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صفحه اصلي > مقالات > مقالات خارجی >  Percutaneous Mitral Valve Repair 
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Percutaneous Mitral  Valve Repair for  Mitral Regurgitation in High-Risk Patients

 

Results of  the  EVEREST II Study

 

Donald D. Glower, MD,* Saibal Kar,  MD,y Alfredo Trento, MD,y D. Scott Lim,  MD,z Tanvir Bajwa, MD,xk Ramon Quesada, MD,{ Patrick L. Whitlow, MD,#  Michael J. Rinaldi, MD,** Paul Grayburn, MD,yy Michael J. Mack, MD,yy Laura Mauri, MD,zzxx Patrick M. McCarthy, MD,kk Ted Feldman, MD{{

 

 

ABSTRACT

 

 

BACKGROUND The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and  REALISM Continued Access Study  High-Risk Arm are prospective registries of patients who received  the  MitraClip device (Abbott Vascular,  Santa  Clara, California) for mitral  regurgitation (MR) in the  United  States.

 

OBJECTIVES The purpose of this  study  was to report 12-month outcomes in high-risk  patients treated with the percutaneous mitral  valve  edge-to-edge repair.

 

METHODS Patients with grades 3 to MR and a surgical mortality risk of $12%, based  on the Society of Thoracic Sur- geons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled.

 

RESULTS In the  studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly  (76     11 years of age),  with 70%  having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to #2þ in 86% of patients at discharge (n ¼ 325; p < 0.0001). Major adverse events at 30  days included death in 4.8%, myocardial infarction in 1.1%, and stroke  in 2.6%. At 12 months, MR was # in 84% of patients (n ¼ 225; p < 0.0001). From baseline to 12 months, left  ventricular (LV) end-diastolic volume  improved from  161     56 ml to 143     53 ml

(n ¼ 203; p < 0.0001) and LV end-systolic volume improved from 87     47 ml to 79     44 ml (n ¼ 202; p < 0.0001). New York Heart  Association  functional class  improved from  82%  in class  III/IV at baseline to 83%  in class  I/II at 12 months (n ¼ 234; p < 0.0001). The 36-item Short Form Health  Survey physical and mental quality-of-life scores  improved from baseline to 12 months (n ¼ 191; p < 0.0001). Annual hospitalization rate  for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n ¼ 338;  p < 0.0001). Kaplan-Meier  survival estimate at 12 months was 77.2%.

 

CONCLUSIONS The percutaneous mitral  valve  device  significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274)  (J Am Coll Cardiol 2014;64:172–81) © 2014  by the  American College  of Cardiology Foundation.

 

___________________________________________________________________________________________


From the *Duke  University Medical Center, Durham, North Carolina; yHeart Institute, Cedars Sinai  Medical Center, Los Angeles, California; zDivision of  Pediatric Cardiology, University of  Virginia, Charlottesville,  Virginia; xAurora Cardiovascular Services, Aurora Sinai/Aurora St. Luke’s Medical Centers, Milwaukee, Wisconsin; kUniversity of Wisconsin School of Medicine and Public Health, Milwaukee, Wisconsin; {Baptist Hospital of Miami, Miami, Florida; #Cleveland Clinic, Cleveland, Ohio; **Sanger Heart and Vascular Institute,  Carolinas Medical Center, Charlotte, North Carolina; yyBaylor  University Medical Center, Baylor  Heart and Vascular Institute, Dallas, Texas; zzBrigham and Women’s Hospital, Boston, Massachusetts; xxHarvard Clinical Research Institute, Boston, Massachusetts;  kkDivision of  Cardiac Surgery, Northwestern  University, Chicago, Illinois; and the {{Northshore  Uni- versity Health System, Chicago, Illinois. Dr. Kar has received honoraria and institutional research support from Abbott. Dr. Lim is a consultant for and has  received research grants from Abbott Vascular. Dr. Whitlow’s institution has  received research support for participating in  the EVEREST trials from Abbott. Dr. Rinaldi is a consultant for  Abbott. Dr. Grayburn has  received grants from Abbott, Medtronic, Baxter, ValTech Cardio, and Guided Delivery Systems; and has  received consulting fees  and/or honoraria from . Abbott, Tendyne, and Bracco  Diagnostics. Dr. Mauris institution has  received research grants from Abbott, Boston Scientic, Cordis, Medtronic, Eli Lilly, Daiichi-Sankyo, Bristol-Myers Squibb, and Sano-Aventis. Dr. McCarthy is a consultant to Abbott and Edwards

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