Document Detail


Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome.
MedLine Citation:
PMID:  17601548     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: We sought to determine both the procedural performance and safety of percutaneous implantation of the second (21-French [F])- and third (18-F)-generation CoreValve aortic valve prosthesis (CoreValve Inc., Irvine, California). BACKGROUND: Percutaneous aortic valve replacement represents an emerging alternative therapy for high-risk and inoperable patients with severe symptomatic aortic valve stenosis. METHODS: Patients with: 1) symptomatic, severe aortic valve stenosis (area <1 cm2); 2) age > or =80 years with a logistic EuroSCORE > or =20% (21-F group) or age > or =75 years with a logistic EuroSCORE > or =15% (18-F group); or 3) age > or =65 years plus additional prespecified risk factors were included. Introduction of the 18-F device enabled the transition from a multidisciplinary approach involving general anesthesia, surgical cut-down, and cardiopulmonary bypass to a truly percutaneous approach under local anesthesia without hemodynamic support. RESULTS: A total of 86 patients (21-F, n = 50; 18-F, n = 36) with a mean valve area of 0.66 +/- 0.19 cm2 (21-F) and 0.54 +/- 0.15 cm2 (18-F), a mean age of 81.3 +/- 5.2 years (21-F) and 83.4 +/- 6.7 years (18-F), and a mean logistic EuroSCORE of 23.4 +/- 13.5% (21-F) and 19.1 +/- 11.1% (18-F) were recruited. Acute device success was 88%. Successful device implantation resulted in a marked reduction of aortic transvalvular gradients (mean pre 43.7 mm Hg vs. post 9.0 mm Hg, p < 0.001) with aortic regurgitation grade remaining unchanged. Acute procedural success rate was 74% (21-F: 78%; 18-F: 69%). Procedural mortality was 6%. Overall 30-day mortality rate was 12%; the combined rate of death, stroke, and myocardial infarction was 22%. CONCLUSIONS: Treatment of severe aortic valve stenosis in high-risk patients with percutaneous implantation of the CoreValve prosthesis is feasible and associated with a lower mortality rate than predicted by risk algorithms.
Authors:
Eberhard Grube; Gerhard Schuler; Lutz Buellesfeld; Ulrich Gerckens; Axel Linke; Peter Wenaweser; Barthel Sauren; Friedrich-Wilhelm Mohr; Thomas Walther; Bernfried Zickmann; Stein Iversen; Thomas Felderhoff; Raymond Cartier; Raoul Bonan
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study     Date:  2007-06-06
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  50     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2007 Jul 
Date Detail:
Created Date:  2007-07-02     Completed Date:  2007-08-09     Revised Date:  2008-02-05    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  69-76     Citation Subset:  AIM; IM    
Affiliation:
HELIOS Heart Center Siegburg, Siegburg, Germany. GrubeE@aol.com
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MeSH Terms
Descriptor/Qualifier:
Age Factors
Aged
Aged, 80 and over
Aortic Valve Stenosis / diagnosis,  mortality,  therapy*
Bioprosthesis*
Female
Follow-Up Studies
Heart Catheterization
Heart Valve Prosthesis Implantation / methods*,  mortality*
Humans
Male
Prospective Studies
Prosthesis Design
Risk Assessment
Severity of Illness Index
Single-Blind Method
Survival Rate
Treatment Outcome
Comments/Corrections
Comment In:
J Am Coll Cardiol. 2008 Jan 15;51(2):170; author reply 170-1   [PMID:  18191744 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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