Thoracoabdominal aneurysm repair using the Unitary Manifold Device

Area of Science:

• Vascular Surgery
• Endovascular Repair
• Aortic Aneurysm Treatment

Background:

• Thoracoabdominal aortic aneurysms (TAAA) present complex treatment challenges.
• Endovascular repair offers a less invasive alternative to open surgery.
• Physician-modified devices allow for tailored treatment of complex anatomies.

Purpose of the Study:

• To evaluate the safety and efficacy of the physician-modified, nonanatomic-based Unitary Manifold (UM) device for TAAA repair.
• To assess outcomes in a consecutive series of all-comer patients treated with the UM device.
• To report technical success, adverse events, and long-term patency rates.

Main Methods:

• Prospective, single-center study of 126 consecutive patients undergoing TAAA repair with the UM device (2015-2023).
• Inclusion of all-comer patients regardless of aneurysm extent, presentation, or prior spinal cord events.
• Data collection on technical success, major adverse events, reinterventions, patency, and mortality.

Main Results:

• High technical success rate of 99.2% (125/126 patients).
• Low reintervention rates for limb patency (2.4%) and overall reintervention (5.6%) at 365 days.
• Respiratory failure was the most common major adverse event (13.5% at 365 days); one case of persistent paraplegia (0.8%).
• No device integrity failures or conversions to open repair were observed.

Conclusions:

• The UM device demonstrates excellent technical success, treatment success, and device patency in TAAA repair.
• Acceptable rates of major adverse events and reinterventions were observed in this diverse, all-comer patient cohort.
• This study represents a broad patient population, offering valuable insights compared to studies using off-the-shelf devices.