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

Horke, A.; Tudorache, I.; Laufer, G.; Andreas, M.; Pomar, J.L.; Pereda, D.; ... ; Sarikouch, S. (2024)

Article / Letter to editor

OBJECTIVES: Decellularized aortic homografts (DAH) were introduced as a new option for aortic valve replacement for young patients.
METHODS: A prospective, EU-funded, single-arm, multicentre study in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement.
RESULTS: A total of 144 patients (99 male) were prospectively enrolled in the ARISE Trial between October 2015 and October 2018 with a median age of 30.4 years [interquartile range (IQR) 15.9–55.1]; 45% had undergone previous cardiac operations, with 19% having 2 or more previous procedures. The mean implanted DAH diameter was 22.6mm (standard deviation 2.4). The median operation duration was 312min (IQR 234–417), the median cardiopulmonary bypass time was 154min (IQR 118–212) and the median cross-clamp time 121min (IQR 93–150). No postoperative bypass grafting or renal replacement therapy were required. Two early deaths occurred, 1 due to a LCA thrombus on day 3 and 1 due ventricular arrhythmia 5h postoperation. There were 3 late deaths, 1 death due to endocarditis 4months postoperatively and 2 unrelated deaths after 5 and 7years due to cancer and Morbus Wegener resulting in a total mortality of 3.47%. After a median follow-up of 5.9years [IQR 5.1–6.4, mean 5.5 years. (standard deviation 1.3) max. 7.6 years], the primary efficacy end-points peak gradient with median 11.0mmHg (IQR 7.8–17.6) and regurgitation of median 0.5 (IQR 0–0.5) of grade 0–3 were excellent. At 5years, 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 aortic valve replacement with excellent haemodynamics.

• Aortic valve disease
• Tissue engineering
• Decellularization
• Allografts

• All authors: Horke, A.; Tudorache, I.; Laufer, G.; Andreas, M.; Pomar, J.L.; Pereda, D.; Quintana, E.; Sitges, M.; Meyns, B.; Rega, F.; Hazekamp, M.; Cesnjevar, R.; Schmiady, M.O.; Pepper, J.; Rosendahl, U.; Lichtenberg, A.; Stadnik, D.; Jashari, R.; Boethig, D.; Bobylev, D.; Avsar, M.; Ruhparwar, A.; Haverich, A.; Cebotari, S.; Sarikouch, S.
• Date: 2024-03-29
• Journal: European Journal of Cardio-Thoracic Surgery
• Volume: 65
• Issue: 4
• DOI: doi:10.1093/ejcts/ezae121