title: A New Specific Device in Transcatheter Prosthetic Paravalvular Leak Closure: A Prospective Two-Center Trial.
abstract: BACKGROUND
  This study sought to compare various outcomes among a new specifically designed transcatheter paravalvular leak closure (TPVLC) device and the devices that are being utilized off-label.
  
  
  METHODS
  Between April 2012 and January 2015, in a prospective two-center study, 52 patients who needed surgical reintervention due to a hemodynamically significant prosthetic paravalvular leak were studied. This study population was divided into two groups. Group I was composed of 32 patients who underwent paravalvular leak (PVL) closure with the currently available devices that are being utilized off-label, while group II consisted of 20 patients who were treated with the new specifically designed Occlutech PVL device.
  
  
  RESULTS
  Demographic and clinical variables indicated a higher rate of atrial fibrillation (P = 0.027) and chronic obstructive airway disease (P = 0.009) in group II. The apical approach was the most commonly used intervention route used for group II (P = 0.019). The procedural success rate was 100% (29 of 29 leaks) in group II while the rate was 92% (39 of 42 leaks) in group I. However, more secondary events were observed in group I, but they did not reach statistical significance (8 vs. 1, P = 0.064).
  
  
  CONCLUSIONS
  With its high procedural success rate and encouraging outcome results, the Occlutech device seems to satisfy the expectations of a specifically designed PVL closure device. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Cardiology Department, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.
authors.forename: Aydin
authors.initials: A
authors.lastname: Yildirim
authors.affiliation: Cardiology Department, Bezmialem University Medical Faculty, Istanbul, Turkey.
authors.forename: Omer
authors.initials: O
authors.lastname: Goktekin
authors.affiliation: Cardiology Department, Acibadem University Medical Faculty, Istanbul, Turkey. sevket5@yahoo.com.
authors.forename: Sevket
authors.initials: S
authors.lastname: Gorgulu
authors.affiliation: Cardiology Department, Acibadem University Medical Faculty, Istanbul, Turkey.
authors.forename: Tugrul
authors.initials: T
authors.lastname: Norgaz
authors.affiliation: Cardiology Department, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.
authors.forename: Emre
authors.initials: E
authors.lastname: Akkaya
authors.affiliation: Cardiovascular Surgery Department, Mehmet Akif Ersoy Chest and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.
authors.forename: Unal
authors.initials: U
authors.lastname: Aydin
authors.affiliation: Cardiology Department, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.
authors.forename: Hale
authors.initials: H
authors.lastname: Unal Aksu
authors.affiliation: Cardiovascular Surgery Department, Mehmet Akif Ersoy Chest and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.
authors.forename: Ihsan
authors.initials: I
authors.lastname: Bakir
mesh_terms: D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D019560:Echocardiography, Three-Dimensional; D017548:Echocardiography, Transesophageal; D005260:Female; D006333:Heart Failure / Q000000981:diagnostic imaging / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D006349:Heart Valve Diseases / Q000503:physiopathology / Q000628:therapy*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D006351:Heart Valves / Q000000981:diagnostic imaging / Q000503:physiopathology; D006461:Hemolysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D011356:Product Labeling; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D019233:Retreatment; D013997:Time Factors; D016896:Treatment Outcome; D014421:Turkey
keywords: paravalvular leak closure; prosthetic valve; specific device