SAN FRANCISCO – Fenestrated endovascular aneurysm repair was associated with a significantly higher mortality and a significantly higher rate of any complication, compared with open surgery, for complex abdominal aortic aneurysm repair, results from a two-center study demonstrated.
The findings suggest that "in very-low-risk patients, open surgery should be considered preferable to EVAR," Dr. Maxime Raux said at the Society for Vascular Surgery annual meeting. "Identifying patients at risk of target vessel difficulties or graft complications may identify the patients at high risk for FEVAR."
Working with researchers at Massachusetts General Hospital, Boston, Dr. Raux and his associates in the of the department of vascular and endovascular surgery at Henri Mondor Hospital in Créteil, France, retrospectively compared 30-day outcomes of fenestrated EVAR (FEVAR) with open surgery repair (OR) of complex abdominal aortic aneurysms performed between 2001 and 2012. FEVAR procedures were performed for high-risk patients at Henri Mondor Hospital while the OR cases were performed at Massachusetts General Hospital.
The researchers excluded patients with type IV thoracic aortic aneurysm (TAA), those with a ruptured or symptomatic aneurysm, those who required redo surgery or who had undergone a previous aortic intervention, and those who required actual or anticipated infrarenal clamp position. Next, they performed propensity score matching to identify clinical and anatomically similar cohorts. This left a study cohort of 42 FEVAR procedures and 147 open repairs.
Compared with the OR group, patients in the FEVAR group were more likely to be male, have heart failure, coronary artery disease, chronic obstructive pulmonary disease, and diabetes, while patients in the OR group were more likely to have hypertension and smoke, compared with their counterparts in the FEVAR group. These differences did not reach statistical significance.
Univariate analysis revealed that, compared with patients in the OR group, those in the FEVAR group had a higher 30-day mortality (9.5% vs. 2%; P = .038), a higher occurrence of any complication (42.9% vs. 23.1%; P = .012), procedural complication (23.8% vs. 7.5%; P = .0044), and graft complication (33.3% vs. 2%; P less than .0001). There were four deaths in the FEVAR group: two cases of mesenteric infarction, one case of multiple organ failure plus mesenteric infarction, and one case of respiratory failure. There were three deaths in the OR group: one intraoperative death, one case of myocardial infarction, and one death of unknown cause post discharge.
Multivariate analysis revealed that patients in the FEVAR group had an increased risk of 30-day mortality (odds ratio, 5.05; P = .039), risk of any complication (odds ratio, 2.3; P = .03), and risk of graft complication (odds ratio, 24; P less than .0001).
Dr. Raux acknowledged certain limitations of the study, including its retrospective design and the potential for selection bias. It also compared a new procedure (FEVAR) to a well-established procedure (OR). "Also, there were no comparisons of target vessel anatomy or considerations related to aortic anatomy," he said.
Based on the results of the study, he concluded that "extension of the infrarenal AAA treatment paradigm shift to EVAR cannot be applied to a similar shift of complex AAA to EVAR. Further evaluation with prospective studies is warranted."
Dr. Raux said that he had no relevant financial conflicts to disclose.