4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation
Laura Mauri, Elyse Foster, Donald D Glower, Patricia Apruzzese, Joseph M Massaro, Howard C Herrmann, James Hermiller, William Gray, Andrew Wang, Wesley R Pedersen, Tanvir Bajwa, John Lasala, Reginald Low, Paul Grayburn, Ted Feldman, EVEREST II Investigators, Howard Herrmann, Ted Feldman, Patrick Whitlow, Vasilis Babaliaros, Mark Reisman, Kenneth Kent, William Gray, Steven Bailey, Michael Rinaldi, Andy Eisenhauer, Richard Smalling, John Carroll, Omar Nass, Andrew Berke, Andrew Wang, Peter Fail, James Hermiller, Reginald Low, Saibal Kar, John Lasala, D Scott Lim, Eric Horlick, Timothy Byrne, Tanvir Bajwa, Stephen Ramee, James Slater, Paul Grayburn, Paul Grayburn, Mansoor Qureshi, Eric Fretz, S Chiu Wong, Wesley Pedersen, Mark Sanz, J Tod Maddux, Robbert Kipperman, John Williams, Brian Whisenant, George Hanzel, Raymond Leung, Mirle Kellett, Robert Kipperman, Ramon Quesada, Vivek Rajagopal, Lou Heller, Daniel Steinberg, Chad Rammohan, Carlos Ruiz, Ziyad Hijazi, Ramesh Daggubati, Randolph Chitwood, Y Joseph Woo, Paul Pearson, Stephanie Mick, John Puskas, Glenn Barnhart, Steven Boyce, Michael Argenziano, Edward Sako, Eric Skipper, Lawrence Cohn, George Letsou, Joseph Cleveland, Deepak Gangahar, Newell Robinson, Donald Glower, Tommy Fudge, David Heimansohn, Nilas Young, Alfredo Trento, Ralph Damiano, Irving Kron, Tirone David, H Kenneth Fang, Daniel O'Hair, Patrick Parrino, Aubrey Galloway, Robert Hebeler, Michael Mack, Andrew Pruitt, John Ofiesh, Leonard Girardi, Vibhu Kshettry, Matt Maxwell, R Mark Bodenhamer, Stephen Clayson, Marc Sakwa, David Ross, Paul Weldner, John Brown, Niberto Moreno, James Kauten, Douglas Murphy, Fred Crawford, Ramin Beygui, Nirav Patel, Robert March, Curtis Anderson, Frank Silvestry, Steven Smart, William Stewart, Stephen Clements, Oana Madalina, Pamela Sears-Rogan, Rebecca Hahn, John Erikson, Geoffrey Rose, Justina Wu, Catalin Loghin, Ernesto Salcedo, Kaliprasad Ayala, Alan Katz, Eric Velazquez, Darrel Solet, John Bates, William Bommer, Robert Siegel, Brian Lindman, John Dent, Melitta Mezody, J Michael Morgan, Abdul Jamil Tajik, Yvonne Gilliland, Richardo Benenstein, Paul Grayburn, Paul Grayburn, Steven Girard, Manjeet Mann, Richard Devereux, Richard Bae, Joseph Knapp, Derek Norman, Steve Horton, Michael Gallagher, Jonathan Choy, John Lualdi, Konstantinos Kougiannis, Rafael Machado, Nirav Raval, Stephen Frohwein, David Gregg, Anita Prakash, Itzhak Kronzon, Jeffrey Soble, Rajasekhar Nekkanti, Laura Mauri, Elyse Foster, Donald D Glower, Patricia Apruzzese, Joseph M Massaro, Howard C Herrmann, James Hermiller, William Gray, Andrew Wang, Wesley R Pedersen, Tanvir Bajwa, John Lasala, Reginald Low, Paul Grayburn, Ted Feldman, EVEREST II Investigators, Howard Herrmann, Ted Feldman, Patrick Whitlow, Vasilis Babaliaros, Mark Reisman, Kenneth Kent, William Gray, Steven Bailey, Michael Rinaldi, Andy Eisenhauer, Richard Smalling, John Carroll, Omar Nass, Andrew Berke, Andrew Wang, Peter Fail, James Hermiller, Reginald Low, Saibal Kar, John Lasala, D Scott Lim, Eric Horlick, Timothy Byrne, Tanvir Bajwa, Stephen Ramee, James Slater, Paul Grayburn, Paul Grayburn, Mansoor Qureshi, Eric Fretz, S Chiu Wong, Wesley Pedersen, Mark Sanz, J Tod Maddux, Robbert Kipperman, John Williams, Brian Whisenant, George Hanzel, Raymond Leung, Mirle Kellett, Robert Kipperman, Ramon Quesada, Vivek Rajagopal, Lou Heller, Daniel Steinberg, Chad