title: Transapical transcatheter aortic valve implantation without prior balloon aortic valvuloplasty: feasible and safe.
abstract: OBJECTIVE
  Currently, preimplant balloon aortic valvuloplasty (BAV) is considered a prerequisite for successful subsequent transapical transcatheter aortic valve implantation (TA-TAVI) using balloon-expandable devices. However, cerebral embolization has been shown to originate at least in part from BAV procedures. Omitting BAV may therefore reduce neurological events after TAVI and facilitate the procedure while yielding non-inferior haemodynamic and clinical outcomes.
  
  
  METHODS
  From May 2011 through December 2012, a total of 50 consecutive patients were treated by TA-TAVI without preimplant BAV (TA-TAVI(-BAV), study group) using the Edwards Sapien XT device (54% male, age 78 ± 8 years, logistic European System for Cardiac Operative Risk Evaluation I 21 ± 14%). Data were prospectively entered into a dedicated database, retrospectively analysed and compared with a consecutive series of conventional TA-TAVI using the same device (control group, n = 50). Reporting of data followed Valve Academic Research Consortium definitions.
  
  
  RESULTS
  Overall device success rate was 94% (47/50) and 86% (43/50) in study and control groups, respectively (P = 0.32). Procedure time was similar in the study group compared with the control group (88 ± 31 vs 91 ± 25 min, P = 0.60), while significantly less contrast was used (138 ± 68 vs 183 ± 78 ml, P < 0.001). Post-procedural peak and mean transvalvular gradients were 16 ± 7 and 8 ± 3 mmHg, respectively, in the study group with similar values in the control group (19 ± 9 and 9 ± 5 mmHg, P = 0.08 and P = 0.09, respectively). Residual paravalvular leakage (PVL) grade 2 was present in 2 and 8% in study and control groups, respectively (P = 0.36), with no PVL >grade 2 in any patient. Rates of 30-day mortality and periprocedural stroke were 4 and 10% (P = 0.44) and 2 and 6% (P = 0.62), respectively.
  
  
  CONCLUSIONS
  TA-TAVI(-BAV) is feasible and safe and has become ur default technique for patients allocated to TA-TAVI with balloon-expandable devices. This approach resulted in less contrast agent used and facilitated the procedure without compromising valve performance. Possible beneficial effects of this approach on the incidence of cerebrovascular events, other periprocedural complications or haemodynamic valve performance need to be verified in larger patient numbers before general recommendations can be made.
authors: Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany lconradi@uke.de.
authors: Lenard
authors: L
authors: Conradi
authors: Department of Cardiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors: Moritz
authors: M
authors: Seiffert
authors: Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors: Johannes
authors: J
authors: Schirmer
authors: Department of Cardiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors: Dietmar
authors: D
authors: Koschyk
authors: Department of Cardiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors: Stefan
authors: S
authors: Blankenberg
authors: Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors: Hermann
authors: H
authors: Reichenspurner
authors: Department of Cardiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors: Patrick
authors: P
authors: Diemert
authors: Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors: Hendrik
authors: H
authors: Treede
mesh_terms: D000368:Aged; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000601:surgery; D063126:Balloon Valvuloplasty; D016022:Case-Control Studies; D003287:Contrast Media / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D061330:Multidetector Computed Tomography; D061646:Operative Time; D011300:Preoperative Care; D012189:Retrospective Studies; D020521:Stroke / Q000453:epidemiology; D014463:Ultrasonography
chemical_list: D003287:Contrast Media
keywords: Balloon aortic valvuloplasty; Stroke; Transcatheter aortic valve implantation