Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment: The VIVID Registry

Matheus Simonato; Brian K. Whisenant; Axel Unbehaun; Jörg Kempfert; Henrique B. Ribeiro; Ran Kornowski; Magdalena Erlebach; Sabine Bleiziffer; Stephan Windecker; Thomas Pilgrim; Daijiro Tomii; Mayra Guerrero; Yousif Ahmad; John K. Forrest; Matteo Montorfano; Marco Ancona; Matti Adam; Hendrik Wienemann; Ariel Finkelstein; Pedro Villablanca; Pablo Codner; David Hildick-Smith; Enrico Ferrari; Anna Sonia Petronio; Jasmin Shamekhi; Patrizia Presbitero; Giuseppe Bruschi; Tanja Rudolph; Alfredo Cerillo; David Attias; Mohammed Nejjari; Alexandre Abizaid; Maurício Felippi de Sá Marchi; Eric Horlick; Harindra Wijeysundera; Martin Andreas; Arun Thukkani; Marco Agrifoglio; Alessandro Iadanza; L. Matthew Baer; Michael G. Nanna; Danny Dvir

doi:10.1016/j.jcin.2023.08.047

Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment: The VIVID Registry

Matheus Simonato, Brian K. Whisenant, Axel Unbehaun, Jörg Kempfert, Henrique B. Ribeiro, Ran Kornowski, Magdalena Erlebach, Sabine Bleiziffer, Stephan Windecker, Thomas Pilgrim, Daijiro Tomii, Mayra Guerrero, Yousif Ahmad, John K. Forrest, Matteo Montorfano, Marco Ancona, Matti Adam, Hendrik Wienemann, Ariel Finkelstein, Pedro VillablancaPablo Codner, David Hildick-Smith, Enrico Ferrari, Anna Sonia Petronio, Jasmin Shamekhi, Patrizia Presbitero, Giuseppe Bruschi, Tanja Rudolph, Alfredo Cerillo, David Attias, Mohammed Nejjari, Alexandre Abizaid, Maurício Felippi de Sá Marchi, Eric Horlick, Harindra Wijeysundera, Martin Andreas, Arun Thukkani, Marco Agrifoglio, Alessandro Iadanza, L. Matthew Baer, Michael G. Nanna, Danny Dvir

Cardiovascular Medicine

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

Abstract

Background: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. Objectives: This study aimed to determine whether device position and asymmetry are associated with these outcomes. Methods: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated. Results: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027). Conclusions: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.

Original language	English (US)
Pages (from-to)	2615-2627
Number of pages	13
Journal	JACC: Cardiovascular Interventions
Volume	16
Issue number	21
DOIs	https://doi.org/10.1016/j.jcin.2023.08.047
State	Published - Nov 13 2023

Keywords

SAPIEN 3
depth of implantation
left ventricular outflow tract obstruction
mitral valve-in-valve
positioning
residual stenosis

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Access to Document

10.1016/j.jcin.2023.08.047

Cite this

Simonato, M., Whisenant, B. K., Unbehaun, A., Kempfert, J., Ribeiro, H. B., Kornowski, R., Erlebach, M., Bleiziffer, S., Windecker, S., Pilgrim, T., Tomii, D., Guerrero, M., Ahmad, Y., Forrest, J. K., Montorfano, M., Ancona, M., Adam, M., Wienemann, H., Finkelstein, A., ... Dvir, D. (2023). Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment: The VIVID Registry. JACC: Cardiovascular Interventions, 16(21), 2615-2627. https://doi.org/10.1016/j.jcin.2023.08.047

Simonato, M, Whisenant, BK, Unbehaun, A, Kempfert, J, Ribeiro, HB, Kornowski, R, Erlebach, M, Bleiziffer, S, Windecker, S, Pilgrim, T, Tomii, D, Guerrero, M, Ahmad, Y, Forrest, JK, Montorfano, M, Ancona, M, Adam, M, Wienemann, H, Finkelstein, A, Villablanca, P, Codner, P, Hildick-Smith, D, Ferrari, E, Petronio, AS, Shamekhi, J, Presbitero, P, Bruschi, G, Rudolph, T, Cerillo, A, Attias, D, Nejjari, M, Abizaid, A, Felippi de Sá Marchi, M, Horlick, E, Wijeysundera, H, Andreas, M, Thukkani, A, Agrifoglio, M, Iadanza, A, Baer, LM, Nanna, MG & Dvir, D 2023, 'Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment: The VIVID Registry', JACC: Cardiovascular Interventions, vol. 16, no. 21, pp. 2615-2627. https://doi.org/10.1016/j.jcin.2023.08.047

