Incidence, predictors and clinical outcomes of residual stenosis after aortic valve-in-valve

Sabine Bleiziffer; Magdalena Erlebach; Matheus Simonato; Philippe Pibarot; John Webb; Lukas Capek; Stephan Windecker; Isaac George; Jan Malte Sinning; Eric Horlick; Massimo Napodano; David M. Holzhey; Petur Petursson; Alfredo Cerillo; Nikolaos Bonaros; Enrico Ferrari; Mauricio G. Cohen; Giselle Baquero; Tara L. Jones; Ankur Kalra; Michael J. Reardon; Adnan Chhatriwalla; Vasco Gama Ribeiro; Sami Alnasser; Nicolas M. Van Mieghem; Christian Jörg Rustenbach; Joachim Schofer; Santiago Garcia; Tobias Zeus; DIdier Champagnac; Raffi Bekeredjian; Ran Kornowski; Rüdiger Lange; Danny Dvir

doi:10.1136/heartjnl-2017-312422

Incidence, predictors and clinical outcomes of residual stenosis after aortic valve-in-valve

Sabine Bleiziffer, Magdalena Erlebach, Matheus Simonato, Philippe Pibarot, John Webb, Lukas Capek, Stephan Windecker, Isaac George, Jan Malte Sinning, Eric Horlick, Massimo Napodano, David M. Holzhey, Petur Petursson, Alfredo Cerillo, Nikolaos Bonaros, Enrico Ferrari, Mauricio G. Cohen, Giselle Baquero, Tara L. Jones, Ankur KalraMichael J. Reardon, Adnan Chhatriwalla, Vasco Gama Ribeiro, Sami Alnasser, Nicolas M. Van Mieghem, Christian Jörg Rustenbach, Joachim Schofer, Santiago Garcia, Tobias Zeus, DIdier Champagnac, Raffi Bekeredjian, Ran Kornowski, Rüdiger Lange, Danny Dvir

Medicine - Veteran's Administration Medical Center

Research output: Contribution to journal › Article › peer-review

63 Scopus citations

Abstract

Objective We aimed to analyse the incidence of prosthesis-patient mismatch (PPM) and elevated gradients after aortic valve in valve (ViV), and to evaluate predictors and associations with clinical outcomes of this adverse event. Methods A total of 910 aortic ViV patients were investigated. Elevated residual gradients were defined as ≥20 mm Hg. PPM was identified based on the indexed effective orifice area (EOA), measured by echocardiography, and patient body mass index (BMI). Moderate and severe PPM (cases) were defined by European Association of Cardiovascular Imaging (EACVI) criteria and compared with patients without PPM (controls). Results Moderate or greater PPM was found in 61% of the patients, and severe in 24.6%. Elevated residual gradients were found in 27.9%. Independent risk factors for the occurrence of lower indexed EOA and therefore severe PPM were higher gradients of the failed bioprosthesis at baseline (unstandardised beta -0.023; 95% CI -0.032 to -0.014; P<0.001), a stented (vs a stentless) surgical bioprosthesis (unstandardised beta -0.11; 95% CI -0.161 to -0.071; P<0.001), higher BMI (unstandardised beta -0.01; 95% CI -0.013 to -0.007; P<0.001) and implantation of a SAPIEN/SAPIEN XT/SAPIEN 3 transcatheter device (unstandardised beta -0.064; 95% CI -0.095 to -0.032; P<0.001). Neither severe PPM nor elevated gradients had an association with VARC II-defined outcomes or 1-year survival (90.9% severe vs 91.5% moderate vs 89.3% none, P=0.44). Conclusions Severe PPM and elevated gradients after aortic ViV are very common but were not associated with short-term survival and clinical outcomes. The long-term effect of poor post-ViV haemodynamics on clinical outcomes requires further evaluation.

