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)
| Original language | English (US) |
|---|---|
| Pages (from-to) | 317-328 |
| Number of pages | 12 |
| Journal | Journal of the American College of Cardiology |
| Volume | 62 |
| Issue number | 4 |
| DOIs | |
| State | Published - Jul 23 2013 |
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Keywords
- mitral regurgitation
- mitral repair
- percutaneous valve therapy
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
4-Year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. / Mauri, Laura; Foster, Elyse; Glower, Donald D.; Apruzzese, Patricia; Massaro, Joseph M.; Herrmann, Howard C.; Hermiller, James; Gray, William; Wang, Andrew; Pedersen, Wesley R.; Bajwa, Tanvir; Lasala, John; Low, Reginald; Grayburn, Paul; Feldman, Ted.
In: Journal of the American College of Cardiology, Vol. 62, No. 4, 23.07.2013, p. 317-328.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - 4-Year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation
AU - Mauri, Laura
AU - Foster, Elyse
AU - Glower, Donald D.
AU - Apruzzese, Patricia
AU - Massaro, Joseph M.
AU - Herrmann, Howard C.
AU - Hermiller, James
AU - Gray, William
AU - Wang, Andrew
AU - Pedersen, Wesley R.
AU - Bajwa, Tanvir
AU - Lasala, John
AU - Low, Reginald
AU - Grayburn, Paul
AU - Feldman, Ted
PY - 2013/7/23
Y1 - 2013/7/23
N2 - 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)
AB - 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)
KW - mitral regurgitation
KW - mitral repair
KW - percutaneous valve therapy
UR - http://www.scopus.com/inward/record.url?scp=84880320907&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84880320907&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2013.04.030
DO - 10.1016/j.jacc.2013.04.030
M3 - Article
C2 - 23665364
AN - SCOPUS:84880320907
VL - 62
SP - 317
EP - 328
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 4
ER -