In-vivo motion of mitral valve annuloplasty devices.

BACKGROUND AND AIM OF THE STUDY: The long-term outcomes of mitral valve repairs are enhanced with an annuloplasty device. Although, in general, semirigid and rigid annuloplasty devices remodel the shape of the mitral valve annulus, the effect of geometric alteration on annular motion has not been fully assessed. Hence, the study aim was to investigate the influence of semi-rigid annuloplasty devices on the motion of the mitral valve annulus in adult sheep. METHODS: Sonomicrometric crystals were attached to semi-rigid annuloplasty devices (CG Future Band and CG Future COMPOSITE Ring), as well as to intra- and epicardiac sites for motion assessment in 13 sheep. Following implantation, hemodynamic and sonomicrometric measurements were collected under normal sinus rhythm and during dobutamine challenge conditions. RESULTS: Sonomicrometric measurements showed variations in the degree of device motion and timing of motion changes, depending on device size and type. Measurement of transverse device width demonstrated a pre-systolic decrease in width. For devices with the largest annular motion, the transverse device width increased during ventricular systole, with an out-of-phase increase in mitral annular septal-lateral distance during diastole. However, the geometric device septal-lateral distance showed minimal change across all devices, indicating maintenance of posterior remodeling geometry. Three-dimensional analyses revealed vertical elevation of the anterior annulus above the posterior annular plane during ventricular systole, consistent with anterior annular folding. The maximum calculated annular area occurred during early to mid-ventricular diastole, providing for maximal valve orifice area during opening of the mitral valve. The minimum annular area occurred near end-diastole to early systole, consistent with valve closing. CONCLUSION: The study results suggest that semi-rigid posterior annuloplasty devices with absent or flexible anterior mitral valve annular segments allow for a dynamic anterior annulus while maintaining aggressive posterior annular remodeling. Future studies should be undertaken to investigate the interaction between the anterior mitral valve annulus and the aortic root following annuloplasty device implantation.

Chronic, preclinical assessment of the Medtronic Advantage aortic valve prosthesis.

BACKGROUND AND AIMS OF THE STUDY: Medtronic, Inc. has designed and developed a new bileaflet, aortic prosthesis (Advantage) and, following an in-vitro analysis, a chronic in-vivo 20-week evaluation was performed in sheep. METHODS: Fourteen adult male and female sheep underwent implantation of either a 19 mm Advantage or St. Jude Medical (SJM) aortic prosthetic valve for chronic in-vivo evaluation, using a previously reported aortic model technique. RESULTS: There were two operative deaths, and the remaining sheep (eight with Advantage, four with SJM prostheses) underwent chronic hemodynamic and pathologic evaluations at approximately 140 days. One sheep (SJM prosthesis) died unexpectedly at 122 days; postmortem evaluation revealed valvular thrombosis, though the valve was well seated with no excessive pannus formation or paravalvular leaks. Hemodynamic and hematologic data in the remaining sheep were comparable. Pathologic examination of the remaining implanted valves revealed well-seated prostheses, with no evidence of thrombosis, no excessive pannus formation, and no evidence of paravalvular leaks. CONCLUSION: This preclinical animal study showed that the Advantage prosthesis has acceptable features, including equivalent hemodynamic and hematologic data, and a lack of pathological abnormalities when compared with a commercially available prosthetic bileaflet mechanical valve.