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Objectives:
Fenestrated EVAR is a novel treatment modality for complex AAAs that could be applied to a greater number of patients compared to open repair. The safety and efficacy of fenestrated EVAR in high risk and frail patients has not been established. The aim of this study was to assess the risk factors, including a simplified frailty index (SFI), for postoperative complications and major adverse events after fenestrated EVAR.
Methods:
Over a 22-month period, 49 patients with complex AAAs underwent fenestrated EVAR with a custom made device, the Zenith Fenestrated AAA Endovascular Graft (Cook Inc, Bloomington, Ind). Perioperative data was collected into a prospectively maintained database. A SFI was calculated according to the presence of 11 items, including diabetes; functional status (not independent); chronic obstructive pulmonary disease or pneumonia; congestive heart failure; history of myocardial infarction; either prior percutaneous coronary intervention, previous coronary surgery, or history of angina; hypertension requiring medication; peripheral vascular disease or rest pain; impaired sensorium; history of either transient ischemic attack or cerebrovascular accident; or history of cerebrovascular accident with neurologic deficit. Perioperative major adverse events were defined as death, hospital re-admission, disability or life threating adverse events at 30 days. Univariate analysis, non-parametric analysis and simple logistic analysis were used.
Results:
The Median age was 73 years (interquartile [IQR] 68-81). Median SFI was 0.27 (IQR, 0.18-0.36). The median number of fenestrations was 2 (IQR, 2-3). Univariate analysis and simple logistic analysis revealed that SFI was not a predictor of post-operative complications and major adverse events at 30 days (p>0.1). BMI, increasing age and cardiac history of arrhythmias or valvular disease were found to be statistically significant risk factors for major adverse events (P<0.05). Patients with lower BMI (25.5[IQR, 20.9-29.6] vs 28 [IQR, 25-31]) (p=0.03), increasing age (78 [IQR 69-84] vs 70 [IQR, 65-75]) (p<0.01) and a history of arrhythmias or valvular disease (47 % vs 4%) (p=0.03) had a higher frequency of major adverse events and postoperative complications.
Conclusion:
Fenestrated EVAR is a safe and effective for the treatment of complex AAAs, even in high-risk and frail patients. Increasing age, BMI and cardiac problems (other than MI and CHF) are predictors of perioperative majors adverts after fenestrated EVAR.