Original language	English (US)
Pages (from-to)	828-834
Number of pages	7
Journal	Heart
Volume	104
Issue number	10
DOIs	https://doi.org/10.1136/heartjnl-2017-312422
State	Published - May 1 2018

Bibliographical note

Funding Information:
Competing interests DD is a consultant for edwards lifesciences, Medtronic and abbott. sB is a proctor and consultant for Medtronic and a proctor for Boston scientific and JenaValve. rl is a member of the Medtronic advisory board. sg is a consultant for edwards lifesciences, Medtronic, surmodics, Osprey Medical and Boston scientific and also repots research grants from edwards lifesciences and Va Office of research and Development. eF reports consulting and proctoring for edwards lifesciences. Dh is a member of the Medtronic advisory board. tZ reports lecture fees from edwards lifesciences and Medtronic. MJr is a consultant for Medtronic, abbott and Boston scientific. sW reports institutional research grants from amgen, abbott, Boston scientific, Biotronik and st. Jude Medical. nMvM reports research grant support from Medtronic, abbott, edwards lifesciences, Boston scientific, claret and essential Medical. nB has received research grants from edwards lifesciences and speaker honoraria from edwards lifesciences, Medtronic and abbott. ac is part of the speakers bureau for edwards lifesciences, Medtronic and abbott, and also reports proctoring for Medtronic. J-Ms reports research grants and speaker honoraria from Medtronic, edwards lifesciences, Boston scientific, and abbott. no other conflicts of interest were reported.

Publisher Copyright:
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Keywords

prosthetic heart valves
transcatheter valve interventions
valve disease surgery
valvular heart disease

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Bleiziffer, S., Erlebach, M., Simonato, M., Pibarot, P., Webb, J., Capek, L., Windecker, S., George, I., Sinning, J. M., Horlick, E., Napodano, M., Holzhey, D. M., Petursson, P., Cerillo, A., Bonaros, N., Ferrari, E., Cohen, M. G., Baquero, G., Jones, T. L., ... Dvir, D. (2018). Incidence, predictors and clinical outcomes of residual stenosis after aortic valve-in-valve. Heart, 104(10), 828-834. https://doi.org/10.1136/heartjnl-2017-312422

Bleiziffer, S, Erlebach, M, Simonato, M, Pibarot, P, Webb, J, Capek, L, Windecker, S, George, I, Sinning, JM, Horlick, E, Napodano, M, Holzhey, DM, Petursson, P, Cerillo, A, Bonaros, N, Ferrari, E, Cohen, MG, Baquero, G, Jones, TL, Kalra, A, Reardon, MJ, Chhatriwalla, A, Gama Ribeiro, V, Alnasser, S, Van Mieghem, NM, Rustenbach, CJ, Schofer, J, Garcia, S, Zeus, T, Champagnac, DI, Bekeredjian, R, Kornowski, R, Lange, R & Dvir, D 2018, 'Incidence, predictors and clinical outcomes of residual stenosis after aortic valve-in-valve', Heart, vol. 104, no. 10, pp. 828-834. https://doi.org/10.1136/heartjnl-2017-312422

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abstract = "Objective We aimed to analyse the incidence of prosthesis-patient mismatch (PPM) and elevated gradients after aortic valve in valve (ViV), and to evaluate predictors and associations with clinical outcomes of this adverse event. Methods A total of 910 aortic ViV patients were investigated. Elevated residual gradients were defined as ≥20 mm Hg. PPM was identified based on the indexed effective orifice area (EOA), measured by echocardiography, and patient body mass index (BMI). Moderate and severe PPM (cases) were defined by European Association of Cardiovascular Imaging (EACVI) criteria and compared with patients without PPM (controls). Results Moderate or greater PPM was found in 61% of the patients, and severe in 24.6%. Elevated residual gradients were found in 27.9%. Independent risk factors for the occurrence of lower indexed EOA and therefore severe PPM were higher gradients of the failed bioprosthesis at baseline (unstandardised beta -0.023; 95% CI -0.032 to -0.014; P<0.001), a stented (vs a stentless) surgical bioprosthesis (unstandardised beta -0.11; 95% CI -0.161 to -0.071; P<0.001), higher BMI (unstandardised beta -0.01; 95% CI -0.013 to -0.007; P<0.001) and implantation of a SAPIEN/SAPIEN XT/SAPIEN 3 transcatheter device (unstandardised beta -0.064; 95% CI -0.095 to -0.032; P<0.001). Neither severe PPM nor elevated gradients had an association with VARC II-defined outcomes or 1-year survival (90.9% severe vs 91.5% moderate vs 89.3% none, P=0.44). Conclusions Severe PPM and elevated gradients after aortic ViV are very common but were not associated with short-term survival and clinical outcomes. The long-term effect of poor post-ViV haemodynamics on clinical outcomes requires further evaluation.",

keywords = "prosthetic heart valves, transcatheter valve interventions, valve disease surgery, valvular heart disease",

