Incidence, Predictors, and Outcomes of Paravalvular Regurgitation after TAVR in Sievers Type-1 Bicuspid Aortic Valves

Andrea Zito; Andrea Buono; Andrea Scotti; Won-Keun Kim; Tommaso Fabris; Chiara de Biase; Michele Bellamoli; Nicholas Montarello; Giuliano Costa; Mesfer Alfadhel; Ofir Koren; Simone Fezzi; Barbara Bellini; Mauro Massussi; Lin Bai; Giulia Costa; Alessandro Mazzapicchi; Enrico Giacomin; Riccardo Gorla; Karsten Hug; Carlo Briguori; Luca Bettari; Antonio Messina; Emmanuel Villa; Mauro Boiago; Enrico Romagnoli; Ady Orbach; Giulia Laterra; Cristina Aurigemma; Marco De Carlo; Matthias Renker; Mario Garcia Gomez; Carlo Trani; Alfonso Ielasi; Uri Landes; Tobias Rheude; Luca Testa; Ignacio Amat Santos; Antonio Mangieri; Francesco Saia; Luca Favero; Mao Chen; Marianna Adamo; Anna Sonia Petronio; Matteo Montorfano; Raj R Makkar; Darren Mylotte; Daniel J Blackman; Marco Barbanti; Ole De Backer; Didier Tchètchè; Giuseppe Tarantini; Azeem Latib; Diego Maffeo; Francesco Burzotta

doi:10.1016/j.jcin.2024.05.002

Incidence, Predictors, and Outcomes of Paravalvular Regurgitation after TAVR in Sievers Type-1 Bicuspid Aortic Valves

Andrea Zito, Andrea Buono, Andrea Scotti, Won-Keun Kim, Tommaso Fabris, Chiara de Biase, Michele Bellamoli, Nicholas Montarello, Giuliano Costa, Mesfer Alfadhel, Ofir Koren, Simone Fezzi, Barbara Bellini, Mauro Massussi, Lin Bai, Giulia Costa, Alessandro Mazzapicchi, Enrico Giacomin, Riccardo Gorla, Karsten HugCarlo Briguori, Luca Bettari, Antonio Messina, Emmanuel Villa, Mauro Boiago, Enrico Romagnoli, Ady Orbach, Giulia Laterra, Cristina Aurigemma, Marco De Carlo, Matthias Renker, Mario Garcia Gomez, Carlo Trani, Alfonso Ielasi, Uri Landes, Tobias Rheude, Luca Testa, Ignacio Amat Santos, Antonio Mangieri, Francesco Saia, Luca Favero, Mao Chen, Marianna Adamo, Anna Sonia Petronio, Matteo Montorfano, Raj R Makkar, Darren Mylotte, Daniel J Blackman, Marco Barbanti, Ole De Backer, Didier Tchètchè, Giuseppe Tarantini, Azeem Latib, Diego Maffeo, Francesco Burzotta^*

^*Corresponding author af dette arbejde

Afdeling for Hjertesygdomme

8 Citationer (Scopus)

Abstract

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR).

OBJECTIVES: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis.

METHODS: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up.

RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)-mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09).

CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up.

Originalsprog	Engelsk
Tidsskrift	JACC. Cardiovascular interventions
Vol/bind	17
Udgave nummer	14
Sider (fra-til)	1652-1663
Antal sider	12
ISSN	1936-8798
DOI	https://doi.org/10.1016/j.jcin.2024.05.002
Status	Udgivet - 22 jul. 2024

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Zito, A., Buono, A., Scotti, A., Kim, W.-K., Fabris, T., de Biase, C., Bellamoli, M., Montarello, N., Costa, G., Alfadhel, M., Koren, O., Fezzi, S., Bellini, B., Massussi, M., Bai, L., Costa, G., Mazzapicchi, A., Giacomin, E., Gorla, R., ... Burzotta, F. (2024). Incidence, Predictors, and Outcomes of Paravalvular Regurgitation after TAVR in Sievers Type-1 Bicuspid Aortic Valves. JACC. Cardiovascular interventions, 17(14), 1652-1663. https://doi.org/10.1016/j.jcin.2024.05.002

