Relation Between Clinical Best Practices and 6-Month Outcomes After Transcatheter Aortic Valve Implantation With CoreValve (from the ADVANCE II Study)
Language English Country United States Media print-electronic
Document type Journal Article, Multicenter Study, Observational Study
PubMed
27776799
DOI
10.1016/j.amjcard.2016.09.016
PII: S0002-9149(16)31576-4
Knihovny.cz E-resources
- MeSH
- Aortic Valve Stenosis diagnostic imaging surgery MeSH
- Bioprosthesis * MeSH
- Humans MeSH
- Postoperative Complications epidemiology MeSH
- Prospective Studies MeSH
- Aged MeSH
- Heart Valve Prosthesis * MeSH
- Transcatheter Aortic Valve Replacement instrumentation MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Observational Study MeSH
- Geographicals
- Europe epidemiology MeSH
Best practices for transcatheter aortic valve implantation with CoreValve include patient screening and valve size selection using multislice computed tomography, adherence to manufacturer recommendations for oversizing, control of implant depth to 6 mm or less, and management of conduction disturbances according to international guidelines. The ADVANCE II study implemented these strategies and demonstrated their relation to clinical outcomes. From October 2011 to April 2013, 200 patients with severe aortic stenosis were enrolled, and 194 were implanted. All imaging and electrocardiographic data were analyzed by an independent core laboratory, and adverse events were adjudicated to valve academic research consortium-2 definitions. The mean age was 80.2 ± 6.7 years and the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 7.2 ± 6.8% for the enrolled patients. At 6 months, all-cause mortality was 9.2%, stroke was 2.6%, and permanent pacemaker implantation was 19.2% for class I and II indications. In patients with implant depth ≤6 mm, both mortality and permanent pacemaker implantation were lower than in patients with depth >6 mm (2.5% vs 14.5%, p <0.01 and 18.1% vs 31.7%, p = 0.03, respectively). The rate of moderate and severe paravalvular leak was 9.8% at 7 days after transcatheter aortic valve implantation, decreasing to 4.3% at 6 months (p = 0.02). Valves were significantly more oversized in patients with mild or less paravalvular leak at day 7 compared with those with moderate or severe (15.8 ± 8.0% vs 11.8 ± 4.9%, p = 0.01). In conclusion, findings from the ADVANCE II study reinforce that adherence to best clinical practices improves patient outcomes.
Cardiothoracic and Vascular Department Azienda Ospedaliero Universitaria Pisana Pisa Italy
Department of Biostatistics North American Sciences Associates Inc Minneapolis Minnesota
Department of Cardiology and Angiology Charite Campus Mitte Kardiologie Berlin Germany
Department of Cardiology Cardiocenter Hospital Podlesi Trinec Czech Republic
Department of Cardiology Glenfield Hospital Leicester United Kingdom
Department of Cardiology Istituto Clinico S Ambrogio Milan Italy
Department of Cardiology Thoraxcenter Erasmus Medical Center Rotterdam The Netherlands
Department of Cardiology Universitätsklinikum Heidelberg Heidelberg Germany
Department of Cardiology University Hospital Antwerp Antwerp Belgium
Department of Heart Valve Therapies Medtronic Minneapolis Minnesota
Department of Interventional Cardiology McGill University Health Centre Montreal Quebec Canada
Department of Medicine 2 Heart Center Bonn University Hospital Bonn Bonn Germany
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