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.