title: The SOURCE Registry: what is the learning curve in trans-apical aortic valve implantation?
abstract: OBJECTIVE
  Trans-apical aortic valve implantation (TA-AVI) has been shown to be a reproducible technique. Early results from the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry identified major access complications associated with high 30-day mortality. Using the SOURCE Registry, we analyze the learning curve for TA-AVI over the first 2 years after commercialization.
  
  
  METHODS
  The SOURCE Registry gathered data for 2 consecutive years at European centers following commercialization of the Edwards SAPIEN bioprosthesis, totaling 2339 patients (1038 in COHORT 1 and 1301 in COHORT 2). Only data from centers that provided all of their consecutively treated patients were included in this study. We compared the 30-day results of TA-AVI from COHORT 1 (C-1: January/2008-January/2009) with the 30-day results of COHORT 2 (C-2: February/2009-January/2010).
  
  
  RESULTS
  This analysis is based on a total number of 575 TA-AVIs in C-1 and 819 TA-AVIs in C-2. Mean age (C-1: 80.7 years, C-2: 80.5 years) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (C-1: 29.1%, C-2 27.3%) were not significantly different. Valve malposition (C-1: 1.6%, C-2: 1.2%), valve migration/embolization (C-1: 0.5%, C-2: 1.0%), and major access complications (C-1: 2.1%, C-2: 1.8%) were in total less frequent, but not statistically significant lower in C-2. However, the reduction of aortic regurgitation >2+ immediately following the procedure (C-1: 4.52%, C-2: 2.1%, p=0.011) and conversion rate to open surgery (C-1: 3.7%, C-2: 1.5%, p=0.0315) reached statistical significance. Postoperative complications included dialysis (C-1: 7.0%, C-2: 5.7%, p=ns), pacemaker implantation (C-2: 7.7%, C-2: 6.7%, p=ns), stroke (C-1: 2.4%, C-2: 2.6%, p=ns), and myocardial infarct (C-1: 0.7%, C-2: 0.4%, p=ns). The total 30-day mortality was 10.8% and not significantly different between the two groups (C-1: 10.8%, C-2: 10.7%, p=ns).
  
  
  CONCLUSIONS
  Although the incidence of technical intra procedural complications has trended downward, reflecting the learning curve for TA-AVI, 30-day mortality was unchanged, likely due to patient co-morbidities not captured by preoperative risk variables.
authors.affiliation: Department of Cardiothoracic Surgery, King's Health Partners, London, UK. olaf.wendler@nhs.net
authors.forename: Olaf
authors.initials: O
authors.lastname: Wendler
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
authors.forename: Holger
authors.initials: H
authors.lastname: Schroefel
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Lange
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.forename: Melissa
authors.initials: M
authors.lastname: Fusari
authors.forename: Paolo
authors.initials: P
authors.lastname: Rubino
authors.forename: Martyn
authors.initials: M
authors.lastname: Thomas
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery*; D001705:Bioprosthesis; D002983:Clinical Competence; D015897:Comorbidity; D004502:Education, Medical, Continuing; D005060:Europe / Q000453:epidemiology; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000193:education* / Q000401:mortality / Q000592:standards; D006801:Humans; D059032:Learning Curve; D008297:Male; D019060:Minimally Invasive Surgical Procedures / Q000009:adverse effects / Q000193:education / Q000401:mortality; D012042:Registries; D016896:Treatment Outcome