Percutaneous repair or surgery for mitral regurgitation
Ted Feldman, Elyse Foster, Donald D Glower, Saibal Kar, Michael J Rinaldi, Peter S Fail, Richard W Smalling, Robert Siegel, Geoffrey A Rose, Eric Engeron, Catalin Loghin, Alfredo Trento, Eric R Skipper, Tommy Fudge, George V Letsou, Joseph M Massaro, Laura Mauri, EVEREST II Investigators, Elyse Foster, Esperanza Viloria, Ted Feldman, John Alexander, Edgar G Chedrawy, Mark B Lampert, Steven Smart, Alan Zunamon, Claudia Focks, Dale Seifert, Beth Garnier, Andrew Wang, Donald Glower, Carmelo Milano, James Jollis, Thomas Ryan, Dana Glisson, Aretha Herron, Sophie Wang, Timothy Byrne, Pierre Tibi, H Kenith Fang, J Michael Morgan, Gabriella Diaz, Hope Mangum, Ramon Quesada, Niberto Moreno, Rafael Machado, Maria Ines Aridid, Paul Grayburn, Azam Anwar, Baron Hamman, Robert F Hebeler, Paul Grayburn, Susan Aston, Andy Eisenhauer, Larry Cohn, Michael Davidson, Judy Mangion, Justina Wu, Denise Cinamon, Tina Sampong, James Hermiller, Keith Allen, Dave Heimansohn, John Bates, Douglas Segar, Charles Taliercio, Anne Taylor, Michael J Rinaldi, Eric Skipper, Robert M Steigel, Geoffrey Rose, Gale Schwarz, Tiffany Michel, Saibal Kar, Raj Makkar, Alfredo Trento, Wen Cheng, Gregory Fontana, Robert Kass, Robert Siegel, Kirsten Tolstrup, Tasneem Naqvi, Kelly Davis, Asma Hussaini, Diana Remba, Patrick Whitlow, Samir Kapadia, E Murat Tuzcu, Marc Gillinov, Tomislav Mihaljevic, Leonardo Rodriquez, William Stewart, Kelly Brezina, Lisa Rittwage, William Gray, Allan Schwartz, Hal Wasserman, Michael Argenziano, Yoshifumi Naka, Craig Smith, Allan Stewart, Mathew Williams, Shunichi Homma, Roy Pizzarello, Linda Gillam, Becky Hahn, Neil Goyal, Edie Escala, Mafo Kamanda-Kosseh, Miriam Lucca-Susana, Vasilis Babaliaros, Ziyad Ghazzal, Thomas Vassiliades, Omar Latouff, John Puskas, Stamatios Lerakis, Stephen Clements, Randolph Martin, John Merlino, Pamela Hyde, Brian Whisenant, Stephen Clayson, Steven C Horton, Eric Johnson, Richard Smalling, George Letsou, Jon-Cecil Walkes, Catalin Loghin, Andrew Hamilton, Mary Vooletich, Pallavi Ahobila-Vajjula, Wes Pedersen, Frazier Eates, Tom Flavin, Timothy Kroshus, Vibhu Kshettry, Richard Bae, Kevin Harris, Desmond Jay, Sara Olson, Peg Demmer, Omar Nass, Deepak Gangahar, R Kent Jex, Kaliprasad Ayala, Susan Krenk, S Chiu Wong, Geoffrey Bergman, Leonard Girardi, O Wayne Isom, Karl Krieger, Arash Salemi, Nickolas Skubas, Richard Devereux, Dolores T Reynolds, James Slater, Aubrey Galloway, Itzhak Kronzon, Gila Perk, Karen Hager, Elise Weisman, Cindy Lau-Yan Yung, Stephen Ramee, Eugene Parrino, Yvonne Gilliland, Sangeeta Shah, Barbara Hirstius, Laurie Ventura, Robert Kipperman, Mohammad Ghani, R Mark Bodenhamer, Scott Lucas, John Randolph, John Williams, Stacie Hanes, Raymond Leung, Roderick MacArthur, John Mullen, David Ross, Jonathan Choy, Alan Jones, Dylan Taylor, Randall Williams, Linda Kvill, Anna Law, Paul Kramer, Brian Castlemain, Andrew Schwartz, Linda Crouse, Carrie Totta, Millie Salkind, Tawny Willson, Andrew Berke, Roberto Colangelo, Paul Damus, Harold Fernandez, Newell Robinson, James Taylor, Aasha Gopal, Alan Katz, Dennis Mihalatos, Elizabeth Haag, Jeannette McLaughlin, Aracely Norales, Mansoor Qureshi, Andrew Pruitt, Bobby Kong, Benjamin McAllister, Steven Girard, Carol Carulli, Tanvir Bajwa, Suhail Allaqaband, David Kress, Daniel O'Hair, Kiran Sagar, Susan Oxborough, James T Maddux, Mark Sanz, Stephen Tahta, Matthew Maxwell, Bradley Berry, Joseph Knapp, Heidi Boehm, Mark Reisman, David Gartman, Joseph Teply, Amish Desai, Kier Huehnergarth, Kimberly Krabill, Inger Rasmussen, Peter