Document Detail

Evolving strategies for the treatment of valvular heart disease: Preclinical and clinical pathways for percutaneous aortic valve replacement.
MedLine Citation:
PMID:  18288759     Owner:  NLM     Status:  MEDLINE    
To decrease the morbidity associated with conventional surgery for calcific aortic stenosis, there has been increasing interest in catheter-based treatment using a stent or frame mounted bioprosthetic valve. Critical to its success is knowledge of pathoanatomy, risk of embolization of calcific debris, and issues associated with device anchoring and paravalvular leaks. In the absence of a chronic animal model of aortic stenosis, development of a catheter-based device has been an iterative process based on experimental and early clinical data gathered abroad, where marketing may be permitted with less clinical data than required in the United States. This process has persuaded many companies to circumvent the time delays occasioned by the FDA regulatory validation of iterative design changes by performing initial studies outside the United States. Because percutaneous aortic valve replacement is considered a Class III device, premarket approval, including defining the patient population, inclusion and exclusion criteria, control population, and interpretable clinical endpoints, is required. In the early clinical experience, percutaneous aortic valve replacement has been directed at high-risk patients who were considered "very poor" or "non-surgical" candidates. Defining and identifying patients for the clinical trial may be challenging, in part because of the difficult selection of an appropriate control group, e.g., conventional aortic valve replacement, best medical management, and/or balloon valvuloplasty.
James I Fann; Nicolas Chronos; Stanton J Rowe; Rob Michiels; Bernard E Lyons; Martin B Leon; Aaron V Kaplan
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Publication Detail:
Type:  Editorial    
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  71     ISSN:  1522-726X     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2008 Feb 
Date Detail:
Created Date:  2008-02-26     Completed Date:  2008-03-27     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  434-40     Citation Subset:  IM    
Copyright Information:
(c) 2008 Wiley-Liss, Inc.
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MeSH Terms
Aortic Valve Insufficiency / therapy
Aortic Valve Stenosis / therapy
Balloon Dilatation / adverse effects,  methods*
Heart Valve Diseases / diagnosis*,  therapy*
Heart Valve Prosthesis*
Heart Valve Prosthesis Implantation / standards,  trends
Risk Assessment
Treatment Outcome

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

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