Sutureless Valve Outcomes in Isolated Aortic Valve Replacement by Surgical Approach: Results from a Prospective International Real-World Registry

Abstract

Objective:

Perceval sutureless valve (Corcym, Saluggia, Italy) has been in clinical use for more than 15 years. The aim of this study is to report clinical and hemodynamic performance from a real-world registry in patients who underwent aortic valve replacement (AVR) with a Perceval, comparing outcomes of minimally invasive (MICS) versus full sternotomy (FS) settings.

Methods:

This prospective international registry enrolled 1,652 patients implanted with a sutureless aortic valve in 55 institutions from 2011 to 2021. Patients with isolated AVR were analyzed by MICS and FS approaches. Preoperative covariates were adjusted with propensity score matching 2:1, reaching a final cohort of 857 isolated AVR patients with 558 patients in MICS and 299 in FS groups.

Results:

Successful first implantation was 98.0% for both approaches (P > 0.999). As expected, surgical timings were significantly longer in MICS versus FS (P = 0.004 and P < 0.001), but intensive care unit and hospital lengths of stay were significantly lower in the MICS cohort, resulting in about 0.5 days and 1.5 days less spent in the intensive care unit and hospital, respectively. The surgical approach did not show any effect on early or late survival, disabling stroke, leaks greater than 2, pacemaker rate, or hemodynamics.

Conclusions:

Our propensity-matched analysis demonstrates the noninferiority of MICS with regard to hard endpoints and better outcomes for secondary endpoints such as reduced length of intensive care and in-hospital stay.

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Keywords

aortic stenosis aortic valve replacement sutureless valves minimally invasive procedures real-world evidence

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