title: Impact of balloon post-dilation on clinical outcomes after transcatheter aortic valve replacement with the self-expanding CoreValve prosthesis.
abstract: OBJECTIVE
  The aim of this study was to assess the incidence and clinical impact of balloon post-dilation (BPD) after transcatheter aortic valve replacement (TAVR) with the CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota).
  
  
  BACKGROUND
  BPD is a widely adopted strategy to reduce the degree of paraprosthetic regurgitation in case of transcatheter heart valve underexpansion. However, controversies still remain regarding its real effectiveness and safety.
  
  
  METHODS
  The ClinicalService (a nation-based data repository and medical care project) dataset was analyzed. All patients were dichotomized according to the need for BPD during the index procedure.
  
  
  RESULTS
  Among 1,376 patients, BPD of the transcatheter heart valve was performed in 272 (19.8%). In 37% of cases, it was unsuccessful at reducing the paravalvular regurgitation to mild or less. No case of valve embolization, new intravalvular regurgitation, coronary occlusion, and aortic root injury occurred during BPD. There were no statistically significant differences between the 2 groups in the incidence of in-hospital all-cause and cardiovascular mortality, neurological events, myocardial infarction, bleeding, conversion to open-chest surgery, and the need for a permanent pacemaker. The need for BPD did not emerge as an independent risk factor for all-cause (adjusted hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 0.81 to 2.19, p = 0.264) and cardiovascular (adjusted HR: 1.48, 95% CI: 0.74 to 2.97, p = 0.265) mortality at 1 year after the procedure. In addition, BPD did not predispose to higher odds of neurological events during 12 months after TAVR (HR: 0.92, 95% CI: 0.45 to 1.88, p = 0.815).
  
  
  CONCLUSIONS
  This large study showed that BPD after TAVR was safe and not associated with increased rates of cerebrovascular events, mortality, myocardial infarction, and aortic root injury.
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy. Electronic address: mbarbanti83@gmail.com.
authors.forename: Marco
authors.initials: M
authors.lastname: Barbanti
authors.affiliation: AOU Pisana, Pisa, Italy.
authors.forename: Anna Sonia
authors.initials: AS
authors.lastname: Petronio
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Capodanno
authors.affiliation: Spedali Civili, Brescia, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Ettori
authors.affiliation: Scientific Institute S. Raffaele, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Clinical Institute S. Ambrogio, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Bedogni
authors.affiliation: Niguarda Ca'Granda Hospital, Milan, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: De Marco
authors.affiliation: AOU Pisana, Pisa, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: De Carlo
authors.affiliation: Spedali Civili, Brescia, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Fiorina
authors.affiliation: Scientific Institute S. Raffaele, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: Clinical Institute S. Ambrogio, Milan, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Testa
authors.affiliation: Niguarda Ca'Granda Hospital, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Bruschi
authors.affiliation: Ospedale Civile, Legnano, Italy.
authors.forename: Arnaldo
authors.initials: A
authors.lastname: Poli
authors.affiliation: AOU Pisana, Pisa, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Giannini
authors.affiliation: Spedali Civili, Brescia, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Curello
authors.affiliation: Spedali Civili, Brescia, Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Maffeo
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Sgroi
authors.affiliation: Ospedale Civile, Legnano, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Martina
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Gulino
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Martina
authors.initials: M
authors.lastname: Patanè
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Ohno
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Guilherme F
authors.initials: GF
authors.lastname: Attizzani
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Immè
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Cannata
authors.affiliation: EMEA Regional Clinical Center, Medtronic Clinical Research Institute, Rome, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Gentili
authors.affiliation: Medtronic Italy, Milan, Italy.
authors.forename: Agnese
authors.initials: A
authors.lastname: Rossi
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology*; D001022:Aortic Valve Insufficiency / Q000209:etiology / Q000517:prevention & control; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D063126:Balloon Valvuloplasty / Q000009:adverse effects / Q000401:mortality; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002561:Cerebrovascular Disorders / Q000209:etiology; D016208:Databases, Factual; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006439:Hemodynamics; D017052:Hospital Mortality; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D009203:Myocardial Infarction / Q000209:etiology; D011474:Prosthesis Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: TAVR; post-dilation; underexpansion