Zito, A, Buono, A, Scotti, A, Kim, W-K, Fabris, T, de Biase, C, Bellamoli, M, Montarello, N, Costa, G, Alfadhel, M, Koren, O, Fezzi, S, Bellini, B, Massussi, M, Bai, L, Costa, G, Mazzapicchi, A, Giacomin, E, Gorla, R, Hug, K, Briguori, C, Bettari, L, Messina, A, Villa, E, Boiago, M, Romagnoli, E, Orbach, A, Laterra, G, Aurigemma, C, De Carlo, M, Renker, M, Gomez, MG, Trani, C, Ielasi, A, Landes, U, Rheude, T, Testa, L, Santos, IA, Mangieri, A, Saia, F, Favero, L, Chen, M, Adamo, M, Petronio, AS, Montorfano, M, Makkar, RR, Mylotte, D, Blackman, DJ, Barbanti, M, De Backer, O, Tchètchè, D, Tarantini, G, Latib, A, Maffeo, D & Burzotta, F 2024, 'Incidence, Predictors, and Outcomes of Paravalvular Regurgitation after TAVR in Sievers Type-1 Bicuspid Aortic Valves', JACC. Cardiovascular interventions, bind 17, nr. 14, s. 1652-1663. https://doi.org/10.1016/j.jcin.2024.05.002

@article{1d64fcf7c4cd4223bff0faf6d2501056,

title = "Incidence, Predictors, and Outcomes of Paravalvular Regurgitation after TAVR in Sievers Type-1 Bicuspid Aortic Valves",

abstract = "BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR).OBJECTIVES: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis.METHODS: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up.RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)-mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09).CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up.",

keywords = "Aged, Aged, 80 and over, Aortic Valve Insufficiency/physiopathology, Aortic Valve Stenosis/surgery, Aortic Valve/surgery, Bicuspid Aortic Valve Disease/surgery, Europe, Female, Heart Failure/physiopathology, Heart Valve Diseases/diagnostic imaging, Heart Valve Prosthesis, Humans, Incidence, Male, Odds Ratio, Prosthesis Design, Retrospective Studies, Risk Assessment, Risk Factors, Severity of Illness Index, Stroke/etiology, Time Factors, Transcatheter Aortic Valve Replacement/adverse effects, Treatment Outcome, paravalvular regurgitation, aortic stenosis, paravalvular leak, bicuspid aortic valve, transcatheter aortic valve replacement",

author = "Andrea Zito and Andrea Buono and Andrea Scotti and Won-Keun Kim and Tommaso Fabris and {de Biase}, Chiara and Michele Bellamoli and Nicholas Montarello and Giuliano Costa and Mesfer Alfadhel and Ofir Koren and Simone Fezzi and Barbara Bellini and Mauro Massussi and Lin Bai and Giulia Costa and Alessandro Mazzapicchi and Enrico Giacomin and Riccardo Gorla and Karsten Hug and Carlo Briguori and Luca Bettari and Antonio Messina and Emmanuel Villa and Mauro Boiago and Enrico Romagnoli and Ady Orbach and Giulia Laterra and Cristina Aurigemma and {De Carlo}, Marco and Matthias Renker and Gomez, {Mario Garcia} and Carlo Trani and Alfonso Ielasi and Uri Landes and Tobias Rheude and Luca Testa and Santos, {Ignacio Amat} and Antonio Mangieri and Francesco Saia and Luca Favero and Mao Chen and Marianna Adamo and Petronio, {Anna Sonia} and Matteo Montorfano and Makkar, {Raj R} and Darren Mylotte and Blackman, {Daniel J} and Marco Barbanti and {De Backer}, Ole and Didier Tch{\`e}tch{\`e} and Giuseppe Tarantini and Azeem Latib and Diego Maffeo and Francesco Burzotta",

note = "Copyright {\textcopyright} 2024. Published by Elsevier Inc.",

year = "2024",

month = jul,

day = "22",

doi = "10.1016/j.jcin.2024.05.002",

language = "English",

volume = "17",

pages = "1652--1663",

journal = "JACC. Cardiovascular interventions",

issn = "1936-8798",

publisher = "Elsevier Inc",

number = "14",

}

TY - JOUR

T1 - Incidence, Predictors, and Outcomes of Paravalvular Regurgitation after TAVR in Sievers Type-1 Bicuspid Aortic Valves

