What were the origins of this collaboration, and whoparticipated in the process of defining and refiningthese standards?
Dr. Lee: The Executive Committee of the Societyfor Vascular Surgery (SVS) commissioned a group ofexperts who possess knowledge of the clinical aspectsand patients' values and preferences in key areas inendovascular therapy where it would be helpful to provideguidelines for the practicing clinician. Endovascular repairof traumatic thoracic aortic injuries was one of these areas.The interdisciplinary group, composed of both vascularand cardiac surgeons, worked in collaboration with anindependent outcomes research organization to providethe best available evidence and grade the quality of thatevidence, which determined the strength of the recommendation.

How were the guidelines ultimately decided upon?Please explain GRADE and how it works.
Dr. Lee: GRADE stands for Grading of RecommendationsAssessment, Development and Evaluation. This methodof presenting recommendations provides superior clarityand separates the quality of evidence (levels: A = high,B = moderate, C = low) from the strength of recommendations(strong, weak) and allows for the inclusion ofpatients' values and preferences in the recommendations.

What criteria might lead to not including a particularguideline?
Dr. Lee: If there was no evidence on which to make arecommendation, it was left out. On occasion, however,select topics of general interest were addressed bypolling the opinions of the expert group, and anattempt at consensus was made. These were reportedas grade 2, level C recommendations.

How would you briefly summarize the guidelines?Which thoracic aortic injury patients should betreated endovascularly, and which should be treatedwith surgery?
Dr. Lee: The guidelines suggest that endovascularrepair of traumatic thoracic aortic injuries be performedpreferentially over open surgical repair or nonoperativemanagement. The guidelines did not specifically addressin whom or which circumstances the two competingtherapies should be applied.

What evidence led to the suggestion that endovascularrepair in thoracic aortic transection leads toimproved outcomes?
Dr. Lee: The combined evidence of 139 studies comprising7,768 patients showed lower rates of mortality,spinal cord ischemia, end-stage renal disease, and lategraft and systemic infections as compared to open surgicalrepair.

Do the guidelines discuss the level of requiredoperator experience or facility requirements tosuccessfully implement endovascular treatmentof thoracic injuries?
Dr. Lee: No. The guidelines did not address suchissues.

Tell us about the issues the committee was surveyedupon that were not included in the meta-analysis.What were the issues? Was any consensus met?
Dr. Lee: The therapy poses several unresolved or controversialissues for which supporting evidence lacks sufficientclarity in the literature due to cohort heterogeneity,size, and length of follow-up. The committee examined,among others, issues such as timing of endovascularrepair in a stable patient, management of minimal aorticinjury, and choice of endovascular or open repair in ayoung patient. Consensus was achieved in some and notin others. In the latter, both the majority and minorityopinions were presented.

Do current stent grafts, which are largely designed andapproved for the treatment of descending thoracicaneurysms, perform adequately in this setting?
Dr. Lee: The committee recognized that the use ofcurrent devices is off-label, each device had a number ofunmet needs, and no one device was ideal for this therapy.There was no clear consensus regarding how thesedevice-related issues should be handled.

In which areas were there clear inabilities to come to aconclusion regarding suggested courses of therapy?
Dr. Lee: As previously indicated, there was lack of consensuson the optimal device to be used for this application.Opinion was further divided on routine revascularizationof the left subclavian artery, heparin administrationduring the procedure, and the optimal postoperativefollow-up strategy.

Will the committee continue to assess new datasetsand update the guidelines as warranted?
Dr. Lee: There are no specific plans at this time, but thatwould be up to the Executive Committee of the SVS.

What needs to be done next in order to better treatpatients with traumatic thoracic aortic injuries?
Dr. Lee: Device improvements clearly are the toppriority. Long-term outcomes and the prospective datacurrently being collected from industry-sponsoredclinical trials should help better define patient selectionand lead to improved overall outcomes.

W. Anthony Lee, MD, FACS, is Director of theEndovascular Program at Christine E. Lynn Heart andVascular Institute in Boca Raton, Florida. He has disclosedthat he is a paid consultant to Bolton Medical and CookMedical, and that he has patent ownership or part ownershipwith Cook Medical. Dr. Lee may be reached at (561)395-2626; walee@sapbc.net.