Fail, Tommy Fudge, Kerry Paape, Michael Trotter, Eric Engeron, Monique Robert, Deanna K Benoit, Eric Horlick, Tirone David, Melitta Mezody, Kristeen Chamberlain, Reginald Low, Jason Rogers, J Nilas Young, Kuppe Shankar, William Bommer, Thomas Smith, Sandhya Venugopal, Kimberly Book, Kori Harder, John D Carroll, Joseph Cleveland, David Fullerton, Robert Quaife, Ernesto Salcedo, Kelly Jones, Howard Herrmann, Michael Acker, Y Joseph Woo, Frank E Silvestry, Susan E Wiegers, Judi Willhide, Terry Mannion, Steven R Bailey, John Calhoun, Edward Sako, John Erikson, Gus Banda, D Scott Lim, Irving L Kron, John Dent, Linda Bailes, Eric Fretz, John G Ofiesh, Manjeet Mann, Liz Martin, Kenneth Kent, Lowell Satler, Augusto Pichard, Ammar Bafi, Steven Boyce, Pamela Sears-Rogan, Stephen Goldstein, Petros Okubagzi, John Lasala, Marc Moon, Ralph Damiano, Benicio Barzilai, Brian Lindman, Jose Madrazo, Alan Zajarias, Michelle Myers, Kim Striler, George Hanzel, Marc Sakwa, Francis Shannon, Michael Gallagher, Pamela Markovitz, Amr Abbas, Hong Huang, Ted Feldman, Elyse Foster, Donald D Glower, Saibal Kar, Michael J Rinaldi, Peter S Fail, Richard W Smalling, Robert Siegel, Geoffrey A Rose, Eric Engeron, Catalin Loghin, Alfredo Trento, Eric R Skipper, Tommy Fudge, George V Letsou, Joseph M Massaro, Laura Mauri, EVEREST II Investigators, Elyse Foster, Esperanza Viloria, Ted Feldman, John Alexander, Edgar G Chedrawy, Mark B Lampert, Steven Smart, Alan Zunamon, Claudia Focks, Dale Seifert, Beth Garnier, Andrew Wang, Donald Glower, Carmelo Milano, James Jollis, Thomas Ryan, Dana Glisson, Aretha Herron, Sophie Wang, Timothy Byrne, Pierre Tibi, H Kenith Fang, J Michael Morgan, Gabriella Diaz, Hope Mangum, Ramon Quesada, Niberto Moreno, Rafael Machado, Maria Ines Aridid, Paul Grayburn, Azam Anwar, Baron Hamman, Robert F Hebeler, Paul Grayburn, Susan Aston, Andy Eisenhauer, Larry Cohn, Michael Davidson, Judy Mangion, Justina Wu, Denise Cinamon, Tina Sampong, James Hermiller, Keith Allen, Dave Heimansohn, John Bates, Douglas Segar, Charles Taliercio, Anne Taylor, Michael J Rinaldi, Eric Skipper, Robert M Steigel, Geoffrey Rose, Gale Schwarz, Tiffany Michel, Saibal Kar, Raj Makkar, Alfredo Trento, Wen Cheng, Gregory Fontana, Robert Kass, Robert Siegel, Kirsten Tolstrup, Tasneem Naqvi, Kelly Davis, Asma Hussaini, Diana Remba, Patrick Whitlow, Samir Kapadia, E Murat Tuzcu, Marc Gillinov, Tomislav Mihaljevic, Leonardo Rodriquez, William Stewart, Kelly Brezina, Lisa Rittwage, William Gray, Allan Schwartz, Hal Wasserman, Michael Argenziano, Yoshifumi Naka, Craig Smith, Allan Stewart, Mathew Williams, Shunichi Homma, Roy Pizzarello, Linda Gillam, Becky Hahn, Neil Goyal, Edie Escala, Mafo Kamanda-Kosseh, Miriam Lucca-Susana, Vasilis Babaliaros, Ziyad Ghazzal, Thomas Vassiliades, Omar Latouff, John Puskas, Stamatios Lerakis, Stephen Clements, Randolph Martin, John Merlino, Pamela Hyde, Brian Whisenant, Stephen Clayson, Steven C Horton, Eric Johnson, Richard Smalling, George Letsou, Jon-Cecil Walkes, Catalin Loghin, Andrew Hamilton, Mary Vooletich, Pallavi Ahobila-Vajjula, Wes Pedersen, Frazier Eates, Tom Flavin, Timothy Kroshus, Vibhu Kshettry, Richard Bae, Kevin Harris, Desmond Jay, Sara Olson, Peg Demmer, Omar Nass, Deepak Gangahar, R Kent Jex, Kaliprasad Ayala, Susan Krenk, S Chiu Wong, Geoffrey Bergman, Leonard Girardi, O Wayne Isom, Karl Krieger, Arash Salemi, Nickolas Skubas, Richard Devereux, Dolores T Reynolds, James Slater, Aubrey Galloway, Itzhak Kronzon, Gila Perk, Karen Hager, Elise Weisman, Cindy Lau-Yan Yung, Stephen Ramee, Eugene Parrino, Yvonne Gilliland, Sangeeta Shah, Barbara