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

Cleveland Clinic, Ohio 44195, USA.
Journal of the American College of Cardiology (Impact Factor: 16.5). 01/2012; 59(2):130-9. DOI: 10.1016/j.jacc.2011.08.067
Source: PubMed


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.
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.
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.
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).
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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Available from: Samir Kapadia
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    • "The minimally invasive MitraClip system has been evaluated in several observational studies in these subjects. The third arm of the EVEREST II study (EVEREST High Risk Study – EVEREST-HRS) had an observational prospective design and included patients who fulfilled the echocardiographic eligibility criteria for a MitraClip procedure and for whom estimated surgical mortality risk was ≥ 12% (> 50% had prior cardiac surgery) [11]. Overall, 78 patients predominantly with functional regurgitation were treated with MitraClip implantation. "
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    ABSTRACT: The percutaneous edge-to-edge repair of mitral regurgitation with a MitraClip device has been recently approved in Europe. The results of the randomized EVEREST II study showed a favourable safety profile of the technique. However, the efficacy in terms of regurgitation reduction in a population with predominantly degenerative mitral disease was inferior as compared to the results of conventional open heart surgery. Nevertheless, up to 50% of symptomatic heart failure patients with severe mainly functional mitral regurgitation are not treated surgically because of very high procedural risk. The registry data suggest that the minimally invasive and generally well-tolerated MitraClip procedure reduces symptoms and need for recurrent hospitalization and improves left ventricular function in inoperable subjects. The ongoing randomized clinical trials with clinical endpoints will further define the current role of percutaneous edge-to-edge repair in heart failure patients with mitral regurgitation.
    Full-text · Article · Nov 2013 · Postepy w Kardiologii Interwencyjnej / Advances in Interventional Cardiology
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    • "One of the arms of this study, EVEREST II HRS, focused on patients at the highest risk of surgery including those with impaired left ventricular systolic function, which was a population similar to the 3 cases presented here. A control group consisted of patients with similar clinical characteristics, who were not included in the study [10]. At 1 year patients who received a clip had higher survival in comparison to those treated conservatively (76% vs. 55%) and better exercise capacity with maximal MR of 2nd degree achieved in 78% of patients. "
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    ABSTRACT: Treatment of hemodynamically significant valvular heart diseases has been the domain of cardiac surgery for decades. However, a promising novel method is the MitraClip system, involving percutaneous connection of insufficient valve leaflets with special cobalt-chrome clips. Our study presents clinical characteristics, course of treatment with the MitraClip system, and immediate and 90-day clinical and echocardiographic follow-up of the first 3 patients treated in our institution. Subsequently, based on data from the literature and our own experience, the current position around the world, and the target group of patients who are most likely to benefit from treatment using the MitraClip system, are discussed.
    Full-text · Article · Jun 2013 · Postepy w Kardiologii Interwencyjnej / Advances in Interventional Cardiology
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    • "For large orifices more clips can be used to effectively reduce regurgitant volume [4]. The Everest studies I and II demonstrated the safety and efficacy of the procedure [5]. Furthermore, Ussia et al. demonstrated an improvement in quality of life in high surgical risk patients undergoing the MitraClip procedure [6]. "
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    ABSTRACT: Background In the last recent years a new percutaneous procedure, the MitraClip, has been validated for the treatment of mitral regurgitation. MitraClip procedure is a promising alternative for patients unsuitable for surgery as it reduces the risk of death related to surgery ensuring a similar result. Few data are present in literature about the variation of hemodynamic parameters and ventricular coupling after Mitraclip implantation. Methods Hemodynamic data of 18 patients enrolled for MitraClip procedure were retrospectively reviewed and analyzed. Echocardiographic measurements were obtained the day before the procedure (T0) and 21 ± 3 days after the procedure (T1), including evaluation of Ejection Fraction, mitral valve regurgitation severity and mechanism, forward Stroke Volume, left atrial volume, estimated systolic pulmonary pressure, non invasive echocardiographic estimation of single beat ventricular elastance (Es(sb)), arterial elastance (Ea) measured as systolic pressure • 0.9/ Stroke Volume, ventricular arterial coupling (Ea/Es(sb) ratio). Data were expressed as median and interquartile range. Measures obtained before and after the procedure were compared using Wilcoxon non parametric test for paired samples. Results Mitraclip procedure was effective in reducing regurgitation. We observed an amelioration of echocardiographic parameters with a reduction of estimated systolic pulmonary pressure (45 to 37,5 p = 0,0002) and left atrial volume (110 to 93 p = 0,0001). Despite a few cases decreasing in ejection fraction (37 to 35 p = 0,035), the maintained ventricular arterial coupling after the procedure (P = 0,67) was associated with an increasing in forward stroke volume (60,3 to 78 p = 0,05). Conclusion MitraClip is effective in reducing mitral valve regurgitation and determines an amelioration of hemodynamic parameters with preservation of ventricular arterial coupling.
    Full-text · Article · May 2013 · Cardiovascular Ultrasound
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