title: Clinical and hemodynamic results after direct transcatheter aortic valve replacement versus pre-implantation balloon aortic valvuloplasty: A case-matched analysis.
abstract: OBJECTIVE
  To evaluate the safety and midterm hemodynamic results of direct transcatheter aortic valve replacement (TAVR) without pre-implantation balloon aortic valvuloplasty (BAV).
  
  
  BACKGROUND
  BAV was considered a mandatory previous step in TAVR procedures.
  
  
  METHODS
  A total of 339 consecutive patients who underwent transfemoral TAVR were prospectively selected. A 1:1 matching was conducted, pairing age, prosthesis type (self-expandable or balloon expandable) and size, and valve calcification grade (48% with moderate to severe valve calcification). Finally, 102 pairs (102 patients with previous BAV and 102 without BAV) were obtained.
  
  
  RESULTS
  Direct TAVR was feasible in all patients without any crossover to BAV group. Device success was achieved in 91.2% and 90.2% of cases in direct TAVR and pre-BAV groups (P = 0.810), respectively, without any differences in balloon postdilation rate and residual aortic regurgitation. The amount of contrast agent, acute kidney injury and myocardial injury was significantly lower in the direct implantation group (P < 0.05). No differences were found in 30-day and 1-year mortality between both groups (4.9% vs. 9.8%, P = 0.177 and 14.0% vs. 23.8%, P = 0.771, respectively). Hemodynamic parameters remained stable after 1-year follow-up in both groups.
  
  
  CONCLUSIONS
  Direct transfemoral TAVR without prior BAV was safe in patients with calcified severe aortic stenosis. Pre-implantation BAV could be omitted in patients undergoing TAVR, without influence in procedure success rate, and subsequent patients' clinical course and valve hemodynamic performance. © 2016 Wiley Periodicals, Inc.
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Carlos
authors: C
authors: Ferrera
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Luis
authors: L
authors: Nombela-Franco
authors: Interventional Cardiology Department, Hospital Universitario Montepríncipe, Madrid, Spain.
authors: Eulogio
authors: E
authors: Garcia
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Pilar
authors: P
authors: Jimenez-Quevedo
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Corina
authors: C
authors: Biagioni
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Nieves
authors: N
authors: Gonzalo
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Ivan
authors: I
authors: Nuñez-Gil
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Ana
authors: A
authors: Viana-Tejedor
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Pablo
authors: P
authors: Salinas
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Jose
authors: J
authors: Alberto de Agustin
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Carlos
authors: C
authors: Almeria
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Fabian
authors: F
authors: Islas
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Leopoldo
authors: L
authors: Perez de Isla
authors: Epidemiology and Statistical Department, Instituto de investigación Sanitaria, Hospital Universitario Clínico San Carlos, Universidad Complutense de Madrid, Madrid, Spain.
authors: Cristina
authors: C
authors: Fernandez-Perez
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Javier
authors: J
authors: Escaned
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Antonio
authors: A
authors: Fernández-Ortiz
authors: Cardiovascular Institute, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors: Carlos
authors: C
authors: Macaya
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000473:pathology* / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D063126:Balloon Valvuloplasty / Q000009:adverse effects / Q000401:mortality; D002114:Calcinosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D006350:Heart Valve Prosthesis; D006439:Hemodynamics; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D020127:Recovery of Function; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D016896:Treatment Outcome; D019564:Unnecessary Procedures
keywords: TAVI; TAVR; balloon aortic valvuloplasty predilation; postdilation; transcatheter aortic valve replacement