Five-year results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement—the ARISE Study and ARISE Registry Data

Abstract

BACKGROUND Decellularized aortic homografts (DAH) were introduced as a new option for aortic valve replacement (AVR) for young patients. METHODS A prospective, EU-funded, single-arm, multicentre study in 8 centers evaluating non-cryopreserved DAH for AVR. RESULTS 144 patients (99 male) were prospectively enrolled in the ARISE Trial between 10/2015 and 10/2018 with a median age of 30.4 yrs, (IQR 15.9–55.1). 45% had undergone previous cardiac operations, with 19% having two or more previous procedures. The mean implanted DAH diameter was 22.6 mm (SD2.4). The median operation duration was 312 min (IQR 234–417), the median cardiopulmonary bypass time was 154 min (IQR 118–212), and the median cross-clamp time 121 min (IQR 93–150). No postoperative bypass grafting or renal replacement therapy were required. Two early deaths occurred, one due to a LCA thrombus on day 3 and one due ventricular arrhythmia 5 h postop. There were 3 late deaths, 1 death due to endocarditis 4 months postoperatively and 2 unrelated deaths after 5 and 7 years due to cancer and Morbus Wegener resulting in a total mortality of 3.47%. After a median follow-up of 5.9 years (IQR5.1–6.4, mean 5.5 yrs. (SD1.3) max. 7.6 yrs.), the primary efficacy end-points peak gradient with median 11.0 mmHg (IQR 7.8–17.6) and regurgitation of median 0.5 (IQR 0–0.5) of Grade 0–3 were excellent. At 5 years, freedom from death/reoperation/endocarditis/bleeding/thromboembolism were 97.9/93.5/96.4/99.2/99.3%, respectively. CONCLUSIONS The 5-year results of the prospective multicentre ARISE trial continue to show DAH to be safe for AVR with excellent haemodynamics.