ARISE closing meeting held on 1st of March 2019 in Hannover - Early results from the prospective European trial on cell-free allografts for aortic valve replacement

Aortic valve replacement (AVR) in children and young adult patients still constitutes a major problem as these young individuals face a difficult choice between a complex, multi-valve procedure such as the Ross-procedure and the life-long medication with blood thinners and their inherent risks once a mechanical prosthesis is chosen. Cell-free allografts may constitute an additional AVR option in such patients as they hold the potential to overcome the high early failure rate of allogenic and xenogenic aortic valve prostheses in children and young adults.

In a European Commission funded project, led by the Hannover Medical School, 9 hospitals, 6 tissue banks and an innovative bio-tech company providing the decellularisation service came together for the world-wide first prospective study on cell-free allografts for aortic valve replacement (Figure 1). 

Primary endpoints were peri-procedural complications (all-cause mortality, major stroke, life-threatening or disabling bleeding, acute kidney injury requiring renal replacement therapy, myocardial infarction, major vascular complications) and heart valve dysfunction (aortic valve area ≤1.2 cm² and mean aortic valve gradient ≥20 mm Hg or peak velocity ≥3 m/s, or moderate or severe prosthetic valve aortic regurgitation) and repeat procedure for valve-related dysfunction (surgical or interventional therapy). Within 3 years (10/2015 to 10/2018) the study consortium was able to include 144 patients, thereby surpassing the calculated sample size of 120 patients. A ten-year follow-up of the patients is planned.

The rate of adverse events was very low in view of the complex patients operated, more than 45 % underwent previous cardiac procedures, which is more than two times higher than in contemporary Ross-procedure registries. Figure 2 provides an overview of the early results.

Figure 1: The ARISE study consortium during the closing meeting on 1st of March 2019 in Hannover

Figure 2: The ARISE study consortium overview

Figure 3: Early results from the ARISE study, freedom from explantation, endocarditis, stenosis, and regurgitation