Acute and 12-month results with catheter-based mitral valve leaflet repair: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study

Patrick L. Whitlow, Ted Feldman, Wes R. Pedersen, D. Scott Lim, Robert Kipperman, Richard Smalling, Tanvir Bajwa, Howard C. Herrmann, John Lasala, James T. Maddux, Murat Tuzcu, Samir Kapadia, Alfredo Trento, Robert J. Siegel, Elyse Foster, Donald Glower, Laura Mauri, Saibal Kar

Research output: Contribution to journalArticle

365 Citations (Scopus)

Abstract

Objectives: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. Background: Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. Methods: Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. Results: Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034). Conclusions: The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).

Original languageEnglish (US)
Pages (from-to)130-139
Number of pages10
JournalJournal of the American College of Cardiology
Volume59
Issue number2
DOIs
StatePublished - Jan 10 2012
Externally publishedYes

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Mitral Valve
Mitral Valve Insufficiency
Catheters
Mortality
Equipment and Supplies
Ventricular Remodeling
Stroke Volume
Thoracic Surgery
Blood Vessels
Hospitalization
Cohort Studies
Survival Rate
Heart Failure
Quality of Life
Safety
Survival

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Whitlow, Patrick L. ; Feldman, Ted ; Pedersen, Wes R. ; Lim, D. Scott ; Kipperman, Robert ; Smalling, Richard ; Bajwa, Tanvir ; Herrmann, Howard C. ; Lasala, John ; Maddux, James T. ; Tuzcu, Murat ; Kapadia, Samir ; Trento, Alfredo ; Siegel, Robert J. ; Foster, Elyse ; Glower, Donald ; Mauri, Laura ; Kar, Saibal. / Acute and 12-month results with catheter-based mitral valve leaflet repair : The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. In: Journal of the American College of Cardiology. 2012 ; Vol. 59, No. 2. pp. 130-139.
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abstract = "Objectives: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. Background: Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. Methods: Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12{\%} were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. Results: Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50{\%} had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96{\%} of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2{\%} and 17.4{\%}, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2{\%} and 14.9{\%}, respectively. The 30-day procedure-related mortality rate was 7.7{\%} in the HRS and 8.3{\%} in the comparator group (p = NS). The 12-month survival rate was 76{\%} in the HRS and 55{\%} in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78{\%} had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89{\%} to class I/II in 74{\%} (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034). Conclusions: The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).",
author = "Whitlow, {Patrick L.} and Ted Feldman and Pedersen, {Wes R.} and Lim, {D. Scott} and Robert Kipperman and Richard Smalling and Tanvir Bajwa and Herrmann, {Howard C.} and John Lasala and Maddux, {James T.} and Murat Tuzcu and Samir Kapadia and Alfredo Trento and Siegel, {Robert J.} and Elyse Foster and Donald Glower and Laura Mauri and Saibal Kar",
year = "2012",
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day = "10",
doi = "10.1016/j.jacc.2011.08.067",
language = "English (US)",
volume = "59",
pages = "130--139",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
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number = "2",

}

Whitlow, PL, Feldman, T, Pedersen, WR, Lim, DS, Kipperman, R, Smalling, R, Bajwa, T, Herrmann, HC, Lasala, J, Maddux, JT, Tuzcu, M, Kapadia, S, Trento, A, Siegel, RJ, Foster, E, Glower, D, Mauri, L & Kar, S 2012, 'Acute and 12-month results with catheter-based mitral valve leaflet repair: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study', Journal of the American College of Cardiology, vol. 59, no. 2, pp. 130-139. https://doi.org/10.1016/j.jacc.2011.08.067

Acute and 12-month results with catheter-based mitral valve leaflet repair : The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. / Whitlow, Patrick L.; Feldman, Ted; Pedersen, Wes R.; Lim, D. Scott; Kipperman, Robert; Smalling, Richard; Bajwa, Tanvir; Herrmann, Howard C.; Lasala, John; Maddux, James T.; Tuzcu, Murat; Kapadia, Samir; Trento, Alfredo; Siegel, Robert J.; Foster, Elyse; Glower, Donald; Mauri, Laura; Kar, Saibal.

In: Journal of the American College of Cardiology, Vol. 59, No. 2, 10.01.2012, p. 130-139.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Acute and 12-month results with catheter-based mitral valve leaflet repair

T2 - The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study

AU - Whitlow, Patrick L.

AU - Feldman, Ted

AU - Pedersen, Wes R.

AU - Lim, D. Scott

AU - Kipperman, Robert

AU - Smalling, Richard

AU - Bajwa, Tanvir

AU - Herrmann, Howard C.

AU - Lasala, John

AU - Maddux, James T.

AU - Tuzcu, Murat

AU - Kapadia, Samir

AU - Trento, Alfredo

AU - Siegel, Robert J.

AU - Foster, Elyse

AU - Glower, Donald

AU - Mauri, Laura

AU - Kar, Saibal

PY - 2012/1/10

Y1 - 2012/1/10

N2 - Objectives: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. Background: Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. Methods: Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. Results: Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034). Conclusions: The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).

AB - Objectives: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. Background: Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. Methods: Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. Results: Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034). Conclusions: The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).

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