Surgical aortic valve replacement with the ATS Enable sutureless aortic valve for aortic stenosis /

"Implantation of an aortic valve that does not need to be sutured in place is reported to reduce the time and invasiveness associated with standard surgical aortic valve replacement, potentially decreasing surgical risk and morbidity in selected patients. The available evidence is limited. It suggests that the procedure is reasonably safe and produces good clinical outcomes up to the limit of follow-up (one year). Optimal patient selection, side effect profile (particularly relative to the more established alternatives), and long-term efficacy (beyond ~1 year) remain to be defined. ... Offset savings may result in some increased efficiency. It is concluded that there is insufficient evidence to support the general introduction of the sutureless aortic valve, but there is sufficient evidence of safety and short term efficacy to justify temporary, conditional approval with maintenance of a case registry"--page iv.