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

Research output: Contribution to journalArticle

268 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)317-328
Number of pages12
JournalJournal of the American College of Cardiology
Volume62
Issue number4
DOIs
StatePublished - Jul 23 2013

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Mitral Valve Insufficiency
Randomized Controlled Trials
Mitral Valve
Equipment and Supplies
Heart Valve Diseases
Mortality
Therapeutics
Safety
Population

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 journalArticle

Mauri, L, Foster, E, Glower, DD, Apruzzese, P, Massaro, JM, Herrmann, HC, Hermiller, J, Gray, W, Wang, A, Pedersen, WR, Bajwa, T, Lasala, J, Low, R, Grayburn, P & Feldman, T 2013, '4-Year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation', Journal of the American College of Cardiology, vol. 62, no. 4, pp. 317-328. https://doi.org/10.1016/j.jacc.2013.04.030
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. / 4-Year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. In: Journal of the American College of Cardiology. 2013 ; Vol. 62, No. 4. pp. 317-328.
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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)",
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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

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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

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