The EVEREST II Trial: Design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation

Mauri, Laura; Garg, Pallav; Massaro, Joseph M.; Foster, Elyse; Glower, Donald D.; Mehoudar, Paul; Powell, F.R.C.P.C. Julie; Komtebedde, Jan; McDermott, Elizabeth; Feldman, Ted

doi:10.1016/j.ahj.2010.04.009

Cited by 179 publications

(85 citation statements)

References 31 publications

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“…Key anatomic inclusion criteria included a regurgitant jet origin associated with the A2-P2 segments of the mitral valve, and for patients with functional MR, a coaptation length of ≥2 mm and a coaptation depth of not >11 mm, and for patients with leaflet flail, a flail gap <10 mm and a flail width <15 mm. 9 LV volumes and ejection fraction were measured using the biplane method of discs. The sphericity index was computed as the ratio of the maximal LV minor to major dimension (end-diastole) from both the 4-chamber and the 2-chamber views.…”

Section: Echocardiographymentioning

confidence: 99%

Percutaneous Mitral Valve Repair in the Initial EVEREST Cohort

Foster

Kwan

Feldman

et al. 2013

Circ: Cardiovascular Imaging

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Percutaneous repair of MR with the MitraClip system (Abbott Vascular, Menlo Park) offers a potential therapy for patients with 3 to 4+ MR. Safety and effectiveness outcomes in these patients have been previously reported from the Endovascular Valve Edge-to-Edge Repair Study (EVEREST) Clinical Trial, including a single-arm feasibility study, 2 a randomized controlled trial comparing the treatment with mitral Background-Percutaneous repair of mitral regurgitation (MR) permits examination of the effect of MR reduction without surgery and cardiopulmonary bypass on left ventricular (LV) dimensions and function. The goal of this analysis was to determine the extent of reverse remodeling at 12 months after successful percutaneous reduction of MR with the MitraClip device. Methods and Results-Of 64 patients with 3 and 4+ MR who achieved acute procedural success after treatment with the MitraClip device, 49 patients had moderate or less MR at 12-month follow-up. Their baseline and 12-month echocardiograms were compared between the group with and without LV dysfunction. In patients with persistent MR reduction and preexisting LV dysfunction, there was a reduction in LV wall stress, reduced LV end-diastolic volume, LV end-systolic volume and increase in LV ejection fraction in contrast to those with normal baseline LV function, who showed reduction in LV end-diastolic volume, LV wall stress, no change in LV end-systolic volume, and a fall in LV ejection fraction. Percutaneous reduction of MR with the MitraClip procedure provides a unique opportunity to examine the extent of reverse LV remodeling in the absence of surgical intervention. We hypothesized that sustained MR reduction would be associated with significant reversal in LV remodeling and sought to investigate the impact of pre-existing LV dysfunction on the extent of reverse remodeling. The primary aim of this analysis was to determine the extent of reverse remodeling at 12 months after successful percutaneous reduction of MR (acute procedural success [APS]) with the MitraClip device. We compared changes in indices of LV remodeling at baseline, and at 12 months, in APS patients with and without sustained 12-month MR reduction. In addition, we compared the extent of remodeling associated with sustained MR reduction in APS patients with and without baseline LV dysfunction. The patients in the EVEREST I safety and feasibility study and those in the roll-in phase of the EVEREST II randomized controlled trial form the basis of the current study. Patients in these studies were followed with echocardiography at prespecified time points, and all of the echo studies were evaluated in a core laboratory as previously described. Conclusions-Patients 5 Methods Study DesignThe study includes 55 patients from EVEREST I, a prospective multicenter, single-arm feasibility study and 52 patients from the roll-in Figure 1. The MitraClip System. A, The MitraClip System is composed by a sophisticated triaxial catheter system (steerable guide catheter and clip delivery system catheter) an...

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Section: Echocardiographymentioning

confidence: 99%

Percutaneous Mitral Valve Repair in the Initial EVEREST Cohort

Foster

Kwan

Feldman

et al. 2013

Circ: Cardiovascular Imaging

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“…Patients with an ejection fraction of less than 25% were excluded and several anatomical criteria were required [44]. For example, primary leaflet malcoaptation could involve the A2 and P2 scallops only.…”

Section: Edge-to-edge (Double Orifice) Repairmentioning

confidence: 99%

Percutaneous approaches to mitral valve regurgitation

Bertog

Franke

Steinberg

et al. 2011

Herz

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Mitral regurgitation is a common problem associated with significant morbidity and mortality. Mitral valve surgery has been the treatment of choice for symptomatic patients with severe mitral regurgitation or asymptomatic patients with high-risk clinical features. However, a significant number of patients remain untreated related mainly due to a projected high surgical risk. Therefore, alternative percutaneous treatments including indirect annuloplasty, which takes advantage of the coronary sinus, and direct annuloplasty have recently been explored. Most recently, promising results of the first randomized trial comparing conventional mitral valve surgery to percutaneous therapy with a clip creating a double orifice much like the surgical Alfieri approach have been presented. Finally, percutaneous mitral valve replacement in an animal model has been pursued. This review serves to familiarize the reader with some anatomical concepts and devices for percutaneous mitral repair.

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“…The Mitraclip system is a catheter based device designed to create a double orifice valve using a user friendly and echo guided approach. The device has been evaluated in a number of preclinical studies and in FDA approved clinical trials [7][8][9][10][11][12] and has been available for clinical use in Europe since September 2008, after receipt of the CE mark. To date, over 2,000 MitraClip implants have been performed worldwide, mainly in high-risk surgical patients.…”

Section: Introductionmentioning

confidence: 99%

Clinical trial experience with the MitraClip catheter based mitral valve repair system

Godino¹,

Giacomini²,

Denti³

et al. 2011

Int J Cardiovasc Imaging

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Severe mitral regurgitation (MR) confers a poor prognosis, in particular for patients with heart failure. Based on the results of the Euro Heart Survey, a large proportion of patients with mitral regurgitation is not referred to surgery and many other patients are rejected for cardiac surgery due to the high surgical risk or co-pathologies. Improving ventricular function with ACE inhibitors, beta-blockers and CRT may reduce mitral regurgitation, but for most patients a mechanical intervention is ultimately preferable. Mitral valve surgery is invasive and requires a long recovery period; therefore, less invasive and effective approaches are highly desirable, particularly in high risk patients. Therefore, new techniques have been recently developed to treat MR with percutaneous approach. The MitraClip device (Abbott Vascular, Menlo Park, CA) is used to treat both functional and degenerative mitral valve regurgitation. Its safety and efficacy has been initially tested in the Endovascular Valve Edge-to-Edge REpair Study (EVEREST), while MitraClip has been compared to surgery in the EVEREST II randomized trial. Besides EVEREST trials, safety and efficacy of the device as well as its health economic value is under evaluation in ongoing registries. Although the field of catheter based management of MR is at an early stage, initial clinical results have demonstrated that catheter based approaches can reduce MR, suggesting there is a great deal of potential for clinical benefit to patients with MR.

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The EVEREST II Trial: Design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation

Cited by 179 publications

References 31 publications

Percutaneous Mitral Valve Repair in the Initial EVEREST Cohort

Percutaneous Mitral Valve Repair in the Initial EVEREST Cohort

Percutaneous approaches to mitral valve regurgitation

Clinical trial experience with the MitraClip catheter based mitral valve repair system

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