AU - Zito, Andrea

AU - Buono, Andrea

AU - Scotti, Andrea

AU - Kim, Won-Keun

AU - Fabris, Tommaso

AU - de Biase, Chiara

AU - Bellamoli, Michele

AU - Montarello, Nicholas

AU - Costa, Giuliano

AU - Alfadhel, Mesfer

AU - Koren, Ofir

AU - Fezzi, Simone

AU - Bellini, Barbara

AU - Massussi, Mauro

AU - Bai, Lin

AU - Costa, Giulia

AU - Mazzapicchi, Alessandro

AU - Giacomin, Enrico

AU - Gorla, Riccardo

AU - Hug, Karsten

AU - Briguori, Carlo

AU - Bettari, Luca

AU - Messina, Antonio

AU - Villa, Emmanuel

AU - Boiago, Mauro

AU - Romagnoli, Enrico

AU - Orbach, Ady

AU - Laterra, Giulia

AU - Aurigemma, Cristina

AU - De Carlo, Marco

AU - Renker, Matthias

AU - Gomez, Mario Garcia

AU - Trani, Carlo

AU - Ielasi, Alfonso

AU - Landes, Uri

AU - Rheude, Tobias

AU - Testa, Luca

AU - Santos, Ignacio Amat

AU - Mangieri, Antonio

AU - Saia, Francesco

AU - Favero, Luca

AU - Chen, Mao

AU - Adamo, Marianna

AU - Petronio, Anna Sonia

AU - Montorfano, Matteo

AU - Makkar, Raj R

AU - Mylotte, Darren

AU - Blackman, Daniel J

AU - Barbanti, Marco

AU - De Backer, Ole

AU - Tchètchè, Didier

AU - Tarantini, Giuseppe

AU - Latib, Azeem

AU - Maffeo, Diego

AU - Burzotta, Francesco

PY - 2024/7/22

Y1 - 2024/7/22

N2 - BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR).OBJECTIVES: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis.METHODS: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up.RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)-mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09).CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up.

AB - BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR).OBJECTIVES: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis.METHODS: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up.RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)-mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09).CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve Insufficiency/physiopathology

KW - Aortic Valve Stenosis/surgery

KW - Aortic Valve/surgery

KW - Bicuspid Aortic Valve Disease/surgery

KW - Europe

KW - Female

KW - Heart Failure/physiopathology

KW - Heart Valve Diseases/diagnostic imaging

KW - Heart Valve Prosthesis

KW - Humans

KW - Incidence

KW - Male

KW - Odds Ratio

KW - Prosthesis Design

KW - Retrospective Studies

KW - Risk Assessment

KW - Risk Factors

KW - Severity of Illness Index

KW - Stroke/etiology

KW - Time Factors

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Treatment Outcome

KW - paravalvular regurgitation

KW - aortic stenosis

KW - paravalvular leak

KW - bicuspid aortic valve

KW - transcatheter aortic valve replacement

UR - http://www.scopus.com/inward/record.url?scp=85198089833&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2024.05.002

DO - 10.1016/j.jcin.2024.05.002

M3 - Journal article

C2 - 38749449

SN - 1936-8798

VL - 17

SP - 1652

EP - 1663

JO - JACC. Cardiovascular interventions

JF - JACC. Cardiovascular interventions

IS - 14

ER -

Incidence, Predictors, and Outcomes of Paravalvular Regurgitation after TAVR in Sievers Type-1 Bicuspid Aortic Valves

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