Original Title: Efectividad y seguridad de los procedimientos endovasculares en las enfermedades de la aorta torácica

Authors' objectives: To assess and synthesize the scientific evidence on the effectiveness and security of endovascular stent-graft for the treatment of thoracic aortic injuries/lesions in comparison with the open surgery.

Authors' results and conclusions: RESULTS: A total of 12 published studies with 2649 patients were finally included in the systematic review. No RCT were found. Two studies present nRCT design and the remaining 10 are prospective observational studies comparing the results of endovascular intervention with conventional open surgery in patients with various lesions of the thoracic aorta, three studies prospectively followed experimental endovascular procedure groups but used historical controls and, finally, only one study used retrospective recruitment. In general, the studies had methodological limitations that reduce the force that can be deduced from their results. Thus, most of the studies included a reduced number of patients with different clinical and demographic characteristics and non-explicit selection criteria. Furthermore, most of the studies had a reduced follow-up time of the patients, most less than two years. Regarding effectiveness results of endovascular treatment, only 6 of the 17 included studies report the global success percentage of the intervention, which varies between 89 and 100%, only 2 studies report the percentages of immediate conversion and post intervention conversion to conventional open surgery. Only 2 studies report the percentage of patients in whom the aortic lesion size increased, was reduced or no change was observed and, finally, only 1 study reports the initial and final size of the lesion. Mean time of the intervention varied from 66 to 182 minutes for endovascular treatment and from 255 to 480 minutes for open surgery intervention. Mean stay time in ICU ranged 0.8 to 13.1 days for endoluminal procedure and 3.8 to 14 open surgery and mean hospital stay varied from 5-21 days for endoluminal intervention and from 10-40 days for convention surgery. Equally, mean transfusion volume needed during the intervention was greater for conventional treatment than for the endoluminal one. With regards to endovascular treatment safety of the thoracic aortic lesions, studies showed that early mortality (5.6%-26.5%) and late mortality (3.6%-52.9%) in conventional surgery was greater than in endovascular treatment (0%-11.9% and 0%-48.6%, respectively). Most frequent causes of death in patients with endoluminal treatment were rupture of the aortic lesion, ischemic vascular problems such as acute myocardial infarction (AMI) or cerebrovascular accident (CVA) and sepsis. Early leaks were most frequently type I (0-6.7%) and type II (0- 10.4%). Late leaks were most frequently type I (0.7-10%). In general, studies showed a greater frequency of complications in treatment of thoracic aortic lesions with open surgery than with endovascular treatment. Paraplegia, one of the complications causing the most concern in thoracic aortic treatment, appeared in a greater percentage in open surgery intervention (2.2%-16.7%) than in the endovascular treatment (from 0%-10.5%). CVA, neurological complications, renal failure and pneumonia clearly appeared less frequently among patients with endoluminal intervention than among patients with open surgery. CONCLUSIONS: To date, according to the results of this review, scientific evidence on the effectiveness and safety of endoluminal treatment of the thoracic aortic lesions is still limited. No RCT comparing endoluminal procedures with conventional surgical treatment have been found and the methodological quality of available comparative studies is low. However, in spite of the limitations of the studies found, the procedure seems to be an alternative to conventional open surgery, above all in terms of lower morbidity and especially for patients with surgical risk. More research from larger well designed trials comparing endoluminal treatment with open surgery treatment in adequately selected patients, with explicit selection criteria in homogenous groups of patients regarding clinical and demographic characteristics, and type of prosthesis, and with longer follow-up is needed to confirm these findings.

Authors' methods: A systematic literature review was performed by searching the following bibliographic databases: MEDLINE Y PREMEDLINE, EMBASE, CENTRAL, SCOPUS and SCI (diciembre 2012). A comprehensive search strategy combining controlled vocabulary and free text was used. In addition, a manual search was performed with the references of included articles. Randomised or non-randomised controlled trials (RCTs or nRCTs) and comparative observational studies published in English or Spanish comparing endovascular stent-graft with open surgery for the treatment of thoracic aortic injuries/lesions were considered for inclusion. Selected outcome measures were intervention success percentage, percentage of conversion to conventional surgery, changes in lesion size, intervention time, anesthesia time, mean stay in ICU and mean hospital stay as indicators of procedure effectiveness. Mortality, leaks, clinical complications and prosthesis related complications rate as procedure safety indicators. The assessment of methodological quality of the included studies was conducted according to the criteria of Scottish Intercollegiate Guidelines Network (SIGN) for different designs. Data are presented through narrative synthesis and tables with description of studies.

Project Status: Completed

Year Published: 2012

URL for published report: https://sescs.es/efectividad-y-seguridad-procedimientos-endovasculares-en-enfermedades-de-la-aorta-toracica/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es