title: The transaortic approach for transcatheter aortic valve replacement: initial clinical experience in the United States.
abstract: OBJECTIVE
  This study sought to investigate the technical feasibility and safety of the transaortic (TAO) transcatheter aortic valve replacement (TAVR) approach in patients not eligible for transfemoral (TF) access by using a device commercially available in the United States.
  
  
  BACKGROUND
  A large proportion of candidates for TAVR have inadequate iliofemoral vessels for TF access. The transapical route (TAP) is the current alternative but is associated with less favorable outcomes. Other access options need to be explored.
  
  
  METHODS
  Forty-four consecutive patients with inoperable, severe aortic stenosis underwent TAO TAVR in our institution. Procedural and 30-day clinical outcomes data were compared with data from 76 consecutive patients who underwent TAP TAVR at our site. Technical learning curves were assessed by comparing outcomes of the first 20 cases with the subsequent patients who underwent each procedure.
  
  
  RESULTS
  The TAO and TAP TAVR groups were similar in terms of device success according to Valve Academic Research Consortium criteria (89% vs. 84%; p = 0.59) and rates of the 30-day combined safety endpoint of all-cause mortality, myocardial infarction, major stroke, disabling bleeding, severe acute kidney injury, and valve reintervention (20% vs. 33%; p = 0.21). The TAO approach, compared with TAP TAVR, was associated with lower combined bleeding and vascular event rate (27% vs. 46%; p = 0.05), shorter median intensive care unit length of stay (3 vs. 6 days; p = 0.01), and a favorable learning curve.
  
  
  CONCLUSIONS
  TAVR via the TAO approach is technically feasible, seems to be associated with favorable outcomes, and expands the current alternative options for access sites in patients with inoperable aortic stenosis who are ineligible for TF TAVR.
authors.affiliation: Multidisciplinary Structural Heart Disease Program at the University of Miami-Miller School of Medicine, Miami, Florida, USA. jlardizabal@heart24.com
authors.forename: Joel A
authors.initials: JA
authors.lastname: Lardizabal
authors.forename: Brian P
authors.initials: BP
authors.lastname: O'Neill
authors.forename: Harit V
authors.initials: HV
authors.lastname: Desai
authors.forename: Conrad J
authors.initials: CJ
authors.lastname: Macon
authors.forename: Alexis P
authors.initials: AP
authors.lastname: Rodriguez
authors.forename: Claudia A
authors.initials: CA
authors.lastname: Martinez
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Alfonso
authors.forename: Martin S
authors.initials: MS
authors.lastname: Bilsker
authors.forename: Roger G
authors.initials: RG
authors.lastname: Carillo
authors.forename: Mauricio G
authors.initials: MG
authors.lastname: Cohen
authors.forename: Alan W
authors.initials: AW
authors.lastname: Heldman
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
authors.forename: Donald B
authors.initials: DB
authors.lastname: Williams
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality* / Q000628:therapy*; D006328:Cardiac Catheterization / Q000379:methods*; D016009:Chi-Square Distribution; D015331:Cohort Studies; D015150:Echocardiography, Doppler; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D061214:Patient Safety; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome