title: Transcatheter aortic valve implantation without balloon predilation: a single-center pilot experience.
abstract: OBJECTIVE
  To assess the results of transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve prosthesis (Medtronic, Minneapolis, MN), without balloon predilation, in high-risk patients with degenerated severe aortic stenosis.
  
  
  RESULTS
  Fifty-one consecutive patients who underwent direct TAVI, 98% through a transfemoral approach. Patients were 79 ± 8 years of age, 74% in New York Heart Association classes III or IV and at high risk for surgical valve replacement (mean logistic EuroScore 20 ± 15). Mean aortic valve area was 0.7 ± 0.2 cm(2). Procedural success rate was 94.2%. In-hospital, there were 2 deaths, 1 minor stroke with minimal sequelae, and 14 (28%) pacemaker implantation. At 30 days, there was one additional stroke and no new deaths. The mean postprocedural transprosthetic gradient was 15 ± 5 mm Hg; periprosthetic severe regurgitation was absent and moderate in one case. After a median follow-up of 7 months, there were five additional deaths (two cardiac), while 84% of survivors were in New York Heart Association classes I or II.
  
  
  CONCLUSIONS
  These results suggest that direct CoreValve implantation in patients with severe aortic stenosis is feasible and may lead to hemodynamic and clinical improvement in patients who are poor candidates for aortic valve surgery, pending confirmation in larger series with longer follow-up.
authors.affiliation: Department of Interventional Cardiology and Cardiovascular Surgery, Hospital Universitario, Fundación Favaloro, Buenos Aires, Argentina. omendiz@ffavaloro.org
authors.forename: Oscar A
authors.initials: OA
authors.lastname: Mendiz
authors.forename: Hugo
authors.initials: H
authors.lastname: Fraguas
authors.forename: Gustavo A
authors.initials: GA
authors.lastname: Lev
authors.forename: Leon R
authors.initials: LR
authors.lastname: Valdivieso
authors.forename: Roberto R
authors.initials: RR
authors.lastname: Favaloro
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000473:pathology* / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D001118:Argentina; D002114:Calcinosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D017548:Echocardiography, Transesophageal; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D006439:Hemodynamics; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D012720:Severity of Illness Index; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
keywords: aortic stenosis; device underexpansion; direct transcatheter aortic valve implantation