Percutaneous Mitral Repair With the MitraClip System. Safety and Midterm Durability in the Initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) Cohort

Ted Feldman, Saibal Kar, Michael Rinaldi, Peter Fail, James Hermiller, Richard Smalling, Patrick L. Whitlow, William Gray, Reginald Low, Howard C. Herrmann, Scott Lim, Elyse Foster, Donald Glower

Research output: Contribution to journalArticle

596 Citations (Scopus)

Abstract

Objectives: We undertook a prospective multicenter single-arm study to evaluate the feasibility, safety, and efficacy of the MitraClip system (Evalve Inc., Menlo Park, California). Background: Mitral valve repair for mitral regurgitation (MR) has been performed by the use of a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed by use of the Evalve MitraClip device to secure the mitral leaflets. Methods: Patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines for intervention and a core echocardiographic laboratory. Results: A total of 107 patients were treated. Ten (9%) had a major adverse event, including 1 nonprocedural death. Freedom from clip embolization was 100%. Partial clip detachment occurred in 10 (9%) patients. Overall, 79 of 107 (74%) patients achieved acute procedural success, and 51 (64%) were discharged with MR of ≤1+. Thirty-two patients (30%) had mitral valve surgery during the 3.2 years after clip procedures. When repair was planned, 84% (21 of 25) were successful. Thus, surgical options were preserved. A total of 50 of 76 (66%) successfully treated patients were free from death, mitral valve surgery, or MR >2+ at 12 months (primary efficacy end point). Kaplan-Meier freedom from death was 95.9%, 94.0%, and 90.1%, and Kaplan-Meier freedom from surgery was 88.5%, 83.2%, and 76.3% at 1, 2, and 3 years, respectively. The 23 patients with functional MR had similar acute results and durability. Conclusions: Percutaneous repair with the MitraClip system can be accomplished with low rates of morbidity and mortality and with acute MR reduction to < 2+ in the majority of patients, and with sustained freedom from death, surgery, or recurrent MR in a substantial proportion (EVEREST I; NCT00209339. EVEREST II; NCT00209274).

Original languageEnglish (US)
Pages (from-to)686-694
Number of pages9
JournalJournal of the American College of Cardiology
Volume54
Issue number8
DOIs
StatePublished - Aug 18 2009

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Mitral Valve Insufficiency
Cohort Studies
Safety
Surgical Instruments
Mitral Valve
Guidelines
Morbidity
Equipment and Supplies
Mortality

Keywords

  • mitral regurgitation
  • mitral repair
  • percutaneous valve therapy

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Percutaneous Mitral Repair With the MitraClip System. Safety and Midterm Durability in the Initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) Cohort. / Feldman, Ted; Kar, Saibal; Rinaldi, Michael; Fail, Peter; Hermiller, James; Smalling, Richard; Whitlow, Patrick L.; Gray, William; Low, Reginald; Herrmann, Howard C.; Lim, Scott; Foster, Elyse; Glower, Donald.

In: Journal of the American College of Cardiology, Vol. 54, No. 8, 18.08.2009, p. 686-694.

Research output: Contribution to journalArticle

Feldman, T, Kar, S, Rinaldi, M, Fail, P, Hermiller, J, Smalling, R, Whitlow, PL, Gray, W, Low, R, Herrmann, HC, Lim, S, Foster, E & Glower, D 2009, 'Percutaneous Mitral Repair With the MitraClip System. Safety and Midterm Durability in the Initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) Cohort', Journal of the American College of Cardiology, vol. 54, no. 8, pp. 686-694. https://doi.org/10.1016/j.jacc.2009.03.077
Feldman, Ted ; Kar, Saibal ; Rinaldi, Michael ; Fail, Peter ; Hermiller, James ; Smalling, Richard ; Whitlow, Patrick L. ; Gray, William ; Low, Reginald ; Herrmann, Howard C. ; Lim, Scott ; Foster, Elyse ; Glower, Donald. / Percutaneous Mitral Repair With the MitraClip System. Safety and Midterm Durability in the Initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) Cohort. In: Journal of the American College of Cardiology. 2009 ; Vol. 54, No. 8. pp. 686-694.
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abstract = "Objectives: We undertook a prospective multicenter single-arm study to evaluate the feasibility, safety, and efficacy of the MitraClip system (Evalve Inc., Menlo Park, California). Background: Mitral valve repair for mitral regurgitation (MR) has been performed by the use of a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed by use of the Evalve MitraClip device to secure the mitral leaflets. Methods: Patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines for intervention and a core echocardiographic laboratory. Results: A total of 107 patients were treated. Ten (9{\%}) had a major adverse event, including 1 nonprocedural death. Freedom from clip embolization was 100{\%}. Partial clip detachment occurred in 10 (9{\%}) patients. Overall, 79 of 107 (74{\%}) patients achieved acute procedural success, and 51 (64{\%}) were discharged with MR of ≤1+. Thirty-two patients (30{\%}) had mitral valve surgery during the 3.2 years after clip procedures. When repair was planned, 84{\%} (21 of 25) were successful. Thus, surgical options were preserved. A total of 50 of 76 (66{\%}) successfully treated patients were free from death, mitral valve surgery, or MR >2+ at 12 months (primary efficacy end point). Kaplan-Meier freedom from death was 95.9{\%}, 94.0{\%}, and 90.1{\%}, and Kaplan-Meier freedom from surgery was 88.5{\%}, 83.2{\%}, and 76.3{\%} at 1, 2, and 3 years, respectively. The 23 patients with functional MR had similar acute results and durability. Conclusions: Percutaneous repair with the MitraClip system can be accomplished with low rates of morbidity and mortality and with acute MR reduction to < 2+ in the majority of patients, and with sustained freedom from death, surgery, or recurrent MR in a substantial proportion (EVEREST I; NCT00209339. EVEREST II; NCT00209274).",
keywords = "mitral regurgitation, mitral repair, percutaneous valve therapy",
author = "Ted Feldman and Saibal Kar and Michael Rinaldi and Peter Fail and James Hermiller and Richard Smalling and Whitlow, {Patrick L.} and William Gray and Reginald Low and Herrmann, {Howard C.} and Scott Lim and Elyse Foster and Donald Glower",
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T1 - Percutaneous Mitral Repair With the MitraClip System. Safety and Midterm Durability in the Initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) Cohort