author = "Sabine Bleiziffer and Magdalena Erlebach and Matheus Simonato and Philippe Pibarot and John Webb and Lukas Capek and Stephan Windecker and Isaac George and Sinning, {Jan Malte} and Eric Horlick and Massimo Napodano and Holzhey, {David M.} and Petur Petursson and Alfredo Cerillo and Nikolaos Bonaros and Enrico Ferrari and Cohen, {Mauricio G.} and Giselle Baquero and Jones, {Tara L.} and Ankur Kalra and Reardon, {Michael J.} and Adnan Chhatriwalla and {Gama Ribeiro}, Vasco and Sami Alnasser and {Van Mieghem}, {Nicolas M.} and Rustenbach, {Christian J{\"o}rg} and Joachim Schofer and Santiago Garcia and Tobias Zeus and DIdier Champagnac and Raffi Bekeredjian and Ran Kornowski and R{\"u}diger Lange and Danny Dvir",

note = "Funding Information: Competing interests DD is a consultant for edwards lifesciences, Medtronic and abbott. sB is a proctor and consultant for Medtronic and a proctor for Boston scientific and JenaValve. rl is a member of the Medtronic advisory board. sg is a consultant for edwards lifesciences, Medtronic, surmodics, Osprey Medical and Boston scientific and also repots research grants from edwards lifesciences and Va Office of research and Development. eF reports consulting and proctoring for edwards lifesciences. Dh is a member of the Medtronic advisory board. tZ reports lecture fees from edwards lifesciences and Medtronic. MJr is a consultant for Medtronic, abbott and Boston scientific. sW reports institutional research grants from amgen, abbott, Boston scientific, Biotronik and st. Jude Medical. nMvM reports research grant support from Medtronic, abbott, edwards lifesciences, Boston scientific, claret and essential Medical. nB has received research grants from edwards lifesciences and speaker honoraria from edwards lifesciences, Medtronic and abbott. ac is part of the speakers bureau for edwards lifesciences, Medtronic and abbott, and also reports proctoring for Medtronic. J-Ms reports research grants and speaker honoraria from Medtronic, edwards lifesciences, Boston scientific, and abbott. no other conflicts of interest were reported. Publisher Copyright: {\textcopyright} Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.",

year = "2018",

month = may,

day = "1",

doi = "10.1136/heartjnl-2017-312422",

language = "English (US)",

volume = "104",

pages = "828--834",

journal = "Heart",

issn = "1355-6037",

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TY - JOUR

T1 - Incidence, predictors and clinical outcomes of residual stenosis after aortic valve-in-valve

AU - Bleiziffer, Sabine

AU - Erlebach, Magdalena

AU - Simonato, Matheus

AU - Pibarot, Philippe

AU - Webb, John

AU - Capek, Lukas

AU - Windecker, Stephan

AU - George, Isaac

AU - Sinning, Jan Malte

AU - Horlick, Eric

AU - Napodano, Massimo

AU - Holzhey, David M.

AU - Petursson, Petur

AU - Cerillo, Alfredo

AU - Bonaros, Nikolaos

AU - Ferrari, Enrico

AU - Cohen, Mauricio G.

AU - Baquero, Giselle

AU - Jones, Tara L.

AU - Kalra, Ankur

AU - Reardon, Michael J.

AU - Chhatriwalla, Adnan

AU - Gama Ribeiro, Vasco

AU - Alnasser, Sami

AU - Van Mieghem, Nicolas M.

AU - Rustenbach, Christian Jörg

AU - Schofer, Joachim

AU - Garcia, Santiago

AU - Zeus, Tobias

AU - Champagnac, DIdier

AU - Bekeredjian, Raffi

AU - Kornowski, Ran

AU - Lange, Rüdiger

AU - Dvir, Danny

N1 - Funding Information: Competing interests DD is a consultant for edwards lifesciences, Medtronic and abbott. sB is a proctor and consultant for Medtronic and a proctor for Boston scientific and JenaValve. rl is a member of the Medtronic advisory board. sg is a consultant for edwards lifesciences, Medtronic, surmodics, Osprey Medical and Boston scientific and also repots research grants from edwards lifesciences and Va Office of research and Development. eF reports consulting and proctoring for edwards lifesciences. Dh is a member of the Medtronic advisory board. tZ reports lecture fees from edwards lifesciences and Medtronic. MJr is a consultant for Medtronic, abbott and Boston scientific. sW reports institutional research grants from amgen, abbott, Boston scientific, Biotronik and st. Jude Medical. nMvM reports research grant support from Medtronic, abbott, edwards lifesciences, Boston scientific, claret and essential Medical. nB has received research grants from edwards lifesciences and speaker honoraria from edwards lifesciences, Medtronic and abbott. ac is part of the speakers bureau for edwards lifesciences, Medtronic and abbott, and also reports proctoring for Medtronic. J-Ms reports research grants and speaker honoraria from Medtronic, edwards lifesciences, Boston scientific, and abbott. no other conflicts of interest were reported. Publisher Copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PY - 2018/5/1

