Document Detail


First clinical experience and 1-year follow-up with the sutureless 3F-Enable aortic valve prosthesis.
MedLine Citation:
PMID:  18255309     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Aortic valve replacement (AVR) with extracorporeal circulation (ECC) is currently the treatment of choice for symptomatic aortic stenosis. However, patients with multiple high-risk comorbid conditions may benefit from reduced ECC time and thus, reduced myocardial ischemia, by the use of sutureless AVR. We describe the initial experience and 1-year results of our first 3F-Enable AVR implants. METHODS: Between 09/05 and 12/05, six patients (age 74+/-1.8 years; three females) with symptomatic aortic stenosis (NYHA III) underwent AVR with an equine pericardial and nitinol-stented sutureless prosthesis. For additional safety up to three stay sutures were placed. Echocardiography was performed preoperatively, intraoperatively, at 6- and 12-month follow-up. Clinical data, adverse events and patient outcome were recorded prospectively. RESULTS: Prosthesis sizes were 27 mm (n=3), 25 mm (n=1), 23 mm (n=1) and 21 mm (n=1). ECC time was 87+/-32 min; aortic clamp time was 56+/-24 min. Prosthesis deployment time was 148 +/- 173 s. There were no intraoperative deaths or complications. At 12-month follow-up mean pressure gradients (MPG) were 6.8+/-3.5 mmHg and aortic valve area (AVA) was 2.2 +/- 0.5 cm(2). One patient underwent successful redo AVR after 8 months due to severe paravalvular leakage (PVL), and one patient died due to lung cancer 10 months after surgery. At 12 months follow-up four out of six patients are alive and asymptotic (NYHA I) with the 3F-Enable aortic valve prosthesis, however, one patient showed mild paravalvular leakage. CONCLUSIONS: These first 1-year follow-up data suggest the feasibility of this new concept of sutureless aortic valve implantation. However, severe aortic insufficiency at 8 months and paravalvular leakage at 1-year follow-up should prompt further procedural and device enhancements.
Authors:
Daniel Wendt; Matthias Thielmann; Thomas Buck; Rolf-Alexander Jánosi; Torsten Bossert; Nikolaus Pizanis; Markus Kamler; Heinz Jakob
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Publication Detail:
Type:  Evaluation Studies; Journal Article; Research Support, Non-U.S. Gov't     Date:  2008-02-05
Journal Detail:
Title:  European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery     Volume:  33     ISSN:  1010-7940     ISO Abbreviation:  Eur J Cardiothorac Surg     Publication Date:  2008 Apr 
Date Detail:
Created Date:  2008-03-17     Completed Date:  2008-08-12     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8804069     Medline TA:  Eur J Cardiothorac Surg     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  542-7     Citation Subset:  IM    
Affiliation:
Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany. daniel.wendt@uk-essen.de
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MeSH Terms
Descriptor/Qualifier:
Aged
Aortic Valve Insufficiency / surgery*
Bioprosthesis*
Epidemiologic Methods
Female
Heart Valve Prosthesis*
Heart Valve Prosthesis Implantation / methods*,  standards
Humans
Male
Prosthesis Design / adverse effects,  standards*
Stents / adverse effects
Suture Techniques
Time Factors
Treatment Outcome

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


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