Document Detail

First-in-man assessment of a dedicated guidewire for transcatheter aortic valve implantation.
MedLine Citation:
PMID:  23339807     Owner:  NLM     Status:  In-Data-Review    
Aims: The aim of this study was to evaluate the safety and performance of a specifically designed, dedicated TAVI guidewire. Methods and results: From May 2011 to August 2012, 39 consecutive patients referred for TAVI were prospectively enrolled in a first-in-man, open label, non-randomised feasibility study to evaluate the safety and performance of a specifically designed, dedicated TAVI guidewire in our institution (mean age 80.4±5.1 years, mean logistic EuroSCORE 26.8±11.7%, n=29 CoreValve transfemoral, n=8 CoreValve direct aortic, n=1 Edwards SAPIEN valve direct aortic, n=1 CoreValve subclavian). The primary safety endpoint was reached successfully with the dedicated TAVI guidewire in all 39 cases with no cases of guidewire displacement from the left ventricle during the procedure. In three cases the wire was repositioned to optimise loop position using a pigtail catheter prior to valve implantation. There were no cases of guidewire-related procedural complications. The mean delivery system tracking time using the guidewire was 1.4±0.6 minutes and the mean deployment time for TAVI was 13.8±7.8 minutes. Conclusions: This represents the first recorded use of a dedicated TAVI guidewire to treat patients with a transcatheter aortic valve. The wire is easy to place, safe to adjust within the ventricle, and the stiffness of the wire facilitates valve tracking through tortuous anatomy. In this study there were no pericardial complications with the use of this dedicated TAVI guidewire.
David A Roy; Jean-Claude Laborde; Rajan Sharma; Marjan Jahangiri; Stephen J D Brecker
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Publication Detail:
Type:  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:  8     ISSN:  1969-6213     ISO Abbreviation:  EuroIntervention     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-23     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101251040     Medline TA:  EuroIntervention     Country:  France    
Other Details:
Languages:  eng     Pagination:  1019-25     Citation Subset:  IM    
Department of Cardiology and Cardiothoracic Surgery, St Georges Hospital, London, United Kingdom.
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