title: Initial experience with the balloon expandable Edwards-SAPIEN Transcatheter Heart Valve in Australia and New Zealand: the SOURCE ANZ registry: outcomes at 30 days and one year.
abstract: BACKGROUND
  We report the findings of the SOURCE-ANZ registry of the clinical outcomes of the Edwards SAPIEN™ Transcatheter Heart Valve (THV) in the Australian and New Zealand (ANZ) clinical environment.
  
  
  METHODS
  This single arm registry of select patients treated in eight centres, represent the initial experience within ANZ with the balloon expandable Edwards SAPIEN THV delivered by transfemoral (TF) and transapical (TA) access.
  
  
  RESULTS
  The total enrolment for the study was 132 patients, 63 patients treated by TF, 56 by TA, and 2 patients were withdrawn from the study. The mean ages: 83.7 (TF) and 81.7 (TA), female: 34.3% (TF) and 61.3% (TA), logistic EuroSCORE: 26.8% (TF) and 28.8% (TA), and with procedural success (successful implant without conversion to surgery or death): 92.4% (TF) and 87.1% (TA) (p=0.32). Outcomes were not significantly different between TF and TA implants. These included one year mortality of 13.6% (TF) and 21.7% (TA) (p=0.24), MACCE: 16.7% (TF) and 28.3% (TA) (p=0.12), pacemaker: 4.6% (TF) and 8.3% (TA) (p=0.39), and VARC major vascular complication of 4.6% (TF) and 5.0% (TA) (p=0.91).
  
  
  CONCLUSIONS
  TAVI in the ANZ clinical environment has demonstrated excellent outcomes for both the TA and TF approaches in highly selected patients. These results are consistent with those demonstrated in European, Canadian registries and the pivotal US clinical trials. ACTRN12611001026910.
authors.affiliation: The Prince Charles Hospital, Brisbane, Australia.
authors.forename: D L
authors.initials: DL
authors.lastname: Walters
authors.affiliation: Flinders Medical Centre, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Sinhal
authors.affiliation: St Vincent's Hospital, Sydney, Australia.
authors.forename: D
authors.initials: D
authors.lastname: Baron
authors.affiliation: Waikato Hospital, New Zealand.
authors.forename: S
authors.initials: S
authors.lastname: Pasupati
authors.affiliation: John Hunter Hospital, Newcastle, Australia.
authors.forename: S
authors.initials: S
authors.lastname: Thambar
authors.affiliation: Royal Perth Hospital, Australia.
authors.forename: G
authors.initials: G
authors.lastname: Yong
authors.affiliation: Prince of Wales Hospital, Sydney, Australia.
authors.forename: N
authors.initials: N
authors.lastname: Jepson
authors.affiliation: Royal North Shore Hospital, Sydney, Australia.
authors.forename: R
authors.initials: R
authors.lastname: Bhindi
authors.affiliation: Flinders Medical Centre, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Bennetts
authors.affiliation: Royal Perth Hospital, Australia.
authors.forename: R
authors.initials: R
authors.lastname: Larbalestier
authors.affiliation: The Prince Charles Hospital, Brisbane, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Clarke
authors.affiliation: Royal North Shore Hospital, Sydney, Australia.
authors.forename: P
authors.initials: P
authors.lastname: Brady
authors.affiliation: Prince of Wales Hospital, Sydney, Australia.
authors.forename: H
authors.initials: H
authors.lastname: Wolfenden
authors.affiliation: John Hunter Hospital, Newcastle, Australia.
authors.forename: A
authors.initials: A
authors.lastname: James
authors.affiliation: Waikato Hospital, New Zealand.
authors.forename: A
authors.initials: A
authors.lastname: El Gamel
authors.affiliation: St Vincent's Hospital, Sydney, Australia.
authors.forename: P
authors.initials: P
authors.lastname: Jansz
authors.affiliation: Flinders Medical Centre, Australia.
authors.forename: D P
authors.initials: DP
authors.lastname: Chew
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality* / Q000601:surgery*; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000706:statistics & numerical data*; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D011183:Postoperative Complications / Q000000981:diagnostic imaging / Q000401:mortality; D015995:Prevalence; D011446:Prospective Studies; D012042:Registries / Q000706:statistics & numerical data; D012307:Risk Factors; D016896:Treatment Outcome; D014463:Ultrasonography
keywords: Aortic stenosis; Aortic valve disease; TAVI; Valvular heart disease