title: Multiplug paravalvular leak closure using Amplatzer Vascular Plugs III: A prospective registry.
abstract: BACKGROUND
  Transcatheter paravalvular leak closure (TPVLC) offers a viable alternative to reoperation but optimal technical strategy is still to be defined. We present a prospective TPVLC registry in which safety and efficacy of multi-plug, single-stage approach were assessed.
  
  
  METHODS
  Patients with heart failure (HF) symptoms caused by PVL were qualified for TPVLC by Heart Team. Ante- or retrograde access was employed for mitral while retrograde only for aortic PVLs. Two to 4 AVP 3 devices were simultaneously implanted into each PVL. Endpoints were defined according to VARC-2.
  
  
  RESULTS
  From 64 referred patients 49, with either mechanical valves (n = 30) or stented bioprostheses, were eligible for TPVLC. PVL location was mitral (n = 29) or aortic (n = 20). In aortic group acute procedural success (APS) ratio was 100% and no MACCEs occurred. In mitral group, first-attempt TPVLC was successful in 22 cases (4/4 in transapical and 18/25 in transseptal access). Second-attempt transapical procedure followed transseptal failure in 5 patients. Mitral TPVLC ultimately proved efficient in 89.7% with 76.5% APS. Cumulatively, TPVLC was accomplished in 46 subjects (93.9%) with 78% APS. When successful, it led to a significant decrease of NT-proBNP concentration and HF symptoms regression. Periprocedural safety endpoints were met in three patients and included non-disabling stroke, and two access site-related complications. In device failure group two patients died (end-stage HF) and two others were rehospitalized.
  
  
  CONCLUSIONS
  TPVLC with simultaneous deployment of multiple AVP III occluders is feasible with high device success rate and no significant periprocedural complications. The clinical benefits of reduction of HF symptoms and hemolysis are evident after 30 days and persist up to 1 year without recurrence of PVL.
authors.affiliation: 3rd Division of Cardiology, Medical University of Silesia, Katowice, Poland.
authors.forename: Grzegorz
authors.initials: G
authors.lastname: Smolka
authors.affiliation: Division of Cardiology, Medical University of Silesia, Katowice, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Pysz
authors.affiliation: Division of Cardiac Surgery, Medical University of Silesia, Katowice, Poland.
authors.forename: Marek
authors.initials: M
authors.lastname: Jasiński
authors.affiliation: Division of Cardiology, Medical University of Silesia, Katowice, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Roleder
authors.affiliation: 3rd Division of Cardiology, Medical University of Silesia, Katowice, Poland.
authors.forename: Ewa
authors.initials: E
authors.lastname: Peszek-Przybyła
authors.affiliation: 3rd Division of Cardiology, Medical University of Silesia, Katowice, Poland.
authors.forename: Andrzej
authors.initials: A
authors.lastname: Ochała
authors.affiliation: 3rd Division of Cardiology, Medical University of Silesia, Katowice, Poland.
authors.forename: Wojciech
authors.initials: W
authors.lastname: Wojakowski
mesh_terms: D000368:Aged; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D001022:Aortic Valve Insufficiency / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D015415:Biomarkers / Q000097:blood; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D018618:Echocardiography, Doppler, Color; D019560:Echocardiography, Three-Dimensional; D017548:Echocardiography, Transesophageal; D004867:Equipment Design; D005260:Female; D006333:Heart Failure / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006349:Heart Valve Diseases / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation / Q000401:mortality; D006461:Hemolysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010359:Patient Readmission; D010446:Peptide Fragments / Q000097:blood; D011446:Prospective Studies; D011475:Prosthesis Failure; D012042:Registries; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D065506:Vascular Closure Devices
chemical_list: D015415:Biomarkers; D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain
keywords: aortic valve; mitral valve; occlude; percutaneous closure; perivalvular leak; valve prosthesis dysfunction