title: Relation Between Clinical Best Practices and 6-Month Outcomes After Transcatheter Aortic Valve Implantation With CoreValve (from the ADVANCE II Study).
abstract: 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.
authors: Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany. Electronic address: jan-malte.sinning@ukb.uni-bonn.de.
authors: Jan-Malte
authors: JM
authors: Sinning
authors: Cardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
authors: Anna Sonia
authors: AS
authors: Petronio
authors: Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors: Nicolas
authors: N
authors: Van Mieghem
authors: Cardiothoracic and Vascular Department, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.
authors: Giulio
authors: G
authors: Zucchelli
authors: Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
authors: Georg
authors: G
authors: Nickenig
authors: Department of Cardiology, Universitätsklinikum Heidelberg, Heidelberg, Germany.
authors: Raffi
authors: R
authors: Bekeredjian
authors: Department of Cardiology, University Hospital Antwerp, Antwerp, Belgium.
authors: Johan
authors: J
authors: Bosmans
authors: Department of Cardiology, Istituto Clinico S. Ambrogio, Milan, Italy.
authors: Francesco
authors: F
authors: Bedogni
authors: Department of Cardiology, Cardiocenter Hospital Podlesi, Trinec, Czech Republic.
authors: Marian
authors: M
authors: Branny
authors: Department of Cardiology and Angiology, Charite, Campus Mitte-Kardiologie, Berlin, Germany.
authors: Karl
authors: K
authors: Stangl
authors: Department of Cardiology, Glenfield Hospital, Leicester, United Kingdom.
authors: Jan
authors: J
authors: Kovac
authors: Department of Biostatistics, North American Sciences Associates, Inc., Minneapolis, Minnesota.
authors: Anna
authors: A
authors: Nordell
authors: Department of Heart Valve Therapies, Medtronic, Minneapolis, Minnesota.
authors: Molly
authors: M
authors: Schiltgen
authors: Department of Interventional Cardiology, McGill University Health Centre, Montreal, Quebec, Canada.
authors: Nicolo
authors: N
authors: Piazza
authors: Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors: Peter
authors: P
authors: de Jaegere
mesh_terms: D000368:Aged; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000601:surgery*; D001705:Bioprosthesis; D005060:Europe / Q000453:epidemiology; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*; D016896:Treatment Outcome