The French National Authority for Health reports on thoracic stent grafts.
OBJECTIVE
This study was conducted to determine the efficacy and safety of stent grafts in the treatment of thoracic aortic aneurysms and dissections.


METHODS
Our health technology assessment method combined a critical review of the literature with experts' opinions. Several databases, useful Web sites, and the gray literature were searched from January 1995 to December 2004. Some manually retrieved major articles published in 2005 were also included. The draft report was submitted to and discussed by a working group of 12 members nominated by relevant medical societies. The amended report was submitted to a multidisciplinary group of 12 peer reviewers for comment.


RESULTS
Endovascular stent grafting (ESG) repair for lesions of the thoracic aorta, including aneurysms, dissections, and aortic isthmus ruptures, is probably beneficial in terms of operative mortality and severe morbidity, with an incidence of paraplegia of 2.1% (range 0%-7%) for ESG vs 5% (range, 3%-15%) for surgery, provided that there is a rigorous medium-term assessment and that anatomic factors are favorable. A proximal neck length of at least 2 cm is needed to insert the stent graft. Indications for ESG in thoracic aortic aneurysm and dissection are similar to those for surgery. Endovascular stent grafting is particularly appropriate in patients with multiple traumas to the thoracic aorta in whom concomitant lesions are a contraindication to open surgery. Endovascular stent graft repair can only be done in public or private centers with expertise in both endovascular and surgical procedures and with adequate technical facilities. Patients should be informed of the advantages and drawbacks of both methods. A multidisciplinary discussion should address risks of converting to open surgery and possible need for a cardiopulmonary bypass. Patients should be monitored annually by computed tomography scan or magnetic resonance imaging and plain radiographs because long-term results are uncertain (possible stent graft deterioration, onset of aortic disease). They should be told of the need for surveillance and possible further treatment.


CONCLUSIONS
A prospective registry of all thoracic aorta procedures (endovascular treatment, open surgery, thoracic ESG plus extra-anatomic bypass) needs to be set up. All practitioners and stent graft manufacturers should contribute to this registry. It should include information on patient monitoring in order to (1) select patients who could be treated by ESG repair, (2) assess the feasibility of a randomized controlled study comparing ESG and surgery, (3) assess the medium-term outcome of different devices, and (4) obtain a better understanding of the health economics aspects.
Corbillon
Emmanuel
E
Haute Autorité de Santé, Saint-Denis La Plaine, France.
Bergeron
Patrice
P
Poullié
Anne-Isabelle
AI
Primus
Celia
C
Ojasoo
Tiiu
T
Gay
Joel
J
D000784:Aortic Dissection / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D017545:Aortic Aneurysm, Thoracic / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D005602:France; D006801:Humans; D009313:National Health Programs; D010264:Paraplegia / Q000209:etiology; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D011475:Prosthesis Failure; D012042:Registries; D018570:Risk Assessment; D015607:Stents; D016896:Treatment Outcome