Y1 - 2018/5/1

N2 - Objective We aimed to analyse the incidence of prosthesis-patient mismatch (PPM) and elevated gradients after aortic valve in valve (ViV), and to evaluate predictors and associations with clinical outcomes of this adverse event. Methods A total of 910 aortic ViV patients were investigated. Elevated residual gradients were defined as ≥20 mm Hg. PPM was identified based on the indexed effective orifice area (EOA), measured by echocardiography, and patient body mass index (BMI). Moderate and severe PPM (cases) were defined by European Association of Cardiovascular Imaging (EACVI) criteria and compared with patients without PPM (controls). Results Moderate or greater PPM was found in 61% of the patients, and severe in 24.6%. Elevated residual gradients were found in 27.9%. Independent risk factors for the occurrence of lower indexed EOA and therefore severe PPM were higher gradients of the failed bioprosthesis at baseline (unstandardised beta -0.023; 95% CI -0.032 to -0.014; P<0.001), a stented (vs a stentless) surgical bioprosthesis (unstandardised beta -0.11; 95% CI -0.161 to -0.071; P<0.001), higher BMI (unstandardised beta -0.01; 95% CI -0.013 to -0.007; P<0.001) and implantation of a SAPIEN/SAPIEN XT/SAPIEN 3 transcatheter device (unstandardised beta -0.064; 95% CI -0.095 to -0.032; P<0.001). Neither severe PPM nor elevated gradients had an association with VARC II-defined outcomes or 1-year survival (90.9% severe vs 91.5% moderate vs 89.3% none, P=0.44). Conclusions Severe PPM and elevated gradients after aortic ViV are very common but were not associated with short-term survival and clinical outcomes. The long-term effect of poor post-ViV haemodynamics on clinical outcomes requires further evaluation.

AB - Objective We aimed to analyse the incidence of prosthesis-patient mismatch (PPM) and elevated gradients after aortic valve in valve (ViV), and to evaluate predictors and associations with clinical outcomes of this adverse event. Methods A total of 910 aortic ViV patients were investigated. Elevated residual gradients were defined as ≥20 mm Hg. PPM was identified based on the indexed effective orifice area (EOA), measured by echocardiography, and patient body mass index (BMI). Moderate and severe PPM (cases) were defined by European Association of Cardiovascular Imaging (EACVI) criteria and compared with patients without PPM (controls). Results Moderate or greater PPM was found in 61% of the patients, and severe in 24.6%. Elevated residual gradients were found in 27.9%. Independent risk factors for the occurrence of lower indexed EOA and therefore severe PPM were higher gradients of the failed bioprosthesis at baseline (unstandardised beta -0.023; 95% CI -0.032 to -0.014; P<0.001), a stented (vs a stentless) surgical bioprosthesis (unstandardised beta -0.11; 95% CI -0.161 to -0.071; P<0.001), higher BMI (unstandardised beta -0.01; 95% CI -0.013 to -0.007; P<0.001) and implantation of a SAPIEN/SAPIEN XT/SAPIEN 3 transcatheter device (unstandardised beta -0.064; 95% CI -0.095 to -0.032; P<0.001). Neither severe PPM nor elevated gradients had an association with VARC II-defined outcomes or 1-year survival (90.9% severe vs 91.5% moderate vs 89.3% none, P=0.44). Conclusions Severe PPM and elevated gradients after aortic ViV are very common but were not associated with short-term survival and clinical outcomes. The long-term effect of poor post-ViV haemodynamics on clinical outcomes requires further evaluation.

KW - prosthetic heart valves

KW - transcatheter valve interventions

KW - valve disease surgery

KW - valvular heart disease

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Incidence, predictors and clinical outcomes of residual stenosis after aortic valve-in-valve

Abstract

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UN SDGs

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