Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data

Abstract

OBJECTIVES Decellularized aortic homografts (DAH) may provide an additional aortic valve replacement option for young patients due to their potential to overcome the high early failure rate of conventional allogenic and xenogenic aortic valve prostheses. METHODS A prospective, European Union-funded, single-arm, multicentre, safety study was conducted in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement. RESULTS One hundred and forty-four patients (99 male) were prospectively enrolled between October 2015 and October 2018, mean age 33.6 ± 20.8 years; 45% had undergone previous cardiac operations. Mean implanted DAH diameter 22.6 ± 2.4 mm and mean durations for the operation, cardiopulmonary bypass and cross-clamp were 341 ± 140, 174 ± 80 and 126 ± 43 min, respectively. There were 2 early deaths (1 LCA thrombus on day 3 and 1 ventricular arrhythmia 5 h postop) and 1 late death due to endocarditis 4 months postoperatively, resulting in a total mortality of 2.08%. One pacemaker implantation was necessary and 1 DAH was successfully repaired after 6 weeks for early regurgitation following subcoronary implantation. All other DAH were implanted as a free-standing root. After a mean follow-up of 1.54 ± 0.81 years, the primary efficacy end points peak gradient (mean 11.8 ± 7.5 mmHg) and regurgitation (mean 0.42 ± 0.49, grade 0–3) were excellent. At 2.5 years, freedom from explantation/endocarditis/bleeding/stroke was 98.4 ± 1.1%/99.4 ± 0.6%/99.1 ± 0.9%/99.2 ± 0.8%, respectively, with results almost identical to those in an age-matched Ross operation cohort of 212 patients (mean age 34 years) despite DAH patients having undergone >2× more previous procedures. CONCLUSIONS The initial results of the prospective multicentre ARISE trial show DAH to be safe for aortic valve replacement with excellent haemodynamics in the short follow-up period.

Donor‐specific HLA antibodies after fresh decellularized vs cryopreserved native allograft implantation

“…Sarikouch et al 13 showed in a recent study important in vivo recellularization with noninflammatory cells in 11 of 364 patients implanted either with an aortic or pulmonary decellularized homograft between 2010 and 2017 in whom a reoperation with graft explanation was necessary for different reasons. The initial results of the multicentric European trial ARISE, analyzing this particular type of fresh decellularized homografts implanted in aortic position in 144 patients also demonstrated excellent early hemodynamic results 14 …”

“…The initial results of the multicentric European trial ARISE, analyzing this particular type of fresh decellularized homografts implanted in aortic position in 144 patients also demonstrated excellent early hemodynamic results. 14…”

Cardiac Surgery 2020 Reviewed

“…The group from Hannover published interesting and important results with decellularized aortic homografts together with a multicenter study assessing the impact of this valve type in young patients (average age 34 years) and in relation to bioprosthetic or mechanical valves and the Ross operation. 46 The authors found that the freedom from a combined endpoint of death, reoperation, structural degeneration, thrombosis or bleeding, and endocarditis was lowest with the decellularized homografts (►Fig. 4A).…”

“…61 Based on over Fig. 4 (A) Central image of a publication on the outcomes of decellularized homografts as possible alternative to biological or mechanical prostheses or the Ross procedure in patients requiring (redo) aortic valve replacement at young age (mean 34 years) 46 (reproduced with permission). (B) Comparison of the treatment effect of early surgical aortic valve replacement compared with conservative management in relation to the degree of chronic kidney disease 47 (reproduced with permission).…”

The reinforced full-root technique for the Ross operation: surgical considerations and operative insights

“…However, young and middle-aged patients requiring AV replacement are still confronted with a treatment dilemma: although mechanical valves bear the risk of thromboembolic and bleeding events, bioprosthetic substitutes have limited durability (2). Nevertheless, emerging technologies in alternative surgical treatment strategies in AV disease have not yet become an armamentarium with acceptable enduring long-term results (3)(4)(5)(6). This includes advancements such as new generations of bioprosthetic substitutes with anticipated improved long-term durability, innovative mechanical prosthesis design with reduced need for anti-coagulation, decellularized allografts with the theoretical potential to overcome the high early failure © Annals of Cardiothoracic Surgery.…”