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Aneurysm III: Interprofessional Care01:26

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Aneurysm management involves either conservative medical therapy or surgical intervention, depending on the size and symptoms of the aneurysm. Conservative management is generally reserved for smaller, asymptomatic aneurysms, while larger or symptomatic aneurysms often necessitate surgical repair.Conservative Medical TherapyFor small, asymptomatic aneurysms, particularly abdominal aortic aneurysms (AAA) less than 5.5 centimeters in diameter, conservative medical therapy is recommended. This...
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"Off-the-shelf" devices for complex aortic aneurysm repair.

Mark A Farber1, Raghuveer Vallabhaneni1, William A Marston1

  • 1Division of Vascular Surgery, University of North Carolina, Chapel Hill, NC.

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Off-the-shelf (OTS) devices for complex aortic aneurysms show promise in reducing wait times. However, many patients still require custom-made devices, and early outcomes with OTS devices need further study due to low numbers.

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Area of Science:

  • Vascular Surgery
  • Endovascular Repair
  • Aortic Aneurysm Treatment

Background:

  • Fenestrated devices for aortic aneurysms typically have a 3-4 week manufacturing time.
  • Efforts are underway to develop "off-the-shelf" (OTS) devices to expedite treatment.
  • This study evaluated the suitability and early outcomes of OTS devices versus custom endovascular options for complex aortic problems.

Purpose of the Study:

  • To assess the feasibility and early results of using off-the-shelf (OTS) endovascular devices for complex aortic aneurysms.
  • To compare the outcomes of OTS devices with custom-made fenestrated endovascular grafts (ZFEN).
  • To identify patient anatomic criteria suitable for OTS devices.

Main Methods:

  • A retrospective review of patients with complex aortic aneurysms treated between July 2012 and September 2013.
  • Evaluation of two investigational OTS devices (Cook p-Branch, Endologix Ventana) and the FDA-approved custom Cook Zenith fenestrated endovascular (ZFEN) device.
  • Analysis of patient selection, implantation rates, and early outcomes.

Main Results:

  • Of 85 patients with suitable aneurysms, only 23% met criteria for OTS devices; 16 received them.
  • Custom ZFEN devices were implanted in 35% of patients, while 44% required alternative strategies.
  • Technical success was 100%, with a 30-day mortality of 2.1% (one ZFEN patient). Major complications occurred in 17% of patients (2 OTS, 6 ZFEN).

Conclusions:

  • OTS devices can reduce waiting times for complex aortic aneurysms, but custom solutions remain necessary for many.
  • Early data suggest no significant renal risks with OTS devices, though patient numbers are small and require cautious interpretation.
  • Further comparative studies are needed to determine the optimal endovascular repair strategy for complex aortic aneurysms.