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A team at Aarhus University Hospital in Denmark combined a device for preserving mitral valves with a small intestinal submucosa (SIS) cardiac repair patch to improve durability

The combined device assemblies were tested in an animal model focused on the acute physiological effects on the repaired mitral valve.
In 2016, an estimated 18,000 operations for degenerate mitral regurgitation were performed in the US.1 Most patients undergo repair attempts instead of valve replacement.1 Adjunct ring annuloplasty, a procedure to tighten, reshape or reinforce the ring (annulus) around a valve in the heart, is a standard procedure during valve repair.2 A repair patch may be used in more complex cases when a patient has limited healthy tissue.3 In all cases, maintaining the natural 3D geometry of the mitral valve annulus, the seat of the valve leaflets, is critical to long-term success.
A group of researchers at Aarhus University Hospital in Denmark hypothesized that implanting an annuloplasty ring into a small intestinal submucosa (SIS) patch reconstruction of the posterior mitral leaflet would improve the durability of the repair.4 The study was performed in an acute porcine model, wherein all animals had the posterior mitral valve leaflet reconstructed with an SIS patch. Data was collected on mitral annular dynamics and leaflet geometry before and after implantation of the annuloplasty ring. The physical dimensions of the annular ring during the cardiac cycle after ring implantation were significantly lower, demonstrating that the ring stabilized the SIS patch reconstruction.

These results were obtained in an acute setting, and so a chronic survival study will need to be performed to determine if the addition of the annuloplasty ring affects the remodeling of the SIS patch long-term. This study demonstrates the potential benefits of combining SIS with other state-of the-art devices to improve patient outcomes.

1 Gammie JS, Chikwe J, Bahwhar V, et al. Isolated mitral valve surgery: The Society of Thoracic Surgeons Adult Cardiac Surgery Database analysis. Ann Thorac Surg. 2018;106:716–727.

2 DiBardino DJ, ElBardissi AW, McClure RS, Razo-Vasquez OA, Kelly NE, Cohn LH. Four decades of experience with mitral valve repair: analysis of differential indications, technical evolution, and long-term outcome. J Thorac Cardiovasc Surg. 2010;139:76–84.

3 Feindel CM, Tufail Z, David TE, Ivanov J, Armstrong S. Mitral valve surgery in patients with extensive calcification of the mitral annulus. J Thorac Cardiovasc Surg. 2003;126:777–782.

4 Poulsen KB, Tjørnild MJ, Skov SN, et al. Annular dynamics and leaflet geometry in patch reconstruction of the posterior mitral leaflet after adding a flexible annuloplasty ring. Cardiovasc Eng Tech. 2020;11(6):748–759.