EVEREST II randomized clinical trial: Predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure

Donald Glower, Gorav Ailawadi, Michael Argenziano, Michael MacK, Alfredo Trento, Andrew Wang, D. Scott Lim, William Gray, Paul Grayburn, John Dent, Linda Gillam, Barathi Sethuraman, Ted Feldman, Elyse Foster, Laura Mauri, Irving Kron

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52 Citations (Scopus)

Abstract

Objective: The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement. Methods: Of 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group. Results: The rate of percutaneous or surgical MV repair at 1 year was 89% (158/178) in patients initially receiving the MitraClip device versus 84% (67/80) in the surgical patients (P =.36). Surgical repair was performed after the MitraClip procedure in 20 (54%) of 37patients (P <.001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology (P =.035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5%) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure. Conclusions: These data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.

Original languageEnglish (US)
Pages (from-to)S60-S63
JournalJournal of Thoracic and Cardiovascular Surgery
Volume143
Issue number4 SUPPL.
DOIs
StatePublished - Apr 2012

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Mitral Valve
Randomized Controlled Trials
Pathology
Logistic Models
Mitral Valve Insufficiency
Equipment and Supplies
Therapeutics
Surgical Instruments
Thoracic Surgery
Regression Analysis
Wounds and Injuries

All Science Journal Classification (ASJC) codes

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Glower, Donald ; Ailawadi, Gorav ; Argenziano, Michael ; MacK, Michael ; Trento, Alfredo ; Wang, Andrew ; Lim, D. Scott ; Gray, William ; Grayburn, Paul ; Dent, John ; Gillam, Linda ; Sethuraman, Barathi ; Feldman, Ted ; Foster, Elyse ; Mauri, Laura ; Kron, Irving. / EVEREST II randomized clinical trial : Predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure. In: Journal of Thoracic and Cardiovascular Surgery. 2012 ; Vol. 143, No. 4 SUPPL. pp. S60-S63.
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title = "EVEREST II randomized clinical trial: Predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure",
abstract = "Objective: The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement. Methods: Of 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group. Results: The rate of percutaneous or surgical MV repair at 1 year was 89{\%} (158/178) in patients initially receiving the MitraClip device versus 84{\%} (67/80) in the surgical patients (P =.36). Surgical repair was performed after the MitraClip procedure in 20 (54{\%}) of 37patients (P <.001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology (P =.035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5{\%}) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure. Conclusions: These data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.",
author = "Donald Glower and Gorav Ailawadi and Michael Argenziano and Michael MacK and Alfredo Trento and Andrew Wang and Lim, {D. Scott} and William Gray and Paul Grayburn and John Dent and Linda Gillam and Barathi Sethuraman and Ted Feldman and Elyse Foster and Laura Mauri and Irving Kron",
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Glower, D, Ailawadi, G, Argenziano, M, MacK, M, Trento, A, Wang, A, Lim, DS, Gray, W, Grayburn, P, Dent, J, Gillam, L, Sethuraman, B, Feldman, T, Foster, E, Mauri, L & Kron, I 2012, 'EVEREST II randomized clinical trial: Predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure', Journal of Thoracic and Cardiovascular Surgery, vol. 143, no. 4 SUPPL., pp. S60-S63. https://doi.org/10.1016/j.jtcvs.2012.01.047

EVEREST II randomized clinical trial : Predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure. / Glower, Donald; Ailawadi, Gorav; Argenziano, Michael; MacK, Michael; Trento, Alfredo; Wang, Andrew; Lim, D. Scott; Gray, William; Grayburn, Paul; Dent, John; Gillam, Linda; Sethuraman, Barathi; Feldman, Ted; Foster, Elyse; Mauri, Laura; Kron, Irving.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 143, No. 4 SUPPL., 04.2012, p. S60-S63.

Research output: Contribution to journalEditorial

TY - JOUR

T1 - EVEREST II randomized clinical trial

T2 - Predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure

AU - Glower, Donald

AU - Ailawadi, Gorav

AU - Argenziano, Michael

AU - MacK, Michael

AU - Trento, Alfredo

AU - Wang, Andrew

AU - Lim, D. Scott

AU - Gray, William

AU - Grayburn, Paul

AU - Dent, John

AU - Gillam, Linda

AU - Sethuraman, Barathi

AU - Feldman, Ted

AU - Foster, Elyse

AU - Mauri, Laura

AU - Kron, Irving

PY - 2012/4

Y1 - 2012/4

N2 - Objective: The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement. Methods: Of 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group. Results: The rate of percutaneous or surgical MV repair at 1 year was 89% (158/178) in patients initially receiving the MitraClip device versus 84% (67/80) in the surgical patients (P =.36). Surgical repair was performed after the MitraClip procedure in 20 (54%) of 37patients (P <.001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology (P =.035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5%) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure. Conclusions: These data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.

AB - Objective: The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement. Methods: Of 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group. Results: The rate of percutaneous or surgical MV repair at 1 year was 89% (158/178) in patients initially receiving the MitraClip device versus 84% (67/80) in the surgical patients (P =.36). Surgical repair was performed after the MitraClip procedure in 20 (54%) of 37patients (P <.001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology (P =.035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5%) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure. Conclusions: These data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.

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U2 - 10.1016/j.jtcvs.2012.01.047

DO - 10.1016/j.jtcvs.2012.01.047

M3 - Editorial

C2 - 22423604

AN - SCOPUS:84858321918

VL - 143

SP - S60-S63

JO - Journal of Thoracic and Cardiovascular Surgery

JF - Journal of Thoracic and Cardiovascular Surgery

SN - 0022-5223

IS - 4 SUPPL.

ER -