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Ann Thorac Surg 2007;83:1310-1318
© 2007 The Society of Thoracic Surgeons

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Original Articles: Cardiovascular

Hemodynamic Performance of the Medtronic Mosaic Porcine Bioprosthesis Up to Ten Years

^a Albertinen Heart Center, Hamburg, Germany
^b Medtronic Bakken Research Center, Cardiac Surgery Clinical Research Department, Maastricht, the Netherlands

Accepted for publication July 18, 2006.

^_* Address correspondence to Dr Riess, Albertinen Heart Center, Department of Cardiac Surgery, Suentelstrasse 11a, 22457 Hamburg, Germany (Email: friedrich-christian.riess{at}albertinen.de).

Background: The Mosaic bioprosthesis (Medtronic, Minneapolis, MN) is a third-generation stented porcine bioprosthesis combining physiologic fixation and amino oleic acid antimineralization treatment to improve hemodynamic performance and durability. The findings of this single-center experience with this valve were evaluated to determine the clinical and hemodynamic performance.

Methods: Between February 1994 and October 1999, we enrolled 255 patients with aortic valve replacement (AVR) with a mean age of 67 years (range, 23 to 82 years) and 47 patients with mitral valve replacement (MVR) with a mean age of 67 years (range, 41 to 84 years) in this post-United States Food and Drug Administration approval prospective and nonrandomized clinical trial. Patients were followed-up, including serial echocardiographic assessment, within 30 days, at 6 months, and annually thereafter. The cumulative follow-up was 1540 patient-years for AVR (mean, 6.1 years; maximum, 10 years) and 250 patient-years for MVR (mean, 5.4 years, maximum; 10 years).

Results: Early mortality after AVR (<30 days) was 0.8%; late mortality per patient-year was 3.5%, including a valve-related/unexplained mortality of 1.1%. Early mortality after MVR (<30 days) was 0.0%; late mortality per patient-year was 2.8%, including a valve-related/unexplained mortality of 1.2%. Median postoperative gradient and effective orifice area for all valves after AVR were (early, n = 252; 5 years, n = 161; 9 years, n = 43) 13.7, 12.3, and 11.7 mm Hg and 1.9, 1.8, and 1.8 cm² at early, 5 years, and 9 years, respectively. With MVR respective data were (early, n = 46; 5 years, n = 25; 7 years, n = 13) 4.6, 4.1, and 3.9 mm Hg and 1.8, 2.2, and 2.3 cm². At 10 years, freedom from adverse events in the AVR group and MVR group was, respectively, thromboembolism, 86.6% ± 6.6% and 86.3% ± 9.8%; permanent neurologic event, 91.2% ± 6.8% and 90.9% ± 8.7%; valve thrombosis, 98.2% ± 0.8% and 100%; structural valve deterioration, 87.1% ± 6.7% and 100%.

Conclusions: Our midterm results demonstrate clinical safety and good performance of the Mosaic bioprosthesis. Continued follow-up will determine if this new design will provide increased durability.

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