title: Comparison of Systematic Predilation, Selective Predilation, and Direct Transcatheter Aortic Valve Implantation With the SAPIEN S3 Valve.
abstract: Despite previously described feasibility, direct transcatheter aortic valve implantation (TAVI) with the Edwards SAPIEN S3 device (S3-THV) (Edwards Lifesciences, Irvine, CA) has not been compared with either a systematic or a selective predilation approach.
  
  
  
  Patients undergoing predilation were divided into a systematic group (regardless of anatomic features) and a selective group (in the context of high valvular calcium burden). Both groups were matched in a 2:1 fashion to patients who underwent direct TAVI. Outcomes were assessed according to Valve Academic Research Consortium 2 (VARC-2) criteria.
  
  
  
  Two hundred eighty-one patients underwent TAVI with the S3-THV in our centre. Of these patients, 58 underwent predilation before device implantation (systematic, n = 26; selective, n = 32). Procedural success was achieved in all patients. Patients in the selective predilation group had severe valve calcification volume-more than double that of the systematic group (445 ± 306 mm3vs 970 ± 578 mm3, respectively; P < 0.0001). There was a trend for less dilation after the procedure in the systematic group compared with the selective group (4% vs 19%, respectively; P = 0.09). Device malposition necessitating a second device to be implanted occurred in 3 cases of direct TAVI (5%) and in none of the patients undergoing predilation (P = not significant). Thirty-day and 1-year mortality rates were similar between the patients who underwent direct TAVI and their predilation counterparts.
  
  
  
  In patients with a moderate aortic valve calcification burden, direct TAVI appears to be feasible and safe. In those with high calcium burden, predilation should be considered after taking into account individual risk profiles.
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Marco
authors.initials: M
authors.lastname: Spaziano
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Fadi
authors.initials: F
authors.lastname: Sawaya
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Andrew
authors.initials: A
authors.lastname: Roy
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Antoinette
authors.initials: A
authors.lastname: Neylon
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Garot
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hovasse
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Hakim
authors.initials: H
authors.lastname: Benamer
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Mauro
authors.initials: M
authors.lastname: Romano
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Unterseeh
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Erik
authors.initials: E
authors.lastname: Bouvier
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Cormier
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.affiliation: Department of Cardiology, Générale de Santé, Institut Cardiovasculaire Paris-Sud - Hôpital Privé Jacques Cartier, Massy, France. Electronic address: t.lefevre@angio-icps.com.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D063126:Balloon Valvuloplasty / Q000379:methods*; D002114:Calcinosis / Q000175:diagnosis / Q000601:surgery*; D004452:Echocardiography; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome