title: Initial findings using the V8 hourglass-shaped valvuloplasty balloon for postdilatation in treating paravalvular leaks associated with transcatheter self-expanding aortic valve prosthesis.
abstract: OBJECTIVE
  The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction of paravalvular leak (PVL) in patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding prostheses.
  
  
  BACKGROUND
  An important limitation of TAVR compared with surgical aortic valve replacement remains the higher incidence of PVL. A commonly used strategy to treat PVL is balloon postdilatation (BPD); however, the optimal technique for treating PVL after TAVR is unknown.
  
  
  METHODS
  We examined consecutive patients with severe, symptomatic aortic stenosis who underwent TAVR with the Medtronic CoreValve followed by BPD with an InterValve V8 balloon for PVL grade ≥2+. Data from echocardiographic, multidetector computed tomographic, and angiographic images were reviewed. The primary endpoint was successful reduction in PVL to grade 1+ or less as assessed by intraprocedural echocardiography.
  
  
  RESULTS
  Eleven patients were studied (median age, 82 years; 64% female). Ten patients (91%) demonstrated successful reduction in PVL after V8 BPD. In three patients, PVL was reduced to zero or trace. PVL remained unchanged in one patient (2+). Two patients had complete heart block associated with valve deployment and received permanent pacemakers. There were no occurrences of annular injury or major adverse clinical events.
  
  
  CONCLUSIONS
  BPD with the V8 hourglass-shaped balloon was feasible in reducing PVL from self-expanding TAVR prostheses. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: Center for Valve and Structural Heart Disease, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: Wesley
authors.initials: W
authors.lastname: Pedersen
authors.affiliation: Department of Cardiovascular Surgery, UniversitätsSpital Zürich, Zürich, Switzerland.
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.affiliation: Center for Valve and Structural Heart Disease, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: John
authors.initials: J
authors.lastname: Lesser
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Neil
authors.initials: N
authors.lastname: Ruparelia
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Figini
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Center for Valve and Structural Heart Disease, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: Anil
authors.initials: A
authors.lastname: Poulose
authors.affiliation: Center for Valve and Structural Heart Disease, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: James
authors.initials: J
authors.lastname: Kolbeck
authors.affiliation: Center for Valve and Structural Heart Disease, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: Michael
authors.initials: M
authors.lastname: Mooney
authors.affiliation: Center for Valve and Structural Heart Disease, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: Robert
authors.initials: R
authors.lastname: Schwartz
authors.affiliation: Center for Valve and Structural Heart Disease, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: Alicia
authors.initials: A
authors.lastname: Youssef
authors.affiliation: Center for Valve and Structural Heart Disease, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: David
authors.initials: D
authors.lastname: Ungs
authors.affiliation: Twin Cities Heart Foundation, Minneapolis, Minnesota.
authors.forename: Irv
authors.initials: I
authors.lastname: Goldenberg
authors.affiliation: Center for Valve and Structural Heart Disease, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: Paul
authors.initials: P
authors.lastname: Sorajja
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D063126:Balloon Valvuloplasty / Q000009:adverse effects / Q000295:instrumentation*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D000072226:Computed Tomography Angiography; D018618:Echocardiography, Doppler, Color; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D061330:Multidetector Computed Tomography; D011474:Prosthesis Design; D011475:Prosthesis Failure; D019233:Retreatment; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
keywords: aortic valve stenosis; heart valve; heart valve prosthesis implantation; transcatheter aortic valve replacement