The primary objective of this single arm, prospective feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated/branched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
Additionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.
Patients may be included in the study if the patient has at least one of the following indications and are anatomically appropriate for treatment with fenestrated/branched stent grafts.
Pararenal, paravisceral, and type I to IV thoracoabdominal aortic aneurysms or chronic post-dissection aneurysms with a diameter 5cm or 2 times the normal aortic diameter.
Aneurysm with a history of growth ≥ 0.5cm per year.
Saccular aneurysms deemed at significant risk for rupture based on physician interpretation.
Less than 18 years of age.
Unwilling to comply with the follow-up schedule.
Inability or refusal to give informed consent by the patient or a legally authorized representative.
Pregnant or breastfeeding.
Single group
Physician Modified Endografts
DeviceModification procedure Description of modified device is detailed in Section 3.5 of IDE. In summary, the steps involved in modification of the Zenith Alpha thoracic stent grafts are; 1. Unsheathing of the stent graft 2. Retrieval of a trigger wire from the inner cannula of the delivery system 3. Rerouting of the trigger wire along the stent graft 4. Removal of proximal barbs. 5. Creation of fenestrations and/or branch cuffs 6. Placement of radiopaque markers around the fenestrations/ branch cuffs 7. Placement of temporary and/or permanent diameter constraining ties 8. (Optional) Placement of preloaded wires through the fenestrations/branch cuffs
Rate of Major Adverse Events
1. Aortic rupture within 30 days 2. Lesion-related mortality within 30 days 3. All-cause mortality within 30 days 4. Permanent paraplegia, defined by lack of resolution at 1 month follow-up 5. Permanent paraparesis, defined by lack of resolution at 1 month follow-up 6. Renal function decline resulting in \> 50% of estimated Glomerular Filtration Rate or New onset renal failure requiring dialysis, defined by ongoing dialysis at 1 month follow-up 7. Severe bowel ischemia, requiring laparotomy 8. Disabling stroke, reported within 30 days of the procedure, without resolution at 90 days post-procedure 9. Myocardial infarction 10. Respiratory failure requiring prolonged (\> 24 hours from anticipated) mechanical ventilation or reintubation
Rate of Technical Success
Successful delivery of the device(s) to the intended target implantation site(s), and successful removal of the delivery system
Rate of Treatment Success
Treatment Success is defined by having met ALL of the following dichotomous conditions. * Technical success (Yes/No) * Absence of death form the initial procedure, secondary intervention for aortic-related cause (Yes/No) * Absence of persistent type I or III endoleaks (Yes/No) * Absence of aneurysm sac expansion \> 5mm (Yes/No) * Absence of device migration \> 10mm (Yes/No) * Absence of failure due to device integrity issues (Yes/No) * Absence of aneurysm rupture (Yes/No) * Absence of conversion to open surgical repair (Yes/No) * Absence of permanent paraplegia, disabling stroke, or dialysis that resulted from the initial operation or a secondary intervention to treat the original aortic pathology (Yes/No)
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