RESULTS
Baseline patient
characteristics
A total of 283 patients across 14 investigational sites consented to
participate. Of these, 258 patients met the eligibility criteria and
received the Magna Ease valve, the outcomes of whom are reported here.
Table 1 summarizes patient baseline characteristics. The average age was
68.5±8.8 years, and 167 (64.7%) were male. Aortic stenosis was the
commonest indication for AVR (70.9%). Procedural data are summarized in
Table 2. Most patients underwent isolated AVR (58.1%), while 41.9%
underwent concomitant procedure(s). Implanted valve sizes were: 19 mm
4.3%, 21 mm 15.9%, 23 mm 38.4%, 25 mm 28.3%, 27 mm 8.9%, and 29 mm
4.3%.
Patient follow-up
Overall, 258 patients underwent a total follow-up of
1,597.6 patient-years: median 7.0 years (5.5–8.0 years). At study
closure, 103 patients (39.9%) had completed the 8-year follow-up and a
further 67 patients (26.0%) were on-protocol with the study valve in
place.
Survival
One death (0.4%) occurred within the early postoperative period, and it
was not valve related. Thirty-seven deaths occurred late, eight of which
were adjudicated to be valve related: two endocarditis, one
thromboembolism/stroke, and five other unknown causes. Figure 2 and
Table 3 display the freedom from all-cause mortality.
Safety
Safety endpoint events were experienced by 109 (42.2%) patients and are
summarized in Table 3 as early event rates and actuarial freedom from
safety endpoints based upon Kaplan–Meier analyses.
Study valve reinterventions were carried out in 18 patients, including
11 explants, six valve‑in‑valve insertions, and one repair procedure
without explant. There were three early reinterventions, all explants
that occurred during the index procedure due to complications during
surgery not related to the study valve. The reasons for the 15 late
reinterventions were endocarditis (n=4), SVD (n=9), NSVD (n=1), and
major paravalvular leak (n=1). Freedom from study valve reintervention
was 89.8% (95% CI 85.1, 94.6) at 8 years. Freedom from explant was
94.8% (95% CI 91.7, 97.9) at 8 years.
In the early period, 13 major bleeding events were reported in 12
patients and three minor bleeding events were reported in three
patients. A further 19 major bleeding events and 14 minor bleeding
events were reported in the late period through to 8 years. No bleeding
events were adjudicated as study valve related. Six cases of prosthetic
valve endocarditis were reported in six patients. Four of these resulted
in study valve explant followed by one death, and one further case
resulted in death, all of which were adjudicated to be study valve
related. The remaining case had high grade lactobacillus bacteremia and
was categorized as valve related. This patient proceeded to develop SVD
and the study valve was explanted. Freedom from bleeding events was
78.0% (95% CI 72.2, 83.7) at 8 years; freedom from major bleeding
events was 85.1% (95% CI 80.0, 90.1) at 8 years.
Hemodynamics
Figure 3 and Table 4 show the hemodynamic performance for each study
valve size; the performance stayed within expected levels over the
observational period. Data on aortic regurgitation are shown in Table 5.
Structural valve
deterioration
Of the 14 patients with SVD, three underwent explant, seven had
valve-in-valve procedures, and four cases were being monitored at study
closure. Freedom from reintervention due to SVD was 93.6% (95% CI
89.3, 97.8) at 8 years.
Functional outcomes
Figure 4 shows the proportion of patients in each NYHA Functional Class
throughout follow-up. At baseline, 67.5% patients were in NYHA Class
I/II, and 32.5% patients were in NYHA Class III/IV. By the 1-year
follow-up, 98.3% were in Class I/II, with 74.8% patients reporting an
improvement in functional class. This improvement persisted up to 8
years for 61.9% patients, with 93.9% of patients in NYHA Class I/II
and 6.1% in NYHA Class III.