title: Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER).
abstract: OBJECTIVE
  The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy.
  
  
  METHODS
  The Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality.
  
  
  RESULTS
  Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction ≤72 h, 1.5%. Perioperative pacemaker implantation was necessary in 116 (6.1%) patients. At discharge, the mean transprosthetic gradient was 10.7 (SD:4.5) mmHg. Incidence of postoperative mild, moderate or severe paravalvular leak was, respectively, 32.1, 5.0 and 0.4%. A total of 444/1767 (25.1%) deaths after hospital discharge were reported: of these, 168 (37.8%) were classified as cardiac death. Preoperative independent predictors of all-cause mortality were male gender (HR: 1.395; 95% CI:1.052-1.849); overweight, BMI 25-30 kg/m2(HR: 0.775; 95% CI: 0.616-0.974); serum creatinine level (every 1 mg/dl increase; HR: 1.314; 95% CI:1.167-1.480); haemoglobin level (every 1 g/dl increase; HR: 0.905; 95% CI:0.833-0.984); critical preoperative state (HR: 2.282; 95% CI: 1.384-3.761); neurological dysfunction (HR: 1.552; 95% CI:1.060-2.272); atrial fibrillation (HR: 1.556; 95% CI:1.213-1.995); pacemaker rhythm (HR: 1.948; 95% CI:1.310-2.896); NYHA Class III or IV (HR: 1.800; 95% CI:1.205-2.689 or HR: 2.331; 95% CI:1.392-3.903, respectively).
  
  
  CONCLUSIONS
  TAVI with a balloon-expandable device in the 'real world' shows good mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance.
authors.affiliation: Department of Surgical Sciences, University of Turin, Turin, Italy salizzonis@gmail.com.
authors.forename: Stefano
authors.initials: S
authors.lastname: Salizzoni
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padova, Italy.
authors.forename: Augusto
authors.initials: A
authors.lastname: D'Onofrio
authors.affiliation: Centro Cardiologico Monzino-Department of Clinical Sciences and Community, University of Milan, Milan, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Agrifoglio
authors.affiliation: Ospedale San Raffaele, Milano, Italy.|Casa di Cura Columbus, Milano, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Ospedale San Raffaele, Milano, Italy.
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.affiliation: Ospedale San Raffaele, Milano, Italy.
authors.forename: Micaela
authors.initials: M
authors.lastname: Cioni
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padova, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Besola
authors.affiliation: Divisione di Cardiochirurgia, IRCCS San Martino-IST, Genova, Italy.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Regesta
authors.affiliation: Divisione di Cardiochirurgia, IRCCS San Martino-IST, Genova, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Rapetto
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padova, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tarantini
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padova, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Napodano
authors.affiliation: Hesperia Hospital, Modena, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Gabbieri
authors.affiliation: Cardio-Thoraco-Vascular Department, University Hospital Policlinico S. Orsola - Malpighi, Bologna, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Saia
authors.affiliation: Ospedale Ferrarotto, Università di Catania, Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.affiliation: AOU Integrata Verona, Verona, Italy.
authors.forename: Flavio
authors.initials: F
authors.lastname: Ribichini
authors.affiliation: AO Papa Giovanni XXIII, Bergamo, Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Cugola
authors.affiliation: IRCCS Policlinico S. Matteo, Pavia, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Aiello
authors.affiliation: AO Brotzu, Cagliari, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Sanna
authors.affiliation: AOU Policlinico Le Scotte, Siena, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Iadanza
authors.affiliation: AOUD Santa Maria della Misericordia, Udine, Italy.
authors.forename: Esmeralda
authors.initials: E
authors.lastname: Pompei
authors.affiliation: AOU Careggi, Firenze, Italy.
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Stefàno
authors.affiliation: Humanitas Research Hospital, Rozzano, Italy.
authors.forename: Antioco
authors.initials: A
authors.lastname: Cappai
authors.affiliation: Ospedale Cattinara, Trieste, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Minati
authors.affiliation: Clinica S. Maria, Bari, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Cassese
authors.affiliation: Clinica S. Maria, Bari, Italy.
authors.forename: Gian Luca
authors.initials: GL
authors.lastname: Martinelli
authors.affiliation: Azienda O.U. Ospedale Maggiore di Parma, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Agostinelli
authors.affiliation: AO San Camillo Forlanini, Roma, Italy.
authors.forename: Rosario
authors.initials: R
authors.lastname: Fiorilli
authors.affiliation: IRCCS Policlinico San Donato, Milano, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Casilli
authors.affiliation: A.O. Cesare Biagio e Arrigo, Alessandria, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Reale
authors.affiliation: Istituto Clinico Sant'Ambrogio, Milano, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Bedogni
authors.affiliation: AOU Pisana, Pisa, Italy.
authors.forename: Anna Sonia
authors.initials: AS
authors.lastname: Petronio
authors.affiliation: AOU Federico II, Napoli, Italy.
authors.forename: Rosa Alba
authors.initials: RA
authors.lastname: Mozzillo
authors.affiliation: Ospedale S. Chiara, Trento, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Bonmassari
authors.affiliation: Clinica Mediterranea, Napoli, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Briguori
authors.affiliation: Città di Lecce Hospital, Lecce, Italy.
authors.forename: Armando
authors.initials: A
authors.lastname: Liso
authors.affiliation: Policlinico Umberto I, Roma, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Sardella
authors.affiliation: Ospedale Niguarda, Milano, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Bruschi
authors.affiliation: Spedali Civili, Brescia, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Fiorina
authors.affiliation: Department of Surgical Sciences, University of Turin, Turin, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Filippini
authors.affiliation: Department of Surgical Sciences, University of Turin, Turin, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Moretti
authors.affiliation: Città della Salute e della Scienza-Molinette, Torino, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: D'Amico
authors.affiliation: Città della Salute e della Scienza-Molinette, Torino, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: La Torre
authors.affiliation: Città della Salute e della Scienza-Molinette, Torino, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Conrotto
authors.affiliation: Cardio-Thoraco-Vascular Department, University Hospital Policlinico S. Orsola - Malpighi, Bologna, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Di Bartolomeo
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padova, Italy.
authors.forename: Gino
authors.initials: G
authors.lastname: Gerosa
authors.affiliation: Department of Surgical Sciences, University of Turin, Turin, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Rinaldi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000601:surgery; D001705:Bioprosthesis; D004452:Echocardiography; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D007558:Italy; D008297:Male; D012042:Registries; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D016896:Treatment Outcome
keywords: Aortic stenosis; Registry; TAVI