Aneurysm-Related Mortality Rates in the US AneuRx Clinical Trial

• Published in: Journal of the American College of Surgeons Vol. 211; no. 5; pp. 646 - 651
• Main Authors: Tavris, Dale R., MD, MPH, Liu, Chih-hsin, RN, MSN, Gross, Thomas P., MD, MPH, Greenfield, Lazar J., MD, FACS
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.11.2010; Elsevier
• Subjects: Absorbable Implants; Aortic Aneurysm, Abdominal - mortality; Aortic Aneurysm, Abdominal - therapy; Aortic Rupture - mortality; Biological and medical sciences; Blood and lymphatic vessels; Blood Vessel Prosthesis - adverse effects; Blood Vessel Prosthesis - statistics & numerical data; Blood Vessel Prosthesis Implantation - mortality; Cardiology. Vascular system; Causality; Cohort Studies; Device Removal - adverse effects; Device Removal - mortality; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous; Endoleak - epidemiology; Endoleak - surgery; Epidemiology; Follow-Up Studies; General aspects; Humans; Medical sciences; Public health. Hygiene; Public health. Hygiene-occupational medicine; Quality of Life; Risk Assessment; Stents; Surgery; Surgical Wound Infection - epidemiology; Survival Rate; United States - epidemiology; United States; North America; America; Vascular disease; Medicine; Treatment; Surgery; Mortality; Rate; Aneurysm; Cardiovascular disease; Clinical trial; Epidemiology
• ISSN: 1072-7515; 1879-1190
• DOI: 10.1016/j.jamcollsurg.2010.08.007

Background The AneuRx (Medtronic) stent graft was approved by the FDA in September 1999. The purpose of this study was to ascertain the aneurysm-related mortality rate of a subgroup of the patient cohort from Medtronic's investigational premarket study. Study Design There were 931 study subjects, from 19 medical centers, who were followed for an average of 3.48 years. Abdominal aortic aneurysm (AAA)-related mortality rates were examined, using death certificates and medical records. Results The 1-month postimplant death rate was 1.61%. Not counting deaths related to the initial implant, there was an increase in the rate of AAA-related mortality after 3 years, from an average of 0.18% in the first 3 years to an average of 1.39% in years 4 and 5. Conclusions Mortality in patients implanted with an AneuRx graft (as determined in this study) probably exceeds that of open procedure patients (based on medical literature) at some point in time, likely within 4 years after implant.