Endovascular exclusion of descending thoracic aortic aneurysms and chronicdissections: Initial clinical results with the AneuRx device

Objective: The objective of this study was to analyze a single-center exper ience in which descending thoracic aortic aneurysms (TAAs) were treated wit h a new self-expanding endovascular prosthesis (Medtronic AVE). Methods: Twenty-six patients (13 men, 13 women) with American Society of An esthesiology grades II to IV and ages ranging from 53 to 92 years (average, 74 years) consented as part of a Phase I Food and Drug Administration-appr oved trial. Treated lesions included TAAs that were 5 to 10 um in diameter, 12 diffuse dilations or fusiform aneurysms, and four saccular aneurysms. T here were also nine chronic dissections (2 aneurysmal dilations and 7 sympt omatic acute recurrent dissections). Three patients (2 with diffuse/fusifor m and 1 with dissection) presented with hemothorax, contrast extravasation, or both. Results: Twenty-five of the 26 patients who consented (96% technical succes s) were treated successfully with no surgical conversions. Eighteen patient s have been followed up from 1 to 22 months (average, 9 months). One patien t is lost to follow-up, and six patients have died (24%). One procedure-rel ated death (4%) occurred within the 30-day postoperative period and was cau sed by diffuse embolization. There were no device-related deaths. Five addi tional patients (20%) have died during the study of comorbid conditions. Co mplications included one massive myocardial infarction 24 hours after the p rocedure requiring balloon counterpulsation and long-term dialysis, one car diac tamponade resulting from central line placement before the procedure, one progression of aneurysm dilation proximal to the device at 1 year, and one bilateral lower extremity paralysis occurring 12 hours after successful deployment. Seven patients (5 women) had femoral artery reconstructions or iliac artery grafts to repair injuries during deployment catheter passage. Other significant parameters included average procedure time (2 hours 40 m inutes; range, 1 hour 30 minutes to 5 hours 30 minutes), 450 cc average blo od loss (n = 25; 100-3000 cc) being replaced by means of autotransfusion wi th only two patients receiving banked blood products, and an average 2 days to resumption of normal diet, 1 day in the intensive care unit, and 5 days ' hospitalization postprocedure in uncomplicated cases (n = 22). One patien t had an endoleak immediately after the procedure that sealed without treat ment. Follow-up of all patients ranging from 1 to 22 months (average, 9 mon ths; n = 18) demonstrates continued exclusion of the aneurysm with no endol eaks and either stable or decreasing aneurysm volume, except in one patient with volume increase and no obvious etiology who continues to be investiga ted. Conclusions: The study suggests that endovascular prosthesis exclusion of T AAs with an AneuRx self-expanding tubular device may be effective in many p atients who are at significant risk for open surgical repair and substantia tes further clinical investigation to confirm these findings.