Document Detail


Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting.
MedLine Citation:
PMID:  20299349     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: This study sought to evaluate the feasibility and early outcomes of a percutaneous edge-to-edge repair approach for mitral valve regurgitation with the MitraClip system (Evalve, Inc., Menlo Park, CA, USA). METHODS AND RESULTS PATIENTS: were selected for the procedure based on the consensus of a multidisciplinary team. The primary efficacy endpoint was acute device success defined as clip placement with reduction of mitral regurgitation to < or =2+. The primary acute safety endpoint was 30-day freedom from major adverse events, defined as the composite of death, myocardial infarction, non-elective cardiac surgery for adverse events, renal failure, transfusion of >2 units of blood, ventilation for >48 h, deep wound infection, septicaemia, and new onset of atrial fibrillation. Thirty-one patients (median age 71, male 81%) were treated between August 2008 and July 2009. Eighteen patients (58%) presented with functional disease and 13 patients (42%) presented with organic degenerative disease. A clip was successfully implanted in 19 patients (61%) and two clips in 12 patients (39%). The median device implantation time was 80 min. At 30 days, there was an intra-procedural cardiac tamponade and a non-cardiac death, resulting in a primary safety endpoint of 93.6% [95% confidence interval (CI) 77.2-98.9]. Acute device success was observed in 96.8% of patients (95% CI 81.5-99.8). Compared with baseline, left ventricular diameters, diastolic left ventricular volume, diastolic annular septal-lateral dimension, and mitral valve area significantly diminished at 30 days.
CONCLUSION: Our initial results with the MitraClip device in a very small number of patients indicate that percutaneous edge-to-edge mitral valve repair is feasible and may be accomplished with favourable short-term safety and efficacy results.
Authors:
Corrado Tamburino; Gian Paolo Ussia; Francesco Maisano; Davide Capodanno; Giovanni La Canna; Salvatore Scandura; Antonio Colombo; Andrea Giacomini; Iassen Michev; Sarah Mangiafico; Valeria Cammalleri; Marco Barbanti; Ottavio Alfieri
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Publication Detail:
Type:  Evaluation Studies; Journal Article; Research Support, Non-U.S. Gov't     Date:  2010-03-18
Journal Detail:
Title:  European heart journal     Volume:  31     ISSN:  1522-9645     ISO Abbreviation:  Eur. Heart J.     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-06-02     Completed Date:  2011-05-25     Revised Date:  2013-05-29    
Medline Journal Info:
Nlm Unique ID:  8006263     Medline TA:  Eur Heart J     Country:  England    
Other Details:
Languages:  eng     Pagination:  1382-9     Citation Subset:  IM    
Affiliation:
Cardiology Department, Ferrarotto Hospital, University of Catania, Via Citelli 6, 95124 Catania, Italy. tambucor@unict.it
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MeSH Terms
Descriptor/Qualifier:
Aged
Anesthesia, General / methods
Cardiac Catheterization / methods
Echocardiography, Doppler, Color
Echocardiography, Transesophageal
Feasibility Studies
Female
Humans
Male
Middle Aged
Mitral Valve / surgery*
Mitral Valve Annuloplasty / instrumentation*
Mitral Valve Insufficiency / etiology,  physiopathology,  surgery*
Prospective Studies
Pulmonary Wedge Pressure
Surgical Instruments*
Treatment Outcome
Ventricular Dysfunction, Left / etiology,  physiopathology
Comments/Corrections
Comment In:
Eur Heart J. 2010 Jun;31(11):1301-4   [PMID:  20385570 ]

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