Rammohan, Carlos Ruiz, Ziyad Hijazi, Ramesh Daggubati, Randolph Chitwood, Y Joseph Woo, Paul Pearson, Stephanie Mick, John Puskas, Glenn Barnhart, Steven Boyce, Michael Argenziano, Edward Sako, Eric Skipper, Lawrence Cohn, George Letsou, Joseph Cleveland, Deepak Gangahar, Newell Robinson, Donald Glower, Tommy Fudge, David Heimansohn, Nilas Young, Alfredo Trento, Ralph Damiano, Irving Kron, Tirone David, H Kenneth Fang, Daniel O'Hair, Patrick Parrino, Aubrey Galloway, Robert Hebeler, Michael Mack, Andrew Pruitt, John Ofiesh, Leonard Girardi, Vibhu Kshettry, Matt Maxwell, R Mark Bodenhamer, Stephen Clayson, Marc Sakwa, David Ross, Paul Weldner, John Brown, Niberto Moreno, James Kauten, Douglas Murphy, Fred Crawford, Ramin Beygui, Nirav Patel, Robert March, Curtis Anderson, Frank Silvestry, Steven Smart, William Stewart, Stephen Clements, Oana Madalina, Pamela Sears-Rogan, Rebecca Hahn, John Erikson, Geoffrey Rose, Justina Wu, Catalin Loghin, Ernesto Salcedo, Kaliprasad Ayala, Alan Katz, Eric Velazquez, Darrel Solet, John Bates, William Bommer, Robert Siegel, Brian Lindman, John Dent, Melitta Mezody, J Michael Morgan, Abdul Jamil Tajik, Yvonne Gilliland, Richardo Benenstein, Paul Grayburn, Paul Grayburn, Steven Girard, Manjeet Mann, Richard Devereux, Richard Bae, Joseph Knapp, Derek Norman, Steve Horton, Michael Gallagher, Jonathan Choy, John Lualdi, Konstantinos Kougiannis, Rafael Machado, Nirav Raval, Stephen Frohwein, David Gregg, Anita Prakash, Itzhak Kronzon, Jeffrey Soble, Rajasekhar Nekkanti
Abstract
Objectives: This study sought to evaluate 4-year outcomes of percutaneous repair versus surgery for mitral regurgitation.
Background: Transcatheter therapies are being developed to treat valvular heart disease. In the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II trial, treatment of mitral valve regurgitation (MR) with a novel percutaneous device was compared with surgery and showed superior safety, but less reduction in MR at 1 year overall. We report the 4-year outcomes from the EVEREST II trial.
Methods: Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the MitraClip (Abbott, Menlo Park, California) device or conventional mitral valve surgery in a 2:1 ratio (184:95). Patients prospectively consented to 5 years of follow-up.
Results: At 4 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the intention-to-treat population was 39.8% versus 53.4% in the percutaneous repair group and surgical groups, respectively (p = 0.070). Rates of death were 17.4% versus 17.8% (p = 0.914), and 3+ or 4+ MR was present in 21.7% versus 24.7% (p = 0.745) at 4 years of follow-up, respectively. Surgery for mitral valve dysfunction, however, occurred in 20.4% versus 2.2% (p < 0.001) at 1 year and 24.8% versus 5.5% (p < 0.001) at 4 years.
Conclusions: Patients treated with percutaneous repair of the mitral valve more commonly required surgery to treat residual MR; however, after the first year of follow-up, there were few surgeries required after either percutaneous or surgical treatment and no difference in the prevalence of moderate-severe and severe MR or mortality at 4 years. (Endovascular Valve Edge-to-Edge Repair Study [EVEREST II]; NCT00209274).
Keywords: LVEF; LVIDd; MR; NYHA; New York Heart Association; left ventricular ejection fraction; left ventricular internal diameter diastolic; mitral regurgitation; mitral repair; percutaneous valve therapy.
Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed