16
No unanticipated adverse device effects (UADEs) were reported throughout the trial. Three explants have
been reported to date; one explant occurred at autopsy, and two during surgical aortic valve replacement
due to severe aortic insufficiency on postoperative day 5 and day 18, respectively. No CEC adjudicated
endocarditis was reported.
The key safety outcomes adjudicated by the CEC for this study are presented in Table 18 through
Table 20.
Valve hemodynamics as assessed by echocardiography is summarized in Table 21 and Figure 18
through Figure 22. The mean DVI increased from 0.27 ± 0.10 at baseline to 0.37 ± 0.09 at 30 days and
0.39 ± 0.11 at 1 year. The mean gradient decreased from 36.1 ± 16.38 mmHg at baseline to
17.4 ± 7.37 mmHg at 30 days, which was maintained at 1 year. The mean peak gradient decreased from
65.0 ± 26.76 mmHg at baseline to 32.7 ± 12.90 mmHg at 30 days, which was maintained at 1 year.
Moderate/severe aortic regurgitation was present in 43.7% of subjects at baseline, which decreased to
2.5% at 30 days and 1.9% at 1 year. Moderate/severe paravalvular leak was present in 6.8% of subjects
at baseline, 2.5% at 30 days, and 1.9% at 1 year.
It is important to note that although mean and peak gradients were significantly reduced as compared to
baseline for the “TAV-in-SAV” procedure, the residual mean and peak gradients were numerically higher
than those observed for TAVR procedures performed for native valve stenosis.
The NYHA class by visit is shown in Figure 23. About 89% of subjects were in NYHA I/II at 30 days and
84% at 1 year as compared to 5% at baseline.
The mean improvement in 6MWD among the Attempted Implant population was 49.8 ± 169.9 meters from
baseline to 30 days and 86.1 ± 142.0 meters from baseline to 1 year.
The mean hospitalization stay among the Attempted Implant population was 7.9 ± 7.0 days, which
included 2.9 ± 5.0 days in the ICU.
The QoL at different time points as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
clinical summary score is shown in Figure 24. The mean KCCQ summary score among the Attempted
Implant population improved from 45.5 ± 21.8 at baseline to 68.0 ± 22.0 at 30 days and 70.4 at 1 year.
Device success was defined as successful vascular access, delivery and deployment and retrieval of
delivery system; correct positioning, intended performance (aortic valve area > 1.2 cm
2
and mean aortic
valve gradient < 20 mmHg or peak velocity < 3 m/s, without moderate or severe prosthetic valve aortic
regurgitation. It was achieved in 61.5 % of patients. In the vast majority of device failure subjects, the
failure was due to unintended performance of the valve; specifically, mean gradient ≥ 20 mmHg or peak
velocity ≥ 3 m/s was observed in 62 cases and moderate/severe aortic regurgitation in 5 cases.