title: Outcomes and predictors of success and complications for paravalvular leak closure: an analysis of the SpanisH real-wOrld paravalvular LEaks closure (HOLE) registry.
abstract: OBJECTIVE
  The aim of the study was to assess the safety and efficacy of percutaneous closure of paravalvular prosthetic leak (PVL) and to identify the predictors of procedural success and early complications.
  
  
  RESULTS
  A total of 514 first-attempt percutaneous PVL closure in 469 patients were included at 19 centres. Technical and procedural success was achieved in 86.6% and 73.2% of the patients, respectively. In multivariate analysis, the independent predictors for procedural success in mitral lesions were the type of device used (AMPLATZER AVP III vs. others, HR 2.68 [1.29-5.54], p=0.008) and the number of procedures performed at the centre (top quartile vs. others, HR 1.93 [1.051-3.53], p=0.03). For aortic leaks the only predictor of procedural success was the leak size (≥10 mm vs. <10 mm, HR 3.077 [1.13-8.33], p=0.027). The overall major adverse events rate (death or emergency surgery or stroke) at 30 days was 5.6%; the only predictor for combined adverse events was New York Heart Association functional Class IV (HR 4.2 [1.42-12.34], p=0.009).
  
  
  CONCLUSIONS
  Percutaneous closure of PVL can be performed with a reasonable rate of procedural success and a low rate of major complications. The type of device used, the accumulated experience and the leak size are predictors of procedural success.
authors.affiliation: Hospitales Universitarios Montepríncipe and Moncloa, Madrid, Spain.
authors.forename: Eulogio
authors.initials: E
authors.lastname: García
authors.forename: Dabit
authors.initials: D
authors.lastname: Arzamendi
authors.forename: Pilar
authors.initials: P
authors.lastname: Jimenez-Quevedo
authors.forename: Fernando
authors.initials: F
authors.lastname: Sarnago
authors.forename: Gerard
authors.initials: G
authors.lastname: Martí
authors.forename: Angel
authors.initials: A
authors.lastname: Sanchez-Recalde
authors.forename: Garikoit
authors.initials: G
authors.lastname: Lasa-Larraya
authors.forename: Manuel
authors.initials: M
authors.lastname: Sancho
authors.forename: Andres
authors.initials: A
authors.lastname: Iñiguez
authors.forename: Javier
authors.initials: J
authors.lastname: Goicolea
authors.forename: Koldobika
authors.initials: K
authors.lastname: Garcia-San Roman
authors.forename: Juan Horacio
authors.initials: JH
authors.lastname: Alonso-Briales
authors.forename: Eduardo
authors.initials: E
authors.lastname: Molina
authors.forename: Jose
authors.initials: J
authors.lastname: Calabuig
authors.forename: Xavier
authors.initials: X
authors.lastname: Freixa
authors.forename: Alberto
authors.initials: A
authors.lastname: Berenguer
authors.forename: Mariano
authors.initials: M
authors.lastname: Valdes-Chavarri
authors.forename: Nicolas
authors.initials: N
authors.lastname: Vazquez
authors.forename: Jose Francisco
authors.initials: JF
authors.lastname: Diaz
authors.forename: Ignacio
authors.initials: I
authors.lastname: Cruz-Gonzalez
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000295:instrumentation*; D019560:Echocardiography, Three-Dimensional / Q000379:methods; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D008944:Mitral Valve Insufficiency / Q000601:surgery*; D011183:Postoperative Complications; D012042:Registries; D055989:Septal Occluder Device / Q000009:adverse effects; D016896:Treatment Outcome