Preliminary Results Of the Phase 1 Evaluation Of the Trivascular AAA Stent-Graft System In the Treatment Of Abdominal Aortic Aneurysm

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Ronald M. Fairman, MD¹, Edward Y. Woo, MD¹, Christopher L. Skelly, MD¹, Rodney A. White, MD², Barry Katzen, MD³, Michel S. Makaroun, MD⁴, Anthony Lee, MD⁵, David H. Deaton, MD⁶, Manish Mehta, MD⁷, Peter Milne, MD¹.
¹Hospital of the University of Pennsylvania, Philadelphia, PA, USA, ²Harbor-UCLA Medical Center, Torrance, CA, USA, ³Baptist Hospital, Miami, FL, USA, ⁴Presbyterian University Hospital, Pittsburgh, PA, USA, ⁵Shands Hospital, Gainesville, FL, USA, ⁶Georgetown University Hospital, Washington, DC, USA, ⁷Albany Medical College, Albany, NY, USA.

BACKGROUND:
The objective of this study is to evaluate the safety and efficacy of the Trivascular AAA Stent-Graft System to electively treat patients with abdominal aortic aneurysms. The Trivascular Stent-Graft is a novel bifurcated device mounted on a 16.5 F delivery system with three nitinol stents which expand to engage the vessel walls. The seal is produced through a network of cuffs and ring-shaped ribs along the trunk and legs that are filled with a liquid biopolymer that rapidly solidifies during the deployment procedure.
METHODS:
The study is a prospective observational study with descriptive components. The two primary endpoints are defined as absence of device related adverse events within one month of the endovascular procedure and absence of Types I, III, and IV endoleaks at one month follow-up. The secondary endpoint is technical success in introducing the delivery system with deployment of the stent-graft in the desired location in the absence of device-related surgical conversion and intra-operative mortality. Primary follow-up evaluations are performed at 1 month, 6 months, 1 year, and annually thereafter. There are no external controls. Patient outcomes are summarized by descriptive statistics.
RESULTS:
54 patients were treated; 29 in the United States and 25 outside the United States. 48 patients completed 1 month follow-up, 26 completed 6 months, and 7 completed 12 months. 82% of the patients were male. 75% of the aneurysms were over 5 cm in diameter and the mean diameter was 5.4 cm ±7. The majority of the patients had anatomic features that precluded treatment with any other endovascular device. These patients had small access vessels, small calcified aortic bifurcations, and/or complicated proximal aortic neck features.
There were no Types I, III, or IV endoleaks at one month. Device-related adverse events included: stent graft migration (0), vessel dissection or perforation (4), stent graft occlusion (3), branch vessel occlusion (1), and aneurysm rupture (0). There was 1 technical failure without conversion due to an access problem resulting in perforation.
11 patients (20%) had adjunctive stents placed in the endoprosthesis at the primary procedure. 3 patients required secondary interventions for limb dysfunction.
1 patient required surgical conversion due to endograft infection that created an aorto-enteric fistula. There were no aneurysm-related deaths nor were there any instances of aneurysm enlargement during follow-up.
CONCLUSIONS:
These preliminary results support the continued investigation of this unique unsupported bifurcated endograft design which achieves fixation using nitinol stents, and seal through the introduction of a liquid biopolymer which solidifies during the deployment sequence. The device has the potential of expanding bifurcated endovascular AAA repair to include for the first time patients who harbor small access vessels, small calcified aortic bifurcations, and complicated aortic neck anatomy.