Long-Term Outcomes of the Mosaic Aortic Porcine Bioprosthesis in Japan　― Results From the Japan Mosaic Valve Long-Term Multicenter Study ―

Abstract

was originally released for investigational use in the USA in 1994 and later approved for clinical use by the US Food and Drug Administration in 2000. It combines tissue fixation with 0.2% glutaraldehyde and zero pressure across leaflets and treatment with α-amino oleic acid (antimineralization) for improved tissue durability and hemodynamic performance. Several early and mid-term studies have established its clinical safety and efficacy, especially in terms of hemodynamic performance and thromboembolic event rates. 6-13 A long-term, prospective, observational, non-randomized study demonstrated acceptable rates of death, reoperation, and explant due to structural valve deterioration (SVD) with the Mosaic bioprosthesis. 14 In Japan, the Mosaic bioprosthesis was first introduced for clinical use in 1999.

Prosthesis–Patient Mismatch after Aortic Valve Replacement with the Mosaic Ultra Bioprosthesis

“…In contrast, early postoperative pressure gradients showed a similar range and pattern as the ones observed in our study. 5,6 Aortic root enlargement allows the implantation of an aortic valve prosthesis larger than the native aortic annulus would otherwise accept. Even though concerns exist about increased mortality with this technique, recent research has shown that aortic root enlargement does not lead to a statistically significant increase in mortality or adverse events.…”

“…The long-term follow-up of the Mosaic bioprosthesis after AVR has shown satisfactory survival, reoperation, and structural valve deterioration rates; however, several published studies have shown a high mean transvalvular pressure gradient and high rates of PPM. [5][6][7][8][9] The Mosaic Ultra (Medtronic plc, Minneapolis, Minnesota, United States of America), another version of the original Mosaic bioprosthesis for aortic implantation, was designed with a smaller suture ring diameter, retaining the original internal orifice diameter, with the sole purpose of allowing the implantation of a prosthesis with a larger EOA in a smaller valve annulus. 10 Only a few published studies with a small number of patients have assessed for PPM after AVR with the Mosaic Ultra.…”