@article{728518c736b240cd8ac2c940dd9f121c,

title = "Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment: The VIVID Registry",

abstract = "Background: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. Objectives: This study aimed to determine whether device position and asymmetry are associated with these outcomes. Methods: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated. Results: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027). Conclusions: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.",

keywords = "SAPIEN 3, depth of implantation, left ventricular outflow tract obstruction, mitral valve-in-valve, positioning, residual stenosis",

author = "Matheus Simonato and Whisenant, {Brian K.} and Axel Unbehaun and J{\"o}rg Kempfert and Ribeiro, {Henrique B.} and Ran Kornowski and Magdalena Erlebach and Sabine Bleiziffer and Stephan Windecker and Thomas Pilgrim and Daijiro Tomii and Mayra Guerrero and Yousif Ahmad and Forrest, {John K.} and Matteo Montorfano and Marco Ancona and Matti Adam and Hendrik Wienemann and Ariel Finkelstein and Pedro Villablanca and Pablo Codner and David Hildick-Smith and Enrico Ferrari and Petronio, {Anna Sonia} and Jasmin Shamekhi and Patrizia Presbitero and Giuseppe Bruschi and Tanja Rudolph and Alfredo Cerillo and David Attias and Mohammed Nejjari and Alexandre Abizaid and {Felippi de S{\'a} Marchi}, Maur{\'i}cio and Eric Horlick and Harindra Wijeysundera and Martin Andreas and Arun Thukkani and Marco Agrifoglio and Alessandro Iadanza and Baer, {L. Matthew} and Nanna, {Michael G.} and Danny Dvir",

note = "Publisher Copyright: {\textcopyright} 2023 American College of Cardiology Foundation",

year = "2023",

month = nov,

day = "13",

doi = "10.1016/j.jcin.2023.08.047",

language = "English (US)",

volume = "16",

pages = "2615--2627",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "21",

}

TY - JOUR

T1 - Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment

T2 - The VIVID Registry

AU - Simonato, Matheus

AU - Whisenant, Brian K.

AU - Unbehaun, Axel

AU - Kempfert, Jörg

AU - Ribeiro, Henrique B.

AU - Kornowski, Ran

AU - Erlebach, Magdalena

AU - Bleiziffer, Sabine

AU - Windecker, Stephan

AU - Pilgrim, Thomas

AU - Tomii, Daijiro

AU - Guerrero, Mayra

AU - Ahmad, Yousif

AU - Forrest, John K.

AU - Montorfano, Matteo

AU - Ancona, Marco

AU - Adam, Matti

AU - Wienemann, Hendrik

AU - Finkelstein, Ariel

AU - Villablanca, Pedro

AU - Codner, Pablo

AU - Hildick-Smith, David

AU - Ferrari, Enrico

AU - Petronio, Anna Sonia

AU - Shamekhi, Jasmin

AU - Presbitero, Patrizia

AU - Bruschi, Giuseppe

AU - Rudolph, Tanja

AU - Cerillo, Alfredo

AU - Attias, David

AU - Nejjari, Mohammed

AU - Abizaid, Alexandre

AU - Felippi de Sá Marchi, Maurício

AU - Horlick, Eric

AU - Wijeysundera, Harindra

AU - Andreas, Martin

AU - Thukkani, Arun

AU - Agrifoglio, Marco

AU - Iadanza, Alessandro

AU - Baer, L. Matthew

AU - Nanna, Michael G.

AU - Dvir, Danny

PY - 2023/11/13

Y1 - 2023/11/13

N2 - Background: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. Objectives: This study aimed to determine whether device position and asymmetry are associated with these outcomes. Methods: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated. Results: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027). Conclusions: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.

AB - Background: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. Objectives: This study aimed to determine whether device position and asymmetry are associated with these outcomes. Methods: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated. Results: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027). Conclusions: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.

KW - SAPIEN 3

KW - depth of implantation

KW - left ventricular outflow tract obstruction

KW - mitral valve-in-valve

KW - positioning

KW - residual stenosis

UR - http://www.scopus.com/inward/record.url?scp=85175444685&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85175444685&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2023.08.047

DO - 10.1016/j.jcin.2023.08.047

M3 - Article

C2 - 37968032

AN - SCOPUS:85175444685

SN - 1936-8798

VL - 16

SP - 2615

EP - 2627

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 21

ER -

Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment: The VIVID Registry

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this