Display Settings:

Format

Send to:

Choose Destination
See comment in PubMed Commons below
N Engl J Med. 2011 Apr 14;364(15):1395-406. doi: 10.1056/NEJMoa1009355. Epub 2011 Apr 4.

Percutaneous repair or surgery for mitral regurgitation.

Collaborators (282)

Foster E, Viloria E, Feldman T, Alexander J, Chedrawy EG, Lampert MB, Smart S, Zunamon A, Focks C, Seifert D, Garnier B, Wang A, Glower D, Milano C, Jollis J, Ryan T, Glisson D, Herron A, Wang S, Byrne T, Tibi P, Fang HK, Morgan JM, Diaz G, Mangum H, Quesada R, Moreno N, Machado R, Aridid MI, Grayburn P, Anwar A, Hamman B, Hebeler RF, Grayburn P, Aston S, Eisenhauer A, Cohn L, Davidson M, Mangion J, Wu J, Cinamon D, Sampong T, Hermiller J, Allen K, Heimansohn D, Bates J, Segar D, Taliercio C, Taylor A, Rinaldi MJ, Skipper E, Steigel RM, Rose G, Schwarz G, Michel T, Kar S, Makkar R, Trento A, Cheng W, Fontana G, Kass R, Siegel R, Tolstrup K, Naqvi T, Davis K, Hussaini A, Remba D, Whitlow P, Kapadia S, Tuzcu EM, Gillinov M, Mihaljevic T, Rodriquez L, Stewart W, Brezina K, Rittwage L, Gray W, Schwartz A, Wasserman H, Argenziano M, Naka Y, Smith C, Stewart A, Williams M, Homma S, Pizzarello R, Gillam L, Hahn B, Goyal N, Escala E, Kamanda-Kosseh M, Lucca-Susana M, Babaliaros V, Ghazzal Z, Vassiliades T, Latouff O, Puskas J, Lerakis S, Clements S, Martin R, Merlino J, Hyde P, Whisenant B, Clayson S, Horton SC, Johnson E, Smalling R, Letsou G, Walkes JC, Loghin C, Hamilton A, Vooletich M, Ahobila-Vajjula P, Pedersen W, Eates F, Flavin T, Kroshus T, Kshettry V, Bae R, Harris K, Jay D, Olson S, Demmer P, Nass O, Gangahar D, Jex RK, Ayala K, Krenk S, Wong SC, Bergman G, Girardi L, Isom OW, Krieger K, Salemi A, Skubas N, Devereux R, Reynolds DT, Slater J, Galloway A, Kronzon I, Perk G, Hager K, Weisman E, Yung CL, Ramee S, Parrino E, Gilliland Y, Shah S, Hirstius B, Ventura L, Kipperman R, Ghani M, Bodenhamer RM, Lucas S, Randolph J, Williams J, Hanes S, Leung R, MacArthur R, Mullen J, Ross D, Choy J, Jones A, Taylor D, Williams R, Kvill L, Law A, Kramer P, Castlemain B, Schwartz A, Crouse L, Totta C, Salkind M, Willson T, Berke A, Colangelo R, Damus P, Fernandez H, Robinson N, Taylor J, Gopal A, Katz A, Mihalatos D, Haag E, McLaughlin J, Norales A, Qureshi M, Pruitt A, Kong B, McAllister B, Girard S, Carulli C, Bajwa T, Allaqaband S, Kress D, O'Hair D, Sagar K, Oxborough S, Maddux JT, Sanz M, Tahta S, Maxwell M, Berry B, Knapp J, Boehm H, Reisman M, Gartman D, Teply J, Desai A, Huehnergarth K, Krabill K, Rasmussen I, Fail P, Fudge T, Paape K, Trotter M, Engeron E, Robert M, Benoit DK, Horlick E, David T, Mezody M, Chamberlain K, Low R, Rogers J, Young JN, Shankar K, Bommer W, Smith T, Venugopal S, Book K, Harder K, Carroll JD, Cleveland J, Fullerton D, Quaife R, Salcedo E, Jones K, Herrmann H, Acker M, Woo YJ, Silvestry FE, Wiegers SE, Willhide J, Mannion T, Bailey SR, Calhoun J, Sako E, Erikson J, Banda G, Lim DS, Kron IL, Dent J, Bailes L, Fretz E, Ofiesh JG, Mann M, Martin L, Kent K, Satler L, Pichard A, Bafi A, Boyce S, Sears-Rogan P, Goldstein S, Okubagzi P, Lasala J, Moon M, Damiano R, Barzilai B, Lindman B, Madrazo J, Zajarias A, Myers M, Striler K, Hanzel G, Sakwa M, Shannon F, Gallagher M, Markovitz P, Abbas A, Huang H.

Author information

  • 1Evanston Hospital, NorthShore University Health System, Evanston, IL 60201, USA. tfeldman@northshore.org

Erratum in

  • N Engl J Med. 2011 Jul 14;365(2):189. Glower, Donald G [corrected to Glower, Donald D].

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.).

Comment in

PMID:
21463154
[PubMed - indexed for MEDLINE]
Free full text
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Atypon
    Loading ...
    Write to the Help Desk