Introduction
Interest and use of rapid deployment, sutureless aortic valve prosthesis technology has grown quickly in recent years. The Perceval S is a self-anchoring bovine pericardial aortic prosthesis mounted on a nitinol stent. This valve has been approved for use in Europe since January 2011, and it received FDA approval in January 2016 for use in the United States. The valve can be used in aortic annular diameters from 19 mm to 27 mm and is available in sizes small (19-21 mm), medium (21-23 mm), large (23-25 mm) and extra-large (25-27 mm). Early European studies suggested use of the valve was safe, shortened times in the operating room and resulted in acceptable short term outcomes.1-3
In a study from Germany of 83 high risk patients (mean EuroSCORE 10±8%) showed 1.2% significant paravalvular leak rate, in-hospital mortality of 2.4%, 6% PPM rate, and 12 month survival of 98%.5 A more modern study from Spain in 2017 examined 448 patients undergoing Perceval implantation with EuroSCORE 11±8, and showed 0.9% paravalvular leak rate, 9% PPM rate, and 12 month survival 98%.6 The Perceval valve was offered as an option for higher risk patients who may benefit from a shortened cross-clamp time. Over time it was found to be valuable in other settings such as facilitating minimally invasive approaches7,8, small annulus9,10, active endocarditis11, re-operative operations12, as a platform for future valve in valve transcatheter valve implantations13,14, and use in calcified homografts and other hostile aortic root situations15,16.
There has been considerable international clinical data and some European cost data presented. However, there is little in the way of cost analysis from the United States where the financial impact of adopting new technology is becoming more important. In this study we sought to review our single center experience with three surgeons using the Perceval valve. We examined our clinical and cost data to better understand how this technology can fit into the toolbox of cardiac surgeons in the United States in an era of increasing TAVR volume.