AU - Feldman, Ted

AU - Kar, Saibal

AU - Rinaldi, Michael

AU - Fail, Peter

AU - Hermiller, James

AU - Smalling, Richard

AU - Whitlow, Patrick L.

AU - Gray, William

AU - Low, Reginald

AU - Herrmann, Howard C.

AU - Lim, Scott

AU - Foster, Elyse

AU - Glower, Donald

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N2 - Objectives: We undertook a prospective multicenter single-arm study to evaluate the feasibility, safety, and efficacy of the MitraClip system (Evalve Inc., Menlo Park, California). Background: Mitral valve repair for mitral regurgitation (MR) has been performed by the use of a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed by use of the Evalve MitraClip device to secure the mitral leaflets. Methods: Patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines for intervention and a core echocardiographic laboratory. Results: A total of 107 patients were treated. Ten (9%) had a major adverse event, including 1 nonprocedural death. Freedom from clip embolization was 100%. Partial clip detachment occurred in 10 (9%) patients. Overall, 79 of 107 (74%) patients achieved acute procedural success, and 51 (64%) were discharged with MR of ≤1+. Thirty-two patients (30%) had mitral valve surgery during the 3.2 years after clip procedures. When repair was planned, 84% (21 of 25) were successful. Thus, surgical options were preserved. A total of 50 of 76 (66%) successfully treated patients were free from death, mitral valve surgery, or MR >2+ at 12 months (primary efficacy end point). Kaplan-Meier freedom from death was 95.9%, 94.0%, and 90.1%, and Kaplan-Meier freedom from surgery was 88.5%, 83.2%, and 76.3% at 1, 2, and 3 years, respectively. The 23 patients with functional MR had similar acute results and durability. Conclusions: Percutaneous repair with the MitraClip system can be accomplished with low rates of morbidity and mortality and with acute MR reduction to < 2+ in the majority of patients, and with sustained freedom from death, surgery, or recurrent MR in a substantial proportion (EVEREST I; NCT00209339. EVEREST II; NCT00209274).

AB - Objectives: We undertook a prospective multicenter single-arm study to evaluate the feasibility, safety, and efficacy of the MitraClip system (Evalve Inc., Menlo Park, California). Background: Mitral valve repair for mitral regurgitation (MR) has been performed by the use of a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed by use of the Evalve MitraClip device to secure the mitral leaflets. Methods: Patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines for intervention and a core echocardiographic laboratory. Results: A total of 107 patients were treated. Ten (9%) had a major adverse event, including 1 nonprocedural death. Freedom from clip embolization was 100%. Partial clip detachment occurred in 10 (9%) patients. Overall, 79 of 107 (74%) patients achieved acute procedural success, and 51 (64%) were discharged with MR of ≤1+. Thirty-two patients (30%) had mitral valve surgery during the 3.2 years after clip procedures. When repair was planned, 84% (21 of 25) were successful. Thus, surgical options were preserved. A total of 50 of 76 (66%) successfully treated patients were free from death, mitral valve surgery, or MR >2+ at 12 months (primary efficacy end point). Kaplan-Meier freedom from death was 95.9%, 94.0%, and 90.1%, and Kaplan-Meier freedom from surgery was 88.5%, 83.2%, and 76.3% at 1, 2, and 3 years, respectively. The 23 patients with functional MR had similar acute results and durability. Conclusions: Percutaneous repair with the MitraClip system can be accomplished with low rates of morbidity and mortality and with acute MR reduction to < 2+ in the majority of patients, and with sustained freedom from death, surgery, or recurrent MR in a substantial proportion (EVEREST I; NCT00209339. EVEREST II; NCT00209274).

KW - mitral regurgitation

KW - mitral repair

KW - percutaneous valve therapy

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