, Monika - Dvorakova, Radka - Hlubocka, Zuzana - Panovsky, Roman - Slaby, Krystof - Kelen, de Oliveira Elayne - Casselmank, Filip - Penicka, Martin
PY  - 2024
TI  - Rationale and design of the ELEANOR trial early aortic valve surgery versus watchful waiting strategy in severe asymptomatic aortic regurgitation, ACRONYM: ELEANOR
JF  - Heliyon
VL  - 10
IS  - 8
SP  - 1-8
EP  - 1-8
PB  - ELSEVIER
SN  - 24058440
KW  - Aortic regurgitation
KW  - Asymptomatic
KW  - Magnetic resonance
KW  - Early surgery
KW  - Randomization
UR  - https://www.sciencedirect.com/science/article/pii/S2405844024055014?via%3Dihub
N2  - Background: The optimal treatment of patients with severe symptomatic aortic regurgitation (AR) is state-of-the-art surgery. Asymptomatic patients with advanced left ventricular (LV) dilatation and/or impaired ejection fraction should undergo surgical treatment, but there is no guidelines consensus on cut-off values for this recommendation. Multimodality imaging has brought new tools for the accurate selection of asymptomatic patients at risk of early clinical deterioration, however, prospective and randomized data are pending. Cardiac magnetic resonance (CMR)derived AR quantification along with LV remodeling assessment appears to be the most accurate tool for a selection of such patients at risk. Trial design: The objective of our prospective and multicenter study is to determine whether patients at risk of early clinical deterioration as per CMR assessment will benefit from early surgical treatment. The study is designed as a superiority trial to demonstrate that early surgical treatment is safe and more effective than the standard treatment. A total of 217 asymptomatic patients with severe AR, but without current guidelines -based surgical indication, will be enrolled across all centers. We expect 24 % of patients identified as high clinical risk and therefore eligible for 1:1 randomization to early surgical treatment within 3 months or a watchful waiting strategy. Follow-up will be annual. We expect a complete restoration of LV size and function along with improved quality of life and physical performance in a short-term follow-up of 12 months. The primary endpoint will be a composite safety and efficacy with all criteria mandatory: 15 % or larger reduction of baseline CMR-derived LV end -diastolic volume index, LV ejection fraction >50 %, and no major adverse cardiovascular events. The annual follow-up will continue for a minimum of 4 years until the required number of endpoints is achieved to show a statistically significant difference in cardiovascular morbidity and mortality in early surgically treated patients. Conclusion: The ELEANOR trial is the first multicenter randomized controlled study to compare early surgical treatment with a watchful waiting strategy in asymptomatic patients with chronic severe AR at high risk of early clinical deterioration as per CMR assessment but without guidelines -based indications for surgical treatment.
ER  -

KOCKOVA, Radka, Jan VOJACEK, Helena BEDANOVA, Petr FILA, Ivo SKALSKY, Daniela ZAKOVA, Michal KLAN, Barbora MIKOVA, Karel MEDILEK, Martin TUNA, Monika FIALOVA, Radka DVORAKOVA, Zuzana HLUBOCKA, Roman PANOVSKY, Krystof SLABY, de Oliveira Elayne KELEN, Filip CASSELMANK and Martin PENICKA. Rationale and design of the ELEANOR trial early aortic valve surgery versus watchful waiting strategy in severe asymptomatic aortic regurgitation, ACRONYM: ELEANOR. \textit{Heliyon}. OXFORD: ELSEVIER, 2024, vol.~10, No~8, p.~1-8. ISSN~2405-8440. Available from: https://dx.doi.org/10.1016/j.heliyon.2024.e29470.

Detailed Information on Publication Record