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November 8, 2013Catheterization and Cardiovascular Interventions

Feasibility and safety of transfemoral implantation of Edwards SAPIEN XT prosthesis without balloon valvuloplasty in severe stenosis of native aortic valve

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Key result

Direct implantation of the Edwards SAPIEN XT valve without prior balloon valvuloplasty was feasible and safe in 10 selected patients, with 0% adverse events at 30 days.

Why the study?

Does direct implantation of Edwards SAPIEN XT without prior balloon valvuloplasty prevent adverse events in patients with symptomatic severe aortic stenosis?

Population

n=10 patients with symptomatic severe aortic stenosis of a native valve and high surgical risk, selected…

Design

Case_series

Follow-up

30 days

Authors

EGEulogio Garcı́aPMPatricia MartínRHRosana Hernández

Discussion

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Member takes

Overview

May support direct SAPIEN XT implantation in selected AS patients; hypothesis-generating and should not yet change practice.

Study Design

Type

Observational (n=10)

Structured PICO

Does direct implantation of Edwards SAPIEN XT without prior balloon valvuloplasty prevent adverse events in patients with symptomatic severe aortic stenosis?

P
Population
10 patients with symptomatic severe aortic stenosis and high surgical risk, selected based on specific echocardiographic criteria, followed for 30 days.
E
Exposure
Direct transfemoral implantation of balloon-expandable Edwards SAPIEN XT valve without prior balloon valvuloplasty
O
Outcome
Feasibility (proper positioning and implantation) and safety (adverse events including death, need for pacemaker, myocardial infarction, or stroke) at 30 days post-proceduresafety

Direct transfemoral implantation of the balloon-expandable Edwards SAPIEN XT valve without prior balloon valvuloplasty is feasible and safe in highly selected patients with severe aortic stenosis.

Limitations

  • The number of patients in whom this technique would be applicable, and their impact on reducing complications has to be determined.

Cite This Study

Garcı́a et al. (2013) conducted an observational in Symptomatic aortic stenosis of a native valve and high surgical risk (n=10). Direct implantation of Edwards SAPIEN XT prosthesis without balloon valvuloplasty was evaluated on Adverse events (death, need for pacemaker, myocardial infarction, or stroke). Direct implantation of the Edwards SAPIEN XT valve without prior balloon valvuloplasty was feasible and safe in 10 selected patients, with 0% adverse events at 30 days.

synapsesocial.com/papers/6a97c169da663e44ef76f888https://doi.org/10.1002/ccd.24766
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Also Consider

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

  1. 1Transcatheter Aortic Valve Implantation for the Treatment of Severe Symptomatic Aortic Stenosis in Patients at Very High or Prohibitive Surgical Risk2010 · 981 citations
  2. 2Percutaneous Aortic Valve Implantation Retrograde From the Femoral Artery2006 · 905 citations
  3. 3Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery2010 · 7,243 citations
  4. 4Current balloon‐expandable transcatheter heart valve and delivery systems2009 · 38 citations
  5. 5Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis2002 · 3,196 citations