Endovascular Repair Of Thoracic Lesions Using Commercially Available Devices: Lessons Learned

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Ravi K. Veeraswamy, M.D., Luis A. Sanchez, M.D., Brian G. Rubin, M.D., Patrick J. Geraghty, M.D., Eric T. Choi, M.D., John A. Curci, M.D., M. Wayne Flye, M.D., Juan C. Parodi, M.D., Gregorio A. Sicard, M.D..
Washington University School of Medicine, St. Louis, MO, USA.

BACKGROUND:
The application of endovascular devices for the treatment of a variety of thoracic aortic lesions has flourished worldwide over the past decade. These grafts provide a less invasive alternative for patients in whom the open surgical options are associated with significant morbidity and mortality. Unfortunately, none of these thoracic devices are currently approved for use in the US and the only option is to use devices approved for other indications or “home-made” devices. We evaluated the safety, efficacy, and outcomes of commercially available endovascular graft components for managing lesions of the thoracic aorta.
METHODS:
Since March 2002, 50 patients with thoracic lesions were treated at our institution using endovascular grafts. Sixteen of these patients (8 males, 8 females; mean age 57.3 years, range 28-92 years) were treated outside of a clinical trial using commercially available endovascular devices. Spiral CT followed by angiography was used for diagnosis and planning in all cases. The indications for treatment included: acute and chronic traumatic lesions(7), symptomatic ulcers(5), focal aneurysms or pseudoaneurysms(3), and symptomatic Type B dissections(1). The endovascular components; including Excluder Aortic Cuffs(7), AneuRx Aortic Cuffs(5), Zenith Aortic Cuffs(1), Zenith Aortic Tube Grafts(1) and graft combinations(2) were placed under fluoroscopic guidance via a femoral(12), iliac(2) or transabdominal(2) approach. Follow-up consisted of spiral CT scans with 3-D reconstructions at approximately 1, 6, & 12 months and at least yearly thereafter.

RESULTS:
Fourteen patients(88%) underwent successful endovascular treatment of their thoracic lesion. One patient had incomplete exclusion of an acute traumatic aortic injury using AneuRx aortic cuffs and underwent elective open repair several days after stabilizing his condition. The second patient underwent endovascular treatment of a symptomatic Type B dissection that after treatment was unchanged distal to the repair. There was no periprocedural mortality and the major complication rate was 19%(3/16) with 2 patients with asymptomatic troponin leaks and one patient developing an iliac rupture at the device introduction site, intraoperative hypotension, and associated postop paraplegia. At a mean follow-up of 9.9 + 3.4 months (range: 1-48 months), all successfully treated patients continue to do well with complete exclusion of the treated lesion.

CONCLUSIONS:
Endovascular grafts can be very useful in the treatment of selected patients with amenable thoracic lesions like aortic injuries in multiple trauma victims. The most practical currently available components, despite their short length, are the Excluder Aortic Cuffs due to their ability to conform throughout the thoracic aortic anatomy, instantaneous graft deployment, and long introducer system. Thoracic endovascular grafts will likely become an integral part of our device armamentarium for the treatment of a wide variety of thoracic lesions when FDA approval occurs and mid- & long-term data become available.