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.