Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device
Jazyk angličtina Země Německo Médium print-electronic
Typ dokumentu klinické zkoušky, časopisecké články, práce podpořená grantem
PubMed
26156945
DOI
10.1093/ejcts/ezv234
PII: ezv234
Knihovny.cz E-zdroje
- Klíčová slova
- Aortic annuloplasty, Aortic insufficiency, Aortic valve repair,
- MeSH
- anuloplastika srdeční chlopně škodlivé účinky přístrojové vybavení metody mortalita MeSH
- aortální chlopeň chirurgie MeSH
- aortální insuficience chirurgie MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- reoperace MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční chlopně umělé škodlivé účinky MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- práce podpořená grantem MeSH
OBJECTIVES: This study assessed the safety and efficacy of an internal geometric annuloplasty ring in a regulatory trial of aortic valve reconstruction (ClinicalTrials.gov Identifier: NCT01400841). METHODS: Sixty-five patients with predominant moderate-to-severe trileaflet aortic insufficiency (AI) underwent aortic valve repair with an average age of 63 ± 13 years (mean ± SD). All had initial implantation of an internal aortic annuloplasty ring to correct annular dilatation and facilitate leaflet reconstruction. Leaflet plication was performed for prolapse in 80% of patients, and more complex leaflet procedures, usually employing autologous pericardium, were required in 22%. Ascending aortic and/or root aneurysms were replaced in 62%. RESULTS: Follow-up was for a maximum of 3 years and a mean of 2 years. No in-hospital operative mortalities, major complications or early or late valve-related events occurred. The annular diameter before repair was 26.5 ± 2.3 mm, and the average ring diameter used was 21.5 ± 1.6 mm. The preoperative AI grade (0-4) was 2.9 ± 0.8 and improved after repair to 0.6 ± 0.7 (P < 0.0001), as did the NYHA class. The mean valve gradient was 8.6 ± 4.3 mmHg, and at 3 years, the Kaplan-Meier survival rate was 95%, with no valve-related mortality. Over the 3 years, aortic valve replacement was required in 7 patients (10.8%) for reasons usually related to surgical technique. Most repair failures occurred early, and results stabilized after 6 months. No structural complications of the rings were observed. CONCLUSIONS: Geometric ring annuloplasty was a safe and effective adjunct to aortic valve repair. Initial correction of annular dilatation seemed to facilitate overall reconstruction. Because most early repair failures were technical, increasing experience with geometric ring annuloplasty for aortic valve reconstruction has the potential to standardize and improve outcomes.
BioStable Science and Engineering Inc Austin TX USA
Cardiothoracic Surgery Associates Nashville TN USA
Department of Cardiac and Thoracic Surgery University of Köln Cologne Germany
Department of Cardiac Surgery Deutsches Herzzentrum Berlin Berlin Germany
Department of Cardiac Surgery Institute for Clinical and Experimental Medicine Prague Czech Republic
Department of Cardiothoracic Surgery Hannover Medical School Hannover Germany
Department of Cardiovascular Surgery Albert Ludwigs University Freiburg Germany
Department of Cardiovascular Surgery Deutsches Herzzentrum München Munich Germany
Department of Cardiovascular Surgery University Heart Center Hamburg Germany
Department of Mathematics Vanderbilt University Nashville TN USA
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT01400841
