St. Jude Medical Toronto biologic aortic root prosthesis: early FDA phase II IDE study results

The Annals of Thoracic Surgery
Thomas G GleasonJoseph E Bavaria

Abstract

Several biological aortic root replacement techniques have distinct advantages over mechanical composite root replacement including better valvular hemodynamic characteristics and the lack of need for anticoagulation. Current biological root replacement options lack proven long-term durability or are limited by technical or practical concerns. We report the early results from a phase II multicenter clinical trial of the porcine St. Jude Toronto Bioprosthesis with BiLinx (Toronto root). 176 Toronto roots were implanted as total aortic root replacement from August 2001 through August 2003. Concomitant cardiac procedures including coronary artery bypass grafting (31%) and ascending aortic replacement (55%) were performed in 74%. Patients were followed clinically and were examined with an echocardiogram at discharge, 6 months, 12 months, and yearly thereafter. Root sizes implanted included 29 mm in 38%, 27 mm in 30%, 25 mm in 20%, 23 mm in 10%, and 21 mm in 2.2%. There are 205 patient years of follow-up through October 2003. Operative mortality was 3.9% (none were valve related) and late mortality was 4%. Operative stroke rate was 1.1% and late stroke rate was 0.6%. Endocarditis developed in 1 patient. Freedom from aortic regurgita...Continue Reading

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Citations

Mar 23, 2007·Cardiology in the Young·Bradley S MarinoGil Wernovsky
Jan 29, 2008·Current Treatment Options in Cardiovascular Medicine·John B de Graft-Johnson, Thomas G Gleason
May 25, 2013·The Annals of Thoracic Surgery·Lars G SvenssonMathew R Williams
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Jan 13, 2019·The Journal of Thoracic and Cardiovascular Surgery·Valentino BiancoIbrahim Sultan

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