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July 31, 2014Clinical CardiologyOpen Access

Transfemoral Aortic Valve Implantation of Edwards SAPIEN XT Without Predilatation Is Feasible

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Key result

Transfemoral TAVI without predilatation was feasible, achieving 100% procedural success and 0% 30-day mortality, with significantly reduced radiation and contrast dye compared to predilatation.

Why the study?

Does transfemoral TAVI without predilatation improve procedural safety and feasibility compared to TAVI with predilatation in patients with native aortic valve stenosis?

Population

56 patients with stenosis of the native aortic valve

Comparison

Transfemoral transcatheter aortic valve… vs Transfemoral TAVI with predilatation

Design

Cohort

Follow-up

30 days

Authors

HMHelge MöllmannJKJörg KempfertJBJohannes Blumenstein

Discussion

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Overview

May support omitting predilatation to reduce radiation and contrast; hypothesis-generating and requires randomized confirmation before practice change.

Study Design

Type

Cohort (n=56)

Structured PICO

Does transfemoral TAVI without predilatation improve procedural safety and feasibility compared to TAVI with predilatation in patients with native aortic valve stenosis?

P
Population
56 patients with native aortic valve stenosis undergoing transfemoral TAVI, comparing 26 treated without predilatation to 30 treated with predilatation.
E
Exposure
Transfemoral transcatheter aortic valve implantation (TAVI) using a balloon-expandable device (Edwards SAPIEN XT) without predilatation
C
Comparator
Transfemoral TAVI with predilatation (historical cohort of 30 patients)
O
Outcome
Procedural success, echocardiographic parameters (AV area, AV gradient, LVEF) prior to discharge, radiation dose, contrast dye amount, periprocedural neurological adverse events, and 30-day mortalitysafety

Transfemoral TAVI without predilatation using a balloon-expandable valve is feasible, safe, and reduces radiation and contrast use compared to standard predilatation.

Limitations

  • Small sample size requiring larger studies to further evaluate the approach
  • Small sample size
  • Retrospective design

Cite This Study

Möllmann et al. (2014) conducted a cohort in Stenosis of the native aortic valve (n=56). Transfemoral TAVI without predilatation vs. Transfemoral TAVI with predilatation was evaluated on Procedural success. Transfemoral TAVI without predilatation was feasible, achieving 100% procedural success and 0% 30-day mortality, with significantly reduced radiation and contrast dye compared to predilatation.

synapsesocial.com/papers/6a9a92e09ded1192d2016ca6https://doi.org/10.1002/clc.22318
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Feasibility and safety of transfemoral implantation of Edwards SAPIEN XT prosthesis without balloon valvuloplasty in severe stenosis of native aortic valve2013 · 23 citations
  2. 2First experience without pre-ballooning in transapical aortic valve implantation: a propensity score-matched analysis†2014 · 27 citations
  3. 3Electrocardiographic and further predictors for permanent pacemaker requirement after transcatheter aortic valve implantation2010 · 119 citations
  4. 4The German Aortic Valve Registry (GARY): in-hospital outcome2013 · 338 citations
  5. 5Guidelines on the management of valvular heart disease (version 2012)2012 · 3,574 citations