title: Feasibility, safety, and efficacy of transcatheter aortic valve replacement without balloon predilation: A systematic review and meta-analysis.
abstract: OBJECTIVE
  To evaluate the feasibility, safety, and efficacy of direct transcatheter aortic valve replacement (TAVR), that is, TAVR without balloon predilation (BPD), by performing a systematic review and meta-analysis of available evidence.
  
  
  BACKGROUND
  Avoiding BPD during TAVR was shown to be feasible in previous studies but the risks and benefits of this technique are unknown owing to the limited number of patients included in these studies.
  
  
  METHODS
  We performed a systematic search for studies comparing direct TAVR vs TAVR performed with BPD. Crude risk ratios (RRs) or mean differences and 95% confidence intervals (CI) for each endpoint were calculated using random effects models.
  
  
  RESULTS
  Twenty studies including 3586 patients (1606 undergoing direct TAVR) were selected for the analysis. Mean device success with direct TAVR was 88% with <5% of bail-out techniques. There were no differences between direct and BPD-TAVR in short-term (in-hospital or 30-day) mortality (RR: 1.06; 95% CI: 0.78-1.43) or cerebrovascular events (RR: 0.92; 95% CI: 0.58-1.46). Direct TAVR associated with reduced moderate or severe paravalvular leak post-TAVR (RR: 0.59; 95% CI: 0.36-0.98) but not with a reduced risk of permanent pacemaker implantation (RR: 0.85, 95% CI: 0.71-1.02). A slight increase in postdilation was observed in direct transfemoral-TAVR recipients (RR: 1.2; 95% CI: 1.00-1.44).
  
  
  CONCLUSIONS
  Direct TAVR is feasible and safe. However, given the unadjusted nature of our results, uncertainties remain regarding the independent effect of direct TAVR on outcomes post-TAVR. Randomized studies are warranted to determine the potential benefits of direct TAVR. © 2017 Wiley Periodicals, Inc.
authors.affiliation: Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.|Signal and Image Processing Laboratory, Rennes 1 University, Rennes, France.
authors.forename: Vincent
authors.identifier: http://orcid.org/0000-0003-0535-2120
authors.initials: V
authors.lastname: Auffret
authors.affiliation: Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors.forename: Ander
authors.identifier: http://orcid.org/0000-0001-5201-447X
authors.initials: A
authors.lastname: Regueiro
authors.affiliation: Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors.forename: Francisco
authors.initials: F
authors.lastname: Campelo-Parada
authors.affiliation: Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors.forename: María
authors.initials: M
authors.lastname: Del Trigo
authors.affiliation: Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors.forename: Olivier
authors.initials: O
authors.lastname: Chiche
authors.affiliation: Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors.forename: Chekrallah
authors.initials: C
authors.lastname: Chamandi
authors.affiliation: Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors.forename: Rishi
authors.identifier: http://orcid.org/0000-0001-8849-7426
authors.initials: R
authors.lastname: Puri
authors.affiliation: Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.
authors.forename: Josep
authors.initials: J
authors.lastname: Rodés-Cabau
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D063126:Balloon Valvuloplasty; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D007902:Length of Stay; D008297:Male; D016017:Odds Ratio; D011183:Postoperative Complications / Q000401:mortality / Q000628:therapy; D012307:Risk Factors; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000401:mortality; D016896:Treatment Outcome
keywords: aortic stenosis; balloon valvuloplasty; transcatheter aortic valve implantation