title: Procedural results and 30-day clinical events analysis following Edwards transcatheter aortic valve implantation in 48 consecutive patients: initial experience.
abstract: BACKGROUND
  Transcatheter aortic valve implantation (TAVI) is a rapidly evolving strategy for therapy of aortic stenosis. We presented the procedural results and analyzed the death causes of 30-day mortality and clinical events in patients who underwent TAVI with Edwards prosthetic valves in University Hospital of Caen, France.
  
  
  METHODS
  The patients with severe aortic stenosis but at high surgical risk or inoperable were considered as candidates for TAVI. Forty-eight patients undergoing TAVI from July 2010 to September 2011 were enrolled in this registry. The Edwards prosthetic valves were solely used in this clinical trial.
  
  
  RESULTS
  Overall 48 patients underwent TAVI, 28 of which accepted TAVI by trans-femoral (TF) approaches, 20 by trans-apical approaches (TA). The aortic valve area (AVA) was (0.70 ± 0.23) cm(2), left ventricular ejection fraction (LVEF) was (57.4 ± 17.6)%, Log EuroSCORE was (19.2 ± 15.8)%, mean gradient was (47.0 ± 16.6) mmHg. There were no significant differences between TF and TA groups in all these baseline parameters. Device success rate was 95.8%, and procedural success rate was 93.7% in total. Procedural mortality was 6.7% (3/48): two deaths in TA group (10%), and one death in TF group (3.6%). Forty-six Edwards valves were implanted: 10 Edwards Sapien and 36 Edwards XT. Procedure-related complications included cardiac tamponade in 2 cases (4.2%), acute myocardial infarction (AMI) in 1 case (2.1%), permanent pacemaker implantation in 1 case (2.1%), life-threatening and major bleeding in 3 cases; access site related major complication in 1 case, AKI stage 3 in 3 cases (6.3%), minor stroke in 1 case (2.1%). Thirty-day survival rate was 89.6%. There were 5 deaths in total (10.4%): 4 in TA group (20%) and 1 in TF group (3.6%).
  
  
  CONCLUSIONS
  The procedural success rate and 30-day mortality were acceptable in these high risk patients with Edwards prosthetic valves in the first 48 TAVI.
authors.affiliation: Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.
authors.forename: Quan-Ming
authors.initials: QM
authors.lastname: Zhao
authors.forename: Therese
authors.initials: T
authors.lastname: Lognone
authors.forename: Calin
authors.initials: C
authors.lastname: Ivascau
authors.forename: Remi
authors.initials: R
authors.lastname: Sabatier
authors.forename: Vincent
authors.initials: V
authors.lastname: Roule
authors.forename: Ziad
authors.initials: Z
authors.lastname: Dahdouh
authors.forename: Massimo
authors.initials: M
authors.lastname: Massetti
authors.forename: Gilles
authors.initials: G
authors.lastname: Grollier
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D006328:Cardiac Catheterization / Q000379:methods*; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000601:surgery*; D016896:Treatment Outcome