EVEREST II randomized clinical trial: Predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure
ABSTRACT The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement.
Of 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group.
The rate of percutaneous or surgical MV repair at 1 year was 89% (158/178) in patients initially receiving the MitraClip device versus 84% (67/80) in the surgical patients (P = .36). Surgical repair was performed after the MitraClip procedure in 20 (54%) of 37 patients (P < .001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology (P = .035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5%) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure.
These data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.
SourceAvailable from: Giuseppe Bruschi[Show abstract] [Hide abstract]
ABSTRACT: New percutaneous technologies are rapidly emerging for the treatment of structural heart disease including mitral valve disease. Preliminary data suggest a potential clinical benefit of percutaneous treatment of mitral regurgitation by the MitraClip procedure in selected patients. Until final data are available from randomized, controlled, multicenter clinical trials, there is an urgent need for a consensus among all the operators involved in the treatment of patients with mitral regurgitation, including clinical cardiologists, heart failure specialists, surgeons, interventional cardiologists, and imaging experts. In the absence of evidence-based guidelines, the heart-team approach is the most reliable method of making proper decisions. This study is the result of multidisciplinary consensus activity, and has the aim of helping physicians in the difficult task of making decisions for the treatment of patients with mitral regurgitation. It is the result of a joint effort of the major Italian Cardiology and Cardiac Surgery Societies, working together to find a proper balance between the points of view of the clinical cardiologist, the interventional cardiologist, and the cardiac surgeon.Journal of Cardiovascular Medicine 03/2014; 15(3). DOI:10.2459/JCM.0000000000000004 · 1.41 Impact Factor
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ABSTRACT: Surgical repair is considered the gold standard in severe mitral valve regurgitation. Multi organ failure due to acute mitral insufficiency however can be challenging to manage as it aggravates to an inoperable state. We report the case of a 59 year old woman which presented with pulmonary oedema due to high grade mitral regurgitation. A recompensation prior to surgery using medical therapy failed and the patient developed a progressive multi organ failure including pulmonary, circulatory and renal failure within days. Symptomatically, our patient could be stabilized employing an extracorporeal membrane oxygenation and an intra-aortic balloon pump. A surgical mitral valve repair was ruled out due to the multi organ failure. We performed an interventional valve reconstruction using the MitraClip™ device continuing the extracorporeal membrane oxygenation and the intra-aortic balloon counterpulsation therapy during the procedure. After clipping, multi organ failure regressed and the extracorporeal membrane oxygenation could be explanted at day two after intervention. © 2013 Wiley Periodicals, Inc.Catheterization and Cardiovascular Interventions 01/2015; 85(1). DOI:10.1002/ccd.25332 · 2.51 Impact Factor
The Journal of thoracic and cardiovascular surgery 03/2014; 147(3):850–852. DOI:10.1016/j.jtcvs.2013.12.001 · 3.41 Impact Factor