Document Detail

Mitral annular reduction with subablative therapeutic ultrasound: pre-clinical evaluation of the ReCor device.
MedLine Citation:
PMID:  20542798     Owner:  NLM     Status:  MEDLINE    
AIMS: To evaluate the potential for mitral annular (MA) size reduction using a novel device utilising therapeutic ultrasound (TU). METHODS AND RESULTS: The ReCor device (ReCor Medical, Inc., Ronkonkoma, NY, USA, Investigational device, not for use in human application) was studied in a closed chest canine animal model (35 dogs). Under fluoroscopy, a 12 Fr TU balloon catheter was advanced into the left atrium (transseptal approach). The TU balloon was inflated with contrast-saline, positioned at the MA and energy delivered circumferentially, to heat the tissue locally. Five TU applications were delivered (at least 60W for at least 40 sec). Relative to baseline, mitral valve annular diameter reduction (measured by transthoracic echocardiography) was 8.4% immediately post procedure(p<0.001), 8.6% at one week (p<0.001), 8.8% at two weeks (p<0.001), 9.3% at three weeks (p<0.001), 10.8% at four weeks (p<0.001), 8.6% at three months (p<0.001) and 5.7% at six months (p<0.001). Histology showed an increase in elastin associated with tissue thickening at the annular level. Transmission electron microscopy demonstrated a decrease in diameter of individual collagen fibres in treated regions compared to controls. CONCLUSIONS: Therapeutic ultrasound (TU) energy application to the mitral annulus is feasible percutaneously. A reduction in annular dimensions occurs immediately and appears to be durable without peri-annular damage.
Hasan Jilaihawi; Renu Virmani; Hiroshi Nakagawa; Anique Ducharme; Yan-Fen Shi; Naima Carter-Monroe; Elena Ladich; Mano Iyer; Atsushi Ikeda; Anita Asgar; Raoul Bonan
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Publication Detail:
Type:  Evaluation Studies; Journal Article    
Journal Detail:
Title:  EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology     Volume:  6     ISSN:  1969-6213     ISO Abbreviation:  EuroIntervention     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-06-14     Completed Date:  2010-09-28     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101251040     Medline TA:  EuroIntervention     Country:  France    
Other Details:
Languages:  eng     Pagination:  54-62     Citation Subset:  IM    
Interventional Cardiology, Montréal Heart Institute, Montreal, Canada.
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MeSH Terms
Catheter Ablation / instrumentation*
Echocardiography, Doppler
Elastin / metabolism
Equipment Design
Feasibility Studies
Fibrillar Collagens / ultrastructure
Materials Testing
Microscopy, Electron, Transmission
Mitral Valve / metabolism,  surgery*,  ultrasonography,  ultrastructure
Models, Animal
Radiography, Interventional
Time Factors
Ultrasonic Therapy / instrumentation*
Reg. No./Substance:
0/Fibrillar Collagens; 9007-58-3/Elastin

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

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