Debate: whether fenestrated endografts should be limited to a small number of specialized centers

TY - JOUR

T1 - Debate: whether fenestrated endografts should be limited to a small number of specialized centers

AU - Haulon, Stéphan

AU - Barillà, David

AU - Tyrrell, Mark

AU - Tsilimparis, Nikolaos

AU - Ricotta, Joseph J

N1 - Copyright © 2013. Published by Mosby, Inc.

PY - 2013/3

Y1 - 2013/3

N2 - Until fairly recently, experience with advanced endovascular technologies, including fenestrated endovascular repair (FEVAR), has been limited to a relatively small number of practitioners worldwide. Excellent outcomes have been achieved by these accomplished surgeons who, at least initially, have primarily used custom-made devices constructed by a single endograft manufacturer. Access to this technology has been limited by the skills necessary for such procedures and by the customization process with industry partners. However, several issues are changing rapidly with FEVAR. Increasing numbers of surgeons now have the necessary endovascular skills, and off-the-shelf endografts from several manufacturers have become, or are becoming, available. Also, the regulatory landscape is changing with device approval in the United States. Surgeons and patients alike are anticipating the widespread adoption of this advanced technology that will surely benefit increasing numbers of patients. Or will it? Will widespread adoption in a larger number of smaller-volume hospitals, by less experienced surgeons, result in poor patient outcomes, or will excellent results continue with more patients benefitting from these technologic advances? These are important questions to ask before such adoption and are the subject of this debate.

AB - Until fairly recently, experience with advanced endovascular technologies, including fenestrated endovascular repair (FEVAR), has been limited to a relatively small number of practitioners worldwide. Excellent outcomes have been achieved by these accomplished surgeons who, at least initially, have primarily used custom-made devices constructed by a single endograft manufacturer. Access to this technology has been limited by the skills necessary for such procedures and by the customization process with industry partners. However, several issues are changing rapidly with FEVAR. Increasing numbers of surgeons now have the necessary endovascular skills, and off-the-shelf endografts from several manufacturers have become, or are becoming, available. Also, the regulatory landscape is changing with device approval in the United States. Surgeons and patients alike are anticipating the widespread adoption of this advanced technology that will surely benefit increasing numbers of patients. Or will it? Will widespread adoption in a larger number of smaller-volume hospitals, by less experienced surgeons, result in poor patient outcomes, or will excellent results continue with more patients benefitting from these technologic advances? These are important questions to ask before such adoption and are the subject of this debate.

KW - Aortic Aneurysm/diagnostic imaging

KW - Aortography/methods

KW - Blood Vessel Prosthesis

KW - Blood Vessel Prosthesis Implantation/adverse effects

KW - Clinical Competence

KW - Computer-Aided Design

KW - Endovascular Procedures/adverse effects

KW - Guideline Adherence

KW - Hospitals, High-Volume

KW - Humans

KW - Learning Curve

KW - Patient Safety

KW - Patient Selection

KW - Practice Guidelines as Topic

KW - Predictive Value of Tests

KW - Prosthesis Design

KW - Risk Factors

KW - Specialization

KW - Surgery, Computer-Assisted/adverse effects

KW - Tomography, X-Ray Computed

KW - Treatment Outcome

U2 - 10.1016/j.jvs.2013.01.001

DO - 10.1016/j.jvs.2013.01.001

M3 - SCORING: Journal article

C2 - 23446130

VL - 57

SP - 875

EP - 882

JO - J VASC SURG

JF - J VASC SURG

SN - 0741-5214

IS - 3

ER -