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Thirty Day Results of a Prospective Multicenter Trial of a New Thoracic Endograft
William D. Jordan, Jr., MD1, Sina Moainie, MD2, Joshua Rovin, MD3, Joseph Bavaria, MD4, Richard Cambria, MD5, Mark Fillinger, MD6, William McMillan, MD7, Jon Matsumura, MD8.
1University of Alabama at Birmingham, Birmingham, AL, USA, 2CorVasc MDs, PC, Indianapolis, IN, USA, 3Cardiac Surgical Associates, St Petersburg, FL, USA, 4University of Pennsylvania, Philadelphia, PA, USA, 5Massachusetts General Hospital, Boston, MA, USA, 6Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA, 7North Memorial health Care Minneapolis, Robbinsdale, MN, USA, 8University of Wisconsin, Madison, WI, USA.
OBJECTIVES:
The conformable GORE TAG Device (CTAG Device) is a new TEVAR device designed to be more conformable in curved anatomy, more resistant to compression, and has wider, overlapping sizing range compared to the predicate TAG Device. This study evaluated the safety and effectiveness of the CTAG Device in the repair of descending thoracic aortic aneurysms.
METHODS:
This is a prospective, multi-center regulatory study with a primary endpoint of freedom from major device event through one month post-treatment.
RESULTS:
One month Results:
Fifty-one subjects were enrolled between October 2009 and October 2010. The cohort was 67% male, 86% Caucasian, and median age was 72 years. Mean maximum diameter of both saccular (n=21, 41%) and fusiform (n=30, 59%) aneurysms was 58.4 mm. Mean total treatment length was 17 cm with average of 1.7 devices. Procedure time averaged125 minutes and blood loss averaged 276 mL. There was one 30 day mortality (2%), and 12 patients (24%) experienced a total of 28 serious adverse events including one case of paraparesis but no central strokes. There was one site reported major device event of access failure (98% freedom from major device event).There were 8 site reported endoleaks (15.7%) (3 Type 1A and 5 Type II). There were no conversions, migrations, fractures, compressions, aneurysm ruptures or enlarging aneurysms at one month.
CONCLUSIONS:
This next generation thoracic endograft has a low rate of major device events through one month with no graft compressions or device failures. The short term data from with this new TEVAR device are consistent with historical data, demonstrate favorable outcomes, confirm low risks for treatment and exhibit a improved benefit-risk profile for the CTAG Device. Follow-up will be continued for 5 years.
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