5-year results from a prospective, single-arm european trial on decellularized allografts for aortic valve replacement-the ARISE study and ARISE registry data.

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.