MODULAR BIFURCATION ENDOPROSTHESIS FOR TREATMENT OF ABDOMINAL AORTIC-ANEURYSMS

Objective The authors analyzed a single group's experience treating ab dominal aortic aneurysms (AAAs) with a new sell-expanding, modular, bi furcated device. Summary Background Data Successful exclusion of AAAs by prototype devices has led to several controlled clinical trials eva luating prostheses designed and manufactured specifically for this app lication. Methods Sixteen patients (15 males, 1 female) of American So ciety of Anesthesiologists grade 2 through 4 and average age of 72 yea rs had AAAs (average 57-mm diameter) treated as part of a phase I Food and Drug Administration-approved trial. Results All patients were tre ated successfully with no surgical conversions. No endoleaks or aneury sm enlargement was noted either predischarge by contrast computed tomo graphy or on follow-up at 1 month by duplex ultrasound examination. At 6 months, 12 of 13 patients who were observed for this interval had n o endoleaks, whereas one patient (patient 3) showed a small area of ex travasation that appeared to arise from the device in an area that was traumatized at the time of deployment. One procedure-related mortalit y (6%) occurred in a patient who died of septic complications secondar y to a gangrenous gallbladder diagnosed 1 day after the procedure. The re were no device-related mortalities. Complications included two ilia c artery dissections, two groin wound infections, and two transient el evations of serum creatinine. Other significant variables including me dian procedure length (5 hours), intensive care unit stay (1 day), hos pitalization postprocedure (4.5 days), and blood loss (1100 mL) all de creased as the study progressed. Blood replacement in all but three pa tients was accomplished by autotransfusion or banked-autologous blood replacement. At 6-month follow-up in 13 patients, the maximum diameter of the aneurysm decreased by an average of 5.6 mm (range, 0-15 mm), a nd the maximal cross-sectional area decreased an average of 20.3% (ran ge, 0-72%). Conclusions This study suggests that endovascular prosthes is exclusion of AAAs using a self-expanding modular device may be effe ctive in many patients who are otherwise surgical candidates for repai r if further clinical studies confirm these observations.