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Direct transfemoral transcatheter aortic valve implantation without balloon pre‐dilatation using the Edwards Sapien XT valve
Author(s) -
Bandali Alykhan,
ParryWilliams Gemma,
Kassam Aliya,
Palmer Sonny,
Williams Paul D.,
de Belder Mark A.,
Owens Andrew,
Goodwin Andrew,
Muir Douglas F.
Publication year - 2016
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.26564
Subject(s) - medicine , balloon , aortic valvuloplasty , aortic valve stenosis , stenosis , surgery , balloon valvuloplasty , cardiology , aortic valve , tamponade , aortic valve replacement
Objectives To evaluate the feasibility and safety of direct transcatheter aortic valve implantation (TAVI) by the transfemoral approach without balloon pre‐dilatation using the Edwards SapienXT valve. Background TAVI is established in selected high‐risk patients with severe aortic stenosis. Balloon aortic valvuloplasty (BAV) is recommended prior to valve implantation, but may contribute to procedural risk. It is unknown whether this is necessary for successful passage and deployment of the device. Methods 81 patients (mean age 84 [95%CI:82–85.8], 62% male, median EuroScore 22.8% [95%CI:20.5–27]) undergoing transfemoral TAVI (35 by direct implantation [direct group]; 46 with balloon pre‐dilatation [balloon group]) between 2010 and 2013 were analyzed for efficacy and safety endpoints. Results Procedural success was 100%. Pre and post‐procedural peak gradients in the direct group were 66mmHg (95%CI:59–72.8) and 14mmHg (95%CI:12–17.8)( P < 0.0001) compared to 76.5mmHg (95%CI:73.7–94.0) and 17mmHg (95%CI:16–19)( P < 0.0001) in the balloon group. Post‐dilatation was performed in 4/35(11.4%) of the direct group and 3/46(6.5%) of the balloon group ( P = 0.83). Post procedure moderate AR was present in 1/35(2.9%) in the direct group and none in the balloon group. In‐hospital mortality (2.9% direct vs. 0% balloon group), stroke (2.9% vs. 4.4%), tamponade (2.9% vs. 2.2%), major vascular complications (2.9% vs. 8.7%) and new permanent pacing (2.2% vs. 0) were similar. Pacing time, inflations, radiation dose and contrast use were all significantly lower in the direct group. Conclusions Direct implantation of the Edwards SapienXT valve during TAVI by the transfemoral route appears safe, efficacious and feasible in those without extreme calcification. © 2016 Wiley Periodicals, Inc.