Clinical Outcomes and Post-Operative Hemodynamics
The 30-day mortality rate was 2% (n = 2) for a EuroScore II predicted mortality of 2.95% (range 0.5 - 16.5%). Both of deaths were in Group No-SCAP (2.9% of 69 patients) but only one was directly related to the procedure; the other one was related to the discovery of a multimetastatic lung cancer leading to an irreversible respiratory insufficiency and multi-organ failure.
There was no significant difference between the two groups regarding the different secondary end-points (table 3). Only one patient (0.9% of overall) in Group SCAP (2.9% of 34 patients) experienced a stroke with a persistent neurological deficit (p = 0.40). Ten patients (10%) presented a new onset of AV-block that required permanent pacemaker implantation, seven (10%) and three (9%) in Goup No-SCAP and Group SCAP, respectively (p = 1.00). Only one (0.9%) paravalvular leak more than trivial was found at the discharge TTE, in the Group No-SCAP (1.4% of 69 patients) and it did not require reoperation.
Post-operative hemodynamics of the Perceval-S are shown in table 4 and in Figure 4. There was no significant difference between the two groups, but we noticed a trend towards lower peak and mean gradients in Group SCAP, which is consistent with a larger overall size of implanted valves. The rate of patient prosthesis mismatch was the same for the two groups.