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

Background 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). Methods 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%. Results 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 regurgitation is to date 100% at discharge, 6 months, and 1 year postimplant. Reoperation of the aortic valve/root was not required in any patient. Six-month mean transvalvular gradients for 21–29 mm valves were 12.8, 8.8, 5.3, 4.9, and 4.7 mm Hg, respectively. Conclusions Aortic root replacement with the Toronto root is safe and provides superb transvalvular hemodynamics with freedom from anticoagulation. The Toronto root seems widely applicable for all types of aortic root pathology and these early data offer very encouraging results. Long-term follow-up is required.