Background: The Toronto Root bioprosthesis with BiLinx anticalcification treatment (St. Jude Medical, St. Paul, MN) was introduced into clinical practice in 2001, mainly for patients with aortic valve disease and additional pathology of the aorta. Patients included in the initial clinical study with core laboratory data evaluation were reviewed.
Methods: A total of 186 patients (62 +/- 11 years, 38 female) received full root replacement at our institution with the Toronto Root bioprosthesis from June 2001 until November 2007. The predominant aortic valve lesion was stenosis in 34, incompetence in 80, and mixed lesions in 72 patients. Additional procedures included replacement of the ascending aorta in 139, replacement of the ascending aorta plus aortic arch in 38, coronary artery bypass graft surgery in 31, mitral valve repair in 26, atrial fibrillation ablation in 14, and atrial septal defect closure in 8 patients. Previous cardiac surgery had been performed in 10 patients. Mean follow-up was 50 +/- 26 months (770 patient-years).
Results: The mean implanted valve size was 26.8 +/- 1.8 mm (14 x 23 mm, 36 x 25 mm, 87 x 27 mm, and 48 x 29 mm). Aortic cross-clamp time was 99.8 +/- 29 minutes, and cardiopulmonary bypass time was 140.9 +/- 52 minutes. All patients showed a clinical improvement of at least one New York Heart Association class during follow-up. Most recent echocardiographic examination revealed a maximum transvalvular blood flow velocity of 2.1 +/- 0.5 m/s and a mean pressure gradient of 9.6 +/- 8.5 mm Hg. Left ventricular ejection fraction was 61% +/- 11%. Early mortality was 5.9% +/- 1.7%, and 5-year survival was 83.3% +/- 3.0%. Patients who underwent isolated aortic root surgery had a 5-year survival of 90.3% +/- 4.2%.
Conclusions: The Toronto Root bioprosthesis is safe and provides good clinical and hemodynamic function after full root replacement with or without additional aortic surgery. Owing to the specific anticalcification treatment, long-term durability may be promising.