Hirstius, Laurie Ventura, Robert Kipperman, Mohammad Ghani, R Mark Bodenhamer, Scott Lucas, John Randolph, John Williams, Stacie Hanes, Raymond Leung, Roderick MacArthur, John Mullen, David Ross, Jonathan Choy, Alan Jones, Dylan Taylor, Randall Williams, Linda Kvill, Anna Law, Paul Kramer, Brian Castlemain, Andrew Schwartz, Linda Crouse, Carrie Totta, Millie Salkind, Tawny Willson, Andrew Berke, Roberto Colangelo, Paul Damus, Harold Fernandez, Newell Robinson, James Taylor, Aasha Gopal, Alan Katz, Dennis Mihalatos, Elizabeth Haag, Jeannette McLaughlin, Aracely Norales, Mansoor Qureshi, Andrew Pruitt, Bobby Kong, Benjamin McAllister, Steven Girard, Carol Carulli, Tanvir Bajwa, Suhail Allaqaband, David Kress, Daniel O'Hair, Kiran Sagar, Susan Oxborough, James T Maddux, Mark Sanz, Stephen Tahta, Matthew Maxwell, Bradley Berry, Joseph Knapp, Heidi Boehm, Mark Reisman, David Gartman, Joseph Teply, Amish Desai, Kier Huehnergarth, Kimberly Krabill, Inger Rasmussen, Peter Fail, Tommy Fudge, Kerry Paape, Michael Trotter, Eric Engeron, Monique Robert, Deanna K Benoit, Eric Horlick, Tirone David, Melitta Mezody, Kristeen Chamberlain, Reginald Low, Jason Rogers, J Nilas Young, Kuppe Shankar, William Bommer, Thomas Smith, Sandhya Venugopal, Kimberly Book, Kori Harder, John D Carroll, Joseph Cleveland, David Fullerton, Robert Quaife, Ernesto Salcedo, Kelly Jones, Howard Herrmann, Michael Acker, Y Joseph Woo, Frank E Silvestry, Susan E Wiegers, Judi Willhide, Terry Mannion, Steven R Bailey, John Calhoun, Edward Sako, John Erikson, Gus Banda, D Scott Lim, Irving L Kron, John Dent, Linda Bailes, Eric Fretz, John G Ofiesh, Manjeet Mann, Liz Martin, Kenneth Kent, Lowell Satler, Augusto Pichard, Ammar Bafi, Steven Boyce, Pamela Sears-Rogan, Stephen Goldstein, Petros Okubagzi, John Lasala, Marc Moon, Ralph Damiano, Benicio Barzilai, Brian Lindman, Jose Madrazo, Alan Zajarias, Michelle Myers, Kim Striler, George Hanzel, Marc Sakwa, Francis Shannon, Michael Gallagher, Pamela Markovitz, Amr Abbas, Hong Huang
Abstract
Background: Mitral-valve repair can be accomplished with an investigational procedure that involves the percutaneous implantation of a clip that grasps and approximates the edges of the mitral leaflets at the origin of the regurgitant jet.
Methods: We randomly assigned 279 patients with moderately severe or severe (grade 3+ or 4+) mitral regurgitation in a 2:1 ratio to undergo either percutaneous repair or conventional surgery for repair or replacement of the mitral valve. The primary composite end point for efficacy was freedom from death, from surgery for mitral-valve dysfunction, and from grade 3+ or 4+ mitral regurgitation at 12 months. The primary safety end point was a composite of major adverse events within 30 days.
Results: At 12 months, the rates of the primary end point for efficacy were 55% in the percutaneous-repair group and 73% in the surgery group (P=0.007). The respective rates of the components of the primary end point were as follows: death, 6% in each group; surgery for mitral-valve dysfunction, 20% versus 2%; and grade 3+ or 4+ mitral regurgitation, 21% versus 20%. Major adverse events occurred in 15% of patients in the percutaneous-repair group and 48% of patients in the surgery group at 30 days (P<0.001). At 12 months, both groups had improved left ventricular size, New York Heart Association functional class, and quality-of-life measures, as compared with baseline.
Conclusions: Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes. (Funded by Abbott Vascular; EVEREST II ClinicalTrials.gov number, NCT00209274.).
Source: PubMed