title: Transfemoral aortic valve implantation of Edwards SAPIEN XT without predilatation is feasible.
abstract: BACKGROUND
  Transcatheter aortic valve implantation (TAVI) without predilatation has fewer procedural steps and thereby potentially fewer complications. This has been demonstrated for the antegrade transapical access; however, whether TAVI can be safely performed without predilatation using the retrograde transfemoral route is unknown.
  
  
  OBJECTIVE
  We postulated that TAVI is feasible with a balloon-expandable device without predilatation using the retrograde transfemoral route.
  
  
  METHODS
  Twenty-six consecutive patients with stenosis of the native aortic valve (AV) undergoing transfemoral TAVI with the Edwards SAPIEN XT prosthesis without predilatation were enrolled in this retrospective study and compared with 30 patients treated previously with predilatation.
  
  
  RESULTS
  The procedure was successfully performed in all 26 patients, irrespective of the AV area and the extent of AV calcification. At baseline mean AV area, mean AV gradient, and median left ventricular ejection fraction were 0.7 ± 0.2 cm(2) , 36.0 ± 17.3 mm Hg, and 55.0% (interquartile range [IQR], 35.0-60.0], respectively; prior to discharge these values were 1.7 ± 0.3 (P < 0.001), 9.8 ± 6.1 mm Hg (P < 0.001), and 57.5% (IQR, 38.7-60.0) (P = not significant). Postdilatation was required in 3 patients due to aortic regurgitation > 2°; this was reduced by the procedure to < 2° in all cases. Radiation dose and amount of contrast dye were significantly reduced in comparison with the predilatation group. No periprocedural neurological adverse events occurred. Mortality at 30 days was 0%.
  
  
  CONCLUSIONS
  TAVI without predilatation using the transfemoral Edwards SAPIEN XT valve is feasible and safe. Larger studies are required to further evaluate this approach.
authors.affiliation: Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.
authors.forename: Helge
authors.initials: H
authors.lastname: Möllmann
authors.forename: Won-Keun
authors.initials: WK
authors.lastname: Kim
authors.forename: Jörg
authors.initials: J
authors.lastname: Kempfert
authors.forename: Johannes
authors.initials: J
authors.lastname: Blumenstein
authors.forename: Christoph
authors.initials: C
authors.lastname: Liebetrau
authors.forename: Holger
authors.initials: H
authors.lastname: Nef
authors.forename: Arnaud
authors.initials: A
authors.lastname: Van Linden
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
authors.forename: Christian
authors.initials: C
authors.lastname: Hamm
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D063126:Balloon Valvuloplasty; D003287:Contrast Media / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D011829:Radiation Dosage; D012189:Retrospective Studies
chemical_list: D003287:Contrast Media
references.citation: Heart Lung Circ. 2008;17 Suppl 4:S73-81
references.pmid: 19010083
references.citation: Catheter Cardiovasc Interv. 2014 Apr 1;83(5):791-5
references.pmid: 24285561
references.citation: Can J Cardiol. 2012 Nov-Dec;28(6):759.e13-5
references.pmid: 22906802
references.citation: Europace. 2010 Aug;12(8):1188-90
references.pmid: 20353965
references.citation: JACC Cardiovasc Interv. 2011 Jul;4(7):751-7
references.pmid: 21777882
references.citation: Circulation. 2006 Oct 10;114(15):1616-24
references.pmid: 17015786
references.citation: Eur Heart J. 2012 Oct;33(19):2451-96
references.pmid: 22922415
references.citation: Circulation. 2010 Feb 23;121(7):870-8
references.pmid: 20177005
references.citation: Semin Thorac Cardiovasc Surg. 2011 Spring;23(1):55-61
references.pmid: 21807300
references.citation: Eur J Cardiothorac Surg. 2015 Jan;47(1):31-8; discussion 38
references.pmid: 24674906
references.citation: Eur Heart J. 2014 Jun 21;35(24):1588-98
references.pmid: 24022003
references.citation: Lancet. 2003 Apr 12;361(9365):1241-6
references.pmid: 12699950