title: Long-term outcomes of percutaneous paravalvular regurgitation closure after transcatheter aortic valve replacement: a multicenter experience.
abstract: OBJECTIVE
  This study sought to evaluate acute and long-term outcomes of percutaneous paravalvular regurgitation (PVR) closure after transcatheter aortic valve replacement (TAVR).
  
  
  BACKGROUND
  Severe symptomatic PVR is a predictor of all-cause mortality after TAVR. The current use of devices for transcatheter closure of PVR has been adapted from other indications without known long-term outcomes.
  
  
  METHODS
  The study population consisted of a series of cases pooled together from an international multicenter experience. Patients underwent transcatheter implantation of a closure device for the treatment of clinically relevant PVR after TAVR with balloon-expandable or self-expandable prostheses. Procedural success was defined by successful deployment of a device with immediate reduction of PVR to a final grade ≤2 as assessed by echocardiography.
  
  
  RESULTS
  Twenty-seven procedures were performed in 24 patients with clinically relevant PVR after the index TAVR procedure (54.2% Edwards Sapien [Edwards Lifesciences, Irvine, California], 45.8% CoreValve [Medtronic, Minneapolis, Minnesota]). The study population included 75% men with a mean age of 80.6 ± 7.1 years and mean Society of Thoracic Surgeon score of 6.6%. The most frequently used device was Amplatzer Vascular Plug (St. Jude Medical, St. Paul, Minnesota) in 80% of the cases. Overall, 88.9% (24 of 27) of the procedures were technically successful and the results assessed by echocardiography were durable. However, cumulative survival rates at 1, 6, and 12 months were 83.3%, 66.7%, and 61.5%. Most of the deaths (8 of 11) were due to noncardiac causes.
  
  
  CONCLUSIONS
  Transcatheter closure of PVR after TAVR can be performed with a high procedural success rate; however, the long-term mortality remains high mainly due to noncardiac causes.
authors.affiliation: Institute of Cardiology, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy. Electronic address: francescosaia@hotmail.com.
authors.forename: Francesco
authors.initials: F
authors.lastname: Saia
authors.affiliation: Cardiovascular Division, University of Miami Miller School of Medicine, Miami, Florida.
authors.forename: Claudia
authors.initials: C
authors.lastname: Martinez
authors.affiliation: Cardiovascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Sameer
authors.initials: S
authors.lastname: Gafoor
authors.affiliation: Cardiovascular Division, University of Miami Miller School of Medicine, Miami, Florida.
authors.forename: Vikas
authors.initials: V
authors.lastname: Singh
authors.affiliation: Institute of Cardiology, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Ciuca
authors.affiliation: Cardiovascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Ilona
authors.initials: I
authors.lastname: Hofmann
authors.affiliation: Institute of Cardiology, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Marrozzini
authors.affiliation: Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Tan
authors.affiliation: Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Webb
authors.affiliation: Cardiovascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.affiliation: Institute of Cardiology, University of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Marzocchi
authors.affiliation: Henry Ford Health System, Center for Structural Heart Disease, Detroit, Michigan.
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D001022:Aortic Valve Insufficiency / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D002170:Canada; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation / Q000401:mortality; D002423:Cause of Death; D005060:Europe; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D055989:Septal Occluder Device; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography; D014481:United States
keywords: closure devices; paravalvular regurgitation; transcatheter aortic valve; vascular plug